chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose Jul2021, 2nd 07Mar2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in July 2021).   On 07-MAR-2023, the patient received the 2nd dose of Shingrix. On 07-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Jul2021, 2nd 07Mar2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 09-Mar-2023 Member of the public reporting she received 1st dose of Shingrix in July 2021 and second dose on 7th March 2021. The reporter consented to follow up via email. The patient received 2nd dose of shingrix on 7th March 2021, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
This spontaneous report as received from a nurse refers to a 56 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route not reported). Concomitant therapies included LYRICA. The nurse reported that the patient complained of neuropathy in her feet and hands. The patient stated she had numbness and tingling in her extremities on unspecified dates in January 2014. The patient visited an unspecified Urgent Care facility on an unspecified date. The urgent care facility prescribed and EMG (Electromyography) and a nerve conduction study on the patient.  The patient was referred to an unspecified neurologist. The patient visited the unspecified neurologist on an unspecified date. The patient was diagnosed with carpal tunnel syndrome. The patient was operated on for carpal tunnel syndrome on na unspecified day in March 2014. The patient stated that she was still experiencing neuropathy in her hands and feet. Additional information has been requested.
He was bleeding, it came out from his rectum through feces; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. The relevant medical history included gout. Concomitant medications included colchicine for gout and a lot of unspecified medications. The patient took a COVID vaccine yesterday and this morning he was bleeding through the 'raw', it came out from his rectum through feces on 07Feb2021. He stated that the next shot was between 27Feb and 19Mar (Clarification unknown). So it was one day between those two days. He said he still was just a little bit, not like he was. No treatment was received for the event. The outcome of the event was recovering.
crying x 12hrs;t100;local erythema & induration whole thigh;tx ice & APAP; crying stopped but swelling persists
PATIENT INDICATES THAT SHE HAS TINNITUS BUT THE NEXT DAY AFTER GIVING HER THE VACCINE, THE NOISE INCREASED AND TO DATE IT HAS NOT IMPROVED
2 days after shot, injection site & arm ached. Then started to itch. Noticed 1 or 2 bumps/blisters started aching more. Blistery/rash area golf ball size with tennis ball size redness. Totally resolved in approx 10 days.
I started to have a sore throat and runny nose on the 1st of September around 4:00pm.
Information has been received from a registered technician concerning her grandson who "during the last week" of January 2002 was vaccinated with a dose of varicella virus vaccine live. On 02/02/2002 the pt developed a vesicular rash over his entire body and a mild cough. There was no other info provided. Additional info has been requested.
Patient accidentally received a PENTACEL vaccine with only the diluent DTAP/IPV portion and not the HIB powder component with no reported adverse event; Initial information received on 27-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old male patient who accidentally received a diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] vaccine with only the diluent dtap/ipv portion and not the hib powder component 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 pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and hepatitis A vaccine (Hepatitis A) for Immunisation.  On 09-Mar-2023, the patient received a 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection (frequency - once, strength - standard, lot UJ736AAA, expiry date - 18-Sep-2023) via intramuscular route in the upper right thigh for Immunisation.  On 09-Mar-2023 the patient accidentally received a pentacel vaccine with only the diluent dtap/ipv portion and not the hib powder component with no reported adverse event (single component of a two-component product administered) (latency: same day)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
11 year-old patient was given a 12+ Pfizer vaccine, instead of a 5-11 year old Pfizer vaccine.
