chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, hives, lips puffy, tounge thick feeling, tight chest(felt like heart-sank, but with palpitations) , became more difficult to breathe (used albuterol)& took Benadryl. Respiratory, palpitations,& hives/ lips went down. Rash still slight. Continued to take Benadryl following 2 days.
This patient broke out in a rash on the next day. A rash to his forehead, arms, legs, and trunk of the body. The rash lasted 1 week.
9AM fingertips blistery, mottled, sl swollen, red w/white dots, voiding more, sl loss of appetite, sleeping normally; grumpy;
Nausea at least daily from day 1. Vomiting 5 times from 12am until 7am on the 23rd. Got treatment prescribed ondansetron 8mg and lordataine 10mg started taking on the 24th. Symptoms almost fully aliveated by the 25th. Still residual nausea and unable to work.
About 12 hours after vaccination, I started to have severe chills, fever, intense headache, body aches, inability to sleep and sweating.  This last 24 hours and then began to dissipate.  The headache left first.  These symptoms mirrored the symptoms I had with COVID minus the sinus drainage and sore throat I had with COVID.  Yet, the symptoms were more intense.  The reaction to the vaccine was the sickest I recall being in the last 20 years.  It was a long 24 hours. I went to the ER and obtained a liter of fluids via IV and motrin type medicine.  I was advised it should last about 24-36 hours and discharged.
was absolutely freezing and would then get hot; never felt so sick in her life; This is a spontaneous report from a contactable consumer or other non health care professional. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 24-years-old) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, while reporter reporting on herself, she reported that her grandson's girlfriend told her that she was absolutely freezing and then would get hot and said that she never felt so sick in her life. She said that it was from the Covid vaccine, but she does not know which one. She does not have a NDC, Lot, or expiration date to provide. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to an 11 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  8/13/2022 - Patient called and reported the following: Patient reports he had an adverse effect to the Moderna booster that he obtained 3 weeks ago. Patient reports he had shortness of breath, pounding heart, fatigue, joint pain, body aches, and swelling. Patient states he is not having symptoms now. Patient state he just wanted to report it. Patient reports being incapacitated from 7/22/22 - 8/4/22 d/t reactions from the COVID vaccine. Patient did not identify any treatment.
Patient arrives to observation at 11:00 following feeling lightheaded and sweaty after receiving the vaccination.  She states she has a needle phobia and "just needs to lay down"  BP 140/79 HR 68 oxygen sat 98% on room air.  She was given some water, utilized slow breathing and relaxation techniques and gold fish crackers .  10:05 BP 132/74 HR 79 Pulse oxygen 100% on room air.   10:20 BP 129/89 HR 77 oxygen sat 100% on room air. patient stated she feels better and was escorted to the exit in a wheelchair at 10:20 am
Narrative:  10/16/2020 COVID swab, result: not detected COVID infection following COVID vaccine series 03/24, Pfizer, dose #1 04/14, Pfizer, dose #2 06/01 COVID swab, result: not detected 06/07 Ct head impression: No acute intracranial abnormality. 08/05 pt cc: cough, headache exposure: unknown 08/09 COVID swab, result: detected
Pain at injection site. Hot at injection site. Slight swelling at injection site. Mild fever. Moderate dizziness. Tired.
CHILLS, fever ~38.8 C, myalgias, severe headache, and back pain  duration 36h
Nausea; Vomiting; Headache; Small fever; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Small fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Small fever). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Small fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Additional information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sudden Hearing Loss Syndrome resulting in vertigo so severe I was in hospital 3 days and rehab 6 more days. While huge improvements have been made, dizziness and balance issues remain unresolved. While hospitalized, an MRI of the brain showed a TIA that appeared to have happened about the same time as the FLUZONE was administered. Saw PCP's PA on 10-01-18. Saw ENT on 10-16-18. Saw PCP on 10-26-18. Saw Audiologist and ENT on 11-14-18 for full hearing and balance testing.
Vaccine that was administered on 8/3/22 expired on 7/31/22
No adverse event; HCP called to report inadvertent administration of VAQTA to a patient on 08/30/2023 after experiencing a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient´s medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 28-AUG-2023, vaccines has temperature excursion for 3 hours 31 minutes with a high of 10.7C, the on 29-AUG-2023, for 32 minutes for a low of 0.5 C.  On 30-AUG-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (0.5ml/once, lot#: X010374 was verified to be valid for syringe formulation with an expiration date of 13-NOV-2024; anatomical location, route of administration and strength were not provided) for prophylaxis. The vaccine administered inadvertently experienced a temperature excursion at -0.4C for 6 hours 5 minutes (product storage error). The vaccine also experienced previous temperature excursion at 0.5C for 32 minutes and 1 C for 2 hours 1 minutes. It was reported that on 31-AUG-2023, vaccines temperature excursion was for 3 hours and 32 minutes with low of -0.4C. It was confirmed no symptomatic adverse events. No additional adverse events (AE) were reported (no adverse event).   This is one of several reports received from the same reporter.
