chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
3/11/21 patient had Moderna vaccine Hospitalized the very next day and never improved to baseline requiring transfer to nursing home after hospitalization. The patient's biological sister had a similar reaction the day after her and was hospitalized and also needed to transfer to a nursing home due to the a D habilitation and her reaction seemed more severe and she had recovered from Covid three months prior In ICU at medical facility. The individual recovered faster from having the actual infection and she did from the vaccine. They had weakness and shortness of breath wheezing that didn't get any better with nebulizer or home treatments and elevated D dimer's in the hospital that they said weren't anything to worry about but they were high levels we saw on the patient portal. I don't know if it was documented as a true potential reaction to the vaccine that actually did have more than just a minor side effect it went away and it was not reported to the nursing home they transferred to they only learned of it because we told them and I don't think it's been reported properly and their medical records for transparency.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, 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 included: "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 08Mar2023 to 13Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
The first day pt had flu-like symptoms, body aches, diarrhea, and vomiting. The second day she felt better yet weak. The third day she had a fever of 102, body aches, nausea, hands had tingly feeling. On the fourth day, nausea persisted, she had loss of appetite and weakness. On the fifth day, bouts of nausea were lessening, she had intermittent diarrhea but not as bad as the first day. As of 8/16/01, she was slightly nauseated.
Day after injection  2-20-2020 severe headache, fatigue - felt flu like, some joint pain - not terrible, very sore at injection site.  2nd day after injection 2-21-2020 most of flu like symptoms were gone - still painful at injection site and now having muscle spasms in the area of the injection.
Chills; 101 degree temperature; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (101 degree temperature) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Lisinopril.).    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (101 degree temperature) and NAUSEA (nausea). At the time of the report, CHILLS (Chills), PYREXIA (101 degree temperature) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (101-degree fahrenheit): (Inconclusive) 101degrees Fahrenheit of temperature at around 2-3am today..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications included Epipen (for emergency), Inhaler (not specified) and Hypertensive meds (not specified). No treatment medications provided by the reporter.   This case was linked to MOD-2021-209227 (Patient Link).
Patient's daughter called and stated that patient was experiencing adverse side effects after receiving the tdap (Boostrix) vaccine yesterday. Symptoms included rapid heart rate, fever of 100.4 degrees Fahrenheit, weakness and fatigue. Patient's daughter stated she called Hospital and the agent she spoke with suggested for her to call us since we gave the vaccine. I suggested to the patient's daughter to take her mother (the patient) to immediate care or the emergency department for further monitoring due to the increase in heart rate. I did let her know that the other symptoms may occur as an immune response to the vaccine but the rapid heart rate should get looked at by a professional healthcare provider. Patient's daughter stated she will take her mother into one of the suggested clinics for further guidance/monitoring.
incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020442 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.   Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Patient recieved Moderna dose #2 at 1034. Left location and returned to vaccination site at 1540 with ccomplaints of "nerve pain shooting down my arm to my fingertips". States that she felt a "zing" down her arm when injected with vaccine. Patient stating she has pain when moving arm, hand and fingers along with when rotating hand into supine position. Patient appears to be bracing/guarding her right arm when moving .Vaccination site at right deltoid within normal limits, no swelling, no redness, no bruising noted. Patient has been taking Ibuprofen and using cold compresses at site before coming in to site. Recommended to the patient that she needs to be assessed and seen at the urgent care or the ER for follow up.
Wrist and hand went numb in the arm right after administration. He could move hand and all fingers as normal and there was no pain, tingling or redness.  He did wait about half hour and continued to move arm to see if any changes. Pt did have full range of motion just complained that hand was numb to the touch.
Heartburn; Severe bloating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 12:00 (Lot number: ER2613) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE taken for blood testosterone decreased. The following information was reported: DYSPEPSIA (non-serious) with onset 23Feb2021 12:00, outcome "not recovered", described as "Heartburn"; ABDOMINAL DISTENSION (non-serious) with onset 23Feb2021 12:00, outcome "not recovered", described as "Severe bloating". The events "heartburn" and "severe bloating" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dyspepsia, abdominal distension.  Additional information: No known allergies. Other medications in two week included Testosterone. No other vaccine in four weeks. No covid prior vaccination. Patient covid tested post vaccination (Nasal Swab). Received BNT162B2, administered in arm left, administration date 16Mar2021 12:00 (Lot number: ER9262) at the age of 43-year as dose 2, single for covid-19 immunisation. Facility type vaccine was Workplace clinic.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. On 08-MAR-2014 the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot # and expiration date not reported). In March 2014, after vaccination the patient experienced swollen, welted arm that was flushed and hot. The pharmacist stated that the patient's arm did not appear as shingles. The patient planned to see a physician. The pharmacist advised the patient to consider ice to the location (date unspecified in March 2014). The patient sought medical attention by contacted pharmacy in March 2014. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Under the armpit swollen ganglion; Swollen upper arm; This is a spontaneous report received from a contactable other healthcare professional, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 as a single dose for COVID-19 immunisation. The Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the left arm, on 25Feb2021 at 18:00 as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks. On 19Mar2021 at 14:00 hours, the patient experienced under armpit swollen ganglion and also had swelling in the upper arm. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was administered for the events. The clinical outcome for the events arm pit swollen ganglion and upper arm swelling were not recovered.   No follow-up attempts possible. No further information expected.
