chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was reported from physician post vaccine pt's bilirubin level checked on was 3.1, on follow up it was 1.8. Physician's office did not feel the reaction was due to vaccine.
Severe body aches, chills, rigors headache starting about 9 hours after vaccine. Arm swollen at site about 20 hours post vaccine.  Symptoms persisted until about 40 hours post vaccine and continued fatigue and backache additional 24 hours.
vaccine expired 7/6/2023 vaccine adminstered on 7/7/2023
Onset of listlessness, sleepiness within 1 hr of vaccine lasting approximately 15 hrs. Would not wake up to eat. Was seen/ evaluated in ER after 10-12 hrs. Kept in ER until she became more arousable/ took Pedialyte.
Administer COVID 19 Moderna Vaccination to patient that was expired on 08/31/2021.
HEART ISSUES (RAPID HEART BEAT REQUIRED MEDICAL ATTENTION); This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: heart transplant (Heart transplant 4 years ago, no heart issues post transplant). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced heart issues (rapid heart beat required medical attention). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues (rapid heart beat required medical attention) was not reported. This report was non-serious.
Patient received his second dose of the Pfizer vaccine and while sitting in the waiting area began to feel hot all over and light-headed. Emergency personnel were called and checked the patient. They concluded that he may have just had an anxiety attack about receiving the vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-JUN-2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-OCT-2015, the patient was treated at an ophthalmology specialty hospital emergency room for a severe viral infection of the retina that may lead to significant vision loss, which was diagnosed as varicella associated acute retinal necrosis. The patient was prescribed valacyclovir hydrochloride (VALTREX) and difluprednate (DUREZOL) and received an injection of intravitreal foscarnet sodium in the left eye. On or about 04-NOV-2015, the patient sought subsequent treatment from a physician at an ophthalmology clinic for a follow up appointment for his diagnosis of acute retinal necrosis. The patient was prescribed atropine and was to continue valacyclovir hydrochloride (VALTREX) and difluprednate (DUREZOL) and has to wear Polycarbonate lenses to protect the left eye. On or about 04-DEC-2015, the patient had further treatment from a physician at an ophthalmology and surgery office for an additional follow up appointment for his diagnosis of acute retinal necrosis. The patient was prescribed a double dose of valacyclovir hydrochloride (VALTREX). As a direct and proximate result of zoster ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Upon internal review, the event of varicella associated acute retinal necrosis was considered medically significant. Additional information has been requested.
experienced some slight itching; This case was reported by a consumer and described the occurrence of injection site itching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy (Allergy to Depo-Medrol).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   The reporter considered the injection site itching to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient could not remember the exact dates of when she received the vaccine but believes it to be last year or possibly 2019. The patient experienced some slight itching the following day that lasted several weeks.   She experienced no other reactions.   Did not consent to follow-up. This case has been linked with case US2021AMR027071, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR027071:same reporter
Pfizer biontech covid 19 Swollen tongue., difficulty swallowing, numb/tingling lips
Felt like I was smacked in the arm for an entire day. Not really any pain immediately after injection, wasn't noticeable for two days. All the sudden I woke up and if felt like somebody punched me in the shoulder, despite no bruises and no physical injuries.
achiness; fever; chills; This is a spontaneous report received from a contactable Consumer or other non HCP from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Batch/Lot number: 30145BA) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; GABAPENTIN; LOSARTAN; LEVOTHYROXINE; AMLODIPINE. Vaccination history included: Bnt162b2 (First dose vaccine LOT# "EM98809"), administration date: 20Feb2021, for COVID-19 immunization; Bnt162b2 (Second dose Vaccine LOT#EN6206), administration date: 11Mar2021, for covid-19 immunization, reaction(s): "Fever". The following information was reported: PAIN (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "achiness"; PYREXIA (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 27Sep2021 16:00, outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probed for the concern, consumer stated, that she had her Pfizer Booster Vaccination (Pfizer, Covid-19 Vaccine) yesterday and today she was fine until this evening. Now she got fever about 100 Degrees and kind of chills, Achy (ache).The patient did not receive any other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Had 2nd booster shot July 2021. Started getting headaches Dec 2021. Saw doctors then finally got an apt with a  Nurologist in April 2022. MRI revealed a cerebral blood clott & I was rushed to the ER and admitted to the hospital stroke trauma team. After 5 days of scans & tests  & IV medication, was sent home with a blood thinners.  8 months later, MRI still shows persistent blood clot, even though it is smaller it is still not dissolved. Healthy, no medication, no family history, hospital labs & tests show all markers normal with no underlying cause for blood clott. Hospital Stroke Team of Neurologist & Cardiologist elimated normal causes and narrowed down to mNra vaccine.
