chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 minutes after vaccination, patient was sitting in waiting room and became very pale and light headed. Mom asked if there was somewhere she could lay down. Mom reported daughter's eyes started to roll slightly back in head very briefly. Patient then moved to sitting position on the floor and I came out and had pt lay on floor with feet elevated. Patient was talking and alert. She was sweaty. Patient was given cold towel for head and remained alert, but in lying position with feet elevated for 15 min. Patient was then moved to sitting position on floor and given apple juice. Patient was then moved to sitting position in chair for another 10 minutes. Patient fully recovered from episode with report of slight headache.
pt to ER & adm to hosp w/swelling to face & hands; no further problems stated;Annual follow-up received on 12/06/00 provided no additional data.
She fell to the floor at home and went "unconscious"; She fell to the floor at home and went "unconscious"; feel uncomfortable; Dizzy; Headache; Felt severe pounding in the heart; Fast heart beat; Felt cold in hands and feet; She had fever later that day 101.4 F; She had chest pain when deep breathing after the fall; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 (Batch/Lot Number: Unknown) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient is not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 first dose on an unspecified date (lot: not reported) for covid-19 immunisation. It was reported that on Friday (07May2021), the patient received 2nd dose of Pfizer Covid vaccine and felt fine. But on next day (Saturday 08May2021) morning, she started to feel uncomfortable, dizzy, headache. She felt severe pounding in the heart and fast heart beat, felt cold in hands and feet. She fell to the floor at home and went "unconscious". Her husband took her up and gave her electrolyte drink and she slowly regained consciousness. She had fever later that day 101.4 F and took Tylenol.  She had chest pain when deep breathing after the fall. Today (09May2021) her fever from vaccination recovered but she still feels chest pain from the fall, planning to see her family doctor next week. The outcome of the event she had fever later that day 101.4 f was recovered; for the event She fell to the floor at home and went "unconscious" was recovering; for all other events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Developed a rash across chest 4 d after injection. Also had myalgias and arthralgias which can be expected.
24hr post vax chills, fever, aches in joints, nausea, dizzy, diarrhea, felt unwell;
Abdominal pain; Was tired and stuff for a couple of days/ Fatigue; She had brain fogginess after the first one; She couldn't remember her husband or dog's name; Diarrhea; Joint pain in elbow; This is a spontaneous report from a contactable other hcp (nurse).  A 49-years-old female patient received bnt162b2 (BNT162B2) (Formulation: Solution for injection, Batch/Lot Number was EL9262, Expiration Date: Unknown) dose 1, single via an unspecified route of administration, administered in Arm Right on 07Mar2021 13:30 (Age at Time of Vaccination 49 years) for covid-19 immunisation.  Medical history included from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.Patient also received bnt162b2  (Formulation: Solution for injection, Batch/Lot Number was EL9262, Expiration Date: Unknown) dose 2, single via an unspecified route of administration on 28Mar2021 for covid-19 immunisation. Not receive any vaccine prior to vaccination. On 07Mar2021 the patient  was tired and stuff for a couple of days/ fatigue, she had brain fogginess after the first one on, she couldn't remember her husband or dog's name and It lasted 3-4 days as well . On 08Mar2021 patient experience abdominal pain, On an unknown date patient also experience diarrhea, joint pain in elbow. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on She has tested negative 13 times. She has been taking Voltaren with expiration Aug2023, and Lot number 3L2E. The treatment was completed. The outcome of events tired and stuff for a couple of days and fatigue, abdominal pain and diarrhoea was recovered on unknown date in Mar2021. The events she had brain fogginess after the first one on, she couldn't remember her husband or dog's name, and It lasted 3-4 days as well was recovered on 07Mar2021. The outcome of joint pain in elbow was unknown.  No follow-up attempts are needed. No further information is expected.
positive COVID pcr test while in immunity period after vaccine.  2nd dose 1/30/2021
Patient spoke with my technician and informed her that he was getting his first covid vaccine and he wanted Moderna.  I went over his consent form and discussed possible side effects and gave him the vaccine.  Afterwards, he laughed and told me he "fibbed" a little.  He said this was actually his third Moderna vaccine.  He said he is an ex-doctor.  He said that he is immunocompromised and taking cellcept.  He said his doctor told him to get a booster.  He waited 15 minutes after the vaccine.  He said he was fine and left.  He did not think it was a big deal that he "fibbed."
