chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RASH LEFT LEG; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: Epstein-Barr syndrome, and drug allergy, and other pre-existing medical conditions included: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 (coronavirus disease) treatment. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 12- AUG-2021 at 14:00 in right arm for prophylactic vaccination. It was unknown if patient experienced any adverse reactions following administration covid-19 vaccine ad26.cov2.s vaccine (dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: unknown) dose was not reported, 1 total, administered on AUG-2021 for prophylactic vaccination which was off label use as inappropriate schedule of vaccine administered (dose number in series 2). Age at time of vaccination 48 years old. No concomitant medications were reported.  On 26-APR-2022, at 18:00 the patient experienced rash left leg (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash left leg, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Pt's grandmother stated that pt's first dose was moderna and needed second dose. Later found pt's record indicated that he had received Pfizer and a different facility.
devel H. zoster rt T12 distribution 2wk p/daughter recv varicella vax;
body aches, chills, night sweats, injection site pain, lymph node pain and swelling, headache
Achy arm at injection site felt on the eve of the injection, but overall moderate- severe  muscle fatigue felt with exercise the next  morning, specifically burning buttock and thigh muscles while power walking the same route I do 4 x/week and difficulty catching my breath on the usual hills.  None of the fatigue was felt the next day on the same route. Also noted on day 7 was a droopy left eyelid that was mostly relieved by using refresh eye wetting drops but that still is present daily. I have had this occur once in my past and had a negative EMG workup. I have a scar on my left eye which may have been the cause and may be what is causing this to happen again. At 14 days I noticed new onset tight achy hips bilaterally, which is funny because one coworker has sudden knee pain/stiffness, and  another awoke with back pain and difficulty getting out of bed. They are still achy today
All of my joints, muscles and nerves felt like they were connected to an electric switch in the on position.  I had a very severe headache, couldn?t control my hands to hold phone or push buttons to call an ambulance, could not control my legs to get on my feet, could not completely wake up, it was as though I had been drugged an would go back to sleep, was confused when I would wake up because the pains were so severe.  When I did wake up after about 24 hrs all of the pains were completely gone as though the electric switch was turned off.
WHEN I ADMNISTERED THE VACCINE, 2 DROPLETS CAME BACK  AND DRIP OFF  THE ARM .
localized reaction/area was about the size of a hand.; large red area around the injection site; Area was painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (localized reaction/area was about the size of a hand.), VACCINATION SITE ERYTHEMA (large red area around the injection site) and VACCINATION SITE PAIN (Area was painful) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 013F21A, 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia, Congestive heart failure, Kidney failure (Stage 4 kidney failure), Hypothyroidism and Hyperlipidemia. Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE, METOLAZONE, DILTIAZEM (CARDIZEM [DILTIAZEM]), ACETYLSALICYLIC ACID (ASPIRIN ENTERIC COATED K.P.), POTASSIUM CHLORIDE (KCL), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D), CENTRUM SILVER [ASCORBIC ACID;BIOTIN;CALCIUM;CALCIUM PHOSPHATE DIBASIC;CHROMIC CHLORIDE;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL SULFATE;NICOTINAMIDE;PANTOTHENIC ACID;PHYTOMENADIONE;POTASSIUM CH, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), FUROSEMIDE (LASIX [FUROSEMIDE]), VITAMIN C [ASCORBIC ACID], PRAVASTATIN, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), HEMP and LORAZEPAM for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced VACCINATION SITE REACTION (localized reaction/area was about the size of a hand.), VACCINATION SITE ERYTHEMA (large red area around the injection site) and VACCINATION SITE PAIN (Area was painful). At the time of the report, VACCINATION SITE REACTION (localized reaction/area was about the size of a hand.), VACCINATION SITE ERYTHEMA (large red area around the injection site) and VACCINATION SITE PAIN (Area was painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.
Congestion; Watery eyes; Allergy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), LACRIMATION INCREASED (Watery eyes), HYPERSENSITIVITY (Allergy) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Since some years the patient has allergies.).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), LACRIMATION INCREASED (Watery eyes), HYPERSENSITIVITY (Allergy) and HEADACHE (Headache). At the time of the report, NASAL CONGESTION (Congestion), LACRIMATION INCREASED (Watery eyes), HYPERSENSITIVITY (Allergy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided. It was reported that the patient took Allegra, whenever she had allergy.
Outbreak of shingles on her back; This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had a shingles outbreak immediately after getting the first Shingrix vaccine. The reporter asked whether the patient should get the second dose. The reporter did not consent to follow up.
