chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site erythematous, edematous, itchy. Skin appears tense over site 110x145mm. Pt had bad headache for 20 min after vax. Rxn site was smaller before running 4 miles & push-ups. Tx'd w/Diprasene lotion, elevate, antihistamines.
I went to my physician's office to receive my first Shingrix injection. The injection was given at approximately 2:00 pm. At approximately 8:00 pm that same evening, I began to get chills. By midnight, I was running a temperature of 103.6. I took Ibuprofen and Acetaminophen to lower my fever. Last night, I had a night sweat that soaked my entire bed, blankets and comforter. Today, almost two days later I feel awful. I did research the side effects and I was aware that some people get a low grade fever and chills. I had no problem with that. But to get a fever of 103.6, I feel is dangerous. If it had gone any higher, I would have had my spouse take me to the emergency room. I did have the shingles when I was in my early 20's. To be honest, I would have rather had another bout of shingles than the side effects of this drug. My physician's office advised me to come back somewhere in the vicinity of 4 months for the second dose. They can forget it. I would not recommended this medication and I will be advising friends and family to avoid receiving it. I'm on day 3 and feel like I was beat up. Although at the writing of this report I'm not running a fever, I feel beat down. I'm weak and have no appetite. I'm hoping this will subside soon. Again, I'm sorry I received this medication and will let everyone I know to avoid it.
Deep low pitch cough uncontrollable, right arm swelling (Guillain Barre Syndrome) per Dr.
My blood pressure was elevated after the first dose of Moderna for about 9 days, going from 150/100 to 175/115 first thing in the morning, with a pulse of 65 (my BMI is normal, 165 lbs. and 5'11").   I also experienced a slightly uncomfortable pressure , like a small pulled muscle, in my left armpit, that went away about the same time the BP dropped back down to my typical readings.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent medical conditions, concomitant medication and medical history was not provided. On 06-AUG-2014 the patient was vaccinated with a 0.5ml dose of (Oka/Merck) VARIVAX (lot# and dose number were not provided), which had undergone a temperature excursion, subcutaneously.  No adverse effect was reported. It was unknown if the patient sought medical attention or not. This is one of several reports received from the same source. Additional information has been requested.
sore right arm/right arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore right arm/right arm soreness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 015M20A, 013F21A and 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore right arm/right arm soreness). At the time of the report, PAIN IN EXTREMITY (sore right arm/right arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient took first booster dose and experienced right arm soreness. After second booster patient also experienced right arm soreness on 16-Apr-2022 outcome of those were unknown.  Treatment medications were not reported.   This case was linked to MOD-2022-660005 (Patient Link).
Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really tired/exhausted; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included Hashimoto's Goitre, migraine, Pacemaker, she just had her third one replaced, that was since I was 27. Concomitant medication included levothyroxine for Hashimoto's Goitre, sertraline, topiramate (TOPAMAX). The patient received the vaccine on 30Dec2020. She had congestion, she was still congested. That night on 30Dec2020 she was tired, just tired and exhausted and woke up Thursday on 31Dec2020, really tired. The patient had been really busy with work with everything, so, she just 'threw to the wind'. She was really tired on Thursday, 31st, just like, she really feel sick, coughing, really exhausted. she came home and just got to go to bed and 7 to 3:30. She felt warm but she didn't get hot and she took temp, she was 101.5. She had chills, a cough. She was so exhausted, everything hurts her. The patient don't feel like terrible, terrible, like mostly she would say Friday on 01Jan2021, she was mostly in bed. She just didn't want to just lay there. She thought that was worse laying there. She didn't know if I was positive with COVID in the middle of this, or was it the vaccine. About causality, the reporter stated that she didn't know, 50-50, it partly felt like she didn't know if she was having a reaction to the vaccine or she was positive for COVID or she was getting (incomplete sentence). She was congested and the all of a sudden, she didn't know if positive for this. She guessed if she get tested which she was assuming if she call or occupational health, they want her to get tested for COVID because she already have the symptoms. She didn't do anything yet for events. She had just been home and quarantined. Her brother who she have been around, he doesn't live with her but he lived down the street. He was in critical care right now in (state) and with COVID, so that's another concern, why she was thinking she could be COVID. The outcome of the events was unknown.  Information for Lot/Batch number has been requested.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced mild after effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild after effects on MAR-2021. This report was non-serious.
No other AE; temperature excursion, with subsequent administration; This spontaneous report was received from a healthcare provider and refers to a 1-year-old female patient. There was no information regarding patient's medical history, concurrent conditions and concomitant medications provided.  On 21-MAR-2022, during 1-year well check, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) 0.5 milliliter, frequency: once, subcutaneously, lot# U006485, expiration date: 26-FEB-2023 and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, frequency: once, subcutaneously, lot# U022320, expiration date: 15-JUL-2023, both for prophylaxis(indication also reported as "1-year-well check"). The aforementioned vaccines underwent a temperature excursion of 1 degree Celsius for 7 hours (product storage error) on an unknown date before administration. On an unspecified date, there were multiple previous temperature excursions. There were no lab diagnostic studies performed. The patient did not seek medical attention. No additional adverse events were reported (no adverse event).