Pt recvd 1st 2 doses of Hep B vax & a 3rd dose on 15MAY90 & had a borderline response;
inject site of HIB vax given 7DEC93 is swollen & reddened w/red ring around area 3x3cm dx cellulitis; also dx w/BOM;
Pt c/o itching at "inj" site immed. after H1N1 injection. also c/o throat itching and positive cough. Palms of hands were also itching. Pt rec'd oral BENADRYL 25 mg and XYZAL 5 mg PO. Then rec'd IM epinephrine, 1:1000 0.3 ml with resolution of symptoms. Pt waited 2 hrs after Epi before D/C from clinic. Mother called the next day and reported she had an asthma attack that night - seen in ER also had hives and received IV BENADRYL and more PREDNISONE.
Headache, Fever (100.4), nausea, fatigue.  Lasted thru the entire day.
No adverse effect; been vaccinated with a complete series of Hepatitis B vaccine, accidentally received doses of RECOMBIVAX; This spontaneous report was received from a nurse referred to a patient of unknown demographics. Information on pertinent medical history, drug reactions or allergy and concomitant medications were not provided. On 18-OCT-2006, the patient had already been vaccinated with a complete series Hepatitis B Vaccine, on 31-JUL-2019, accidentally received Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose details and route unknown), (lot # R03617 (this lot is not valid for Hepatitis B Vaccine (Recombinant), expiry date: 08-OCT-2021) for prophylaxis (accidental overdose). The two doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) were the patient's fourth and fifth lifetime doses of Hepatitis B Vaccine. No adverse effects reported.
Then 10 days later got Covid; This is a spontaneous report from Pfizer sponsored program from a contactable consumer (patient). A female patient of an unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient received her 1st dose on an unspecified date in Jan2021 and then 10 days later got Covid. She was told to wait until 01May2021 to get her 2nd dose. She wants to know if this then would be her 2nd dose or if she would have to start the process over again. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :PFIZER INC-2021443522 same drug and patient, different event and drug dose
Headache, large localized reaction of swelling, redness, itching at site of injection - left arm.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 17-year-old male patient received, on 07Jun2016, at around 2:00 or 2:30 PM in the afternoon, the first dose of TRUMENBA at 0.5 ml, single dose. No other vaccines administered at that time. Relevant medical history and concomitant medications were unknown. On 08Jun2016, at roughly 11:00 AM, the mom called the doctor's office and said her son woke up and wasn't feeling well. His symptoms included: headache, stomach cramps, shaking, weakness, tired, and shivering. The patient was seen by the doctor that day, 08Jun2016 around 3:15 PM and apparently the patient was feeling a little bit better at that time. Clinical outcome of the events was recovering at time of this report. Follow-up (05AUG2016): Follow-up attempts are completed. No further information is expected.
Severe Abdominal Cramps; generalized body aches; headache got worse; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL PAIN (Severe Abdominal Cramps), MYALGIA (generalized body aches) and HEADACHE (headache got worse) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, LORAZEPAM, LISINOPRIL, METOPROLOL and OMEPRAZOLE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) and HEADACHE (headache got worse). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN (Severe Abdominal Cramps) and MYALGIA (generalized body aches). The patient was treated with TRAMADOL for Pain, at an unspecified dose and frequency. On 08-Mar-2021, DYSPNOEA (shortness of breath) had resolved. On 14-Mar-2021, ABDOMINAL PAIN (Severe Abdominal Cramps), MYALGIA (generalized body aches) and HEADACHE (headache got worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up information received on 22Jul2021 contains 2nd dose detail.
Patient states that after receiving a PNEUMOVAX on 10/29/2011, her left arm was extremely swollen & tender. Her doctor prescribed a 10 day course of KEFLEX 500 mg, 1 TID for possible infection.
Syncope, Dizziness.  In syncopal event, pt sustained a head injury and abrasions to R forehead, L hand/knuckles, R side.  Pt has a hx of fainting w/ BCM implant 10 yrs ago.  Finished a workout this AM, last day of menses.  Pt continued to complain of dizziness and placed on the floor despite   Called 911 and the patient was transported to the ER.
This case was reported by a pharmacist via call center representative and described the occurrence of asthma in a 65-year-old female patient who received SHINGRIX (batch number B9739, expiry date 20th November 2020). Concomitant products included fluticasone propionate, ADVAIR, latanoprost, Levothyroxine, Metformin, Montelukast, nateglinide, Rosuvastatin and TRADJENTA. On 24th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced asthma. On an unknown date, the outcome of the asthma was not recovered/not resolved. The reporter considered the asthma to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reporting that one of her patients who received 1st dose of SHINGRIX was experiencing asthma symptoms. The patient noted she has not had asthma symptoms for years.
feeling really hard; Can't get up; so much pain in armpit, on site of injection; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really hard), DYSSTASIA (Can't get up) and VACCINATION SITE PAIN (so much pain in armpit, on site of injection) in a 48-year-old female patient 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 February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced FEELING ABNORMAL (feeling really hard), DYSSTASIA (Can't get up) and VACCINATION SITE PAIN (so much pain in armpit, on site of injection). At the time of the report, FEELING ABNORMAL (feeling really hard), DYSSTASIA (Can't get up) and VACCINATION SITE PAIN (so much pain in armpit, on site of injection) had not resolved.            Concomitant medications were not reported. Treatment medications were not reported.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,01 total, administered to the right arm on 31-MAR-2021 for covid-19 prophylaxis. The patient experienced felt light headed for 15 mins when treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received additional dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered to left arm on 04-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 38 years old. No concomitant medications were reported. On an unspecified date in JUL-2022, patient had symptoms after patient tested positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (Dose number in series 2), after the husband got covid-19 when came back from traveling. Patient did not saw a physician when patient got covid-19. This is the only time patient got sick after getting the covid vaccine and booster (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221134142. This report was associated with product quality complaint: 90000259271.; Sender's Comments: V0: 20221135292- confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.