chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Moderna vaccination during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Moderna vaccination during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Moderna vaccination during pregnancy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   No treatment medication were reported.
Persistent low grade infectious symptoms after second Pfizer dose. Had the typical mild immune response that resolved in 24-36hours post immunization then ~4 days later a secondary response that has essentially persisted since that time (~2months at this writing). Have confirmed that never had actually COVID infection and otherwise normal labs to rule out other etiologies of similar symptomology.
Pt alerted us ahead of time that he had fainted one time prior when he received a vaccine.  We had staff sit next to him in the waiting area after his vaccination.  About 1&1/2 min post vaccination he started feeling light headed and sick to his stomach.  He let our staff know and I immediately went to check on him.  He was sitting on floor, then decided to lay down because he was feeling sicker.  I took his BP and it was 100/60.  He said the top number normally runs around 160.  His skin was cool and he was sweating all over.  We called 911 to evaluate the pt.  While we were waiting we put his feet up on a pillow and got him some water.  After about 5 min he decided he wanted to try and sit when his color started coming back.  We got him to a sitting position and the medics finally arrived.  As they were checking him he felt bad again and laid on their cot.  Their evaluation was that his numbers were all fine.  He was feeling better and they got him to a standing position and he was able to walk out of the store.
My menstrual cycle was much heavier with more intense cramping. I had to change my tampon twice between 8am and 12pm.; My menstrual cycle was much heavier with more intense cramping.; I typically have vaginal discomfort due to childbirth 10 years ago but it became much more painful (4 on a scale of 1-10) this cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 08:30 (Lot number: FC3182) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 29Aug2021 12:00, outcome "unknown", described as "My menstrual cycle was much heavier with more intense cramping. I had to change my tampon twice between 8am and 12pm."; DYSMENORRHOEA (non-serious) with onset 29Aug2021 12:00, outcome "unknown", described as "My menstrual cycle was much heavier with more intense cramping."; VULVOVAGINAL DISCOMFORT (non-serious) with onset 29Aug2021 12:00, outcome "unknown", described as "I typically have vaginal discomfort due to childbirth 10 years ago but it became much more painful (4 on a scale of 1-10) this cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, vulvovaginal discomfort.  Additional information:  it was reported that patient did not receive any other vaccine in four weeks. It was reported that her menstrual cycle was much heavier with more intense cramping. She had to change her tampon twice between 8 am and 12 pm. She typically had vaginal discomfort (due to childbirth 10 years ago), but it became much more painful (4 on a scale of 1-10) this cycle. She stopped using tampons after she had to change the second time, and began using pads to try to ease the pain. The pain continued for the next two days. The heavy menstruation continued for three straight days. The last two days of her cycle were very light. She was diagnosed with PCOS at 22. Patient had COVID prior vaccination and was not tested for COVID, post vaccination.  Follow-up attempts are completed. No further information is expected.
Severe vertigo and lightheadedness Lot of panic and anxiety, sharp increase of heart rate. Extreme case triggered once while driving Neurologist diagnosed with vestibular neuritis
Patient admitted into hospital on 10/04/2016 due to diagnosis of "dehydration secondary to vomiting and fever". Was stated that "symptoms started 5 days prior to admission. Had given TYLENOL. Had some sweats and chills. No Rash. Decreased appetite. Won't drink milk, but does take little water. No wet diapers since night before mouth and tongue get red when she gets a fever. No blood in stool. No blood or bile in emesis. Throws up after anything gets to her stomach. "Dad was taking medication for H. pylori. Given IV fluids during course of hospitalization.
About 30 minutes after vaccine felt LE heaviness, and weakness, hypersensitive to touch, painful with touch, also some tingling in legs. Later hat T 100.4 and Headache. Next morning SXS much better but still present and triage advised ER so pt did. Admitted, neuro consult, IV steroids, next AM SXS gone. 12/4/06 Received medical records from hospital which reveal patient admitted 9/2-9/3/06 w/dx lower extremity weakness, pain & paresthesias and low grade fever 100.4.  Neuro consult done & dx w/T8 transverse myelitis.  Patient refused LP.  Patient received high dose steroids x 2 with complete resolution of all symptoms. FINAL DX: Acute transverse myelitis at T8.
Felt well for 12 hours. Then: Pain in lungs, kidneys, joints, muscles; Chills (do not know if had fever; very high perspiration); Extreme pain and burning in all of sinuses, felt like the membranes were on fire; All pain was so extreme I truly wanted to kill myself; We were told to take paracetamol at the time of vaccination, but disregarded the advice; Started taking paracetamol after getting it next morning from our pharmacy; Was sick for three days, but the worst lasted for about 22 hours.
