chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive COVID19 test by PCR; Positive COVID19 test by PCR; This is a spontaneous report from a contactable other hcp  (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single, dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:00 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) (at the age of 61-year-old) as dose 1, single for covid-19 immunisation. Medical history included HBP. There were no concomitant medications. On 01Aug2021 12:00, the patient experienced positive covid19 test by pcr. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. Upon follow-up on 04Aug2021, the product Quality Complaint group provided additional investigational results which indicated the following: Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. and product type. The final scope included the reported finished goods lot EN6203, fill lot EN5336, and the formulated drug product lot EN5324. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events were reported as recovering.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The case will be reassessed if additional information becomes available on the vaccination dates of the second dose.
Vasovagal syncope within 5 minutes of dose. Rapid recovery and discharged home after 20 minutes
HOSPITAL COURSE:   Patient is a 84 y.o. female with a PMH of RA, T2DM, chronic back pain, peripheral neuropathy who presented to the ED for a fever of 102.4. She was admitted for sepsis likely due to acute cystitis. Found to be COVID positive, initially diagnosed 1/4 per daughter.   Sepsis Acute cystitis E. Coli ESBL bacteremia UA consistent with UTI. BCx 2/13 with growth of E. Coli ESBL. - s/p ceftriaxone (2/13-2/15) - ID consult:             - midline placed for IV ertapenem x 10 days (end 2/24)             - routine labs on 2/21, RN to remove PICC after last dose on 2/24, no ID follow-up needed   COVID-19 Acute hypoxic respiratory failure Diagnosed positive 1/4 per daughter. Negative LLE US for DVT, negative CTPA for PE. - per Infection Control, positive test on admission likely prolonged shedding and not active infection.   RA Followed by Rheumatology. - PTA methotrexate, sulfasalazine, folic acid
Pt was given vax transplacentary. No problems during pregnancy. No further information was given.
Vaccine administered to a 17 years old male patient by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 17 years old male patient by mistake) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 17 years old male patient by mistake). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 17 years old male patient by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant and treatment drugs were not provided
Pt. fainted roughly 30 seconds after vaccine administration - had some jerky motions in chair, but did not fall.  Pt. loss of consciousness less 2 minutes.
the patient was previously infected with HPV; This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age and ethnicity. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On an unknown date, the patient was probably vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route and site of administration, lot # and expiration date were not reported) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) intramuscular injection (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced human papilloma virus (HPV) infection. She sought medical attention by contacting unspecified Healthcare Provider and the treatment (unspecified) was given for the event. On an unknown date, she had a colposcopy done at unspecified location and at the time of the report (reported as "now"), she was HPV negative. The outcome of the event was reported as recovered on unspecified date. No causality assessment was provided by the reporter.
patient received flu vaccine IM/LD and pneumonia vaccine IM/LD on 10-14-08 per LPN. patient returned to clinic on 10-16-08 with swelling, redness and tenderness in Lt arm from shoulder to elbow on front side only. Patient then tells nurse she had a reaction 6 yrs ago and had forgotten it was from a pneumonia shot. Instructed patient to put warm moist compresses, TYLENOL for pain and BENADRYL for allergic reaction. Will call clinic in am and relate progress, have been unable to reach patient for last 2 weeks.
rash on face,neck,back,arms,shoulders; chills; Itchy and hot; Itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 18Feb2021 [Thursday] at 16:45 (at the age of 68-year-old) as single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history of the patient included none. Patient has allergy to eggs, garlic. Concomitant/other medications in two weeks included levothyroxine sodium [SYNTHROID], venlafaxine hydrochloride [EFFEXOR], cetirizine hydrochloride [ZYRTEC], hydrochlorothiazide taken for unspecified indications. Patient previously received Penicillin, statins on an unspecified date and experienced allergy. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient did not have COVID prior vaccination and was not tested post vaccination. On 23Feb2021 [Tuesday] at 16:45, 5 days later, patient woke up from very restless night with rash on face, neck, back, arms, shoulder. Itchy and hot, had chills but no fever. Patient was taking Benadryl. It has taken all day to. Outcome of the events were resolving.  Follow-up attempts completed. No further information expected.
