chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on 03May2021(at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021(at the age of 56-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 03May2021, the patient experienced a little numbness on the left side of her jaw and tongue. It was unknown whether any therapeutic measures were taken as a result of the adverse event. It was unknown whether the patient had been tested for COVID-19, since the vaccination. The clinical outcome of the event little numbness on the left side of her jaw and tongue was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 5/5/00, right arm started swelling, pt had myalgia, fever, and chills. On 5/6/00, pt developed high fever, large red firm area on right arm, chills, and vomiting. Pt was admitted to hospital and given Ancef and IV fluids for right arm cellulitis. Follow-up reports that the child is still having problems with swollen arm, soreness, diarrhea (due to massive doses of antibotics). The diagnosis is a severe allergic reaction and cellulitis.
fever; sore throat; stomach ache; sick to the stomach; chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, sore throat, stomach pain, upset stomach and chills. On an unknown date, the outcome of the fever, sore throat, stomach pain, upset stomach and chills were unknown.   It was unknown if the reporter considered the fever, sore throat, stomach pain, upset stomach and chills to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reporting a patient reported to him that the patient experienced fever, sore throat, stomach ache, being sick to the stomach and chills after receiving a dose of Shingrix. The reporter consented to follow up.
adverse reaction; 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 VACCINATION COMPLICATION (adverse reaction) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        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.   Concomitant medication information not provided.  Treatment information not provided.
Onset: 12 hours after vaccine  Symptoms: Nausea, chills, fever, headache  Treated with naproxen Duration: 36 hours
HA, chills, fever, nausea, vomiting, fatigue, inability to eat, diarrhea, muscle aches
Swollen and painful axillary lymph nodes in the arm of the vaccine administration. Worst day after vaccination progressively improving over 5 days.
injection site pain in shoulder right hand is getting painful and stiff, feels numb hard to open fingers and grip
Pt has extensive small cell lung cancer stage IV with metastasis and came to the hospital for shortness of breath.  The pt started cycle 4 of her aggressive chemo on 1/19.
This spontaneous report was received from a medical assistant referring to a 5 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 27-MAR-2018, the patient was administered an improperly stored VARIVAX (lot reported as: N022978; Expiry date: 23-AUG-2019) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 15 °F to 46°F (32.2°F) for 9 hours and 27 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several cases received from the same reporter.
Wrong Vaccination was give.  My son was given the HPV vaccine which is for women 18-26 years old.  So far just normal post vaccine responses.  Some blotching of skin, fever, and vomiting.  Pediatric office contacted me on March 8th to report the wrong vaccination administration
The following morning around 7:30am, these symptoms occurred after both doses (1st dose was 1/15 at 4:30pm at same location): pounding in ears, blurred vision, and feeling like I would pass out. This happened any time I tried to sit up, for the first two hours of the day. Went away after that, but still occasionally would get pounding in ears for the next 24 hours.
Patient not talking, Chills, trembling hands and upper body,   eyes staring upward,  fever up to 101,  fever decreased to normal in one hour after giving 325 gr. Tylenol
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: patient reported redness in her eyes, and went to urgent care and noted inflammation and prescribed steriod eye drop for redness which helped with redness.
Hives on back. Began to itch in evening after vaccine. Large hives developed and continue to persist
Had onset of itchy rash at the site and just below it on the left arm, improves with Benadryl, worsens with friction or heat. Otherwise well, no fever, no pain at the site, no sign of cellulitis, no systemic allergic symptoms.
This spontaneous report as received from a pharmacist refers to a 56 year old female patient with allergy to erythromycin, allergy to penicillin, rheumatoid arthritis. The pharmacist stated that she was unsure if the patient had ever received a dose of M-M-R II prior tot he dose she received on 01-OCT-2014. On 01-OCT-2014 the patient was vaccinated with M-M-R II serum albumin (HSA) (lot # J013069, expiration date 16-OCT-2014, 0.5 ml, subcutaneously) due to having serology testing dose on an unspecified date that showed that the patient was immune to mumps and measles but not to rubella. Concomitant therapies included prednisone (manufacturer unknown), methotrexate (manufacturer unknown), hydroxychloroquine sulfate, metoprolol (also reported as TOPROLOL), aspirin (also reported as baby aspirin) and atorvastatin. On 20-OCT-2014 the patient developed unspecified itchy rash on her arms, face, neck and trunk as well as unspecified joint pain and fever. There was no lab diagnostic studies performed. The physician informed that as a treatment the patient took unspecified non-steroidal anti-inflammatory drugs (NSAID's) and antihistamines as needed on 25-OCT-2014. The pharmacist reported that the rash was almost gone since an unspecified date, the outcomes of the events were also reported as recovering. The patient sought medical attention and was seen by the physician on 25-OCT-2014. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
Made arm red; arm hurt; head hurt; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema of extremities, pain in arm and headache. On an unknown date, the outcome of the erythema of extremities, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: The case  was received from the patient via interactive digital media. The reporter stated that there was an injection for this problem and they just gave it to me.  The reporter stated that strong it made his/her arm red and hurt for 4 days, more apart for 2 days head hurt but the physician told him/her that it was worth it because the pain of the injection was nothing compared to the pain of the sores that came out of the shingles so that's his/her story. The injection was called zoster.
