chrisvoncsefalvay/vaers-outcomes huggingface dataset:
is not good at walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "is not good at walking".  Additional information : A caller was calling on behalf of her husband and herself. She said that her husband was a senior who was not good at walking around and he was homebound too. Her husband managed to get himself a shot to a supermarket where they did covid shots and she had a home visit for her shot. The second time they had shots was a home visit and that was in Aug. She wants to know if they can arrange another home visit for the bivalent vaccine. Also the caller mentioned that when she had those two vaccines she said it's like not feeling so great but she's fine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300177504 same reporter/drug, different patient/AE;US-PFIZER INC-202300177505 same reporter/drug, different patient/AE;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-JUL-2016 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml (lot # L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature  excursion eight time. The total cumulative excursion time of the first time was 204 hours with the lowest recorded temperature of 33 Fahrenheit degree; the second time was 444 hours with the lowest recorded temperature of 34 Fahrenheit degree; the third time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree; the fourth time was 24 hours with the lowest recorded temperature of 21.7 Fahrenheit degree; the fifth time was 1732 hours with the lowest recorded temperature of 29 Fahrenheit degree; the sixth time was 24 hours with the lowest recorded temperature of 31 Fahrenheit degree; the seventh time was 96 hours with the highest recorded temperature of 48 Fahrenheit degree; the eighth time was 304 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R)/ freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EAU. The following day at 3AM I woke up with chills, a mild fever of 100.0, a headache, and back pain.  Towards the end of the day I felt tired, however not sure if that was from the vaccine or because I did not sleep well. Tylenol reduced symptoms and they did not greatly interfere with my day.  The following morning all side effects were gone and I was back to completely normal.
Swelling of (R) leg (DTaP) side extending from thigh to upper calf. 3 days after imm. still w/ mild swelling of right thigh, knee and calf. Walking well, no erythema.
Report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 2nd dose01/27/21 Diagnosed covid positive:09/07/21 Symptom onset:09/07/21 Exposure:community Symptoms:fatigue, muscle aches, sore throat, HA
Dose administered after use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication details were provided. No Treatment medication details were provided.  DOSE 1 was administered on 23Sep, 8am and DOSE 2 was administered 24Sep around 1:30pm.   On 24 Aug 2021,Vial went from freezer to refrigerator. At 6 am Vial from refrigerator, stored at the appropriate room temperature for 15 minutes before 1st puncture and administered to patient immediately after 1st puncture.   Neither vial went through a previous temperature excursion.  It was reported that the patient had no adverse events.   This case was linked to US-irms-MOD21-147703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: follow up received with no new information. On 01-Oct-2021: Follow-up information added in I narrative supplement.
swelling the size of a golf ball at the injection site; swelling the size of a golf ball at the injection site; Initial information received on 09-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old male patient who experienced swelling the size of a golf ball at the injection site (swelling and vaccination site reaction), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AA expiration date: 30-Apr-2019 via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious swelling the size of a golf ball at the injection site (swelling and vaccination site reaction) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Lab data was not reported.  The pharmacist stated that she administers this patient's Fluzone HD vaccine yearly for the past 5 or 6 years and he has no history of a reaction such as this.  Final diagnosis was swelling and vaccination site reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both the events.  List of document held by sender: none.
Patient received vaccine on 04/23/21. Four days later developed chest pain. Patient believed this was related to normal symptoms post vaccination. His pain worsened and patient eventually presented to hospital and found to have inferior infarct, with 100% RCA complicated by VSD and RV failure requiring ECMO support
Feeling weak; Feeling / sleepy; Temperature this morning of 101 degrees and now / below 100 degrees.; Burning sensation on his back; This case was reported by a consumer and described the occurrence of weakness in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th February 2021, 1 days after receiving Shingrix, the patient experienced weakness, sleepiness, fever and burning sensation. On an unknown date, the outcome of the weakness, sleepiness, fever and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the weakness, sleepiness, fever and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient and reports he was having adverse effects to his second Shingrix vaccine.  The patient received his second Shingrix vaccine and the next day the patient feeling weak and sleepy. The patient temperature this morning of 101 degrees and now, in the afternoon, it was below 100 degrees. The patient reported a burning sensation on his back. The patient was treating symptoms with Tylenol with good results. The reporter did not consent to follow-up.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment was provided by the reporter.
