chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. This 50-year-old female consumer reported. A 50-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 25Feb2021 at 11:45 (at the age of 50-year-old) as 1st dose, single for covid-19 immunisation at clinic. Medical history included asthma from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing. Patient had no known allergies. The concomitant medications were not reported. patient received other medication prior two weeks of vaccination. Patient was not received any other vaccine prior four weeks of vaccination. On 25Feb2021 at 12:15 AM, 30 minutes after vaccination, the patient experienced trouble breathing and felt dizzy. Patient visited to Emergency room/department or urgent care for the events. Since vaccination patient not tested for covid-19. Therapeutic measures were taken as a result of the events with Albuterol, Epi pen, Benadryl, Pepcid and Prednisone. The outcome of the events were resolving. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician reported 3 kids (including the patient) last 2 years; patient reported flu-like symptoms with high fevers after the use of meningococcal group b rlp2086. No other vaccine given at the time. Some went to the ER and were diagnosed with having vaccine reaction. The outcome of the events, flu-like symptoms and high fevers, was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018325373 Same reporter and suspect drug, similar events in different patients; US-PFIZER INC-2018325368 Same reporter and suspect drug, similar events in different patients.
expired vaccine was administered to seven patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered to seven patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered to seven patients). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered to seven patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The pharmacist reported that the expired vaccine was administered to seven patients. One vial was moved from the freezer to the refrigerator on 01-SEP-2021,   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received on 16 SEP 2021 contains NNI.
9/23/2021 2:30pm- Resident noted having agitation this shift taking his right arm and banging on the wall with his right arm noted 3 new discolorations to his right forearm and hand. Resident continued to bang on wall hospice notified visited resident to assess status change. Resident noted having agitation this shift taking his right arm and banging on the wall with his right arm noted 3 new discolorations to his right forearm and hand. Resident continued to bang on wall hospice notified visited resident to assess status change. New order for Seroquel 25mg in the am and 2 25mg tabs at bedtime with prn dose 25mg as needed for agitation q6h will evaluate need for prn medication on 10-7-21. Resident is resting comfortably in his bed at this time.  9/23/2021 9:30pm- Resident noted to be non responsive with no audible or visible signs of life. Unable to obtain BP. Unable to auscultate apical pulse or palpate any peripheral pulses. Respirations are nonexistent. Pupils non reactive to light, fixed and dilated. Hospice notified of findings. Family notified, son stated he did not set up funeral home arrangements and will be calling right away and would contact facility. Pronouncement of death made by Dr.
Hives all over body and in mouth-contacted M.D./mother. Unable to reach by phone-mutiple messages left. Mother left message that hives had resolved and child had no other problems.
On 6/10/09 patient felt generalized joint pain. Noticed swelling both ankles. Reported as non-pitting. Denise treatment. Joint pain resolved by 6/11/09. Present at center today with non-pitting edema left ankle. Reports hx ankle injury (sports related) and has occasional swelling of both ankles.
asthma attack occurred @ 9:40-1hr p/vax;albuterol inhaler used w/improvement;@ 10:15 started itching all over body w/no rash;MD ordered med;no fever or change in vital signs;
hot, red, itchy and felt like bees stinging me 2nd day severe Vertigo and vomiting 3-4 days severe diarrhea (with nausea) 9 days later arm swelled and got very red and sore for over a week  Still hurts 6 months later
Information has been received from a consumer concerning his 29 year old wife who in approximately January/Febraury/2001 was vaccinated with the second dose of varicella virus vaccine live (site unknown). The pt had a titer drawn within one month of receiving the second vaccine and it showed protection. On 09/07/01, it was reported that the pt had her titer drawn "this summer", and it was negative for protection against varicella. It was also reported on 09/07/01, that the pt had a follow-up titer about three week ago and it was again negative for protection. The pt sought unspecified medical attention. FOLLOW-Up information, received on 10/10/01, indicated that an unspecified date, the pt received the third dose of varicella virus vaccine live (site unknown), administered IM, instead of SC. This does not comply with the recommended dose administration. The pt's husband, a registered nurse, reported that this was the first dose in the second series of varicella virus vaccine live, due to the fact that his wife failed to seroconvert after previous vaccinations. In addition, he indicated that he could not be sure that the vaccine was stored at the proper temperature. Additional information has been requested.
