chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excoriations in the injected arm; patient developed rash papular/ rash was similar to a dermatitis; This non-serious case was reported by a physician via call center representative and described the occurrence of excoriation in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan, simvastatin, desvenlafaxine and colecalciferol (Vitamin D3).   In AUG-2019, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced excoriation (Verbatim: excoriations in the injected arm) and papular rash (Verbatim: patient developed rash papular/ rash was similar to a dermatitis). The outcome of the excoriation and papular rash were not reported.   It was unknown if the reporter considered the excoriation and papular rash to be related to Shingrix.     It was unknown if the company considered the excoriation and papular rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR104229   Additional Information: GSK Receipt Date:28-JUL-2023 The physician reported that the patient developed rash papular excoriations in the injected arm (no shingle rash) after getting the first dose of Shingrix on August 2019. The rash was similar to a dermatitis going from the back of the deltoid to the wrist at the time of vaccination. The  patient was under several medications (Statins, Losartan, simvastatin, desvenlafaxine, Vitamin D 3), the same medication that was using during Shingrix administration.  The reporter did not consent to follow up. The Vaccine Administration Facility was the same as Primary Reporter. This case had been linked with US2023AMR104229 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104229:Same patient 2 dose
two days after vaccine and flu shot I started having a mild rash/hives type reaction. It was mostly on my stomach and forearms. It didn't itch and I felt fine. about 5 days after shots I had swelling in my elbows and my upper and lower legs, including my ankles.
3:10pm C/O Dizziness 3:30pm Patient reported feeling better. 182/87, 170/100, HR 82, O2Sat 97.
headache; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 10Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. Therapeutic measures were taken as a result of headache that included Tylenol. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Moderna COVID?19 Vaccine EUA  On the next day:  Fever t=102.5 F,  Severe fatigue,  Nausea, Stomach Pain after taking Tylenol.  Please note that in April 2020 I was sick with Covid-19 for almost 2 weeks. It might be possible that my reaction to the 1st dose is due to the presence of antibodies in my system, i.e. it's very similar to what many people experience after the 2nd dose.
Patient did not necessarily have an adverse event that was measurable but was given the second dose prior to the 2 month interval from the first shot due to using multiple providers.  Patient after getting the dose reported this was second dose when told he would be called to schedule his second dose.
(?) hours, post vax, child had problems with breathing. Problem reported 7 months, post vax. Not seen by PCP for follow-up.
1/2 hour after leaving clinic, left arm started hurting. Went to sleep when arrived home. Woke at approximately 7pm for work and could not move left arm. Went to work where sxs continued to progress. Neck became swollen. After work at 0740 11/4, pt called triage nurse to discuss sxs. Fingers began tingling and pt felt nauseated. Injection site was red and swollen. Could not move arm >4 inches. Triage nurse instructed pt to report to clinic ASAP and to apply cold pack to site. Also encouraged to take APAP for swelling. When arrived at clinic, temp was 99.1 and increased to 100.9 over visit. Given diphenhydramine and APAP. Allergist consulted. Symptoms: 1. Headache, 2. Myalgia, 3. Phlebitis, 4. Fever, 5. NauseaVomiting Suspect Drug # 1 Dosing: Left arm. Treatment Drugs Used: 1 - Acetaminophen Dose: 650 Units: Freq: QID Route: PO, 2 - Diphenhydramine Dose: 25 Units: Freq: QID Route: PO.
Swollen right arm in deltoid area injection site; pain arm, muscle pain in shoulder, girdle; pain middle back area given 7/21/05. Persist up through 7/26/05.
Edema and large indurated area (painful) that began around injection site and over a 1-2 week period moved down to elbow/forearm. Resolved with MEDROL dosepak.
Pt grandmother called to inform us that patient had some bruising at the injection site and some red spots..the red spots then traveled to the stomach area and Dr. advised for pt to take some benadryl and use topical hydrocortisone cream.
body aches; fever of 100.9F; feels beat up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (fever of 100.9F) and FATIGUE (feels beat up) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and ALLOPURINOL (ALOPRINOL) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (body aches), PYREXIA (fever of 100.9F) and FATIGUE (feels beat up). At the time of the report, PAIN (body aches), PYREXIA (fever of 100.9F) and FATIGUE (feels beat up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.9f (Inconclusive) fever of 100.9F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Patient received the vaccine after expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry). On 12-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that vaccine was punctured on 11 May 2021 at 10:30 am and administered on 12 May 2021 at 09:00 am. No adverse event was reported by the patient.
