chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe chest pain; This is a spontaneous report from a contactable consumer (patient). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0198), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jul2021 at 15:30 (at the age of 14-years-old) as a DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or perfumery. The patient medical history was none. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jun2021 at 02:30 PM (at the age of 14-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced severe chest pain on 18Jul2021 at 05:00. No treatment was received for the event. device timestamp was reported as, 19Jul2021. Outcome of the event was recovered in 2021.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 65 year old patient of unknown gender. On 29-OCT-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose, frequency and route not reported) and a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route not reported) at the same office visit. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Left leg swollen; Rash; Itching; Benadryl Sat and Sun 8-16-08,8-17-08
Patient reported "chest fluttering," palpitations, fast heart beat that happened intermittently, and fluctuation in heart rate that began 4 days after immunization. Patient went to the emergency room upon experiencing these symptoms. Patient reported having an EKG, chest x-ray, and other monitoring performed, all of which had normal results. Heart rate was determined to be fluctuating up and down in the ER. Patient was discharged without treatment. Patient reported these symptoms lessened but maintained for about a week after he first experienced them. Patient has fully recovered, though expressed concerns about residual effects.
MUSCULAR MILD ACHES GRADUALLY DEVELOPED TO STRONG ACHES TO PAIN AND MUSCLE TIGHTNESS BY 3 HRS OF SYMPTOMS ONSET.(ARMS AND THIGHS). TENDERNESS AT LYMPH NODE AREAS OF AXILLA AND GROIN. LIGHT SWEATING W/O FEVER BY 8 HRS OF SYMP ONSET. GENERALIZED MALAISE AND TIREDNESS FOR 15 HRS FROM SYMPS ONSET. TOOK TYLENOL 650 MG PO., Q 4HRS WITH IBUPROFEN 800 MG
Inadvertently administered the/vaccine/subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist informed that a student inadvertently administered the Shingrix vaccine to a patient subcutaneously instead the recommended intramuscular injection, which led to intramuscular formulation administered by other route. No data about the patient was reported. The reporter consented to follow up.
110PM pt recv vax;210PM nausea,queasy,dizzy;progressed to pt going home ill;nausea cont (dizziness) all that day in 1/2 of following day;no tx other than bed rest
Moderate to severe pain on both shoulders to the point that couldn't sleep on either side. Problems lasted 4 days on right shoulder, and close to 1 week and 1/2 on pneumonia side. It was very sore. Today feels ok but still feels soreness when massage or put pressure on area.
16:14 - vaccine administered 16:24 - itchy throat, chest, and left arm; throat tightened 16:29 - coughing and wheezing; hives on chest, neck, L shoulder; took 1000 mg Benadryl 16:34 - epipen administered
Pain immediately after injection with increasing discomfort and decrease reange in motion as days went on. Taking Nsaid and applying heat to site 2/16/21- folllow up= pain and still not the best range of motion- will be getting MRI and seeking orthopedic Unknow- no follow up with orthopedic
This spontaneous and non valid report was received from a Registered Nurse concerning to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. Since 29-SEP-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# N000175, expiration date 20-SEP-2018 (dose was not reported) for prophylaxis. It was reported that the vaccines were exposed to temperature of 32 Fahrenheit grades (°F) range for a time frame of 23 minutes and previous temperature excursion was between 32°F (Fahrenheit) to 35°F (Fahrenheit) for 1 hour and 49 minutes. The data logger was involved. However, no adverse effects were reported and no product quality complaint was involved.
24hrs post 2nd Dose Pfizer.  Bradycardia, chest pain, fever, skin patches heat sensation, swollen testicals, lymph nodes swollen, entire body joint pain, severe headache, foggy, extremely tired.  At 9:25am (24hrs after 2nd dose) I was able to muster enough energy to text.  15 minutes later my heart was beating so slow I was unable to move my hand to grab my phone. It was like I was paralyzed for a couple hours other than my heart beat hurt and below 30 bpm for a couple hours. In and out of being awake.  After a couple hrs I was able to move and my heart was beating faster. My chest hurt significantly for 12 days. May 13th, (9days post) I went to Emergency Room in evening.  Fear of blood clots with chest hurting and extreme fatigue.  ER preformed an XRAY for heart size and lungs, Blood work for blood clots and markets for heart attach.  All came in negative to a heart related event causing pain.
