chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: ZOLOFT, start date: Nov2010, stop date: 24Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2023) Positive, notes: I started Paxlovid the same day I tested positive for Covid; (Feb2023) negative, notes: I tested negative for Covid seven days after my positive test; (Feb2023) negative, notes: Symptoms returned three days after negative test; (24Feb2023) Positive, notes: I tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : vaccine received and other medication in 2weeks. Had a rebound case. She tested negative for Covid seven days after her positive test. She started Paxlovid the same day her tested positive for Covid. Took Paxlovid for five days with no lessening of her symptoms. Symptoms increased on day three of Paxlovid from mild to more severe. Tested negative on the seventh day after her positive test. Symptoms returned three days after negative test and she tested positive today. Also, world's worst metallic taste from Paxlovid, Yuck. she wouldn't take it again for this reason.
Shot painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had the shingles 2 years ago it was horrible. The patient received a shot of Shingles vaccines and was painful. The follow-up could not be possible as no contact details were available. For tolerance of 2nd shot of Shingles vaccine, refer case US2021AMR197125.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197125:Same reporter.
swollen lymph node after receiving the first dose of pfizer covid vaccine; This is a spontaneous report from contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 at age of 63-year-old at single dose for SARS-COV-2 immunization. The patient's medical history and concomitant medications were not reported. The patient was calling to report a swollen lymph node (Apr2021) after receiving the first dose of the Pfizer covid vaccine. The patient asked "Is this side effect something to worry about, or is it going to go away?", the response was "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response". The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
did fine 1st day, next day had leg muscle weakness and that night had nausea and vomiting. 3rd day-all muscle hurt but not as intense. Had a headache but relieved with pain me. 4/19-much better.
multiple syncopal episodes the day after receiving vaccine, resulting in tibial/fibular fracture and hospitalization
This spontaneous report as received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received ROTATEQ 0.5 millilitres suspension, orally (Lot# J001814, expiry date: not provided). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Fahrenheit) for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. There was no product quality complaint involved. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009970, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
Muscular pain Swollen lymphs  on left armpit Nausea Sharp pain in abdominal area and in the waist & back when urinating
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient tested positive for Covid-19 on 18Apr2021 and tested positive again last Saturday (05Jun2021).Patient's second dose is due today; Patient tested positive for Covid-19 on 18Apr2021 and tested positive again last Saturday (05Jun2021).Patient's second dose is due today; This is a spontaneous report from a contactable pharmacist. A 40-years-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced patient tested positive for COVID-19 on 18Apr2021 and tested positive again last Saturday (05Jun2021). The patient second dose was due on the date of reporting. The pharmacist wanted to know if the patient in the pharmacy can receive the second dose of the Pfizer BioNTech COVID-19 Vaccine despite a history of COVID-19 infection. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021 and sars-cov-2 test: positive on 05Jun2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and covid-19 cannot be totally excluded
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Upon completion of vaccination-patient was with parents & brother-was asked twice to wait for 15 min for observation-but mother would only wait outside-returned approx 10-15 min after with daughter saying she felt a lump in throat-had patient sit in room, asked about other symptoms (none at that time)-offered to call 911-mother decided to take her across street to urgent care. Called mom later to check on patient and told she was given Epipen at urgent care and went to hospital from urgent care
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hi BP" (unspecified if ongoing), notes: Hi BP; "Known Allergies: Penicillin" (unspecified if ongoing), notes: Known Allergies: Penicillin. The patient's concomitant medications were not reported. The patient did not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine reported as yes.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative, notes: day 8; (2022) positive, notes: day 9. Therapeutic measures were taken as a result of drug ineffective, covid-19. Reported Event: On day 8 patient was antigen neg on day 9 patient became again antigen positive and started to experience worsening COVID symptoms. Symptoms continue to worsen to day 12 (today). For the 1st 8 days, essentially had no Symptoms feeling just fine. By day 11 patient was as sick as patient can remember in a long time. Anti-viral details: product COVID-19 Treatment, brand Paxlovid, treatment start date was 25Jun2022, treatment stop date was 29Jun2022 and indication was Treatment of COVID-19. It was reported that, Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating and Seriousness criteria-Congenital anomaly/birth defect reported as no.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had the shot ~2pm on Tue, Oct 24; during the night I felt restless and got up around 2am Wed, Oct 25; tried going back to bed ~3:30am, but couldn't sleep; ~6:00a I was able to go back to sleepy, but it wasn't until much later in the morning (maybe ~10am) that I realized this was probably a vaccine reaction (since I often have trouble sleeping); I noted that my muscles were achy and it felt like I had a fever; I finally took my temperature around 2pm Wed, Oct 25, and found it was 100.6; symptoms felt similar to my COVID reactions, but when I got my COVID vaccine on 10/6/23, I had no adverse reactions this time; also had my flu vaccine on 10/3/23
Recurrence of crescentic GN; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) in a 79-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Recurrence of crescentic GN) to be related.    No concomitant and treatment medications were reported. Company comment: This literature-non-study case concerns a 79-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (reported as Recurrence of crescentic GLOMERULONEPHRITIS). No dates about the first and the second dose of mRNA-1273 vaccine, and no onset date of the event were reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539885, MOD-2022-539902, MOD-2022-539903 (Patient Link).; Sender's Comments: This literature-non-study case concerns a 79-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (reported as Recurrence of crescentic GLOMERULONEPHRITIS). No dates about the first and the second dose of mRNA-1273 vaccine, and no onset date of the event were reported; hence, latency cannot be assessed. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Rapid HR, aches, dry mouth, lethargy, chills x 3 days.
