chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the shot by a student tech. I went back to work. At the end of the work day (appx 5 hours later) I started to feel a heating sensation in my left arm. By time I reached home, I felt drained. A family member made an observation that I received the shot high in my arm; unlike their experience where the shot was received lowered. I could not reach my hand above my head without the assistance of my right arm.  For the next few days, I did the following (alternated taking Tylenol and Advil), massage arm with rubbing alcohol (91%), exercise arm, and used a heating pad.  There was no soreness were I received the shot. The pain was in the muscle. It was extremely intense when I tried to make a circular motion between the positions of 12 o'clock thru 3 o'clock and vice versa. There was a popping in my shoulders when making the motion. It hurt when I put my arm behind back between shoulder blades. It hurt when making certain motions when getting dressed (e.g. pulling socks apart to put on feet).  This continued for about 11 days. I still feel slight pain, but it appears to be going away.
13 y/o male became "light headed" and passed out in the lobby of the office ~ 15 min after recieving Tdap and Menactra. He was pale, diaphoretic and B.P. was lower than previously.
Incomplete course of vaccination; lost his balance / balance issues; dizziness; This case was reported by a consumer via call center representative and described the occurrence of loss of balance in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 6th September 2019, the patient received PNEUMONIA VACCINE. On 7th September 2019, 1 days after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Meclizine, the patient experienced loss of balance and dizziness. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with meclozine hydrochloride (Meclizine). On an unknown date, the outcome of the loss of balance and dizziness were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the loss of balance and dizziness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received an unspecified pneumonia vaccine together with the Shingrix and the next morning, he was dizzy and lost his balance.   The patient went to the emergency department and had an unspecified brain scan, which ruled out stroke or other anomaly.  The patient was given Meclizine and monitored, and then released. The patient was followed up by a neurologist who recommended balance therapy for 6 weeks and 12 sessions.   The patient reported that this did not ease the dizziness or balance issues. The patient reported that the dizziness was more apparent after meals. He was continuing to report dizziness and loss of balance. It was unknown if the reporter considered the loss of balance and dizziness to be related to Pneumonia vaccine. The reporter consented to follow up.
patient was inavertently administered with am expired dose of M-M-R II; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 11-MAR-2021, the patient was vaccinated with an expired 0.5 mL dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S006646 exp date 05-MAR-2021) (route not reported). It was reported that the product had never had a temperature excursion and was supported per the post-expiry memo.
sweating; lips are starting to swell; hot; rash; chills; headache; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), LIP SWELLING (lips are starting to swell), FEELING HOT (hot), PAIN IN EXTREMITY (arm hurt) and RASH (rash) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 08-Feb-2021, the patient experienced HYPERHIDROSIS (sweating), LIP SWELLING (lips are starting to swell), FEELING HOT (hot), RASH (rash), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Headache, Lip swelling and Pain in arm, at an unspecified dose and frequency. On 08-Feb-2021, HYPERHIDROSIS (sweating) and CHILLS (chills) had resolved. At the time of the report, LIP SWELLING (lips are starting to swell), FEELING HOT (hot), PAIN IN EXTREMITY (arm hurt), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Heartbeat thing; High BP; ministroke; transient global amnesia; sore arm; A Spontaneous report  was sent by Consumer concerning a 55 year female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke, transient global amnesia, heart rate increased and blood pressure is high.  No medical history was reported. Concomitant medications was not reported.  22 Jan 2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection and experienced sore arm in the evening. She took Tylenol and Motrin.  On 02 Mar 2021 the patient received the second dose of vaccine and experienced sore arm before she received the shot.   On 21 Mar 2021 she had mild stroke, and she was diagnosed with Transient global amnesia. Which they said is precursor to stroke. On 22 Mar 2021, patient experienced heartbeat thing; blood pressure recorded high.The patient has undergone MRI, CAT scan, EKG, Chest x-ray done and blood drawn in ER. Laboratory details are not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the events, mild stroke, transient global amnesia, heart rate increased and blood pressure is high was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
pt reported to ER 1AUG97 PM w/paroxysmal sz like activity witnessed by ER attendants;mom states activity began shortly p/vax;involved rhythmic back arching,extreme extension, tongue protrusion & staring;pt afeb & stable VS in ER:
Initial symptoms of chills and heart racing. Initial HR was 119 with slight dizziness. Reassurance, rest, granola bar. Return to normal HR, BP 02 sat normal, normal CV exam
legs hurting; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. Calling on behalf of 92-year-old uncle received first dose of vaccine. The patient's medical history and concomitant medications were not reported. The patient had complaining of legs hurting on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.
GOUT FLARE UP ON RIGHT FEET; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included HBP, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced gout flare up on right feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gout flare up on right feet. This report was non-serious.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 23-AUG-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number J003360, Exp. Date: 21-JUN-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Atrial Fibrillation; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 17:00 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIAGRA taken for erectile dysfunction; CENTRUM SILVER +50; CLARITIN D 12 HOUR. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot # unknown, Arm Left, 10:00 AM), administration date: 24Mar2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Lot # unknown, Arm Left, 10:00 AM), administration date: 03Feb2021, when the patient was 51 years old, for Covid-19 Immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 18Dec2021, outcome "recovering", described as "Atrial Fibrillation"; IMMUNISATION (hospitalization, medically significant) with onset 18Dec2021, outcome "recovering", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative. Therapeutic measures taken as a result of the eventts included cardioversion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
PATIENT GIVEN MODERNA FIRST DOSE ON 04/30/21 BY HCP ON DUTY. PATIENT CAME WITH MOM. BOTH RECEIVED MODERNA. HCP ON DUTY DID NOT NOTICE AGE UNTIL VACCINE GIVEN. CAME TO PHARMACY FOR 2ND DOSE MODERNA 06/03/21. MOM CONSENTED TO SECOND SHOT.
