chrisvoncsefalvay/vaers-outcomes huggingface dataset:
more painful; Suspected vaccination failure/had 2nd dose, had another outbreak; had another outbreakthis month/outbreak was actually worse this time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had been getting shingles since mid 20s).   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In August 2022, between 7 and 8 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 30-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had been getting shingles since his/her 20s. The patient finally decided to get Shingrix vaccine at 56 of age. The patient had the 2nd dose of the vaccine in January 2022 and this vaccine did not work for him/her. The patient had the another outbreak this month (August 2022). The patient stated that so did not thought this was a cure all, the manufacturer stated this was only 90 percent effective, unfortunate for he/she among the 10 percent. The patient stated that the outbreak was actually worse this time and a lot more painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
covid; covid; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid".  Clinical course: It was reported that patient received Pfizer covid vaccine. It was reported that patient opt out of the call due to dealing with covid. Exact date of being diagnosed with covid was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events drug ineffective/COVID-19 cannot be ruled out.
Immediate upper arm/bicep pain.  Site swelling, itching, rash and unable to lift arm or lift anything with that arm until approximately January 17, 2023.  Since January 17, 2023 I still experience bicep pain, an inability to use it fully to lift or do day to day functions.  I have not been able to lie on that side on my arm in that area since the day of the vaccination.
12/21/2020 3:00PM Abdominal  l quad pain, nausea sore arm, headache, fever 101.9 with chills -- tylenol, ibuprofen some relief. 12/22/20 tylenol in  AM-- low grade fever persists with headache, some nausea.
Muscle pain in both legs; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Muscle pain in both legs) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included SPIRONOLACTONE, TOPIRAMATE (TOPAMAX), PROGESTERONE, TESTOSTERONE and METFORMIN for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (Muscle pain in both legs). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain in both legs) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Patient received dose 2 of the Pfizer COVID vaccine (lot EW0161, exp 7/2021) at 1315. At 1322, patient raised her hand to signal she felt unwell. EMT and PHN approached. Vital signs: pulse 107, O2 99%, respirations 20, blood pressure 114/82. Patient reported feeling hot and dizzy. Patient stated she ate breakfast and had been drinking fluids. Allergies to mustard, chlorhexidine. Medical conditions include asthma, anxiety, and vocal cord disfunction. Medications include albuterol, Zyrtec. At 1325, patient reported an improvement in symptoms. PHN offered Benadryl but patient declined. At 1330, vital signs: O2 98%, pulse 107, respirations 18, blood pressure 112/78. Patient reported continued improvement as her dizziness had resolved but she still felt hot and wanted to go oputside. PHN encouraged patient to stay for 30min since start of symptoms but patient stated she wanted to leave to get some fresh air. EMT noted that the corner of the room where patient was seated felt warm. At 1340, PHN and EMT monitored patient as she stood up. Patient reported no dizziness. Patient left walking with steady gait at 1345.
Headache, tiredness, muscle pain, chills, joint pain,  soreness at injection site and nausea caused from the really bad headache.
6 days post vax came to clinic presenting areas of redness, soreness & swelling 5-6 inches distal of inj site-exam shows irregular, right red, very tender, swollen patch of skin, not raised & another satellite lesions just medially;
headache; nausea; Fever  98.7 to 100; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea) and PYREXIA (Fever  98.7 to 100) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever  98.7 to 100). On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) had resolved and PYREXIA (Fever  98.7 to 100) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 to 100f (High) 98.7 to 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
nurse gave double dose of the ipol to the patient with no reported adverse event; Initial information was received  on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that nurse gave double dose of the IPV (VERO) [IMOVAX POLIO] to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  unknown dose of suspect ipv (VERO) (suspension for injection)(strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient reported that nurse gave double dose of the ipol to the patient with no reported adverse event (extra dose administered) (latency: same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event nurse gave double dose of the ipol to the patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Her arm is a little sore; the tissue paper is red after wiping her anal area/ reddish looking poop/ there are pieces of blood or something is different; This is a spontaneous report from a contactable other Health Professional (patient).  A 75-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization, also reported as for work. Medical history included ulcer (15 to 20 years before 06Jan2021). Concomitant medication included prasugrel from Apr2020 and ongoing as blood thinner, acetylsalicylic acid, ascorbic acid (ASPIRIN) from Apr2020 and ongoing as blood thinner. The patient went to the bathroom in the morning 06Jan2021, she had to poop. When she wiped, it was reddish looking. The patient stated her stool color was normal, but the tissue paper is red after wiping her anal area. At first she thought hm oh well. Then she had been to the bathroom a couple of times 06Jan2021, and that the same thing happened. She had never experienced that before. It seems to her that there were pieces of blood or something was different. She wasn't hurting or anything. She was not weak or anything at this time. Her arm was a little sore, but she expected that. She was concerned about the color. She worked in the mammography department. She didn't have a prescribing doctor. She got it at work. She had noticed a difference of color in her poop. It had been the same all day. The outcome of the reddish poop was not recovered, of sore arm was unknown. The patient asked would the vaccine cause rectal blood upon wiping after defecation?; Sender's Comments: Reported blood in stool is considered intercurrent and unrelated to BNT162B2. 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.
