chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose: had a headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced headache. The patient reported that after getting the second dose she had a headache. The patient also wanted to know the expiration date for the COVID vaccine she got. The outcome of the event was unknown.
This spontaneous report was received from a nurse refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of ROTATEQ, oral (strength, dose and lot # were not reported). It was reported that the vaccine was not monitored for unspecified period of time and there were no temperature logs available. The reporter was not aware of any adverse experiences at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Rash, burning of skin, headache, swollen glands, prickling of skin, cough, heaviness in chest.
bring down my period blood; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (bring down my period blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (bring down my period blood). At the time of the report, MENSTRUAL DISORDER (bring down my period blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Pain, swelling, redness and itch at vaccine site. Swelling and redness and itching about 6 inches in diameter,  quite painful and very tender to touch.
Tired now; flu like symptoms; red splotches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH MACULAR (red splotches) and FATIGUE (Tired now) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 641L20A and N4017294) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) for Blood pressure high, SERTRALINE HYDROCHLORIDE (SERTRALINE A) for Depression, TOPIRAMATE for Headache, CEFIXIME (FLEXERIL [CEFIXIME]) for Muscle relaxant and rest, TRAMADOL for Pain.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and RASH MACULAR (red splotches). On 26-Apr-2021, the patient experienced FATIGUE (Tired now). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved, RASH MACULAR (red splotches) had not resolved and FATIGUE (Tired now) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitants included thyroid and cholesterol medication, Treatment medication included Dermand cream.
pt recvd flu vax & devel redness, edema, soreness in the arm of inject; pt was seen by MD who felt this was a reaction to serum; pt was treated w/ATB for cellulitis; as of 16NOV92 sx are almost resolved;
4/2/08 mth. called.  Reports pt. began fever of ~101 degrees at approx. 8:30PM.  Took to MGH ER, and temp. by ear thermometer was 99.6 degrees.  Was rechecked with other thermometer and was 103 degrees.  Sent to another ER by PMD.  At other ER, seen by MD and admitted at approx. 1230PM.  Had blood and urine tests per moth.  Stated MD said all normal.  Was kept for observation.  Received Rocephin injection 3/5/08.  Fever went down to low-grade 3/5/08 that night and ran low-grade for a few days.  Was discharged 03/06/08, and mth. states Dr. said possibly vaccine related and vaccine allergy possibly.  Have requested hospitalization notes.5/15/08-records received for DOS 3/5-3/6/08-DC DX: Acute febrile episode status post immunizations. Developed low grade fever within a few hours after vaccine administration. Fever to 103.5 and fussy.
became ill; This case was reported by a consumer via call center representative and described the occurrence of illness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.   On an unknown date, the patient received Shingrix and PNEUMONIA SHOT. On an unknown date, unknown after receiving Shingrix, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingrix.  Additional details provided as follow: This case was reported by the patient's friend. The age group was not reported but it was selected as adult as per vaccine indication. The dates, patient demographics or specifics of the event were not known. Formulation of shingrix was not specified. The patient received Shingrix and pneumonia shot on the same day and became ill. No further information was provided
Fever 100.7, chills, body aches, headache x 24 hrs
pt was given APAP prior to inject of DTP; DTP given 930AM @ 130PM pt began to vomit, t101, c/o h/a; had convuls;
Left arm swelling and redness, rash had gone away and then came back. It is really itchy. Narrative:
She was taken off of life support 2 weeks ago; found her unresponsive in her home; heart inflammation; This is a spontaneous report from a Pfizer-sponsored program a regulatory authority via a contactable consumer. The consumer reported similar events for three patients. This is the first report. A 42-year-old female patient received bnt162b2 (COMIRNATY Lot number was not reported) via an unspecified route of administration on an unspecified date (at 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first single dose of bnt162b2 (COMIRNATY Lot number was not reported) on an unspecified date for covid-19 immunisation. The consumer stated that no past medical history that he is aware of. Her daughter found the patient unresponsive in her home after her second dose of the Pfizer BioNTech Covid-19 vaccine and was diagnosed with heart inflammation. She was taken off of life support 2 weeks ago. The outcome of the events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101377482 same reporter and drug, different patient and similar event;US-PFIZER INC-202101377481 same reporter and drug, different patient and similar event; Reported Cause(s) of Death: Unknown cause of death
Incorrect dose of state FLUZONE given. 0.5 ml of state FLUZONE given, instead of 0.25 mL.