Sore arm; Red bumps on arm; a rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE SWELLING (Red bumps on arm) and INJECTION SITE RASH (a rash on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE SWELLING (Red bumps on arm) and INJECTION SITE RASH (a rash on her arm). On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 31-Jan-2021, INJECTION SITE SWELLING (Red bumps on arm) and INJECTION SITE RASH (a rash on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 26-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source.  Additional information has been requested.
aortic aneurysm; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2021 as dose 3 (booster), single (Lot number: EL0182) at the age of 63 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EL8982), administration date: 12Jan2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2nd, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EL9269), administration date: 03Feb2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: AORTIC ANEURYSM (medically significant) with onset 21Jun2022, outcome "recovered" (22Aug2022). Therapeutic measures were taken as a result of aortic aneurysm. Additional information: the patient underwent surgical repair for the event of aortic aneurysm. The patient provided information to the reporter regarding the reported adverse event(s) with the use of the product. The reporter considered the Pfizer product had a causal effect to the adverse event.; Sender's Comments: Based on the known the information available the Causal relation between the event AORTIC ANEURYSM and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
I had diarrhea; and I had a horrible nightmare; I was really tired. Diarrhea symptoms for 5 weeks ( at least one week after the 2nd dose of vaccine).  I saw the doctor on the 14th of January. He just told me to drink water.
5 minutes after receiving the vaccine, the patient felt dizzy.  She was sitting upright in a chair at the time.  She passed out and had a small seizure.  We moved her to the floor and her breathing became very shallow.  We adminstered an epi-pen at 1:41 pm and called 911.  We took her BP using an automatic cuff at 1:45 and it was 96/64.  We handed her care over to EMT at 1:50 pm.  They transported her to ER because her lactic acid was very high.
Presented to ED complaining of headache, myalgias and pain most intense at right shoulder/axilla. No fever, rash, focal neuro symptoms, chest pain or SOB. No erythema, warmth or induration. No joint swelling.
April 8th at 11pm I started to have slight body aches. I woke up at 3am with intense body aches/ chills/sweats, felt like I had a cabin fever for the entire day of April 9th. I felt dizzy,  had a headache, my eyes aches and very very fatigued and couldn?t eat. Night of April 9th I started to not feel so dizzy but I was very very hot and could not cool down. Ever since April 10th I?ve have runny/stuffy nose/ body aches, sore throat, I developed a cough week of April 12th, eyes ached and very very fatigued. Today, April 21st, I am still a little fatigued, little soar throat, but runny/stuff nose still, and body soreness/aches.
experiencing a sensation of burning and pinching needles in the skin of the arms, legs and stomach; experiencing a sensation of burning and pinching needles in the skin of the arms, legs and stomach; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included multiple sclerosis and very sensitive skin. The patient's concomitant medications were not reported. The patient reported 2 days after the administration of the first dose of the Pfizer's COVID-19 vaccine she began experiencing a sensation of burning and pinching needles in the skin of the arms, legs and stomach on an unspecified date with outcome of unknown. The consumer reported that her physician recommended her to treat the symptoms with paracetamol (TYLENOL), rest and hydration.   Information on the lot/batch number has been requested.
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
within 12 hours of my third and fourth vaccination(Moderna, ) my urine was the color of black coffee.  It cleared gradually within a week.  There was never any pain.  I drank lots of water.  I am concerned about possible kidney damage if I take the fifth dosage.
Experienced shingles episodes approximately yearly from age 50-58. No recurrence until approximately one week after shingles vaccine. Most current episode was most intense pain of all previous episodes
Dizzy, heart accelerating, couldn't stand up later diagnostic POTS neurological: burning, pain, numb, red, sensory nerves
RIGHT ARM COULD NOT LIFT-UP; NUMB ON THE RIGHT ARM WHERE THE VACCINE WAS GIVEN; 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, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, once toatal administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced right arm could not lift-up. On 13-MAR-2021, the subject experienced numb on the right arm where the vaccine was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numb on the right arm where the vaccine was given and right arm could not lift-up was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Pt recvd 1st dose of hep B vax 27JAN91 & devel T-100 & swollen hands.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had sore arms.  No other details were provided. This case linked with US2019AMR206161, US2019205723 and US2019205719, reported by same reporter.
