chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID breakthrough case. I received my 2nd booster shot on 05/04/2022 and my COVID symptoms started on 05/26/2022 it was in the morning cough, asthma, stuffy nose, later that day I had low grade fever. 05/28/2022 high grade fever. I also did a COVID home test that day which was positive. I did a tele heath with doctor who prescribed me with PAXLOVID for 5 days. I finished my whole course. I am recovering but I still have cough and congestions.
Nausea and diarrhea that lasted for approximately 24 hours on 2/1, three days after vaccination
Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X). On an unknown date the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size and generalized hives. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient reported DOB as 10/22/2008 when their actual DOB is 10/22/2009. Patient was under the age of 12 when Pfizer vaccine was administered.
Bad Headaches at the top of my head started on March 25th.  March 30th went to ER with Bells Palsy, tingling in arms, hands felt dumb and felt strange (almost as though I had frost burn) when I would run them under water.  Also experience excruciating pain the shoulders and hamstrings. Has a Lyme's test, EKG and CT Scan.  All negative. Put me on predisone.  Had to get a 2nd prescription because was still experiencing a lot of pain.  Went for an MRI  and had another Lyme's test.  Everything negative.
I had no reaction til almost a week later when my left arm started to itch and gets worse each day.  It is red and warm in the vaccination area. Do I need to do anything at this point?
Blank look stare, non-responsive, zombie/ irriatable, clingly, not hungry, only breastfeed, lost acquired skills stop talking, stop smiling, had slight fever on off for a week. 11/18/09 Medical records received for dates 2/1/07 to 4/11/08. Well child exams WNL 2/07 to 4/08. Pt had wellness exam 4/11/08 WNL received vax.
Acute Pericarditis - pt. transported to hospital w/ complaints of severe shortness of breath and pain upon inhalation, diagnosed w/ acute pericarditis during ER visit 12/30/21 via MRI and Heart Ultrasound, treated with NSAIDS and colchicine x 1 month,  initial tests showed moderate pericardial effusion
missed 2nd shingrix..over 2 yrs; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked if the patient start over.
mild to moderate anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had a mild to moderate anaphylactic reaction. He just wonders if there is provisions. Reporter asked if Pfizer was helping with clinic and EMT (Emergency Medical Technicians) bills. It was protocol, they had to take her. Now they have a 1800 fee from the hospital, and 800 for the ambulance. That is a lot of money. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
itching and rash. allegra took 12am recommended antihistamine of choice (benadryl, claritin, zyertec) as labeled and if in unresolved within 3 days to see PCP for prescriptions. advised to monitor for SOB, swelling of throat/face, difficulty swallowing. Caller verbalized understanding.
Cataract; This is a spontaneous report from a Pfizer sponsored program COVAX US SUPPORT. A contactable pharmacist reported for a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had cataract surgery on 04May2021 and was taking an antibiotic eye drop and a steroid eye drop. Her second dose of the Pfizer Covid 19 vaccine was scheduled for tomorrow (21 days). Reporter asked if safe for her to take the vaccine. The outcome of the event cataract was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Due to implausible temporal association, the event of  Cataract is assessed as unrelated to suspect product BNT162B2.The patient has been on the medication for just 21 days, while it is known that the process of cataract is slow and takes months to years.   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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient inadvertently received vaccine after published expiration date. Moderna company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 at time of administration. Patient also did not call into complain of adverse event.
59 days out from her first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (59 days out from her first dose of the Moderna Covid 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (59 days out from her first dose of the Moderna Covid 19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (59 days out from her first dose of the Moderna Covid 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were provided.  No treatment information  was  provided by the reporter.   Reporter did not allow further contact
Patient reports feeling sick within a couple of hours after vaccination.  "Felt sick" all weekend, "pain all over", fever (no temperature taken), shortness of breath, mild cough, poor appetite, and "in bed all day".  Denies any chest pain, headache, or new dizziness.
squamous cell carcinoma; Skin lesion; This case was reported by a physician via call center representative and described the occurrence of squamous cell carcinoma in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced squamous cell carcinoma (serious criteria GSK medically significant) and skin lesion. On an unknown date, the outcome of the squamous cell carcinoma and skin lesion were unknown.   It was unknown if the reporter considered the squamous cell carcinoma and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm. On an unknown date, the patient reported to her primary care physician for a skin lesion that appeared on her left arm. The primary care physician referred the patient to a dermatologist and the lesion was diagnosed as squamous cell carcinoma. The treatment for the event was not reported. The reporter consented to follow up.
