chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same Reporter
nasal stuffiness & dec dyspnea;pt has hx of sinus allergy;
My left hand, right side of my face and right foot were numb; numbness in my left hand; My left hand, right side of my face and right foot were numb; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient, received bnt162b2 (BNT162B2, solution for injection, batch/Lot Number: ER8729), first dose at unspecified route of administration, administered in left arm on 09Apr2021 13:00 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Apr2021, within minutes of getting the vaccination the patient felt numbness in left hand. Throughout the rest of the day his left hand, right side of the face and right foot were numb. It's been 3 days and he still felt numbness in left hand. No treatment was given for the events. On 09Apr2021 outcome of the events was not recovered.   Follow up #1(PRD/SRD 13Apr2021): Vaccination facility zipcode was added.  No follow-up attempts are needed. No further information is expected.
redness and swelling at injection site. Left thigh, warm to touch, itchiness, 1 dose of Benadryl given in clinic, no other treatment needed
This spontaneous report as received from a physician refers to a female patient of over the age of 65 years with unspecified cancer. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a first dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). On an unknown date, about one year after vaccination, the patient developed shingles. On an unknown date, about one year after developing shingles, the patient was vaccinated with a second dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with the a first dose of  VARIVAX. On unknown date the patient experienced a severe local reaction (location of the upper part of the unspecified arm and around the injection). Unknown the specific type of reaction. The patient's titers done recently were shown then patient is not immune. Additional information has been requested.
Sept 20- Received 4 month vaccines  had a rectal temp of 99.9  Sept 21- Went to the ER  for fussiness,  Bulging fontanelle, facial flushing, poor feeding.  temperature of 102 Sept 22- Continued fussiness, poor feeding fever all day high of 101 Sep 23- Fever over 100.5 continued fussiness poor feeding Sept  24, went to pediatrician for follow up advised to do sponge baths and tylenol. Sept 24-  fever over 101 sept 25 - return to pediatrician for fever over 100.5  for more than 2 days sept 26- went to ER for fever of 103  ER provided tylenol and fluids. babye has been fussy and crying for 3 hours straight each day
rapid heart rate for two days after;  difficulty sleeping. Kidneys ached afterwards. Also felt my organs in my front lower portion of body ache as well. Everything subsided by that Friday 10/15.
Patient presented to pharmacy less than 24 hours after vaccination with PNEUMOVAX on left arm. Arm was red and swollen the entire upper arm to the elbow with pain.
sore arm, feel chills, feel feverish,  Took acetaminophen at 11:30 p.m. (on 03/29/21) and at 5:30 a.m. (03/30/21)  Still feel unwell; will take more acetaminophen around 11:30 a.m. on 03/30/21
bad headache; nervous; This is a spontaneous report from a contactable consumer (Patient). A 23-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 23-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC, 2.5mg once a day) taken for anxiety from an unspecified start date and ongoing, has been taking for maybe 8 or 9months. No additional Vaccines Administered on Same Date of the Pfizer Suspect: No prior vaccinations within 4 weeks, no AE(s) following prior vaccinations. On an unspecified date in Apr2021, the patient experienced bad headache, nervous. No treatment received for bad headache. It was reported that with the new variant, his family convinced him to get the second one, which was last Tuesday. Headache after first dose: Was maybe 3 hours later and lasted for 2 days. The patient underwent lab tests and procedures which included blood test: on 2021 Had blood drawn 2 months ago at the doctors, there was nothing serious that came up. The outcome of event (nervous) was unknown, the outcome of event (bad headache) was not recovered.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Vaccine error, 19 y.o. got the pediatric dose of Hep A vaccine.
104.7 temperature came out of no where accompanied by a episode of him zoning out for 3-4 minutes.   The on call Dr was called and I was advised to give a fever reducer and watch him closely.   Between 5/6 and 5/9 his fever never got below 102 with or without a fever reducer.   The on call was called a second time on 5/7 and I was advised to increase the amount of Tylenol and motion.   5/8 a third call to the on call was made due to another 3-4 minute episode of zoning out and again I was told to watch him and take to urgent care of we were too concerned.   His fever finally broke on 5/9 and has only been up to 101 since then.
