chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART ATTACK; HUGE BLOOD CLOTS; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Consumer reported that on an unspecified date, the patient got the shot and shortly he was dead from a heart attack caused by huge blood clots of the size of a tennis ball. It was unknown if an autopsy was performed.    The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of heart attack and huge blood clots on an unspecified date. This report was serious (Death).; Sender's Comments: V0 20211116646-COVID-19 VACCINE AD26.COV2.S- Heart attack, huge blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK; HUGE BLOOD CLOTS
PSEUDO LYMPHOMA. Information has been received from the patient's mother concerning her daughter with no pertinent medical history who was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. It was noted by the mother that the patient developed Rosai-Dorfan syndrome after being administered hepatitis B virus vaccine rHBsAg (yeast). The patient was being treated with prednisone. It was noted that a variety of tests were done to identify autoimmune disorders. It was also noted that the patient had not recovered at the time of the report. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia & NauseaVomiting Narrative:  missed one day of work following second dose due to above symptoms
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4203909-00 (RA). A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; upadacitinib (RINVOQ), oral since 01Nov2021 (ongoing) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "unknown", described as "RHEUMATOID ARTHRITIS FLARE"; BLOOD PRESSURE INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "blood pressure had been higher than usual/Her most recent blood pressure reading were 132/88 and 155/100/ Increased blood pressure"; PALPITATIONS (non-serious) with onset Nov2021, outcome "not recovered", described as "HEART PALPITATIONS OCCASIONALLY"; SINUS PAIN (non-serious), outcome "unknown", described as "Sinus pain"; HEADACHE (non-serious), outcome "unknown", described as "HEADACHES". The event "rheumatoid arthritis flare" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Dec2021) 132/88; (Dec2021) 155/100. The action taken for upadacitinib was dosage not changed. Causality for Rinvoq (upadacitinib): The reporter's causality for the event(s) of increased blood pressure, heart palpitations occasionally, sinus pain, headaches and rheumatoid arthritis flare was not provided. Causality for Pfizer BioNTech Covid-19 vaccine (tozinameran): The reporter's causality for the event(s) of increased blood pressure was possible, heart palpitations occasionally, sinus pain, headaches and rheumatoid arthritis flare was not related. Follow-up (09Mar2022): This is a solicited Follow-up report based on information received by Pfizer (Manufacturer Control Number: 21K-163-4203909-00). Updated information included: patient demographics, event information, reporter opinion of causality, suspect drug information and narrative description. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Headache, Nausea Vomiting chills, malaise, pain in injection arm Narrative:
Warm to the touch; Swelling; Redness; Soreness/Pain; Temperature of 100.3 F; This spontaneous case from the United States was received on 08-Oct-2021 from pharmacist via Regulatory Authority (reference number: SEQW21-03532) and concerned a 5-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 07-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose 0.5 ml, route of administration and anatomical location not reported) for influenza prevention. The batch number reported was 308466 and expiration date 30-Jun-2022.  On the same day, at night after receiving Flucelvax Quadrivalent, the patient experienced soreness and temperature of 100.3 F. Pharmacist mentioned that the patient was tense during the administration of vaccine.  On 08-Oct-2021, one day after receiving Flucelvax Quadrivalent, the patient developed redness, swelling, warm to the touch and pain. The patient started treatment with Tylenol (paracetamol).  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 5-year-old patient experienced pain, skin warmth, swelling, pyrexia, and erythema within one day after receiving Flucelvax Quadrivalent. The patient's medical history and concomitant drugs were not reported. Due to plausible chronology, causality is assessed as possibly related.; Sender's Comments: A 5-year-old patient experienced pain, skin warmth, swelling, pyrexia, and erythema within one day after receiving Flucelvax Quadrivalent. The patient's medical history and concomitant drugs were not reported. Due to plausible chronology, causality is assessed as possibly related.