Missed 2nd dose; Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 10-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not reported.  Treatment information was not provided by the reporter.  The patient denied 2nd dose of the vaccine and did not received the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Reporter Address details updated. Patient demographics was updated. Suspect product Batch/Lot number was updated.
the antibody test she did in September of 2021 after her 3rd dose showed no antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (the antibody test she did in September of 2021 after her 3rd dose showed no antibodies) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 839902 and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant on 04-Jul-2011.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ANTIBODY TEST NEGATIVE (the antibody test she did in September of 2021 after her 3rd dose showed no antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (the antibody test she did in September of 2021 after her 3rd dose showed no antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: negative (Negative) no antibodies.         Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt went to doctors office w/swollen arm, producing pus. Pt now on abx w/arm in sling.
This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 08-year-old, child, male patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, which was considered as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M000997, expiration date 07-JAN-2018) for prophylaxis (dose and route of administration were not reported). The vaccine was stored at >5°Fahrenheit, but <14°Fahrenheit for 10 minutes. There were no previous temperature excursions. No adverse effects were reported. Temperature excursion information was obtained from a digital data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008691: US-009507513-1702USA002833.
This case was reported on 09-APR-2014 from a physician. This case involves a 16 year(s) old Male who was vaccinated with Yellow Fever Vaccine on 31 March 2014, batch UH599AA (dose, route and site of administration not reported). The patient's medical history and concomitant medications were not reported. Within 30 minutes after vaccination, the patient experienced hives, difficulty breathing and swallowing. Epinephrine was administered and breathing and swallowing improved. The patient continues to have hives. Laboratory tests were not reported. Further details were not available at the time of this report. The patient outcome was not reported. Documents held by sender: none.
WOKE UP AT 2:30 FOR WORK. TOOK SHOWER AND GOT DRESSED THEN DRANK A CUP OF COFFEE. ABOUT 3:00 AM STARTED TO GET A MASSIVE BURNING SENSATION ON MY BACK AND THEN THE MOST UNBEARABLE CHEST PAIN. HAD WIFE LOOK AT BACK AND TOOK PICTURE OF VERY LARGE AREA THAT LOOKED LIKE A SEVERE ALLERGIC REACTION. ABOUT 10" HIGH AND 8" WIDE.  HAVE PICTURE OF AREA. I WENT TO THE ER AT HOSPITAL AND THEY STARTED RUNNING TESTS TO DETERMINE CAUSE OF SEVERE CHEST PAINS. AFTER A CAT SCAN THEY SAID THEY CAN'T DETERMINE WHAT IS CAUSING LARGE AREA ON BACK AND CHEST PAINS BUT FOUND TWO ANEURYSM'S ON MY DESENDING AORTA AND I WAS IMMEDIATELY ADMITTED FOR SURGERY. NO ONE COULD OR WOULD TELL ME WHAT THE CAUSE OF THE CHEST PAINS WERE CAUSED FROM.
patient stated that the next day she had pain in her legs and she had trouble moving them. She went to the hospital 18 days later, with spasms, and pain, and nerve problems. Patient started to have pains in her upper body and middle body. Patient went to urgent care twice. Patient was denied for MRI by insurer.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescriber/administered by a pharmacist (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 10-APR-2015 the patient was vaccinated with GARDASIL (unknown dose and lot number) via intramuscular route which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of GARDASIL underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
24 hours after the 3rd covid Pfizer vaccine, patient developed brown-colored urine. Similar episode after receiving 2nd covid Pfizer vaccine, and the brown-colored urine self-resolved after 72 hours at that time.
Received injection on 12/31/12. Spot 3 1/2 inches swollen and center red and tender to touch.
Mother claims developed some reddish raised rashes on her face and body at night while at home. She had just received MMR,VZV and Hep A shots earlier in the day. Otherwise she was acting well, continued to eat well and was playful. Denies any fever, no diarrhea, no coughing.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/19/2021. Client given Pfizer EW0162 IM in right deltoid.
Mom reports that on 10/30/2021 after receiving the HPV vaccination, patient noticed increase in hair loss.  Patient was seen in Urgent Care 10/30/2021 -mild anemia noted Hg 11.3 normal MCV. remainder of CBC normal. BMP and TSH normal. ESR 23. CRP normal. Was seen at Dermatology on 11/01/2021. Dx with alopecia aerate. Has tried steroids, etc without improvement. Continues to have ongoing hair loss-lost eye lashes, lost 50% of her hair (lots of patches) remainder of hair very brittle.