On 1/28/99, the pt received his first injection of Lymerix. with no ill effects. On 2/19/99, the second dose was given and sometime afterward he experienced joint pain and general illness. He was tested for Lyme antibody and was negative. On 1/10/00, the pt received his third injection of Lymerix and one month later on 2/12/00, blood work was performed. An enzyme linked immunosorbent assay was used to test for Lyme antibody. The ELISA revealed anti - IgK antibodies and no anti - IgG antibodies. This was reported as lack of effect.  The previous experience of joint pain and general illness was not reported after the third dose of Lymerix.
did not return for second dose until today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2nd July 2023, batch no. 2KE55 and expiry date 22nd September 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: did not return for second dose until today). The outcome of the incomplete course of vaccination 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 Information: GSK receipt date: 24-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist reported that  the patient received 1st dose of Twinrix and did not return for 2nd dose until today (on the day of reporting), which led to incomplete course of vaccination.  The reporter consented to follow up.
Thrombocytopenia, Arthralgia, fatigue, injection site pain  Narrative:
soreness; The dose 0.3ml dose diluted with 0.8ml instead of 1.8ml; Patient got a super concentrated dose of the vaccine; This is a spontaneous report from a contactable pharmacist. An 84-years-old male patient received bnt62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0178; Expiration Date: Aug2021), dose 1 via an Intramuscular route of administration at Right Deltoid on 25May2021 at 07:24 (at the age of 84 years) as dose 1, single for COVID-19 immunization. Dose: 2 (batch number and expiry date was not reported) via intramuscular at right deltoid on 15Jun2021 09:58 as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported on 25May2021 at 07:00 in morning, the pharmacist gave a patient the dose 0.3ml dose diluted with 0.8ml instead of 1.8ml. The patient received a super concentrated dose. Pharmacist wanted to know whether to revaccinate or how it will affect the patient. It was confirmed that no other patient received product from this vial. On 26May2021, the patient experienced soreness. Outcome of the event soreness was recovered 16Jun2021 and unknown for other events.  Follow up (12Jul2021): Added new event soreness.
improperly stored vaccine was administered to a consumer; This spontaneous report was received from a nurse and refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-SEP-2020, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously, lot # S005249, expiration date 20-FEB-2021 (strength and dose were not reported) for prophylaxis.  On an unknown dates, the dose of the vaccine was exposed to temperature excursion at 54.32 Fahrenheit (F)  for 7 hours and 14 minutes. There was no previous temperature excursion reported. The call was due to digital data logger.
Mother of child states she saw erythema and swelling at site of vaccine administration. Pt c/o pain and difficulty walking.
felt ill fir 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received first vaccine last month of the reporting and really felt ill for 2 days. They said the 2nd was worse so would prepare to take a couple days to veg out next time. It was worth it though, did not want shingles. Additional supportive information: Follow-up would not possible as no contact details were available.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the first of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 at a single dose and influenza vaccine at unknown dose and frequency, both via an unspecified route of administration in the arm on an unspecified date for routine vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date it was reported that during the flu season, for the first four patients, the pharmacist co-administered the flu vaccine with pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the same arm with an inch apart. The patient called back and stated that it hurt. The patient reported that the arms were swollen and got a lump. The pharmacist thought that the events happened between Sep2017 and Nov2017 and she believed that the patient had recovered completely on an unspecified date in 2017. The pharmacist stated he changed his vaccinating procedures to one vaccine in each arm and hasn't had any problems since. Information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2017527178 same reporter, drug and event/ different patients.
Pfizer second dose COVID vaccine was administered in error to patient who was due to receive second dose Moderna vaccine.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or about 25-JUL-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. Outcome of the event was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates since 29-AUG-2016, improperly stored M-M-R II (rHA, lot # L036851, expiration date 23-SEP-2017, rHA, lot # L049316, expiration date 03-DEC-2017; dose and route were unknown) were administered to unspecified patients. No adverse experiences have been reported. The vaccines were exposure at 52 Fahrenheit degree for 35 minutes. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.