chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is slightly itchy and scratching; there's a pinkish area approximately an inch in diameter; This is a spontaneous report from a contactable consumer or other non hcp. This (Age:90; unit: Unknown) female consumer reported that the patient received the  bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, Injection for injection, dose 1 at an unspecified date (Batch/Lot number was not reported, expiry date: unknown) as SINGLE DOSE for covid-19 immunization on Wednesday (age at vaccination: 90 (unit not specified)). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm is slightly itchy and scratching (pruritus) on an unspecified date, there's a pinkish area approximately an inch in diameter (erythema) on an unspecified date. The outcome of all events was reported as unknown.  Follow-up attempts completed. No further information expected.
Swollen, red, pain, and itching at site of injection.  Still continuing 4 days after injection. Fatigue, body aches, headache - lasted for about 24 hours.  Took Tylenol for one day, every 6 hours.
Patient developed paresthesia/sensory changes and lower back and abdominal pain. Found to have likely Guillain Barre syndrome. No motor involvement and discharged home.
Large, raised, red, hot, itchy area at site of injection, achy joints and muscles, fatigue, headache
4 hours after vaccination she was not lucid and spiked a high fever.  Admitted to hospital.  White blood count 0.  Liver function affected.  Diagnosis an inflammatory reaction to flu shot.  10-27-2009  Medical records, discharge summary and ICD9 coding received for DOS 9/16-9/18. FINAL DX:  Pancytopenia, transaminitis, coronary artery disease, hypokalemia, probable severe reaction to the influenza vaccination. Patient presented in ED with fever of 102, hallucinations. Was concurrently being treated for UTI and had seen PCP same day.  Received flu vaccine. 3-4 hours later developed chills, fever hallucinations and delusions. Also reported nausea. Treated empirically for urosepsis. C/O frequency, urgency and dysuria.  Subsequently developed pancytopenia and transaminitis. Pancytopenia improving. Transaminitis resolving. Hypokalemia resolved. Discharged to home with planned follow-up. ICD Codes: 809, 780.97, 284.89, 599, 995, 276.8, 414.01, 250, 401.9, 272.4, E949.6, 790.6.
Pfizer-BioNTech COVID-19 Vaccine EUA Within 5-10 minutes of vaccine, burning and tingling sensation started in chest, moving into throat, tongue, mouth, nose, and ears. Flushing sensation and red ears. Increased heart rate, resolved after a few minutes. Was treated in the ER and released from hospital. EKG and vitals were checked, no labs drawn. Occasional burning and tingling sensation but resolves within a few minutes, mainly in chest and tongue. Occasional symptoms ceased in about 3 hours.
administered Ipol post excursion after it had exceeded extended stability data and was no suitable for use with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administered IPV (VERO) [IPOL] post excursion after it had exceeded extended stability data and was no suitable for use 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 MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) ; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for prophylactic vaccination  (Immunization).  The reporter informed that the temperature excursion was caused by a air conditioner malfunction and the temperature reached 0.8 C for duration of 36 hours 38 minutes. The punctured Ipol was not covered under the extended stability data.  On 29-Jul-2022, the patient received first  dose of suspect IPV (VERO), with an unknown formulation and strength, at dose of 0.5 ml once, (lot: U1A451M ; expiry date: 20-Feb-2023)  via intramuscular route in the right deltoid for immunization.  It was reported that  the patient was administered Ipol post excursion after it had exceeded extended stability data and was no suitable for use with no reported adverse event (poor quality product administered) (onset date: 29-Jul-2022) (latency: same day)  following the administration of IPV (VERO).  Action taken : not applicable.  Outcome: unknown   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 guidelines. 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.
Patient called the pharmacy 7/13/18 at 6:20 PM. She is experiencing a sore arm, stiff neck and an ear ache. She is also very tired and lethargic.
Severe ongoing headaches, severe vomiting after two weeks of injection, severe ongoing diarrhea after two weeks of injection, delayed emptying of stomach contents to digestive tract, nausea, stomach cramping, afraid to eat food due to symptoms, joint discomfort, fatigue.
Patient was admitted with cellulitis of the lower legs. She has been treated with antibiotics, leg wounds debrided and is overall stable. Wound care service has recommended wrapping the legs for compression to help with edema and to allow wounds to heal, but pt cannot tolerate any kind of compression to the legs and has refused to allow wrapping. She is discharged back to her Skilled nursing facility in stable condition. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Headache, pain in the shot location, pain in all the body, chills, fever, difficulty to sleep.
