chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a clinical medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. Since 21-MAR-2016 the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L020865 with expiration date 09-FEB-2017, dose unknown) orally. The temperature/time frame was 8.5 Celsius degree for 2.5 days (60 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Feeling very tired; This is a spontaneous report from a contactable reporter. A 57-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6205) as first dose on 08Mar2021 at 12:00 pm on her left arm for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history reported included hypothyroidism and high blood pressure. Concomitant medications taken include Baby aspirin, Tenormin, Rosuvastatin and Levothyroxine that was taken within two weeks of vaccination for unknown indication. Patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, patient started feeling very tired.No therapeutic measures were taken for the adverse event. The clinical outcome of the event was tiredness and did not recover from the event at the time of reporting. No follow-up attempts are needed. No further information is expected.
Starting on day 8 after receiving the vaccine, I got severe body aches and a fever of 100.8 that lasted for 2 days. The next 2 days I had a severe headache, nausea and diarrhea. On day 12, I woke in the morning with a nasty rash down the insides of my arms that spread to my body, back and insides of my thighs that I am still recovering from.
Pt was inadvertently given the Moderna monovalent booster instead of the Moderna Bivalent booster.  She is scheduled to come in and get the bivalent.
The patient was given the first dose of the Pfizer covid vaccine, subsequently he was standing waiting with his mother for his younger sibling to receive his vaccine and after I had administered that, I turned around and saw that he was starting to lean over and his mother and I went to grab him as he went down and he fainted momentarily. We slowed his descent, but he had a small abrasion on his head (I think from the carpet).  He said he felt dizzy and nauseous.  I'm  not sure if he was also watching while I was giving his sibling the shot and  that exacerbated the situation. We had him checked out by EMT and he was fine after the initial fainting.
Swelling and discomfort at injection site - 3 x 3 in diameter - raised, hot - patient noticed swelling on 10/25/07 in pm - progressively increased
SKIN LESION; SKIN IS EXTRA DRY; HURTING ARMPIT; ITCHING EYES; BURNING EYES; INJECTION SITE TENDERNESS; FLU LIKE SYMPTOMS; SPENT ALL DAY SATURDAY IN BED, DROWSY; SEVERE UPPER BACK PAIN; SEVERE NECK PAIN; ON AND OFF CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 around 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe upper back pain. On 26-MAR-2021, the subject experienced severe neck pain. On 26-MAR-2021, the subject experienced on and off chills. On 26-MAR-2021, the subject experienced mild headache. On 27-MAR-2021, the subject experienced spent all day saturday in bed, drowsy. On 28-MAR-2021, the subject experienced flu like symptoms. On 29-MAR-2021, the subject experienced hurting armpit. On 29-MAR-2021, the subject experienced itching eyes. On 29-MAR-2021, the subject experienced burning eyes. On 29-MAR-2021, the subject experienced injection site tenderness. On 30-MAR-2021, the subject experienced skin lesion. On 30-MAR-2021, the subject experienced skin is extra dry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe upper back pain, severe neck pain, spent all day saturday in bed, drowsy, flu like symptoms, on and off chills and mild headache on 29-MAR-2021, had not recovered from itching eyes, and burning eyes, and the outcome of hurting armpit, injection site tenderness, skin lesion and skin is extra dry was not reported. This report was non-serious.
Rash at injection sight, spreading down the arm and shoulder blade; Rash at injection sight, spreading down the arm and shoulder blade; Very itchy; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERO0734) via an unspecified route of administration in the right arm on 05Apr2021 at 16:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously took penicillin and experienced penicillin allergy. Concomitant medications taken within two weeks of vaccination included metoprolol (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and simvastatin (SIM); all from unknown date and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 15Mar2021 at 16:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 07Apr2021 at 15:15, the patient experienced rash at injection sight, spreading down the arm and shoulder blade. Very itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash at injection sight, spreading down the arm and shoulder blade and very itchy was not resolved at the time of this report . No follow-up attempts are needed. No further information is expected.
