chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer.   A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization.  Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
Left upper arm at inject site w/moderate amount of edema and redness and warm to the touch. Small slit like open area at inject site. No drainage noted. PT returned to clinic 24 hrs post injection for above assessment. Continued on progress note.
No adverse events noted, patient reports she feels fine.. Given at 9:30am on 8/23/22, drawn up on 8/22/22 at 8:40am.  Spoke to Pfizer and they stated since administer time exceeded 24 hours, may not be as effective. Referred to  site for further guidance.
It felt like a mild punch in my arm; A little sluggish in the head; Like a little head cold; Felt sleepy for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It felt like a mild punch in my arm), HEAD DISCOMFORT (A little sluggish in the head), NASOPHARYNGITIS (Like a little head cold) and SOMNOLENCE (Felt sleepy for 1 day) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FEELING ABNORMAL (It felt like a mild punch in my arm), HEAD DISCOMFORT (A little sluggish in the head), NASOPHARYNGITIS (Like a little head cold) and SOMNOLENCE (Felt sleepy for 1 day). On 12-Feb-2021, SOMNOLENCE (Felt sleepy for 1 day) had resolved. At the time of the report, FEELING ABNORMAL (It felt like a mild punch in my arm), HEAD DISCOMFORT (A little sluggish in the head) and NASOPHARYNGITIS (Like a little head cold) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-482921, MOD-2022-482874 (Patient Link).
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Headache, Fever, Diarrhea & Nausea Vomiting
pt recv vax 29JAN97 & 8FEB97 pt devel a macular-papular, blanching rash all over the body, felt to be measles, w/URI sx;it was also noted that pt had a diaper rash poss d/t candida;tx med;
None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
ONE MONTH AFTER TAKING THE VACCINE, I HAD A TERRIBLE THROAT PAIN, COUGH, FEVER, NECK PAIN, EAR PAIN, JOINTS PAIN, EXCESSIVE TIREDNESS.
6-7 hours after vaccination, tightnes in upper chest and throat. Developed fever of 102 and chills. Strong muscle pain in both arm. Symptoms subsided over 2-3 days except chest tightness and generally not feeling well.  08/23/2018 Fever gone but short of breath, chest tightness when laying down, dry cough and feeling ill. 08/23/2018 Family doctor said to use ProAir and use Benadryl. 08/25/2018 Temp of 100.5, fatigued, coughing and tightness. 08/26/2018 Went to Urgent Care due to increasing cough, chest tightness. Treatment: Z-PAK, steroid injection, Albuterol nebulizer & antihistamine routinely.  08/30/2018 Bronchitis and fever. Symptoms tightness in chest occurred for 2 1/2 months after Shingrix
neuropathy/being worse at night/severe neuropathy; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy/being worse at night/severe neuropathy) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71UOL) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation (Past medical history of A fib,) and Back discomfort. Concurrent medical conditions included Drug allergy, Osteoarthritis and Neuropathy since 21-Jan-2021.   On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2022, the patient experienced NEUROPATHY PERIPHERAL (neuropathy/being worse at night/severe neuropathy) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). The patient was treated with GABAPENTIN for Neuropathy, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy/being worse at night/severe neuropathy) and CONDITION AGGRAVATED (Condition aggravated) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that 5 days after the 1st vaccine the patient developed severe neuropathy which she still had and was on medication for it. Patient was taking Gabapentin. At the time there was not reported of that side effects. The reporter stated after every booster they get the side effect neuropathy being worsened at night after the 4th dose and after the booster. Next one 5 days after the first dose was when they neuropathy and it was severe but never went away. The patient saw a neurologist about a month later. Company comment: This spontaneous case concerns a female patient of an unknown age, with current condition of neuropathy, who experienced the unexpected and serious (medically significant) event of NEUROPATHY and condition aggravated, on the night of the fourth dose of mRNA-1273.222 vaccine, and after an unspecified time interval after the booster dose with mRNA-1273.222 vaccine. She developed neuropathy 5 days after the 1st dose with mRNA-1273 vaccine which worsened after the last doses. Patient was taking Gabapentin. The event had not resolved. No further clinical information was available for medical review. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report.   This case was linked to MOD-2021-016971 (Patient Link).
pt recvd vax 7OCT95 & 21OCT95 pt devel a rash on the lt leg;no further details known as of the date of this report;
This spontaneous report was received from a registered pharmacist refers to an adult female patient of unknown age. On an unknown date, the adult patient was vaccinated with a 2 doses of MMR II (lot number, expiry date and route was not reported) when she was a child. On an unknown date, the patient had low rubella titers. Treatment was not provided. The outcome of low rubella titers was reported as not recovered. Additional information has been requested.
had the first dose of Shingrix in 10/2020 and is overdue for the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020, intramuscularly).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was planning on scheduling an appointment at this time. The reporter consented to follow up.
