chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of vaccination error in a 8-year-old male subject who was vaccinated with BOOSTRIX, GlaxoSmithKline.  Previous history of rash with unknown vaccine.  Previous and/or concurrent vaccination included HEP A given on 28 March 2008; POLIO VIRUS given on 28 March 2008; MMR II (strain not specified) given on 28 March 2008; VARIVAX given on 28 March 2008.  On 28 March 2008 at 08:45 the subject received BOOSTRIX (.5 ml, unknown, left arm) and experienced vaccination error.  At the time of the report, no adverse event had been reported.  Follow-up received on 01 April 2008 via the nurse.  The nurse reported that the subject complained that his arm was sore.  The outcome was unknown at the time of reporting.  No further information was reported.
Fever of 104.2F; hands/feet purple; rapid breath and lesion in right temporal area.
All I got was a sore arm for a day; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient had Shingles vaccine and experienced sore arm for a day. The patient feels lucky compared to other COPD (chronic obstructive pulmonary disease) patient. The follow-up would not possible as no contact details were available. For tolerance of Flu vaccine refer case US2021AMR094074, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094074:Same reporter.
Chills, cough, general unwell feelings for 10 days, noticed fluttering of heart for several weeks afterwards.
Nausea; Extreme Fatigue; Felt ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), NAUSEA (Nausea) and FATIGUE (Extreme Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history was reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (Felt ill). On 06-Mar-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Extreme Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt ill), NAUSEA (Nausea) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Pyrexia: 1001.1 Fever of 100.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Information was included Tylenol. No concomitant product was reported.
Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Swelling; Injection site reaction; She could not eat; Diarrhea; Chills; Redness extending from injection site; Fever; Headache; Fatigue; Muscle pain; Joint pain; Nausea and vomiting; Rash; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DECREASED APPETITE (She could not eat), DIARRHOEA (Diarrhea) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Previously administered products included for Drug use for unknown indication: FLU Shot on 27-Sep-2023; for COVID-19 vaccination: Pfizer, Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with FLU Shot, Pfizer, Pfizer, Pfizer and Pfizer.   On 01-Oct-2023, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting). 23-Oct-2023, the patient experienced DECREASED APPETITE (She could not eat). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting) had not resolved and DECREASED APPETITE (She could not eat), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient received the shot, she had been very tired, she could not eat. The injection site was still hard as a rock and it was painful to move the left arm (Injected arm).
No additional AE reported; A patient was administered an expired MMR II.; This spontaneous report was received from a nurse manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.      On 22-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Albumin status: recombinant human albumin (rHA)) (strength, dose and route were not reported; lot# was S005248 and expiration date was 20-FEB-2021) for prophylaxis (expired product administered). No additional adverse event (AE) was reported. The vaccine never had a prior temperature excursion.
Severe rash around mid-section, severe fatigue,  HA, exacerbation of POTTS disease
Less than 1/2 hour after injection loss of cognitive ability slept 4 hours better next day. After 1 week sore throat and sore muscles, cough, sinus problem 3 days still having symptoms.
Began feeling dizzy 3/3/11, next morning felt chills/sweats, no high fever. Dizziness continued, becoming more serious that evening. Has a nose bleed, next day felt faint, nauseous, dizzy and continued chills/sweats, body soreness, started to have breathing difficulty, gotten worse, seen provider that day. Treated with Zyrtec, Zithromax, albuterol, nebulizer.
According to the nurse present, he was on his way out the door when symptoms started. Had syncope episode with dyspnea and facial rash and c/o tongue itching. Became nauseated with vomiting and sweating. He was given epi pen jr., O2 started, ambulance transported him to hospital where he was observed overnight with no other adverse events.
