chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case involves a 19 years old female patient who was administered with the expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines or concomitant medication(s) were given to the patient. On 28-Nov-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (once in total, standard,  lot number U6787AA and expiry date 11-Aug-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (same day latency). It was reported "Medical Assistant calling to report that a patient received and expired dose of MENACTRA. Caller is wanting to know if the dose is valid or if needs to be repeated. MENACTRA U6787AA EXP 08-Nov-2021." At time of reporting, no adverse event was reported. 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.
Symptoms:  fatigue, SOB, chest pain middle of chest b/t breasts, tachycardia started 3/22pm and worsened overnight to morning of 3/23/21.  "Felt like heart attack".  Crick in neck developed overnight after fixing pillows to help with leaning forward b/c that position felt better.  Ambulance called 3/23 around 10am.  CXR, abdom ultrasound, CT angiogram, lab work completed.  MI and PE ruled out.  No gallstones, other organs ok on u/s.  Small pericardial effusion noted on CT.  Symptoms improved after Toradol 15mg x1.  Chills developed around 3pm.  Discharged to home.   Tylenol given at home, chills subsided.  Pt felt better later that evening 3/23.  Minimal chest pain on 3/24 pm and 3/25 pm. Continues to improve.
Red, swollen area at injection site.  Warm and slightly firm to the touch.  Round shape, approximately 1.5" diameter.  First noticed 8 days after injection, but may have appeared earlier.  No treatment.
On 10/26/2000, employee awoke with maculopapular rash on face, arms, back, chest, and abdomen; also, headache, cold symptoms, runny nose, joint pain. No visible swelling at present. States he feels like he is getting the flu. No fever. Takes only Dayquil.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates since 29-AUG-2016, improperly stored ROTATEQ (lot # L039141, expiration date 16-AUG-2017, oral; dose was unknown) were administered to unspecified patients. No adverse experiences have been reported. The vaccines were exposure at 52 Fahrenheit degree for 35 minutes. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
severe fatigue, fever chills within 24 hrs lasting 2 days after second dose fatigue, bruises, petechiae after second vaccine diagnosed with ITP on 5-20-21
Aches, chills, redness, itching, and swelling at injection site. Redness went almost all the way around arm. Bigger than softball size. As of today, still looks blue and purple, size of baseball. Still itches
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive; (Aug2023) Positive. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
post menopausal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (post menopausal bleeding) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 022C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POSTMENOPAUSAL HAEMORRHAGE (post menopausal bleeding). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (post menopausal bleeding) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Her last period was in June of 2020. She was scheduled for an ultrasound & biopsy next week.  Company comment: This is a spontaneous case concerning a 55-year-old, female patient with relevant concurrent medical condition of menopause with last menstrual period of 19 months ago, who experienced the unexpected non-serious event of post menopausal bleeding. The event post menopausal bleeding occurred 27 days after the third dose of mRNA-1273 vaccine administration. Patient was scheduled for an ultrasound & biopsy. The outcome of the event post menopausal bleeding was not resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with relevant concurrent medical condition of menopause with last menstrual period of 19 months ago, who experienced the unexpected non-serious event of post menopausal bleeding. The event post menopausal bleeding occurred 27 days after the third dose of mRNA-1273 vaccine administration. Patient was scheduled for an ultrasound & biopsy. The outcome of the event post menopausal bleeding was not resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
After 13 hours from the shot, I had onset chills and body aches. These lasted for 6 hours. I then had a fever of 101 for the next 6 hours. Throbbing headache came around 18 hours after reviving the shot, my arm was also extremely tender to touch. I took ibuprofen 800mg around hour 20. This helped the headache. I had a racing heart rate through the fever. The symptoms lasted for about 36 hours. Following this, I had onset allergies (stuffy nose, dry cough, difficulty breathing, swollen face, watery eyes). Claritin had helped a little bit and swelling went down.
After I went to bed, it was pronounced burning in my feet. Lasted a short time and went a way.
I felt faint 10 minutes after the shot (that came on quickly), then felt slightly dizzy, but after a couple of hours felt okay. Last night and today - noticeable soreness in left arm. Slight chills today (can't quite get warm). I am not sure about the type of flu shot (there were many listed) and definitely don't know the manufacturer.
Friday 6/22 no adverse event. Saturday 6/23 sick in every cell of body, pain all over. Sunday 6/24 bedridden-delirious-painful extreme itching.
