chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizzness; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzness), NAUSEA (nausea) and VOMITING (vomiting) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzness), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzness), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Normal reaction of sore arm 12-24 hours after injection. No symptoms until this morning, 1/31/21. Woke up with a very sore left arm around injection site. Rash appeared this afternoon. Still very sore. Not itchy. Rash is swollen and warm.
abdominal pain, loose stool, emesis, blood in stool, diagnosis:  diverticulitis
I experienced  after 40 or 50 minutes I felt funny. I felt fatigue, sleep and after that I felt a sharp pain from my neck to my upper back.
1 st shot--- sore arm & very tired.  3rd day my teeth & gums became very sensitive to cold.  I still have this side effect.  2nd shot I had soreness in arm & tired again.  Also soreness under left arm where shot was given.  A few weeks later I started to have problems with my left knee.  Also had a UTI.
Rash and 99. Strep rash face, trunk, ext, maculopapular pink, seen on 2/16 and 2/19/15. Rash cleared on face and became more prominant on ext. by 2/18/15, then resolved.
Is pregnant:Yes; After shot 1: sore left arm; This is a spontaneous report from a contactable consumer, the patient.  This consumer reported in-formation for both mother and fetus/baby. This is a maternal report. A 38-years-old pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included pregnancy, anal fissure and hornet stings from an unknown date and unknown if ongoing. Concomitant medications included Prenatal MVI, Vit D3 and topical Nefedipine taken for an unspecified indication, start and stop date were not reported. No COVID prior vaccination and COVID tested post vaccination. The patient did not receive other vaccine in four weeks. The patient was exposed to vaccine while she was pregnant. Last menstrual date was 02Feb2021, her gestation period was 10 and expected delivery date was 09Nov2021. Patient experienced sore left arm after first shot on an unspecified date. The patient received no treatment. The clinical outcome of event sore left arm was recovered.
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose 46 days ago and still has yet to receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose 46 days ago and still has yet to receive the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose 46 days ago and still has yet to receive the 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact
pt devel fever 105/high pitch crying w/in 8 hrs of vax;
Patient reports left shoulder pain following vaccine administration. States that he is unable to lift left arm past shoulder height; has moderate pain with attempts. Has been referred for physical therapy.
no adverse effects reported; the patient received an improperly stored dose of VARIVAX; This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S005078, expiration date 19-FEB-2019, for prophylaxis (dose, frequency and route of administration were not provided), which was reconstituted with a sterile diluent (lot #, expiration date and route of administration were not provided). The vaccine was exposed to a temperature of -14 to 10 degrees Celsius for 45 minutes and -9 to 8 degrees Celsius for 75 minutes. There were no previous temperature excursion. The call was made because of digital data logger. There were no adverse effects reported. The outcome of product storage error and no adverse event was unknown.
fever; Initial information regarding an unsolicited valid non-serious case received from a consumer via social media and transmitted to Sanofi on 10-Dec-2020.  This case involved patient with unknown demographics who experienced fever (Pyrexia), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history and concomitant medications were unknown.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown), after administration of INFLUENZA VACCINE, the patient developed a non-serious fever (pyrexia).  Final diagnosis was pyrexia.   It was not reported if the patient received a corrective treatment.  At the time of reporting, event outcome was unknown.  There would be no information available on batch number for this case.
On March 19th, he received the Johnson & Johnson vaccine and, within a week or so, became profoundly fatigued, short of breath with any exertion and began to lose weight. We have evaluated him extensively and he does have an interstitial lung disease but pulmonary function testing is normal. A 6 minute walk showed a decreased exercise capacity with very mild desaturation and a cardiopulmonary exercise test was read as showing combined cardiac, pulmonary and possibly muscular causes for a decreased exercise capacity.  However, my reading along with another specialist in this area is does not suggest any cardiopulmonary cause for dyspnea.  I sent him for nerve conduction studies which confirmed a neuropathy without evidence of findings consistent with ALS.  I ordered a neurology consult and that is scheduled for March.
Information has been received from a health professional concerning a 13 year old female who on 14-AUG-2007 was vaccinated in the left arm with Gardasil (lot number reported as "0802U"). Concomitant therapy included MENACTRA (lot #42235AA) and BOOSTRIX (lot # C2734AA). On 19-SEP-2007 the patient experienced enlarged tonsils, throat culture have been performed. She has been seen five times for the same reason and has been referred to an ENT. Additional information has been requested.
Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness; Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness; Headaches; Neck pain; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Neck pain), PARAESTHESIA (Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness), HYPOAESTHESIA (Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness) and HEADACHE (Headaches) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2022, the patient experienced NECK PAIN (Neck pain) and HEADACHE (Headaches). On an unknown date, the patient experienced PARAESTHESIA (Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness) and HYPOAESTHESIA (Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness). At the time of the report, NECK PAIN (Neck pain), PARAESTHESIA (Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness), HYPOAESTHESIA (Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Magnetic resonance imaging: Bunch of MRI's with no remarkable findings.         No concomitant medications were reported. Patient had seen multiple healthcare professionals including 2-3 internal medicine doctors, a rheumatologist, a gastroenterologist, and a neurologist for the symptoms. Patient had been taking muscle relaxants and anti-inflammatories for the symptoms.   Reporter did not allow further contact
Patient broke out with full body, pruritic rash on arms, trunk, back, and legs approximately 1 week after receiving the first dose of Moderna covid-19 vaccine.  Rash continues to spread onto face, and non-responsive to anti-histamine.  Short term course of PO steroid recently prescribed, which has helped alleviate itching and has stopped spread.
This spontaneous report as received from a consumer via Clinic refers to a currently 69 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Two doses administered on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old male patient who received DTPa (Infanrix) (batch number 3M9Y7, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received Infanrix. On an unknown date, the dose was an unknown dose. On 27th September 2022, the patient started Infanrix Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter reported that the patient of 1 year and 6 months old received 2 doses of Infanrix vaccine on the same day. The reporter did not consent to follow up. Additional supportive information: The patient received a two dose of Infanrix on the same day, which led to overdose.
Information has been received from a female nurse practitioner who in 1994 was vaccinated with hepatitis A virus vaccine inactivated, hepatitis B vaccine, recomb, and hepatitis C virus vaccine (unspecified) and experienced swelling of the joints for 3 to 4 months and then it went away. Additional information is not expected.
At Day 9, after first dose I experienced extreme fatigue.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 68 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 01Mar2021 12:00 (Lot number: EN6203) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Factor V Leiden" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; CYANOCOBALAMIN; CALCIUM; OCUVITE; OSTEO BI-FLEX. Past drug history included: Diclofenac, reaction(s): "Drug allergy"; Gabapentin, reaction(s): "Drug allergy"; Keflex, reaction(s): "Drug allergy". The following information was reported: FATIGUE (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "At Day 9, after first dose I experienced extreme fatigue.". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366577 same patient, vaccine different dose, different AE.
fever of 103 degrees / after 3 days the fever came down to 99 degrees; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose on 13th September 2020 and experienced sore arm, refer case US2021066283).   On 13th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 13th March 2021, less than a day after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received dose 2 and on same evening, the patient experienced fever of 103 degrees Fahrenheit. The fever lasted several days, but after 3 days the fever came down to 99 degrees Fahrenheit with acetaminophen therapy. The patient did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021066283:same patient (2nd dose)
mom stated noticed localized red area on lt leg @ DTAP inj site approx 4x4cm marked area w/Sharpe marker, parent instructed to return to clinic if size of red area inc;no temp or other complaints;
Headache, soreness at injection site, chills, nightsweats, fatigue, sensitivity to light, joint pain, upset stomach
Tightness in chest, pain in chest, and shortness of breath. Started late May 13, subsided enough to get some sleep. Awakened by the pain and shortness of breath around 7:30 am May 14. Unable to get out of bed. Called 911 for ambulance. Patient was taken to Hospital Cardiac. EKG showed ST elevation, thus L & R Catheterization was performed. Negative for MI, but diagnosed with Pericarditis, kept overnight in hospital and prescribed Indomethacin (Indocin) 3 times daily for 14 days. Released from hospital May 15. Recovery continues at home.
