chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At about 0130 on 01/13/21, I woke up not feeling well (I had also not been sleeping well prior due to arm pain and minor aches). I became extremely dizzy and lightheaded feeling like passing out, I was tachycardic, had increased respirations, pale (per my husband), felt hot and cold, and was sweating. I also became very anxious. I had to go lay on the bathroom floor - my husband woke up with me and got me some water, Ibuprofen, and a cool rag for my head. He also said I wasn't sleeping well - moving around and making noises before then. I laid on the floor about 15 minutes until the symptoms had improved, but still didn't feel well.  No further episodes at this time. Only other issues are the continued expected possible side effects (arm pain, body aches). I did notify our Nurse Manager this morning as well.
Extreme weakness; Diarrhea has been house bound; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of weakness in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19 (since December 2021). Concomitant products included amlodipine besilate.   On 17-MAR-2023, the patient received Shingrix. On 18-MAR-2023, 1 days after receiving Shingrix, the patient experienced weakness (Verbatim: Extreme weakness) and chronic diarrhea (Verbatim: Diarrhea has been house bound). The outcome of the weakness and chronic diarrhea were not resolved.   It was unknown if the reporter considered the weakness and chronic diarrhea to be related to Shingrix.     It was unknown if the company considered the weakness and chronic diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUL-2023 The reporter reported that the patient administered Shingrix vaccine and had extreme weakness and chronic diarrhea. The reporter thought intervention required of seriousness for extreme weakness and chronic diarrhea. The reporter reported that the patient took amlodipine besilate for hypertension. The reporter reported that patient also suffered from long Covid. The reporter did consent to follow up.
Information has been received from a woman working in a physician's office concerning a 6 yr old female who on 10Jul01 was vaccinated with a SC first dose in the right arm of varicella virus vaccine live. On 02Nov05 the pt experienced chickenpox disease post vaccination, described as a mild case with 25-30 lesions that were mostly on the trunk, back and chest. It was noted that the pt's mother had shingles 2 weeks prior. It was reported that the pt recovered on 22Nov05. Medical attention was not sought. Additional information is not expected. The pt's brother experienced a runny nose and skin lesions following vaccination with varicella virus vaccine live (WAES0512USA00454).
Patient experienced raise in blood glucose immediately following vaccination. Her alarm sounded at 203 and then eventually went down. Patient was observed for 30 minutes following vaccination.
Child reports "right arm, at shoulder still hurts where shot was given."  Right deltoid is the site of a Tdap injection only.
Right Bell's palsy started 3 days after vaccination. I am caring for the patient as her ophthalmologist.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Oct-2021 at 9:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). On 27-Oct-2021 at 9:55 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 38.67.  Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM temperature was 29, and 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021.2 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021., vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021.4 vials were sent to clinic. Vaccine BUD date was 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I think shot triggered an attack of pleurisy as those were my exact symptoms; chills; fever; Pains in chest like pins and needles all around chest muscles; breathing became very difficult and painful; breathing became very difficult and painful; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself (patient).  A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 05Nov2021 at 14:15 (at the age of 73-years-old) as dose 3 (booster), single for covid-19 immunization. Patient medical history included migraine and hypothyroidism. No known allergies were reported. Concomitant medications included erenumab aooe (AIMOVIG) on 04Nov2021. Patient was on shot 43 of Aimovig. Patient did not have Covid prior to vaccination and was not tested for it post vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Historical vaccination included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 20Mar2021 at 10:45AM (at the age of 73-years-old) as dose 2, single and bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 10:30AM (at the age of 73-years-old) as dose 1, single for covid-19 immunization and experienced got tired and headache during both doses. Patient got booster shot 215p on Friday. On 06Nov2021 07:00 All day on saturday patient got chills and fever and was laying down. At 7pm fever got at 103 degrees. Pain in chest like pins and needles all around chest muscles and breathing became very difficult and painful. Took Tylenol for fever. Fever started to drop. Took another Tylenol and by 11 pm the severe chest pains eased and I fell asleep. On waking, breathing and chest had returned to normal. Fever gone. I think shot triggered an attack of pleurisy as those were my exact symptoms. I never had pleurisy before but my husband has and he said that is what I had. Therapeutic measures were taken in response to events and Tylenol 500 mg was taken. The patient underwent lab tests and procedures which included body temperature: 103 degrees on 06Nov2021. The outcome of events was recovered on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Persistent migraine not responsive to medication with onset approximately 48 hours after vaccine and proceeding to this report. I am a sufferer of migraines, but this is especially intense and persistent.