Covid-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021; Covid-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021; This is a spontaneous report from a contactable pharmacist reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 12Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 with symptoms starting on 21Jan2021 and positive test on 22Jan2021 (medically significant) with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jan2021.    The information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.  However, based on the mechanism of action of the vaccine, it appears unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
red rash at injection site; This is a spontaneous report from a contactable Consumer. This 35-year-old female consumer (patient) reported. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 12:00 (at the age of 35-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism, dermatitis contact, food allergy. Concomitant medication(s) in two weeks included levothyroxine. The patient had allergies shellfish, adhesive. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 16:45, the patient experienced red rash at injection site 8 days after receiving vaccine "COVID Arm". The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. Information on the batch number has been requested. Follow-up attempts completed. No further information expected.
Patient had mild vaginal spotting on day of and prior to vaccination. She was pregnant and miscarried/started bleeding more heavily 20 days later.
Lt. upper arm erythema, edema, and pain. Lt. shoulder stiffness and pain, headache, stiff neck. Prescribed OMNICEF 300mg bid x 10 days.
A two to three inch diameter circular red rash at the injection site for over a week post 3rd booster shot. Pt reported having similar side affects with the 3rd shot as the other two, but the severity of symptoms has been getting worse. Red rash is very warm to the touch
After I received my first Pfizer vaccine I had a sore arm. What followed has been a nightmare. I started experiencing severe shoulder pain in my left arm and numbness/constant tingling in my arm. The tingling started in my shoulder and went all the way down to the tips of my fingers. I began to not be able to sleep at night because of my shoulder pain and the numbness in my entire arm I was experiencing. After going to the doctor I was prescribed a muscle relaxer to help manage my pain. It's been 3 weeks since I got the vaccine and I'm still having strange sensations through my body, the pain in my left arm/shoulder has gone away but it moved to the right side of my neck. When I try to turn my head I get this weird "electric"/tingling feeling that shoots up the back of my head and shoots down my arm at the same time. I can not function the pain is so horrible. I was a healthy 26 year old woman before this vaccine. I'm afraid I will never return to normal.
Tinnitus  I usually have slight ringing but has been much more prevalent since receiving the vaccine. Left ear only, left arm received vaccine.
Initial report received on 05 July 2012 from an electronic lay press article. A male patient (age and birth date not reported), who was also a hospital employee, received an injection of PERTUSSIS VACCINE, manufacturer unknown, (lot number, route, site and side were not reported) on an unspecified date. Approximately two weeks prior to 04 July 2012, the patient developed a nasty cough. Approximately one week prior to 04 July 2012, the patient went to clinic and complained of nasty cough. On Monday, 02 July 2012, test results for whooping cough were positive. "He was vaccinated against pertussis, but it wasn't effective." The patient's past medical history, allergies, and concomitant medications were not reported. Treatment for the patient was not reported; however, anyone with direct exposure to the patient was required to be treated with antibiotics. The patient's outcome was not reported. Documents held by sender: None.
Patient hospitalized for a surgical procedure for 6 hours on 4/6/21. This is within  6 weeks of receiving COVID vaccination.
Myalgia, Diarrhea, pain at injection site Narrative:  Myalgia and inection site pain/myalgia and diarrhea by 9pm on date of injection 12/29/20. Myalgias continued for 2 days and resolved by day 3.
The pt started to feel burning sensation and swelling after two hours after injection. The injected arm, left arm got swollen and hot, face feel hot but with no fever.
Sore arm; Bodyache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Bodyache) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date, Depression since an unknown date and Anxiety since an unknown date. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, LEVOTHYROXINE SODIUM (TIROSINT) for Hypothyroidism.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Bodyache) and FATIGUE (Fatigue). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm), PAIN (Bodyache) and FATIGUE (Fatigue) had resolved.            There was no treatment  received. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-005858 (Patient Link).
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 30-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX, expiry date 27-JUL-2017 (dose, route and site of administration and lot # were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient report severe redness, pain, and warmth at the site of her Zostavax injection.
On 1/12/2018 patient reports a rash starting on her ears, neck and shoulders that spread to her lower back. Also complains of confusion, increased anxiety, increased fatigue, and muscle weakness. Rash resolved after treatment with steroids but is now returning.
Started feeling itchy the evening I got the shot, woke up the next morning to hives up and down my legs and arms. Granted it isn't uncommon for me to get hives, but wanted to report so that data can be collected and investigated to see maybe what else might be in the vaccine that could cause folks to have these effects.
Upon waking on 10/17/16, patient noticed redness, warmth and swelling on her left arm where her flu shot was given.
