chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; feeling dizzy; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient had large golf ball or softball sized welt, hot to touch, swollen, at the injection site, drunk and dizzy feeling, after vaccinated with Fluarix Quadrivalent 2019-2020 season. This case linked with US2019AMR181651, US2019AMR181432 and US2019AMR181650, reported by same reporter.
Became cold and clammy, tingly hands - presyncopal.  Was given Decadron and Zantac IV and prescribed oral prednisone and Zantac.
Patient with mild shortness of breath for the past month. Travel a week ago. Received vaccine 03/29/21. Admitted on 04/11/21 for increased shortness of breath. CT angio showed extensive segmental pulmonary embolii. Patient doing well and discharged to home on 04/12/21 after being placed on Lovenox then transitioned to Eliquis.
The patient did not have an adverse event, however, the patient was not 18 years of age when the dose was administered. Moderna has not yet been approved for patients under 18.
This case was reported by a consumer via call center representative and described the occurrence of tingling in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Embrel). On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In September 2018, less than a year after receiving SHINGRIX, the patient experienced tingling (serious criteria hospitalization). On 27th September 2018, the patient experienced tingling lips. On an unknown date, the outcome of the tingling and tingling lips were not recovered/not resolved. It was unknown if the reporter considered the tingling and tingling lips to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she went to the emergency room on 18th September 2018 because she was having tingling in her left arm and left leg. The patient was admitted to the hospital and stayed for three days. All tests were negative and she was discharged. The patient indicated that the reaction was worsening and the tingling involved both arms and her face.  On 27th September 2018, 73 days after receiving vaccination, also, stated that she started experiencing tingling in her lips and nose. The reporter did not know if these symptoms were related to the SHINGRIX. The reporter seemed somewhat confused and phone and had difficulty recalling dates and when symptoms occurred.  The reporter was unable to provide the location where the vaccination was administered on her body.
PATIENT RECEIVED MODERNA VACCINE ON 1/20/21 DOSE #2. PATIENT REPORTS VULVA LESIONS 3 DAYS AFTER RECEIVING VACCINE. PATIENT STATED SHE HAD TO RECEIVE MEDICAL TREATMENT FOR LESIONS. PATIENT THEN CONTRACTED COVID LAST MONTH HAD A REOCCURANCE OF THE LESIONS. PATIENT STATED SHE AND HER PROVIDER FELT LIKE THESE LESIONS WERE RELATED TO THE VACCINE. PATIENT STATED SHE HAD NEVER HAD THE LESIONS PRIOR TO GETTING THE 2ND DOSE OF THE COVID VACCINE.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Information has been received from a health care professional concerning a 7 day old female pt, who on 2/28/2000, was vaccinated with the first dose of Hepatitis-B vaccine recombinant (yeast). On 3/3/2000, the child expired. The cause of death was unknown. The medical examiner did determine that no congenital anomaly was determined. Follow-up information received from a registered nurse indicated that the suspected cause was sudden infant death syndrome, although the final autopsy results were not available, there were no gross anatomical abnormalities. The nurse stated that
This spontaneous report as received from a pharmacist refers to a 29 year old female patient. The patient's concurrent condition included asthma. The patient had no drug reactions or allergies. On an unspecified date in October 2016, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscular injection (dose, lot number and expiration date were not provided), due to increased risk of pneumoccocal disease due to asthma, and with a dose of an unspecified Flu vaccine (dose, route of administration and anatomical location were not provided). The patient did not take any concomitant medication. On an unknown date, the patient experienced redness, swelling, and soreness from the shoulder to the elbow, and soreness in the breast. The reporter could not verify whether either of the vaccines had been administered in the affected arm.. It was unknown by the reporter, whether any lab diagnostics studies have been performed. It was unknown if the patient received any treatment. The outcome of breast pain, pain in extremity, swelling and erythema was unknown. The relatedness between the supspect therapies and the events was not reported. No product quality complaint was involved.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA006102: US-009507513-1702USA005964: US-009507513-1702USA006265:
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 026A21A and 041J21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (heart problems).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. It was reported that patient did not had any allergies or prior COVID-19 diagnosis.   This case was linked to MOD-2022-507166, MOD-2022-507717, MOD-2022-507713, MOD-2022-507719 (Patient Link).
