chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame; Dose administered after exposure to room temperature greater than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature greater than 24 hours) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Jul-2022 at 10:30 AM, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature greater than 24 hours). On 19-Jul-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature  greater than 24 hours/dose was administered outside the standard time frame) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature greater than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that vial was taken out of the fridge on 18-Jul-2022 at 10:30 AM. It was also reported that vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 degree celcius to 25 degree celcius is equal to 46 degree to 77 degree F) was reported as 27 hours approximately. No treatment medications were reported
Severe pain upon breathing beginning 07/22/2021; went to medical facility the morning of 07/24/2021 and after x-Ray the doctor there sent me directly to another medical facility where subsequent bloodwork (D-dimer) warranted a CT scan of lungs which showed pulmonary embolism right lung and pleural effusion left lung. Prescribed Elliquis blood thinner and told to follow up with hematologist ASAP and PCP.  Hematologist required visit to PCP. PCP ordered leg ultrasound and abdominal/pelvic CT scan to check for possible underlying reasons. All were clear of any evident reasons to trigger the blood clot in the lung.
itching in her arms, face, neck and her trunk; redness of the skin; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a 23-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  It was reported that this patient was given the first dose of COVID-19 vaccine within the last week.  The patient experienced itching in her arms, face, neck and her trunk, redness of the skin with no airway problem after her first dose (Dec2020). Patient took Benadryl for the symptoms and they went away completely within minutes. The patient was told that they cannot get the second shot. So the doctor wanted to find out if that information was true or not; if they could get that second shot. Outcome of events was recovered.  No follow-up attempts possible. No further information expected. The following information on the batch number has been requested.
Joint pain; Fever; Chills; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (advil) at a dose of UNK dosage form. At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue, cramp and chills. On an unknown date, the outcome of the fatigue, cramp and chills were unknown. It was unknown if the reporter considered the fatigue, cramp and chills to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. No further information was provided by the caller, as caller refused to provide the further information and the identity of the patient. This case was linked to case US2018038368 and case US2018GSK042362, reported by the same reporter.
No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered/VAQTA - HGS: 5/31/2022; This spontaneous report was received from a pharmacist and refers to a patient of unknown age ang gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 31-MAY-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W002889, expiration date: 06-MAR-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported as above 47 F (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA000873:
SWELLING OF INJECTION SITE APPROXIMATELY 5 INCHES IN LENGTH WITH LARGE HARD LUMP IN THE AREA.  VERY RED AND HOT TO TOUCH; SWELLING RESOLVED FOUR DAYS AFTER VACCINATION; DISCOMFORT CONTINUES I WEEK AFTER INJECTION.
Dizziness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Low grade fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. On 06-Mar-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, PYREXIA (Low grade fever) had resolved.            No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
BURNING SENSATION IN CHEST; HEADACHE; FEVER; CHILLS; NAUSEA; FATIGUE; DRY COUGH; JAW AND CHEEKS HURT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included donated blood, and donated blood, and concurrent conditions included penicillin allergy, and sulfonamide allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 10:20 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced dry cough. On MAR-2021, the subject experienced jaw and cheeks hurt. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021 21:00, the subject experienced chills. On 09-MAR-2021 22:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 10-MAR-2021, the subject experienced burning sensation in chest. On 10-MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation in chest, and nausea on 10-MAR-2021, and fatigue on MAR-2021, was recovering from fever, chills, and headache, and the outcome of dry cough and jaw and cheeks hurt was not reported. This report was non-serious.
Pt vaccinated with DTP developed high pitched irritable cry, unconsolable x 1 to 1 1/2 hr. Large golf ball size knot at injection site. Seen by MD fever 102, Given Tylenol & use compress. Only DT in future. 05DEC90 T99.2, knot quarter size
Pt was given the Pediatric Pfizer (5-11 year old), Lot FL0007, exp 3-22, instead of the Pfizer for 12 years and older. I spoke to the mother and she said the patient is doing fine, just tired. I apologized to the mother and explained that the CDC considers the daughter to be fully vaccinated and her second dose will be the Adult Pfizer for 12 years and older. I told her we will phone her dr about what happened. She was very nice and patient.   I accidentally started typing in the vaccine record in line 22 instead for the correct line. Pt only received the one Pediatric Pfizer
flu symptoms; Initial information regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional on 27-Oct-2020.  This case involves patient (unknown demographics) who got flu symptoms (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication 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 not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient got flu symptoms (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
9/1 - I had pertussis and chicken pox vaccines since I'm a new mom with no immunity to those.  9/2 - I had low grade fever and fatigue.  9/3 - I noticed a sore, half dollar size red circular blotch around one of the shots (not sure which). 9/5 - the red blotch doubled in size and was somewhat itchy. 9/8 - it is fading and much less sore or itchy.
Narrative:  51 yo male with hx of HLD presented to same day access/urgent care after he developed jitteriness and dizziness following his second Moderna dose on 4/26/2021. BP was noted to be elevated at 163/107 initially and came down to 144/92 after patient settled down. Pulse was 101 upon arrival and went down to 88. According to notes, pt did have one cup of coffee earlier today. He tolerated his first dose 4 weeks ago with no issue. Patient was given zyrtec 10mg during the visit (not sure why). Patient was discharged after his vitals and symptoms improved.