Severe head pain Sore throat  Congestion of sinus, ears, and chest Persistent cough Severe fatigue Inflammation causing more frequent/stronger spasms
Breakthrough COVID infection after Pfizer vaccine.  Patient tested positive via antigen rapid test and PCR 1-hr test on 8/16/2021.  Moderate symptoms of sinus congestion, runny nose, lethargy, loss of taste.
Approximately 2 hours after vaccines were administered, patient was drinking 2 oz Neosure formula. Then while burping patient, mom noted stiffening of upper and lower extremities, with milk coming out of nose and mouth. (+) Facial cyanosis, not breathing. Mom gave CPR.  Patient revived after approximately 5 minutes. 06/06/07-records received for DOS 4/25-4/26/07. DC DX: Premature infant presently at 38 weeks gestational age, premature at 32 1/2 weeks. Acute life threatening event possible from vaccine reaction. Gastroesophageal reflux. Two to three hours after vaccines noted to have stiffening of body specifically upper extremities and lower extremities with milk coming our of nose and mouth. Some facial cyanosis and no respirations. Apnea lasted about 5 minutes.
For a total of 9 days, the patient experienced severe head aches, extreme fatigue, dizziness, stomach pain, and joint pain.  He had to miss more than a week of school.
Not help with Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date, refer case US2023AMR038443).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Not help with Pain).  Rechallenge with Shingles vaccine was positive. The outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038442   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a consumer via interactive digital media. The patient reported that, his/her doctor gave the patient another Shingles vaccine booster (2nd) dose and that did not help with the pain. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038442:Same reporter
Swelling of face, eyes, tongue; tingling hands & scalp; racing/rapid heart beat.  Called family doctors office, explained symptoms and was advised to take a Benadryl and rush to the ER if I started having difficulty breathing.  I took a Benadryl which helped alleviate most symptoms within that day except for the racing heart beat, which continued (and still continues periodically).  I visited my doctor at 2 weeks still w/the racing heartbeat and he confirmed that I was still having a reaction to the TDAP, but that it should resolve itself with time.  He advised that I not agree to another TDAP vaccination.
Nausea and headache that lead to diarrhea and vomitting at 3:30am the morning after receiving the vaccine.
My right eye lid now twitches throughout the day.  It now happens maybe hourly.  It previously used to happen maybe twice a year before the  Covid shot, but  now it is a regular, occurrence.  It is happening as I type this form.
Initially after the vaccination shot Patient had swelling and bruising at the injections sites.  Following days frequent nosebleeds and easy and excessive bruising on the legs.We reported it to the dr however, was informed not to worry about it too much. It has been almost two years since the vaccinations and she still is dealing with the frequent nosebleeds and bruising. Before she was vaccinated for 7years of her lif she did not have problems with  nosebleeds or bruising.
10/13/21 PATIENT SEEN IN THE ER WITH KONWN COVID 19 ILLNESS. REPORTEDLY RECEIVED REGENERON AND DECADRON TREATMENT. PATIENT WITH LOW BP . ADMITTED TO INPATIENT HOSPITAL WITH COVID  19 PNEUMONIA, ACUTE RESP FAILURE DUE TO COVID 19, SPETIC SHOCK, ACUTE KIDNEY INJURY.10/19/21 PATIENT AND FAMILY WOULD LIKE TO NOT HAVE ANY FURTHER INTERVENTION  AND WOULD LIKE TO TRNSITION BACK TO CONSERVATIVE TREATMENT MEASURES.    ANY ADDITIONAL INFORMATION REGARDING THE OUTCOME SHOULD BE DIRECTED TO REHAB FACILITY.    NOTE: NO VACCINE LOT NUMBER WAS ENTERED INTO THE DATABASE. so not able to provide that information .
pt recvd vax & exp mono-like synd including chills, fever, arthralgia, noc sweats & fatigue; pt missed work & had multiple studies to r/o viral, lymphomas etc; all were neg x/sed rate;
Headache, Myalgia, fatigue Narrative: missed 1.5 days f work following second dose
two broken blood vessels in right eye in three week period. Each lasted 8-10 days before resolviving.
03/29 & 30 & 31/2021 @ 17:15- 12:00: sore arm and sore at injection spot.   03/30/2021 @ 18:00-21:00 (until sleep):full body flu like soreness and lethargy. Dizziness, tiredness, cold sweats, mild headache, uncomfortable tightness (otherwise normal) breathing. Back, knee, ankle, hip, finger soreness and tightness.   03/31/2021 @ 06:45- 16:30 (current time) mild soreness of body muscles. Previous symptoms have significantly subsided.
extreme numbness on the left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL0142) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, NDC: unknown , LOT: EL0142 , EXP: unknown), administration date: 20Jan2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days", "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days", "but every bone and everything hurt for two days", "but every bone and everything hurt for two days". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "extreme numbness on the left hand".  Additional Information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: All in left arm. The patient took no other vaccine within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200222075 Same patient/ similar drug, different AE in seperate time gap
Pt was inadvertently given a Menveo vaccine on 8/8/23 after having her required dose on 8/4/23, she was given two full doses of the vaccine  4 days apart.  She was due for her booster dose on 8/4/23 and had that dose, however she received a second dose 4 days later. Pt had previously received a Menactra dose on 2017.