Injection site redness approx 5 min after injection small approx 3 cm in size
Real tightness in her arm; This is a spontaneous report from a contactable consumer (patient) self-reported. A 48-year-old Female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, on 29Apr2021 at 10:10, as single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On 29Apr2021, the patient experienced real tightness in her arm, describing it as her arm had tied up in a knot. It started a couple of hours after the shot. Patient stated she took a shower when she got home, and it did seem to ease it up and again described her arm as tight and wound up but no pain. Outcome of the event were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Large swollen, golf ball sized abscess or reaction left upper deltoid.  Sore and tender, started 2 days after vaccine
Patient reports Shortness of Breath starting the morning after taking the shot. He states SOB is worse on exertion.
This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 07Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2595) at the age of 65 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Bad knees" (unspecified if ongoing), notes: Other medical history: bad knees,; "Over weight" (unspecified if ongoing), notes: Other medical history: overweight; "Known allergies: several, not serious allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Dec2021, stop date: 09May2022; TRIAMTERENE, start date: 01Dec2021, stop date: 09May2022. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01May2022) Negative; (07May2022) Positive; (09May2022) Positive. Therapeutic measures were taken as a result of Covid-19 with Paxlovid, treatment start date: 25Apr2022, treatment stop date: 29Apr2022.
Rash on face, still here after 3 weeks; day after was tired, nauseated, muscle and joint paint, swollen lymph nodes, that has resolved itself
She didn't get her second dose one month after her 1st dose/ it was past the recommended time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She didn't get her second dose one month after her 1st dose/ it was past the recommended time) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She didn't get her second dose one month after her 1st dose/ it was past the recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She didn't get her second dose one month after her 1st dose/ it was past the recommended time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No Treatment medications were provided.
Initial report received from healthcare professional on 29 Jan 2010: This patient received FLUVIRIN batch number 102136P, expiry date Mar 2010, 0.5 mL intramuscular on unspecified date.  No adverse reaction was reported.
High fever 102.5, cough, ear infection, nebulizer meds Albuterol, Amoxicillin, cough syrup, Tylenol.
Death Narrative: Death on 03/21/2021. 2nd dose administered 46 days before serious event. Patient had been admitted to the hospital for AMS of unknown etiology concerning for sepsis with multiple sources and was on comfort care measures only. There are no indications that death was related to the vaccine.
4 hours following the vaccine (booster of Moderna, patient had previously received 2 Pfizer vaccines) patient reports he passed out and woke up 12 hours later feeling paralyzed and unable to get up. He attempted to get up; has severe rug burn, called his son and slowly recovered.  6 days later (today) he states he is back to normal just feels muscle soreness and tiredness. At the time of the adverse event he states he did not seek medical attention
That evening just not feeling well. Serum going in arm was very uncomfortable. Arm from shoulder to elbow hurt rest of day. Next day woke up with very rapid racy heart beat, weakness, dizziness, slight nausea.  All symptoms lasted two full days and night. "Slight" recurrence 5 days later lasting half of day with same symptoms.
None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 10-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
30 minutes after injection temporary paralysis of face lips and tongue. Partially resolved after 5 minutes fully resolved after 3 hours
she injured her back; This is a spontaneous report from a Pfizer-sponsored Regulatory Authority Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164) dose 1 via an unspecified route of administration on 30Jul2021 as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were was not reported. On 15Aug2021, she injured her back and she was under different medication such as steroid (Intent: treatment), now she is supposed to get her second dose on 18Aug2021 however that needs to be canceled because she is still under medication (treatment) she was schedule for the second dose on 25Aug2021, this coming Wednesday however she thinks she is still unable to make it Wednesday. She was still worried about her condition (Clarification unknown). She was on a lot of medications she does not know if she could be on these medicines when she got the vaccine she was taking 'Mobic' (Not clarified) now which is anti-inflammatory, she thinks and steroid 'Dosepak', she finished steroid 'Dosepak' today, she needed to move it (second dose) ahead a little bit because of the medication. She was seeking for advice. The outcome of event was unknown.  Information on the lot/batch number has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Got some plaques and when they would heal/new ones would come out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. On 11-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced PSORIASIS (Got some plaques and when they would heal/new ones would come out.). At the time of the report, PSORIASIS (Got some plaques and when they would heal/new ones would come out.) had not resolved. No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis.    On 29-May-2021 at 12:40 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that is on an injections for ulcerative colitis. Second dose of vaccine was taken on 29-MAY-2021 at 12:40 and have started with diarrhea a few minutes ago.
Raised red rash on arms, hands, neck, chest, forehead that started about 4 hours after vaccine received. taking benedryl
Patient developed Severe INflammatory response syndrome .  Was hospitalized as her cbc was abnormal and no infection could be found, could not walk or take care of herself
A little sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (A little sore arm after second dose). On 09-Apr-2021, MYALGIA (A little sore arm after second dose) had resolved.            Patient took Skyrizi injection in Feb 2021 (600mg) and May 2021 (300mg) and she was scheduled to have another Skyrizi injection in Sep 2021. Treatment Information was not provided. The patient had a little sore arm which lasted for 2 days.   This case was linked to MOD-2021-307186, MOD-2021-307237 (Patient Link).
tired; Injection site pain/ sore right arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in 2018).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 30 days after receiving Shingrix, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported that he received Shingrix on right arm, intramuscularly about 4-5 weeks ago and he has been extremely tired which started about a month ago. He was also sore for a day or two at the injection site. The patient was over age 60 but refused to provide a date of birth. The reporter consented to follow-up. Call notes stated that can follow-up with the patient.
ADMINSTRATION ERROR, ALREADY RECEIVED FLU VACCINE ON 9/28/2022.