chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to 2 newborns (numbered 82 and 83). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 08-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Pt (15 yrs old) received first dose of vaccine (Lot #EW0164) on 4/16/2021 with his mother (legal guardian). Pt returned to  site with mother (legal guardian) for his 2nd dose of Pfizer. MD made aware of situation and does not agree for pt to receive 2nd dose of vaccine per protocol until 12-15 year olds can legally be vaccinated. Mother agrees to return with her son when the vaccination change is made. Pt mother denied adverse reactions.
Flublok was given to a six month old patient/No AE; Initial information was received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six months old female patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age)  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was also a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  There will be no information available on the batch number for this case.  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 Directive and Module VI of the 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.
Rt side flu shot no problem. Left side PNEUMONIA shot 11/05/16 AM woke up an my left arm is swollen 2 times its normal size and could hardly move it. I had to lift it up to move lasted 1 day and 1/2 before the swelling went down.
Itching at injection site  in the afternoon of 02/07 then swelling, redness and heat during the night causing sleeplessness. Symptoms continuing now on 02/08 though not quite as bad.
My mom died the next morning after administration of the bivalent vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster; bivalent), single (Lot number: GJ5342) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Alzheimer" (unspecified if ongoing), notes: Alzheimer; "Anxiety/depression" (unspecified if ongoing); "Anxiety/depression" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Severe arthritis" (unspecified if ongoing). Concomitant medication(s) included: VALPROIC ACID; SERTRALINE; LOSARTAN; TYLENOL; ATENOLOL. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 14Sep2022, outcome "fatal", described as "My mom died the next morning after administration of the bivalent vaccine". The patient date of death was 14Sep2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical information: Patient's age was reported as 83 (unit not reported). Vaccine was administered by public. The event did not result in emergency room or office visit.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: My mom died the next morning after administration of the bivalent vaccine
had a dream that someone or something had ahold of him three different times trying to pull him somewhere he didn't want to go; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 05Feb2021 08:00 (Lot number: EJ1686) at the age of 82 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, administered in the left arm), administration date: 15Jan2021 08:00, when the patient was 82 years old, for COVID-19 immunisation. The following information was reported: ABNORMAL DREAMS (non-serious) with onset 07Feb2021 01:00, outcome "unknown", described as "had a dream that someone or something had ahold of him three different times trying to pull him somewhere he didn't want to go". Therapeutic measures were not taken as a result of abnormal dreams.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. He had no known allergies.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021236488 Same reporter, suspect drug, and event; different patient
Sore arm, body aches, fever (100.2), headache, and tiredness
3 days p/vax pt devel fever & 104 febrile seizure. exp shaking. dx bilateral otitis media. febrile seizure.
Swelling, redness in area of vaccination, rash all over body. Applied ice, TYLENOL & BENADRYL.
mistakenly mixed the powder component (ActHib) of Pentacel with sterile saline and failed to use the DTaP/IPV portion with no reported adverse event; mistakenly mixed the powder component (ActHib) of Pentacel with sterile saline and failed to use the DTaP/IPV portion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reported that mistakenly mixed the powder component (Acthib) of Pentacel with sterile saline and failed to use the Dtap/Ipv portion with no reported adverse event , it involved vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , with an unknown formulation and strength, (lot: UJ660AAA ; expiry date: 25-Feb-2023) via unknown route in unknown administration site for immunization.  On an unknown date the reporter mistakenly mixed the powder component (Acthib) of Pentacel with sterile saline and failed to use the Dtap/Ipv portion with no reported adverse event (product preparation error)  (single component of a two-component product administered) (latency: same day) .  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 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.