Fever; Chills; Body aches; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 13:45 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included Covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 the patient experienced fever, chills, body aches and sore injection site. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fever, chills, body aches, sore injection site were unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was given second dose of vaccine on 0412/2021. She developed severe pain of forearm and wrist. She had applied ice to site and today noticed a bruise on her inner wrist (4 x 2 inch). Denies taking any blood thinner and denied trauma. No warmth or pain at this time. She took 800 mg Ibuprofen night before vaccine for back injury.  She applied ice to site. PCC: Advised to FU with pcp, urgent care or ED for cbc and coags. Although Pfizer vaccine has not been known to cause clotting issues and sx could be unrelated it is best to r/o. Caller will be going to home on Friday and said she might wait to fu with pcp there.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1 , single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Oct2023 to 29Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300356711 Same patient, different product, different dose/event;
Breakthrough case admission after 2 vaccines Moderna 2/2/21 Lot# 023M20A;  Moderna 3/22/21 Lot# 047A21A
mark on arm size of a ping pong ball; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (mark on arm size of a ping pong ball) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 SCAR (mark on arm size of a ping pong ball). At the time of the report, SCAR (mark on arm size of a ping pong ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter (consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Jan2021 as dose 1, single (batch/lot number: EL3303), in left arm, on 16Feb2021 as dose 2, single (batch/lot number: EM9810), in left arm and on 19Nov2021 as dose 3 (booster), single (batch/lot number: FY1620) at the age of 54 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medications included: OMEPRAZOLE; SIMVASTATIN; EFFEXOR; VITAMIN D [VITAMIN D NOS]. Past drug history included: Codeine, reaction(s): "allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.
given 1 month after 7th birthday; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided are as follows: The patient received Kinrix approximately 1 month after 7th birthday, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Redness in the face an neck, slight swelling. Mouth going numb. Both lasting only 30 seconds to a minute. Happened 20 minutes after the shot.
Within 24 hours of receiving vaccine developed local at site. On 4/15 she developed neck pain, headache, fatigue, stomachache and nausea. She contacted her pharmacy but did not feel she needed to be seen in office.
Tingling, numbness, and feeling of coldness primarily in the left arm near the injection site, but extending to other parts of the body as well including the face and shoulder.
Ongoing evaluation- elevated blood pressure. Normal EKG in hospital- Cardiologist- Abnormal EKG (2 of them after follow-up with cardiologist) and abnormal stress test. Diagnosed mid Jan 2022 with COVID-19 on a rapid test and NEGATIVE on a PCR test.  Unknown if I had COVID or not.
This spontaneous report was received from a pharmacist and refers to a 19-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 02-AUG-2016, the patient received his first dose of GARDASIL injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 16-OCT-2016, the patient received in error a dose of MENACTRA injection (dose, route of administration, anatomical location, lot # and expiration date were not reported), instead of GARDASIL. The pharmacist did not know why this medication error occurred. On 01-FEB-2017 (reported as "today"), the patient returned to the pharmacy to receive his third dose of GARDASIL and during that vaccination session the error was discovered. On 01-FEB-2017, the patient received his second dose of GARDASIL injection (lot # L026034 with expiration date at 23-JUL-2017) (dose, route of administration and anatomical location were not reported) for prophylaxis. The patient did not experience an adverse effect. No product quality complaint (PQC) was involved. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA  Injection site soreness x 48 hours. No treatment. Spontaneous resolution. Fever x 24 hours, started morning after injection. No treatment. Spontaneous resolution. Widespread muscle soreness x 24 hours, started morning after inj. No treatment. Spontaneous resolution.
Myalgia, Arthralgia, Fever, NauseaVomiting, cramps, Narrative:
Chills; Fever; Headache; Body ache; Vomiting; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (sore arm after receiving 1st dose on 19th August 2019, see case US2019AMR197056). Concomitant products included ibuprofen.   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 28th October 2019, the patient experienced vomiting. On 29th October 2019, the patient experienced chills, fever, headache and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vomiting, chills, fever, headache, general body pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, chills, fever, headache, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced vomiting, body aches, chills, fever, headace, and a sore arm. 8 hours after vaccination patient experienced vomiting. One day after vaccination patient experienced chills, fever, headache and general body pain. The patient did not consent to follow up.
miscarriage; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (miscarriage) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Abortion spontaneous after receiving a dose of mRNA-1273 vaccine. The onset date of event and vaccination date were not reported. It was reported that the patient lost her baby 3 days after vaccination. Clinical course and treatment details were not reported. The last normal menstrual period (LMP) and obstetrical ultrasound dating were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Abortion spontaneous after receiving a dose of mRNA-1273 vaccine. The onset date of event and vaccination date were not reported. It was reported that the patient lost her baby 3 days after vaccination. Clinical course and treatment details were not reported. The last normal menstrual period (LMP) and obstetrical ultrasound dating were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: we called 911   3 emt arrived they took her vitals and stayed with her and her father for roughly 20 minutes  and she left with her father
This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A male patient of unspecified age received PREVNAR 13 on unknown date, at single dose. Medical history and concomitant medications were not reported. The patient experienced hearing loss after he was administered with PREVNAR 13. Event outcome was not provided at the time of report.