chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid like symptoms; Covid like symptoms; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4067741-00). A contactable consumer (patient himself) reported that a 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; at the age of 64 years old), via intramuscular on 07Apr2021 (Batch/Lot number was not reported) as dose 2, singe; and via intramuscular on 10Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; and, adalimumab (HUMIRA; solution for injection in pre-filled pen, Batch/Lot number was not reported), via subcutaneous from an unspecified date to 28Aug2021, at an unknown dose and frequency, and via subcutaneous from 2021 (Batch/Lot number was not reported) to an unspecified date, at an unknown dose and frequency for moderate to severe rheumatoid arthritis. The patient's medical history included ongoing moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On unspecified date in 2021, it was reported that the patient experienced COVID like symptoms with humira (adalimumab) and covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient underwent laboratory test and procedures on unspecified date in 2021 which showed negative COVID test. The reporter's causality for the event(s) of COVID like symptoms was not provided. The action taken in response to the events for adalimumab was temporarily withdrawn. The outcome of the events was recovering.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
c/o pain lt arm inject site to hand p/getting vax 22JUL94; 25JUL94 c/o pain & soreness shoulder (lt) to midway lt forearm using hand able to lift arm; no reddness or swelling; arm feels warm to touch; t100.1, 100.3, 100.2;
This case was reported by a physician via sales representative and described the occurrence of fever in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 1 November 2013 the subject received 1st dose of PEDIARIX (unknown). On the evening of 1 November 2013, within hours of vaccination with PEDIARIX, the subject experienced fever greater than 100 degrees. Early on the morning of 2 November 2013. the fever was resolved. It was reported that the physician intends to complete the PEDIARIX vaccination series. The sales representative reported another case on behalf of the physician with INFANRIX, please see A1049741A.
Large, red, swollen, hot to touch are on left thigh, with induration. Treatment is BENADRYL and Cephalexin.
headache; chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, chills, and nausea on an unspecified date. The patient asked if she is going to get the same reaction on the second dose. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Rash noted on back and chest 5/20/06. Rash noted on wrist R 5/22/06. 11 days post vaccine.
Approximately 2 weeks after receipt of this vaccine my son developed high fevers of 103-104 and developed red raised papules all over his body. These persisted for approximately 4 weeks in duration. My son was lethargic and had regression in his verbalization and intermittent diarrhea. I tried to get into our pediatrician for an assessment but they were unable to see him in until much later in the afternoon so we opted to see another pediatrician that day. We were told it was a fever of "unknown origin" but the physician documented it in my sons chart as an "adverse vaccine reaction" within 1 month of receipt of the vaccine series. We were never told by either physician that his reactions were a vaccine related despite the fact both pediatricians noted in his medical records that his reactions was vaccine induced. I only discovered this after requesting his medical records in 2017. That is why there was a delay in reporting.
This spontaneous report was received from a medical assistant concerning multiple patients (demographics unknown). The patients pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of ROTATEQ (Lot # L035510, expiration date: 13-MAU-2017) oral. The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34.2 F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
SEVERE HEADACHE, COLD CHILLS, FINGERS TURNING WHITE, CHEST PAINS FROM SHAKING, SHORTNESS OF BREATH, DIZZINESS, WEAKNESS, FAST HEART BEAT AND THEN I GOT HIVES WHEN I LEFT THE HOSIPITAL ON 10/4/2012.
Approximately 36 hours after vaccine administered pt got 103.2 degree temp. Vomited 4 times. TYLENOL and MOTRIN given ZOFRAN given.
pt recv vax 01FEB95 & 11FEB95 devel a fever of 101, profuse rash on trunk, stomach, back, neck arms & legs; seen by MD 13FEB95 fever of 100, runny nose & crankiness; MD stated that the pt had a nl rxn to MMR
Pt presented to the ER with vaginal bleeding and was found on u/s to have a missed abortion 12/04/09 ED records received for DOS 11/15/09. Pt. who is six weeks pregnant presents with spotting, abdominal pain. Discharged to f/u with OB MD. DX: threatened abortion 12/10/09 Medical records received for DOS 12/01/09. Pt. requesting D&E for missed abortion.