Next day post vax, the pt developed a headache. On 9/10, the pt's headache became severe with bubbling feeling in head and back pain. Evaluated by MD on 9/11/00. Treated with Motrin. On 9/16 and 9/17, the pt experienced increased pain in lower back. On 9/19, the pt was feeling too weak to walk.
Erythema multiform and swelling at injecting site as big as baseball, redness warm to touch.
SORENESS IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (subcutaneous, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of soreness in arm was not reported. This report was non-serious.
Pt devel fever later that eve of 105 went to ER; pt also devel cough & vomited x 4; still w/fussiness & fever p/seen in ER:
she twisted her knee in her garden; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIGAMENT SPRAIN (non-serious) with onset 28Mar2021, outcome "unknown", described as "she twisted her knee in her garden".  Additional information: Caller had the first dose of the Pfizer COVID-19 vaccine in (state) last Saturday (27Mar2021). Everything went smoothly. The next day (28Mar2021), she twisted her knee in her garden. She wanted to know if it would be safe to take Tylenol or ibuprofen after vaccination. She also wanted to know if there was a protocol or timeframe before taking these medications after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On January 25, 8 days post vaccine, the patient developed soreness, redness, and raised rash at the site of vaccine.
Health nurse gave immunization at school.  Student received Hep B #1, and Td vaccine.  Sent to snack area for snack and 10 minute wait.  Student reported "he didn't feel well", stood from sitting position and fell.  hoC brief, lost bladder control.  Chipped tooth in fall.
A rash started on my chest the day after injection and spread to include my neck, abdomen, back and around the groin  area; it became very red, hot and itchy.   I also felt enervated and woozy. The rash was worst the first few  days and then gradually faded by the end of a week.  The following week the rash reappeared in a small area of my chest one afternoon but was gone the next morning.  I still get some itching in that area off and on and sometimes just a faint look of red.
pacing heartbeat 20-30 min later after getting the vaccine while driving home; felt like tachycardia; very anxious; pain/ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Multiple sclerosis. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), IBUPROFEN, CLONAZEPAM (KLONOPIN), DONEPEZIL, ACETYLSALICYLIC ACID (ASPIRIN 81), ARMODAFINIL, Cyclobenzopril, CHLORTHALIDONE, OMEPRAZOLE, LOSARTAN, PRAVASTATIN, IV IgG infusion, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea). At the time of the report, HEART RATE IRREGULAR (pacing heartbeat 20-30 min later after getting the vaccine while driving home), TACHYCARDIA (felt like tachycardia), ANXIETY (very anxious), PAIN (pain/ache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 125/65-70 125/65-70. On an unknown date, Heart rate: 100 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Percocet, Ibuprofen.
*Pfizer-BioNTech COVID-19 vACCINE eua,  Patient complained of pain and tingling starting 7 days post vaccination from the knees down to the bottom of the feet. The pain  and tingling in his feet is most  severe. The pain wakes him up at night during sleep to the point that  he is unable to fall back asleep, and the pain and tingling is still there when he wakes .  The tingling and pain is not noticeable once the patient is working, and once he wakes he still has the symptoms, but it is not as bad as it is during the night. He had not experienced this pain or tingling ever before having the vaccination.
Per mom... swollen all over body, extreme pain in hand and bottom of feet, itching throughout entire body, rash on ear, back, leg, arm , chest and back of neck. Swollen lips, couldnt open his right eye.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 75-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 15-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804111 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from reporter on 14-Nov-2018: The info number (SEQ18-02667) was added in additional information tab. No new information was received. Hence, no changes were done in the narrative.
