chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Over 3-4 days had the expected flu-like symptoms (headache, fever, body ache, chills, etc.).  On the second day had intense pain in base of lungs that would intensify in waves alongside elevated heart rate (just under 100bpm, measured oxygen level was still 98%).  The pain lasted about 4-6 hours and then subsided.
I was positive for COVID-19 on 06FEB2023, I had a low grade fever and I had a sore throat and I didn't feel very well. I did call the tele health and I got prescribed for paxlovid. I started feeling better about 4 days after taking the medication.
Cystic bumps appearing within hours of my injection all over my face as well as heavy irregular bleeding beginning the morning after receiving my second dose, abnormal bleeding of 2-3 weeks per month that lasted approximately 9 months and only resolved with birth control changes with an increased dose of estrogen.
NAUSEOUS / FELT LIKE THROW UP FOR 3 DAYS; VOMITING; DIARRHEA; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced nauseous / felt like throw up for 3 days, vomiting, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from nauseous / felt like throw up for 3 days, vomiting, and diarrhea. This report was non-serious.
My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
It first started with my right eye feeling heavy as if it was going to close on its own.  This went on for weeks and progressed down the right side of my face and jaw.  My jaw was completely moving to the right side of my face which made it difficult to talk.  This then progressed to the closure of my right eye and then progressed to the left side of my face. Spasms of my face muscles made it hard to talk and keep my eyes open. About a few months later I got spasms throughout my entire body.
Did not feel well; Heart rate increased; Rhabdomyolysis; Feeling almost Fainting after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criterion medically significant), PRESYNCOPE (Feeling almost Fainting after first vaccine) and HEART RATE INCREASED (Heart rate increased). On 23-Apr-2021, the patient experienced MALAISE (Did not feel well). At the time of the report, RHABDOMYOLYSIS (Rhabdomyolysis), PRESYNCOPE (Feeling almost Fainting after first vaccine), MALAISE (Did not feel well) and HEART RATE INCREASED (Heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Heart rate: 150. On 23-Apr-2021, Blood test: Normal. On 23-Apr-2021, Electrocardiogram: Normal. On 23-Apr-2021, X-ray: Normal.     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.   No concomitant medication was provided. No treatment medication was provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-243078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Upon internal review on 26-May-2023 significant corrections performed to upgrade the seriousness to Medically Significant for the event of Rhabdomyolysis; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of more than - 15 but less than -10 degrees Celsius for 3 hours 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006632.
Patient felt difficult swallowing at observation area. Able to talk clearly. O2 Sat 100%. Benadryl given at 1127. Patient arrived at ED a few hours after but symptoms had resolved. Given steroids and prescriptions for managing allergic reaction at home if needed.
I95.9 HYPOTENSION 8/27/2021 WEAKNESS I95.9 HYPOTENSION 8/27/2021 ASCENDING THORACIC AORTIC ANEURYSM I95.9 HYPOTENSION 8/27/2021 ASCENDING THORACIC AORTIC ANEURYSM I95.9 HYPOTENSION 8/27/2021 ESRD (END STAGE RENAL DISEASE) I95.9 HYPOTENSION 8/27/2021 CKD STAGE 4 (GFR 15-29) I95.9 HYPOTENSION 8/27/2021 WEAKNESS I95.9 HYPOTENSION 8/27/2021 WEAKNESS
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 27-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 f for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccines were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Severe pain in shoulder joint occurring the day after vaccination. Limited range of motion. Muscle not sore. Persistent pain. No numbness or tingling.
History of Present Illness     31-year-old male with no past medical history presenting with left-sided facial weakness after receiving the first dose of the COVID-19 vaccination 2 days ago. States that several hours after receiving the vaccination he noticed left-sided tongue numbness.  He was able to tolerate oral intake without difficulties and handle his secretions.  The following day his wife noticed facial asymmetry of his lip left side of his face involving his forehead.  Patient is denying any extremity numbness or weakness, head injury, trouble speaking, confusion. No recent travel or skin changes.  No similar reaction to vaccinations in the past.
