chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.21. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976.
A bunch of issues suddenly with memory and hallucinations; A bunch of issues suddenly with memory and hallucinations; This spontaneous case was reported by an other health care professional and describes the occurrence of HALLUCINATION (A bunch of issues suddenly with memory and hallucinations) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (A bunch of issues suddenly with memory and hallucinations) (seriousness criterion medically significant) and MEMORY IMPAIRMENT (A bunch of issues suddenly with memory and hallucinations). At the time of the report, HALLUCINATION (A bunch of issues suddenly with memory and hallucinations) and MEMORY IMPAIRMENT (A bunch of issues suddenly with memory and hallucinations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient received a COVID booster last week but brand of product was unknown.  No additional adverse events. No product quality complaints.  No treatment medications was reported.  Company comment: This spontaneous case concerns an elderly patient of unspecified gender  ,with no medical history reported, who experienced the unexpected serious (medically significant) event of Hallucination which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly patient of unspecified gender  ,with no medical history reported, who experienced the unexpected serious (medically significant) event of Hallucination which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Intense muscle aches and back ache.  Head ache.  Fever and chills. Fatigue.  It lasted about 18 hours.
At about 24+ hr, pruritis, warmth, elevation, about 5 cm around injection site, although not symmetrically, clearly more cephalad, margin slightly irregular.  Mild improvement with triamcinolone. 0.5% bid.  However, due to persistence of symptoms, Keflex 500 mg tid was started.  It was clearly improved, but near next dose symptoms recurred though less intense.  3 days later it is clearly improved but not resolved.  Was this cellulitis and/or covid arm?  I think it was both.
1hr p/vax devel SOB & syncope given epi, taken to clinic;tx DPH & solumedrol;bronchospasm, hypotension, syncope;
I had fatigue, cough, sore throat, and fever only at night. I tested positive at home for COVID-19. Then I went to a pharmacy to test again and it came back positive as well. When I spoke to my doctor we decided not to take anything. I am still coughing and still a little tired but getting better.
pt recv vax;devel chicken pox;seen by MD w/ rash consisting of 20-25 lesions on face,chest,stomach; low grade fever which persisted for 1 day;more lesions appeared later everywhere;
Rotavirus detected after having received the first dose of Rotarix; This case was reported by a other health professional via sales rep and described the occurrence of rotavirus test positive in a infant patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix (oral). On an unknown date, unknown after receiving Rotarix, the patient experienced rotavirus test positive. On an unknown date, the outcome of the rotavirus test positive was unknown.   It was unknown if the reporter considered the rotavirus test positive to be related to Rotarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was not reported but was captured as infant as per vaccine indication. The patient recently had rotavirus detected after vaccination with Rotarix. This case has been linked to US2019AMR164484, reported by the same reporter.      Lab Comments: On an unknown date, lab test was perfomed
Fever and prolonged 45 min seizure after 3rd, DTaP, HIB, Prevnar, HepB. Valium given: seizure stopped
POST VACCINE FELT DIZZY AND SWEATY, LIKE SHE WAS GOING TO FAINT. BROUGHT TO OBS AND PLACED IN TRENDELENBERG. FELT RELIEF AFTER 20 MINS. VSS FROM LYING TO STANDING, HR LOW AT BASELINE. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S RELIEVED AT 1457.  1446 INITIAL BP 131/86 HR 52 SATS 98% RA 1450 SITTING BP 124/82 HR 53 SATS 98%  RA 1455 STANDING BP 139/83 HR 53 SATS 98% RA
All post viral symptoms instantaneously resolved; This is a spontaneous report from a contactable physician (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 and severe post-viral symptoms. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) 1st dose on unspecified date for COVID-19 Immunization. The patient experienced all post viral symptoms instantaneously resolved on an unspecified date. It was reported that patient suffered from severe post-viral symptoms for 7 months after recovering from COVID. One week after their second dose of the Pfizer COVID -19 vaccine, they commented that all post viral symptoms instantaneously resolved. The outcome for event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shingles; I had a terrible immune reaction; This case was reported by a other health professional via interactive digital media and described the occurrence of abnormal sensation of limbs in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced abnormal sensation of limbs and immune-mediated adverse reaction. On an unknown date, the outcome of the abnormal sensation of limbs was not recovered/not resolved and the outcome of the immune-mediated adverse reaction was unknown.   It was unknown if the reporter considered the abnormal sensation of limbs and immune-mediated adverse reaction to be related to Shingrix.  Additional details were received as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received and had terrible immune reaction. The patient still had shingles like feeling in right leg. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
It was discovered after vaccination that the vaccine was expired. It was pulled from the freezer on 6/23 and is only valid for 30 days at refrigeration. Patient did not report any adverse event.
