chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Invalid Dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Invalid Dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Invalid Dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Invalid Dose) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL  single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 24 hours with highest recorded temperature of 30.8 temperature of 30.8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reported received from the same source. Additional information has been requested.
All the side effects listed except for Anaphylaxis, swelling of the lymph nodes and vomiting; All the side effects listed except for Anaphylaxis, swelling of the lymph nodes and vomiting; All the side effects listed except for Anaphylaxis, swelling of the lymph nodes and vomiting; A spontaneous report (United States) was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events all the side effects listed except for anaphylaxis, swelling of the lymph nodes and vomiting.  The patient's medical history was not provided. Concomitant medications reported were Blood pressure medications, Antidepressant medications, Anxiety medications for drug use for unknown indication.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient experienced the event(s) all the side effects listed except for anaphylaxis, swelling of the lymph nodes and vomiting.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), all the side effects listed except for anaphylaxis, swelling of the lymph nodes and vomiting was unknown.
got a cold; runny nose; muscle pain at the injection site.; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in arm right on 26May2021 09:00 (at the age of 58 years old) as 1st dose, 0.3 ml single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other products. No patient history. No family medical history relevant to adverse events. No history of previous immunizations with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took vitamins including vitamins C. The patient reported that she received the first dose of the vaccine on 26May2021 and about 2 weeks after that dose got a cold and runny nose on an unspecified date. The reporter stated that still had a little cold. Cold started 5 days ago and was still getting over it and stated that she was not very strong. The reporter stated that after the first dose, had just a little muscle pain at the injection site that went away the following day on an unspecified date. She only had the cold around one week. It was almost the third week already after getting the first vaccination. The patient stated that she did not have any symptoms, just had a cold and just took NyQuil, DayQuil, and Tylenol as treatment for the cold and getting better, she was fine. She was healthy when she took the first vaccination. However, did not have an allergic reaction after the vaccine. The adverse event did not require a visit to emergency room/physician office. She was scheduled for the second dose tomorrow, 16Jun2021. She asked if can proceed with the second dose tomorrow. She also asked if she was going to postpone the dose for tomorrow, did she had to start from vaccine 1 again. She clarified that it was a matter of three weeks to have vaccine, there was grace period of 3 weeks before one can take Vaccine 2. If she postpones Vaccine 2 to a later date, would she had to start all over again from Vaccine 1. Investigation Assessment: No. Relevant Tests: None. The clinical outcome of the events got a cold, runny nose was recovering and muscle pain at the injection site was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021711273 same reporter/product/event, different patient.
Dizziness, offerrted bottled water and apple juice, patient felt better. BP 116/80, P64, RR20
I had bumps all over on my neck and next day it went to my face; 15 minutes after the vaccination my necks started itching, the right side of my neck; rash on the neck and her face; rash on the neck and her face; Heart palpitation; my heart just started pounding; Allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer reported for herself that. A 43-years-old female (Non-Pregnant) patient received first dose of bnt162b2 (Pfizer vaccine, COVID 19 Vaccine, mRNA, solution for injection, Batch/Lot number: EL3302, expiry date: unknown), dose 1 via an unspecified route of administration, administered in arm right on 13Jan2021 (Age at vaccination 43 year) as dose 1, single for covid-19 immunisation. Patient medical history included don't have ovaries, don't have gallbladder. Patient concomitant medication included golden pill, echinacea for unspecified indication start from unspecified date if ongoing unknown. Patient experienced her side effects back in Jan's patient had her 1st dose on 13Jan2021, she had rash on the neck and her face, heart palpitation; my heart just started pounding, allergic reaction in Jan2021 and 15 minutes after the vaccination my necks started itching, the right side of my neck on 13Jan2021. Patient had bumps all over on my neck and next day it went to my face on 14Jan2021. Patient taken treatment of Benadryl, 50 mg, two times a day. Patient underwent lab test which included SARS-CoV-2 test which result was unknown on unspecified date. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 03-APR-2018, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
reporting vaccine error.. pt received first dose of boostrix on 2/14/2019 and another dose 6/9/2022 not separated by recommended 10 year time frame no adverse reaction reported
last night around 10 my arm got heavy i started to get headache and chills. i started shacking so bad i couldn't brush my teeth. body aches. The headache that is severe. from my base of my head to my temple and i feel nauseas. I feel like i have the flu
Heart attack 18 days after vaccination. Not sure if this is directly related, but it was within 30 days, so I wanted to report it.
Patient received three Covid vaccine boosters  on 10/27/21, 4/13/22,  and on 5/4/22. Patient said she forgot she received the second booster on 4/13/22. Patient said she had no symptoms and was fine. Vaccine was administered by Hospital staff where she works.
A report has been received from a Pharmacist concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The pharmacist reported that they inadvertently ADMINISTERED AN EXPIRED FLUMIST which started on 06-Jan-2013. The outcome of the event of ADMINISTERED AN EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Vitritis, left eye; presented as floaters and flashes 1 day after vaccine.  No improvement with topical steroids.  Taken for diagnostic vitreous biopsy,  which was positive for VZV PCR.  Treated with oral valacyclovir (1gram TID) x 6 weeks with full recovery.
Patient with swollen and redness on (R) upper arm where pneumonia vaccine was administered. Pt also c/o headache, fever, body aches, nausea and congestion. Patient seen today by clinician and prescribed KEFLEX 500 mg 4 x/day x 7 days. Patient will f/u tomorrow.
c/o sz on 17FEB93 taken by ambulance to ER; blood tests done; no LP done; given med r/o sepsis; rash noted; 18FEB93  repeat sz, whole body unconscious lasting 1/2 min;
Extreme temp swings leading to chills, sleeplessness, sweating, fever of 102, pain in lower extremities, dizziness, extreme fatigue, nausea headache, pain in injection site persisting through 11/1/2021.