Child developed varicella 12/11/2001. Rash scattered on face, chest and back. More than sixty lesions present.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 at 15:30 as dose 8 (booster), single (Lot number: FL0447) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown) and as dose 7 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date: 09Jun2023, Treatment stop date: 13Jun2023); Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225278 Same patient/product, different dose/events;US-PFIZER INC-202300225108 Same patient, different drug/AE.;
Pt described what she called "COVID Arm" Was a rash that developed around the injection site. Starting hurting when she laid on the arm that she received the vaccine, then the next day she said it starting itching. Pt was taking OTC Benadryl. Pt came back to the pharmacy two day later stating a rash, that looked like a burn, developed on her stomach. Pt was told to follow up with her physician and to go to ER if anything should get worse.
1st dose November 23, 2021 Dull, constant headache (occasionally intensifies) since receiving first dose that has yet to go away over 6 weeks later.  2nd dose December 21, 2021 Headache intensified significantly after dose for a few days (approximately 72 hours). It was more of an intense, throbbing headache. Would worsen upon bending down and the return back up. On December 22, 2021, also had bad body aches and chills (felt like I couldn?t get warm even inside with heat). Strange skin rash on the arm where vaccine was administered that lasted for a few days (approximately 72 hours) was noticed on December 23, 2021. As mentioned above, the dull, constant headache (occasionally intensifies) remains and has yet to go away over 6 weeks after the first administration. The headache is refractory to multiple interventions including ibuprofen, acetaminophen, eating, drinking water, massage, etc.
Nausea and vomiting -- I started to feel nauseous on Saturday morning (4/10), the day after getting my first dose of the vaccine (so about 18 hours later). I vomited 5 times between ~11am and 5:30pm Saturday. I got very dehydrated, and went to the ER (about 5:30pm), where I got IV fluids and anti-nausea medication. I was also given an epipen because of history of allergies. Nausea subsided by the time I left the ER Saturday night, and my stomach felt normal by late Sunday.  Headache -- I had a bad headache on Saturday and Sunday. It was very bad around 6pm Saturday; the worst state lasted about an hour. Malaise -- I was tired/low energy for about 5 days. Back to normal energy by Friday (a week later). Arm swelling -- A week after (Friday evening 4/16), the arm where I got the injection started to hurt and was swollen and hot to touch. (No rash though.) This went away after about a day.
consumer is 24-weeks pregnant with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involved a 16 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE in context of consumer is 24-weeks pregnant with no adverse event (Maternal exposure before pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Oct-2020, the patient received at a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number-U7012AA, Expiration date- 30-Jun-2021) via intramuscular route in the left arm while she was 24-weeks pregnant (Maternal exposure before pregnancy).  No adverse event was reported.  No laboratory test was reported.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
it was like someone was jumping up and down on his cheast/then pain went down left arm/heart attack; felt like his eyes were spinning in his head; cold sweats; myopericarditis; This spontaneous report was received from a 64 year old male consumer reporting on himself. The patient's concurrent conditions included allergy to nitrates and nitroglycerin. There was no pertinent medical history. On 27-SEP-2017, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route not reported) in the left arm. Concomitant therapies included vitamins and supplements.     The patient reported that he received the influenza virus vaccine (unspecified) in the right arm twenty minutes prior  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). He stated that immediately after the vaccine was given, he said to his wife "something was wrong" it was like his eyes were spinning in his head. The patient stated that he had cold sweats and was told to sit for a few minutes, but he went home. The patient reported that the next day on 28-SEP-2017, he went to the emergency room for 4-5 hours where they tested everything and gave him "intravenous" and was sent home. The consumer reported that two weeks later, on 10-OCT-2017 at 2:00am he woke up and said it was like someone was jumping up and down on his chest. He went to the bathroom, got a glass of water and then pain went down left arm. The patient went to emergency room again and they did blood tests which included troponin levels (first one was zero, second one was 1.38 and third one was higher). The patient was told that he had a heart attack and was admitted for five days. The patient additionally stated that during hospital stay they did a catherization, no blockages, but had inflammation around heart (myopericarditis) and inflammation of lining of heart and muscle. The patient reported that the only reason they said it was a heart attack was because of enzyme on blood test levels were high. The patient was scared to get the Covid vaccine, so this was why he wanted to find out the ingredients of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to compare. At the time of the report, the patient had recovered.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Upon internal review heart attack and myopericarditis were considered to be medically significant.
Severe neck and shoulder pain lasting more than 3 weeks now. Same thing happened with second shot.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of and local swelling. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of and local swelling were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of and local swelling to be related to SHINGRIX. Additional details were reported as follows: The vaccine was administered in the first week of August. The patient reported swelling, redness and hot to touch the area below the injection site. The swelling also presented in the arm pit area of that same arm. The swelling lasted 2 months. The reporter gave consent to follow up. The patient declined to provide her phone number.
Got H1N1 vaccine on 10/20/2009. Was 6 weeks pregnant. Got an upper respiratory tract infection (cough runny nose, malaise, fatigue) day after vaccination, but was otherwise doing fine until 11/29/09 when she started bleeding and had a miscarriage. Sought care at ER. D&C done today. Was 10 weeks pregnant. Dr thinks embryo stopped growing around 6 weeks, a 1st trimester termination of pregnancy in 2004. No other pregnancies. Took influenza vaccine 7 years ago. No problems. Does not think miscarriage is due to flu vaccine.
Patient states swelling, redness, and tenderness began in area of injection about five days after she received shot. Seen in office on 8/3/11 and treated with oral antibiotics.