Itchy hives under arm of the injection site arm, cortisone cream , 3-5 days
I started with muscle pain the next day and the next night shivers and cold, and all the not feeling right.
no symptoms were reported; altered dosing schedule; This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 01-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in vial, (strength and route of administration were not reported), (lot # R009614 and expiry date 30-NOV-2020 verified to be valid) for prophylaxis. On 18-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in vial, (strength and route of administration were not reported), (lot # R009615 and expiry date 07-DEC-2020 verified to be valid) for prophylaxis. The patient was scheduled to get her third dose on 13-MAR-2020. No symptoms were reported.
Pt experienced a red raised lump and sneezing. She received the high dose flu vaccine and was not of age 65.
Urticarial rash immediately after vaccines administered localized to injection sites on both thighs.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with M-M-R II (expiration date 29-MAR-2018, subcutaneous) (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with expired dose of with M-M-R II. The outcome of the event was unknown. The outcome of the event was unknown.
Patient presented to a vaccination clinic on 10/05/2022 @1250 patient was given a Covid Pfizer Monovalent vaccine by accident. The intended vaccination was Covid Pfizer Bivalent vaccine. No adverse reactions were noted, patient educated on the need for revaccination with correct Pfizer Bivalent vaccine.
Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period). At the time of the report, PRODUCT STORAGE ERROR (Modena Cocid-19 vaccine was possibly administered to less than 40 patients after potentially being stored in the refrigerator for 4 days over 30 day recommended storage period) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant  medications were not provided. Treatment information were not provided.
extra dose of DTAP AND IPV; extra dose of DTAP AND IPV, IPOL received on Nov 29th 2021, Kinrix received on June 28th 2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included PEDIARIX (received 1st dose on 10th October 2017), PEDIARIX (received 2nd dose on 18th December 2017), PEDIARIX (received 3rd dose on 20th February 2018), Infanrix (received 1st dose on 4th December 2018), Infanrix (received 2nd dose 29th November 2018) and IPOL (received on 29th November 2021).   On 28th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were 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: 28-JUN-2022 Reporter's Comment: The patient received a 1st dose of Kinrix in 28th June 2022. The reporter reported that patient got an extra dose of DTAP AND IPV. The reporter consented to follow up. Additional Supportive Information: The patient received 1st dose Kinrix after receiving 3 doses of Pediarix, 2 doses of Infanrix, 1 dose of IPOL, which led to extra dose administered and wrong vaccine administered.
body aches; diarrhea; high fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (high fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 immunization.     The patient's past medical history included COVID-19 in November 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (high fever). At the time of the report, PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided.
10day p/vax pt woke up w/axillary temp of 100f & red raised rash on trunk, p/bath more on neck, face, diaper area.
48 hours after my booster I started to develop a rash. In a few hours it covered my torso, arms and legs. Itchy, bumpy, lesions that then resolved into what looks like a sunburn.
At about 2 in the morning I let my dog outside and it was cold after that I had uncontrollable shaking for about 5 hours it was severe
This spontaneous report as received from a company refers to a female patient of unknown age who presented a claim to the client of the company. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # reported as H018340, exp. date March 2014. On 28-DEC-2012 (reported as date of loss), the patient experienced an adverse reaction to the PNEUMOVAX 23. The outcome of adverse reaction was unknown. Additional information has been requested.
Fever 01/10/2005, ER 01/12/2005.  Sepsis requiring hospitalization for 2 days. Discharge summary states viral infection. msv Medical records state cough, diarrhea. msv
This spontaneous report as received from a physician refers to a 5 years old male patient. The patient was vaccinated with dose 2, 0.5 ml of PROQUAD (merck) (lot # (H015643)) on 07-JAN-2013. On 07-JAN-2013 the patient experienced local reaction at the injection site. The patient did not develop a fever. TYLENOL was given as treatment. It was unknown if the patient had sought medical attention. The patient was recovered. Additional information is not expected.
fever for one day -101 degrees-began and ended 11/1- took a Tylenol rash on backs of thighs-ongoing severe  ear pain and pressure as well as impaired hearing - left ear-began 11/3-ended that evening after doctor recommended that I take an antihistamine.
