Covid Vaccine Harms - Alarming Headlines

Medically significant adverse vaccine reactions, 1 person for every 9 vaccinated according to MHRA staff.

mRNA Vaccine Harms - Alarming Headlines

N = 36,604, Active surveillance

15,764 (52.1%) had an adverse reaction

9,670 (61.3%) had a level of seriousness)

4,134 considered medically serious

36,604

4,134 = 8.85

So about 1 in 9 had a serious vaccine reaction.

Batch-Dependent Safety Signal: Nationwide Analysis of Suspected Adverse Events Following COVID-19 Vaccination in Germany

190,034 submissions from 36,604 registered individuals

Enhanced monitoring used for;

Two cases of Guillain-Barre syndrome (GBS), (both after a first dose of the AstraZeneca)

Two cases of transverse myelitis, (again, after a first AZ)

Two cases of Bell’s palsy reported.

ADRs belonging to the ‘Pregnancy, Puerperium and Peri-natal Conditions’ and ‘Reproductive System and Breast

Disorders’

26 females who reported an ADR from the ‘Pregnancy, Puerperium and Perinatal Conditions’,

with a total of 28 ADRs reported.

2,416 vaccinated pregnant women

There were 19 reports of spontaneous abortion

11 reported after a first dose of COVID-19 vaccination,

seven with the Pfizer BioNTech vaccine,

three with AstraZeneca,

one with Moderna.

In eight (72.7%) of the reports occurring after a first dose vaccination, given in the first trimester.

Median time from the last reported vaccination to the reported date of spontaneous abortions

After receiving a first-dose vaccination (n = 11) was 27 days (IQR: 18–47 days)

After a second dose of vaccine, (n = 8) was 33.5 days (IQR: 24–53).

Tinnitus, (mostly after AZ)

1.9% (n = 73) reported tinnitus or related reactions.

54 reactions reported after first dose

16 with the second dose

6 after the third dose.

Approximately two-thirds of the reported tinnitus related reactions were ongoing at the most recent submission (n = 51),

whilst less than a third were reported as resolved (n = 25).

Full text link for paper

Yellow Card Vaccine Monitor (YCVM)

Established by the UK Medicines and Healthcare products Regulatory Agency (MHRA),

to facilitate active monitoring of adverse reactions following COVID-19 vaccination,

and further characterise safety in populations under-represented in clinical trials.

Methods

Randomly selection, invited to register and actively contacted to seek further information on the vaccines received and adverse events they experienced.

E.g.

Sub-cohort of pregnant and breast-feeding women

Assessment of two safety signals, menstrual disorders, and tinnitus.

36,604 individuals registered, with 30,281 reporting vaccination.

Median follow-up was 184 days.

Demographics of the recruited cohort reflected the vaccinated population and timing of invitations.

15,764 (52.1%) of those reporting vaccination, reported experiencing at least one adverse reaction. However, nearly all were expected acute reactions.

And only 4,134 (13.7%) reported an event considered medically serious.

The data raised no safety concerns in pregnant and breast-feeding patients.

Data on the incidence of tinnitus were used to support regulatory action on this signal.

Discussion Active surveillance provided a complimentary data source for monitoring the safety of COVID- 19 vaccines.

Publishing delay

Data collected until December 2022

Peer reviewed publication in Drug Safety, Sept 2025

Preprint published, November 2024

BUT

The seriousness of an ADR could be reported by selecting from the optional seriousness categories.

ADR occurred in temporal association

Over 1.4 million random invitations were sent out during the study period.

A total of 36,604 individuals (2.5%) registered with the Yellow Card Vaccine Monitor (YCVM)

YCVM,

Numerous (self) selection biases

A totally non-randomised sample

Arthralgia and myalgia were considered medically serious events according to the MedDRA medical terminology system.

adverse drug reactions were “self-reported” and “suspected”.

Little attempt to confirm that these were genuine ADRs.

No baselines, no comparison with the unvaccinated

Most ADRs were acute, mostly transitory, e.g. pain at site, pain in extremities, fatigue, headache, pyrexia, achy muscles and joints, nausea, rash.

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