chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; She got the booster dose and her hair started falling out again; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program via Regulatory Authority.. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 06Nov2021 (Lot number: 32030BD) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "A little anemic" (unspecified if ongoing); "Borderline diabetic" (unspecified if ongoing). There were no concomitant medications. No prior Vaccinations (within 4 weeks). Vaccination history included: bnt162b2 (Dose: 1, Lot number: EN6203), administration date: 26Feb2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "Hair failing about within a month of first dose"; bnt162b2 (Dose: 2, Lot number: EP6955), administration date: 19Mar2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "After her second dose, her hair started to fall out even more". The following information was reported: ALOPECIA (medically significant) with onset Nov2021, outcome "unknown", described as "She got the booster dose and her hair started falling out again". The event did not require emergency room visit or physician office visit.; Sender's Comments: Based on temporal relationship the causal association between the reported events and the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Pain at injection site since immunization, topical ice used first few days, Ibuprofen 2 tabs taken before bed each NOC. Sleep interrupted first few nights.
Both his feet and ankles are swollen as if it is water retention; Both his feet and ankles are swollen as if it is water retention; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both his feet and ankles are swollen as if it is water retention) and JOINT SWELLING (Both his feet and ankles are swollen as if it is water retention) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Peripheral neuropathy (Legs and feet).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (Both his feet and ankles are swollen as if it is water retention) and JOINT SWELLING (Both his feet and ankles are swollen as if it is water retention). At the time of the report, PERIPHERAL SWELLING (Both his feet and ankles are swollen as if it is water retention) and JOINT SWELLING (Both his feet and ankles are swollen as if it is water retention) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Seen in office 9:00 AM 04/01/2005 for well child visit. Temperature 100.0 degrees Fahrenheit, and cold symptoms. Physician Assistant encouraged vaccination- Gave PREVNAR  only. Pt to get MMR and HIB at Health Dept due to insurance. Developed fever to 104, febrile seizure lasting 5 minutes at 7:30 PM. Evaluated at ER, went home after recovering.
Patient and patient mother request booster dose of Pfizer. Dose given one moth early on 11/10/21 , due on 12/8/21. Mother is aware and ok with the dose being early as the family is going on vacation and patient will have additional protection against Covid.
The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered; The patient administered dose that was more than 30 days after it was in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered dose that was more than 30 days after it was in the fridge) and PRODUCT STORAGE ERROR (The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered dose that was more than 30 days after it was in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered dose that was more than 30 days after it was in the fridge) and PRODUCT STORAGE ERROR (The vaccine was expired (more than 30 days it was in the fridge) and then stored in the fridge before administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was stated that the reporter had identified an issue that staff were not dating the boxes of vaccine when placed them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which meant that all doses were administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA (Emergency Use Authorization). This includes 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge). The reporter was further informed that the reporter team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 09-May-2022 and 9 patients on 11-May-2022 (vaccine expired 05-May-2022). These patients were included in the spreadsheet. The vaccine in question had not experienced any temperature excursions. No reported adverse reaction of patient to the HCP (health care professional) knowledge. No treatment medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not received other medication in 2 weeks. The patient received Paxlovid for Treatment of COVID-19 on 10Sep2022 and stopped on 11Sep2022, and had adverse event: Metallic taste in mouth, major headache, stiff neck on 10Sep2022 at 11:30 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
40 year old female with history of anxiety.  Seated in vehicle with good skin color, lung sounds clear, no respiratory distress.  EMS summoned, patient refused transport and advised of risks.  Patient understood risks and was advised to call for rescue if symptoms developed.
LITTLE SORENESS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced little soreness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little soreness and fever was not reported. This report was non-serious.
Severe rash and itching from neck down to thighs, swollen lip. The first trash occurred after my second injection at the injection site which was a rash where the band aid was placed. One week after on June 4th, I woke up with a fever and vomiting diarrhea. Weekly after that, swollen lips, to the severe rash outbreaks weekly. My doctor prescribed 10mg of cetrizine two times per day for one month... that did not help. The dosage was increased to 20mg twice per day, for one month, did not help. Then added additional allergy medication Cingular once per day with cetrizine 20mg twice per day. Still not helping.