Abdominal pain, right mid and upper abdominal pain and right mid and upper back pain, nausea, minimal vomiting, body aches.
Patient was a 17 year old female who received Moderna vaccine at long term care facility Covid Clinic.  Patients mother worked at facility and brought patient to receive vaccination.  No adverse events noted
little bit of headache; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (little bit of headache) and INJECTION SITE PAIN (soreness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (little bit of headache) and INJECTION SITE PAIN (soreness at the injection site). At the time of the report, HEADACHE (little bit of headache) and INJECTION SITE PAIN (soreness at the injection site) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable since the patient had taken both doses of the vaccine. No concomitant drugs and treatment medications were reported.   Reporter did not allow further contact
Pt was given dose of pfizer infant covid-19 instead of pfizer pediatric covid-19
This spontaneous report was received from a pharmacist refers to a currently 33 year old female patient. Information on pertinent medical history and concomitant medications were not reported. The patient was allergic to Penicillin. On an unknown date in 2016, the patient was vaccinated with M-M-R II injection 0.5 ml once subcutaneously (lot # L024267 and expiry date: 01-JUL-2017) for fertility (product use in unapproved indication). On an unknown date, the patient underwent a "blood test" by an unknown healthcare professional (not further clarified) and her titer results were negative for measles, mumps, and rubella. It could not be further determined if the patient received any prior doses of M-M-R II as part of routine vaccination. No treatment was given to treat the adverse events. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as not recovered/not resolved. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Redness and swelling at site of immunizations; 3cm X 5cm diameter of erythema and 2cm X 3cm diameter of induration.
got both doses, have just had another case, 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 time).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both the doses of Shingrix vaccine when it first came out and have just had another case of Shingles. The patient stated that when he/she got the vaccine, the patient was told it was for life, but the patient was reading now that it was good for 4 years or more. This case was considered to be a suspected vaccination failure case, as the details regarding completion of time to onset and laboratory confirmation for shingles were unknown.
Pain in leg, couldn't walk, numbness in leg (upper thigh). Numbness has continued for the last three weeks. Referred to a specialist.
fever was noticed the evening  of the immunization. patient has been treating and controlling fever with tylenol and ibuprofen and drinking plenty of fluids and resting.  patient was seen and examined by local emergency room and also by primary  care . Both health care providers stated to patient that they suspect COVID-19 due to patient stating he has no taste with fever.  Patient has had fever on and off since evening of 7-10-20 until 7/16/20. Now his fever has passed. Patient continues to rest and drink ample fluids to stay hydrated and also is watching temperature; while awaiting COVID test results from emergency room.
There were not any adverse events reported , but we noticed that there were 2 vaccine consent forms for the patient. He was checked in by the facility twice and then proceeded to 2 different pharmacists to receive his 2nd COVID vaccination at 2 different times The patient was assessed by RPH in charge and nurse on duty, with a follow up phone call to his PCP. No adverse events reported, as all vitals were normal. Doses were given at 9:30 am and 2:30 pm.
pt recvd vax & devel cervical lymphadenopathy, a fever, arthritis & flu symptoms; pt stated  it felt like an exacerbation of her underlying connective tissue disease;
Rash started on wrists, sides, itchy. Spread to arms, legs, trunk, very slight on palms, not on face or soles of feet. Gradually became more raised and more red rash.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x 1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 712 hours with lowest recorded temperature of 33F (0.555555556 Celsius) and other one for 216 hours with lowest recorded temperature of 3 F (0 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)", This is one of several cases from the same reporter. Additional information has been requested.
Kinrix instead of Infanrix; Kinrix given to patient ; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th June 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Kinrix instead of Infanrix at the age of 15 months, which led to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event was reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. This case had been linked with case US2022025615, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022025615:Same reporter.
Headache, Nausea, Chills, Fever, Body Ache, Arm Pain (at shot)