Patient has a major thyroid Hashimoto event - confusion, loss of mobility in lower legs (resulted in fall).
A mother reported that her 7 year old daughter received an injection of Prevnar on 11/14/00. Approx. 15 minutes, post vax, the child "fell to the floor, her eyes rolled back into her head and she was jerking". She was treated with an "ammonia inhaler". The child also developed soreness at the injection site. Follow up states the patient recovered.
ACHES; CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 15:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 23:00, the subject experienced chills. On 30-MAR-2021 23:00, the subject experienced fatigue. On 30-MAR-2021 23:00, the subject experienced fever. On an unspecified date, the subject experienced aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, chills, fever and aches was not reported. This report was non-serious.
DTaP given 06/17/2003: Patient present to clinic on 06/20/2003 with erythema left anterior thigh 2 hours after immunizations.  Was started on Keflex 200mg per mouth every 8 hours x 10 days
No adverse affects have  been reported.  This report is to notify of a 16 year old patient receiving a covid immunization only certified to be given for 18 year old and older.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as L04475, expiration date reported as 12-MAY-2017, lot # M004116, expiration date reported as 12-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
About 82mm area of erythema, swelling, tenderness. Zyrtec, Motrin .
13 y/o M reported feeling anxious, lightheaded, and nauseous during post recovery. Patient then started to vomit. He reported that he was nervous for the shot. BP was taken at start (118/50) and again before discharge (108/60). SpO2 remained between 97-100. Patient felt better after emesis and water was provided and patient laid down on floor with legs elevated for another 15 minutes. Patient reported feeling completely fine after 15 minutes and left clinic with guardian.
This is a spontaneous report from a Pfizer-sponsored program [IBCC (Inbound Call Center for HCPs)]. A contactable nurse reported that a 85 year-old female patient received, on 19Jun2017 around 10 am, the first dose of PREVENAR 13 (lot S06823, expiry date May2018, NDC number: 0005197102) intramuscularly, in the right arm, at 0.5 ml, single, for immunization. Relevant medical history included diabetes (ongoing). Concomitant medications included oral atenolol, Tablet, 50 mg, twice daily, from an unspecified date, in Nov2016 (ongoing), for blood pressure; vitamin b complex (Tablet) 1 DF, daily, from an unspecified date, in Jun2014 (ongoing); FLONASE (Nasal spray, solution) 50 mcg, two spray each nostril daily, from an unspecified date, in Jun2014 (ongoing); hydrochlorothiazide / losartan potassium 12.5 mg/50 mg, one tablet daily, from an unspecified date, in Aug2016 (ongoing); metformin hydrochloride 500 mg, daily from an unspecified date, in Apr2017 (ongoing), for diabetes; oral nifedipine Tablet, 600 mg, daily from an unspecified date, in Feb2016 (ongoing), oral simvastatin Tablet, 20 mg, daily from an unspecified date, in Jun2015 (ongoing); oral vitamin D nos, capsule, 50000 one weekly om an unspecified date, in Apr2017 (ongoing); and nystatin cream 100,000 per 0.1 unit cream, from an unspecified date, in Jun2014 (ongoing). On 19Jun2017, about 5 to 10 minutes after receiving the vaccine, the patient's right arm swelled up. No medical treatment provided for adverse event and no hospitalization was required. The patient did not recover from the adverse event at time of this report.
Tender Arm; Arm Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender Arm) and MUSCULOSKELETAL STIFFNESS (Arm Stiffness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tender Arm) and MUSCULOSKELETAL STIFFNESS (Arm Stiffness). At the time of the report, TENDERNESS (Tender Arm) and MUSCULOSKELETAL STIFFNESS (Arm Stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
received a box of expired Fluzone High Dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA392579 (CLUSTER).  This case involves an Elderly patient (gender: unknown), reportedly received a box of expired Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] dose for jun 30, 2022 and gave all 10 doses with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route, frequency: unknown) (lot number: UJ772AA and expiry date: unknown) in unknown administration site for prophylactic vaccination (Immunisation), reportedly received a box of expired fluzone high dose for jun 30, 2022 and gave all 10 doses with no reported adverse event (expired product administered) (unknown latency).  It was reported, office wants either replacement / refund for the box and has only the empty box to return. It is unknown if there were lab data/results. Patient did not experience any additional symptoms/events.  Action taken with Quadrivalent Influenza Vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  At time of reporting, the outcome was 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.; Sender's Comments:  SAD20220921002678:
consumer was given an expired dose of pentacel with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was given an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/ IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] 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 ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 12-Oct-2023, the patient received a, expired 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/ IPV(VERO)/HIB(PRP/T) Vaccine (lot UJ785AA, Expiry date: 09-Oct-2023 with unknown strength)  via intramuscular route in the left thigh as immunization with no reported adverse event (expired 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 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.
Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tired) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tired). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 08/27/2021. PATIENT WAS FULLY VACCINATED ON 02/19/2021
I had a nasty cough, my sinuses were swollen, I had to continuously clear my throat. I took a home COVID-19 test that came back negative. I went to a Clinic they did a routine exam, did not run any test. I was given medication, Augmentin, Benzonatate, and an Albuterol Sulfate Inhaler. I have been using this regimen for a little over a week now, I have a lingering cough but I do feel that I am getting better.