chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 3:00 am on 04/23/22 I woke up with nausea, vomiting, cold sweat, headache, chills, myalgia, sharp ear pain, and took some Tylenol. I felt very ill Saturday and Sunday with high fever of 103 that would not decrease below 101 even with fever reducers, I had myalgia, chills, and I vomited frequently. On Monday my symptoms had not improved so I reached out to my doctors office and was told to go to the ER. They ran some tests and administered IV fluids and was given Phenergan anti-nausea medication to take at home as well. The ER concluded it was symptoms of an adverse reaction to the vaccine after testing. Tuesday I was experiencing fever although most symptoms were milder at this point. I have been experiencing lingering symptoms although the anti-nausea medicine has helped with the vomiting.
headache; body aches; clammy and sweaty; blood pressure spiked; heart pounding; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 27Feb2021 14:00 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. Medical history included mitral valve prolapse (no medications); arthritis (no medications being taken). Concomitant medication(s) included atorvastatin, levothyroxine taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks, patient had no COVID prior vaccination, no COVID tested post vaccination and no known allergies. The patient about 8 hours after receiving the vaccine his blood pressure spiked to 152. He do not normally have high BP and it usually around 115-120 and as low as 110 in the mornings. He could feel his heart pounding and his hands and feet were clammy and sweaty. This continued for about an hour and then it began to drop to normal on 27Feb2021 22:00. The following day had body aches and a headache but his BP was at 120 on 28Feb2021. No treatment was received in response to event. The patient underwent lab tests and procedures which included blood pressure measurement: around 115-120 and as low as 110 in the mornings on unspecified date, blood pressure measurement: spiked to 152 on 27Feb2021, blood pressure measurement: 120 on 28Feb2021. The outcome of events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient received Tdap shot on 08/28/2014 at 30 weeks pregnant with healthy baby. Patient had Gestational Diabetes, but otherwise healthy pregnancy. Fetus was healthy with no birth defects, was active baby. Fetus died on or about 09/03/2014 in the womb and was stillborn on 09/04/2014.
The patients complain of headache and a sore throat , we put on her on oxygen and verify her blood pressure and then we call 911, the 911 arrive to the store and tranfer the the patient to the hospital.
On June 9, 2021 my arms started hurting from my shoulders to my wrist and fingers.  It would get worst at night and then it kept getting worse that I was having trouble sleeping and when I would get up in the morning I could hardly brush my teeth or hair....it progressive got worse that I was having extreme pain trying pull up my pj bottoms and get dressed.  Then on June 23rd I woke up at 1:00am and in extreme pain, I could not move my arms and the pain in my fingers felt as though they would explode.  When i stood up a felt as though I would pass out and was sweating and very pale.  My daughter took my to the ER (I have not gone to a ER in 30 yrs)  The ER ruled out bool clot, heart attack and stroke.  They told me it was an inflammatory response possible to the Covid vaccine and to go see my Rheumatologist.   As of today 9/1/2021 I am still in chronic pain in my shoulders, wrist and hands.  I haven't slept well, have difficulty dressing, driving and doing everyday activities without being in pain.  I have had to be on steroids, have steroid injections, 3 MRI's and numerous blood tests.   I was never told this could happen, I was never given any information at all on the vaccine.   I have become very depressed and can hardly get though the day.  It has caused me to not be able to do my job as efficiently as once need and cry throughout my day just trying to complete tasks.
The first vaccine made me sick for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Covid vaccine (On an unknown date patient received covid vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: The first vaccine made me sick for 2 days). The outcome of the sickness was resolved (duration 2 days).   The reporter considered the sickness to be possibly related to Shingrix.     The company considered the sickness to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023. This case was reported by a consumer via interactive digital media It was reported the patient got shingles. The patient received covid vaccine. It was reported patient cannot say that patient was even aware that it was a threat before got it. The patient received Shingrix and vaccine made sick for 2 days, the patient not used to this. The reporter thought that the event might had been related to product/device.
Pts outside the 6 month window, HCP gave the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's comment: The pharmacist reported that when this happened before, the patients were late for their second dose of Shingrix and it was outside the 6-month interval, when she gave the second dose. No further details regarding patient or product available but registered pharmacist agreeable to follow-up. The registered pharmacist did not know how many patients this occurred with either. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.  This case has been linked to the US2022AMR070596 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070596:Same reporter.
I was also short of breath, feeling breathless; my face was swollen; about a week and a half later the same type of rash showed up on my face and neck area. This time it was worse than the first time to the point that my ear lobe was weeping; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 17Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 24Feb2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization and experienced rash basically on her face and neck. The patient stated that she received her second dose on 17Mar2021 and reported that about a week and a half later the same type of rash (as after first dose) showed up on her face and neck area. This time it was worse than the first time to the point that her ear lobe was weeping. She was also short of breath, feeling breathless and her face was swollen. When the rash was the worst the breathing was also worse. It does seem to be going away and it was getting better then. The clinical outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Received Moderna COVID vaccination on 12/25/20 at 7:50am.  Felt fine with vaccine and immediate period.  woke up with pain in arm 1900.  Upset stomach 3am.  Vomited.  Presented to COVID vaccination clinic at 9am.  Headache on left side of head, nausea, malaise, achy.  Tingling down left arm and into hand.  Swelling at the site.  Red skin size of a dime at injection site.  Reports she worked last night 2300-7am.  No fever.  Iced the arm.  Took Aleve.