Fatigue, knot at inj site, Face scratching, rash all over face. Skin is peeling. It is spreading.
Immediately following administration of vaccine pt lost consciousness for approx 1 minute, had a small seizure during this time. B/P 120/48.
5 minutes-dizzy 60 minutes jaw numbness 6-7 days later vomiting and diarrhea
Pt experienced: *Tenderness at pneumonia injection site *Flu-like symptoms  *Upper arm where pneumonia shot was given is painful, red, swollen and skin is a little hard. *Redness is about the diameter of a baseball *no fevers
About 2min after injection (s/s) Pt got hot, very moist feeling, felt nauseated, dizzy. After she sat for about 5-10 min and had drank of H20 she felt better. I've talked to with Pt and she is fine. She was ok after about 15min.
no adverse effects; a patient received improperly stored vaccine.; This spontaneous report was received form a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, exact dose, frequency, route of administration, anatomical injection site were not reported; lot number 1006345 is an invalid lot number for varicella virus vaccine live (Oka/Merck), expiration date was reported as 20-FEB-2022) as prophylaxis. On 15-FEB-2021, the patient was vaccinated with the second dose improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered in the right arm (strength, frequency route of administration were not reported; lot number S021322 has been verify to be a valid lot number for varicella virus vaccine live (Oka/Merck), with expiration date on 09-JUL-2021) as prophylaxis ; with the second dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) rHA administered in the right arm (strength, exact dose, frequency, route of administration, anatomical injection site were not reported; lot number S020962 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, with expiration date on 07-JUL-2021) as prophylaxis; diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid administered in the right arm (strength, dose, frequency, indication, and route of administration were not reported; lot number reported as C5643CP with expiration date on 17-JUL-2021); hepatitis A virus vaccine (unspecified) administered in the left arm (strength, dose, frequency, indication, and route of administration were not reported; lot number reported as ZJ363 with expiration date on 12-JUN-2022); influenza virus vaccine (unspecified) administered in the left arm (strength, dose, frequency, indication, and route of administration were not reported; lot number reported as 7P5BE with expiration date on 30-MAR-2021); and with poliovirus vaccine inactivated (unspecified) administered in the left arm (strength, dose, frequency, indication, and route of administration were not reported; lot number reported as R1F97 with expiration date on 03-OCT-2021).  Administered doses of vaccines experienced temperature excursion of 37.9  degrees Fahrenheit for 7 hours and 12 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Vestibular Neuritis - intense vertigo, imbalance, loss of coordination and strength leading to 5 day hospitalization stay following 2nd vaccination on March 12, 2021. Complete loss of vestibular nerve in left ear, with continuing long term dizziness and balance issues  9 months later and after 6 months of vestibular occupational therapy.
On November 23, 2022, I noticed a small nodule on the right side of my neck. I didn't pay a lot of attention to it at that point. On November 30, 2022, I noticed it again and made an appointment to see my doctor. I was prescribed amoxicillin for five days. I was asked to come back for a follow up visit in three weeks. During the follow up, I was told I needed a CAT scan of my neck. I was referred to an ENT Specialist. The CAT scan is scheduled for Friday. My appointment with the ENT is next week.
Dizziness at 10:10 AM immediately following vaccine-with nausea. Nausea, lethargy and headache on 10/21/09. 10/22/09-lethargy and nausea.
Pt recvd vax 13JUL93 3 to 4 days vax pt devel redness @ the inject site & dizziness; pt devel hyponatremia & was hospitalized; lentigines synd; MD felt pt sx had nothing to do w/vax;
Patient developed hives on various parts of her body a few days later. She went to the doctor and was given a steroid injection.
Headache, Arthralgia, Fever, Fatigue, chills, injection site pain and swelling Narrative:
11/10/11 at 820 mother called states arm received HPV et-tetanus swollen, hot, large knot felt. Denies fever or redness recommended eval per MD. After checking the record - mother wrong T-DAP given alone Rt deltoid and Lt deltoid was HPV & flu shot - mother said when she got 2 shots. Dr office reported Lt arm - quarter size red/swollen tender area. Dr instructions wait 30 min after next HPV shot.
Fever and muscle aches for 24 hours; This month, on May 27th, I Had chest pain. Dr had me go to ER - and they did tests - the chest pain went away after about two days.
Left leg began to itch. Hives on back of left leg. No treatment. Appears to be subsiding next day 3/5/21
Redness and swelling to (R) thigh 3/4 in x 1 in in size. Fever 100.9 F. TYLENOL as per package instructions/cool compress.