Information has been received from an office manager concerning an approximately 17 year old male patient who on an unspecified date was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIBAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune. The patient was administered at least one dose of RECOMBIVAX HB, lot# 603895/0748V. The patient required a fourth dose of the vaccine (lot# and date unspecified). The patient's titer after the fourth dose was unknown due to lack of follow up. No other adverse experience was reported. The patient did not develop hepatitis B. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 30-NOV-1992 (at the age of 10 weeks) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V), (adult dose, vaccine; actual dose unspecified), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow-up information has been received from an office manager who indicated that the currently 17 year old patient non-smoker with no pre-existing allergies or medical conditions on 16-SEP-2010 was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown). On 30-NOV-1992 the patient was vaccinated with a second dose of RECOMBIVAX HB (lot# 603895/0748V) in his left leg. On 08-APR-1993 the patient was vaccinated with a third dose of RECOMBIVAX HB (manufacturer unknown). Concomitant vaccination administered on 30-NOV-1992 included a first dose of ACEL-IMUNE (lot# 330-910) in his left leg, an oral first dose of ORIMUNE (lot# 334-9500667E) and a first dose of B-CAPSA 1 (lot# M020JE) in his left leg. On 20-MAR-2010 a hepatitis B surface antibody test was performed, result was negative: "patient is presumed to be not immune to infection with HBV". On 05-APR-2010 the patient was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown). On an unknown date another Hepatitis B surface antibody test was performed, results were pending. The reporter considered the events to be non-serious. This is one of several reports received from the same source. Additional information is not expected. This is an amended report event "vaccinated with lot # 0748V on 13-NOV-1992" coded to overdose was deleted and narrative was updated. The patient had laboratory work (hepatitis B surface antibody quantitative).
PATIENT REPORTS RED AREA ON UPPER LEFT ARM. Patient states it looks like cellulitis
I DEVELOPED VERITGO AFTER THE VACCINE 11 AFTER THE SHOT, AND IT LASTED FOR THREE DAYS
That evening hurting right arm - red and swollen and it itched like crazy. And then over the next couple of days it got better. And then it started itching a lot. And then it was kind of stressful time and I noticed that five to seven days later, I noticed that my arm was itching more and hurting and noticed it was really, really hot. I had rectangular shaped bright red spot. It was 2 inches by 2 1/2 inches. It was bright red, hot, and hurt like crazy. I put ice on it and it got better over the next week. I think I still have a knot - maybe a knot - that arm is still a little sore and there is kind of a firmer area where that shot was. But no redness or itching anymore. I had chills and felt like I had a fever. I had stomach cramps and body aches - it felt like I had the flu for 24-48 hours after the shot - but that is kind of a typical flu shot response that I even get for that shot. Everything is what I've experienced with the flu vaccine but not the arm.
Vaccines given 10/17/19 on 10/19/19 pt vomited 2x called office triage and was advised to go to ER due possible dehydration DX: viral gastroenteritis
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299813, 2018SA299814, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 66 years old female patient (height: 64.75, weight: 137) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no 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.
Started with headache then general body aches which was mostly manageable, then chills and dizziness. I took 3 ibuprofen. I took a hot bath for.about 30 minutes and most of the issues subsided for about 2 hours then returned (all that I described above) but more intensely, the chills became shakes even with wearing a large hoodie and large sweatpants. Also joint paint started. Taking a 2nd bath now and somewhat subsiding again but still have aches including a stomach ache now, joint paint, and feel very hot.
Burning, curing injection, injection site not, swelling, severe HA x 3 days, doesn't feel well, diarrhea-received vaccine on 9/13/13. Came in 9/16/16.
Within an hour or so of the vaccine, I felt dizzy, short of breath and pains in my head.  Not really a headache, but pains in my head.  I started running a fever that night.  A call to the pharmacist advised me to take an antihistamine, which helped.  I ran a fever the next day, all day, and slept all day.  The second day I felt better, but still a bit dizzy.  About the 4th day after the shot, at night, my skin was hyper sensitive all over.  It itched where my head touched the pillow and the sheet on top of my body was irritating.  More antihistamine helped me to sleep eventually.  Have had some lingering dizziness.
Pneumococcal vaccine administered in 2007 and on 15-OCT-2007; This spontaneous report has been received from a healthcare provider via medical records and from a lawyer from a case in litigation for zoster vaccine live (ZOSTAVAX) (1803USA004717), concerning a 73-year-old male patient.  On 03-DEC-1999, the patient was vaccinated with the first dose (reported as series 1) of pneumococcal vaccine (manufacturer unknown) (dose, route od administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date in 2007, the patient received the second dose (reported as series 2) of pneumococcal vaccine (manufacturer unknown) and on 15-OCT-2007, he received his third dose (reported as series 3) (dose, route od administration, anatomical location, lot # and expiration date were not provided for both) for prophylaxis (inappropriate schedule). On 01-DEC-2014, he received his fourth dose (reported as series 4) of pneumococcal vaccine (manufacturer unknown).  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-1803USA004717:
Started to have pain in right posterior side of neck and the  sternocleidomastoid muscle (right side). Placed on bed rest for 2 days. Full recovery then. No fevers. 8/24/04 Note: This report is 18 months old. Corrections to immunization information were received by telephone and the entire immunization record was received by fax from agency. Corrections were sent to Receipt & Control for scanning. Medical records are not available for ship personnel no longer aboard. The patient is no longer employed on ship and probably has the supplemental health record in her possession and that is the record that would explain the AE. There is no forwarding address for the patient and in fact, she may be living out of the country. There is no formal hospital aboard this ship, so it is questionable that she was "admitted" at the time of the AE. She may have been observed in Sick Bay or possibly confined to quarters. It is doubtful she was taken to a hospital off the ship. CASE IS CLOSED AS IS.