Patient developed right calf pain on 10/30/21, diagnosed with right gastronemius vein DVT and posterior calf vein DVT on 11/2/21 in ER
Received Varivax vaccine right upper arm on 10/22/02. On Sunday 11/3/02, injection site became red, sore, itchy, hot. Developed low-grade fever and subsequent sites of macular papular itchy  lesions scattered on torso, extremities, one on face. Excluded from work until lesions dried.
This spontaneous report was received from an office manager regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On an unknown date, the office manager reported that there was possibly a fourth patient who had a reaction after receiving a dose of PNEUMOVAX 23 from the lot # H013847. It was unspecified if the patient had sought medical attention. No treatment was reported. The outcome of the adverse event was unknown. This is one of several reports received from the same reporter regarding patient #4. Additional information has been requested.
No adverse event; First dose on 25-Feb-2021 and second dose on 01-Jul-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-Feb-2021 and second dose on 01-Jul-2021) and NO ADVERSE EVENT (No adverse event) in a 77-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) solution for injection for an unknown indication.    No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On 01-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-Feb-2021 and second dose on 01-Jul-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at a dose of Unknown and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) at a dose of Unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 25-Feb-2021 and second dose on 01-Jul-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient had no known allergy.  No concomitant drugs were taken by patient.  Primary reporter contact for lot number information was not available.  Causality for Humira (solution for injection in pre-filled syringe): the reporter's causality for the event(s) of diabetic, asthma was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.   This case was linked to MOD-2022-620189 (Patient Link).
Joint pain on her shoulder  it was painful to raise the arm  different side from the injection site.; Burning unbearably on hand; her hand was dry; Little redness on thumb, redness from wrist to knuckles; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Little redness on thumb, redness from wrist to knuckles), BURNING SENSATION (Burning unbearably on hand), DRY SKIN (her hand was dry) and ARTHRALGIA (Joint pain on her shoulder  it was painful to raise the arm  different side from the injection site.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder, Interstitial pneumonitis, Paroxysmal atrial fibrillation, Alopecia, Rosacea and GERD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), PREDNISONE, MYCOPHENOLIC ACID, METOPROLOL, SPIRONOLACTONE, SILDENAFIL, EZETIMIBE, SULFAMETHOXAZOLE, CYANOCOBALAMIN (VIT B12), MONASCUS PURPUREUS (RED YEAST RICE), UBIDECARENONE (CO Q10) and IRON for an unknown indication, ALPRAZOLAM, RITUXIMAB and VITAMIN D NOS.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Little redness on thumb, redness from wrist to knuckles). On 30-Jan-2021, the patient experienced DRY SKIN (her hand was dry). On 31-Jan-2021, the patient experienced BURNING SENSATION (Burning unbearably on hand). On 01-Feb-2021, the patient experienced ARTHRALGIA (Joint pain on her shoulder  it was painful to raise the arm  different side from the injection site.). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Little redness on thumb, redness from wrist to knuckles) and BURNING SENSATION (Burning unbearably on hand) was resolving, DRY SKIN (her hand was dry) had not resolved and ARTHRALGIA (Joint pain on her shoulder  it was painful to raise the arm  different side from the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       30Jan2021 her hand was dry, and she put a little cream on it.
Chicken pox-like blisters over most of body. Itchy puss filled blisters are itchy and seem to be spreading. Hundreds of blisters covering legs and lower torso, fewer on upper torso.  No fever or other symptoms.
Felt like 'jolt of caffeine' starting at site of injection then to full body sensation. Narrative:  Immediately after injection felt like 'jolt of caffeine' starting at L deltoid injection site, then to full body sensation 7/10 lasting 3min. Denies palpitation, dizziness or sob. VS: 132/81, hr 83-86, 02sat 98% which he states is his baseline. 5min later down to 3/10 which he says is his normal. After 10min stand/walk without return of abnormal stimulant sensation. Observed additional 15 minutes w/o incident.