Pt has a red hot bump on (L) arm where IM vaccine was given, also another large red hot bump where SQ vaccine was administered as well.
Report A0371755A describes an injection site reaction in a 4-year-old male who received diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  This report was received from a manufacturer (HQ475104FEB2001).  Medical history, concurrent conditions, and concurrent mediations were not specified.  On 12/17/2002, the vaccinee received an injection of Infanrix.  On 12/18/2002, the vaccinee developed an injection site reaction.  Treatment and outcome were not specified.
Patient reported having low fever for 2 days after vaccination and feeling dizzy the next day. She spoke with her doctor and was advised to call the pharmacy to report the adverse effects
Asthma triggered throughout the day in shorter spans of time; hard time inhaling air, shortness of breath; blue lips; pale; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 23-years-old via an unspecified route of administration, administered in arm left on 10Apr2021 10:15 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation.  Medical history included asthma and eczema from an unknown date and unknown if ongoing. Concomitant medications included albuterol sulfate and loratadine, pseudoephedrine sulfate (CLARITIN-D); all taken for an unspecified indication, start and stop date were not reported. The patient reported that his asthma triggered throughout the day in shorter spans of time, hard time inhaling air, shortness of breath on 11Apr2021 11:00; emergency Albuterol Sulfate inhaler not working to help, had to go to ER where they gave steroids for his lungs and breathing and out him in oxygen. He was told that he had blue lips and was pale on 11Apr2021 11:00. He was in ER for 4-6 hrs then hospitalized for one day to monitor and gave medicine. Then he was advised to go to the doctor and get referral for pulmonologist for asthma. Basically all of Sunday, his asthma would get triggered few hours then got short within every 30 min then every 5 min and inhaler stopped working to help the situation. Diagnosed with asthma since kid but had no serious issues prior to vaccination, only after vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized due to the events for 1 day. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Apr2021. Therapeutic measures were taken as a result of the events which included treatment with Steroid, IV Fluids, Albuterol, Advent, oxygen tank. The patient was recovering from the events.
symptoms started 6 hours after vaccination Fever up to 103 body pain headache stomach pain fatigue
I had the ZOSTAVAX injection at a pharmacy. In a few hours, I got a terrific headache that lasted until 8/7/2009. The right top of my head felt extremely sore and I felt a lump was there. I should have called the doctor but it was evening and night. I found it hard to concentrate the next morning. The right arm of the injection -- but not the same area -- became very swollen and had a raised hard lump which was very red. that lasted about 3 days after starting BENEDRYL. I itched at that area mainly but also itched all over my body. The next day I then began to break out with hives on the palms of my hands. The pharmacist told me to take BENEDRYL which I did. I was getting better and then had diarrhea and threw up and was very ill. It is now 8/8/2009 and I feel that I am much better. I don't know if there is permanent damage. I don't know if I was bleeding on the right side of my head -- I don't know what was causing all of these problems by taking the vaccine. I need to know what to tell my doctor that I was allergic to that was in the vaccine. The next morning. I noticed I couldn't think of my multiplication tables when doing math, which I never had problems before. I hope there is no permanent damage and would like some possible explanations. This was about 20 years ago. I've never smoked. I'm on oxygen. I'm not a drinker. I'm 65 and not pregnant. No liver or kidney problems that I know of....
p/vax pt devel two lesions;each about 4-5mm on lt lower lid;almost looked like papillomas or scalations;MD reported that the lesions are flesh colored;
Low grade fever, chills, headache, lethargic , no appetite , ear ache, slight cough.
