chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 or 2 per week) on 01-Sep-2020, Spontaneous abortion on 23-Sep-2020 and C-section (34 weeks due to an accident) on 15-Aug-2017. Concurrent medical conditions included Allergy to nuts (Tree nut allergy.) and Allergy to nuts (Peanut allergy.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2021 to an unknown date for Pregnancy, VITAMIN B6 and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 05-Feb-2021 at 10:13 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 05-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2020, Pregnancy test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-230191 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Second dose, event details added. On 07-Aug-2021: Follow up information received no new information.
chills; fever; headaches; Nausea; general feeling of unwellness; A 54-year-old male received MassBiologics Td vaccine (Lot # A115A1) on 3/25/19 at an urgent care facility for wound prophylaxis. A few hours post vaccination, the patient experienced chills, fever, headache, nausea, and a general feeling of unwellness, with the nausea resolving same day.  During follow-up performed 2-months post vaccination, the patient indicated the chills and fever resolved within 12 to 15 days post vaccination but that he is still experiencing headaches.  The patient reported that he visited his primary care physician (PCP) twice for the headaches (dates unknown) and that blood work and other unspecified testing resulted in normal findings; his PCP has not be able to provided him with a cause for his headaches and they remain unresolved.; Sender's Comments: All adverse events in this case were assessed as non-serious and labeled.
One of them sleeps all day; Extreme fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (One of them sleeps all day) and FATIGUE (Extreme fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (One of them sleeps all day) and FATIGUE (Extreme fatigue). At the time of the report, SOMNOLENCE (One of them sleeps all day) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no patients' concomitant medications pertinent medical history, drug reactions and allergies reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX 0.65 ml (lot #, expiration date, site of vaccination were not reported) subcutaneously. On an unknown dates, the patients experienced redness, swelling, warmth and pain at the injection site. No lab diagnostics studies were performed. The patients sought medical attention, visited pharmacy and received BENADRYL as a treatment. The outcome of the events was reported as resolved (dates, unspecified). The relatedness between the events and ZOSTAVAX were not reported. Follow-up information has been received from the pharmacist on 09-JUL-2015. On 08-JUL-2015, a phone call was placed to the pharmacist. The pharmacist stated that she had no additional information to report. She provided all the information she had when she called in the adverse event. She also stated that she made the call due to the increase in the number of patients that experienced an adverse events at the injection site. She stated that no additional adverse event had been reported since then. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled follow up information has been received. Narrative was updated.
Had a fever; So tired, couldn't get off of the couch; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (8 years before reporting). Concurrent medical conditions included immune system disorder nos, asthma and atopic dermatitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR007153  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after her first Shingrix dose she had a fever and was so tired she couldn't get off of the couch for three days. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2022AMR007153.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR007153:Same reporter
Episode of unresponsiveness 2 days post vax;DTP/HIB vax on 18MAR91-1st episode found on the floor asleep lasting approx 1hr-2nd spell was described as very brief no jerking, shaking or color change;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 06-SEP-2016, the patient was inadvertently vaccinated with M-M-R II, albumin status recombinant human albumin (rHA), subcutaneously, in the right thigh, lot # M001200, expiry date 28-AUG-2016. No adverse effects were reported. Additional information has been requested.
pt transferred from hospital for evaluation of elevated troponin; pt found to have a positive COVID test and UTI; while pt was being assessed he went into cardio respiratory arrest; ACLS protocol was performed and a pulse was regained; spoke with pt's wife and she requested no future CPR; pt arrested again and died in the hospital
Narrative: 3/13/2021 COVID Moderna vaccine #2 (CPVOD Moderna vaccine #1 was 2/13/2021) CVA on 4/22/2021, //cerebral venous sinus thrombosis 5/4/2021 Date Eliquis 5mg bid started: ~7/2/21, previously on dabigatran started on 5/4/21 (but did not tolerate Pradaxa) Indication: cerebral venous sinus thrombosis (CVST) Estimated duration of therapy: TBD, at least 3-4 months (Neuro continuing at least through end of Sept) Anticoagulation history: Patient diagnosed with cerebral venous sinus thrombosis 5/4/21 via MRI, Previously was started on clopidogrel 75mg daily for suspected CVA on 4/22/21. Patient experienced severe allergic rxn to clopidogrel, required and medication to stop rxn, It was during this hospitalization that pt was diagnosed with CVST. - Patient States "Depression" symptoms really started after her second dose of COVID vaccine along with neurological symptoms which lead to eventual diagnosis of cerebral venous sinus thrombosis.