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and have the following symptoms: fever, fatigue, runny nose, occasional cough. I had televisit with a healthcare practitioner and was prescribed with PAXLOVID for 5 days. As of today 06/27/2022 I am on my 3rd day of taking PAXLOVID and I am starting to feel better, my temperature has been normal. I haven't re-tested myself yet.
Doctor determined superficial thrombophlebitis on left hand where IV 4 weeks before was taken out while at ER for kidney stone 2/18/2021.  Hand was somewhat sore for weeks before vaccine.  J & J vaccine on 3/12/2021.  5 days later 5/17/2021 left hand very painful and huge blood clot.  Went to doctor and diagnosed blood clot and precribed clindamycin 300 mg 3X a day for 7 days.  It wasn't until the 7th day the pain was gone and swelling of the vein back to normal.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 15 patients (age and gender not reported) who were vaccinated with unstable product reached 34f-64f dose of FLUZONE QUADRIVALENT (Batch number: UT6259KA/ UT6259LA, expiration date: 30 Jun 2019, dose, route and site of administration was not reported) on an unspecified date from 16 Oct 2018 till 23 Oct 2018. It was an actual medication error due to product storage error. It was unknown if patients had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
On May 11, 1999 the pt experienced arm pain just above the elbow. On 06/01/1999 she sought medical attention, she was treated with ibuprofen, heat on the arm, and vitamins with iron. On May 28, 1999 the pt was advised by MD to take acetaminophen. On June 2, 1999 the pt's mother reported that her arm condition had improved her pain was subsiding, and her grasp was stronger. She continued to take ibuprofen. The mother also stated that the pt would follow through with OVA testing, and with vitamin therapy. On Jun 8, the student complained of some soreness above and below the right elbow. Her grasp was not as strong, but she could write. On June 4th and 5th 1999 the pt's father indicated that her arm condition was fine, able to move freely with no pain or weakness.
She got infected with currently raging Indian variant of the coronavirus few days back/symptoms were mild; She got infected with currently raging Indian variant of the coronavirus few days back/symptoms were mild; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RxPathways from a contactable consumer (patient's daughter). A female patient of an unspecified age received BNT162B2, dose 2 and dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 2 doses of COVID vaccine in February and got infected with currently raging Indian variant of the coronavirus few days back. Luckily because of the vaccine, her symptoms were mild and she only got cough for 2 days. Outcome of the events was unknown. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date  (Indian variant).  Information on the lot/batch number has been requested.
This spontaneous prospective pregnancy report as received from a nurse refers to a 21 year old female patient. On 02-JAN-2014, the patient received first dose of GARDASIL (dose and frequency not reported). On 13-MAR-2014, the patient was vaccinated with her second dose of GARDASIL (dose and frequency not reported). On 25-MAR-2014, the patient reported to the practice that she was pregnant. The patient sought medical attention by consulting her physician. No adverse effect has been observed or reported. The nurse stated that the administration of the third dose of GARDASIL would be deferred until the patient would deliver her infant. The patient had her LMP (Last Menstrual Period) on 18-FEB-2014. An EDD (Estimated Date of Delivery) was 25-NOV-2014. The patient was exposed to GARDASIL during the first trimester of pregnancy. The pregnancy outcome was unknown. Additional information has been requested.
1/21/21@1815-Vaccine administered; 1/22/21-0300 to 0400, employee developed a high fever and nausea.  1/22/21@1530 employee checks into ED for further evaluation.  CXR ; 1L IV fluids given along with IV Zofran for nausea.  employee reced a prescription for more Zofran and instructions to treat fever with Tylenol.