her arm was sore; 8 inches wide red; warm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was sore), ERYTHEMA (8 inches wide red), VACCINATION SITE WARMTH (warm) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 PAIN IN EXTREMITY (her arm was sore), ERYTHEMA (8 inches wide red), VACCINATION SITE WARMTH (warm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (her arm was sore), ERYTHEMA (8 inches wide red), VACCINATION SITE WARMTH (warm) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Patient's first name was corrected and patient declined further follow-up.
Patient received the shot, then sat in chair in waiting area. He became dizzy, we believe and fell over. Pharmacist reported he was pale and sweaty. He also vomited, and hit his head. He was transported to the hospital by 911. The pharmacist had him lay and not move and gave him an ice pack for behind his neck while waiting for emergency personnel.
Patient presented to emergency department on 11/26/2021 with poor appetite and shortness of breath. Patient found to have COVID-19 infection and admitted for further management. Patient was discharged home on 11/29/2021. Patient presented to emergency again on 12/3/2021 due to acute hypoxic respiratory failure, physical deconditioning, poor functional performance, and dysphagia. He was treated with  steroids and required noninvasive positive-pressure ventilation. Palliative care was consulted and patient was changed to comfort measures on 12/7/2021. Patient expired on 12/10/2021
Developed low grade fever, muscle aches, headache, decreased appetite the day after the vaccination (same symptoms after the 1st dose 2 months ago). Symptoms mainly resolved after 24 hours.
Pt reports a swollen lump on the bicep of her right arm. She states she first noticed it on 5/26/21 and that it is just above her elbow crease. She says that on 5/26/21 it was approximately the size of an egg, and felt hard. She states it is smaller and softer today, 5/27/21. She says it never hurt, wasn't red, and didn't bother her much. Advised to seek medical care if it worsens or increases in size again.
Dizziness, Headache, NauseaVomiting, insomnia, mental fogginess, hot/cold flashes, bradycardia Narrative: Noted sore arm for 2-3 days following the 1st dose. Received 2nd dose at 8:30 am on 2/5/21. Noted onset of nausea at 1:00 pm. At 3:30 pm had sudden onset of nausea/vomiting with severe heaving/emesis. Also onset of /headache. Nausea continued through 2/7/21 - treated with ondansetron every 8 hours. Also reports insomnia, brain fog, dizziness. Intermittent hot and cold flashes, but no fever. She has chronic PVCs and also noted more apparent bradycardia than usual - pulse running in the 40-50s (usually 50-60s). She is usually in the 50-60s. No known prior COVID infection.
fever 101.6 at 8 a.m. dropped to 99.9 by 8:40 a.m.  (after tylenol)
Baseball sized knot. Hard. Hot. Dizzy. Watery mouth. Migraine. Nausea. Red patch with bumps. Couldn't move arm up or out.  Swelling has now gone down. I can move my arm again. However I have been lethargic ever since & constant migraines. I feel overall weak.
asks if she can get the vaccine even though she feels weak and can't fall asleep; can't fall asleep; This is Spontaneous report from a Pfizer sponsored program. A female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "asks if she can get the vaccine even though she feels weak and can't fall asleep"; INSOMNIA (non-serious), outcome "unknown", described as "can't fall asleep".  Additional information: Caller stated that she got the 1st dose on 28Mar2021 and has a 2nd dose schedule tomorrow 21Mar2021. Caller asks if she can get the vaccine even though she feels weak and can't fall asleep. Caller called in yesterday saying that she received the 1st dose a few weeks ago. She is scheduled for the 2nd dose today but is not feeling well. Yesterday rep transferred to alternate department to report AE but caller was on hold for three hours then call was disconnected. caller wants to know if she can reschedule the 2nd dose of the covid vaccine read off scheduling FAQ and offered number for PMI for more info on if it is okay to get vaccine late but caller declined and disconnected call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
little soreness; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Patient is taking medications as blood like thinner and for osteoporosis. She has allergies previously to grass and dust mites. She always has a wet nose when having allergies and does a nose drop and cleaner. Her nose was always on the runny side, she cannot live without a tissue. She uses a nasal spray and the cleaner. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, amlodipine, simvastatin, acetylsalicylic acid (BABY ASPIRIN) as blood thinner and paracetamol (TYLENOL ARTHRITIS) for osteoporosis. On an unspecified date in Jan2021 she had little soreness and had no other symptoms. The patient was asking if she should stop taking the BABY ASPIRIN and TYLENOL ARTHRITIS now that she got the vaccine. She read some place one should not take any aspirin. The case was reported as non-serious. The outcome of the event was unknown.
