chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:14 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 48.78.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, 10 AM temperature was 34, 37 respectively total doses given for the day was 184 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-202, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 PM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43.  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 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.
pt recvd flu shot 25OCT94; states devel h/a w/stiff neck & shoulder on arm administered on the 3rd following noc then swollen glands behind both ears lasting 2 more days;
insomnia; severe chills; bodyaches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 47 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular, Manufacturer: Pfizer), administration date: 23Feb2021, when the patient was 46-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular, Manufacturer: Pfizer), administration date: 03Feb2021, when the patient was 46-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 12Apr2022, outcome "unknown", described as "bodyaches"; INSOMNIA (non-serious) with onset 12Apr2022, outcome "unknown"; CHILLS (non-serious) with onset 12Apr2022, outcome "unknown", described as "severe chills". It was unknown if therapeutic measures were taken as a result of insomnia, chills, pain.  Additional information: Patient had vaccine at workplace clinic. He did not take other vaccine in four weeks. He was not tested covid positive prior to vaccination and was not tested positive after vaccination.  No follow-up attempts are possible. No further information is expected.
Joint pain in knees, hips and lower back that lasted several days.  General feeling of malaise that lasted two weeks.  A rash spanning from the injection site and extends approximately 6 inches down my arm.  Since 8/4/22 I've had a red rash with tiny bumps throughout it.
Pt. received subq dose of ZOSTAVAX in left arm on 11-30-11. On 12-10-11 called pharmacy stating she had developed a painful rash day after receiving shingles shot & it was getting worse. Advised pt. to see Dr. as soon as possible. Dr. diagnosed shingles. Rash is on one thigh. Treated with LYRICA.
no adverse effects reported; 0.5mL of an adult dose of Vaqta was administered to a 17 year old patient as the patient's adolescent dose; This spontaneous report was received from a nurse, referring to a 17 year old patient, of unspecified gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug allergies or reactions were not reported.  On 12-APR-2019, the patient was vaccinated with 0.5 milliliters of an adult dose of hepatitis a vaccine, inactivated (VAQTA), administered intramuscularly, lot # R030120  with expiration date 15-NOV-2019, for prophylaxis (incorrect dose administered), the anatomical site of injection and the dose number were not provided. There were no adverse events reported.
Fever of 101.5 F; nauseated; diarrhea; headache; light headed; hot around the injection site; very red around the injection site; hard around the injection site; Bursitis on the left arm; soreness spread under the left arm; soreness spread around the left breast; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache) and DIZZINESS (light headed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast). At the time of the report, PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), DIARRHOEA (diarrhea), HEADACHE (headache), DIZZINESS (light headed), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE ERYTHEMA (very red around the injection site), VACCINATION SITE MASS (hard around the injection site), BURSITIS (Bursitis on the left arm), PAIN IN EXTREMITY (soreness spread under the left arm) and BREAST PAIN (soreness spread around the left breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is treated with Tylenol.   This case was linked to MOD-2021-056285 (Linked Report). This case was linked to MOD-2021-247019 (Patient Link).; Sender's Comments:  MOD-2021-056285:
Pt recvd 2 doses of Engerix-B & 1st dose recvd 6 months ago @ which time pt became deathly ill; reporter unaware of any further description regarding event; 2nd dose recvd recently although pt did not want it; 2nd dose tolerated well;
Fever of 101-103 which lasted on and off until 02/15, largely swollen and red leg (not only at injection site), immobility of leg for 3 days after vaccine. Fever broke on 02/15 and bodily rash occurred.
Shivering, shuffling of feet, trouble standing and walking, falling, fever, weakness, high blood sugar
devel high pitch screaming cry > 3 hrs; temp 101 or less; large local redness, swelling w/knot present x 1mo;
-Severe chills/shakes lasting approximately 1 hour, (onset about 12 hrs after receiving vaccine) followed by intense sweating and feeling of being overheated lasting for approximately 1 hour. -general feeling of being unwell (body aches, tiredness) starting about 18 hrs after receiving vaccine and lasting approximately 12 hours
Patient stated swelling all over body and face, join and bone pain, headache, dizziness, difficulty breathing, and fever of 103
No additional AE; Administered an improperly stored dose; This spontaneous report was received from a medical assistant concerning a 53-year-old unknown gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.   On 13-SEP-2023 at 10:09, measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection (lot# U039664, expiry date: 15-DEC-2023) was improperly stored at room temperature (22 degree Celsius). It never returned to recommended range because the refrigerator was not operational. On 20-SEP-2023, the patient was vaccinated with the improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection 0.5 mL (route of administration, and anatomical location not provided) as prophylaxis (product storage error). There were no adverse effects reported. No additional adverse event (AE) was reported (no adverse event).  This is one of 2 reports received from the same reporter (RA #2309USA007541).; Sender's Comments:  US-009507513-2309USA007541:
Following Dtap Hib vaccine pt was very tired, then developed high fever and limpness/unresponsiveness. Taken to ED bloodwork normal. Fever decreased with Tylenol/Ibuprofen. Seen also 5/23/06 normal examination.
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 06-JAN-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccines was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013914: US-009507513-1711USA013915: US-009507513-1711USA006083:
Headache; Pain in the patella of the right knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the patella of the right knee) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Ankylosing spondylitis and Crohn's disease.    Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease.   On 12-Jan-2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRALGIA (Pain in the patella of the right knee). In September 2021, the patient experienced HEADACHE (Headache). At the time of the report, ARTHRALGIA (Pain in the patella of the right knee) was resolving and HEADACHE (Headache) had resolved.            No concomitant medication information was reported.  No treatment medication was reported.  I Primary reporter did not have the lot number information, because the packaging was discarded.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna .
Arm was sore that next day and inflamed; red and a little hot. The arm was sore. That lasted for two - three days. Then two weeks after that, the arm swelled up again. It was red, very itchy and swollen and warm to touch; inflamed. It got pretty large. It was in the area of the shot. The arm wasn't real real sore like when I first got the vaccination. Dr telemed appt. She thought it might be cellulitis - and she gave me an antibiotic - Cephalexin - 500 mg -4 times/day. It still took about a week to two weeks for it to calm down.
Other 11/12/2021 03:16 PM Communication: Pt was administered her first Janssen vaccine today by RN. After vaccine was administered, went to get her water while I sat with patient and informed her of Vsafe, Pt became very pale. I asked her if she wanted to lay down. She agreed. i went to look for an open room and as soon as I came back which was only a couple seconds later, I lifted patient up from the chair and pts eyes rolled back, she fell on me and started to convulse and her arms became hard. Then told me to put her on the floor. I yelled for help, the AED cart. I asked someone to call the paramedics and to bring over a Dr., came over to assist me with the AED cart. Dr then came over to access pt. Pt was recommended to go to ER but choose not to go. She did sign and AMA. I will send VAERS report online and Incident report will go in her chart. Waited with pt until her car ride came to pick her up.
PRESSURE IN HEAD; PRESSURE AND RINGING IN EARS; LOWER BACK PAIN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced pressure and ringing in ears. On MAR-2021, the subject experienced lower back pain. On 29-MAR-2021, the subject experienced pressure in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in head, pressure and ringing in ears, and lower back pain. This report was non-serious.
Big red patch near vaccination site on shoulder. Shoulder is inflamed, painful, and hot to the touch.
I had an allergic reaction ? my throat started to swell. I called 911. Was given Benadryl at health department before the ambulance arrived. Once at the hospital, I received more Benadryl, Prednisolone, and Pepcid.
Increased redness and development at 3x4 cm patch of clear vesicles on back of (R) arm. Sx develop 24 hours after vaccine. Redness progressed with 10 x 5 cm surrounding erythema with swelling.
Patient experience a large knot in her arm at injection site the size of a golf ball she reported that it was hot to touch red in color and itched for 48 hours then resolved.
Symptoms started the night she got the shot. Had sleepless nights and was very fussy for one week. No cough, no fever, no site redness. Mom refused to given child the second shot. Mom states child got better for a couple of days and then got sick again with cold symptoms. Has not taken child to MD. Did have a call into him today to have him call her back about symptoms.
no adverse effect; Patient was inadvertently administered a dose of MMR II that was expired; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reaction/ allergies were not reported. Concomitant medications included sterile diluent. On 21-JAN-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot number N032427 and expiry date 16-NOV-2019 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No adverse events were reported. No product quality complaint (PQC) was reported.
no adverse event; Received Monovalent booster instead of Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-672558, US-MODERNATX, INC.-MOD-2022-672557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672558:1st Elderly patient US-MODERNATX, INC.-MOD-2022-672557:1st Elderly patient
fainting; after any time the patient stood up, the blood pressure dropped/blood pressure still drops when standing up/low blood pressure; dizzy and lightheaded; 3rd dose (booster); This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  An 18-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 06Jan2022 12:45 (lot number FJ1611) at the age of 18-years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was reported as "none". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 2, lot number EW0177, location of injection: arm left), administration date: 21May2021, when the patient was 17 years old, for COVID-19 immunization, reaction: "inappropriate schedule of product administration"; and Bnt162b2 (dose 1, lot number EW0176), administration date: 06May2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Jan2022 12:45, outcome "unknown", described as "3rd dose (booster)"; SYNCOPE (medically significant) with onset 07Jan2022 04:00, outcome "recovering", described as "fainting"; ORTHOSTATIC HYPOTENSION (non-serious) with onset 07Jan2022 04:00, outcome "not recovered", described as "after any time the patient stood up, the blood pressure dropped/blood pressure still drops when standing up/low blood pressure"; DIZZINESS (non-serious) with onset 07Jan2022 04:00, outcome "recovered" (08Jan2022 16:00), described as "dizzy and lightheaded". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (07Jan2022) low; (07Jan2022) dropped. Clinical course: Approximately "14 hours" (as reported) after the 3rd dose (booster), the patient experienced a fainting episode and low blood pressure. For several hours, after any time the patient stood up, the blood pressure dropped, and the patient was dizzy and lightheaded. 36 hours later, the dizziness has stopped but the blood pressure still drops when standing up but not as much as earlier. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has not been tested for covid-19.  Follow-up (11Jan2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028847 same patient, different vaccine dose/AE
Systemic: Nausea-Severe, Systemic: Vomiting-Severe; symptoms lasted 1 day.
Pt friend stated he will pass out when getting vaccine.  He did.  Was ready with ammonia break pack.  Pt immediately responded.  Had him wait 30 minutes instead of 15.
Swelling in left arm where shot was administered. Swelling from wrist to shoulder - swelling started being noticed on 10/03/2014 - still swollen on 10/06/2014.
Diarrhea; Nausea; Body ache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and MYALGIA (Body ache). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash and red blotches. On an unknown date, the outcome of the injection site rash and red blotches were recovering/resolving. It was unknown if the reporter considered the injection site rash and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a red, blotchy area around the injection site. The rash was slowly lessening. On 25th August 2018, the patient came back with rash, it was not sure when exactly the rash started. This case has been linked with US2018155213, reported by the same reporter.