Immediately after the injection, my arm started to get sore (10:05 am).  Around 9:30 pm I got severe chills. Arm continues to be sore on day 2. Can't lay on that side.
Irritability, large (golf ball) lump at injection site, red and painful. Slight nausea. Aching all over and quite fatigued for 5 days.
3/6/21- One week after shot: Extreme chest pain lasting a week - plus (still ongoing) and indigestion.   3/12/21 - Two weeks after shot: large rash on injection arm. Red, hot, inflamed, itchy. Increasing in size over at least 3 days extending from shoulder to 1-2? above elbow.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 02-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Took ZOSTAVAX 3/4/08 Lot #1836U Expos/14/09 Developed shingles 5/23/09 4 other patients see #13 have also had shingles > 1 year after ZOSTAVAX (different lots I think). Someone keeping track of efficacy? At $225/vaccine, it should work.
Fever Body Aches Chills Abdominal Cramps Random Cycle Bleeding Heavy Large Blood Clots Out of Nose and from Cycle  Sores on Arms Severe Chest Pains Blood Pressure Spikes
Injection given 12-14-18 on administration, pt said feel a little pain of it going in. Said by evening had swelling at site & pain over the next day or two that radiated from shoulder to elbow & around upper chest & back. Felt a few chills but no fever. Pain resolving over time. No known medical treatment sought. Partner had gotten shot at same time with no adverse effects seen.
Rec'd IZ at 1230pm 12/12/06 at 530pm same day started nausea, vomiting, diarrhea lasting 12 hours taken to ER and rec'd IV fluids and anti nausea. RX 12/13/06 spiked temp 101.9 that lasted 24 hours mother gave children. Motrin temp broke today 12/15/06 child lethargic, loss of appetite.
Allergic type rash on full body; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable healthcare professional. A 47-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 27Oct2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 29Oct2021, the patient experienced allergic type rash on full body. The event resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with dexamethasone (MANUFACTURER UNKNOWN) and hydroxyzine hydrochloride (VISTARIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event allergic type rash on full body was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Day 8: tender, swollen lymph node in armpit on left side (injection side); red, itchy rash on upper left arm (injection area)
Feeling nauseous, after an hour went into diarrhea, then vomiting, down to dry heaves over a period of 8-10 hours.  No fever, no headache, no respiratory issues, no body aches. When finally subsided, couldn't drink or eat, continued feeling nauseous.  After 36 hours, returned to normal but remain very tired.
Pt made three trips to Er with seizurre like behavior on 4 occasions and he fine: being within 1/2 hour after vaccine administeration. Pt is being evaluated by a neurologist pending CT. Dilantin 100mg 1 po CAM 2 poq pt will have EEG done.
Head hurt, after second vaccine; Ears hurt, after second vaccine; Bad cough, after second vaccine; Bad cough, after second vaccine was reported as worsened; Asthma attacks worsened, with wheezing, after second vaccine; Asthma attacks worsened, with wheezing, after second vaccine; Blood in urine, after second vaccine; bad reaction to the second dose of the Covid vaccine/ why do they make vaccines with ingredients that people are allergic to; This is a spontaneous report from Pfizer-sponsored program via contactable consumer or other non hcp. A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 16Jul2021 10:00 (Age at vaccination 66-years old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing asthma from when she was a little baby, Ongoing chronic obstructive pulmonary disease (COPD), 6 or 7 months ago, Ongoing bad heart, heart surgery about 2 years ago, kidney problems, from when she was born and liver disease about 10 years. There were no concomitant medications. Previously, patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 25Jun2021 01:30 PM (Age at vaccination 66-years old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date of Saturday night, the patient experienced head hurt, after second vaccine, ears hurt, after second vaccine, bad cough, after second vaccine; bad cough, after second vaccine was reported as worsened, asthma attacks worsened, with wheezing, after second vaccine, blood in urine, after second vaccine, bad reaction to the second dose of the covid vaccine/ why do they make vaccines with ingredients that people are allergic to. Patient underwent emergency room visit and received treatment, given 20mg of Prednisone, to take one tab by mouth, every 12 hours for 5 days. She was denied for Tylenol as a treatment for pain due to liver issues. Therapeutic measures were taken as a result of head hurt, after second vaccine, ears hurt, after second vaccine, bad cough, after second vaccine; bad cough, after second vaccine was reported as worsened, asthma attacks worsened, with wheezing, after second vaccine, blood in urine, after second vaccine, bad reaction to the second dose of the covid vaccine/ why do they make vaccines with ingredients that people are allergic to. The outcome for the events Asthma attacks worsened, with wheezing, after second vaccine, Blood in urine, after second vaccine, bad reaction to the second dose of the Covid vaccine/ why do they make vaccines with ingredients that people are allergic to was unknown, while other events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Hives; Itching of hands/wrists; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via unspecified route of administration in the left arm on 15Mar2021 at 16:30 (at the age of 20-year-old) for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via unspecified route of administration in the left arm on 22Feb2021 at 16:30 for COVID-19 immunisation. The patients concomitant medication included birth control pills. The patient was allergic to peanuts and tree nuts. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. The patient experienced hives and itching of hands/wrists on 16Mar2021 at 23:30 hours. The patient did not receive any treatment for the adverse events. At the time of report, the clinical outcome of the event hives and itching of hands/wrists were not recovered.   No follow-up attempts are needed. No follow-up information is expected.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Sudden hearing loss Sudden hearing loss in both ears but stronger in the left ear, also menstruation-type blood loss when I am menopausal since I was 50 years old, I am currently 56 years old.
