chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (Dose number in series: 1). She reported that she did not have any reaction or fever to the first shot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: 20-MAR-2022) dose (dose number in series: 2) was not reported, 1 total, administered in left deltoid on 27-OCT-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.   On 27-OCT-2021, the patient had a mild headache last night. Do not normally get headaches, but it went away. It was so mild it was not an issue this. (Dose number in series: 2)  On 28-OCT-2021, about 5pm, the patient had a low grade fever (caller very specific it was low grade). Laboratory data included: Body temperature (NR: not provided) 99.1 F. (Dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from mild headache on 28-OCT-2021, and had not recovered from low grade fever.  This report was non-serious.  This case, from the same reporter is linked to 20211059158.
It was reported that a 50-year-old female patient received an Imovax IM Rabies vaccination on 24-Aug-2000 at 12:00pm. Reportedly the patient called Health Dept. late morning 12-Sep-2000 to report that about 8pm the evening before she noticed that her left deltoid "felt like the day I go the shot" and left lateral arm from deltoid distally including back of left hand felt like it was "asleep". This continues today and has not changed in response to Ibuprofen by mouth. From additional information received 9-Jan-201, patient information was updated and reportedly the patient received 9 doses of Rabies vaccine ID in the period of 1982 to 1999. Patient is scheduled to call the reporter in one to 2 days to report status.
I got serious calf pain and racing heart beat directly following the vaccine. My heart was beating over 100 beats per minute and did not stop until I was diagnosed with Graves disease and treated.
Allergic reaction to COVID-19 mRNA vaccine. High severity - anaphylaxis.
Headache and fever around 9 pm. Both legs start to feel increasingly sore around hamstrings and below buttock. Chills around 10 or 11 pm. Headache, fever and chills subsided around 2 or 3 am. Leg pain continued strongly. I am unable to lay in bed without triggering pain in my legs. I move to the living room floor to sleep because the hard surface feels better on the legs. I go back and forth between standing and laying on the ground. Stretching helps some. Strong pain did not subside until about 6 am. The pain in the right leg did not heal with physical therapy, rest and stretching until about 8 months later. Pain in my left leg continues. I am still undergoing physical therapy. I suspect hamstring tendinopathy. This pain is triggered with sitting, lying on my back in bed and can be felt when running or the action of loading the hamstring in a lengthened position.
Upper lip swelling day after my second vaccine that is painful and significant. Swelling has not resolved with Benadryl that was suggested and remains significantly swollen and inflamed.  Right side of upper lip started swelling first and then it slowly spread to the left side of the upper lip. Bottom lip not impacted. No other signs of respiratory distress or rash. I did spike a fever exceeding 103.6 after the vaccine and had aches/chills/nausea/headache but these were all expected. The lip swelling has been the outlier.
Sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced sore arm after receiving 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189737:same reporter US-GLAXOSMITHKLINE-US2020189738:same reporter US-GLAXOSMITHKLINE-US2020189741:same reporter
Diarrhea X 5 days, followed by rash on face, following by fever up to 104 and inability to nurse possibly due to sore throat.
Pt recvd 3 Hepatitis-B vax doses on 26JUL89, 29AUG89, & 25JAN90 following these titer=103; one yr later titer=3;
My arm has been hurting since I had the 1st doce. When I lift up, it hurts so much. There's no swolen or rashes. Just pain. Why is that so after so long?
Day 7 after receiving vaccine, noticed a bump on the injection; 4 days later, noticed rash on legs and feet and now spreading to trunk.
Breastfeeding baby has fever again after I received t he covid shot  happened for shot 1 and 2
My eyes was dropping. Half of my face was numb. I felt really strange so I went to the ER. I was diagnosed -  Bell's palsy.
This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 75-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 24th September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 25th September 2018, 1 days after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced cold symptoms, chills, runny nose and headache. On an unknown date, the outcome of the cold symptoms, chills and headache were unchanged and the outcome of the runny nose was recovering/resolving. It was unknown if the reporter considered the cold symptoms, chills, runny nose and headache to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was reported by the patient's wife. The patient received an unspecified influenza vaccine on Monday. The patient experienced cold like symptoms which consisted of chills, headache, and runny nose. The patient stated that, the physician did not specify which manufacturer was used, but referred the reporter to GlaxoSmithKline (GSK). The patient did not know if the vaccine was FLUARIX or FLULAVAL. This case was one of the 2 cases, reported by the same reporter.
