chrisvoncsefalvay/vaers-outcomes huggingface dataset:
65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month; This spontaneous case was reported by a physician and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Arthritis and Obesity.   In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not have any previous issues with her reproductive system, and she had never had uterine cancer or anything like that. No concomitant drug was reported. Reporter was asking for any reports of menstrual period in elderly, after receiving Moderna COVID-19 vaccine. Doctor stated that he was trying to work her up.  No treatment drug was reported.  Company comment.  This spontaneous case concerns a 65  year  old female patient, with relevant medical history of obesity, who received three doses of mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant) event of postmenopausal haemorrhage. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that after the booster dose the patient started having her menstrual period every month. The outcome of the event was not recovered. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history could be risk factor for the event. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   Reporter did not allow further contact
Severe headache; Fever; Muscle and joint pain; Muscle and joint pain; Lethargy; This is a spontaneous report from a contactable consumer (patient) reported.   An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via unspecified route of administration, administrated in left arm on 03Feb2021 at 15:00 as 2nd dose single for COVID-19 immunization. The patient medical history included fibromyalgia, arthritis. Allergies to medications, food, or other products: amoxicillin. Patient received first dose (BNT162B2, Batch/Lot no: EL0140) via an unspecified route of administration, administrated in right arm on 01Jan2021 at 10:00 for COVID-19 immunization. the patient concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in hospital. On 04Feb2021 at 03:00am, patient experienced severe headache, muscle and joint pain, fever, lethargy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started feeling really tired and congested, and took a COVID-19 test and was positive. Was prescribed PAXLOVID. Started feeling better a few days later. Then a week later I started getting cold symptoms again and retook the COVID-19 test and was positive. Rested at home with OTC medications. Tested negative but still feel more tired than I did before testing positive.
Patient presented to Hospital via EMS secondary to a fall outside where she fell of her hands and knees complaining of weakness and unable to get self up.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter was office manager. The age at vaccination was not reported. The reporter called to report that, the patient was administered an expired dose (10 days after expiration date) of Boostrix, which led to expired vaccine used. The reporter did not consent to follow-up. The reporter stated that she did not want to report anything.
nausea, vomiting, diarrhea, gi discomfort approx 12 hours s/p 2nd injection
This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), stumbling, disorientation, pallor, clamminess and blurred vision. On an unknown date, the outcome of the passed out, stumbling, disorientation, pallor, clamminess and blurred vision were unknown. It was unknown if the reporter considered the passed out, stumbling, disorientation, pallor, clamminess and blurred vision to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. At the time of discharge, the patient went to the restroom and came out of bathroom stumbling, disoriented, pale and clammy. He developed extreme blurred vision for about 3 minutes and almost completely passed out on to the reporter. The patient's blood pressure was measured as 82 per 48, but 100% oxygen saturation was noted. The reporter was able to stabilize the patient after about 8 to 10 minutes and then he was monitored for a while after and was discharged in stable condition. The patient had not eaten in almost 22 hours, so the reporter was sure that it had a lot to do with the events, but just wanted to report it and see if this was something occurring more frequently.
MMR vaccine administered IM in right deltoid instead of SQ 2 calls made to pt 2/4/09 for f/u - no answer Merck contacted- indicated vaccine may be less effective via IM route but not to revaccinate
Swollwn lymph node of L arm on day 3, general inj site discomfort, body aches/fatigue day 1 and 2  Narrative:
she bled at injection site after administration and some vaccine; she bled at injection site after administration and some vaccine; This is a spontaneous report from a Pfizer sponsored program support. A contactable health care professional reported for the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had bled at injection site after administration and some vaccine might have come out. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever; vomiting; muscle aches; joint aches; flu-like symptoms/Felt like a bad case of the flu.; sore arm; inflamed lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 at 13:00 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history included pemphigus vulgaris and irritable bowel syndrome (IBS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. The patient previously received tetanus vaccine (MANUFACTURER UNKNOWN) for immunisation on unknown date and experienced allergy to vaccine. On 29Sep2021 at 15:00, the patient experienced fever, vomiting, muscle aches, joint aches, flu-like symptoms, sore arm, inflamed lymph nodes and felt like a bad case of the flu. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever, vomiting, muscle aches, joint aches, flu-like symptoms, sore arm, inflamed lymph nodes was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Chest discomfort; Back ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received. It contains no new information.
Day 6-itchy rash/hives on bilateral upper arms Day 7- itchy rash/hives on bilateral upper arms and bilateral upper legs  Day 8-itchy rash/hives on bilateral upper arms, bilateral upper legs, and bilateral scapular areas
Shingles was reactivated within 2 hours of shot in the same place it has appeared several times. Lasted a few days. Used a creme doc gave me. Did not seek treatment.
Basic fatigue and arm tenderness with in 24hours. Symptoms went away. Few days later servers pain in left underarm near lymph nodes. Pain lasted 5 days. Pain became less intense day 2 but developed intense itch at injection site. Lump, rash, tenderness, and pain developed at injection site again and lasted for 5 days.