A woman (age is unknown) received an immunization with MassBiologics' Td (Lot# A079B) on September 1, 2016 in the upper arm (route of administration is unknown). On the same day, she experienced muscle pain and spasms, joint pain, headache, nausea, tingling sensations, itching, and swollen hands; along with upper arm redness, swelling and pain. The symptoms were initially reported as mild but worsened the next day and the patient developed a bump at the injection site.  No information is available on whether the patient sought medical care or took any medication for these symptoms. At the time of the report, the patient's symptoms had not recovered/resolved. Reporter's Comments: The patient reported this event to the vaccine distributor (Akorn) who then reported the event to MassBiologics. The Akorn report indicated that the patient thought she had received the Tdap vaccine, however, Akorn was able to confirm that the lot number provided was a MassBiologics Td lot and alerted the patient that she had received the Td vaccine. Sender's Comments: Based on information provided to MassBiologics, all of the adverse events described in this case were assessed as non-serious. Muscle pain (myalgia), joint pain (arthralgia), headache, nausea, swollen hands (peripheral edema), and the local redness (erythema), swelling, and pain along with the nodule (induration) at the injection site are labeled reactions described in the product insert. The itching (pruritis) may also be associated with injection site reaction as described in the label, but it is unclear from the report if this pruritis was generalized or localized. Muscle spasm is unexpected as it is not a labeled reaction, though a sensation of spasm could occur in association with muscle pains. The development of tingling sensations/paresthesia is unexpected, as it is not described in the package insert. MassBiologics (Sender) attempted to follow up with the patient (primary source reporter) on two occassions as summarized below: Follow up on October 4, 2016: MassBiologics called the patient and left a voicemail requesting a call back to obtain additional and follow-up information for this event and to check on the current status of her symptoms. Follow up on October 10, 2016: The patient answered the phone but told MassBiologics that she was not feeling well and was unable to speak at that time. She acknowledged that she received the voicemail left by MassBiologics on October 4, 2016 with MassBiologics' contact information and said she would be in-touch at a later date to discuss the event. The patient did not follow up with MassBiologics after the October 10, 2016 phone call and no further attempts were made to contact the patient.
Approx. 6 hours after my son recieved his immunizations he had a fever followed by feeling lightheaded and dizzy. When he woke up in the morning I noticed that the top of his leg where he recieved the shots was very red, swollen and hot to the touch and the area of redness continues to grow on a daily basis. It has been 3 days so far.
got the two shots doses and still got shingles for a second time after two years/ suspected Vaccination failure; got the two shots doses and still got shingles for a second time after two years; forced me to bed rest; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and bed rest. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles and bed rest were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the bed rest to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received two shots doses and still got shingles for a second time after two years and experienced shingles and forced to bed rest. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. The information regarding consent to follow up was not reported. This case was linked with case US2021AMR041531.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041531:1st-shingles case
Foggy headed, stuffy nose, chills, fever, cold sweats, body aches, severe headache,  extreme fatigue all lasting two days so far
This spontaneous prospective pregnancy report was received from a nurse practitioner, concerning an 18 year old female patient with none pertinent medical history or drug reaction allergies. On 21-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). Other suspect therapies included PROQUAD (Merck) given the same day (Lot #, dose and route not reported). Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 09-JUL-2013 and EDD of 15-APR-2014. Initial exposure to GARDASIL was at 6 week(s). The outcome of a patient received GARDASIL and PROQUAD while pregnant was unknown. Laboratory diagnostic studies were not performed and no treatment was given for the adverse event. The patient was seen for routine prenatal care on 03-SEP-2013. Additional information has been requested.
Patient began itching at injection site and since then has developed a rash on the back of her arm that extends down to her elbow. No infection identified.
BLURRED VISION; METAL TASTE IN MOUTH; MUSCULAR WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blurred vision, metal taste in mouth, and muscular weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metal taste in mouth, blurred vision and muscular weakness was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
HEP A WAS THE FIRST VACCINE TO BE ADMINISTER ON (L) THIGH. SHE HELD HER BREATH FOR 10-15 SECONDS, . SHE STARTED TO CRY BUT IT WAS A WEAK CRY &  BECAME SLEEPY FOR COUPLE SECONDS BUT SHE NEVER STOPPED BREATHING. SHE DID NOT HAVE GENERALIZED MOVEMENTS ON HER EXTRIMITIES OR STIFFNES NO L.O.C., IN 15 TO 20 SECONDS SHE WAS BACK TO COMPLETLY NORMAL SELF. I, SUGGESTED TO HOLD OFF ON REMAINING VACCINES ,BUT MOM WANTED TO CONTINUE WITH REST OF THEM WHICH WERE UNEVENTFUL. PATIENT WALKED OUT OF THE OFFICE.