patient started filling flush and warm about 20 mins after vaccination.  in standing position felt slightly dizzy and nausea, Laid  down felt better but still hot.  no medication given.  HR was 70 Stats 98.  Patient laid down for one hour when she felt better.  next two days patient had redness and warmth at site of injection about the size of a quarter.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL (dose, lot number and route not provided). The patient had side effects from GARDASIL but the reporter did not provide any details. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medication was reported.  On 09-Jan-2023, 26 patients received Bivalent vaccines from 2 different Bivalent lot numbers. 16 Patients Vaccination Cards reflects the wrong lot numbers and pharmacist could not figure out which patient's records were wrong.  All patients received the correct vaccine and bivalent dose. The error only involved documentation.   The Bivalent boosters was administered from Bivalent Lot numbers: 061F22A and AS7170B. Batch number AS7170B was written on all 26 patient's vaccination cards. Can not distinguish which patients received which dose.  The patients did not reported any adverse reactions.  This case contains information for 16th of 16 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:Master case
small fiber neuropathy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 2, single (Lot number: EZ32489) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "Prolactinoma and infertility" (unspecified if ongoing); "infertility" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. Vaccination history included: BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EJ1685), administration date: 19Dec2020, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: SMALL FIBRE NEUROPATHY (disability) with onset 05Feb2021, outcome "recovered with sequelae", described as "small fiber neuropathy". The event "small fiber neuropathy" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures post vaccination: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of small fibre neuropathy which included IVIG, Lyrica, gabapentin, steroids. Clinical course: Diagnosed with new small fiber neuropathy requiring 8 doses of IVIG due to the covid 19 vaccination. Recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event small fibre neuropathy and the suspect product BNT162b2  cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
COVID; COVID; This is a spontaneous report from a contactable consumer. An 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 maybe about 11:30am at single dose for COVID-19 immunization. Medical history included ongoing lung disorder started maybe 10 years ago or more, ongoing eye disorder onset may have been about 1 year ago, Carpel tunnel surgery on Jan2021 which was done on both wrists, ongoing weight decreased about 2 years ago, patient had cancer and has had some problems; they were going to the health clinics at the time and she had a horrible cough; she thinks, but does not know, if they did a bronchoscopy; but she saw some doctors and a cancer specialist. The patient had unknown concomitant medications for Thyroid. The patient was diagnosed with COVID 23Jan2021 and hospitalized in response which is ongoing. She is scheduled to get the second dose of Pfizer COVID-19 Vaccine on 27Jan2021. The patient body temperature is usually about 97.5 or 97.6 degrees Fahrenheit; but on Saturday: 23Jan2021 her temperature was 101.5 degrees Fahrenheit. Patient had her son take her to the hospital where they did the COVID test and it was positive for COVID; so she was admitted to the hospital for this on 23Jan2021. She is hospitalized at the same hospital where she was administered the first dose of Pfizer COVID-19 Vaccine and the hospital staff were shocked that she had gotten one of their Pfizer COVID-19 Vaccines. The patient was at the hairdresser's on 22Jan2021 who said the patient did not look good then; that she really looked sick; but apparently the patient did not have any symptoms 22Jan2021. It was not until unknown time on 23Jan2021 that her temperature went up; patient feels like her reaction is to the fever; where she just wants to sleep all the time. Patient probably does not have any energy. Caller does not hear her coughing when she talks to the patient. Caller clarified that to her awareness the patient's potential exposure to COVID positive persons would have been through the grocery store; or the health plex gym where caller and the patient go together but the patient said the health plex gym machines are spaced out well and there are no known exposures to COVID positive persons. Outcome of events was unknown.
Pt states he experienced syncope while in 30 minute waiting area.  CNA found him on floor. Moved to w/c to observation area to cot.  BP 120/68 P80.  Rested for 15 minutes til there was no diaphoresis.  Pupils reactive & talking.   Left w/o assistance.  Advised to have 2nd pfizer shot on cot.
This spontaneous report as received from a nurse refers to a patient of unknown age. No current condition was reported. No historical medication was reported. Approximately in 2014, the patient was vaccinated with ROTATEQ lot number reported J005713, expiration date 25-OCT-2015 (dose, strength and route was not reported). No concomitant medication was reported. Nurse stated that an unspecified number of patients received (unspecified doses in series) ROTATEQ that was stored at 47F for 120 hours. Nurse also reported that temperature issue occurred on 29-JUN-2014 through 03-JUL-2014 so doses administered somewhere after 04-JUL-2014 and 23-SEP-2014. No adverse event was reported. The outcome of ROTATEQ stored at 47F for 120 hours was unknown. This is one of the several reports. Additional information has been requested.
Sharp pain in both arms,  and by the neck; Sharp pain in both arms,  and by the neck; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen (Advil) for pain.   On 16th August 2019, the patient received the 1st dose of Shingrix. In August 2019, the patient started Advil at an unknown dose and frequency. In August 2019, less than 2 months after receiving Shingrix, the patient experienced nausea. On 19th August 2019, the patient experienced pain in arm, neck pain and headache. The action taken with Advil was unknown. On an unknown date, the outcome of the pain in arm, neck pain, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, neck pain, headache and nausea to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient stated that approximately 3 days after receiving the vaccine, she developed sharp pain in both arms, and by the neck.  The patient also developed a headache. Patient stated that she went to see her doctor and received acupuncture to help with the pain, however, this did not resolve the pain.  The patient stated that she was also taking Advil and other pain medications for the pain, which were not helping. On an unknown date, less than 2 months after receiving a dose of Shingrix, Advil and pain medications, the patient was also experiencing nausea that she believed was caused by the pain medications. The reporter considered the nausea to be related to Advil and pain medication as well. It was reported that emergency room visit required. The contact information not available at the time of the call. The reporter did not provided any additional information. The reporter consented to follow up. This case had been linked to the case US2019166404, reported by same reporter. In the XML document outcome of events was reported as recovering, but in Argus its mentioned as not recovered, so kept as reported in Argus.
Swollen ankles. Went to MD and received phone call from office saying I was to report to ER. Red blood count was 6.2 at ER. Found HGB to be 5.9. Received 4 pints of blood and severe arthritis on right thumb and left elbow.
Patient received immunization on 10/26/17. His wife called the pharmacy on 10/27/17 and stated he had severe swelling at injection site. Patient was advised by pharmacist on duty to proceed to physician's office for evaluation. Patient then presented to the pharmacy on the morning of 10/28/2017. The injection site was swollen and a rash was visible. He denied any fever but stated he did not feel well. The site was warm to the touch. Patient was again advised to have the reaction evaluated by a physician. *Patient also received an influenza immunization on 10/26/2017 but was given at a different healthcare facility. It is unknown which manufacturer/version of immunization was given.
Patient is pregnant, doctor wanted to have her TDAP vaccination, we admisnistered on 08/29/2018, patient came on 09/04/2018, she said she had a swelling on the injection site, bump, red under skin, no rash, no itching, but it was reducing or going down the extent day by day.
several hr p/vax pt started getting rash all over, lips feel numb, n/v, dizziness;went to ER dx w/rxn to vax;rx for pills to settle stomach but pt unsure of med name;denies med @ ER;felt better around 8Pm;