Patient received Pfizer vaccines on 3/3/21 and 3/24/21. Tested positive for COVID by PCR on 4/9/21.  Symptom onset date of 4/9/21 with fever, cough, fatigue. Has underlying immunocompromised status.
Vomitted at 1:40 a.m. on 10/14/21. Then had chills and headache. At 5:15 took temperature and it was 100.7. Took Tylenol. Exhausted. Slept a lot. Left arm hard and painful. At 5:30 p.m. fever was up to 102.4. Took more Tylenol. Fever broke,  but still no energy and slept most of day. No fever on 10/15/21, but still today, 10/17/21 left arm hard and painful at injection site and around it.  I did not seek treatment.
1/8/21  approx 7pm- chills, headache, fatigue, mild muscle aches, mild nausea. Lasted overnight; relieved with tylenol, ibuprofen Ok after able to sleep and during the day 1/9/21 sundown - low grade fever 99.1F, fatigue, headache; relieved by 500mg tylenol
index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing; Cannot straighten his hand completely or put his fingers together; really weird feeling, strange feeling; bent thumb and forefinger; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing), MOBILITY DECREASED (Cannot straighten his hand completely or put his fingers together), FEELING ABNORMAL (really weird feeling, strange feeling) and FINGER DEFORMITY (bent thumb and forefinger) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing), MOBILITY DECREASED (Cannot straighten his hand completely or put his fingers together), FEELING ABNORMAL (really weird feeling, strange feeling) and FINGER DEFORMITY (bent thumb and forefinger). On 05-Mar-2021, FINGER DEFORMITY (bent thumb and forefinger) had resolved. At the time of the report, MUSCULAR WEAKNESS (index finger really really weak/little bit in the thumb (weak)/hard to hold on a thing), MOBILITY DECREASED (Cannot straighten his hand completely or put his fingers together) and FEELING ABNORMAL (really weird feeling, strange feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant FU / 1 extra event and outcome
Vaccine recipient received Moderna vaccine on 12/29/2020 and experienced a metallic taste in throat and tongue. Vaccine recipient was observed for a total of 40 minutes for any other signs/symptoms. Then recipient was then cleared from the clinic to leave. During a follow-up phone call 12/29/2020, vaccine recipient reported that metallic taste went away on its own. She reported to have developed a headache around 2:30 pm that went away after taking two Excedrin tablets. Moderna COVID- 19 Vaccine
Fever (103 F), neck/back pain, myalgia, decreased energy decreased on evening of vaccination. Mild sore throat with exudate left tonsil with slight erythema - throat CX neg, rapid strep neg, monospot neg. Went to ED dx'd with UTI (Asx, UA with mod lk est, 16 WBC, Tr bac) treated with Bactrim - Fever resolved within 3-4 d, neck pain resolved but continued pain along thoracic/lumbar spine.
Patient reported an arm that was extremely red that started the day after receiving the vaccine up to around 2 days ago (8/14/19-8/25/19). He also reported that the injection site is extremely itchy and has not subsided in itchiness.
Today is the first  day, started in the early morning hours, Vertigo , off balance, dizziness... I?ve never had this before
developed bell palsy after the first covid vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's parent) reported a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient developed bell palsy after the first covid vaccine on an unspecified date. The reporter was inquiring how to receive the second dose. The outcome of the event was unknown.  Information on batch/lot number has been requested.
He was given a child dose 0.2ml of the pediatric PFIZER dose. When he should have received 0.3ml of the adult PFIZER vaccine since he had just turned 12 years old.