chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017 at 14:06, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704
On 11/15/21 I woke up with hives covering scalp, ears, and neck. Over the next two days they continued to become more severe, covering most of my body, including torso, upper thighs, elbows, behind knees, and swelling on eyes. Symptoms are being reduced by Cortisone shots and daily use of high levels of OTC and Rx antihistamines.
Pt recv vax on 3/16/99; on same day pt exp painful/ swollen vax site, fever x 3 days; tx=Benadryl, Tylenol
Joint pain and stiffness throughout body.  Became prominent and intense at aproximately one week after injection.  Continuous and persisting.  Had workup by rheumatologist.  Blood tests show no RA, but arthritis indicated in all joints x-rayed except left knee (pain in knee is pronounce as all other joints)
Extensive swelling, aching pain, extensive redness and itching, slight temperature.  Continuing at 12/8/2016.
This spontaneous report as received from a pharmacist refers to a 73 years old male patient with no drug reactions/allergies. The patient was vaccinated SQ with 0.65 ml ZOSTAVAX (lot # 670614/0620AA) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had a rash and "full blown shingles". The patient sought medical attention by visiting to pharmacy and physician office and was treated with valacyclovir and TYLENOL with codeine. The outcome of rash and full blown shingles was reported as recovering/resolving. Additional information has been requested.
itchy hives on neck; itchy hives; This case was reported by a consumer and described the occurrence of hives in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced sore arm, refer case US2021AMR215015).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were recovering/resolving.   It was unknown if the reporter considered the hives and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. Patient received second dose of shingles vaccine a few days ago about 2.5 months after the first dose and experienced more significant issues like extremely itchy hives on neck. The patient could not wait for them to go away.  The hoped that it's not a recurring issue. It started going away yesterday, and was even better on the day of reporting. The patient never had hives before and had not been exposed to any strange environmental situations.  The patient did not wore cologne or put any chemicals on his/her body.  The patient reported that it seemed like it's going to be completely fine in another couple of days; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215015:same reporter
This spontaneous report as received from female medical assistant of unknown age reporting of herself with no pertinent medical history and drug reactions or allergies. The reporter stated that she received two doses of M-M-R II as a child on unspecified dates. She stated that over the last ten years, she had received two additional doses of M-M-R II on unspecified dates. Concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot number were not reported). On an unknown date, the reported stated that "recently" she had titers drawn and her titers for mumps were negative. She stated that they were "under 90" (units not reported). No symptoms or disease reported. The reporter did not sought medical attention. The patient did not received a treatment. The outcome of her titers for mumps were negative was reported as not recovered. Additional information has been requested.
Swelling all over her body, ear popping all the time, hands and feet are numb, torso swollen and numb, face swollen and red. Taking steroids for four days. Went to hospital. Then went to other facility.
Immediately after receiving  both vaccines, the Patient became nauseated and about 15-20 seconds later he vomited x2.  Pt did not lose consciousness nor did he have any difficulty with breathing.  After vomiting, the Patient stated that he immediately began to feel better
Generalized hives more on chest, neck and arms after shots; more pronounced erythematous rash, tender to touch, minimally raised approx 10 x 6 cm at site of TRUMENBA 2.5 hrs after the shot.
Arm tender where I got the shot, Chills, upset stomach, headache, no energy, right calf cramping.  Day 2,  I have a bump where the shot was but I didn't have it on day 1.
DIAPHORESIS Narrative:  Felt sweaty, rapid hr which subsided after 30 min. Initial 137/81 HR 119; End 123/48 HR 92 O2 SAT 97
Metallic taste in mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant product use was Allergy pill.  Treatment medication include toothpaste, gum and mouthwash.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow- up document contains updated date of  birth of the patient and updated batch/lot number of the suspect drug
Redness appeared by the injection site, half way down to the elbow; Loss of appetite; 101F fever lasted three days; chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy NOS from 2003 to 2004 and Crohn's disease. Concurrent medical conditions included Osteoporosis, Small fiber neuropathy (Autonomic small fiber Neuropathy) and Diastolic heart failure. Concomitant products included VEDOLIZUMAB (ENTYVIO) and PYRIDOSTIGMINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, 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 DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (101F fever lasted three days), CHILLS (chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness appeared by the injection site, half way down to the elbow) had resolved.            No treatment medications were provided Patient stated that - redness pretty much went away week and a half later   This case was linked to MOD-2021-289115 (Patient Link).
CHRONIC DIZZINESS, NAUSEA, FULLNESS AND PRESSURE IN BOTH EARS BUT LEFT LASTED MUCH LONGER, UNSTABLE BLOOD PRESSURE, SYMPTOMS LASTED JUST OVER TWO MONTHS.
COVID-19; COVID-19; FACILITATED COLLECT  This is a non study report received from a contactable consumer (patient) and physician based on information received by Pfizer  (manufacturer control number: 21K-163-3959431-00).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization; pancreatin (CREON), orally from an unspecified date (Batch/Lot number was not reported), at unknown dose for exocrine pancreatic insufficiency. Medical history included exocrine pancreatic insufficiency. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trail. The patient experienced covid-19 on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of event was unknown. Causality for BNT162B2 as per reporter was not reported. Causality for pancreatin as per reporter  was not provided.  The reporter's assessment of the causal relationship of event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Should have started menstrual period anywhere from 3/18/21 to 3/22/2021, but did not get until 4/1/2021, which was 39 days from the previous period.  Normally get them about 25 days apart.  Then got it again on 4/19/2021.  So it appears the vaccine gave me irregular periods, which I read has happened to others, so I am reporting it.  Could be coincidence, but thought I should report anyway.