Within 5 minutes of receiving my vaccine, I got a strong metallic taste in my mouth. My vaccine was less than an hour ago, but I still have the metallic taste.
Malaise, myalgia & erythema one day post immunization. Treatment: supportive care.
PATIENT STATES SWELLING AT INJECTION SITE AND DIFFICULTY MOVING HER ARM.
body hurts; Itchy; fever; chills; swollen right arm; injection site reactions as Red mark; Burning and Painful area on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills) and INJECTION SITE SWELLING (swollen right arm) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills), INJECTION SITE SWELLING (swollen right arm), INJECTION SITE ERYTHEMA (injection site reactions as Red mark) and INJECTION SITE PAIN (Burning and Painful area on the right arm). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills), INJECTION SITE SWELLING (swollen right arm), INJECTION SITE ERYTHEMA (injection site reactions as Red mark) and INJECTION SITE PAIN (Burning and Painful area on the right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 99-101.9 (High) 99-101.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
pain rt arm, rt thigh & both pretibial area;persisted for greater than 1wk;
Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jul2021 (Lot number: EW0180) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain". Therapeutic measures were taken as a result of myalgia.  Additional information: Prior vaccination before four week : No. Muscle pain started before I took the second dose. The first dose I took on July 9(Confirmed as 09Jul2021) and the second dose I took on 30Jul2021  No follow-up attempts are possible. No further information is expected.
vaccine was out of date. exp.11/01/2020, child did not have any reaction or problems
DOUBLE VISION; VERTIGO (DIZZINESS); FEELS NAUSEA; DIARRHEA; SEVERE HEADACHES; CANNOT DO DAILY ACTIVITIES(LIFTING OBJECTS, COOKING, AND PICKING UP 4 YEAR OLD GRANDDAUGHTER); CANNOT DRIVE AND IS HOME BOUND; FEELING VERY ILL; COULDN'T USE ARM DUE TO NUMBNESS; NUMBNESS IN ARM AFTER INJECTION/NUMBNESS TRAVELED TO HANDS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, and thyroid, and other pre-existing medical conditions included: The patient does not have any other known conditions. The patient takes vitamins. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis.  On 16-MAR-2021, the patient experienced couldn't use arm due to numbness. On 16-MAR-2021, the patient experienced feeling very ill. On 16-MAR-2021, the patient experienced numbness in arm after injection/numbness traveled to hands. On SEP-2021, the patient experienced cannot do daily activities (lifting objects, cooking, and picking up 4 year old granddaughter). On SEP-2021, the patient experienced cannot drive and is home bound. On 24-SEP-2021, Laboratory data included: Blood test (NR: not provided) Results not reported. On an unspecified date, the patient experienced double vision, vertigo (dizziness), feels nausea, diarrhea, and severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't use arm due to numbness, and numbness in arm after injection/numbness traveled to hands, had not recovered from diarrhea, double vision, cannot drive and is home bound, and cannot do daily activities(lifting objects, cooking, and picking up 4 year old granddaughter), and the outcome of vertigo (dizziness), severe headaches, feels nausea and feeling very ill was not reported. This report was non-serious.
Flu like syndrome could not tolerate being up out of bed for very long, about 3 hours. Low energy, strength, tired, poor sleep, GI Disturbances, symptoms lasted over 9 days.