Bloody stools; Abnormal nose bleeds; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in right arm in a pharmacy or drug store facility on 04Aug2021 04:45 (Batch/Lot number was not reported) (at the age of 27-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, the patient has been tested for covid-19. The patient had no relevant medical history and there were no concomitant medications. The patient had no known allergies. On 05Aug2021, the patient experienced bloody stools and abnormal nose bleeds. The patient further stated that it's been consist and starting to worry her. No treatment received for the events. The patient underwent lab tests and procedures which included covid test (nasal swab) post vaccination which was negative on 17Sep2020 (pending clarification). The patient had not yet recovered from the events.  Information on the lot/batch number has been requested.
No adverse event; a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 27-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose).    No concomitant medication details was reported. No treatment medication details was reported.   Patient received first primary monovalent dose at a different facility on unknown date and Lot number, expiry date was unknown.
accidentally gave the vaccine that had an expiration date of 1/1/2023. called Glaxo smith kline and was informed that vaccine was still good for another 30 days past expiration date listed
LETHARGY; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced really bad side effects (Fever, Lethargy, Nausea). The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever, lethargy and nausea was not reported. On an unspecified date, the patient received additional Non-company suspect vaccine included mrna 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date, the patient experienced headache for 24 hours. The patient did not experienced fever after booster dose. The action taken with mrna 1273, was not applicable. The patient recovered from headache, on an unspecified date. This report was non-serious.
Dose administered after manufacturer date of expiry; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No relevant medical history or conditions, allergy, concomitant diseases and risk factor were reported. No other vaccines in the 4 weeks prior to COVID-19 vaccine were reported.  No concomitant medication was reported. No treatment information was reported.
This spontaneous report was received from a pharmacist refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX vial, (lot #, expiry dates, dose, frequency and route of administration not reported). On unspecified dates, after the vaccine was injected, some of the dose leaked out of the injection site. No adverse effect reported for these unspecified patients. The outcome of the events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
next day patient had sore R arm and large lump at site of vaccine.  Also had back pain, fatigue, headache, sore throat.
Horrible sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Horrible sinus headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS HEADACHE (Horrible sinus headache). At the time of the report, SINUS HEADACHE (Horrible sinus headache) outcome was unknown.            No treatment information was reported.  The patient experienced a horrible sinus headache after the second dose of vaccination.   This case was linked to MOD-2021-396066, MOD-2021-396164 (Patient Link).
Extreme fatigue; headache; heart was racing; nausea; diarrhea and body aches. These lasted until 06:00 AM the next day. A little headache and arm soreness still that next day - by noon that day I was feeling myself again.. I took ibuprofen for the headache and that helped.
Moderna COVID-19 Vaccine EUA Tenderness at injection site, sore shoulder and neck, throbbing pain at injection site while laying down for sleep, frequent urination,  loss of sleep
On 06/28/02, pt noticed a painful lump in right armpit (a little smaller then the size of a marble). On 06/29/02, pt noticed a swollen, blotchy spot on her right arm, in the triceps area (a little larger than a quarter). Referred to physician.
tingling @ site, flushed, vertigo, tenderness @ site, SOB, tickle in throat, h/a;
5 days after vaccine administered, I began having diarrhea.  My mother passed away on 3/12/21, so I did not seek treatment until April. I was scheduled for a repeat colonoscopy for May after polyp removal Nov 2020, so prior spoke to my primary care CRNP and then gastroenterologist.  Microscopic colitis was diagnosed through additional testing during colonoscopy.  Neither CRNP or Gastro doc felt it was related to vaccine  as they had seen no data on that kind of reaction and my brother had a history of ulcerative colitis, so I did not report until I had my booster today and nurse administering said I should report
swelling of hands, arms paresthesias of lt arm; grip strength diminished sujective;
Within 10 min - significant vasovagal rx - req. 2 hrs obs.
Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about 01-MAY-2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Began with itching arm then periodically other places. Then she stated she felt cold and began shivering. This began approximately 15 minutes post injection. Patient was given BENADRYL followed by 1 dose EPIPEN after a few minutes went with EMS.
Possibly had a temperature excursion, unknown whether or not there was patient involvement; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date unknown) and (batch number AMVA714A, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVENAR 13) (batch number DL2861, expiry date unknown), (batch number EK6267, expiry date unknown) and (batch number FF7357, expiry date unknown) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) (batch number FW2328, expiry date unknown) for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number EW6499, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received PREVENAR 13. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received PREVNAR 20 and TRUMENBA. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: The vaccine coordinator reported that they possibly had a temperature excursion with Menveo with batch number AMVA660A and AMVA714A for 6 minutes, temperature 2.0 Degree Celsius. The patient also received Prevenar 13 with batch number DL2861, EK6267 and FF7357 Prevenar 20 and Trumenba. The reporter stated it was unknown whether or not there was patient involvement. The reporter reported that she was looking for the stability information. Additional Supportive Information: The patient received a dose of Menveo involved in a temperature excursion, which led to incorrect storage of drug.
pt recvd 1st dose of Engerix-B & has been very ill w/nausea & vomiting for the past 24 hrs; also lethargic;
Swollen, red, warm, tender (L) upper arm - cellulitis. Keflex 250 BID x 1 wk.