30 minutes after vaccine administration patient experienced transient tingling in her left hand. Otherwise patient was stable so patient declined offer of oral diphenhydramine. After checking in with patient an hour after we offered diphenhydramine tingling seemed to have gone away/patient did not report any symptoms.
Redness at (R) upper arm at injection site started 6/1/07-size of 2 quarters. Redness spread 8 x 10" indurated warm to touch by 6/2/07 (circled in ink). Motrin, cool compress.
Pain, redness and swelling to injection site (LUE). Elevated temperature, muscle weakness and nausea. Pain continued while other fever and nausea subsided by 10/22. Pain to LUE continues and has increased radiating from neck to elbow. Decreased range of motion and significant loss of mobility is affecting every day life from sleep to hygiene to driving. At times I am unable to move left arm at all. Have had to use right arm to move left arm due to loss of control and ability to use muscles in LUE. Symptoms worsening and MD contacted 10/30/12. "Tingling" and numbness shooting down towards left hand has started today, 10/30/12.
Seizure that lasted 1 1/2 hours even when given medicine in the ER. Kept in ICU 3 days. Ended up handicapped.
Muscle and whole body aches, headache, loss of appetite lasted about 24 hours. Treated with Tylenol, sleep, extra fluids.
Pt. reports that one hour after vaccine administration swelling and pain occurred to site of injection and has continued through day of reporting to Co Health Department 10/26/15.  Reports that she has not done any follow up with provider, no analgesics, no cold pack or warm pack to comfort site or symptoms.
Day 2 broke out in hives and headache  Day 3- starting feeling extremely fatigue  Day started feeling sore, legs hurt, and muscle aches  Today Day 9 legs still sore and muscle aches, and fatigue   Taking Benadryl at night for itching due to hives and Tylenol for soreness and muscle aches
right axillary lymphadenopathy  after getting vaccine in right arm. inflammation caused pressure on right side of chest resulting in visit to ER to have vitals assessed and EKG completed.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19), PERIPHERAL SWELLING (A little bit of swollen knot), VACCINATION SITE ERYTHEMA (Redness at the injection site) and UNDERDOSE (Some of the vaccine leaked out of where the needle goes into the syringe) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), MONTELUKAST SODIUM (SINGULAIR) and ELUXADOLINE (VIBERZI) for an unknown indication, SALBUTAMOL.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (A little bit of swollen knot), VACCINATION SITE ERYTHEMA (Redness at the injection site) and UNDERDOSE (Some of the vaccine leaked out of where the needle goes into the syringe). On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19). On 18-Feb-2021, UNDERDOSE (Some of the vaccine leaked out of where the needle goes into the syringe) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19), PERIPHERAL SWELLING (A little bit of swollen knot) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: (Positive) Positive.         Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Doctor thinks Patient has Positive COVID-19; Reporter's Comments: This report refers to a case of Underdose, for mRNA-1273, lot #: 031M20A, with associated AEs.  Based on the current available information and temporal association between the use of the product and the start date of the events, Injection site Erythema and Peripheral swelling, a causal relationship cannot be excluded.
vaccines given post excursion with no reported adverse event; vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from other health care professional.  This case involves a 11 years old male patient to whom vaccines given post excursion with no reported adverse event and vaccines being given post temperature excursion with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE)  for Prophylactic vaccination.  On 02-May-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE , once (lot: U6737AA; expiry date: 09-Jul-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that vaccines were given post temperature excursion (product storage error) (Poor quality product administered) (latency: same day).  Action taken: not applicable.  Corrective treatment: not reported  Outcome: unknown  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 the 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.; Sender's Comments:  01090544: 01092869: 01092879: 01092814: 01092832: 01092891: 01092746: 01092709: 01092741: 01092787: 01092803: 01092850:
low grade fever; chest pain; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), CHEST PAIN (chest pain) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 28-Feb-2021, the patient experienced PYREXIA (low grade fever) and CHEST PAIN (chest pain). On 27-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, PYREXIA (low grade fever) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Mother reports that the patient is disabled that's why she is qualified.
severe Migraine since May 20th, 2021 after getting the first dose of Pfizer vaccine. Migraine medicine every single day and was prescribed a steriod dose pack.