Narrative:  Patient received the COVID Pfizer booster in October 2021 and  presented to PCP in November 2021 with lingering arthralgias, myalgias with  edema. He was given an 84-day titration course of prednisone and a Medrol dose  pack. Patient found some relief after trialing 2 steroids, but he later was diagnosed  with RA and with images presenting mild degenerative joint disease.
Pt passed out, fell on floor 2-3 min p/MMR was administered, unconscious approx 30 sec; Client stated he had felt dizzy a/passing out; pt became diaphoretic; ambulence was called; Pt given 02; heart rhythm-normal sinus; Refused to go to ER;
Generalized maculo-papular rash. Treated with Benadryl for itching.
covid-19 virus test positive; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
MODERNA COVID VACCINE # 3 GIVEN 12/7/21, LOT # 027H21B; pt had been seen at Healthcare for A. Fib with RVR and positive for COVID; pt was in CCU trying to get A Fib under control and treatment for COVID pneumonia (specific tx not in medical record); pt transferred to Hospital to see transplant hepatology; pt with encephalopathy, UTI, total bilirubin elevated, blood culture with gram positive cocci; given ABX; A Fib tx with medications; acute on chronic kidney disease; pt worsened clinically; DNR/DNI; transitioned to comfort care and sent home with hospice where he passed away
Chest pains experienced in upper left chest afternoon after received vaccines and continued into following morning. On day following vaccination at approx. 12 noon, experienced lightheadedness, dizziness, and felt like was going to pass out.
Info has been received from a physician concerning an adult female with a history of chickenpox as a child who subsequently, developed a rash over her anterior and posterior trunk and itching after daily exposure to pts who received a dose of varicella virus vaccine live. No treatment was given and no other symptoms occurred. Unspecified medical attention was sought. At the time of this report, the pt was recovering and her rash was noted to be fading. It was also noted, the pt was not a recipient of the vaccine and did not directly administer the vaccine. Additional info has been requested.
Td booster given at 2:30PM 05/17/04 at Drs office that evening pt c/o muscle spasms and swollen throat. Taken to ER. Dx: Reaction to Td. Vaccin. 5/19/04 taken back to ER with c/o trouble breathing . Dx: acute pharangitis
Biopsy proven Pityriasis Lichenoides et Varcelliformia Acuta (PLEVA) one week after getting the bivalent booster; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 11-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 immunization; Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown.), for COVID-19 immunization.  The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "Biopsy proven Pityriasis Lichenoides et Varcelliformia Acuta (PLEVA) one week after getting the bivalent booster". The event "biopsy proven pityriasis lichenoides et varcelliformia acuta (pleva) one week after getting the bivalent booster" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: Pityriasis Lichenoides et Varcelliformia Acuta. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta.  Clinical course: The patient received treatment with topical steroids and oral doxycycline for the event. No COVID prior vaccination. Not tested for COVID post vaccination. Other vaccine in four weeks was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Pityriasis Lichenoides et Varioliformis Acuta and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Nausea with the headaches; excruciating headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 10:30 (Lot number: ER8733) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for hypertension, start date: 2020 (ongoing); LISINOPRIL taken for blood cholesterol, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, Route: Injection, Anatomical Location: Left arm), administration date: 05Mar2021, when the patient was 78 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 26Mar2021, outcome "not recovered", described as "excruciating headache"; NAUSEA (non-serious), outcome "recovering", described as "Nausea with the headaches". Therapeutic measures were taken as a result of headache.  Additional information: Concomitant Products Atorvastatin patient gets them through the mail. Reporter stated that she had to go get the bottles to confirm the dosages for her medications. Prior Vaccinations (within 4 weeks) was Pfizer COVID Vaccine, 1st dose. No Family Medical History Relevant to adverse events. Relevant Tests were None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. It was reported that about 3 hours after administration patient experienced an excruciating headache. Reporter queried that how long the headache may last. They had been constant every day since then got the shot. She thought the headaches would go away on their own, but she said that they seem like they are getting worse sometimes. She had a headache so bad the other day she felt nauseous, like she was going to throw up. Reporter stated that the nausea comes and goes, it just depends on how bad her head was hurting. Reporter seriousness for the events were Unspecified. Patient was taking Pfizer covid vaccine because "didnt want to get the virus". Treatment: None, she thought they were going to go away by themselves, but they were not. She took Acetaminophen (Possible Lot number: OKV1626; Expiration: AUG2022) when her headaches get really bad, but it did not help. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Reporter reports none but call handler she did have the 1st dose of the Pfizer COVID Vaccine on 05Mar2021 in the left arm via injection. Adverse event did not require a visit to Emergency Room or Physician Office.   No follow-up attempts are possible. No further information is expected.
