chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not reported.   Reporter did not allow further contact
Temp of 103-105 orally. "Hurts all over," "trouble keeping fever down" mom states.
inflammatory symptoms; was sick but didn't get tested; This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (inflammatory symptoms) and ILLNESS (was sick but didn't get tested) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 022M20A) for COVID-19 prophylaxis. No medical history was provided by the reporter. Concomitant products included COLECALCIFEROL (VITAMIN D3) and MAGNESIUM for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammatory symptoms) and ILLNESS (was sick but didn't get tested). At the time of the report, INFLAMMATION (inflammatory symptoms) and ILLNESS (was sick but didn't get tested) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient might had COVID in September/August 2021 but did not get tested. No treatment information was provided by the reporter. Concomitant product vitamin D3 was administered in winter.   This case was linked to MOD-2022-640775 (Patient Link).
Shooting pain in/ around heart for 3 hours. It started about 2 hours after the shot. Sharp shooting pain that was much worse on deep inhales and when stretching chest open.
Patient received the vaccine on August 24 at approximately 4 PM.  On the evening of August 26 patient developed facial and upper body hives and itching.
Severe Myalgia causing difficulty in walking; Severe Myalgia causing difficulty in walking; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of GAIT DISTURBANCE (Severe Myalgia causing difficulty in walking) and MYALGIA (Severe Myalgia causing difficulty in walking) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Severe Myalgia causing difficulty in walking) and MYALGIA (Severe Myalgia causing difficulty in walking). At the time of the report, GAIT DISTURBANCE (Severe Myalgia causing difficulty in walking) and MYALGIA (Severe Myalgia causing difficulty in walking) 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 was not provided. Treatment information was not provided.
Initially sore (L) arm, proceeded to extreme arthralgia, fever, chills, GI distress, dizzy, extreme muscle weakness making it difficult to walk or turn over in bed. Legs were so weak I couldn't stand up once sitting without help. No resp. distress. Legs still weak, wobbly 3 days later. 7 days later still some achiness in legs, muscles. Intermittent fever.
cold-like symptoms; runny nose; body aches/pains; sinus drainage; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), MYALGIA (body aches/pains), SINUS DISORDER (sinus drainage) and OROPHARYNGEAL PAIN (sore throat) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 078C21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), MYALGIA (body aches/pains), SINUS DISORDER (sinus drainage) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), MYALGIA (body aches/pains), SINUS DISORDER (sinus drainage) and OROPHARYNGEAL PAIN (sore throat) 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.   This case was linked to MOD-2021-261589 (Patient Link).
Sore arm, hot to the touch, aches and pains shooting to her back. No temperature and diarrhea.
"FELT COLD"; EARACHE; FATIGUE; ARM PAIN; SWOLLEN LEFT AXILLARY  Narrative:   Other Relevant History:
Patient woke up more disoriented than usual, dizzy, short of breath, chills, headache, congestion, and blurred vision.  She was taken to the ER, but refused a CT scan. She was given a saline bolus.  As of 03/19/21 her vision is still blurred and she is more disoriented than her baseline.
The next day after receiving the vaccine, at 9:15 am her hand became numb and she was unable to control or move it.  She could not grip the steering wheel or hold anything.  She shook her hand and it returned to normal.  At 10:15 itjhappened again.  It happened a few more time while at work.  She also had a few epidsodes in which her jaw became slack and off to the side and she had to close her mouth with her hand, because she could not control her jaw.  The episodes lasted about 10 seconds and then they would disappear.  She reported her symptoms to the us at about 12:30 PM, 2/23/2021.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 78-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Numbness on toes and legs; Fever; The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on toes and legs) and PYREXIA (Fever). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (The patient developed chronic inflammatory demilating polyneuropathy CIDP 3 days after receiving second dose of the vaccine on 16Apr2021) and PYREXIA (Fever) outcome was unknown and HYPOAESTHESIA (Numbness on toes and legs) had not resolved.            Caller also mentioned that her son has numbness still after 8 weeks and also specified as numbness went away with steroid medication and reappeared after completing the dose.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company comment: 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.; Sender'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
my tongue has swollen; small red sores on the sides and underneath my tongue; small red sores on the sides and underneath my tongue; bitten my tongue in 2 places which are now white; bitten my tongue in 2 places which are now white; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, Expiry date: unknown, age at vaccination: 62-year-old), via an unspecified route of administration in Arm Right on 26Jan2021 08:00 AM as dose 2, single for covid-19 immunisation administered at hospital. Medical history included hypertension, type 2 diabetes mellitus, asthma and seasonal pollen allergy. Previously the patient received first dose of bnt162b2 (Lot number EJ1686), in Arm left on 07Jan2021 07:15 AM for covid-19 immunization. Concomitant medications included terazosin hydrochloride (HYTRIN), metformin and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient was not tested positive for Covid-19. On 01Feb2021, the patient reported, he had his tongue swollen and had small red sores on the sides and underneath his tongue and because of the swelling he had bitten his tongue in 2 places which are now white. No corrective treatment was taken. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Had received a flu shot and 24 hour later the area around the site was red, hard, warm and very sore. It kept getting larger and pretty much involved the whole upper arm. There was a small blister in the center of reddened area.