Sore arm; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL0142; Expiration Date: 21May2021), intramuscular on the left deltoid on 30Dec2020 as dose 1, single, for COVID-19 immunization at the workplace clinic (not a military facility). Medical history included ongoing hypothyroidism from 2014; ongoing migraines from 08Oct2020; and ongoing seasonal allergies from 2012. Concomitant medication included ibuprofen on 28Jan2020. On 30Dec2020, the patient had sore arm. The patient's x-ray on 09Feb2021 showed no abnormality. The outcome of the event was unknown. The reporter's assessment on the causal relationship between the suspect vaccine and the event was related.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 4:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient age was reported age 47.90. No concomitant medication was reported by reporter. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
pt recvd 1 dose of Engerix-B immed following vax devel blurred vision; MD visit was required;
This report was identified from a line listing obtained on request by the Company from the FDA (HA# 697927) under the Freedom of Information Act and refers to a 14-year-old female patient with no concurrent illness or medical history. The patient had no concomitant medications. On 24-MAY-2017, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly in the left deltoid, lot # M041212, (dose and expiry date were not provided) for prophylaxis. The patient and her mom left office approximately 10 minutes after injection. Front desk employee came back stating that the patient fainted in elevator. The patient was given water and dextrose, electrolytes (unspecified) (PEDIALYTE). The physician stayed with the patient and her mom until she was feeling better. Blood pressure was checked; however, no result was provided. No other laboratory tests were performed. It was also reported that the patient had not eaten since 10:00 o'clock that day (24-MAY-2017). The outcome of the event was reported as recovered on the same day. Causality assessment was not provided. Follow up information was received from a licensed practical nurse via FDA on 15-APR-2019. The primary reporter was updated to a licensed practical nurse. The patient had no illness at the time of vaccination. Follow up information has been received from the licensed practical nurse on 02-MAY-2019. The reporter stated that was unable to locate the patient shared in the letter. Upon internal review, syncope was now considered to be medically significant.
Headache; Mucus in back of throat; Body Aches all over; swollen underarm lymph node on left side (left shoulder vaccine site); Fever of 99.9; Tiredness; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 11Jan2022 15:00 (Lot number: FJ1614) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JORNAY PM; METHYL PHENIDATE [METHYLPHENIDATE]; GUANFACINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 14Jun2021, when the patient was 12 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173), administration date: 20May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Headache"; INCREASED UPPER AIRWAY SECRETION (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Mucus in back of throat"; PAIN (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Body Aches all over"; LYMPHADENOPATHY (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "swollen underarm lymph node on left side (left shoulder vaccine site)"; PYREXIA (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Fever of 99.9"; FATIGUE (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Tiredness"; LETHARGY (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "lethargy". The events "headache", "mucus in back of throat", "body aches all over", "swollen underarm lymph node on left side (left shoulder vaccine site)", "fever of 99.9", "tiredness" and "lethargy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, increased upper airway secretion, pain, lymphadenopathy, pyrexia, fatigue, lethargy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Jornay / methyphenidate 100mg, Guanfacine 4 mg within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
5 mins after administration, patient reported slight throat constriction and bad taste in mouth. Patient was given water and reported feeling better, but refused to sit down, saying it made her feel worse. After 10 mins, she reported tingly scalp and numbing tongue. She was given 50mg liquid diphenhydramine at approximately 12:50pm. Patient then left the pharmacy sometime thereafter.
No adverse effect reported; second dose of PROQUAD was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, and drug reactions/allergies were not provided. The patient was administered a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) on 16-JAN-2015.  On 26-DEC-2017, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number and expiration date were unknown) subcutaneously for prophylaxis.  On 12-JUN-2019, the patient did not have his/her vaccination record upon visiting office, at which time a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S000620, expiration date 06-JUL-2020) subcutaneously for prophylaxis. Once the patient's vaccination record was obtained, it was discovered that the patient had already received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (extra dose administered). No adverse effect was reported. No product quality complaint (PQC) was involved.