Information has been received from a licensed practical nurse concerning an approximately 9 week old female patient without drug reaction or allergies. There was no pertinent medical history. On 11-DEC-2014 the patient was vaccinated with her first dose of ROTATEQ (lot# K007244, expiration date 16-MAR-2016, dose not provided) orally as standard 2 month appointment. No concomitant medication was involved. On 12-DEC-2014 the mother of the patient sought medical attention from the nurse's facility by calling the office. The mother stated that her daughter, who was the patient, was gassy and irritable after the administration of ROTATEQ on approximately 11-DEC-2014. No treatment was given for these events. No lab diagnostics study was performed. The outcome of these events was reported as recovered on an unknown date. The relationship between ROTATEQ and these events was unknown. This is one of two reports received from the same reporter. The other report was 1502USA005198. Additional information has been requested.
This is a prospective pregnancy case. This 31-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 6th August 2015. Concomitant products included Prenatal Vitamins. The subject's last menstrual period was on 24th December 2014 and estimated date of delivery was 25th September 2015. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. On 6th August 2015, less than a day after receiving BOOSTRIX, the subject developed injection site (Non-serious). Additional event(s) included shoulder pain on 6th August 2015 and vaccine exposure during pregnancy. The outcome of injection site pain was unchanged. The outcome(s) of the additional event(s) included shoulder pain (unchanged) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the injection site pain and shoulder pain to be related to BOOSTRIX. HCP initially called for information regarding side effects of BOOSTRIX, specifically arm pain. Additional details were provided as follows: On 6th August 2015, the patient received BOOSTRIX on left deltoid (batch number NL7K3, expiry date 15th September 2017). On 6th August 2015, less than a day after receiving BOOSTRIX, the patient experienced left arm and shoulder pain. The patient experienced increased pain over the weekend which intensified with range of motion. The patient visited to the clinic for the investigation of that discomfort. The injection site was not red and swollen and there were no other abnormalities. No further information was available regarding events.
improperly stored vaccine administered; no adverse event; This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 20-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot: T014835, expiration date: 17-JUL-2021 (exact dose and route of administration were not provided) for prophylaxis.  The vaccine experienced temperature excursion of 50 degrees Fahrenheit for 1 hour. There was no previous temperature excursion detected. The digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Rec'd varicella vaccine 3/4/10. 4-5 days later developed rash on legs and arms (per chart notes-erythematous papules). Pruritic. Given BACTRIM-rash worsened. Seen by dermatology service who thought rash was likely either atypical varicella reaction vs hypersensitivity reaction to vaccine. Client states had rash 4 wks before varicella vaccination and rec'd steroids.
Toddler seen at clinic 02Apr05 AM for fever, swelling at immunization site, Lt (DTaP). Rx: PCN and Tylenol. Seen in ER 02Apr05 PM due to fever 103/vomiting. Dx: probable viral URI, immunization site okay, mother 04Apr05.
About a minute after the injection the patient complained of heart racing, pulse 94, feeling anxious, elevated blood pressure, 164/90,  slight rash- hives like around upper torso only.  Patient put to lie down on exam table and  PCP called. Patient was here for a visit with Dr. Patient calmed down and rash gone and B/P and pulse back to normal within 15 minutes.  Visit continued with PCP Patient feeling fine when she left
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot number N000238 with expiration date of 25-OCT-2019, lot number N003701 with expiration date of 01-NOV-2019, lot number N008079 with expiration date of 02-DEC-2019, lot number N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot number N020613 with expiration date of 05-MAY-2020, lot number N002202 with expiration date of 04-NOV-2019, lot number N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot number N000175 with expiration date of 20-SEP-2018, lot number N005618 with expiration date of 04-OCT-2018, lot number N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot number M019924 with expiration date of 02-SEP-2018, lot number N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 degrees F (degrees Fahrenheit) to 35 degrees F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to three female patients vaccinated with improperly stored VAQTA (lot number N019924 with expiration date 02-SEP-2018) on 27-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973,  1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Tested positive for COVID19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines were not provided,  Several medications to treat COVID19 symptoms prescribed by patients doctor  Action taken with mRNA-1273 in response to the event was unknown   Reporter did not allow further contact
Client reported that she "felt a woosh" and needed to get air. She felt "dizzy" and like she was having a hard time catching her breath.