chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chill; temp of 99.6; body malaise; pain at injection site; This is a spontaneous report from a contactable Nurse.  A 49-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number Ek5370 via an unspecified route of administration on 17Dec2020 15:00 at single dose (first dose) vaccine location=Left arm and lot number EL3246 on 05Jan2021 at single dose (second dose) vaccine location=Left arm for covid-19 immunisation. Patient age of vaccination is 48 years. Facility type vaccine: Hospital  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension, gastrooesophageal reflux disease, erectile dysfunction, milk allergy and arthritis. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), ibuprofen (MOTRIN [IBUPROFEN]), lisinopril (LISINOPRIL), paracetamol (TYLENOL), sildenafil (SILDENAFIL). On 06Jan2021 07:00 the patient developed chill, temperature of 99.6, body malaise, and pain at injection site. The patient recovered from events. in Jan2021 and no treatment was received. the action taken is not applicable.
Mom called clinic & reported child developed t102 ax following inject, painful lt foot swollen unable to put on shoe x 2 days; elevated foot apply ice pack given child APAP; PC 12JUN91 child better no f/u necessary;
got sick to his stomach; threw up; doesn't feel good; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 65 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "got sick to his stomach"; VOMITING (non-serious), outcome "unknown", described as "threw up"; MALAISE (non-serious), outcome "unknown", described as "doesn't feel good". Additional information: Reporter is the patient's mother. Reporter stated that something the patient ate wasn't good and he got sick to his stomach and he doesn't feel good. Patient was supposed to get his shot at 3:30 if he feels alright. He has not yet received his second dose of the vaccine at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
the same day i had the same symptoms i had with the having covid in 2020. I was really tired for the most f the days and had to nap a couple of times throughout the day. my apatite was really bad and was grumpy for most of the time. I got endometritis after the vaccination as well.  the arm was really itchiness and a red bump.
8/14, four days after vaccination, developed unusual bruising with red spots on the opposite arm of injection. 8/18 began passing bright red blood with loose stools consistently. 8/24 began passing dark blood clots with loose stools, no bright blood present. During this time, began noticing small red and purple spots on different parts of the body, three on the right arm, two on right thigh, one small raised patch on left forearm. 8/24 developed a deep cramp like pain in the hand which persisted and a vein became inflamed and red on the night of the 25th. Checked into the ER early morning on 8/26. Chest CT was clear, platelets were normal range, D-Dimer test was elevated. Was given fluids and sent home after a few hours with a referral to a gastroenterologist. Symptoms still present.
Fever; bodyache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (bodyache) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PYREXIA (Fever), MYALGIA (bodyache) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), MYALGIA (bodyache) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: inconclusive (Inconclusive) fever.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.    Reporter did not allow further contact
99.2F temperature/  increased temperature; headache; tiredness; muscle pain; hot flashes; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of body temperature increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received Shingrix. On 6th August 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, hot flashes and difficulty sleeping. In August 2020, the patient experienced body temperature increased, headache and tiredness. On an unknown date, the outcome of the body temperature increased was not recovered/not resolved and the outcome of the headache, tiredness, muscle pain, hot flashes and difficulty sleeping were unknown.   It was unknown if the reporter considered the body temperature increased, headache, tiredness, muscle pain, hot flashes and difficulty sleeping to be related to Shingrix.  Additional details were received as follows: Age at vaccination was not reported. The patient received Shingrix and that night she had difficulty sleeping due to hot flashes, muscle pain, tiredness, headache, and 99.2F temperature. The patient had increased body temperature till the time of the report. The reporter refused to follow up.
After waiting the required 15 minutes left the pharmacy. About 10 minutes later while driving my entire left arm including my hand became numb and my tongue and back of my throat felt like it was swelling. I was close to an ER and went there. They took my blood pressure and sent me back to the waiting room. I was not comfortable waiting as I was having difficulty breathing and was scared so I left and picked up Benadryl and took 50 mg immediately.
Narrative: COVID infection following COVID vaccine series 01/22, Pfizer, dose #1 02/12, Pfizer, dose #2 08/16 pt cc: cough, fatigue, rhinorrhea exposure: unknown 08/22 COVID swab, result: detected 08/22 SARS-COV-2 Variant Sequencing result: pending
Moderate soreness I?m at injection site. Still severe to touch. Can?t sleep on it but can exercise with little pain.  Continued inflammation. No other side effects noted.
This spontaneous report was received from a physician assistant via a company representative referring to a 22 year old non-pregnant female patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown by reporter. Concomitant medications included GILDESS. On 31-MAY-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, Lot # M040412 with an expiration date on 30-JUN-2019 (strength and dose were not reported) for prevention of HPV. On 02-JUN-2017, the patient had developed hives on both of her legs. The patient was advised by physician assistant to treat the hives with cool showers, compresses, Calamine lotion, unspecified antihistamine and unspecified hydrocortisone. The patient sought medical attention and she was not hospitalized. It was unknown if any laboratory study was performed. At the reporting time, the outcome of urticaria was unknown. The causality assessment between the event and vaccination with GARDASIL 9 was not provided. Additional information has been requested.
Lingering pain--unlike previous COVID shots or any other vaccines, which typically didn't last beyond the first day or so. The pain  radiated down my entire arm and nothing soothed it--every position I placed my arm in, hurt. There was also numbness felt throughout my arm, into my fingers, especially when my arm was in a specific position. Any normal activity (driving, cleaning, working, etc.) led to pain and numbness--I constantly had to shake the numbness out or reposition my arm.