Started as a small knot in her leg with redness.  By 6/17/2010 at 9:00 AM the knot was the size of my fist.  By 6/18/2010 the knot is even bigger.  I took her to her pediatrician's office and was told by 3 nurses and the doctor available, that it was a normal reaction and to just use cold compresses and Tylenol.
1st vomited on 7/31. I vomited again on Aug. 5. I had gas pains spreading up my back. I received a 2nd Hep B vaccine on Aug. 8th
Loss of taste  Loss of smell  Upper respiratory tract infection, unspecified type  Fatigue, unspecified type
Developed pneumonia, hypoxemia and new onset atrial fibrillation all diagnosed within two days of the vaccine.  Had COVID19 in 2020 but got three immunizations anyway in 2021.
pt recvd vax 17DEC93 & 3 hrs p/vax exp pale, limp- high pitched crying for approx 3 hrs; MD called;
This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. On 22-FEB-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, route, dose not reported). No concomitant medications were reported. On an unknown date, the patient subsequently found out that she was 2 to 4 weeks pregnant. The LMP (last menstrual period) was estimated as an unknown date in 2013 and EDD (expected date of delivery) was not known. The pregnancy outcome was pending. The patient sought medical attention (contacted her physician). This physician was not the reporting physician). Additional information is not expected as without any patient identifying information, the reporter was unable to provide information.
11/13/22 presents to ED for "breathing problem". PMHx of "Parkinson's disease, atrial fibrillation"
Late onset of headache, body aches and fatigue around 6 pm on 5-18. Around 11:50 pm on 5-18 muscle cramping with sharp pains in left arm and left leg. Around 12:15, I became feverish and unnaturally cold. Shortly after, my whole chest and neck felt tight and almost as if I had advanced stage bronchitis. I took 2 Benadryl, 4 tylenol and my 90mg inhaler before laying down under 3 winter blankets. Waking up the next morning at 6:40, I still had chest tightness but had a sore throat, coughing, and swollen neck glands. I took 2 more Benadryl and 2 Tylenol for the headache, body aches, and mild fever before driving my child to school at 7:20. I went to an appointment at 11:00 am on 5-19 and left there around 11:45 still suffering from muscle cramping and aches (though much mellower than before) and proceeded to the store to buy Dayquil cold and flu which alleviated all but the persistent headache, fatigue, and injection site tenderness.
Medication error (medication error), Redness of eyes (ocular hyperemia), Pain eye (eye pain), tearing eyes (lacrimation increased).
blistering (herpes simplex); Muscle aches; stiffness; lethargy; soreness; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in left arm on 16Mar2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had allergies to NSAIDs and anti-inflammatory medications, morphine - ivory soap. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included paracetamol (TYLENOL) 500 mg for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 23Feb2021 at 16:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 (day after second dose), the patient experienced lethargy and soreness at injection site (vaccination site pain). On 19Mar2021 (three days post injection), the patient experienced muscle aches and stiffness. On 21Mar2021 (five-seven days post injection), the patient experienced severe blistering (herpes simplex) covering top lip under nose. The events did result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included antiviral ointment and oral medication. The clinical outcome of the events lethargy, soreness at injection site (vaccination site pain), muscle aches and stiffness and severe blistering (herpes simplex) were resolving at the time of this report.   No follow-up attempts possible. No further information expected.
Sudden onset of severe bilateral tinnitus about 12 hours after vaccine that is much more extreme than what I have been managing since 2006. This is a major impact on the quality of life and has completely disrupted my sleep.
Immediately after administration patient became faint, flushed, tachycardiac (rate in the 100s), short of breath and developed a metallic/plastic taste in her mouth.  She did not complain of swelling of the mouth or throat.  Within 3 minutes her heart rate decreased into the 80s.  We monitored her for 45 minutes, her symptoms were resolved after this time.