This is a spontaneous report as received from a Registered Nurse. The nurse reported that unspecified patients were vaccinated on unspecified dates with improperly stored doses of M-M-R II lot number L026551, expiration 16-JUL-2017; VARIVAX lot # L042267, expiration 27-OCT-2017 (MARRS# 1607USA004854) and PROQUAD lot number L9465057 expiration 17-MAY-2017 (MARRS# 1607USA-011587). No adverse effect reported. No further information received. Lot number L9465057 is an invalid lot number for PROQUAD. This is one of several reports from same reporter. Additional information has been requested.
Came to ER c/o diffuse abdominal pain.  Dx with UTI three days prior.
The same day of vaccination 1. Trembling in the hands 2. Lack of Coordination 3. Patient had no grip 4. Numbness in hands and head  From 3 to 4 weeks after being vaccinated patient had a stroke for which he was hospitalized 45 days
patient with airway allergic reaction requiring admin. of pediatric epi pen and call to 911.  patient recovered quickly after epinephrine administered.  911  team arrived and continued to monitor patient.  patient also received  flucelvax vaccine at the same visit.
Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer.
Sore arm; Mildly swollen arm; Weakness; Tiredness; Nausea; Vomiting; SOB; Cough; This is a spontaneous report from a contactable healthcare professional, the patient. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 24Aug2021 at 17:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient was pregnant at the time of vaccination. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Aug2021 at 21:30, the patient experienced sore arm, mildly swollen arm, weakness, tiredness, nausea, vomiting, shortness of breath (SOB) and cough. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, mildly swollen arm, weakness, tiredness, nausea, vomiting, shortness of breath and cough were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
HE SAID THAT 30 SECONDS AFTER THE SHOT HE FELT REALLY BAD.   HE SPENT 1 HOUR SITTING IN HIS CAR IN THE PARKING LOT AND 1/2 HOUR IN TOWN.  HE SAID HIS EYES FELT FUNNY.  HE INSISTED THAT THIS BE REPORTED.
On 9/27 evening had chest pain though they were normal. On 9/28 mid morning more chest pain. Talked to Dr and we agreed to monitor at home. Elevated HR as well with SOB. It start to improve each day. On 9/30 went for bike ride (normal exercise) and start to have chest pains that were worst. Each day they were getting worst. Went to see  PCP on 10/4 as chest felt like muscle strain and the boarder of the heart.  Lab, EKG and echo was ordered. Heart rate was 150s at times while walking and SOB due to elevated heart rate. Started Lasix and taking Motrin regularly. As days when on chest pain, dizziness, and nausea happened. On 10/11 woke up and all symptoms resolved.
Same day of vaccination at 4:30 pm had burning of neck and spine that didn't last very long. At 8:00 pm that night she had chills. On the same dat at 8:00 pm she had chills. On 1/22/21 at 3:00 shew had a rash and tongue swelling. At 4:00  pm on 1/22/21 she starting having vomiting that lasted until 7:00 pm. In addition, she had a fever of 103 degrees, vertigo, pain throughout her body, weakness, headache, and swelling of her lymph nodes.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (all the side effects), MOTION SICKNESS (Motion sickness), VERTIGO (Vertigo), EYE PAIN (Eyes hurt) and DIZZINESS (Felt dizzy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vestibular nerve damage (vestibular nerve damage in the ears) since an unknown date. Previously administered products included for Product used for unknown indication: Levaquin. Past adverse reactions to the above products included Tremor with Levaquin. Concurrent medical conditions included Vertigo (Patient states that Vertigo attacks are on/off prior to Moderna vaccine doses) and Hypothyroidism (No recent change.). Concomitant products included LEVOTHYROXINE, FISH OIL, CENTRUM SILVER +50, D-MANNOSE, VACCINIUM MACROCARPON (CRANBERRY D) and VITAMIN D3 for an unknown indication.   On 01-Apr-2021 at 10:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021 at 10:12 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION COMPLICATION (all the side effects), MOTION SICKNESS (Motion sickness), EYE PAIN (Eyes hurt), NECK PAIN (pain in neck), RASH (rash in the right arm), ARTHRALGIA (Pain in shoulder), NAUSEA (Slight nausea) and HEADACHE (Bad headache, pain in back of the head,). On 03-May-2021, the patient experienced VERTIGO (Vertigo). On 04-May-2021, the patient experienced DIZZINESS (Felt dizzy) and FATIGUE (tired). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), MYALGIA (Muscle ache), CHILLS (chills) and PYREXIA (fever). The patient was treated with MECLOZINE HYDROCHLORIDE (BONINE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 01-May-2021, VACCINATION COMPLICATION (all the side effects), MOTION SICKNESS (Motion sickness), EYE PAIN (Eyes hurt), NECK PAIN (pain in neck), HYPERHIDROSIS (Sweating), RASH (rash in the right arm), ARTHRALGIA (Pain in shoulder), NAUSEA (Slight nausea), HEADACHE (Bad headache, pain in back of the head,), MYALGIA (Muscle ache), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Felt dizzy) and FATIGUE (tired) had resolved.            Treatment drug included Tylenol. Patient experienced side effects from Cipro (Nausea) and no allergic reaction.   This case was linked to US-MODERNATX, INC.-MOD-2021-103068 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Concomitant medications updated. Outcome of events updated. Stop date of events updated. Events updated. Patient details are updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103068:First Dose Case
Sweating profusely, nauseous, Back and side pain, shaking, shortness of breath
CoughWheeze, Syncope, erratic atrial fibrillation, cough, shortness of breath, fluid build up, chest pressure Narrative:
Received Moderna vaccine and pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna vaccine and pregnant) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna vaccine and pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received Moderna vaccine and pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
No additional AEs or PQC reported; reported expired dose of V ARlV AX administered; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concurrent conditions were not reported.  On 15-MAR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002846 and expiration date 23-JAN-2022, 0.5 milliliter subcutaneously for prophylaxis. No additional events were reported.