Symptoms appeared within 24 hrs. tactile fever regressed -> decrease in speech, decrease in recognition, withdrawn, clumsy, lasted 4 weeks then slowly resolved.
1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Blood pressure high.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021) outcome was unknown.            Patient didn't had Covid-19 prior to or after the getting the vaccines. Concomitant medication stated lot of medications that controlled high blood pressure with specific medication information declined. It was reported that patient had 1st dose on 17 January 2021 and 2nd dose on 21 February 2021, more than 1 month apart. No treatment details were reported.
Information had been received on 02-MAY-2017 from a pharmacist who reported that a patient (age and gender not reported) received ZOSTAVAX (date of vaccination, dose and lot#/expiration not reported) subcutaneous with sterile diluent "in the back of the arm, not the preferred area for injection". Pharmacist was not able to provide the lot#/expiration date for the properly stored sterile diluent used to reconstitute the vaccine. No adverse events reported. Pharmacist disconnected the call prior to most fields being asked therefore most fields are not applicable. No further information to report. Additional information has been requested.
24 hours after shots given, swelling size of grapefruit, red and hot. Treatment, BENADRYL, TYLENOL and cold packs.
Mom states pt felt warm on Sunday but did not take temp; Pt given APAP q4hrs; Temp on Monday was 103.6R &  104.5 R next day; Pt seen by MD who felt it was rxn to inject; Later pt devel red rash on face which started becoming blotchy;
Immediately after booster she had joint pain for a few days, worst in areas of prior surgeries. About a week later she began developing granulomas at the sites of prior surgeries done over the past 15 years by one surgeon (did NOT develop granulomas at other surgical sites). Had granulomas removed in a series of operations, see below.
got it from the shot / suspected vaccination failure; got it from the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's buddy. The age at vaccination was not reported. The patient got the shingles from the shot also. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has bene linked with US2021AMR198995 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198995:Same reporter
Client received the 1st COVID vaccine Pfizer (5 yo - <12 yo Lot #FL007 and exp 03/01/2022) at 12:52PM. RN noted the client was 12 years old after administration of the COVID vaccine 5 yo - <12 yo. RN provided education to the client and her mother regarding the medication the client received and recommended per CDC guidelines the client will receive the Pfizer Vaccine for 12 years of age and older for her second dose.
Painful swelling of hands and fingers, and pain in finger tipis. He had sensation of rash on upper back and shoulders but was unable to see if there was a rash. This lasted for 10 minutes.
A report was received from a health care professional on 11/04/03, concerning a female vaccinee of unknown age who developed a quarter sized knot which was red and hot an unspecified length of time after receiving Fluvirin vaccine on 10/07/2003. The outcome was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending. Cross reference with: PJP20030785, PJP200300786 and PJP200300988.
pt recvd vax; pt vomited 6 times & devel a fever of 102; pt exp bilateral arm pain, neck pain, stomack pain, pain behind the eyes & was pale;
Shortly after the vaccine, I started having extremely bad hip pain where I couldn't sleep. My legs and hips were swelling, and I would have to stop walking because of the swelling and pain. Those symptoms have subsided, but I can't walk the way I used to. I got 2 blood clots underneath my toenails when we were walking 20,000 steps. I've never had blood clots before. I had periods every 2 weeks and eventually they stabilized but they are sometimes light sometimes heavy and they're no longer 28 days consistently anymore. Right after the shot, I had intense diarrhea that seemed uncontrollable and that happened twice after the vaccine. That also subsided as well. Haven't been the same in regard to memory since the vaccine as well. My blood sugars also were elevated after the vaccine, and they're currently bouncing, but I did just switch insulins so that maybe it as well.
Slight chest pain a few minutes after receiving vaccine. Gradually subsided.   Pain returned the next day around 11:45PM and currently (time is 1:12AM October 3)  have feelings of slight chest pain and fast heartbeat. Heart rate monitor app on smart phone measured around 120-150bpm.  Will go to doctor if it persists tomorrow.