Very sick; Atrial fibrillation, led to having an ablation; This case was reported by a physician via sales rep and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2020, the patient received Shingrix. On 5th July 2020, 2 days after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the patient experienced sickness. On an unknown date, the outcome of the atrial fibrillation and sickness were unknown.   It was unknown if the reporter considered the atrial fibrillation and sickness to be related to Shingrix.  Additional details were provided as follows: The physician himself reported the case. The age at vaccination was not reported. The reporter received one dose of Shingrix and on 5th July 2020 ,experienced atrial fibrillation which led to having an ablation.  The reporter claimed to had been very sick following administration of Shingrix.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (exact dose and dates of dose were not known) and three weeks after the dose, the patient developed musculoskeletal pain in her legs. The patient has been sent to two neurologists and a conclusive diagnosis has not been obtained. No additional information is available. The patient sought medical attention, office visit. Additional information has been requested.
diagnosed with hypertension; muscle cramps and spasms all over her body; pain in joints/persisted in hands, feet and knees; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (diagnosed with hypertension) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023c21a and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (diagnosed with hypertension) (seriousness criterion medically significant), MUSCLE SPASMS (muscle cramps and spasms all over her body) and ARTHRALGIA (pain in joints/persisted in hands, feet and knees). At the time of the report, HYPERTENSION (diagnosed with hypertension), MUSCLE SPASMS (muscle cramps and spasms all over her body) and ARTHRALGIA (pain in joints/persisted in hands, feet and knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 192/99 (High) Highest and 150-160 (High) averaging 150-160 after medication. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.         No concomitant medication was provided.  Patient explains that shortly after getting the second dose, she started having muscle cramps and spasm all over her body.  She called her doctor who advised her to drink more water.  The muscle cramps and spasms continued even after drinking more water.  Then a week or so after that, she noticed pain in her joints.  This also persisted in her hands, feet and knees.  She was seen by a doctor who also checked her blood pressure and noticed it was high and sent her to the hospital.  She was not admitted but they ran tests, EKG and XRay, which came back normal.  She was diagnosed with hypertension.    Patient was prescribed a medication for her HBP but says the highest its been was 192/99 and after medication it is averaging 150-160.  Prescribed treatment medication was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe pain in arm, neck, back. But the arm area where shots were given pain goes up to shoulder, I can't sleep on that side, can't reach for anything with that arm. Pain is getting so bad.
MA incorrectly placed DTap on the patient. Vaccines for pt. and another patient were pulled at the same time, and MA took the DTap from the other paitent's tray, resulting in pt. receiving another dose. Dr. was made aware, and adivsed no harm to the patient. Dr. informed the mother of the incident. Patient has a follow up appointment in 1 week.
Prescribed 3 day Azithromycin due to flu-like symptoms arm began to ache, by 2am pain increased and had fever also. Pain increased on 8/18 took Tylenol and Benadryl, arm was also red. On 8/19 arm was swollen, red, hot, are affected extended from shoulder to elbow sensitive underneath arm pit. On 8/20 seen by nurse problems started to resolve by then.
INJECTION SITE SORENESS, FATIGUE, JOINT MUSCLE PAIN, CHILLS, TEMPERATURE ELEVATION 99-99.8, HEADACHE, BACK PAIN
On January 21st, noticed a rash on multiple areas of the body and by the morning of January 22nd it had spread and some had turned into welts.  Also lips starting swelling and chin hardened (onset of edema).  Went to the community med check and was given a steroid injection and due to the swelling in my face, was sent to ER for observation.  In the ER, I received Benedryl and Pepcid.  I was told that it looked like a systemic reaction from a medication.  They suggested I discontinue the minocycline since that was the newest medication that I had been on so I quit that immediately.  I was sent home with prednisone and this cleared up the rash/welts.  Of note, once the rash started, the COVID injection site starting getting red, swollen and itchy as well.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored ROTATEQ (lot # L037574, expiration date 01-JUL-2017, lot #L038536, expiration date 19-AUG-2017, strength, dose and route were not reported). No adverse event reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
Loose stool; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIARRHOEA (Loose stool) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Loose stool) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient was administered typhoid vaccine and subsequnetly hepatitis A vaccine. Shortly afterwards, patient reported feeling dizzy, hot, and wanting to pass. Patient reported symptoms began to subside after approximately 10 minutes and was observed for any additional reactions for approximately 25 minutes. After that time, hepatitis B vaccine was administered and patient began to feel dizzy again and began to shake in arms and legs. Pharmacy called 911 and paramedics arrived 5 minutes later.