2 days after administration of PNEUMOVAX 23, pt. went to Urgent Care w/complaints of redness, swelling, hot to touch skin from left side of neck down through the left hand. Pt. experienced twinges in arm, tingling in fingers as well as blotches.
Right after PCV23 was administered, patient started crying and writhing because of abdominal and back pain.,His face was transiently reddened, palms felt sweaty and he would not permit exam of his back and abdomen. Vital signs: O2 sat in RM air 96%, HR 78. BP right arm seated 112/68. After about 5minutes he reverted to baseline. Abdo and back exams were normal, and lower extremities CNS exam was also normal. After 30minutes observation, patient was deemed to be well enough to be discharged home
Within 5 minutes he developed throat discomfort, cough, and wheezing. Given Epinephrine IM and Albuterol treatment via nebulizer. In 10 minutes, his skin began to itch severely and within 15-20 minutes, developed hives from head to toe. Given Zyrtec/Orapred. over the next 2 hours, his cough/wheeze subsided but skin remained red and itchy.
12 hours after sec.dose vacc.severe pain in lt side of the theeth in upper jaw and lt side of the nose. Analgesics work only 1,5 h. Next day swelling left side of the face with bruce bellow lt eye.Dgn; 12 hours after sec.dose vacc.severe pain in lt side of the theeth in upper jaw and lt side of the nose. Analgesics work only 1,5 h. Next day swelling left side of the face with bruce bellow lt eye.Dgn; 12 hours after sec.dose vacc.severe pain in lt side of the theeth in upper jaw and lt side of the nose. Analgesics work only 1,5 h. Next day swelling left side of the face with bruce bellow lt eye.Dgn; This is a spontaneous report from a contactable physician (patient). A 69-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER 8730), via an intramuscular route on 28Mar2021 at 11:30 (at the age of 69-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included breast cancer on 2017, hypothyroidism (minimal changes), known allergies to Quinolones. The patient concomitant medications included Tamoxifen20mg, levothyroxine sodium (EUTHYROX) 25 microgram for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL 9269), via an intramuscular route on 06Mar2021 at 09:30 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 01:00, the patient experienced 12 hours after second dose of vaccine severe pain in side of the teeth in upper jaw and side of the nose. Analgesics work only 1.5 h. Next day swelling left side of the face with bruce bellow lt eye. Dgn, with herpes zoster without skin changes, than post herpetic neuralgia. Seen by dentist and ENT specialist. Still in pain worse at night but now on and off. Patient received treatment for events with valacyclovir, gabapentin, prednisolone. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
6-24-08 Mother called via telephone & said childs arm was very red & swollen & warm to touch.  Said it is about 4 inches in length on L arm & goes up onto shoulder.  Instructed mother to take child to PCP for evaluation & then come by our office so we can evaluate the arm.  Mother took child to doctor.  Dx adverse reaction but wrote letter stating that child can have a TD booster in future.  Mother did not bring child here.  Said Dr. had child take BENADRYL for reaction.
Patient came into pharmacy on 1/11/18 reporting that she has cellulitis at the site of her ZOSTAVAX injection. She showed me the spot, and it's about 1 inch in diameter around the injection site. It is red in color and circular in appearance. She went to the doctor and is being treated for it with cephalexin 500 mg 1 by mouth twice a day for 10 days.