chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cannot raise arm; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise arm) and VACCINATION SITE PAIN (very sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise arm) and VACCINATION SITE PAIN (very sore arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise arm) and VACCINATION SITE PAIN (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. No treatment medication was reported.
chills a thousand times worse than normal; Chills with shakes that are  uncontrollable; I got my shot the following day I had fevers; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are  uncontrollable) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY WAS REPORTED BY REPORTER.     On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are  uncontrollable). At the time of the report, CHILLS (chills a thousand times worse than normal) and TREMOR (Chills with shakes that are  uncontrollable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced with chills a thousand times worse than normal, and chills with shakes that are uncontrollable. no medical history was reported. no concomitant medication was reported.
Patient had vaccines (below) on 1/22/15. On 2/10/15 developed grand mal seizure < 5 minutes and fever up to 102 F. Also diagnosed with croup on 2/11/15- given oral steroids.
Woke up the morning following dose 1 of Moderna with swollen eyelids along with red and itchy rashes on my upper eyelids. It has been 12 hours since then and the swelling and rashes have decreased but are still there. I took an oral antihistamine and it helped a little bit.
Sneezing a lot, after the first and second vaccine; Right arm with rising and swelling: described as red in a crescent moon shape at injection area, after first vaccine; red in a crescent moon shape at injection area, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; Vaccine poured and trickled out of arm, after first vaccine; This is a spontaneous report from a contactable consumer.  A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 (caller states it was the evening) (Batch/Lot Number: EW0161) as 1st dose, single for covid-19 immunisation (Reported as because she is her daughter's mother, and told her daughter to get the vaccine. her daughter's school is making all the seniors get the shot to go back to school). Medical history included Birth control. Family Medical History relevant to AE was No. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE) from Mar2021 (two months ago) taken for birth control. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AEs following prior vaccinations was None. Caller states she is calling for her daughter. Caller confirms she is calling about the Pfizer vaccine, confirmed as the Covid 19 vaccine. Caller states that when her daughter went and got the injection, some of the vaccine poured out of her arm, vaccine poured and trickled out of arm, after first vaccine was on 21Apr2021 3:20 pm. Caller states that 3 days later (in the morning), her daughter's arm started to get a rising, later clarified as swelling. Caller states that it was red, in a crescent moon shape, and raised up off her arm at the injection site. Caller states it was really huge. Caller states that she called the pharmacy and she was told to give her daughter Benadryl and Cortisone cream. Caller reports that this treatment was effective. caller then reports that her daughter had lasting effects, clarified as sneezing a lot, after the first injection and then it got more intense after the second injection. The event was not required a visit to Emergency Room and Physician Office. Relevant Tests was None. No Investigation Assessment. Treatment received for the events. Outcome of red in a crescent moon shape at injection area, after first vaccine was recovered on 26Apr2021 (also reported the area is still a little brown spot but not raised up off her arm). Outcome of Sneezing a lot was not recovered. Outcome of the events was unknown. Seriousness criteria is Medically Significant.  Information on Lot/Batch number was available. Additional information has been requested.
Sudden Sensorineural hearing loss right ear, still ongoing. Diagnosed 10/05/2021 Tinnitus, ongoing
This non-serious spontaneous case, initially received from pharmacist on 26-Sep-2018, concerns a male patient of unspecified age. On an unspecified date, when trying to administer the FLUAD (TIV) [batch number: 250788, expiry date: 13-Apr-2019] to the patient, the syringe got leaked around the Luer-Lok (explicitly coded as syringe leak). It was reported that the health care professional (pharmacist) exposed to the vaccine (explicitly coded as occupational exposure while administering product). No vaccine was administered to the patient. No adverse events were experienced after the vaccine exposure. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding reference number was (number: 1033569).
First few days had chills, extreme sweating, nausea, and then ended up in hospital with irritation and inflammation of heart lining and walls.
Body aches and low grade fever. Became 102 degree fever on second day. Large area of redness around injection site. OUTCOME: I'll be danged if I'm going to get a flu shot again. I never get the flu anyway. This is ridiculous.
Diarrhea; Stomach problem; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient had diarrhea and stomach problem. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 103, vomiting, convulsions, congestion, increased heart rate, abnormal breathing.
Left sided numbness in neck face and arms 2 weeks after injection. General malaise and weakness. Headache and clogged sinuses. 3 emergency room visits, prednisone and motrin ordered. Symptoms began 4/2/21 and to date 4/17 they are still present. unusual headache and neck pain and weakness and occasional shortness of breath are occurring and my left ear is blocked.
Also felt extremely tired; Loss sense of smell for about 10 days; Loss sense of taste for about 10 days; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss sense of smell for about 10 days), AGEUSIA (Loss sense of taste for about 10 days) and FATIGUE (Also felt extremely tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-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 ANOSMIA (Loss sense of smell for about 10 days), AGEUSIA (Loss sense of taste for about 10 days) and FATIGUE (Also felt extremely tired). At the time of the report, ANOSMIA (Loss sense of smell for about 10 days), AGEUSIA (Loss sense of taste for about 10 days) and FATIGUE (Also felt extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Dose number of vaccine, suspect start date and laboratory test were updated, along with a new event "Tiredness".
Red itchy rash at injection site and larger red itchy rash below and side of injection site. Started about day 5, lasted through 8.