This spontaneous report was received from a 58 year old female patient via social media regarding herself. No medical history and concurrent conditions were reported. On an unknown date (also reported as few years ago), the patient was vaccinated with varicella virus vaccine live (Oka/Merck)(Manufacturer unknown) (lot number and expiry date unknown)  for prophylaxis. No concomitant medications were reported. On an unknown date the patient developed chickenpox from someone with shingles who did not know she was contagious. This inspite of having chicken pox vaccine a few years ago. The outcome of chickenpox was unknown. The relatedness of the event with varicella virus vaccine live (Oka/Merck)(Manufacturer unknown) was unknown. Additional information has been requested.
burning patch; broke out in hives; allergic reaction; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 01Sep2021 at 09:00 (Batch/Lot Number: FF2588) as dose 1, single (at the age of 46-years-old) for Covid-19 immunisation. Medical history included occasional allergies seasonal. The patient's concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccine was administered on the same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). After getting the first dose of Pfizer COVID vaccine, the patient had an allergic reaction. She had a burning patch 4 hours after getting the first dose (01Sep2021 at 13:00). The patient asked if it is okay to proceed with the second dose. It was also reported that she worked as a technician and did not have a prescribing doctor. She got the first dose on 01Sep2021 at 9AM and the reaction started on her side. She went to the emergency room, and they said she broke out in hives. They saw her in the emergency room at 12:33pm so the hives started before then. They took about 4-5 days to go away. She was taking Benadryl 50mg every 6 hours for 24 hours and was told to wear loose clothing. No relevant test done. The patient recovered from the events burning patch and 'broke out in hives' on an unknown date in 2021 while the outcome of the rest of the events was unknown. The events required Emergency Room Visit.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
12/18/2020 1st Covid vaccine Pfizer EH9899 7a Left arm 1/7/2021 2nd Covid vaccine Pfizer EL3246 &:40p  Left arm 4/31/2021 ill 4/15/2021 tested positive for covid with PCR test
This spontaneous report as received from healthcare worker regarding an unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not reproted. Between 06-MAR-2015 and 31-MAR-2015, the unspecified number of patients were vaccinated with improperly stored GARDASIL, 0.5ml, intramuscular, lot # K006117; expiry date: 14-JAN-2017 and lot# K007828; expiry date: 02-MAR-2017 (dose(s) in series unspecified). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same reporter. Additional information has been requested.
Speech was affected; he could not speak; Face was drooping; fever; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced speech was affected; he could not speak, Face was drooping, and fever. The patient's medical history was not provided. No concomitant medications were provided.  On 25-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) via an unknown route for prophylaxis of COVID-19 infection.  On the same day, 25-Feb-2021, the patient experienced speech was affected; he could not speak, face was drooping, and fever. At the beginning, his speech was affected but by the time he went to the emergency room, he could not speak.  No treatment information was provided.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the reported events was unknown.  The reporter did not provide a causality assessment for the events.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Stroke, unable to know name, where she was, date, time of year, misusing words, speaking incoherently word finding, memory issues, etc. Permanent memory/word finding disability Note: 7 days at Hospital, 7 days at Rehabilitation Hospital
Pain in hips and legs worse at night. Have cut work hours to help. Pain in other parts like chest, head, and arms and ankles. No pain medication helps. insomnia- difficult to get deep sleep. Memory loss.  60 day follow up states: No pt has not recovered from adverse events. Still have difficulty sleeping due to pain in hips and legs. Have had to reduce activity and work hours due to pain.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
I had a seizure around 5 minutes after the shot. I was feeling sweat and my vision started to fade...I can explain further on a call or email.
IPOL being administered to a patient after the expiration date with no reported adverse event; Initial information received on 24-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient and it was reported that ipol (IPV (VERO)) being administered to a patient after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 19-Aug-2022, the patient received a fourth dose of suspect IPV (VERO) (formulation, strength: unknown) lot R1F801M, expiration date: 28-Sep-2021, via intramuscular route in the left arm as Immunization.  On 19-AUG-2022 the ipol being administered to a patient after the expiration date with no reported adverse event (expired product administered) same day following the administration of IPV (VERO). Caller stated that a patient was administered an expired dose of IPOL and would like to know if it a valid dose. Caller also wanted to provide feedback to Sanofi and suggested that the full year be written out in the expiration date with four numbers instead of two because they thought the first two numbers was the year that the product expired.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (IPOL being administered to a patient after the expiration date with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 047B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction. Concurrent medical conditions included Diabetes, Hypertension, Obesity, Hyperlipidaemia, Drug allergy (Allergy to Lisinopril), Drug allergy (Allergy to Irbesartan), Environmental allergy and Drug allergy (Allergy to atovaquone- proguanil). Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, TESTOSTERONE for Erectile dysfunction, LOVASTATIN for Hyperlipidaemia, AMLODIPINE for Hypertension.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not reported.   Reporter did not allow further contact
Approximately 1 hour after receiving listed vaccinations, child's head and body shook in a seizure-like manner while mother was holding him.
On May 25, 2018, patient was lying in bed with mother when mother noted a period of baby's eyes moving back and forth, side to side, along with grimacing gestures for app. 30 seconds. No fever or illness reported at the time. Quickly recovered and was responsive, alert and "normal" after that.
Flu-like symptoms including muscle and severe joint aches,  skin hurt to touch, malaise, nausea, abdominal discomfort, slightly elevated blood pressure, and extreme fatigue started within 5 hrs and got progressively worse. The discomfort in the left arm worsened to the point of making it difficult to raise the arm.  Took 1 Aleve with no relief.  These symptoms lasted approx 26 hours. It started to subside after taking 1 Excedrin at hour 26. It gradually got better and by the following day it was resolved except for the discomfort in the left upper arm which was 75% improved.
Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 07-OCT-2013 at a family practice as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2015, patient was treated by a physician at the family practice for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with interference into the eyes. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster, or shingles with interference into the eyes was determined to be a medically significant event. Additional information has been requested.
received both doses when age 16; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) outcome was unknown.            No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-299844, MOD-2021-308656, MOD-2021-299882 (Patient Link).