pt brought to hosp with increasing SOB, dyspnea on exertion, orthopnea, significant hypoxemia; placed on CPAP; positive for COVID; COVID pneumonia; acute renal failure; transferred to ICU; placed on bronchodilators, ABX, remdesivir, dexamethasone, baricitinib; poor prognosis; required intubation; complicated with MRSA bacteremia; status changed to DNR and eventually comfort care; pt died in the hospital
This case was reported by a healthcare professional via Merck and described the occurrence of brachial neuritis in a subject of unspecified age and gender who was vaccinated with DTP (manufacturer unspecified). On an unspecified date the subject received unspecified dose of TDaP (unknown). At an unspecified time after vaccination with DTaP vaccine and unspecified, the subject experienced brachial neuritis. The healthcare professional reported the subject "experienced brachial neuritis. The after receiving TDaP. This occurred at some unspecified time in the past". At the time of reporting the outcome of the brachial neuritis was unspecified.
No additional AE; Expired Varivax administered; Information has been received from a pharmacist concerning to a 12 month old patient (gender not reported). On 11-SEP-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. R013568, exp. date 13-MAY-2020), 0.5 milliliter (route not reported) for prophylaxis. No adverse event was reported.
WE ADMINISTERED A SECOND DOSE FROM A VACCINE VIAL WHICH PASSED ITS BEST USED TIME.   ADMINISTERED AT 8:25AM VACCINE BEST USED TIME WAS 1:35AM 08-21-21
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, dose number, route, anatomical place of vaccination, lot# and expiration date were not provided). After administration it was discovered that an unspecified flu shot and a pneumococcal vaccine (manufacturer unknown) was received 2 to 3 weeks before. No adverse effect reported. Additional information has been requested.
Information has been received from a physician concerning a 5 year old female who on 07-AUG-2008, was vaccinated with her first dose of VARIVAX vaccine (Oka/Merck) (Lot # 658576/1271U). Concomitant therapy also included on 07-AUG-2008, at the same appointment, second dose of MMR II vaccine (Lot # 656617/0416U), and PEDIARIX. Two days after vaccination the patient experienced generalized vesicular rash described by the physician as a"classic chickenpox". The diagnosis of chickenpox was confirmed by a dermatologist. The patient has itching and was still breaking out all over her body. The patient has been prescribed BENADRYL and ATARAX. Laboratories test included: Complete blood count (CBC), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), protein C and Complement Activity Enzyme Immunoassay (CH50) (results not provided). Additional information has been requested.
Pt states she got her Shingrix and Flu shot Monday around 10. She woke up Tuesday AM feeling very sick. Symptoms included muscle aches, migraine, chills, face was red, eyes burning, and a rash on her neck, chin, back and groin area. She describes the rash as blotchy with some red pin prick looking spots.
welts; swelling; purple; blisters; antibiotic allergies; blistering across the ends of nerves; This case was reported by a consumer via call center representative and described the occurrence of welts in a female patient who received Flu unspecified (Influenza vaccine) for an unknown indication.   Previously administered products included Flu vaccine with an associated reaction of anaphylactic reaction. Concurrent medical conditions included allergy to antibiotic.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine, the patient experienced welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash. On an unknown date, the outcome of the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash were recovered/resolved.   The reporter considered the welts, swelling, skin discoloration, blister, allergy to antibiotic and blistery rash to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had gone into anaphylaxis from a previous flu shot, for no reason other than possible antibiotic use. The patient received a flu vaccine at least 15 years.  It was reported that the morning after she got the vaccine she woke up with huge solid welts from head to toe and she was swollen and purple.  Several months later the patient had blisters that looked almost like a tree across her back, apparently she was blistering across the ends of nerves.  The physician said this was also a reaction to the flu vaccine. She has severe antibiotic allergies, so it is thought the reaction was due to trace amounts of antibiotics in the vaccine. The reporter did not consent to follow-up. The reporter declined to provide additional information since it was reported to the Health Department at the time it occurred. A clarification has been requested to create an additional case for the same patient who received flu vaccine and had anaphylaxis reaction.