Tremors, chills, chest pain, weakness, vasovagal, migraine, brain fog, premature ventricular contractions, postural tachycardia, pelvic and prostate pain, extreme pain in feet, chronic fatigue, lightheadedness, joint pain.
4AUG92 recvd vax; pt devel mild fever, refusing feeding, intermittent screaming & crying; hives;
Sorting through autoimmune disorders; Having some joint pain; +ANA; This spontaneous report was received from an optometrist concerning her daughter, a 17 year old female patient. The patient did not have known drug reactions or allergies, concomitant medications or pertinent medical history.  On 08-JUL-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular for prophylaxis (dose, frequency, anatomical location, lot number and expiration date were not provided).  On an unspecified date in July 2020 (reported as "a couple of weeks later, sometime in the middle of July), the patient started having some joint pain (arthralgia). In approximately September 2020 (reported as "now"), they were sorting through autoimmune disorders to see what was wrong with her. On unspecified dates in 2020, they performed blood panels and tests on her, and the patient had an antinuclear antibody positive (+ANA) came back, but that was all, so far. No additional adverse events were reported.   The outcome of autoimmune disorder, antinuclear antibody positive and arthralgia was reported as not resolved. The reporter did not provide any causality assessment.  Upon internal review, autoimmune disorder was determined to be a medically significant event.
Sudden onset knee pain/inflammation/diving way and clicking (no injury)  Hypothyroid flare up (elevated TSH, no sleep, constipation, brain fog) Slowing down/late ne striating
S/P Pediarix vaccination 4/16 in PM patient had right sided seizure. Patient went to ER.
Got my 2nd vaccine on December 22 and on December 29th my spotting started and turned to heavy bleeding on January 16th. Same happened with my first vaccine (Pfizer EWO198) that I got on August 2nd at the same pharmacy.  I was bleeding three weeks. This time it has been 19 days.
severe taste of garlic; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN 6200) at 70-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination.  The patient's medical history included allergies to bees and wasps from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the bnt162b2 for COVID-19 immunization on 02Feb2021 at 70-years-old (Lot Number: EL 9265, administration time: 10:00, vaccine location: Left arm, dose number: 1). On 03Mar2021 at 12:00, the patient experienced severe taste of garlic (non-serious), where gum and mints did not help. There were no therapeutic measures taken, however, a physician office visit was required. The clinical outcome of the event was not recovered. The patient was not tested for COVID post vaccination.   No follow-up attempts are needed. No further information is expected.
Second day had fever and extreme lethargy.  A few days later broke out in body rash that is still here a few weeks later. Went to doctor and she said it looks like P. Rosea. Rash covers full back, chest, stomache, partial neck and legs.  No history of this.
1-05-2009 received flu vaccine. Pt reports that evening feeling chilled, dizzy, weak, severe aching bit. Forearm and difficulty breathing, pale, HR102,BLP 132/751 no fever, lasting approximately 4 hours or until going to sleep
6/8 Headache, Chills, Fatigue 6/9 Headache, Chills, Fatigue 6/10 Headache,  Chills, Fatigue, cough,  1st dose was May headache, chills, fatigue, rash
Patient felt dizzy and lightheaded after the vaccine.  Patient's mother came to pharmacy and informed us of this, and we gave her drinks and crackers.  She felt better in 15 minutes.  Patient stayed in vaccine room and did not wait outside the room where patients were supposed to wait.  I wasn't aware of this as well, as I was helping out for only a day.
39 yo male employee with history of Covid 3/2020, and SVT s/p ablation x 2 (2002, 2008) who came to hospital S/P Covid vaccination for recurrence of SVT.  Given 50 mg IV benadryl prior to arrival to hospital.  Prior to discharge had recurrence of SVT to HR 170.  Placed in Obs overnight for telemetry monitoring.  No events overnight.  No dyspnea, fever, body aches, or hives.  Discharge patient home with follow up with MD for possible holter monitor.
Sudden fatigue; Chills (97.9F temp); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 (at the age of 65-years-old), as single dose for COVID-19 immunisation. The patient had no medical history and allergies to medications, food, or other products. The concomitant medication included tylenol (MANUFACTURER UNKNWON) at a dose of 500 milligram (mg) 2 times a day from 18Mar2021 at 23:00 for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced sudden fatigue and chills on 19Mar2021 at 19:30. The patient underwent lab tests and procedures which included body temperature on 19Mar2021 at 19:30 and it was 97.9 degree Fahrenheit. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue and chills were resolving at the time of this report. No follow-up attempts possible. No further information expected.
3-4 weeks after her second dose of the COVID-19 vaccine, she started limping and complaining of left ankle pain. She was evaluated by pediatric rheumatology as inpatient on 3/25/2022. She was initially treated with naproxen but her symptoms did not resolve. At her follow up visit with pediatric rheumatology she continued having symptoms of left ankle pain and was prescribed etanercept under the diagnosis of Chronic Non-bacterial Osteomyelitis (CNO). She has a follow up clinic visit to evaluate for the effectiveness of etanercept therapy on 7/7/2022.