c/o increased HR & B/P, facial flushing and chest "discomfort" off and on from 1/9/10 through 1/19/10
Elevated resting heart rate. Average  BPM 105 for about 24 hours.  Resting heart rate is normally in 68-73 range.  Fluttering heart feeling. Irregular bear feeling for about 24 hours.
Left arm began to swell and redness at the injection site.  Increased the next day of 4-5 inches of swelling with borders, all upper arm is swollen with redness and very warm to touch.  Complaining of some pain in shoulder and left thumb from swelling.
75 minutes post vax on 12/21/99, the pt/surgeon was in the middle of an operation when he suddenly experienced diffuse arthralgias throughout his body. Three minutes later, he experienced rigors. The adverse reaction was severe enough that the surgeon had to step away from the operation that he was performing. The rigors spontaneously resolved after a duration of two minutes, and the pt could then continue the operation. The arthralgias resolved after approximately one hour.  The most recent information received on 1/5/00 reports the condition of the pt is resolved.
Sunday evening, exactly one week post vaccination,  I noticed that my shoulder at the injection site was itching. When I reached to scratch it I noticed that I had a raised bump that was hard to the touch and warm. There is a slight reddish/brownish discoloration of the skin over the knot. It is not painful and I have no corresponding muscle pain/discomfort. As I type this 10 1/2 hours after noticing the knot initially, the itching has lessened and the knot seems to be dissipating.
Pt. vomited rotavirus vaccine immediately after administration in mouth. Pt. con't to vomit after 2 additional attempts to administer. Pt. wasn't able to even swallow any of the vaccine. Pt. was well at the time of admin.
pt recvd vax & had local rxn & pain; c/o of redness; inject site hard; hot/ cold chills; blurred vision; c/o nausea; diarrhea; ache all over;
body aches; fever; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced general body pain and fever. On an unknown date, the outcome of the pain in arm, general body pain and fever were recovered/resolved.   The reporter considered the pain in arm, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister. The patient experienced arm pain the day of the injection that got worse over the next few days and then resolved. On an unknown date less than a year after receiving a dose of Shingrix, the patient also noted extreme body aches all over that last a few days and resolved. The patient also had fever that resolved. This was 2 of 3 cases reported by same reporter. There is a discrepancy with respect to the outcome of the events redness, arm pain, arm pain and Fever outcome is reported as recovered. the outcome reported in the source document was recovered with sequel.  The outcome for all the events retains as per the structural field.
myocarditis documented by laboratory (elevated troponins,) abnormal ECG, abnormal echocardiogram. treated with anti-inflammatories , beta blocker, colchicine .  presented with chest pain . angina , diaphoresis, decreased heart function .
experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.) and COVID-19 (COVID-19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 012F21A, 030M20A and 038A21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: EMPAGLIFLOZIN (25 mg), ASCORBIC ACID 2-O-GLUCOSIDE (10 mg 4 tables a day) and ALOGLIPTIN (12.5 mg.). Past adverse reactions to the above products included No adverse event with ALOGLIPTIN, ASCORBIC ACID 2-O-GLUCOSIDE and EMPAGLIFLOZIN. Concurrent medical conditions included Type 2 diabetes mellitus.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (COVID-19). On 02-Jun-2022, the patient experienced VACCINATION SITE PAIN (experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.) had not resolved and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.  On 27 Oct 2022, the patient took MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with batch number 021H02N  as a dose 5 and did not experience any adverse event.