chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up at around 10am because my body was itching all over. I went to the bathroom and looked in the mirror and my body was covered in hives, especially on my neck, chest, stomach, back arms, and thighs. My face and eyelids were swollen. I was having trouble breathing and was lightheaded. My vision started to go black so I lied down on the bed and my boyfriend called 911.   The paramedics arrived and administered Benadryl and Dexmethasone intravenously. They stabilized me and took me to the nearest hospital. I stayed there for about 6 hours for observation and testing. The hives and swelling faded after a couple of hours. No additional allergic reactions/symptoms occurred while I was there.
blotchy red rash at base of left neck - persistent - didn't resolve; 1/12/21 - same area became itchy, raised and coalesced
Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/07/22 at approximately 10:10am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient did not respond to attempts to contact. No adverse side effects or event as result of dose reported.
The needle got block and didn't went all inside the muscle maybe half a needle stay outside; The vaccine didn't went all into the muscle and some went subcutaneous; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected events of incorrect route of product administration and wrong technique in device usage process. The events incorrect route of product administration and wrong technique in device usage process occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Loss of vision L eye with pain. Was able to see DO next AM. Dx secondary noninfectious iridocyclitis left eye. Thought to be secondary to autoimmune disease.
Information has been received from a health authority (case # 84292) (local case # IT173/08) concerning a 14 month old boy who on 05-NOV-2007 was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot # 654405/0471F) (batch # ND70600) and concomitantly with the first dose of PRIORIX (batch # A69FA949A). Both vaccines were administered via subcutaneous route in an unspecified site of administration. On 12-NOV-2007 he presented with hyperpyrexia and convulsion crisis due to hyperpyrexia. He was admitted to the hospital. The patient completely recovered on 15-NOV-07. Other company number included E2008-04011. The case is closed.
Cellulitis, swollen, redness, sourness, tender; ice area, BENADRYL po. prn.
Client c/o flush that washed over her while waiting 15 minutes.  Also stated tachycardia and "skipped heart beats."  She stated that the skipped beats started about a week after her first dose of Pfizer.   BP 128/82, pulse 88 with 1 skipped beat every 1-2 minutes by palpation.  She refused EMS, went home in car after 50 minutes. At 4:15 p.m. called after another episode of flushing and tachycardia, feeling "weird." Went to urgent care and had EKG, normal compared to one 2 years ago. NP and a consulting doctor diagnosed vaccine reaction, advised fluids and rest. BP and pulse continue to fluctuate. Per client, 2/2/21 a.m. her pulse goes from 80-112. She will continue to monitor.
Slight swelling on one side of my face from the cheeks down to my chin and jawline; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient do not want to report anything exactly, patient would like to ask a question or two. Patient got the Pfizer vaccine 2 weeks ago, the first dose and a couple of days after that patient noticed slight swelling on one side of patient face from the cheeks down to patient chin and jawline and patient was just wondering is that Covid vaccine related. Is that something that you have seen, or heard patient hesitate to get to the doctor because patient have not got patients second one. Do patient take the second one, can you advise me. The health department that gave the shot told patient to contact you. Patient have 2 questions to ask, is this a common side effect that patient should not be concerned about Is it something that will go away Is it safe to get a second vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nurse administered too much vaccine.  Patient notified.  Experiencing fever and flu like symptoms.  Advised to return to clinic or emergency room for worsening symptoms.
Same day of vaccine around 8pm I started having a lot of chills & my heart palpitations  were very low. I had a lot of pain on the vaccine site. This symptoms lasted only overnight the next day I was fine.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015435, expiration date 17-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
ACHES; FEELING VERY MISERABLE; CHILLS; NOT FEELING WELL AT ALL; FATIGUE; FEVER BUT NO ACTUAL FEVER; This spontaneous report received from a consumer concerned a 48 year old male. 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced aches. On 09-APR-2021, the subject experienced feeling very miserable. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced not feeling well at all. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced fever but no actual fever. Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, fatigue, chills, feeling very miserable, and fever but no actual fever, and the outcome of not feeling well at all was not reported. This report was non-serious.