Rash on few fingers look like psoriatic but it selected not the knuckles but between dip and pip joints where their is hair.; Rash on few fingers look like psoriatic but it selected not the knuckles but between dip and pip joints where their is hair.; Rough skin and you could feel lampiness under the rash; skin is red and looks like increased melanocytes; skin is red and looks like increased melanocytes; This is a spontaneous report from a contactable physician (patient). A 64-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number:  ELO140, Expiration date; unknown), via an intramuscular route of administration, in Arm Left on 31Dec2020 08:00 as Unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not have covid prior to vaccination. On 08Jan2021, the patient experienced rash on few fingers look like psoriatic but it selected not the knuckles but between dip and pip joints where there was hair. Rough skin and they could feel lumpiness under the rash. Hair got destroyed above skin used steroids. Improved. But still skin was red and looked like increased melanocytes. don't know if it was TH1 immune response. adverse event resulted in patient visited Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included metamyelocyte count: increased on skin is red and looks like increased melanocytes, sars-cov-2 antibody test: negative on 24Dec2020. Therapeutic measures were taken as a result of events. Patient was treated with high potency steroid creams for the events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Fatigue, soreness in shoulder,  body ache;  Tylenol and sleep for about 24 hours.
Fever, body aches - visit to urgent care next day from onset.  Stepdad positive test day before
Pt felt dizzy after vaccine. Denies any chest pain, SOB, nausea or vomiting. At this time patient feels better and does not want to go to hospital blood pressure 160/93, 98,16 150/88,84,18
On Thursday, December 16, 2021 I went to a local pharmacy (PRIVACY) for a scheduled vaccination appointment. The pharmacist was supposed to administer a COVID-19 Pfizer booster shot and a routine flu shot. Instead, the pharmacist mistakenly administered two Pfizer booster shots (two separate injections - one in the right arm, one in the left arm) around 12:15PM. Following this mistake I went to the local health center at PRIVACY where I reported the incident to my doctor around 3:00PM on December 16. At their direction I began taking Tylenol every 4-6 hours to mitigate side effects.  Beginning the afternoon of December 16 and persisting through the night of December 17, I experienced a fever, fatigue, headache, nausea, and vomiting. I also experienced symptoms of dehydration as I was not able to hold down water without vomiting. While the vomiting  subsided the night of December 17, I continued to experience fatigue, nausea, and headache through December 18.  Pharmacy has not notified me of any potential long-term adverse effects to my health as a result of this incident.
Pt arrives to ED and admitted on 07/30/2021. His c/o were increased sob, cough, and fever r/t covid-19 dx a week ago. Pt reports sore throat and generalized fatique. On going fevers and chills at home. Pt is tested as positive for COVID.   Pt discharged on 08/04/2021 in stable condition and on home oxygen 2-3 liters.
-Rash on throat similar in appearance as rash known as "covid arm"; no treatment; resolved in 2 weeks -Pain at injection site; no treatment; resolved in 3 days
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medical history and no drug reactions/allergies. On 22-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # H020846, exp 20-FEB-2014) subcutaneously. There was no concomitant medication. The pharmacist reported that a patient experienced an injection site reaction following vaccination with ZOSTAVAX. The pharmacist described the injection site reaction that started the day after vaccination with ZOSTAVAX on 23-APR-2013, as a swollen, itchy, red area at the injection site. The pharmacist reported that the original injection site reaction improved (time frame of improvement unspecified), but there was still a discolored area at the injection site, described as looking like a bruise, but did not hurt or itch. The patient contacted pharmacist for medical attention. No treatment was given for the events. No lab diagnostics studies were performed. This is one of several reports from the same source. Additional information has been requested.
Dizziness and vertigo started about 10days-2weeks after shot- ongoing.  being treated supportively
Pt recvd vax & approx 30 mins following the vax exp a severe h/a;
Initial swelling and soreness right after injection.  Swelling and pain continued for the next few days, Motrin 800mg and Benadryl 25mg  at bedtime were taken.  Swelling and pain persisted.  Area became hard, red, itchy and raised over the holiday.  Swelling, redness and itchiness became worse over the weeknd into Monday. I was unable to lift my arm, bring it behind my back or reach.  It was very painful and hot.   I then contacted employee health.  They did not feel it was infected but was the delayed reaction to the moderna vaccine.  I did not feel comfortable with this and I then contacted my physician who looked at it and felt it was in fact cellulitis, I was sent for a ultrasound to rule out a blood clot and labs and an IV infusion of Rocephin as well as oral antibiotics.  I received my first infusion yesterday.  The swelling has improved greatly, however the redness has spread beyond the marked area on my arm and I will be receiving another dose of IV Rocephin today.  My labs showed my CRP was elevated  and my ALT/AST were elevated as well.