Rash to (B) legs day of vaccine and following day - T. 100 - red - not dark red or purple. No itchy - blotchy - warm to touch - resolved without intervention.
Thiis spontaneous report was received  from a medical assistant refers to an unspecified number of patients, age and gender were unknown. Medical history was unknown. In 2014 the patients were vaccinted with LIQUID PEDVAXHIB (lot number, expiration date, route and dosage were unknown). Which was improperly stored since 20-MAR-2014. No adverse effects reported. Concomitant therapy was unknown. This is one of several reports received from the same reporter. Additional informatin is not epxected because no physician details were provided.
mild fever; chills; Second dose of vaccine adminsitered on 25-Feb-2021>35 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (mild fever), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy (Allergic to ace-inhibitors and penicillin).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days). On an unknown date, the patient experienced PYREXIA (mild fever) and CHILLS (chills). At the time of the report, PYREXIA (mild fever) and CHILLS (chills) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days) to be not related. No further causality assessments were provided for PYREXIA (mild fever) and CHILLS (chills).    No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD-2021-002585, MOD-2021-002585 (Patient Link).
Severe headaches; High blood sugars; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 06Jan2022 at 12:00 (Lot number: unknown) at the age of 42 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication included: INSULIN.  The following information was reported: HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Severe headaches"; BLOOD GLUCOSE INCREASED (non-serious) with onset 07Jan2022, outcome "not recovered", described as "High blood sugars". The events "Severe headaches" and "High blood sugars" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and blood glucose increased.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment taken as a result of headache and blood glucose increased included treatment at doctors office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that the pt inadvertently received 2 doses of vax of 9/21/98 one hour apart. No adverse experience occurred and the pt reportedly recovered from this experience.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks 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: Lot number and onset date of shingles were unknown. At an unknown time after the 1st dose of Shingrix, the patient developed shingles. The reporter consented to follow up.
no adverse effects were reported; the patient was inadverently administered an expired dose of MMRII; This spontaneous report was received from a health professional (medical assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 30-MAY-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (rHA)) (strength, dose, frequency, anatomical location was unknown) of lot # N024696 and expiry date 07-APR-2019 via subcutaneous route for prophylaxis (expired product administered). The patient's concomitant therapies included sterile diluent. (lot# S000130 and expiry date 23-AUG-2021). No adverse effects reported. No temperature excursion reported. No product quality complaint (PQC) reported.
Patient stated she developed red hives and became SOB  about 10-12 hours after vaccine.  Patient stated her throat itched and she had a burning sensation in her lips and mouth.  Patient also stated she developed a HA.
woken up in the middle of the night with heart racing and felt like i couldn't breathe. after a few minutes my heart rate went back to normal and difficulty breathing subsided to shortness of breath that lasted 6 more days. 20 days later heart still feels a little weird and shortness of breath returns for a moment, slight tightness of chest persists but very minor symptoms.
Chills; Scratchy throat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "Chills"; THROAT IRRITATION (non-serious) with onset 13Mar2021, outcome "not recovered", described as "Scratchy throat". Therapeutic measures were taken as a result of chills, throat irritation.  Additional information: The patient reported that she had quite a few different side effects from the beginning after receiving the COVID-19 vaccine. She reported that she is still having chills and she has a real kind of, not sore throat, but a scratchy throat. She reported that the other side effects that she had just kind of disappeared but she is still having chills. She drank some hot tea and she got warmed up and then she hasn't gotten rid of the chills since. She stated that the chills began the day after she got the first original shot on 13Mar2021. She reported that she did not pay that much attention to it and that she felt maybe that was something she was just going through. She reported that when the chills kept going on, she just drank some tea and lemon and honey which warmed her up but then the chills came back again, the chills did not want to go away. She reported that her chills are about the same, that she will try to drink something warm to get the chills down. She stated that drinking something warm would help her for a while and then the chills come back.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 Weeks after receiving my second COVID19 vaccine I had a first time generalized seizure while out on a walk with my family.  Cat scan, MRI, routine EEG all clear. Sleep deprived EEG found evidence of seizure  activity in the right anterior temporal region.
Child felt sick, lethargic and vomited five times. No fever or diarrhea. Child was seen in office and felt better at 11:30 a.m. Later had diarrhea stool too. Child had restaurant food after shot.