Diarrhea; Nauseous; Red spot at the injection site; Feeling bad/ Felt like got hit by train; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Feeling bad/ Felt like got hit by train), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (white blood cells are very low). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling bad/ Felt like got hit by train). On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad/ Felt like got hit by train), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chemotherapy: unknown (Inconclusive) unknown. On an unknown date, White blood cell count decreased: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15-Apr-2021, no new information was recorded On 20-Apr-2021: Follow up received on 20-Apr-2021 included email address
Dosing Error (Interchangeability with Pfizer Covid-19 vaccine); Inappropriate schedule of vaccine administered; A spontaneous report report was received from a other HCP concerning a  patient (age and gender unknown) was participating in the mRNA-1273 emergency use program and experienced  Dosing Error (Interchangeability with Pfizer Covid-19 vaccine).   The patient's medical history is not included. No relevant concomitant medication were reported.  On 15th Jan 2021, the patient received the 1st dose of Pfizer vaccine and on 28 Jan 2021 the patient received the 1st dose of Moderna vaccine.  Laboratory detail not included.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of wrong vaccine administered and inappropriate schedule of vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
Extreme vertigo lasting more than one month; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:00 as dose 4 (booster), single (Lot number: FiH9694) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial flutter" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hx breast CA" (unspecified if ongoing); "known allergies: sulpha" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; FAMOTIDINE; METOPROLOL; XARELTO; ATORVASTATIN. Past drug history included: Iodine, reaction(s): "known allergies: Iodine". Vaccination history included: moderna covid-19 vaccine (Dose 1,, lot number: 026L20A, administration time: 07:00 PM, vaccine location: Left arm, ), administration date: 13Jan2021, when the patient was 67-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 2,, lot number: 010M20A, administration time: 12:00 PM, vaccine location: Left arm), administration date: 26Feb2021, when the patient was 67-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 3,, lot number: 939905, administration time: 03:00 PM, vaccine location: Left arm), administration date: 01Nov2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 29Sep2022 at 06:00, outcome "recovering", described as "Extreme vertigo lasting more than one month"; BRAIN FOG (non-serious) with onset 29Sep2022 at 06:00, outcome "recovering". The events "extreme vertigo lasting more than one month" and "brain fog" required physician office visit. Therapeutic measures were taken as a result of vertigo, brain fog. Additional information: the patient had no other vaccine in four weeks. The patient had no been diagnosed with COVID-19 prior to vaccination, didn't tested for COVID-19 after vaccination. Treatment: Physical therapy, medication, home exercises.
This case was reported by a consumer (also the subject) and described the occurrence of allergic reaction to tetanus shot in a female subject aged between 20 and 29 years old who was vaccinated with Tetanus shot (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date when the subject was "about 22" she received a dose of tetanus shot (details unknown). At an unspecified time after vaccination with tetanus shot, the subject experienced allergic reaction to tetanus shot, hive, whooping cough and cough incontinence. The subject reported that she was allergic to a tetanus shot as she broke out in hives. She stated that she has had whooping cough a couple of times "lately" and when she coughs; she loses lots of urine further described as urine pours out of her. As a result she cannot go anywhere for a few months. At the time of reporting the outcome of the events was unspecified. The subject was inquiring about the possibility of receiving a whooping cough shot.
Per the mother patient had temp. 99-100.4 daily, off/on since vaccines given on 2/5. On 2/14 patient had seizure taken to ER Temp 100.6 during the wait, temp was fluctuating up to 104. At ER diagnosed with simple febrile seizure per ER doctor. No other symptoms at time of seizures or after. Per mother patient back to normal.
patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA416564, 2022SA416822, 2022SA417045, 2022SA418179, 2022SA419029 and 2022SA418179.  This case involves a 4 years old female patient received IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2022, the patient received 0.5 ml dose of suspect IPV (VERO), suspension for injection from a punctured vial (lot V1B901M; Expiration Date :22-Jun-2024) via unknown route in unknown administration site for immunization after it was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency; same day).  This situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  Action taken: not applicable.  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.
5 days later I was in kidney failure; Started getting sick that night; Many other infections and blood disorders.; Many other infections and blood disorders.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had covid in Nov2020", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Started getting sick that night"; RENAL FAILURE (hospitalization) with onset 2021, outcome "not recovered", described as "5 days later I was in kidney failure"; INFECTION (non-serious), BLOOD DISORDER (non-serious) all with onset 2021, outcome "not recovered" and all described as "Many other infections and blood disorders.". The events "5 days later i was in kidney failure", "started getting sick that night" and "many other infections and blood disorders." required physician office visit. Therapeutic measures were taken as a result of renal failure. Clinical course as: In Mar2021 patent had first Pfizer vaccine. Started getting sick that night and 5 days later patient was in kidney failure. Patient had been hospitalized 6 times and had dialysis twice. Many other infections and blood disorders, always recover but comes back. Patient have been to numerous doctors and didn't know where to turn to. Patient was a healthy person of 67.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.