Narrative:  56 yo F with PMH of afib. Reported diahrrea, chills, fever, and body aches following second dose of COVID-19 vaccine received in Jan 2021. Those  sx lasted about 1 week. About 6 months later, in June 2021, she was admitted for having palpitations. On admission, she was found to have tachycardia and  uncontrolled atrial fibrillation. She was also found to have a PE. On workup of Afib, she was found to have hyperthyroidism with TFTs showing TSH <0.01 and free T4: 4.32. The patient denies a prior history of hyperthyroidism. She has not been exposed to ionizing radiation in the past. She did receive iodinated contrast on admission with a CT angiogram to diagnose a PE. The patient denies any family history of thyroid problems. She has not had a viral URI recently and denies thyroid tenderness. Denies any history of autoimmune conditions. Has not  been on amiodarone or lithium. Unclear if vaccine contributed to patient's hyperthyroid. Treated with methimazole.
Sept 18, 2022 (5 days after vaccine) became quickly ?exhausted? while doing an easy hike and felt generally unwell that day. Slept poorly that night and woke am of Sep 19 with shortness of breath and heart palpitations??went to ED where land and EKG were done. Labs basically OK. EKG  with multiple PVC?s. Drive back home and followed up with Internal Medicine doctor at local facility.
Patient reports a rash hot and painful size of a small tangerine, asked her to take a photo and follow up with md if getting worst.  ice and benedryl if needed. Patient got prescription for bactrim ds for 7 days
Fingertip turned blue after 4 mins. Patient elevated hand x 15 mins. Blue fingertip resolved but then had redness/swelling below infiltration site.
states she had nausea and diarrhea afternoon that she received the vaccine and into the following day with lack of appetite; had not eaten anything
No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 12-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a healthcare facility/home (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated (by an unspecified health care professional) at the healthcare facility/home for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Developed cough, headache, fatigue on 5/15/2021.  Diagnosed with COVID on 5/17/2021.  Week following diagnosis, developed worsening headache, diarrhea, sinus congestion, sinus pressure.
I got the 2017 flu shot. My arm has been sore ever since. Its hard to lift anything or hold me weight up (doing planks, etc.). There feels like there's a "bunch" in my arm where the shot was given.
Her throat felt like it was swollen and bumpy; The patient also felt as if there was a rash on her face, however a rash was not present; Her throat felt like it was swollen and bumpy; Her throat felt like it was swollen and bumpy; This spontaneous report has been received from a physician referring a 30-year-old female patient.  The patient's medical history included papanicolaou smear abnormal. The patient's drugs reaction or allergies includes problem with diphenhydramine hydrochloride (BENADRYL) in the past. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  administered as prophylaxis (strength, dose description, vaccination scheme, lot number, expiration date, anatomical location and route of administration were not provided).  On an unknown date, at an unspecified time after the vaccination, the patient felt like her throat was closing off (throat tightness). The patient also felt as if there was a rash on her face, however a rash was not present (sensory disturbance). Her throat felt like it was swollen and bumpy (sensation of foreign body and pharyngeal swelling). Due the events, the patient went to the emergency department to seek care, however the wait was too long to see a provider, the staff at the emergency department advised her to take diphenhydramine hydrochloride (BENADRYL), which she did. The patients physician was not convinced that the patients symptoms were from the vaccine, the provider was assessing if it perhaps environmental conditions (such as something in the air) could have caused the patients symptoms however the patient reported that she did nothing unusual the day of the symptoms other than going to the park and eating lunch with her mother. The outcome of the events was not reported.  The causality assessment between the events and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
approx 3 wks p/vax pt began having szs, repeating Q 20min, sometimes more frequently; had many tests (EEG, MRI,Ventricularoscopy) was dx by MD as having Infantile spasms, hydrocephalus; lost eye sight; put on several meds;
"He had heat flashes"; "He was cold and then hot"; had Diarrhea"; "We just laid around for two days doing nothing"; "He felt achy, like achy bones"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH ("He had heat flashes"), BODY TEMPERATURE FLUCTUATION ("He was cold and then hot"), DIARRHOEA (had Diarrhea"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("We just laid around for two days doing nothing") and MYALGIA ("He felt achy, like achy bones") in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced HOT FLUSH ("He had heat flashes"), BODY TEMPERATURE FLUCTUATION ("He was cold and then hot"), DIARRHOEA (had Diarrhea"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("We just laid around for two days doing nothing") and MYALGIA ("He felt achy, like achy bones"). On 17-May-2021, HOT FLUSH ("He had heat flashes"), BODY TEMPERATURE FLUCTUATION ("He was cold and then hot"), DIARRHOEA (had Diarrhea"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("We just laid around for two days doing nothing") and MYALGIA ("He felt achy, like achy bones") had resolved.      No concomitant medications were provided Treatment for the events were not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-067576 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067576:CROSS LINKED WITH WIFE CASE
Received shot right arm within days the left arm began to ache - the pain growing intense as time past. Then about 2-3 months later right arm began to ache.