it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine
Information has been received from a health professional, physician and a 57 year old female who on 09-NOV-2006 at 4 pm was vaccinated IM, into the right upper arm, with a 0.5 ml first dose of Pneumovax 23 (lot 651437/0899F). Concomitant therapy included WELLBUTRIN and aspirin. On 09-NOV-2006, at approximately 10 p.m., the patient experienced cellulitis like reaction with redness, swelling and warmth at the injection site. The patient reported that "the whole upper part of my arm and underneath got swollen, red and itchy." The patient sought medical attention and was treated with elevation, ice and BENADRYL. There were no laboratory or diagnostic tests. At the time of the report, the patient was recovering. The licensed practical nurse expressed concern that three patients in the same week had these reaction and stated that they were no longer giving Pneumovax 23. She stated that she "will await the results of whatever investigations will be done." The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government agency and was released by the regulatory agency. No further information is available.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "The second time, the second vaccination I had a delay in my menstrual cycle for over 49 days"; Bnt162b2 (DOSE 3, BOOSTER (SINGLE)), for COVID-19 immunization. The following information was reported: DYSMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "received the second booster in October; experiencing similar side effects that my menstrual cycle is again delayed with just very painful cramps because I haven't started yet, but it's delayed".    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.
FEVER OF 103 CHILLS SWEATS MIGRAINE WHOLE BODY ACHES  LOSS OF TASTE
She showed up at the hospital today and received her Covid shot.  She had no reaction to the first shot.  About 14 minutes after the shot she felt mildly short of breath.  Reportedly there was no signs of increased work of breathing.  She had no throat swelling or change in voice.  Patient reports these symptoms were different from her baseline asthma so the decision to call a Code 44 was made and she was brought to the ED.  Since that event her symptoms have improved.  She denies any chest pain or pressure.  She denies any recent illness prior to the event.  She denies any lightheadedness or syncope.
This spontaneous report was received from a female patient of an unknown age who was also a pharmacist reporting on herself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date in November or December 2016, while the pharmacist administered a dose of ZOSTAVAX 19400 plaque-forming unit (PFU) with its sterile diluent (manufacturer unknown) (lot #, expiration date, dose, route of administration or anatomical location were not reported for both); some of the vaccine could have gotten on her person (Occupational exposure to product/ Accidental exposure to product). No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA006421.
This infant had a fine rash to her legs with a few spots developing in the afternoon to the abdomen.
Pt started to develop a rash on her stomach on 6/15/23. The rash spread to her right arm on 6/16/23. On 6/17/23 it spread rapidly over her face, both arms, full torso and back. By 6/18/23 it was covering her legs and genitals as well. She didn't appear to be itchy from the rash - the only noticeable symptom was that she was uncomfortable when in her carseat. She never got open blisters.
administered first dose of Pfizer to patient. Patient was waiting 15 minutes post vaccine and when we went to check on him before closing for lunch, patient reported SOB and difficulty breathing. He stated he was currently a Nurse and requested administration of Epipen. administered 1 dose of EpiPen. Patient requested a second dose of Epipen but did not appear to need another dose and reported tightness lifted off chest but still SOB noted. called 911. administered patient 25 mg Benadryl liquid dose as secondary measure per protocol. Patient consumed 2 bottles of water prior to Ambulance arriving about 25 minutes after calling 911. Patient refused to lie down in supine position. He reported to EMTs that he had allergy to NSAIDs and Zoloft, so updated patient's PQCF form to reflect since patient originally reported NO to DRUG ALLERGIES. Patient left with EMTs on stretcher but reported SOB improving but still present.
Started with sore throat, then runny nose, then dry cough, then sinusitis, along with myalgia, fatigue, and excessive sleep.
was tested and diagnosed positive for the SARS-CoV-2 infection; was tested and diagnosed positive for the SARS-CoV-2 infection; developed symptoms after being exposed at work on 27Dec2020; This is a spontaneous report from a contactable nurse. A male patient (reporter's husband) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as the first dose via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got exposed as a first line nurse working in the emergency room. The nurse reports that her husband developed symptoms after being exposed at work on 27Dec2020 five days after being administered with the first dose of BNT162B2 and he was tested and diagnosed positive for the SARS-CoV-2 infection on 27Dec2020. The outcome of the events was unknown.  Information about Lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported "tested and diagnosed positive for the SARS-CoV-2 infection" is related to BNT162B2.  Event occurred only 5 days after receiving first vaccine and patient was exposed to virus at work.
Temperature of 105F, listless, dehydrated, pale and "clammy", 5 days after each of 2 PCV7 doses. Treated with Motrin and antibiotics.
Pfizer dose 1 12/23/20 dose 2 1/12/21  EE tested positive 10/22/21