On 10/11/2017 (5 days after receiving immunizations), pt began to have loose occasional cough, decreased appetite and activity. She vomited once on 10/15. Mother hasn't checked temperature though felt warm to touch. She gave her tylenol which helped at first though eventually didn't. Mother denied recent exposure to animals or recent foreign travel. Pt has been having adequate fluid intake and urine output. Mother denies diarrhea, dyspnea, erythema of hands/feet, lip irritation/cracking, nasal drainage and rash. On 10/16/2017, baby had a temperature of 102.9 F rectally. She looked irritated, tired, had dry lips, and R ear erythema. I placed her on Amoxicillin and will be following up with her closely.
Body aches; Significant injection site pain; Overall ill feeling; N/V; N/V; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 14:00 (Lot number: FF2590) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Structured information(Patient episode name): Rheumatoid arthritis. Concomitant medication(s) included: METHOTREXATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EP6955), administration date: 24Mar2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EL3248), administration date: 04Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 14:00, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Significant injection site pain"; MALAISE (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Overall ill feeling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 29Nov2021 23:30, outcome "not recovered" and all described as "N/V". Therapeutic measures were not taken as a result of pain, vaccination site pain, malaise, nausea, vomiting.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications that the patient received within 2 weeks of vaccination was Methotrexate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. known allergies was KNDA. Device Date: 29Nov2021  Follow-up attempts are completed. No further information is expected.
I received the shingles vaccine a week ago.  The next day, my upper arm was totally swollen.  A huge red blotch was in the center where the shot was given, and there was redness all around that.  There was significant pain, and it was awfully itchy.  It got worse over the next few days.  I couldn't sleep for three nights because of the swelling and pain.   Yesterday, the swelling had totally subsided and the red center blotch turned somewhat black and blue, so I know it is going away.  But when I initially asked about any side effects of the vaccine, I was told there might be a few hours of swelling and redness, and that wasn't the majority of people.  After my symptoms worried me, I asked another person about her experience with the vaccine, and she had the same outcome as I did.  So I am reporting this to make sure that you know this is not an uncommon reaction to the shingles vaccine, and the truth should be told to those asking about potential reactions to the vaccine.  I have never had an adverse reaction to any other medications/vaccines...only this one.
This patient developed a severe, multisystem inflammatory syndrome after covid vaccination that necessitated hospitalization for 6 days. It involved skin (rash), liver (elevated bilirubin and asT/alt), bone marrow (leukopenia, thrombocytopenia), cns (hallucinations, visual disturbance), and musculoskeletal system (synovitis). Inflammatory markers were markedly elevated with ferritin over 1000 and CRP over 100. COVID infection was definitively excluded.
inspected the injected arm of the female patient and described it as "a gnarly golf ball size" bump/bump at injection site (arm); This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: inspected the injected arm of the female patient and described it as "a gnarly golf ball size" bump/bump at injection site (arm)).  The outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Arexvy.     It was unknown if the company considered the injection site swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-SEP-2023 GSK field representative spoken to a physician's assistant regarding a female patient who received AREXVY.  The reporter did not have the patient's initials or date of birth. The patient was 65 years of age or older (elderly). The reporter did not have the lot number of the AREXVY that was administered. The vaccine was administered at a pharmacy and not at the provider's office. The physician's assistant inspected the injected arm of the patient and described it as "a gnarly golf ball size" bump.  The physician's assistant was not sure if the bump was due to the AREXVY medication itself or if it was "the pharmacist jabbing her arm"  that was possible improper injection technique. The reporter was not informed that GSK safety would contact and she was unaware. The reporter consented to follow up.
Anaphylactoid reaction; Dyspnoea; Swollen tongue; Throat tightness; This case was received via FDA VAERS (Reference number: 1072186) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTOID REACTION (Anaphylactoid reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Egg allergy and Allergy to vaccine (flu vaccine).   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ANAPHYLACTOID REACTION (Anaphylactoid reaction) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness). At the time of the report, ANAPHYLACTOID REACTION (Anaphylactoid reaction), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. Waiting on the EMS to arrive the patient started having rebound anaphylaxis so was given shot of another EpiPen. Patient was then put into EMS and left for the hospital.  Company Comment : 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.; 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.
Same day of vaccine administration, pt reported swelling of hands, feet, eyes. Also, developed flu-like symptoms. Referred to her PCP.
Beginning 10.5 hours afterreceiving my second Pfizer Covid vaccine I started having body aches, headache, fatigue, nausea and fever. The body aches progressed to skin and joint pain similar to a terrible sunburn. I was unable to sleep more than 2 hours in a 36 hour period. The fever subsided after about 20 hours and the joint and skin pain subsided after 32 hours. Regularly administered Tylenol brought the fever down a bit but made no impact on the body/skin aches.
Individual had a syncopal episode after approximately 1-2 minutes after receiving the 2nd dose Pfizer lasting approximately 30-45 seconds.
Pt had trouble sleeping, energy, dropped severely, lost of appetite, rapid breathing, low grade fever. Contacted doctor who recommended to bring the child for evaluation. Parent has been giving pt Advil to help with the symptoms.
FLUZONE HD PF NDC 49281-0397-88 lot #: UI430AA Exp: 20Mar2016. Swollen & painful left arm after receiving vaccine.
About  24 hours after the vaccine administration, he became unresponsive at the nursing home. He was sent to the hospital where he is now on a heparin drip due to bilateral Pulmonary Embolisms and multiple DVTs.
Patient had administered with Pediatric Pfizer Vaccine(5 to 11yrs). Pediatric  vaccine is not strong enough to get protection. patient was contacted to revaccinated but she has not come back yet to pharmacy