TINGLING IN RIGHT HAND; TIREDNESS AND FATIGUE; TWO VACCINE DOSES GIVEN IN ERROR; ACHES AND PAINS ESPECIALLY IN KNEES; COLD CHILLS; LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, high hemoglobin, and ragweed allergy, and other pre-existing medical conditions included: Patient did not have any history of drug abuse or illicit drug use. The patient never had the covid-19 virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021, and dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced aches and pains especially in knees. On 08-APR-2021, the patient experienced cold chills. On 08-APR-2021, the patient experienced low grade fever. On 08-APR-2021, the patient experienced mild headache. Laboratory data included: Body temperature (NR: not provided) Low grade. On 24-SEP-2021, the patient experienced two vaccine doses given in error. On 13-OCT-2021, Laboratory data included: Antibody test (NR: not provided) levels were greater than 2500. On an unspecified date, the patient experienced tingling in right hand, and tiredness and fatigue. Treatment medications (dates unspecified) included: ibuprofen, mecobalamin, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains especially in knees, cold chills, low grade fever, and mild headache on 08-APR-2021, and tiredness and fatigue, had not recovered from tingling in right hand, and the outcome of two vaccine doses given in error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211031574.
I received my shot in right buttocks.  After a week the lymph nodes in right groin area were significantly swollen.
No real pain at injection site. Next day I started getting pain in my shoulder, I didn?t think anything of this because everyone said the pain would be at the injection site. The pain in my shoulder has just gotten increasingly worse every day, I cannot lift my arm chest level or above without pain, simple household tasks are hard, even just washing and brushing my hair. I am now getting pain down my arm into my wrist. I have to take Tylenol/Advil multiple times a day just to get through it. Sleeping is painful and I wake up throughout the night in pain and the morning is especially sore.
Treatment of COVID-19; Treatment of COVID-19; Pfizer, administration date=05Feb2021; Moderna, administration date=23May2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NOREL AD; NASAL [SODIUM CHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; PHENYLEPHRINE; SUDAFED 12 HOUR.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown", described as "Pfizer, administration date=05Feb2021; Moderna, administration date=23May2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes, Anti-viral details: Product- COVID 19 Treatment Brand- Paxlovid Treatment start date:17Dec2022 Treatment stop date:21Dec2022.  Indication- Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, the reported events Interchange of vaccine products, Drug ineffective and Covid-19 cannot be excluded for the suspect product BNT162b2.
Lt hand swollen with erythematous rash on palm and smaller rashes on lt forearm, clustered vesicular lesions on fingers also.
10 weeks after Shingrix 1st shot I have shingles. Recieved treatment at my GP. It was very painfull with sores on my back and chest with burning  and tingles from head to legs
Covid19 breakthrough.  1st vaccine received on 02/12/2022.  78 y/o with PMHX Afib, CKD, SIADH, Pulmonary HTN, newly diagnosed Colon Cancer, Anemia and GIB admitted to hospital for Right Colectomy.  Pre procedure Covid test Positive, pt asymptomatic.  Surgery performed on 03/07/2022.  Pt remains afebrile but began to have SOB requiring O2 at 5LNC-92%  on 03/09/2022.  Pt currently on O2 at 2L NC sat 100%.   CXR with small bilat pleural effusions and opacification of lower lobes likely consolidation or atelectasis.  No current covid treatment.
Immediate pain during and after injection which appeared to be too high.  Significantly reduced range of motion with pain arc.
Clammy, fever to 101, light headed, malaise, joint pain, fatigue
Monday evening while at work hives began in right arm, spread to hand and other arm.  Tuesday AM, woke with hives on entire body.  Wednesday woke with swollen upper lip.  Saw own physician and was prescribed Zantac every day for 1 week.