Allergies; Sinus problems; Dizziness when he is up and moving around; Equilibrium is off; Fatigued; This is a spontaneous report from a contactable consumer (patient who is a transit operator). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration in right arm, on 25Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing urinary incontinence (use of medication that does not make him run to the bathroom and helps him hold his urine), ongoing acne, drowsy, and ongoing flow of urine or weak bladder. The patient's concomitant medications included fesoterodine fumarate (TOVIAZ; Expiration Date: 04Dec2021) (about 2 weeks prior to getting the COVID-19 vaccine) for urinary incontinence, doxycycline (Expiration Date: 26Nov2021; makes him drowsy) for acne, and tamsulosin (Expiration Date: 12Nov2021) for flow of urine or weak bladder; all from Jan2021 and ongoing. The patient does not take any of these medications while driving. The patient took his first Pfizer COVID-19 shot on 25Jan2021 (Monday). The patient had been experiencing dizziness which started a few days after getting the vaccine (Jan2021). The patient was supposed to work from Tuesday to Friday, but he did not go into work on Wednesday. The patient was unsure of the specific day the dizziness started. The patient did have allergies (unspecified date), but when he called in his doctor, he sent him a medication for allergies, meclizine (Expiration Date: 28Jan2022). Normally, the medication takes a couple days to make him feel better. After he took meclizine for dizziness, he feels better. The patient notices the dizziness when he is up and moving around. The patient can tell something is off, like his equilibrium is off in Jan2021. It may not be due to the shot, but looking at the paper it says tiredness, which he has been feeling fatigued (also started a few days after the vaccine, but he is unsure specifically what day) and dizziness, which he has in Jan2021. The medication he is taking (meclizine), can also do the same thing, but never for this long. When he takes it, it normally makes him feel better after a few days. The patient has sinus problems as well on an unspecified date, but never lasting this long. The patient had not started feeling better since taking the medication, meclizine (as reported). The patient also said that meclizine could be causing the fatigue because it does make his drowsy and he just sleeps when he takes it - he cannot take it when he drives. The patient would go back for the second dose on 15Feb2021. The patient was recovering from "Dizziness when he is up and moving around". The outcome of "Allergies" was unknown. The patient had not recovered from the remaining events.
Febrile seizure 8/17/10, 24 hours after PCV13 given. Fever thought secondary to viral syndrome. Fever lasted 4 days.
Gingivostomatitis. Swollen lips, swollen gums, lacerations on gums and tongue x two weeks and continuing
24 hours after vaccination developed a mild erythematous rash on abdomen and left upper arm. Itchy, not painful. No shortness of breath, lip swelling, tongue swelling. Rash present 30 hours after onset, when patient presented to clinic today.
The pt had the varicella vaccine on 4/29/1996. He had a varicella exposure on 3/4/01. He developed varicella on 3/17/01. Pt had varicella with >700 lesions. Pt had at least 700 lesions.
3-28-08 Today, pt. reported, approx 30 mins. 3-26-08 after receiving Td imm-onset of dizziness, R sided throbbing headache & R arm soreness-headache & dizziness went away after eating a meal.  Exp'd diarrhea thru-out night.  On 3-27-08->arm soreness still present with "a little swelling".  Felt feverish-took Benadryl for swelling.  Today (3-28-08)-headache present "across forehead, little dizziness & increased R arm swelling & decreased soreness.
Patient received Prevnar 20 vaccination on Wednesday 07/19/2023. Patient came in on Sunday 07/23/2023. "Does this look normal to you?" Patient had red, hot, swollen arm. She had been marking the swelling from Friday to Sunday. The redness was moving down her arm. Stated Thursday she could not move her arm, was running fever, and arm started swelling. I informed her to go to urgent care to receive treatment as she might be having a late allergic reaction to the vaccination. I told her to put an ice pack in the mean time to help slow/reduce the swelling. I also told her that I would follow up/report with her MD and report this. If anything else were to happen, please let us know so we can report more. I gave patient scan receipt so they could help urgent care know what vaccine she received.
Nasua, diahria, burning pain in abdomen from day of vaccination, still present today
Red dots similar to chickenpox; Redness on her arm around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAPULE (Red dots similar to chickenpox) and VACCINATION SITE ERYTHEMA (Redness on her arm around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and MULTIVITAMIN & MINERAL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAPULE (Red dots similar to chickenpox) and VACCINATION SITE ERYTHEMA (Redness on her arm around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAPULE (Red dots similar to chickenpox) and VACCINATION SITE ERYTHEMA (Redness on her arm around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 05-Mar-2021 morning, the site was more red probably 2 inches in diameter.
Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Mar-2020, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 04-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication were provided It was reported that patient still had a cough but much better took time to get through this. No treatment details were provided
temp, pain, swelling, redness-infect @ inj site-saw MD tx w/PCN;
1st dose 2020, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The pharmacist called reporting a patient received his first dose of Twinrix in 2020 and had not yet received dose 2. The reporter consented to follow up. No additional details to share as pharmacist was at home when she called. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Injection site - pain, sore; This is a spontaneous report from a non-contactable consumer or other non-HCP (patient himself). A 40-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 18Feb2021 08:45 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Vaccination facility type was reported as Clinic. Patient medical history included peanut allergy. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other medication within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The reported seriousness of the case was non-serious. On 18Feb2021 at 10:00, the patient experienced injection site pain/sore. Therapeutic measures were taken as a result of injection site pain/sore included Tylenol. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
had small bruising on his arm; This is a spontaneous report from a non-contactable consumer for his father-in-law. This elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were not reported. It was unknown if the patient received  any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient experienced small bruising on his arm. It was unknown if treatment was received for small bruising on his arm. The clinical outcome of small bruising on his arm was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe abdominal pain; cramping; Chills; Malaise; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021). Concomitant products included paracetamol (Tylenol).   On 1st February 2022, the patient received the 2nd dose of Shingrix. On 1st February 2022, less than a day after receiving Shingrix, the patient experienced abdominal pain, cramp, chills and malaise. On an unknown date, the outcome of the abdominal pain, cramp, chills and malaise were unknown.   It was unknown if the reporter considered the abdominal pain, cramp, chills and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix a day before reporting and since receiving the second dose the patient had been experiencing severe abdominal pain and cramping, chills and malaise. The patient had also received Tylenol for unknown indication. The caller was requesting information regarding the side effects associated with the Shingrix vaccine. Spoke from Shingrix frequently asked questions content and the Shingrix package insert.  Provided medical advice disclaimer.  Caller provided permission to contact health care professional. No additional details were provided by the caller. The reporter consented to follow-up.
& cellulitis VANCOMYCIN, ACETAMINOPHEN, DOXYCYCLINE
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received SHINGRIX. Concomitant products included vitamin D, Vitamin C and Aspirin Baby. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 9th April 2018, the outcome of the injection site pain was recovered/resolved. In April 2018, the outcome of the injection site erythema was recovered/resolved. The reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported on behalf of her husband (patient). Concomitant medication included Multivitamin. The caller stated that the patient received the SHINGRIX vaccine last Monday before the date of reporting and later that day he experienced adverse events. The caller stated that the patient's redness went away immediately, however, the soreness lasted approximately 5 days then resolved. The patient has denied permission to contact their physician. This case has been linked with case US2018067040 (for patient's wife), reported by the same reporter.
Sore and swollen gums, dizziness, fatigue, red and flushed face
talking out of his head; Got the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 84 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Dec2021 10:30 (Lot number: FJ1620) at the age of 84 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "pacemaker" (ongoing), notes: He had medical conditions. He had the pacemaker for several years, maybe 2 to 3 years. There were no concomitant medications. Past drug history included: Timolol maleate, start date: 2021, stop date: 17Nov2021, notes: He took some eye drops and they took him off of those on 17Nov2021. The eye drops were Timolol Maleate. Caller had to put on her glasses to provide product information because it is tiny print on the bottle. Expiration: Nov2022. Lot: O8OL066. Strength: 0.5%. He was using it once a day. She doesn't know why Dr. withheld gave him the eye drops. He used them for maybe two months. Vaccination history included: Bnt162b2 (First dose, Lot number: EL9262, Expiry: May2021, He didn't have anything with the first dose of COVID19 vaccine), administration date: 21Jan2021, when the patient was 83 years old, for COVID-19 Immunization, reaction(s): "He didn't have anything with the first dose of COVID19 vaccine"; Bnt162b2 (Second dose, Lot number:EL9266, Expiry: May2021), administration date: 10Feb2021, when the patient was 83 years old, for COVID-19 Immunization, reaction(s): "fever". The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 10:30, outcome "unknown", described as "Got the booster"; FEELING ABNORMAL (non-serious) with onset 13Dec2021 22:30, outcome "recovering", described as "talking out of his head".   Additional information included The patient got the booster yesterday. Yesterday he was talking out of his head. He had not done anything different besides getting the shot yesterday. The booster was for COVID19. No prior vaccinations (within 4 weeks) and relevant tests. The patients had family medical history relevant to AE included his grandmother had some problems a long time ago, but caller doesn't know much about that because his grandmother died before caller was involved with the family. Product Complaint included caller reporting adverse event with the COVID Vaccine for her husband.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored M-M-R II lot# K018990 with expiry date: 15-OCT-2016, L015280 with expiry date: 30-APR-2017, L047134 with expiry date 24-NOV-2017 and L012482 with expiry date: 10-APR-2017 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Arm began swelling after injection with same amount of pain as previous injection later that evening.  Rash noted 45 hours after injection with urticaria on upper trunk and neck.  No rash noted after first injection in August.