I had a sore throat and a hoarse voice. The next day I got a stuffy and runny nose. On the third day it was of those with my throat worse and Laryngitis. On the 12th I had no voice at all and still had a sore throat. My voice improved but there was yellowing and green mucus draining from my nose with sneezing and coughing. I contacted Dr.  On the 14th I had no voice and was contacted by the doctor to take a COVID-19 Test and I tested at home, and it was negative. I got a prescription of Clavulanic Acid and Amoxicillin I took that for seven days. There was some improvement, but I was still coughing up mucus and they called in another prescription for a Z pack and Azithromycin. This helped a little bit. The mucus is now gone.  Last night though, I woke up sneezing with a runny nose. I have also been taking Claritin once a day, thinking it might help avoid me having a secondary bacterial infection.
cold like symptoms.; Around 11a or noon, I had severe chills; Fever; Headache; severe headache woke me up Friday morning; received my 3rd injection; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold like symptoms.), OFF LABEL USE (received my 3rd injection), HEADACHE (severe headache woke me up Friday morning), CHILLS (Around 11a or noon, I had severe chills) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced OFF LABEL USE (received my 3rd injection). On 20-Aug-2021, the patient experienced HEADACHE (severe headache woke me up Friday morning). On an unknown date, the patient experienced NASOPHARYNGITIS (cold like symptoms.), CHILLS (Around 11a or noon, I had severe chills), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold like symptoms.), HEADACHE (severe headache woke me up Friday morning), CHILLS (Around 11a or noon, I had severe chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown and OFF LABEL USE (received my 3rd injection) had resolved.            No Concomitant medication information was reported.   Reporter did not allow further contact
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX with lot # M036295 and expiration date on 13-FEB-2018, also the lot # reported as M040143 and expiration date on 27-MAR-2018 (strength, dose, route of administration and anatomical location were not provided) reconstituted with an sterile diluent (manufacturer unknown) (lot #, expiration date, strength, dose and route of administration were not provided), for prophylaxis. The storage temperature was reported as 6 to 14 degrees Fahrenheit (°F) (8 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006600: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA010489.
Rapid, strong heartbeats felt in neck and head woke me at approx 4:30 a.m. Blood pressure was 185/102. Took BP meds (.5 mg Ramipril and 25 mg hydrochlorothiazide). Waited 15 minutes and BP was 167/101. Waited another 15 minutes and BP was 149/91. Saw doctors PA in the afternoon, BP was 162/81.  PA administered EKG, blood work, and spent a significant amount of time listening to heart, lungs and carotid arteries. Everything was in normal range except sugars, but an A1C test was normal.  PA said to take an extra Ramipril at night and track BP at home for 7 days.  BP went down each day and on  2/26 was in normal range. However, after 7 days, she said to permanently stay on the evening addition of Ramipril.
Fainted about 10 minutes after vaccination, on the sidewalk after leaving store. A passer-by called for an ambulance. Patient was taken to Hospital and was cleared with no further injuries.
Has a rash on bend of elbow, both arms on right shoulder, on neck and inside of thigh on the right leg.
sx of cold stuffy nose mild ST and cough and then 17May positive rapid Ag; sx of cold stuffy nose mild ST and cough and then 17May positive rapid Ag; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 26-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient has been diagnosed with COVID-19 prior to vaccination or not and has been tested since the vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022 at 14:00, outcome "unknown" and all described as "sx of cold stuffy nose mild ST and cough and then 17May positive rapid Ag". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Nasal Swab; (17May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
At 08/30/2013 patient presented to clinic with complaints of swollen lips and eyes, also local swelling at the injection site (left deltoid muscle).
This spontaneous report was received from a physician via a company representative concerning a 65 year old female patient. The patient's pertinent medical history included a previously diagnosed of diabetes (unspecified date). The patient had no known drug reactions or allergies. On 07-JUL-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # L002310; expiration date: July 2016) (dose and route not provided). On the same day, the patient was also vaccinated with a dose of PREVNAR (dose, route and lot # not provided). Concomitant medications included unspecified medications. No adverse event was reported. There were no laboratory tests or diagnostic studies performed. Additional information has been requested.
Patient c/o "skin aches", "sweating", "continual urge to pee", "weakness", and "irritability".  Diagnosed with a urinary tract infection during visit.
pt mistakenly administered second dose 3/23, 20 days after first dose.  second dose lot# 040a21a.  no adverse events reported.
3OCT95 pt recvd vax in AM; 3OCT95 PM pt screamed for 4-5hrs that same afternoon;