This spontaneous report was received from a nurse and refers to a 3 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
This case was reported by a health professional in the United States on 27 August 2007. A four-year-old male patient with no medical history received the following vaccinations on 17 August 2007: DAPTACEL (lot number C2651AA) in the left deltoid, IPOL (lot number Z08722) in the left deltoid, and MMR (Merck, lot number 0424U) in the right outer aspect of arm. On 18 August 2007, the entire outer portion of the patient's left upper arm became swollen, hot, red and tender. He presented to the emergency room and was diagnosed with cellulitis. Treatment was unknown, the event subsequently recovered. A corrective version has been created using the latest receipt date in order to update the seriousness criteria. The previous version had "Other - medically significant" as seriousness criteria, however the event is non-serious and criteria was entered in error. Follow-up information received on 13 November 2007 from a health care professional. Relevant diagnostic testing was none. The patient was not seen in the office for follow-up. The patient was treated with BACTRIM. The patient recovered from the event.
COVID-19 pneumonia; COVID-19 pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4188611-00.  A 40-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Route of Admin: 1)Intra-muscular), administration date: 05May2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose, Route of Admin: 1)Intra-muscular), administration date: 04Nov2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "recovering" and all described as "COVID-19 pneumonia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: In 2021, the patient experienced Covid Pneumonia. The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter Causality for humira (adalimumab): for the event(s) of covid pneumonia was not reported. The reporter Causality for Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): for the event covid-19 pneumonia was not related. The event abate after stopping drug was: NA  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and known drug safety profile  the event of Drug ineffective , COVID-19 pneumonia was assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association.
The entire circumference of the arm where shot was given was red, very large, down to the elbow.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 26-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  HCP reported that the facility where she works, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9(-18.9) Fahrenheit degrees.  The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute.  The vials were stored frozen.  Visual inspection did not note any vaccine state change.  Treatment information was not provided.   This case was linked to MOD-2022-591989 (Patient Link).
pt recv vax 22MAY95 & 11APR96 pt exp a rash which was reportedly not chicken pox & not d/t the varicella vax;
Adverse Reaction Notes 1205 itchiness and rash light red to arms and back. Reports allergy to shrimp. 2 nd vaccine . No SOB. BP 155/90, resp 18, Sats 98, HR 78. 1208 Educated on the side effects of Benadryl and rational.verbalized understanding and to the administration. 50 mg right deltoid administered by Paramedic 1223 rash and itchiness improved. Educated on S/S to seek immediate care for and to continue taking Benadryl 25 mg every 6 hours for the next 24 hours. Left ambulating accompanied by friend who's driving. All information translated by portegues speaking staff
lost his sense of taste; cannot feel anything in his mouth; lost his sense of taste and smell; runny nose; fever; headache; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 37-year-old male patient reported that they received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9269), via unspecified route of administration in right arm on 05Feb2021 14:25 (at the age of 37 years) as a DOSE 1, SINGLE for COVID-19 immunization. Patient had no medical history and had not received concomitant medications (Other Products). Patient was not administered with any other additional Vaccines on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that he had a very slight headache on 10Feb2021 that was no big deal. Patient stated that he received the Pfizer vaccine 10 days ago, on Friday before, then six days later on 11Feb2021 he had a fever which he knew was a side effect of the vaccine. The day before the fever was very brief, maybe two hours in the night. Then a couple of days later on 13Feb2021 he had a runny nose. It was a crazy runny nose, he had to breathe out of his mouth and was using lots of paper. On 14Feb2021 patient woke up and lost his sense of smell and on 15Feb2021 lost his sense of taste and he cannot feel anything in his mouth. He wanted to know if these are reported adverse events (AEs) associated with the vaccine. Then he noticed he could not smell anything. He put perfume up to his nose and could smell nothing. He thought maybe he lost his sense of smell due to the runny nose but the next day on 15Feb2021 he lost his sense of taste and he was concerned about that and was querying were these all are part of the side effects of the vaccine or something else and queried for was that the vaccine working on him. Patient reported that his wife cooks and puts in lots of flavors but he can smell or taste nothing, perfume nothing. He can't smell or taste cheese or ham. He doesn't taste or smell coffee. He can only tell hot or cold. He was scheduled to receive the second dose of the vaccine on 26Feb2021. Patient had not attended any physician or emergency room (ER) visit for the experienced events. Outcome of event headache was recovered on 10Feb2021, fever was recovered on 11Feb2021, runny nose recovered on 14Feb2021, lost his sense of taste and smell was not recovered, cannot feel anything in his mouth was unknown.   Follow-up attempts completed. No further information expected.
Information has been received from a Certified Medical Assitant refferring to a 74 year old female patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was inadvertenly administrated a second dose of PREVNAR 13 (route of admistration, lot number, expiration date, dose, dosage and anatomical location were unknown) instead of an intended dose of PNEUMOVAX23 for prophylaxis (route of administration, lot number, expiration date, dose, dosage and anatomical location were unknown). The reporter stated that this occurred by mistake and it was not confimed if the event ocurred due to product confusion.  Addittionally, there were no adverse effects reported. There was not Product Quality Complaint involved. Additional information has been requested.