Day of shot: sore arm within 30 minutes of the vaccine, headache slowing worsening throughout the day, and little nausea before going to sleep. Following morning I have a bad headache and took 2 Aleve while feeling like I just want to throw up.
Delayed rash on arms & legs; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EN6201) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]; VITAMIN B-12; VITAMIN D NOS; MELATONIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL9261, Vaccine location: Left arm), administration date: 25Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 16Jul2021, outcome "not recovered", described as "Delayed rash on arms & legs"; FATIGUE (non-serious) with onset 16Jul2021, outcome "not recovered", described as "severe fatigue". The events "delayed rash on arms & legs" and "severe fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, fatigue.  Additional information: Other vaccine in four weeks: No. Other medication in two weeks: Advil, vitamin b-12, d, melatonin. The patient experienced Delayed rash on arms & legs, severe fatigue 6 months after 2nd dose. Her daughter also had delayed rash reaction. The worst of the rash lasted a month. Still experiencing small areas of rash on arms. She still was experiencing terrible fatigue and saw a naturopathic doctor. Adverse event start date: 16Jul2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit. The patient did not recover. Treatment was taken for the AE which included Supplements/homeopathic remedies. No Covid prior vaccination.  Follow-up attempts were completed. No further information was expected.
This is a spontaneous report from a contactable nurse via a Pfizer Sales representative. This nurse reported similar events for three patients. This is the first of three reports. A child (age and gender unknown) received a dose of PREVNAR 13 intramuscularly in the thigh as a catch-up dose on 30Sep2010. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were none. On 30Sep2010, while the patient developed rashes at the injection site with a radius greater than 2 to 5 inches. Relevant lab data was unknown. The event did not require an emergency room or doctor visit. At the time of the report, the patient, currently 3 years old, had not recovered from the event. Follow-up (17Oct2011): Follow-up attempts completed. No further information expected.
fever; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, PYREXIA (fever), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking unspecified concomitants for thyroid cancer.  The patient experienced dizziness, headaches, and fever following her dose and was taken by the rescue squad to the emergency room for her symptoms. She was not admitted to the hospital but was discharged from the emergency room after receiving a steroid injection for her symptoms.
This case was reported by a physician and described the occurrence of hypotonia in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included Hib vaccine given on 14 July 2008. There were no concurrent medications. On 14 July 2008 the subject received 1st dose of PEDIARIX at 0.5 ml in the left thigh and 1st dose of PREVNAR (unknown). Fifteen minutes after vaccination with PEDIARIX, at an unspecified time after vaccination with PREVNAR, the subject experienced hypotonia, inconsolable crying, and pallor. This was considered to be a systemic reaction. Within about fifteen minutes, the issues resolved. The subject was taken to the local emergency room and admitted for overnight stay in the hospital. She was evaluated with EEG, EKG, lab work and chest x-ray, all of which the physician reported were normal. The physician questioned the lot of PEDIARIX given since she had another 2 month old with adverse events also. This was considered to be a product complaint. In the physician's opinion, the events of hypotonia, inconsolable crying and pallor were all possibly related to treatment with PEDIARIX. This case is linked to case A0739957A. The first case involving a 2 month old that experienced adverse events following administration of the same lot of PEDIARIX.
Hives on legs, arms and face.   Treatment with allergy medicine,  hydrocortisone ointment, oral steroid, Tylenol.
Nausea, hot flashes, and chest pain with racing heart about a half hour after being given the Covid vaccine.  Pepcid and Zyrtec given.
Vaccine administered to patient post expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  It was reported that patient had received the additional dose.  Date the vial was initially stored in refrigerator was 31 Aug 2021 and the vial did not undergone any temperature excursions.  No treatment medications was reported   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up document received includes no new information.
Developed a severe case of cellulitis. Fever, chills, sweats, swelling on site of needle in right arm and severe swelling and redness in area next to where needle when in.  Extreme pain for 5-7 days.  Put on antibiotics, ceflex and cipro, pain relievers, and steroids.
Pain in injection location (left shoulder-bicep) started approx 0.5 hr after injection (6:30 pm 12/05/2012.  Woke up next morning 4:30 AM 12/06/2012 with severe pain in left bicep-could not raise left arm above shoulder.  No visible signs at site of injection.  Went to work. Approx 11 am 12/06/2012 started feeling warm and weak but pain in shoulder subsiding.  Came home and went to bed.  4 PM 12/06/2012 woke up, very hot, oral temp 104.3 F.  Blood pressure 130/71 81 bpm.  Ate small meal, drank approx 1.5 liter iced tea, took 2 x 325 mg acetominophen. Slept again. Woke up 9:15 PM 12/06/2012 oral temp 100F BP 142/78 78 bpm. Took 3 x 325 mg acetominophen. Slept again. 12:15AM 12/07/2012 woke up.  Oral temp 98.5 BP 126/78 69 bpm.  Took 3 x 325 mg acetaminophen. Slept. 7:15AM 12/07/2012 woke up; shaved/showered. 8 AM 12/07/2012 oral temp 98.6 BP 127/82 75 BPM.  Filed this report.