O42.02 - Full-term premature rupture of membranes, onset of labor within 24 hours of rupture
Intense fatigue combined with strong muscle aches throughout, leading to sleeplessness combined with severe lethargy. Did not seem to have a fever, though didn't check it. Some site-injection pain, though not nearly as severe as with the first dose (2/26/21, COVID19 (Moderna) 001 A21 A).   The symptoms had abated by late afternoon on Saturday, 3/27/21. Acetominophen helped.
pt recv vax & w/in 15min of pvax pt devel an allergic rxn characterized by a red, raised, itchy area @ the inj site;pallor;wheezing & lightheadedness;tx w/epi & DPH;
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. This case is a report of 8 Patients in the exposed cohort who experienced epilepsy, while 23 of the unexposed cohort experienced epilepsy. Of the 8 patients in the exposed group age: 1 was age 18; 5 were in age group 19-24; 2 were in the age group of 25-29. Sex: 2 female, 6 male. Of the 23 patients in the unexposed group age: 1 was 18; 18 were in the 19-24 age group; 2 were in the 25-29 age group; 2 were in the 30-34 age group. Sex: 6 female; 17 male.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 18-JUN-2013 (reported as possibly 2 days ago (specific date was unspecified) the patient was vaccinated with a dose of ZOSTAVAX (dose, site of administration, route not reported). It was reported that you need an X-ray and need to take 150 mg of prednisone 1 day prior to the X-ray. Pharmacist was given this information from an unspecified person from the patient in the pharmacy at and therefore has limited information. The reporter stated ZOSTAVA was dispensed to an unspecified physician's office for administration to the patient. The reporter stated the patient will be needing to take prednisone (50mg every 6 hours) for a total of 3 doses in 1 day, to be done 1 day prior to the X-ray. The reporter feeled the patient may have had a pre-existing condition that required the X-ray but was unsure. The pharmacist feel the patient needing and X-ray was unrelated to the patient receiving ZOSTAVAX. The outcome of event was unknown. Additional information is not expected.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist 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  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Died 2 weeks after getting it; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died 2 weeks after getting it". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: Her father died 2 weeks after getting the vaccine. She do not really support any type of vaccines for COVID (I do support most other vaccinations though) as her dad died 2 weeks after getting it and also there is proof you can still get COVID after being vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died 2 weeks after getting it
Febrile temp of >103, nausea, vomiting, diarrhea, HA, body aches, chills, Injection site pain, redness, and swelling.
Shingrix vaccine at 40; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 40-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, received dose of Shingrix, at the age of 40 years old, which led to inappropriate age at vaccine administration.
pt recv vax & was found to be a nonresponder p/3,4, & 5 doses of vax;1mo p/5th dose exp aching & arthralgia;tx w/pred;
Pt came in to receive 2 month f/u vaccines. At 1416 on 26 Oct 07, patient received Rotavirus orally (lot# 0875U Exp: 06 Oct 2008), Pedarix (Lot# AC21B114BB Exp: 26 Sep 09), HIB (Lot#: UF065AB Exp: 24 Nov 08), Prevnar (Lot#: 87014SE, Exp: May 09). Few minutes later at around 1425 after receiving those vaccines, patient developed shallow breathing, became lethargic, developed mild rash (mild petechiae) on trunks and arms (thoracic area). Pt was admitted to ICU for continuous assessment, observation and supportive care.  At 1530: VSS (POX 100%, HR 140, RR 40, Temp (axillary) 98.4. No medication required.  Pt stayed over night and discharged the next morning recovered. 12/14/07-records received for DOS 10/26-10/27/07-DC DX: ALTE.  Candidiasis oral thrush. Signs of respiratory distress, became letheragic and breathing shallow 2 mintues after leaving clinic. PE: Slight pallor, behaving lethargically and slight shallow breathing. Physical stimulation required. Rash developed throughout trunk of body. Normal exam, rash resolved.
This spontaneous report was received from an office manager, referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-SEP-2017, the patient was administered VAQTA 25/0.5 injection, for prophylaxis. Lot number was N012324 and expiration date 05-APR-2018 (route of administration and anatomical location were not provided). The reporter stated that on the day of the vaccination, the patient received two pediatric doses of VAQTA and that no adverse effects were reported after the administration.
Patient called 9/8/21 stating that she had pain in her arm and is unable to use it. She is concerned that her vaccine was given to high and possibly in the bursa. She was contacting her primary care as well.
Information has been received from a physician concerning an approximately 6 year old patient who was vaccinated with a dose of Varivax. "Last year", the patient developed shingles. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient called clinic and stated that she was having radiating pain down to hand from injection site.  Denies pain during injection.  Stated that it started approximately 3 hours later. She applied ice which made it feel worse when the ice was removed and took tylenol before she called.  It was too soon to know if Tylenol helped.
Information has been received from a physician concerning a 6 year old female with seasonal allergies and no past medical history  who on 03/07/1996 was vaccinated with a first dose of VARIVAX (0.5 ml) (site unknown). Concomitant vaccination the same day included a first dose of MMRII and the fourth dose of ACTHIB. There was no illness at the time of vaccination. On 08/28/2001, the pt developed an itchy rash on her left thorax, dermatome just below the nipple with linear distribution. The pt was seen by the physician on 08/30/2001 and diagnosed with herpes zoster with bacterial super infection also described as shingles of right T4 dermatome with secondary cellulitis. The pt was treated with amoxicillin (Augmentin) 400 mg BID, which started on 08/30/2001. There was no collection of a specimen, it was reported that the vesicles were "probably dried".  It was noted that there was no rash at the site of of injection. The pt was afebrile, however other systemic symptoms reported were otorrhea and impertigo. The patient's pain was reported to be  8 on a scale of 0-10. It was also noted that the pt did not have a history of chicken pox or recent exposure to chicken pox of herpes zoster. The pt did not any adverse reactions following previous vaccinations It was reported that the pt recovered on 10/05/2001.