patient came in for meningitis vaccines and assumed it was for Menactra; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].instead of MENINGOCOCCAL VACCINE and   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA.  It was of actual medication error due to  wrong vaccine administered  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Flu symptoms; Suddenly started cold; Weakness in body; Sore throat; I take flu shot and that make me sick; Fever (on and off); This is a spontaneous case from initially received from other non-health professional(consumer) via agency (reference number: SEQ19-07489) on 16-Dec-2019, concerning a patient of unspecified age and gender.   The patient's medical history and concomitant medications were not reported.   On 13-Dec-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.    On 14-Dec-2019, one day after vaccination, the patient experienced flu symptoms, suddenly started cold, fever (on and off), weakness in body and sore throat.   The patient stated that after taking a flu shot, that made her/him sick.   The event of flu symptoms' was assessed as serious due to the criterion of medical significance, per company.   The reporter considered the events as related to Flucelvax Quadrivalent.  Company comment: The patient developed influenza, feeling cold, asthenia, oropharyngeal pain, malaise and pyrexia one day after Flucelvax Quadrivalent was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient developed influenza, feeling cold, asthenia, oropharyngeal pain, malaise and pyrexia one day after Flucelvax Quadrivalent was administered. Chronology is plausible. More information regarding medical history and concomitant medications is needed. Based on provided information, causal role of the suspect product is assessed as related.
The injection site of varicella @ left upper arm has redness, swollen, skin is rough , it is warm to touch, size 4.5cm x 5.0 cm, but no fever.
Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 24-Apr-2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On 26-Apr-2022, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information provided.  The dose number of suspect Moderna vaccine was reported as COVID Booster (1 in 1 Once).  It was unknown if patient was enrolled in a COVID-19  clinical trial.  For the co-suspect Humira, action taken was reported as unknown, de-challenge reported as not applicable and reporter causality was reported as no reasonable possibility/ not related.  Company comment: This spontaneous case was received via another Manufacturer and concerns a 26-year-old female patient, with medical history of Rheumatoid arthritis in treatment with ADALIMUMAB, who experienced the unexpected serious (medically significant) AESI of RHEUMATOID ARTHRITIS, in the context of the administration of mRNA-1273 vaccine as booster dose for COVID 19 vaccination (unknown schedule). Latency cannot be assessed, as vaccination date was not reported. Rheumatoid arthritis flare up lasted for two days. The mentioned medical history remains as a confounder, and Adalimumab was reported as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case was received via another Manufacturer and concerns a 26-year-old female patient, with medical history of Rheumatoid arthritis in treatment with ADALIMUMAB, who experienced the unexpected serious (medically significant) AESI of RHEUMATOID ARTHRITIS, in the context of the administration of mRNA-1273 vaccine as booster dose for COVID 19 vaccination (unknown schedule). Latency cannot be assessed, as vaccination date was not reported. Rheumatoid arthritis flare up lasted for two days. The mentioned medical history remains as a confounder, and Adalimumab was reported as a co-suspect drug. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A non-serious spontaneous report of pregnancy was received from a consumer concerning herself, a 25-year-old female. Neither patient's past medical history, concomitant medications nor obstetrical history was reported for this patient. On 12-Aug-2011, the patient received FLUMIST and then two weeks later she got pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The event was considered to be recovered. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
(R) thigh has some induration no redness. Hx of benign red swollen, swelling subsided.
3 hours post vaccine pt noted right hand felt warm, no other signs, symptoms. Normal exam.
12 hours post Moderna booster, chills along with a fever lasting 24 hours. 48 hours later extreme energy (fatigue is normally an everyday MS symptom) accompanied by inability to fall asleep, which is never an issue for me. I've now been up 20 hours straight with no feeling of being tired. I also have not felt hunger since the booster shot. All the above follows exactly what I experienced after my 2nd dose of the COVID-19 vaccine.