Arm pain in injected arm; Headache; Chills; Joint pain; Tiredness; Fever; Diarrhea; Irritability; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 13:00 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and various eye conditions requiring medication. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included amlodipine besilate (NORVASC) and bromfenac sodium (PROLENSA); both for an unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 13:15, the patient had arm pain in injected arm, headache, chills, joint pain, tiredness, fever, diarrhea and irritability. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain in injected arm, headache, chills, joint pain, tiredness, fever, diarrhea and irritability was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
reactive arthritis/polymyalgia rheumatica symptoms; decreased hearing; reactive arthritis/polymyalgia rheumatica symptoms; post-vaccination related joint pain; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 22-JUN-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, vaccination site and route of administration were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (onset date not further specified), the pt suffered and was diagnosed with decreased hearing, reactive arthritis/polymyalgia rheumatica symptoms and post-vaccination related joint pain. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using Company's product. The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of his condition. The outcome of the events was unknown The causality assessment was related.   Upon internal review, the event of polymyalgia rheumatica symptoms was considered to be medically significant.
has been exposed several times in the last week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  An 81-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious) with onset 09May2022, outcome "unknown", described as "has been exposed several times in the last week".  Additional information: Reporter stated that she has had four Pfizer shots and hasn't had COVID. Also, stated she was not sure if it was Pfizer shots and she has been exposed several times in the last week.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
She states that on a regular basis she usually gets up at 0300 but this morning she got at 0630 and had nausea.
Red blotch where the shot was given / 3 inches long and 2 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch where the shot was given / 3 inches long and 2 inches wide) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AuA) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH MACULAR (Red blotch where the shot was given / 3 inches long and 2 inches wide). At the time of the report, RASH MACULAR (Red blotch where the shot was given / 3 inches long and 2 inches wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
STARTED WITH DRY COUGH, THEN CONGESTION IN MID NOVEMBER, BY DECEMBER 21 HAD PNEUMONIA IN BOTH LUNGS, BUT COVID TESTED NEGATIVE.  JAN 13, 22 COUGHING ALOT, AND TESTED POSITIVE FOR COVID ON 1/17/22 AT DOCTOR'S CARE .  STARTED PAXLOVID TABLETS ON 1/17/22 WITH OXYGEN LEVEL DROPPING TO 92-94. FOLLOW-UP DONE WITH PRIMARY CARE PHYSICIAN.  WENT BACK TO NORMAL ABOUT 1/26.
This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 21-year-old, adult, female patient. The patient's historical condition included allergic rhinitis. The patient's vaccination history included unspecified influenza vaccinations and 2 weeks later, experienced fever body aches, upper and lower respiratory tract congestion, and cough persisting for several weeks thereafter (in 2009). The patient experienced reproducible likely non-immunoglobulin E (non-IgE) medicated reactions (reproducible with subsequent vaccinations of approximately same severity) after influenza vaccination in 2010 also. The patient was allergic to sulphonamide drug (reported as sulpha drugs). The patient had no current illness. On an unspecified date in 2011, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2011, two weeks after vaccination, the patient experienced reproducible likely non-IgE medicated reactions (reproducible with subsequent vaccinations of approximately same severity) like fever (101-104-degree), body ache, upper and lower respiratory tract congestion, and cough persisting for several weeks. The patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. The outcome of the events was not reported. The reporter assessed this case as non-serious.
Unknown. 11/6/09 Autopsy report received. DOD 10/12/09. Anatomic Diagnosis: 1. Coronary artery disease. 2. Cardiac rupture with cardiac tamponade. 3. Pleural effusion. 4. Status post cholecystectomy and appendectomy.   11/12/09 Coroner - Final Cause of Death: Severe coronary atherosclerosis.
Dizziness; fever; Shaking Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (fever), CHILLS (Shaking Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PYREXIA (fever), CHILLS (Shaking Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PYREXIA (fever), CHILLS (Shaking Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to ED with fevers, chills, nausea, vomiting, and diarrhea for three days and angioedema for one day. Received antihistamines, ondansetron, and IVF. Changed lisinopril to losartan. Patient discharged to home medically stable.