This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a female patient who received FLUARIX QUADRIVALENT (batch number 7994K, expiry date 16th June 2016). On 7th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2015, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder pain. On an unknown date, the patient experienced neuritis and bursitis. On an unknown date, the outcome of the shoulder pain, neuritis and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neuritis and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was reported by a nurse to a pharmacist. There were 5 employees who received FLUARIX QUADRIVALENT, and experienced increasing pain at the shoulder, one week later after vaccination. Among the 5 employees 2 patients were female and the genders of the other 3 patients were unknown. One of the patients was treated at the emergency room. Other patients were seen by their primary care physician and diagnosed with possible bursitis or neuritis. The patients were underwent Nuclear magnetic resonance, but it was unknown that, who amongst 5 patients underwent had the test and what are the outcomes. It was reported that, according to one physician the cause of the events was maladministration, but the nature of maladministration was not certain. The reporter stated that, she provided all the information she had available.
Patient's left arm was red and swollen around the vaccine site as well as around the circumference of the arm in that area. Patient saw doctor on Thursday, 9/21/17 and was given an antibiotic (amoxicillin 500 mg 1 BIDx10d) since the doctor thought it was an infection from the shot. I spoke with patient at the pharmacy when she came to pick the antibiotic.
Pt w/ hx of DM currently on Glipizide 10mg BID and Insulin Glargine 12units QHS.  Pt vomited 50mL of digested food.  Pt c/o flushing/sweating, nausea, and tingling at upper lip.  Pt given PO fluid 1120mL inc. orange juice.  Pt likely had a vasovagal episode given flushed and nauseous.  No hives, stridor, wheezing, c/f anaphylaxis. Given lip tingling (as swelling or problem swallowing), given 50mg PO benadryl.  BP 178/115, HR 95, RR 18 -- > 148/100 -- > 145/96, 90, 16 -- > 138/93 -- > 146/97, 86, 16.  Pt feels much improved and requests to leave 30mins after initial adverse reaction began.  Pt stable and released from the vaccination site.  ER precautions discussed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: En6199), in right arm, on 27Mar2021 as dose 2, single (Lot number: Ep6955), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: Ff2590), in right arm and on 14Jun2022 as dose 4 (booster), single (Lot number: Fj4989) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Stenosis" (unspecified if ongoing); "arthritis in neck" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive; (09Jul2022) Postive, notes: tested positive again, today and the test registered positive, very quickly. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: 6 days after completing the Paxlovid, and progressively feeling better every day during those days, my symptoms returned and I felt as I did when I first got sick, sneezing, congestion, coughing, headache, low grade fever and diarrhea. I tested positive again today and the test registered positive very quickly. Now I am having to start isolation all over again and exposed friend I was around on day 11 thinking I was well.
thumb not straight; fatigue; nausea; cold extremities; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue) and NAUSEA (nausea) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information was reported.     On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 30-Jan-2021, the patient experienced MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue), NAUSEA (nausea) and PERIPHERAL COLDNESS (cold extremities). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 30-Jan-2021, CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight) and NAUSEA (nausea) had resolved. On 31-Jan-2021, FATIGUE (fatigue) and PERIPHERAL COLDNESS (cold extremities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue) and NAUSEA (nausea) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00417120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO Medical History Information was reported.     On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 30-Jan-2021, the patient experienced MUSCLE SPASMS (thumb not straight), FATIGUE (fatigue), NAUSEA (nausea) and PERIPHERAL COLDNESS (cold extremities). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, bid. On 30-Jan-2021, CHILLS (chills), PYREXIA (fever), MUSCLE SPASMS (thumb not straight) and NAUSEA (nausea) had resolved. On 31-Jan-2021, FATIGUE (fatigue) and PERIPHERAL COLDNESS (cold extremities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 at 11:00 as dose 4 (booster), single (Lot number: 439199), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (22Jun2022) Positive, notes: Home test. Therapeutic measures were taken as a result of drug ineffective,  covid-19.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of COVID-19 ,drug ineffective.