It was reported in a published article that a female patient in 1984 was vaccinated with a post partum dose of rubella virus vaccine live (second generation). Subsequently she had three miscarriages before delivering a boy in September 1987. The author noted that vaccinaton of women around conception may lead to stillbirths, premature delivery, and vanishing twins. It cal also be frequently associated with an early onset of autism. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. It was reported in a published article that this patient delivered her first child, a female in 1984, and received rubella virus vaccine live post partum because she had remained rubella susceptible. After three miscarriages the patient delivered a male in September 1987 and received another post-partum dose of rubella virus vaccine live because she had no detectable rubella immunity. While breast feeding he third child, a female, the patient received her third rubella virus vaccine live booster in four years as she was still rubella susceptible. According to the reporter the patient's son has autism and the patient's daughter has severe dyslexia, serious learning disabilities and ADHD. It was unknown if medical attention was sought.
cellulitis/ cellulitis from the injection site down to the antecubital fossa; looks like chickenpox; This case was reported by a physician via call center representative and described the occurrence of cellulitis of arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and varicella-like rash. On an unknown date, the outcome of the cellulitis of arm and varicella-like rash were unknown.   It was unknown if the reporter considered the cellulitis of arm and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a patient with rheumatoid arthritis developed what looks like chickenpox and cellulitis (according to their primary care physician) from the injection site down to the antecubital fossa. The patient was also on methotrexate. The date of administration was also not available. The six month mark since the first dose will be in two days. Th e lot number was not available. The reporter was did not consent to follow-up.
My first shot came with full body hives, sweats, and I slept for three days straight. Felt normal in a little over a week. My second shot, I work up the next morning with one of the worst headaches I've ever had. I started to develop a fever. 101.5. It spiked at 102. The fever was off and on for three days. I couldn't stop sleeping. I could only stay awake for a couple of hours at a time. That lasted for four days. Now today marks the two week anniversary and I can only stay awake for six or seven hours at a time, then I'll sleep for seven or eight, and repeat. I am SO tired I can barely function. I talked to a doctor friend who suggested I file a report here. I don't have health insurance and can't go to the doctor.
The night of the vaccination I had a sore arm, fever,and chills. The third day I started having a pain that felt like a Charlie horse in my left leg behind the knee. Went to the doctor that Monday, I was giving an X-ray which showed nothing. On that next Friday I went to the ER where they found I had developed 2 blood clots in calve and behind the knee. Since then I have been put on blood thinners.
Itchy spots; Allergic rash; Rash on all of her joints was reported as worsened; Has to live with this rash and it's driving her nuts; Shingles; Another rash/rash on all of her joints; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 30Aug2021 (Batch/Lot Number: FC3182) as SINGLE for covid-19 immunization. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection) at the age of 79-years-old via an unspecified route of administration on 09Aug2021 (Batch/Lot number: EW0198) as SINGLE for covid-19 immunization. Patient medical history included, allergic to sulfa from an unknown date and unknown if ongoing. There were no concomitant medications reported. On an unspecified date in Sep2021, somewhere around 4 to 5 days after the vaccination, the patient developed shingles and another rash that was not diagnosed as shingles and she went to her HCP last saturday and stated that "the rash on the left side of her neck definitely feels like shingles and it was heading towards her eye. On an unspecified date, she also developed a rash on all of her joints which was started a little bit after the shingles, maybe a day or two after and it is still spreading every day and was worsened. Patient reported that shingles stayed the same but as far as the other rash that one keeps getting new spots every day. On an unspecified date, it was reported that patient had to live with this rash and it's driving her nuts, found some itchy spots which she didn't paid attention, allergic rash which is like hives. Patient was asking if sulfa drugs are in the Pfizer COVID-19 vaccine because she is allergic to it and wanted to know if this had been reported as side effects with the Pfizer COVID-19 vaccine. The outcome of event for shingles and rash was not recovered whereas for remaining events it was unknown.  Information on the lot/batch number has been requested.