syncope, sweating, light headed, temporary sight disruption/ low heart rate, dizzy, nausea, flushing
"I have chills, severe intestinal pain, nausea, headache, exhaustion, nasal congestion."
back muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "recovering", described as "back muscle pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experienced migraine headache so severe it prompted a visit to her primary care provider and three emergency room visits.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer and described the occurrence of nerve disturbance in a 64-year-old female subject who was vaccinated with FLULAVAL. A physician or other health care professional has not verified this report. The subject's medical history included reaction to preservatives. This subject had no adverse events following receipt of prior immunizations with influenza virus vaccines. The subject reported that she did not have any adverse events following receipt of previous vaccinations, but noted that she does not get vaccinations. Concurrent medications included CARDIZEM and TOPROL. No other vaccinations were administered on the date of receipt of FLULAVAL. On 14 October 2008 at 11:30 am the subject received "the one and only" dose of FLULAVAL (unknown, right arm). On 15 October 2008, 1 day after vaccination with FLULAVAL, the subject experienced nerve disturbance described as "nerve endings felt weird", diarrhea and total exhaustion. The subject consulted a healthcare professional regarding the event. At the time of reporting the outcome of the events was resolved. The subject reported that the exhaustion is not flu-like. She could not further describe what she meant by her nerve endings feeling weird. The consumer reported that one other subject experienced adverse events following receipt of FLULAVAL. Please see case A0753992A.
Record indicated that patient was due for DTP, HAV, and HPV. Dose #7 (given on 7/3/13) was listed as incorrect spacing, and another dose was due on 2/5/14. Vaccine was administered and found on 2/6/14 that record indicating incorrect spacing was wrong. Dose given on 2/5/14 for Tdap was not needed. Record took dose given on 2/5/14 as valid.
PAIN AFTER VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 18-FEB-2022) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced pain after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain after vaccine was not reported. This report was non-serious.
This spontaneous report as received from a Licensed Practical Nurse refers to a 31 year old female patient who on 16-JUN-2015 was inadvertently vaccinated with PROQUAD (Merck), subcutaneous (dose, lot # and expiration date were not provided) instead of M-M-R II and VARIVAX (Merck) (wrong drug administered). No adverse effects reported. Additional information is not expected as the reporter refused additional contact.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     Patient had no allergies. Other vaccine was not given to the patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Diabetes.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This Spontaneous case concerns a 53-year-old male patient with no medical history reported, who experienced the unexpected nonserious AESI event of COVID-19 which occurred on unspecified day in February 2022 after the second dose of mRNA-1273 vaccine received on unspecified date. SARS-CoV-2 test was positive as of February 2022. Lack of efficacy cannot be concluded as dates of vaccination details were not provided. Ongoing pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority's reporting.   This case was linked to MOD-2022-549198 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 53-year-old male patient with no medical history reported, who experienced the unexpected nonserious AESI event of COVID-19 which occurred on unspecified day in February 2022 after the second dose of mRNA-1273 vaccine received on unspecified date. SARS-CoV-2 test was positive as of February 2022. Lack of efficacy cannot be concluded as dates of vaccination details were not provided. Ongoing pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority's reporting.
Visual disturbance for less than 1 minute. Headache that lasted several hours (can not directly correlate headache to vaccine - could have been limited caffeine intake that morning)
Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a little swollen at the injection site.
Most food (besides sweets) don't taste the same; Metallic taste in mouth at all times; This is a spontaneous report from a contactable consumer (patient, self-reported). A 42-year-old non pregnant female received second dose of f BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Ew0171 and expiry date was not reported), intramuscularly in Arm Left, on 23Apr2021 at 02:30 PM (age at vaccination: 42 years), as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient did not test for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0150 and expiry date: 31Aug2021), intramuscularly in Arm Left, on 01Apr2021 at 07:30 AM, as dose 1, single for COVID-19 immunization. The patient reported that, on 02Jun2021, she had metallic taste in mouth at all times. Most food (besides sweets) did not taste the same and very metallic or ferric. She also experienced constant burning smell/taste. Sweet foods were ok, but any other food such as meat and vegetables taste like metal and were gross. This change in smell ability could be a serious issue if she would be unable to do her job as a scientist in a chemical lab since she cannot determine chemical potency. The patient did not receive any treatment for the events. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101128399 same patient, different dose/events