Narrative: He developed mild diarrhea and myalgia the same day after the initial vaccination, which resolved by the next day. He took acetaminophen, which a/w resolution of the myalgia. Normal foods had been consumed and he denies prior h/o food sensitivities or intolerance. Neither sx was a /w other common adverse effects such as vomiting, abdominal cramping, rash/urticaria, or headache.
vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.; Dose administered more than 12/24 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12/24 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12/24 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12/24 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was unknown if patient diagnose with/ tested positive for Covid-19 ever.  It was unknown if patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  It was unknown AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The vial was initially stored in the refrigerator on 11 Jul 2022. Date and time vial was first punctured was 13 Jul 2022 at 9:30 EST.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Seconds (long enough to draw a vial).  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-608992, MODERNATX, INC.-MOD-2022-608988, MODERNATX, INC.-MOD-2022-608999 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-608992:Patient 2 (Same reporter) MODERNATX, INC.-MOD-2022-608988:Patient 1 (Same reporter) MODERNATX, INC.-MOD-2022-608999:Patient 4 (Same reporter)
This is a spontaneous report from a contactable consumer, the patient. This 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3184) via intramuscular route in the right arm on 27Aug2021 at about 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. There were no vaccinations received prior to the COVID-19 vaccine. There was no family medical history. The patient had the COVID vaccine first dose on Friday morning about 9:30. On Friday night (27Aug2021), she got sick really bad. She had chill, fever, ache, and couldn't sleep well. On 30Aug2021, Monday morning, she woke up and noticed rash, red, itchy, burning rash appeared on patient's arm, leg and little on stomach. On 30Aug2021 in the afternoon, patient experienced nausea. Patient states, today rash and red nowand still itchy and burning  Itching. The patient wanted to know if this is a known issue and how long it usually lasts. She inquired if she needs to go and see a doctor about it. Patient was taking diphenhydramine hcl (BENADRYL) 47.5 mg each dose as treatment. She stated, "Perhaps I did not do anything." Lab test included P & J on 28Jul2021, procedure on her job; not further specified. The outcome of the events 'Rash, Red, Itchy, Burning rash' was not recovered, while of the other events was unknown. Follow-up (09Sep2021): Follow-up attempts are completed. No further information is expected.
later diagnosed with coeliac disease; Hepatitis B antibody; received a dose of Engerix B four months ago and was scheduled for a second dose tomorrow (this dose had to be rescheduled due to the COVID-19 pandemic; This case was reported by a consumer and described the occurrence of celiac disease in a adult male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received 4 months before reporting (December 2019)).   On an unknown date, the patient received Hepatitis B vaccine and the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Engerix B adult, the patient experienced celiac disease (serious criteria GSK medically significant), therapeutic response decreased and social problem. On an unknown date, the outcome of the celiac disease, therapeutic response decreased and social problem were unknown.   It was unknown if the reporter considered the celiac disease and therapeutic response decreased to be related to Hepatitis B vaccine.  Additional case details were reported as follows: The reporter was patient's mother. Age at vaccination was not reported. At the time of reporting patient was 18 years old. The patient had received his childhood hepatitis B immunizations but was later diagnosed with coeliac disease. As the consumer read online that coeliac patients might not get protective antibody responses, the patient´s physician tested for hep B antibodies which came back negative. Therefore, the patient received a dose of Engerix B four months before day of reporting and was scheduled for a second dose day after reporting (this dose had to be rescheduled due to the COVID-19 pandemic). The reporter requesting consent to follow up.      Lab Comments: on an unknown date lab test was performed.
3 days p/shot was put into hosp w/bacterial meningitis; 12 days in hosp;
Patient fully vaccinated (Janssen) on 3/10/2021. Patient COVID-19+ and admitted to hospital on 1/11/2022.
Rash; This spontaneous report was received from a physician concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine and experienced a rash.   The patient's medical history was not provided. Concomitant Medications were not reported.   On 04 Jan 2021, the patient received a dose of mRNA-1273 (batch number Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced rash.  The physician was seeing multiple patients and was extremely rushed. The physician also stated that the patient also had fillers  The action taken for Moderna COVID-19 Vaccine was not reported.   The outcome of rash was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event rash, a causal relationship cannot be excluded.
sore arm  - started about 24 hrs later and lasted about 2 days severe headache - started about 24 hrs later and persists still chills and sweating - started about 36 hours later and persists still stomach ache and diarrhea  - started the 15th, worsened over days and still persists fever - although I felt like I had a fever i did not record a fever until the 21st-22nd--it was 100.2
Headache; Fatigue; Arm soreness at site of injection; Postnasal drainage; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 20Feb2021 at 17:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergies, obesity, depression, anxiety and attention deficit hyperactivity disorder (ADHD). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (ACETAMINOPHEN), cetirizine (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); all from an unknown start date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021, the day after the vaccination, the patient experienced headache, fatigue and arm soreness at site of injection. Few days later in Feb2021, the patient experienced postnasal drainage and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fatigue, arm soreness at site of injection, postnasal drainage and sore throat was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: 18 weeks pregnant patient presented to emergency department with lightheadedness and presyncope.  Patient monitored, IV fluids administered, symptoms improved/resolved, and patient discharged to home medically stable. Birth weight not available: patient still pregnant.
SIDS; gross autopsy report consistent w/dx of SIDS; DTP, OPV, HIB given 25NOV91; no rxn for 44 hrs p/vax; mom noted irritability for 2 hrs then found pt dead p/being asleep for 2 hrs;
the dose she received yesterday had expired by 30 minutes; moderate fatigue; diarrhea; lot of pain in her arm, moderate pain in her arm; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a 50-year-old female patient (reporter's wife).  A 50-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 05Jul2021 (50-years-at the time of vaccination), (Batch/Lot Number: EWB171) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "My wife got the Pfizer BioNTech Covid 19 vaccination yesterday, she had moderate fatigue, diarrhea and a lot of pain in her arm, moderate pain in her arm, now today was the day at pharmacy where was get her vaccination at, said that the vaccine that she got yesterday was expired 30 minutes, it was 30 minutes then she was given a next shot and she was and it was like that after the pharmacy tonight to get another shot and what I am concerned about is before her reaction been worse after giving the 2nd shot." Reporter was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. The clinical outcome of the events was unknown.   Further probing could not be done as reporter don't want to share further information. Hence, limited information available over the call.