About 10 hours after my second dose of Pfizer I got a horrible headache, body aches, uncontrollable chills/shaking, and fever reaching 103 degrees.  This lasted for about 12 hours. Following that, I just had body aches and a headache until approximately 30 hours after the shot during which time the fever came back to 102 degrees, chills, and vomiting.  This lasted for 10 more hours ending approximately 40 hours after the injection of the vaccine.
arm was a little sore; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to case ID: 2020SA294179, 2020SA294195, 2020SA294181, 2020SA294133, 2020SA294183, 2020SA294184, 2020SA294185, 2020SA294186, 2020SA294187, 2020SA294188, 2020SA294189, 2020SA294190, 2020SA294191, 2020SA294192, 2020SA294193, 2020SA294194,  2020SA294182.  This case involves a female patient (unknown demography) with an unknown age who reported that her arm was a little sore (pain in extremity), while she received vaccine Influenza Vaccine.  Medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, patient stated that her arm was a little sore (pain in extremity) (Unknown latency) following the administration of Influenza Vaccine. Reporter stated that she and her husband for flu shot and didn't hurt.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
Muscle pain; Weakness; Headache; Shivering; Nausea; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2021, the patient received the 1st dose of Shingrix. On 5th February 2021, 1 days after receiving Shingrix, the patient experienced muscle pain, weakness, headache, shivering and nausea. On an unknown date, the outcome of the muscle pain, weakness, headache, shivering and nausea were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, weakness, headache, shivering and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient got his first shingrix shot a day before reporting and experienced muscle pain, weakness, headache, shivering, and nausea on the day of reporting. The reporter did not consent to follow up.
substernal chest pain; shortness of breath; Troponin peaked at 9.100; This is a spontaneous report from contactable physician. A 30-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), intramuscular in left arm on 04Mar2021 at 15:45 at single dose for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient has no known allergies and has other medications in two weeks. It was unknown if the patient has other vaccine in four weeks. He has no COVID prior to vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunization. The facility the vaccine was administered was reported to be other. On 07Mar2021, the patient who has no prior medical history was admitted for substernal chest pain and shortness of breath; troponin peaked at 9.100 with no EKG changes. Heart catherization was normal. The patient was not tested for COVID post vaccination. The events resulted in emergency room/department or urgent care and required hospitalization for one day. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history and drug allergies or reactions were reported. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
12 hrs p/inject devel fever, generalized muscle aching, fatigue; required bed rest & analgesics; sx subsided in 24 hrs;
Shoulder pain and diagnosed with frozen shoulder. Patient is also experiencing insomnia due to the pain.
Child was very resistant and crying when he received vaccination. About 3 mins after vaccination he became pale, unresponsive and had seizure like activity in his arms and legs momentarily. Fully recovered after several minutes.
Pericarditis - recurrent and mild pleural effusion Colchicine, NSAIDs Outcome - to be determined. Comes and goes
Case previously recorded as MA2009-3819. Initial case report received from a nurse on 11 NOV 2009. A patient 35-year-old female was vaccinated into the deltoid with 0.5 mL S-OIV FLUVIRIN (batch no. unknown) i.m on 28 OCT 2009. The patient was unaware that she was pregnant (8th week of gestation) at the time of the vaccination. No adverse event was reported.
Chills, Sweats, Bad body aches Saturday night through Sunday Morning-  Took Tylenol Tiredness- throughout Sunday Chills- Sunday night- Tylenol Monday felt good-  Monday night slight temp 99.5 and shortness of breath  Took Tylenol  Tuesday Feel fine headache and slight shortness of breath.
Rash on arm Itchy  Warm and hard Lasted about 48 hrs did not see a doctor
Headache, CoughWheeze, chills, sore at injection site, Narrative:  Per nursing report: "states took 2nd dose of Moderna vaccine yesterday about 11:30. States this morning c/o soreness to right arm and coldness to feet with mild bodyaching, headache to left eye and temporal lobe."