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's age group was taken based on the product indication as no other patient details were provided. The unspecified number of patients received SHINGRIX and experienced flu like symptoms with the 2nd dose of SHINGRIX, but no other issues with the second dose. This case has been linked with case US2018GSK152349 reported by the same reporter.
I felt lousy all over, achy, no energy, I was coughing crud out of my lungs, I didn't notice that I had a fever. I made an appointment with my doctor, she did a COVID-19 test and an Influenza A and B test. The COVID-19 test came back positive, the Influenza A and B came back negative. I was prescribed doxycycline to take for five day. I do feel better today, every day is getting better, I am coughing a little less every day.
a 15 year old male patient received a dose of Flublok Quadrivalent in error instead of Fluzone Quadrivalent/No AE; a 15 year old male patient received a dose of Flublok Quadrivalent in error instead of Fluzone Quadrivalent/No AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional (medical assistant).  This case involves a 15 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1936, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid on 07-Nov-2019 in error instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Pfizer 8/19 and 9/9. Positive on 1/3
Ran a fever for 3 days (2/9/03, 2/10/03, 2/11/03) of around 100-101.  Ran a fever on 2/12/03 of 99.4.  Experienced fatigue for up to 2 weeks following the vaccination.
Patient developed syncope within a minute or 2 after getting flu shot. Was sitting down, complained about getting dizzy turned pale and started sliding off the chair. I grabbed him by shoulders to prevent from falling and tapped his cheek. He opened his eyes almost immediately. I told him to bend down and keep his head between his legs. Called 911. He said he felt better but after few min of sitting straight turned pale again so I told him to keep his head down till paramedics came. Told him to make sure to get someone to walk with him home since he didn't want to go with paramedics. But he just left.
got a shingles shot, few years later got shingles / suspected vaccination failure; shingles; 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, several years 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 itself. The age at vaccination was not reported. The patient got a shingles shot and a few years later got shingles. The patient enquired what was with that. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
I had a scratchy throat, inflamed sinuses, a mild cough, sneezing, and a little bit of diarrhea. I had severe leg cramps last night. I have cramps in my finger and hands as well. I called Telehealth and they prescribed me with prednisone and Flonase. Then they added azithromycin and cough syrup for me to take as well.
Constant ringing in both ears within 10 minutes of vaccine. Ongoing to this day. Mentioned to worker at the time, was told I'd be fine. Never stops!
THERE IS SWELLING AT THE SITE AND IT HAS BECOME ITCHY AND HAS CAUSED REDNESS AS WELL. SAME SYMPTOMS FOR A WEEK NOW. SOMETIMES THE ITCHING COMES AND GOES.
Vaccine expiration date was 6/3/2023, vaccine given on 6/5/2023.
my voice has changed from a clear voice to a hoarse voice; This is a spontaneous report from a contactable consumer (patient). An unspecified gender 84-year-old patient received the second dose of BNT162B2 via an unspecified route of administration in Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration in Feb2021 as single dose for COVID-19 immunization. On an unspeicified date, the patient's voice has changed from a clear voice to a hoarse voice that people have a hard time understanding. Patient's vocal cords have been examined and have been found to be cancer free. The patient's family doctor had tried antibiotics and antihistamines to no avail. The patient wondered whether had recorded anyone else with him problem. For the record the patient was 84 year-old. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Alopecia all hair has completely gone even eye lashes eyebrows scalp- all no sign of any return
Adverse event 4/17/2021: severe chills, high fever (max = 102.7 F) that persisted on and off until 4/22/2021. Worst fevers were at night. Required support from spouse to do every day tasks. Stayed in seated or prone positions the majority of the time from 4/17/2021 to 4/19/2021. Treated with Tylenol. I would take 500 mg every 4 hours or 1000 mg every 6 hours and as I got further into the week I tried not to take Tylenol to avoid masking symptoms, but I would take it if temperature spiked which would happen randomly. Adverse event 4/19/2021: Hives developed on scalp and forehead following approximately 30 minutes of exposure to sunlight. These hives began to spread through 4/20/2021 and into 4/21/2021 to eventually cover entire upper torso including stomach, back, chest, neck, face and head. Treated with Singulair and Zyzol starting 04/21/2021 and stopped treatment once hives were gone on 4/23/2021.
After waking up the next morning and walking around for 20-30 minutes, overcome with cold sweats and a feeling I was going to pass out if I didn't lie down.  Sat down and cold sweats passed after about 3-4 minutes.  Had the same reaction after my 2nd series of the Pfizer/BioNTech vaccine.
ADMITTED TO HOSPITAL ON 2/10/2022 FROM LTCF DUE TO UTI AND VERY LETHARGIC WITH MENTAL STATUS CHANGES, ALSO DEHYDRATION.