Episode of syncope at 12 pm resolved in a few minutes 2/6/21. Had to lie down for 2 hours. Did not require medical treatment.
Severe body ache; Chills; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on an unknown date (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced severe body ache 1 day after the 2nd dose, chills 1 day after the 2nd dose and tiredness during 3 days after the 2nd dose. Therapeutic measures were taken as a result of body ache, chills, tiredness and included treatment with tylenol. The clinical outcome of the events severe body ache, chills and tiredness were all resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Instructed not to get the second dose; COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and INTENTIONAL DOSE OMISSION (Instructed not to get the second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Instructed not to get the second dose). At the time of the report, COVID-19 (COVID-19) outcome was unknown and INTENTIONAL DOSE OMISSION (Instructed not to get the second dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information included antibody treatment on 13 Apr 2021 due to which the patient was advised not to receive the second dose for 90 days from the treatment.
Noted malaise, fever 101, nausea and vomit x 1, 12 hours after vaccine. Also red quarter sized swelling over injection site that progressively grew to 12cm at 72 hours at injection. Persistent fever 100-102.1 with Tylenol. Painful left upper arm injection site.
Extreme headache, body chills, fatigue  Metallic taste still after 3 days
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 10-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805506 was crossed linked to original cases 201804863 due to same reporter.
Patient received Moderna vaccine at 17 years of age. Patient asymptomatic and no treatment needed.
Headache same side as where vaccine was given. Throbbing pain in same side ear. Lower back aches same side of vaccine given. Vertigo symptoms 3 days ( especially when in bed at the time of switching side to sleep and at times while standing.
Pruritus; paresthesia across body, particularly extremities; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 13Jan2021 10:15 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension (HTN). Concomitant medication included amlodipine besilate (NORVASC) and metoprolol tartrate (LOPRESSOR). About 8 hours after immunization, patient started to have pruritus and paresthesia across body, particularly extremities on 13Jan2021 06:00 PM. Therapeutic measures were taken as a result of the events which included Hydroxyzine Hcl (ATARAX). The outcome of the events was not recovered. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Not covid tested post vaccination.  Information on the lot/batch number has been requested.
Temperature was 100.8; Sneezing; Blowing his Nose; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose), COUGH (Coughing) and PYREXIA (Temperature was 100.8) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016A201) for COVID-19 prophylaxis.    Co-suspect product included non-company product TAFAMIDIS (VYNDAMAX) capsule for an unknown indication.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient started TAFAMIDIS (VYNDAMAX) (unknown route) 61 milligram once a day. On 14-Oct-2021, the patient experienced SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose) and COUGH (Coughing). On 15-Oct-2021, the patient experienced PYREXIA (Temperature was 100.8). At the time of the report, SNEEZING (Sneezing), NASAL CONGESTION (Blowing his Nose), COUGH (Coughing) and PYREXIA (Temperature was 100.8) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, Body temperature: 108. On an unknown date, SARS-CoV-2 antibody test: Results not available.   No concomitant medication details were provided.   Reporter stated that patient thinks, was not sure, but thinks, that he may have Covid.  Caller states she wonders if he should continue taking the medication, Vyndamax Caller states the patient started taking Vyndamax and he has had no reaction of any kind. He takes the medication after breakfast around 09:30 and he has no side effects. Patient was outside for a while, and he started sneezing and blowing his nose so caller thought maybe it was allergies. Caller states he woke up today and he was doing the same thing, so she took his temperature and it was 100.8 and it was a little lower than that before. Caller states he hasn't taken Tylenol or anything like that. Caller states she talked to her Sister, who is a nurse, and she said that no doctor was going to want to see him if he has those symptoms, unless he can verify that he doesn't have Covid.  Caller stated that he has had the Covid Shot and the Flu Shot and he had no reactions to those.  Caller stated he had the Moderna shot for the Covid. Caller states they went and got a test today and they should have those results within 24 hours or on Sunday. Caller states he is just a little tired.   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.