Information has been received from a grandmother concerning her now 5 year old grandson with an antibiotic allergy, who in approximately 1999 at the age of 18 months was vaccinated SC with a dose of MMR II. A few months after receiving the vaccine the pt developed myasthenia gravis. It was reported that "now" the pt had a feeding problem and facial muscular problems. The pt had not yet recovered from his experiences. It was noted that the pt had been taking "some medication" for treatment but recently stopped taking all medication. Upon internal review myasthenia gravis was considered to be an important medical event (OMIC). Additional info has been requested. THe follow up received on 8/5/03 from the physician indicated that she did not have the pt's chart and therefore did not have any dates available. The physician confirmed that the pt did receive a dose of MMR II. It wsa reported that the pt was diagnosed with myasthenia gravis and subsequently had a thymectomy. The pt was treated with monthly IVGG injections, prednisone, and Imuran. He was weaned off of the prednisone over the past month. The physician noted that she did not think that the myasthenia gravis was related to MMR II. The physician stated that she would provide additional info. Upon internal review myasthenia gravis was considered to be an important medical event (OMIC). Additional info is expected.  In follow up info the physician indicated that the pt began with a swallowing dysfunction in November of 1999, developed ptosis in December of 1999 and was diagnosed with myasthenia gravis in January 2000. The physician reported that the pt required a prolonged hospialization (several days). It was also reported that the pt's experiences resulted in a persistent or significant disability/ incapacity. It was noted that the pt had not recovered. Additional info is expected.
numbness to the left side of the face / tonque.  pt denies any difficulty swallowing / breathing &/or other s/s.   No visual swelling to the tongue.  Medics present.  pt. waiting another 30 mins to be monitored.
Fever of 101, Headache, chills, diarrhea, tiredness.  Fever, headache and chills abated after about 12 hours.  Tiredness and diarrhea abated after about 2 days.
PT called us a week later and said she went to ER for allergic reaction couple hours later.
says in her arm where her shot was given is sore; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL0140; expiration date: not known), via an unspecified route of administration on right arm on 18Dec2020 10:00 at single dose for covid-19 prevention. Medical history included ongoing arthritis probably since ten years ago (2011), ongoing osteoporosis at least since five years ago, maybe longer, and ongoing Barrett's esophagus probably since five years ago (2016). Family included ongoing high cholesterol diagnosed probably 20 years ago (2001), her whole family has it and was managed or lowered with medication. There were no concomitant medications. The patient said in her arm where her shot was given was sore on an unspecified date. The first time she got the injection in her right arm, but the second time her right was still hurting. The outcome of the event was not recovered.
Localized, large rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Localized, large rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE RASH (Localized, large rash at the injection site). At the time of the report, VACCINATION SITE RASH (Localized, large rash at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment related information has been reported. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new significant information was received. Patient's contact information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 63 year old female nurse who on an unspecified date was vaccinated subcutaneously with a first dose of ZOSTAVAX.  Concomitant therapy included "Eleva" and lisinopril.  Within 24 hours of vaccination the patient developed soreness at the injection site as well as redness at the injection site "about as large as a lemon", lasting two weeks.  The patient was recovered at the time of reporting (date unspecified).  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
p/vax pt began to exp pain lt deltoid which radiated over cap of shoulder & down into axillae;felt liked a fractured rib w/deep breathing-diff to breathe x 72hr;
Slight sore throat first 1/2 day. Sore throat, aches, fever up to 99.3, runny nose, slightly congested chest: 2 days. No energy extremely tired on 3rd day. Tired for 5 more days. Took Ibuprofen, Vitamin C and Zinc supplements.
Threw up; A spontaneous report was received from registered nurse on 07SEP2023 regarding a patient of unknown age and gender who "threw up" (PT: Vomiting) following the administration of Vaxchora (cholera vaccine live oral; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient threw up about one hour after receiving Vaxchora.  The outcome of the reported event was unknown.  The action taken with Vaxchora with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient received Vaxchora and he threw up (vomiting) an hour later. Considering the limited case information, the role of Vaxchora cannot be ruled out and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.  Significant follow-up information was received from the nurse on 19SEP2023.  It was reported that the patient did not have any disease and was completely healthy. The patient was allergic to penicillin.  On 01SEP2023, the patient received Vaxchora and threw up after 4-5 hours of Vaxchora administration. Reportedly, the patient vomited only once, and no treatment was provided for the same.  The patient recovered from the reported event on 01SEP2023.  Company comment: It was reported that a patient received Vaxchora and he threw up (vomiting) after 4-5 hours. Considering the limited case information, the role of Vaxchora cannot be ruled out and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vaxchora and he threw up (vomiting) after 4-5 hours. Considering the limited case information, the role of Vaxchora cannot be ruled out and the causality of vomiting is assessed as possible. The case is considered non serious as per medical assessment.