First / 10/2019. Due to COVID restrictions / second dose was not received; This case was reported by a consumer via call center representative and described the occurrence of social problem in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in October 2019, in left upper arm).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination not applicable. Due to COVID restrictions, the second dose was not received. Consented to follow up. This case is linked to the case US2021086465 and US2021AMR087889, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086465:Same reporter US-GLAXOSMITHKLINE-US2021AMR087889:Same reporter
Pharmacist reported received on 15 Jul 2022 a dose of Havrix that had expired on 18 Jun 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comments: The case was reported by patient who was pharmacist. The Pharmacist received the dose of Havrix on 15 July 2022 that had been expired on 18 June 2022. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Headache, Myalgia, Fever, NauseaVomiting, redness/swelling of eyes; loss of appetite Narrative:
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feeling awful), chills, pyrexia (slight fever), myalgia (severe body ache) and nausea in an 81-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. No medical history reported. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feeling awful), chills, pyrexia (slight fever), myalgia (severe body ache) and nausea. The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, feeling abnormal (feeling awful), chills, pyrexia (slight fever), myalgia (severe body ache) and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
booster; hives; 2 episodes of mosquito bites; I noticed a marked change in color perception post shots/ Probably around Sept noticed the colors (cars outdoors) were dull again. Post shot, colors bright again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Oct2021 11:00 (Lot number: FF2589) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma" (ongoing), notes: long time; "high blood pressure" (ongoing), notes: progesterone i am taking baby aspirin not normally prone to blood clots just in case.; "nasty cough", start date: 2019 (unspecified if ongoing), notes: i had a really nasty cough Nov/Dec 2019. Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement; PROGESTERONE (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); BABY ASPIRIN (ongoing); ALVESCO taken for asthma (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Lot/batch no. - EN6198, Administration time=11:00, Anatomical site of Injection = left arm, Route of administration - intramuscular, Route- intramuscular), administration date: 02Mar2021, for COVID-19 immunization; Bnt162b2 (2nd Dose, Lot/batch no. - ER2613, Administration time=11:00, Anatomical site of Injection = left arm, Route of administration - intramuscular), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives"; ARTHROPOD BITE (non-serious) with onset Oct2021, outcome "unknown", described as "2 episodes of mosquito bites"; DYSCHROMATOPSIA (non-serious) with onset Oct2021, outcome "unknown", described as "I noticed a marked change in color perception post shots/ Probably around Sept noticed the colors (cars outdoors) were dull again. Post shot, colors bright again."; IMMUNISATION (non-serious) with onset 27Oct2021 11:00, outcome "unknown", described as "booster". Additional information: Reason for third dose reported as "2 episodes of mosquito bites or hives on left arm, so to see if these happen on rt arm". Prior vaccination and relevant tests were reported as none. Reported "I had a really nasty cough Nov/Dec2019: coughed so hard thought my uterus would fall out - all kidding aside, the non-cold cough was brutal. would like to know if it might have been c-19. I noticed a marked change in color perception post shots. wondered if due to Pfizer shots. I am an artist, so this was/is amazing. I know now that it is due to shot, because I put off getting the booster. beyond the recommended 6 mos. probably around Sept noticed the colors (cars outdoors) were dull again! post shot? colors bright again".  No follow-up attempts are possible. No further information is expected.
Client was given a dose of Janssen COVID vaccine.  After vaccination the nurse realized the the Janssen vaccine was punctuated about 6 and 1/2 hours prior.  The vaccine had been stored at 40 degrees F the whole time it was open.  Client had no adverse reaction to the vaccine during his 15 min observation period.
Six hours after receiving my second dose of Moderna my body started shaking so badly that I was unable to sit up or swallow.  I had violent tremors for over 30 minutes and then my temperature spiked to 102.3 for 2 days and on the 3rd day my temperature was around 99.9.  This lasted all weekend even with the therapy of ibuprofen and Tylenol .
This spontaneous report as received from a nurse refers to a 10 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route of administration were not reported, lot # L043703 with expiration date :03-NOV-2017). No adverse reactions were reported. Additional information has been requested.
ARTERIAL DISSECTION; This spontaneous report received from a parent via social media via a company representative concerned an adult female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced arterial dissection, it weakened her artery from neck to brain that it tore. Reporter stated "J and J almost killed my adult daughter. "Arterial Dissection". The specialist told us it was caused by the J and J shot. It weakened her artery from neck to brain that it tore". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arterial dissection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220865333-covid-19 vaccine ad26.cov2.s-Arterial dissection . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Excruciating lower back pain; My physical therapist thinks it's my sciatic nerve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08May2023 at 15:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "Excruciating lower back pain"; SCIATICA (non-serious), outcome "not recovered", described as "My physical therapist thinks it's my sciatic nerve".  Additional information: The patient was asking if there is any information on vaccine causing sciatic nerve pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: called pt at end of shift   states still experiencing tingling/numbness into her left hand   stateted if gets worse or does not resolve in a day  to call md
Information has been received from a nurse concerning a dialysis patient who was vaccinated with five doses RECOMBIVAX HB (dates of vaccination were 8-AUG-2006 (40 mcg/ml), 16-SEP-2006, 17-FEB-2007, 19-JAN-2008, and 19-FEB-2008). On an unspecified date the patient became positive for Hepatitis B. Patient outcome was not provided. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-AUG-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On or about 02-SEP-2015, the patient was treated at a dermatology clinic for a blistering vesicular outbreak that was diagnosed as herpes zoster. The patient was prescribed FAMVIR for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Talking in her sleep; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP TALKING (Talking in her sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), ATORVASTATIN, CLONAZEPAM and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLEEP TALKING (Talking in her sleep). On 18-Apr-2021, SLEEP TALKING (Talking in her sleep) had resolved. Not Provided          No treatment information was provided.
Wrong Diluent used . was diluted with bacteriostatic sodium chloride . not sodium Chloride supplied with vaccine , Patient was contacted to return for vaccine repeat r/t recommendation of manufacturer .