I received my first dose on Jan 08, 2021, at 11:30 am. On Jan 09, 2021, at 11:30 pm, I began to feel a burning sensation on my left calf. I found a hive (6"x3"). It was itching and swollen. I took Benadryl. When I awoke the next day, it had gone away. I received my second dose on Feb 03, 2021, at 11:00 am. On Feb 03, 2021, at 11:03 pm, I began to feel a burning sensation on my right arm right above my elbow where it bends. I found a hive (2"x2"). It was itching and swollen. I took Benadryl. When I awoke the next day it had gone away.
A circular erythamatous, swollen area about 1 inch x 1 inch in size on left lateral thigh.
Patient got severe chills and was feverish starting about 12 hours after receiving the vaccine. She states that she felt "flu-ish" for the following day. These side effects were so severe that she could not leave her bed for most of the day. All side effects resolved within 48 hours.
Headache, chills, fever (unsure of temperature since thermometer did not work, but not super high), increased sensitivity to light and to dust and other trigger allergens, shaking/shivering,
described it as little rashes on both arms and legs and possibly other places too; This is a spontaneous report from a contactable HCP. This HCP reported that a 32-year-old female patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE at single dose for COVID-19 immunisation on 20Apr2021. Relevant history was unknown. Relevant concomitant drug was unknown. The patient had the first dose of the Pfizer covid 19 vaccine 'today' at 1:15. About 1 to 1.5 hours later, she noticed what she thought was a bug bite on her ankle then realized it was on both legs, arms and hands. Caller described it as little rashes on both arms and legs and possibly other places too. Caller stated she took benadryl. Caller asked if there is something she should do other than take benadryl. Caller noted she knows if it gets worse to go to ER and she is planning to see her PCP in three days.  Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
10-19-10 - Poor appetite - not herself. 10-20-10 - temp. fussy, even her little fingers hot 101 degrees 1/2 tsp. TYLENOL given, finally slept. 10-21-10 Called clinic for advice, given cool bath, playing with her on floor, seizure activity, to clinic, ambulance to hospital. Pneumonia (L) lung, antibiotic therapy started. Temp at 101 degrees - 102 degrees, sent home. Up most of the night. Friday 10-22-10 - fussy, poor appetite, temp 100 degrees, poor sleeping Saturday 10-23-10 continued to be fussy & temp 99 degrees - 100 degrees did want to drink fluids Sunday 10-24-10 fever broke - good appetite, back to normal self & routine. June 2010 - fever induced seizure with resp. arrest, grandpa did CPR many bacterial infections, testing done for URI - chronic, no allergies found.
Tierdness day of for 2 days. Blackout and fever the next day. Blackouts are still going on
Patient reports fever, chills, achy 5 hrs after vaccination, abrupt onset and cessation sx lasted approx. 1 hr. Arm soreness for 3 days. Occurred with both injections, but less after second.
About 5 hours after receiving vaccines child had fever 102.9 and unconsolable crying.  Child proceded to stiffening entire body for a few seconds and then slept for 30 min.  Upon awakening the child was fine.  There seemed to be grunting during and after the episode of stiffening.  Child was fine during the day but continued to run fever for the next two nights.  Child again had a similar event on Monday night and thus brought the child to the clinic today.
Started with a fever that progressed to a Chinese, fatigue up to 102.3 at worst for two days.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the 1st shot and still got the Shingles, now they tell that the patient need a 2nd shot, the patient could not afford it. No contact details were available.
problem/ bout put me in the hospital; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (problem/ bout put me in the hospital) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (problem/ bout put me in the hospital) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (problem/ bout put me in the hospital) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious event of Vaccination complication that resulted in hospitalisation after mRNA-1273 vaccine. The reporter stated a "problem/ bout put me in the hospital". The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Follow-up received is Non Significant. Reporter's qualification is updated.; Sender's Comments: This is a spontaneous case concerning a patient of unknown demographics with no medical history reported, who experienced the unexpected serious event of Vaccination complication that resulted in hospitalisation after mRNA-1273 vaccine. The reporter stated a "problem/ bout put me in the hospital". The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Dizziness; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 22May2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Other medical history reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EW0164) via an unspecified route of administration in the left arm on 22May2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23May2021, the patient experienced dizziness/vertigo. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Flonase. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness/vertigo was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
patient was given 0.5ml of moderna instead of the 0.25ml she should have received for a booster.  Patient reported no ill effects.