My 15 month out son was given 1ml of hep b (the adult dose) instead of .5ml the child dose.  He then had a fever of 104. Fever reduced to 102 and lasted 4 days. We?re on the forth day and he?s still not himself.
Within the first five minute became very sleepy, had slurred speech, was difficult to arouse and developed a mild facial twitch.  Had to assist with walking out of the store and to home.  Gave fluids at home and laid in bed.  Aroused him every few minutes.  AFter 60-90 minutes began to become more alert.  Took 2-3 hours to become fully alert.  Has residual sleepiness for 48 hours.  Twitch resolved over 2-4 hours.
Case number PHEH2014US017056, is an initial spontaneous report from a medical assistant received on 21 Aug 2014. This report refers to a 4-month-old male patient. Past medical history and concomitant medications were not reported. He was unintentionally administrated with MENVEO (batch number: A12129) intramuscularly on 21 Aug 2014. No adverse reaction was reported following maladministration (wrong vaccine administered).
Broke out in red rash to face in afternoon after receiving vaccine in am. Rash spread to rest of body by the evening. Benadryl given in clinic.
On 10/31 at 3am he thought the alarm was going off for the smoke detectors and realized that was a loud ringing in his ear. After that he has had serious migraines constantly. He went to the ER but they found.
Immediate. Increased heart rate, nausea, dizziness. Feeling of scared, ER diagnosed panic attack.
she still caught the damn thing; she still caught the damn thing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EM9809, Expiration Date: Jun2021), on 09Mar2021 as dose 2, single (Lot number: EN6205, Expiration Date: Jun2021) and on 02Dec2021 as dose 3 (booster), single (Lot number: FH8030), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX. Past drug history included: Biaxin, reaction(s): "a horrible taste". Vaccination history included: Shingles shots (does just fine with those), for Immunization; Flu shot (every year), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "she still caught the damn thing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.The patient was treated with Paxlovid.  Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EM9809, EN6205 and FH8030 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 EM9809, EN6205 and FH8030, fill lot EM9807, EN5337 and FH4343, the formulated drug product lot EM9805, EN5326 and FA9187 respectively. 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.  Additional information: The number was unknown.  No follow-up attempts are possible. No further information is expected.
Less than 24 hours after vaccination 102 fever, headache, nausea.  Took Motrin. Chills at night. the next day woke with 101 fever and slight headache. Pajamas soaked with sweat.
Pt. had fainting episode, lasting momentarily. Monitored and watched in office for 25 min.
Patient got his 1st dose of the Pfizer COVID-19 vaccine (Lot #: EW0179, Exp: 5/1/21) at 1444 on 04/27/21 and at about 1446 started feeling dizzy like he was going to faint. This client understood what was going on and while sitting in the vaccination chair, he slowly put his hands on the floor and put himself in the seated position. He then slowly laid down on the floor and put his legs up on his chair preparing for this syncopal episode. The EMT was alerted by this client's nurse that he felt dizzy and then notified the lead nurse, about the situation. The client was lying down on the floor for a couple minutes and at about 1448 was able to get up and sit himself back on the chair. Client felt stable enough to walk over to the observation area and sit down in the zero gravity chair for a few minutes. The client drank some water while sitting in the zero gravity chair and at about 1452 was no longer dizzy or light headed and went over to sit in one of the regular chairs in the observation area to wait out the rest of his 15 minute period. The client explained that syncopal episodes after vaccinations regularly happen to him and that this is not out of the ordinary. The client explained that he ate and drank before his vaccination, takes no medications, and has no medical history. At about 1500 the client was stable and was able to ambulate out of the facility and to his car and verbalized feeling capable of driving himself home since he was no longer feeling dizzy or lightheaded.
First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left side numb (face, head, shoulder, arm), loss of voice Next 28 days and current: loss of voice, swallowing hard, shoulder pain, limited shoulder movement, tight neck in the left side