Itchy, chicken pox-like blisters - a few on each arm and approximately 10 pox around belly area.
Local erythema of forearm within 48 hours, topical treatment, vaccine administered as if it were PPD in error.
When her son, who is 46 years old, got his first COVID vaccine, he was so dizzy for an hour that he couldn't drive home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 46-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as " When her son, who is 46 years old, got his first COVID vaccine, he was so dizzy for an hour that he couldn't drive home".  Additional information: The patient got his first COVID vaccine, he was so dizzy for an hour that he couldn't drive home. That was his only reaction to the whole thing. He was young and healthy. He said that he was so dizzy that they had him sitting for an hour until he could walk and go home and what happened with patient was an immediate reaction. The patient got the second COVID vaccine and had no problems other than feeling like he got over the flu the day after his second COVID vaccine. Second one was nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Four hours after injection:   Grit in the eyes, weakness, achiness, deep cough, vomiting, diarrhea.  Lasted 1 hour.  Weakness, aching muscles lasted into following day.  Soreness at site of injection lasted for two days.
Severe headache, body aches, N, stiff neck; swollen, red, hot tender vax site; increased BP (156/106). Developed cellulitis by day 3-4.
day of vaccine 1/7: @ 10pm I started experiencing  sore arm at injection site, and body aches. 1/8-1/10: low grade fever (100), and fatigue. 1/11-1/12: headache w/ severe pain in front left side of head when doing any type of physical activity, small amount of numbness in left side of face and ears hurt.  1/13-1/14: sore throat.
concurrent antineutrophil cytoplasmic autoantibody; antiglomerular basement membrane glomerulonephritis; This literature-non-study case was reported in a literature article and describes the occurrence of ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Concurrent anti-GBM nephritis and ANCA-mediated glomerulonephritis after second dose of SARS-CoV-2 mRNA vaccination. Kidney Int Rep.     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, the patient experienced ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) (seriousness criterion medically significant) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) (seriousness criterion medically significant). At the time of the report, ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (concurrent antineutrophil cytoplasmic autoantibody) and ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE (antiglomerular basement membrane glomerulonephritis) to be possibly related.    Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Company Comment: This literature-non-study case concerns a 23-year-old male patient with no relevant medical history, who experienced serious unexpected events of antineutrophil cytoplasmic antibody and anti-glomerular basement membrane disease. The events occurred unspecified time after the second dose of the Moderna COVID-19 vaccine. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This literature-non-study case concerns a 23-year-old male patient with no relevant medical history, who experienced serious unexpected events of antineutrophil cytoplasmic antibody and anti-glomerular basement membrane disease. The events occurred unspecified time after the second dose of the Moderna COVID-19 vaccine. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
After 2nd dose of oral typhoid vaccine, client developed rash - after 3rd dose, rash increased and fever to 102 as well as sore throat developed. Saw PMD who felt that oral typhoid had activated varicella virus  (chickenpox at 3 years) causing rash.
persistent inconsolable crying greater than 3 1/2hr-stopped for 5min then started all over again;
Symptoms: Day 0 - 8/28/2021 Extremely mild injection site pain; Day 1 - 8/29/2021~36 hours post-injection: Acute extreme abdominal distension (bloating), shortness of breath, dizziness, pre-syncope, confusion, lack of concentration, sweating. Took 20mg Diphenhydramine and laid supine followed by nap. Symptoms subsided. Day 2-4 -3-4 daily bouts of dizziness, bloating, shortness of breath, lack of concentration. Eating food worsened bloating. Assumed possible constipation and dosed with Magnesium Citrate. Diarrhea followed, along with assumed dehydration/malnutrition. Began mostly liquid diet (meat broths) along with occasional crackers, grilled chicken, and vegetables like bell peppers, green beans, and potatoes. Day 5 - 9/2/2021***ER visit at 6:30PM 9/2/2021.*** Roughly the same symptoms as Day 1: Acute extreme abdominal distension (bloating), shortness of breath, dizziness, pre-syncope, confusion, lack of concentration, sweating. Tests included: EKG, Chest X-ray, shoulders-to-waist CT scan. Full blood work. All came back normal. IV administered for hydration, vital signs were monitored for 2-3 hours. All normal. Doctor prescribed ondansetron for nausea, which was not present; Day 6 and onward Switched to diet of oatmeal, cereal, bananas, grilled/baked chicken, lightly seasoned ground beef, green beans, yogurt. Symptoms show improvement.