This is a spontaneous report from a contactable physician (mother in law). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness on her arm after the injection (vaccination site erythema) on an unspecified date. The event lasted a few days, then it completely self-resolved. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Patient received Fluad Influenza vaccine from us at Flu Clinic conducted at a Care Home where the patient resides. Neither the patient, or the facility's staff disclosed to the vaccinating pharmacist that the patient had received a flu vaccine during our vaccination screening process. This vaccine duplication error was discovered when we were reporting our dose to the state immunization registry.  Upon our follow-up with the patient, the facility has not reported that the patient experienced any adverse effect since receiving the second flu shot.
Initial report received on 02 September 2008 from a healthcare professional. A 68 year old male patient developed  wheezing 72 hours after had received a first subcutaneous right deltoid 1 ml injection of JE-VAX (lot number EJN233R, reported as CJN233R), an injection of IPOL (lot number and route/site unknown), an injection of TYPHIM Vi (lot number and route/site unknown), and an injection of a Hepatitis B vaccine (manufacturer, lot number and route/site unknown) on 26 August 2008. The patient had a history of no known allergies, atrial fibrillation, hypercholesterolemia, and hypertension Concomitant medications were COUMADIN, Lisinopril, TOPROL XL (reported as Topril XL),  ZETIA, TRICOR, simvastatin (reported  as Symvasto), and Sertraline (reported as Certraline HC). The patient had no illness at the time of vaccination. When the patient developed the wheezing 72 hours after vaccination, he had no shortness of breath, urticaria, chest pain or facial swelling. Corrective treatment was not reported. The wheezing lasted three days and the patient recovered. Follow-up received from a health care professional on 16 October 2008. The reporter was not able to provide additional information about the IPOL, TYPHIM Vi and Hepatitis B vaccines as the were administered at the public health department, not at the reporter's facility.
Patient reported swelling, pain, nausea and vomiting. Patient attended hospital following day. Rx for Ibuprofen, ZOFRAN.
STANDARD TITLE: DISCHARGE SUMMARY                                   DICT DATE: JAN 17, 2020@11:55     ENTRY DATE: JAN 17, 2020@11:55:10        DICTATED BY:                 ATTENDING:                  PRINCIPAL DIAGNOSIS: (REQUIRED ITEM)  Right Upper extremity Cellulitis after  immunizations SECONDARY DIAGNOSIS:  Right olecranon bursitis due to cellulitis Hx of Gouty arthritis Hyperlipidemia Hypertension CKD Asthma OSA on CPAP PTSD ATTENDING: MD CHIEF COMPLAINT: Right arm pain, swelling with stiffness for past few days.  HISTORY OF PRESENT ILLNESS:   Pt is a 63 y/o male with pmhx OSA on CPAP, HTN, CKD stage 3, HLP, GERD and  Gout presents with right elbow pain and swelling. Patient received pneumonia  immunization on 1/7/20. Patient reports initially noted right elbow stiffness on  1/8/20. He then noted upper arm erythema and went to see his PCP on 1/9/20.  Symptoms were thought to be related to immunization reaction thus he was advised  to take Benadryl, NSAIDs and heat/cold. On the 11th, erythema progressed toward  elbow with associated inability to bend elbow and pain. He sought care at his  PCP office and was advised to come to the ED for further management.   In the ED, he was treated with colchicine, ketorolac and vancomycin. He is being  admitted for RUE cellulitis and right olecranon bursitis.  HOSPITAL COURSE:   Pt was admitted to 4M, vitals stable, he was afebrile. He was alert, oriented,  not toxic appearing. Physical exam significant for right arm swelling, pain and  redness extending to right elbow, some bogginess but no collection. He was  empirically started on IV vancomycin, pain control, prednisone and allopurinol  for elevated uric acid level and prior h/o gout. He continued to improve and ROM  improved. UA levels returned to normal. He improved and redness/swelling  improving. Vancomycin was changed to doxycycline. Pt was encouraged mobility, to  avoid stiffening. MRI was obtained revealed mild tendonosis, triceps tearing and  mild bursitis. OT was consulted to recommend exercises. He was stable for  discharge. If no improvement, consider referral to ortho. He was provided  topical diclofenac for pain.
Positive COVID results; Positive COVID results; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL3247) at the age of 39 years as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "Positive COVID results". The patient underwent the following laboratory tests and procedures: body temperature: (08Dec2021) 99 Fahrenheit, notes: Low grade fever of 99F; sars-cov-2 test: (10Dec2021) positive, notes: Nasal Swab, Covid tested post vaccination and Covid tested post vaccination.