A large red itchy rash has appeared on my left shoulder, the same arm I received the vaccine shot. It's about 3 inches by 2 inches in size.  This started today, 8 days after receiving the vaccination. Otherwise, I feel fine.
Patient reported this morning that she started with a pounding headache, then got severe diarrhea, cold, clammy skin, Then nausea and violent vomiting. She has been having a hard time getting of bed this morning. She had dry heaves this morning also.
No adverse event; 14-APR-2021 received her second dose; This spontaneous report was received from a Nurse Prescriber concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported.  In approximately 2013 (reported as about 8-9 years ago), the patient was vaccinated with the first dose of unidentified Merck hpv vaccine, injection (name and lot number not provided) as prophylaxis (route of administration, site of administration, expiration date were not reported). On 14-APR-2021, she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), injection, 1 dose, lot number R028656, expiration date reported and validated as 27-JUL-2021, as prophylaxis (route and site of administration not provided) (inappropriate schedule of vaccine administered). No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The patient did not report any additional adverse experiences; expired dose of PNEUMOV AX 23 was administered to an adult patient; This spontaneous report was received from a pharmacist via company representative and refers to an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 15-JUL-2021, the patient was vaccinated with single expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, route of administration, anatomical location and lot number were not reported)for prophylaxis (expired product administered). Vaccine expired on 12-JUN-2021.  The patient did not report any additional adverse experiences.
Patient states the following day after she received the two vaccinations (Patient also received shingrix on the other arm), she had redness and warmth 4 inches below injection site (right deltoid). Patient states she did not have any pain. It continued to grow in size the following day. Patient states seeing provider on 10/8/2020 and was diagnosis with cellulitis according to patient. Patient was prescribed cephalexin 500 mg capsules to take 3 times daily for 7 days. Size of area was about 3x2 inches at the time of picking up prescription at 10:10 am.
PT JUST HAD SOME LIGHTHEADNESS AND NAUSEA FOR ABOPUT 1 MINUTE. SHE WAITED FOR 30 MINUTES POSTS VACCINATION  AND FELT FINE
hardness; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (hardness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) in a 51-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INDURATION (hardness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE INDURATION (hardness), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
swelling; lack of sleep following the second vaccine dose; This is a spontaneous report from a daily monitoring. A non-contactable consumer (patient) reported a patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient has been taking a lot of prednisone due to swelling following her second Pfizer COVID-19 vaccine. She also cited a lack of sleep following the second vaccine dose. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I woke up in the morning and experience mild to moderate dizziness, and it was constant.
Alzheimers patient - these were new symptoms that were not there before the vaccination.  woke up and could not keep her balance.  Unable to walk or sit up without assistance.  Unusually unaware of husband or surroundings.  Have not sought medical treatment yet.
Atrial Fibrillation;  This is a solicited report received from contactable reporter(s) (Pharmacist), Program ID: (165487).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 78 years for Covid-19 immunisation; axitinib (INLYTA, NDC: 00069014501), since 26Oct2021 (ongoing) (Lot number: FP9291, Expiration Date: 31Oct2024) at 3 mg 2x/day, oral for renal cancer. The patient's relevant medical history included: "Hypertension" (ongoing). No known drug allergies.  Concomitant medication(s) included: XARELTO; PREDNISONE; HYDRALAZINE; FOLIC ACID; CARVEDILOL; ISOSORBIDE MONONITRATE; OMEPRAZOLE; DILTIAZEM; KEYTRUDA. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, life threatening) with onset 25Jul2022, outcome "unknown". Patient reported Atrial Fibrillation within hours of having his Pfizer booster dose. Hospitalized for cardioversion then released to home. Reported via VAERS.The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High. The action taken for axitinib was dosage not changed. Therapeutic measures were taken as a result of atrial fibrillation.  The reporter's assessment of the causal relationship of "atrial fibrillation" with the suspect product(s) BNT162b2 and axitinib was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, there was not a reasonable possibility that the event Atrial Fibrillation was related to the suspect vaccine (BNT162B29) and the suspect drug axitinib. The event was  more likely consistent with an underlying medical condition.