Vomited, coughing & sneezing, sleeping more than usual & not eating as well as usual; cries when eating; not nl cry; regular PE, HEENT: nl, alert, well-hydrated, neck supple, lungs clear; Dx: possible rxn to immun vs. viral syndrome;
Mother called to report a reaction.  RN returned mothers call and spoke with father who stated they took the child to the ER around 5:30PM 01/23/04.  Child had whelps over entire body, fever around 101, irritable, MD ordered Benadryl 1tsp every 4-6 hours and follow up with regular MD.  Child has appointment this afternoon with personal physician.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jan2021 as dose 1, single (Lot number: 012L20A), in right arm, on 02Feb2021 as dose 2, single (Lot number: 010M20A), in left arm, on 24Aug2021 as dose 3 (booster), single (Lot number: 04021A), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: 002M12A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: AVAPRO, start date: Jan2017; CRESTOR, start date: Jan2017, stop date: 01Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.
Sore arms; Some heart palpitations; Very sensitive to light one side of head; chills; felt like she has been hit by a truck. It liked knock her out.; Headache on one side of head/ serious headache; Feel a lot of pressure on one side of head; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9261, expiration date unknown) on 22Mar2021 at age of 49-year-old via an unspecified route of administration on the left arm at single dose for COVID-19 immunisation. Patient previously received 1st dose of BNT162B2 (Lot number: EL9266) via an unspecified route of administration on the left arm on 25Feb2021 at age of 49-year-old at a school for COVID-19 immunisation. Medical history and concomitant medication was reported as no. The patient stated she was not sure if someone else has been reported it. She was having headache. She was having headache on one side of head, also one week has been down. She was having serious headache and she just wanted to know if this was something that has been reported. Patient stated after the vaccine, she was having sore arms, noticed some heart palpitations, also didn't feel any nausea, chills and pulse (pending clarification). But she did feel like she has been hit by a truck. It liked knock her out. She was out for like two days. She had recently been having headache on one side of head. When she bend down, she felt a lot of pressure on one side of head and also light. She was very sensitive to light one side of head. Patient was receiving ongoing Tylenol 500mg, 2 tablet, twice a day as treatment. Onset date of "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was 04Apr2021. Outcome of event "headache on one side of head/ serious headache" and "feel a lot of pressure on one side of head" was not recovered, of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
2 wks. 6 days after MMR and Varicella vaccines, developed vesicles on multiple sites.
UPPER RESPIRATORY INFECTION; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis.  No concomitant medications were reported.  On an unspecified date, the patient experienced upper respiratory infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from upper respiratory infection. This report was non-serious.
No additional AE/no PQC; received improperly stored ROTATEQ, VAQTA, and GARDASIL 9 vaccinations; This spontaneous report was received from a nurse referring to an 18-month-old female patient. The patient's concurrent conditions and medical history were not reported.   Concomitant therapy included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella vaccine (manufacturer unknown), hepatitis b vaccine (manufacturer unknown), and measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN).     On 23-JUN-2023, the patient was vaccinated with an improperly stored dose of hepatitis A Vaccine, inactivated (VAQTA) lot# X003791 and expiration date 01-JUN-2024 in the left thigh as prophylaxis (strength, dose, route, and vaccination scheme frequency were not provided). It was reported that vaccine temperature excursion was not viable and occurred from a data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice. There was no adverse effect reported.  The action taken with the vaccine was reported as "returned, waste in progress".   This is one of several cases by the same reporter. ; Sender's Comments:  US-009507513-2307USA012178:
No additional AE information; temperature excursion; Information has been received from an administrator referring to a 17 years old patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 10-MAY-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022, strength, dose, frequency and route unknown) for prophylaxis (incorrect product storage). No adverse effects were reported.  The stored temperature was 0.34 degree Celsius. The time frame was 0.77 hours on 18-MAR-2021. There was no previous temperature excursion. The temperature excursion was detected by a data logger.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2105USA004751:
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days.  tiredness and muscle soreness, intermittent nausea lasted for 5 days
anaphylactic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a patient of an unknown age and gender 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 ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment drug information reported.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.