Axillary swelling and pain (severe) on the same side as injection, fever, severe myalgia, vomiting, debilitating fatigue and inability to perform ADLs. Symptoms are ongoing at 48 hours after dose.
Loss of feeling in hands and feet, progressed to arms and legs. Dizziness, forgetfulness, confusion.
vaccine administered to 16 year old; A spontaneous report was received from a pharmacist (a PharmD) concerning a 16-year old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) at the age of 16 years old (product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The vaccine was administered to a 16-year-old patient.  Action taken with mRNA-1273 in response to the event was not applicable.   The event, received vaccine at the age of 16 years old, was considered resolved.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
Onset time is listed as when noticed. Son complained of pain with movement immediately after injection to upper arm. Site had severe swelling and was very warm to the touch.
VACCINE WAS NOT DISPOSED OF DURING THE PREVIOUS NIGHT. MORNING SCHEDULE WAS HECTIC WITH MANY PATIENTS EARLY FOR VACCINE APPOINTMENTS AND REQUIRING TRANSLATORS. INTERN PHARMACIST CAME INTO ADMINISTER VACCINES AND DID NOT DOUBLE CHECK IF THE VACCINES WERE JUST OPENED AND DREW VACCINE THAT WERE OPENED THE DAY PRIOR. VACCINES WAS 4 HOURS POST 12 HOURS PUNCTURE EXPIRATION. PATIENT WHERE GIVEN PFIZER AS 2ND BOOSTER. PATIENT WAS CONTACTED AND REPORTED NO ADVERSE EVENT FROM THE VACCINE .
Woke up with almost all my hair on my pillow. The rest fell out during the next few days. Loss of all body hair except eyebrows and most eyelashes. No abnormal hair loss prior to this event. Some hair on head has grown back.
Vesicular eruption at injection site on right thigh. Typical varicella lesions.
light fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (light fever) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (light fever). At the time of the report, PYREXIA (light fever) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Delayed menstruation. Menstrual cycle has consistently been 28-32 days for years, this is extremely abnormal and concerning. I am not pregnant and I do not use hormonal birth control.
Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna) in an elderly female patient 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the first dose from Pfizer's COVID-19 vaccine and the second dose from Moderna) had resolved.     This case was linked to MOD21-064472, US-MODERNATX, INC.-MOD-2021-060574 (E2B Linked Report).; Reporter's Comments: This report refers to a case of wrong dose administered for mRNA-1273 with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060574:Same reporter (MOD21-064472)
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL instead of 0.25mL / dose. The manufacture provided 0.5mL single dose vial and noted contained 0.25mL
The patient verbalized feeling dizzy 6 minutes after getting his vaccine. RN checked vital signs every 5 minutes. Initial BP=76/52 HR - 50. Final BP=107/72 & HR=56 O2 sat=100% RN advised patient to follow up with PCP patient agreed. RN walked patient to his car at 6:45pm, patient's partner drove him home. 5:47 pm BP=94/56 HR=52 O2 sat=98% 5:53pm BP=102/67 HR=53 O2 sat=100% 5:59pm BP=106/72 HR=51 O2 sat=100% 6:10pm BP=127/80 HR=69 6:15pm BP=120/84 HR=57 6:17p BP=113/67 HR=53 6:26pm HR=56 BP=107/72 6:40pm BP=114/72 HR=56 O2 sat=100% RN gave the patient electrolytes to drink twice. The patient verbalized that he hasn't seen a PCP in over a year because he doesn't have health insurance. RN advised patient to follow up with a doctor as soon as possible. The patient said that he will get health insurance from his partner's job in 2 weeks for anything today and hasn't slept well in the past 5 days due to insomnia. RN patient to his car once his blood pressure stabilized. He partner was in the car and drove the patient home.
Patient received Moderna as dose 1 on March 29,2021.  We erroneously gave him Pfizer 21 days later (today, 4/20/21).  No adverse reactions reported.  Patient alerted of issue.