Non - IC patient received Moderna full dose 0.5mL as B1 in error as indicated in this report - Incident happened 11/08/21, discovered 04/28/22
FEELS BAD FOR COUPLE OF DAYS; HE WAS COLD; COUGH; THROAT IS VERY UNCOMFORTABLE WHEN HE TALKS; BLOOD FROM HIS NOSE; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089076), for bnt162b2. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose number unknown, single for COVID-19 immunization. Medical history included type 2 diabetes with diabetic nephropathy, diabetic nephropathy, hyperglycaemia and Unspecified cirrhosis of the liver. Concomitant medications included lenvatinib mesilate (LENVIMA) taken for Liver cell Carcinoma; Ibuprofen (IBUPROFEN) taken for an unspecified indication and canagliflozin (INVOKANA [CANAGLIFLOZIN]), sitagliptin (JANUVIA [SITAGLIPTIN]), tenofovir alafenamide fumarate (VEMLIDY), carvedilol (CARVEDILOL), glipizide (GLIPIZIDE), simethicone (SIMETHICONE) and pravastatin sodium (PRAVASTATIN SODIUM), all were taken for an unspecified indication from an unknown start and stop date. Patient wife reported that, patient received covid vaccine last Friday on 09Apr2021 and on an unspecified date in Apr2021 feels bad for couple of days. He was cold but getting better, sometimes he coughs and his Throat was very uncomfortable when he talks and also he talks he has blood from his nose. She stated blood pressure little higher since starting on Lenvima. Physician was aware. The patient underwent lab tests and procedures which included blood pressure measurement results with little higher. Outcome of he was cold was recovering and outcome of other events was unknown.  No follow-up attempts needed. No further follow-up information expected.
This case was reported by a other health professional via call center representative and described the occurrence of erythema in a male patient who received FLULAVAL QUADRIVALENT 2017-2018 season) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced erythema, feeling hot, swelling, local reaction and allergy to vaccine. On an unknown date, the outcome of the erythema, feeling hot, swelling and local reaction were recovered/resolved and the outcome of the allergy to vaccine was unknown. It was unknown if the reporter considered the erythema, feeling hot, swelling, local reaction and allergy to vaccine to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were provided as follows: This case was reported by an allergist. The age at vaccination was not reported. The patient does not have an egg allergy. After receiving FLULAVAL vaccine, the patient experienced large local reaction which was just hot, red swelling. The reporter was concerned that the patient may be reacting to a component of the vaccine (glycerin, gelatin, etc). The reporter does not know what components were in the vaccine. For tolerance to the further dose of FLULAVAL refer case US2018GSK210320, reported by same reporter for the same patient.
"A single dose of an mRNA COVID-19 is incorrectly administered either before or after administration of Janssen COVID-19 vaccine." (Pfizer Lot No. EWO173 administered IM LD on 9/5/21 - post vaccine patient reported prior J&J received on 3/20/21) Signs and symptoms: None Diagnosis and treatment: No adverse reaction observed or reported. Patient observed for 15 minutes per CDC protocol. Patient released from mobile vaccination clinic in unremarkable, stable condition.  Diagnosis: Vaccine error related to administration of mRNA COVID-19 after previous administration of Janssen COVID-19 vaccine. Supervisor reported event to site manager  for VAERS reporting.
First dose back in possibly11/2020 / Potential first/second dose / (7/29/2021); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   On 29th July 2021, the patient received the 2nd dose of Shingrix. On 29th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacist had enquired to proceed with Shingrix series. Pharmacist would like information if potentially a third dose was required with series. Pharmacist stated that additional dose had not been administered. The reporter did not consent to follow up.
Onset of shingles 16 days after 1st covid vaccine over L1 dermatone, mild discomfort with only a few vesicles. No prior shingles outbreaks or known triggering factors. Treated with a course of Valtrex
Approximately 17 hours after receiving the booster shot (7:50AM), my wife collapsed unexpectedly onto the floor.  There was no loss of consciousness.  Throughout the day she exhibited trouble breathing, extreme confusion and disorientation, inability to wake or stay awake, had pale skin, would not/could not speak, and was at times combatant.  An ambulance was called at approximately 5:20PM and the initial assessment was that she was having a stroke in progress.  She was airlifted to a Level 1 trauma hospital and treated.
Fatigue started 6 hours and intensified by 19 hours to the point I could not work.   I had difficulty staying awake. Symptoms gradually lessened but continue today 6 months later.  and I have worked with difficulty. There was no treatment.