First day typical symptoms, second day rapid heart beating, felt weak and nauseous.  The next day body pains that have not stopped since. Especially in the right upper side by my rib. The pain leads into chest pains and feels almost hard to breathe.  I even got a hida scan to test my gall bladder and it is normal. But the pain hasn?t stopped since I got my vaccine.
Pt received Pfizer toddler vaccine that was mixed incorrectly.  The vaccine was reconstituted with 1.3 mls instead of the correct 2.2 mls of saline. The vaccine was more concentrated b/c of this error
Redness, swelling and pain at injection site and down arm. Patient treated with ice and ibuprofen.
Face, mouth, neck, and throat tingling and then numb for an hour. No difficulty breathing and the numbness stopped on its own.
on 1/20/21 began itching in the evening.  on 1/21/21 developed redness which got worse until 1/24/21 when called the dr.  Had a Doctor appt. on 1/26/21 and started on Prednisone pack.  This helped decrease the redness, itching.
Mom reported the next day pt had soreness around the injection site, headache, body aches, and fatigue. Ibuprofen administered by parents who report some relief.
-fever (up to 103F) x 11 days -chills x 11 days -muscle/body aches x 11 days -fatigue x 11 days -swollen lymph node x 10 days -rash (red, raised, dry/scaly) on bicep area of left arm (same arm as injection site) x 11 days -nausea/diarrhea x 3 days (starting on 1/18/21) -decreased appetite x 2 days (starting on 1/18/21)
830AM started to get tightening of the chest shortly p/inj then about 10AM became SOB;120PM still having some SOB-advised to seek med attention if it gets any worse;
Patient informed that they had swelling and pain in left arm injection site the day following injection.  Informs the pain was in upper arm, concerned that the injection was given too high.  Pain still persists even 2+ months later but is slowly getting better.
Patient reported temporal HA's, cold sweats at night, feeling warm (no temp taken), discomfort, swelling, redness and small blister at injection site Mon after having the injection the previous Fri.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: After improving and testing negative; (2023) Positive, notes: 6 days after stopping Paxlovid - high temp, positive COVID test and other symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This patient was homeless. Partner was with patient on the night of 6/12 when patient complained of not feeling well and attributed it to side effects of his COVID vaccine, which he received two days prior. Patient declined to go to the hospital. When partner woke up the morning of 6/13, the patient was found dead. A coroner's report is expected sometime within the next 4-6 weeks.
Had shot on Tues  Nov 5, 2002.  By Sat Nov 9 I was experiancing considerable pain at the back left side of my head.  Note that the pain was located on the outside of my head, not inside. The pain continued to increase and spread to my left ear and into my left neck muscle. Went on a trip. As the trip progressed the pain intensity increased to the point where I  to start taking the pain killer HYDROCODN/APAP Tabs to sleep or contnue. On Fri Nov 22 the pain progressed to my left thigh muscles and I coudn't stand the situation any longer and went to the ER.  After a CAT Scan and blood checks the only thing they could determine was that the blood check indicated a possible VIRAL infection, for which there was nothing they could do. The pain is now over my entire body, particularly the large muscle groups.  The outer head pain has seemed to decrease from its origional intensity.  I went to my personal physian,Wed nov2.  He couldn't determine a cause either but said there may have benn an interaction of the Flu ahot and the Coumaden I take.  He didn't think it was likely.  My question to you is have you received similar complaint's from others?  If so, can you provide a remidy or at least an explanation so I can obtain an effective treatment.  I am 68 years old and have NEVER, to my knowledge experienced pain of this magnitude.  At present it is very painful to just walk around the house at a very slow pace. Before, I was running 10-14 miles/wk and  walking another 6-8 miles.  Thanking you in advance for your consideration of my proble.  Hope to hear from you next week . In the section below it asks what type immunization I received?  I don't know!  All I know is that it was a flu shot.  The entry in 13 is not correct because I have been unsble to eliminate it.