Case number PHEH2013US018827 is an initial spontaneous report received from a nurse on 05 Sep 2013. This report refers to a 36-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11082) intramuscularly in the deltoid on 23 Aug 2013. It was reported that on the same date she experienced pain and soreness in the injection site (deltoid/shoulder area). The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Pt was accidentally given the pediatric dosage of Moderna COVID-19 vaccine,  0.25ml = 25mcg. After review of CDC's, "Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates". Error was corrected by administering 0.25ml (25mcg) of Adult Moderna COVID -19 Vaccine on the same day so pt got a total of 0.5ml = 50mcg. Pt tolerated well.
J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/28/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/28/2023 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/28/2023 IRON DEFICIENCY ANEMIA
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 20-MAR-2017 at 14:57, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457
Undiluted pediatric Pfizer COVID-19 dose given resulting in higher dose instead of 10 mcg dose.  Error was discovered after patient and parents had left pharmacy.  Attempted to call phone number left on vaccination form three different times on three different days but no answer or call back from patient's parents.
R leg swollen, reddened, warm to touch. Pt stated hurt to walk on. No fever. Too to urgent care, given Abx >10cm aea.
Pt exposed to varicella in March, 2000. Pt had vaccine on 8/22/96. On 3/20/2000, pt had an outbreak of 50+ varicella lesions. He recovered on his own with no complications.
Urticaria, nonpruritic, without any systemic complaints otherwise; This is a spontaneous report from a non-contactable nurse. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient previously did not receive any medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, 2 days after the COVID shot, the patient experienced urticaria, nonpruritic, without any systemic complaints otherwise. The patient had COVID 3 months ago and towards the end developed similar presentation of urticaria. These 2 events were the only time he had ever had urticarial lesions in his life. The event resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of urticaria, nonpruritic, without any systemic complaints otherwise which included treatment with antihistamines. The clinical outcome of the event urticaria, nonpruritic, without any systemic complaints otherwise was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
For both dose #1 (025LZ0A) in left arm, and dose # 2 in this report, redness and swelling at injection site.  Dose 1 started 1 wk after injection, lasting about 10 days.  Dose #2 of this report, still present. Looks like cellulitis, probably covid arm?
Left arm severe pain 2am that continued for two weeks.  I had should surgery in the left arm 18 months prior.  I was unable to lift my left arm past 30 degrees for two weeks.  After two weeks it became incrementally better every day.  It took 3 weeks to get full range of motion back. Low grade fever 20 hrs post vaccine which lasted 10 hours.
Listed on previous screen. Visual issues. I had a mild version of this reaction to the first dose (1/22) and a more moderate reaction after the 2nd one (2/19). It was not listed on the side effects. I had visual issues of halo and flashing lights sporadically. After the first dose, only a few days. After the 2nd dose, 2 weeks solid. It is resolved now and I did not seek medical care. I had had surgery on both retinas over the last 5 years, so I am not sure if this exacerbated something in my eyes related to vascular dilation or something nerve related. It did only occur right after both doses (Moderna) and so I do believe it is somehow connected. That being said, it did not stop me from daily functioning and I do not at all regret the vaccine. Just wanted to tell someone.  Another friend reported similir visual issues and I encouraged him to report it as well.
passed away; blood in lungs; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) and PULMONARY HAEMORRHAGE (blood in lungs) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and PULMONARY HAEMORRHAGE (blood in lungs) (seriousness criteria death and medically significant). The patient died on 18-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        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.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.; Reported Cause(s) of Death: unknown cause of death
Large Red lump on left buttock, the size of a fifty cent piece, thought it was an insect bite. Apply Benadryl. By Sunday morning spot very larger and now spreading. Hot, burning and very itching down the back of my leg.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history. There were no concomitant medications. 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.  Clinical course: Report about COVID treatment: Yes. Patient Adult (18-64 Years) with Current age: 48 Years, male. Vaccine received and no other medication in 2weeks. Anti viral details: product: COVID 19 Treatment, Paxlovid (Treatment start date: 18Jan2023, Treatment stop date: 23Jan2023). Vaccine dose number= 4 and adverse event: Covid rebound after Paxlovid on start date: 28Jan2023 with treatment AE: No. No known allergies, No other medical history.   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.
Rash on right hip; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration on 30Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021, the patient experienced rash on right hip. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of rash on right hip was not recovered.   No follow-up attempts are needed. No further information is expected.
The patient presents for 3 days of weakness.  Patient states that for the last 3 days other than standing up with his walker he was unable to leave his chair.  He states he urinated on himself and stooled on himself during this time.  He was diagnosed with COVID recently.  He does state that he had all 4 COVID shots.  He denies fever denies cough he has had increased stooling however.
received the vaccine from beyond use date 06/26/21; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the vaccine from beyond use date 06/26/21) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the vaccine from beyond use date 06/26/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the vaccine from beyond use date 06/26/21) outcome was unknown.        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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Patient received Moderna for dose 1 at different facility. We gave dose 2 on 3/25/21 with Pfizer. Patient returned to our pharmacy on 3/26/21 to bring to our attention. Patient not experiencing any effects from it. We also reported error  to patient's primary physician.
Fully vaccinated with moderna vaccine x 2. Tested positive for COVID 19 on 02/15/22. Admitted to a local Medical Center on 02/15/2022. Expired on 03/05/2022 while still hospitalized.