Hospitalized 02-14-16. Confusion, ataxia, loss of appetite - wt loss, personality changes, motor and cognitive impairment, impaired executive function. She was admitted to hospital on 2-14-16 (x20 days). This illness attacked with a vengeance, "like a runaway train". Within a few days, mother could not move or make a sound. PML is an unrelenting, devastating disease.
I had a small fever and light cough, accompanied by muscle aches and fatigue for a few days. After the these side effects subsided, I cannot smell anything unless it?s a VERY strong odor and I can only taste strong flavors like licorice. I can also only detect if things are bitter, salty, sweet or citrusy.
10/28/99:Pt. rcvd Hep A vaccine.11/24/99:Pt. complained of joint pain,rash on thighs,wrist achy,less active,foot pain,sore throat(which was positive for Strep),fevers up to 102.Joint pain became migratory,& rash spread all over body.
Usual, but seemed a bit more than heard. I did not know that dizziness was a side effect until after this happened.  As we were walking home form the vaccination I felt a little dizzy.  The dizziness increased and lasted until this morning, the 2 morning after the vaccine.  The dizziness impacted my balance, especially as I changed positions.  I had to grab onto a wall or a person to steady myself each time I stood up.  Not looking forward to #2!
Within 24 hours, headache, chills, fatigue, achy. Seems to be subsiding by day 3.
Aching arm; Low grade fever; Headache; Nausea; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 16Aug2021 at 15:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified multivitamin for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Jul2021 at 12:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. On 17Aug2021 at 12:00, the patient experienced aching arm, low grade fever, headache, nausea and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aching arm, low grade fever, headache, nausea and body aches was resolved on an unknown date in Aug2021.   No follow-up attempts are possible. No further information is expected.
Very sore Left deltoid muscle and is unable to lift arm without assistance of other (right) arm.
Narrative: Patient reported the day after receiving the influenza (Fluad) vaccine he experienced body aches, headache, nausea and fever. Symptoms went away within 48 hours, no treatment necessary.
Information has been received from a physician concerning his 4 year old son who "at age of 1", in 2005 was vaccinated with a dose of VARIVAX (Oka/Merck). "Within the past week", in July 2008 the patient experienced shingles. Unspecified medical attention was sought. At the time of the report, the patient was recovering. Additional information has been requested.
The patient reported that she had a red, itchy, and hard left arm that extended to her elbow after receiving her first moderna vaccine .  The reaction appeared 3-4 days after her shot.  It resolved after 2 weeks and she did not seek any medical treatment during that time.
Body aches; soreness at injection site; lumps in left armpit; slight fever; This is a spontaneous report from a contactable consumer. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:15 (27-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation at workplace clinic. Patient is not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included norethisterone acetate taken for contraception, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:00 AM for covid-19 immunisation. On 19Feb2021 09:00 the patient experienced body aches, soreness at injection site, lumps in left armpit, slight fever. Patient did not receive any treatment for adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient developed chest pain and shortness of breath starting 36-48 hours after receiving booster shot. Patient had diffuse ST changes on EKG and elevated troponins suggestive of peri/myocarditis.
Sore and redness and itching at injection site of left deltoid, size about 3 x 5 inches.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-DEC-2016 (reported as today at the time of the report), the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot #K018960, expiration date: 15-OCT-2016, dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Rash appeared on the trunk, small red maculopapular spots, bright red in color, slightly itchy,  with clusters of a few at each spot. Majority of the spots appears within the bra line of the patient, started about a week and a half after the first done (1/22/21) but became increasingly worse two days after the second dose (was received on 2/12/21).  First there were many more on the trunk with some patches increasing in size and rash starting to appear on arms and legs as well. Tried benadryl, fexofenadine, and hydrocortisone which helped minorly. Sought medical advice in the clinic (5 days post second dose) and couldn't identify other source of rash (no new product, no bugs bites, etc). Was prescribed triamcinilone acetate cream to help relive itching and redness, which as of 2/24/2021 is improving slowly.
Patient arrived for second dose of COVID vaccine and told me he had a "frozen shoulder" off and on starting 3 days post vaccine. He had reached out to doctor and had a video visit where they believed he may have (SIRVA) and will make a follow up live visit shortly.