Started menstrual cycle 6 days early; Its been 11 days and im still menstruating; This is a spontaneous report from a Non-contactable consumer(herself). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0191 and expiration date), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on an unspecified date. The patient experienced started menstrual cycle 6 days early its been 11 days and I am still menstruating. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt in MD office 16NOV93 for breathing problems; immun. given; 1142AM pt shaking, screaming & jerk (arm/leg); screamed in pain/fear PM of 16NOV03; seen in ER; dx pertussis react;
Area was red and warm to touch. Size: 7.0cm. round.  Patient was vomiting the night of the injection. Was given Benadryl allergy 25mg po Q 6 hours as needed.
The next day, my arm got swollen up and was hot and itchy.  I had a low-grade fever. I had a dry cough.  I could not breathe a little bit.  These symptoms lasted about a week.   I contacted the pharmacist and they told me to take Benadryl and Tylenol.  I went doctor about my cough.  They did a chest x-ray, normal result.
WITHIN 3 HOURS OF RECEIVING THE VACCINE, THE PATIENT DEVELOPED A LOCALIZED ITCHY RASH AND SWELLING JUST BELOW THE INJECTION SITE ON HER ARM.  NEITHER THE ITCH NOR THE SWELLING SPREAD BEYOND THE UPPER ARM.  EACH SYMPTOM LASTED ABOUT 2 DAYS.  OBTAINED SOME RELIEF BY ICYING THE AREA AFFECTED.  PATIENT STATES THAT SHE HAS NEVER HAD THIS FOLLOWING A FLU VACCINE.
This spontaneous report as received from a healthcare worker refers to an 18 year old patient of unknown gender. On 06-JUN-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Started with a headache and fever for 3 days. Throwing up blood. Has open sores in the back of her cheek and throat. Sent pictures to her rheumatologist and she stated that she is having a bad reaction to the vaccine. Have an appt in a few days.
Syncope the evening of 4/12, witnessed by family. Woke up sweaty, chills and disoriented. Within 30 minutes overall felt much better. Residual symptoms the following day - chest tightness, anxious, fatigue.
This spontaneous report was received from a pharmacist via a field representative, concerning an adult female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On approximately 11-AUG-2017 (reported as "6-8 weeks ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, an anatomical location were not provided), for prophylaxis (reported as "vaccination"); and developed diffuse redness at the injection site, an inch to an inch and a half in diameter, and there the skin was elevated. No treatment was given for the events and it was unknown if laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. The outcome of the injection site erythema and the skin disorder was unknown. The causal relationship between the injection site erythema and the skin disorder with ZOSTAVAX was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1710USA013257.
vaccinated while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccinated while pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 30-Mar-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccinated while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccinated while pregnant) had resolved.        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.   Patient reported no medical history No treatment was reported  The patient was 36 weeks pregnant.
This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unkonwn age and gender. On an unspecified date the multiple unspecified patients were administered GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports feeling dizzy, lightheaded, passed out 3 times, clammy, anxious.  EMS assessed patient, BP:84/63, pulse 41, spo2 97-99%, BS 154, second set of v/s; BP: 99/66, pulse: 52, third set of v/s; BP: 105/68, pulse: 63-75. Patient reports he has  history of passing out with needles , he reports feeling better, symptoms improved,  refused transport to ER, he was cleared by EMS.
pruritis and urticarial rash immediately post vaccine administration; EPiPen 0.3mg IM & Benadryl 25mg PO administer, symptoms resolved
Blood pressure going as high as 206/128.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 09Feb2021 08:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medications included losartan, loratadine (LORTAB), piroxicam (FELDENE), fluoxetine hydrochloride (PROZAC), simvastatin (ZOCOR), budesonide (ENTOCORT) all are taken for an unspecified indication, start and stop date were not reported. It was reported that blood pressure going as high as 206/128 12Feb2021 23:30pm. Even taking blood pressure medication lotrel it's only going to 138/80 at the lowest. Usually runs 95/60 to 105/75. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Mild pain on the injection area; Mild headache; Some fever over night; Just tired; Muscle aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Mild pain on the injection area), headache (Verbatim: Mild headache), fever (Verbatim: Some fever over night), tiredness (Verbatim: Just tired) and muscle pain (Verbatim: Muscle aches). The outcome of the injection site pain, headache, fever, tiredness and muscle pain were not reported.   It was unknown if the reporter considered the injection site pain, headache, fever, tiredness and muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, headache, fever, tiredness and muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by the patient via interactive digital media. The received 1st shot out of two shot and experienced pain on the injection area, some fever overnight and mild headache on the first night. On the second day the patient was just tired and had some muscle aches but well worth it. The patient had seen his/ her loved one who have not had the shots and got shingles, which was very painful and lasted about two weeks. The patient did not want to experience that condition The follow-up could not be possible as no contact details were available.