Patient (my son) office visit was to receive: 1. PDD Test (TB-Bubble) 2. Influenza Seasonal QIV only.  While administering the PDD Test (TB-Bubble) on his left-lower forearm (Intradermal) the NP inadvertently administered a  Johnson  & Johnson COVID-19 Vaccine - in the wrong location - not Intramuscular - and without request or awareness of the patient, who had already had Covid-19 (07/02/2021 - 07/09/2021).  Once injected there was immediate reaction with a large rise/bubble at the injection site and high level of pain described by the patient.  The NP immediate realized the deviation and informed the patient of what had occurred. The NP then proceeded to the 1. PDD Test (TB-Bubble) in the right lower forearm 2. Influenza Seasonal QIV, despite the known deviation. The NP did not provide the: Manufacture, Lot, or NDC related to the COVID-19 Vaccine for this visit (this information was excluded from his"IMMUNISATIONS Administered in the Summary of Care)  The NP also refused to provide a Vaccine Card or any documentation of the event. It was until a follow-up visit to get the PPD test read that he was informed that the Manufacture of the COVID-19 Vaccine was Johnson & Johnson (but still was never provided: Lot, NDC or Vaccine Card or any documentation of the related to the COVID-19 Vaccine event).  On 08/24/2021 I reported to this to pharmacy and they opened CASE.  Note: They have not made contact with me and I have not been successfully in making contact with them.  On 08/31/2021 I reported to this to "Johnson & Johnson" and they opened REQUEST (and J&J documented a report).
Small breakout of shingles; Red scaly patch; scaly patch; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 9th November 2020, 4 weeks after receiving Shingles vaccine, the patient experienced shingles, red rash and skin scaly. On an unknown date, the outcome of the shingles, red rash and skin scaly were unknown.   It was unknown if the reporter considered the shingles, red rash and skin scaly to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingles shot about 4 weeks ago and had red scaly patch on my right side.  The reporter asked could a small breakout of shingles occur after a shot.
pt recv vax JUN97 & in late JUL97 a negative titer was drawn;
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information concerning the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, route of administration were not reported; lot # M033611, expiration date 02-MAR-2018), for prophylaxis. The vaccine underwent a temperature excursion of 31 degrees Fahrenheit or colder (25.2 degrees Fahrenheit) for 16 hours and 48 minutes, for two cycles. No previous temperature excursions were reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013862: US-009507513-1705USA011701:
Patient reported having a rash on his lower back starting 11/2/19 following receiving vaccines.  He stated recently he has noticed some swelling of his lymph nodes in his groin
gave Menactra SQ by mistake instead of IM/no AE; inappropriate age at vaccine administration/no AE; Initial information received on 26-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist with live follow-up on same date.  This case involves a 66 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that gave Menactra SQ by mistake instead of IM/no AE and inappropriate age at vaccine administration/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot 46365AA and expiry date: 20-Sep-2024 via subcutaneous route in the right arm.  It was a case of actual medication error due to inappropriate route of vaccination and inappropriate age at vaccine administration.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
19 hours after 2nd Moderna vaccine started severe abdominal pain and nausea with vomiting.  Diagnosed with acute appendicitis. Had appendectomy on 3/7/21.
Approximately 24 hours after injection, pt developed a quarter sized area of induration and erythema at site (left anterior thigh). Increase in size over 24 hours. Then increase rapidly to about 5-6cm area next day. Not particular tender and ambulated well. No Dx given P O diphenhydramine and P O steroid x 4 days.
Received a dose from a vial after 14 hours since it was punctured for the first time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial after 14 hours since it was punctured for the first time) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.     On 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial after 14 hours since it was punctured for the first time). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial after 14 hours since it was punctured for the first time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Date the vial was initially stored in the refrigerator was 06 Aug 2021.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: two days in a row of negative antigen test; (unspecified date) Negative, notes: two days in a row of negative antigen test; (26Jul2023) Positive; (27Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (28Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (29Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (30Jul2023) Positive, notes: positive antigen tests on Day 1, 2, 3, & 4; (31Jul2023) Positive; (01Aug2023) Negative; (02Aug2023) Positive; Polymerase chain reaction positive: (26Jul2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 49 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0170), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0170), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: Ff2593), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "OCD" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: SYNTHROID; BUPROPION; PRISTIQ; VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Nov2022, outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794032 same patient/drug/event, different time period;
down for the day; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (down for the day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025020A) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (down for the day). At the time of the report, VACCINATION COMPLICATION (down for the day) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, after 2nd dose the patient was down for the day and had to call in sick from work.  No corrective treatment was provided.
pt recv vax & devel an inj site rxn;this is one of two patients from this site who exp above rxn p/vax;
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 192 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
(2) lg. areas of erythema, one inferior aspect of (R) upper arm & elbow.
Initial report received from a healthcare professional on 09 December 2013. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (route, dose number, batch number and anatomical site of vaccination was not reported) on unspecified date. On an unspecified date, the patient had soreness of the arm which last for a month. Corrective treatments and laboratory investigations were not reported. The outcome of the event was unknown. Documents held by sender: none.
Fever; swollen lymph nodes; euphoria; out of body experiences; joint pain; swollen joints; muscle pain; chills; headache; stomachache; diarrhea; disequilibrium; shingles; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 19Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) since an unknown date. The patient previously received NSAIDs in the past used for unknown indication and on an unknown date and experienced an allergy to analgesics. 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 receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 14:45, the patient experienced fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium and shingles. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events fever, swollen lymph nodes, euphoria, out of body experiences, joint pain, swollen joints, muscle pain, chills, headache, stomach ache, diarrhea, disequilibrium, shingles were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 11May2021 at 14:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.