High fever, severe headache, entire upper arm edematous, erythematous.  Treated with cool compresses.
THIS IS AN ADMINISTRATION ERROR REPORT AND NOT AN ADVERSE EVENT REPORT.  CHILD RECEIVED 3RD DOSE OF PFIZER 6 WEEKS FROM 2ND DOSE  INSTEAD OF THE 6 MONTH INTERVAL FROM 2ND TO 3RD DOSE.  THIS INCIDENT HAPPENED AT A SCHOOL VACCINATION EVENT WHEN PARENT TURNED IN PAPERWORK AND CONSENT TO HAVE HER CHILD VACCINATED.  SHE PUT INCORRECT DATE OF BIRTH FOR CHILD SO WAS NOT FOUND IN STATE IMMUNIZATION SYSTEM.  MOM STATES SHE TURNED IN PAPERWORK BECAUSE SHE THOUGHT SCHOOL WAS ASKING FOR HER CHILD'S RECORD OF RECEIVING THE VACCINE INSTEAD OF WANTED TO HAVE HER CHILD RECEIVE THE VACCINE.  MOM STATES CHILD IS DOING FINE AND NO ADVERSE REACTION FROM RECENT VACCINATION ON 10/22/2021.
This spontaneous report was received from a nurse concerning to a 1 year old female patient. Medical history and concurrent conditions were not reported. On 18-JUN-2014, the patient was vaccinated with the first dose of VARIVAX lot # J011125, expiration date 05-SEP-2015, 0.5 ml, subcutaneous in the right arm. Other suspect therapies included MMR II, lot number 1720AA, expiration date 17-APR-2015, rHA status, 0.5ml subcutaneous route. Concomitant therapies included VAQTA, lot number J005010, expiration date 23-OCT-2015, 0.5 ml, intramuscular in left arm. On 18-JUN-2014, patient "instantaneously" experienced redness and swelling at the injection sites for MMR II and (Oka/Merck) VARIVAX. The areas that were swollen were further described as 3.5 to 4 inches in diameter, golf ball size, raised and looked like they were going to blister, injection sites were still painful, swollen, red and with erythema when patient left the healthcare providers office. Patient did not experience an adverse site reaction at the VAQTA injection site. Patient received medical attention treatment in the healthcare providers office included BENADRYL and ice. No lab diagnostics studies were performed.  Additional information has been requested.
Covid-arm.  Red, itchy, lump at the injection site. The red site has continued to grow. It is now 9 days since the vaccine was received.
Pt. given DTP, MMR, OPV & Hib-titre on 04Dec90.  Rec'd Acetaminophen every 4 hrs after immuniz.  Behavior changed noticeably at 8pm same day, became lethargic, irritable w/ some occas "jerkiness" of limbs.  Awoke w/ T104.5(R), fever cont'd.
Not sure of vaccine name other than seasonal Influenza manufactured by GlaxoSmithKline/GM2TF. I am an RN, I've gotten flu shots every year for about 15 years. The injection itself was not painful, but became painful within a few hours as expected. Soreness lasted a couple of days but then seemed to abate. Soreness has been increasing again since (est) 9/22/17. I have a moderate amount of pain in my near injection site when I perform certain activities such as reaching out or above my head, steering my car, etc. The pain wakes me up multiple times during the night. There is no lump or local inflammation, but I am unable to perform full range of motion on that arm.
ACUTE HYPOXEMIC RESPIRATORY FAILURE  4/20/2022 --  RECURRENCE OF SAME SYMPTOMS
Immediately, post vax, on the way home, mother noticed a high fever. She gave him a tepid bath which did not help so she took him to ER. 15 days later, the child developed seizures and was unable to move leg. On 1/98, the pt was referred to CCS and dx'd with Cerebral Palsy. This was not reported to PH until screened for immunizations on 7/25/01. The 7/7/97 was only PH visit. Child was treated and received further immunizations from other facility.
This spontaneous report has been received from a medical assistant /office manager, referring to a 22 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 18-JUN-2018, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis, instead of VARIVAX No adverse effects were reported.
urticarial rash at the R upper arm injection site almost two weeks after the administration Moderna 039K20A 80777273 10-NDC