Same day as vaccination ee had comiting, diarrhea, nausea, severe headache lasted for 10 days.
Has pain around injection site of COVID vaccine; This is a spontaneous report from a non-contactable Physician. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID vaccine. The patient's medical history and concomitant medications were not reported.  The patient had pain around injection site of COVID vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Bullous Pemphigoid on the skin; This case was reported by a physician via call center representative and described the occurrence of bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 1 week after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was recovered/resolved.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and a week after or so patient developed Bullous Pemphigoid. On 3rd September 2020, patient went to dermatologist and after consulting with the dermatologist, it was stated that he developed a Bullous Pemphigoid on the skin which already went away.  The physician had questioned if 1st dose of Shingrix would be enough since patient was afraid to receive 2nd dose. Health care professional stated that no data of Batch Number or Expiration Date was available as patient got the shot at a different facility.  No further details were reported. The reporter consented to follow-up.
Pt was well and went to sleep at approximately 10:30 pm. Found at 6:00 am not breathing. Pt had been put to sleep on her side but was found on stomach.
Information has been received from a pharmacist concerning a patient who in December 2007 "about 2 weeks ago", was vaccinated inadvertently with varicella virus vaccine live (Oka/Merck). The pharmacist reported that the pharmacy might have dispensed varicella virus vaccine live (Oka/Merck) in error; this was not product confusion. The patient sought medical attention at the physician's office. There was no adverse event reported. There was no product quality complaint. Additional information has been requested.
arm was sore; felt generally tired; She had fever (100.3F); chills; nausea; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Feb2021 at 15:30 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), on an unspecified date for COVID-19 Immunization. On 04Feb2021 at 12:00, the reporter stated that her arm was sore (in which she also experienced on her first dose). She also felt generally tired. She had fever (100.3 Fahrenheit), chills, and nausea. Her fever already went down to 99.5 Fahrenheit and it has been that way ever since. She wanted to know how long the fever would last. The reporter stated that she can take something other than Tylenol for the fever she has experiencing after getting the second dose of the Pfizer vaccine. The patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit on 04Feb2021 and body temperature: 99.5 Fahrenheit on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Red swollen, painful, hard felling (solid) area around injection site. 1 and 1/2 inch in diameter. Recommended cold compress, instructed to call MD or pharmacist if it does not improve or gets worse.
Syncope within 1 minute of receiving Varivax and Gardasil-HR decreased to 60, BP dropped to 90/50-patient slumped over-patient back to normal approx 25 minutes later
experienced soreness in the arm; This spontaneous report was received from a consumer referring to herself, a female patient of unknown age. The patient did not have any pertinent medical history, concurrent conditions, drug reactions or allergies. No information was provided regarding the patient's concomitant medications.  On an unknown date in 2013, the patient was vaccinated with an unspecified zoster vaccine live (manufacturer unknown) in the left arm as prevention of shingles (dose, dose number, route of administration, lot number and expiration date were not reported).  On an unknown date in 2013, the patient experienced soreness in the arm (pain in extremity). The patient did not seek for medical attention and did not received any treatment; but she recovered from the event.  At the time of the report, the causality assessment between pain in extremity and zoster vaccine live (manufacturer unknown) was not reported.
Numbness and tingling began in the legs one week after the vaccination. Symptoms progressed to numbness/tingling  on the face and around the eyes.
Spontaneous menstrual cycle within 1-2 hours of injection; abnormal in nature with heavier flow than normal cycles. Cycle lasted approximately 7 days. Numbness extending from forearm to left cheek; started within 12 hours, lasted 12 hours. Tenderness at injection site within 4 hours, lasted 24 hours. Fever 101 degrees and chills; started approximately 16-20 hours post injection,  lasted approximately 12-16 hours.
He had be seizure free from March 2022 until he had seizures on 9/17, 10/8, and 10/14 .  They started one month after changing from Abilify to Risperdal. No other major medical events.
This spontaneous report was received from a physician assistant referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 06-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (route, lot # and expiration date were not reported). On an unknown date, the patient experienced cellulitis at the injection site. It was stated that the patient was send to the emergency room and was treated with unspecified antibiotics per intravenous route. At the time of reporting the outcome of injection site cellulitis was unknown. A product quality complaint was not involved. The causality assessment between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
symptomatic COVID-19 after being vaccinated with 1 dose of J&J vaccine 1/11/22: pt starts having productive cough and weakness 1/19/22: COVID-19 positive test   Acute hypoxemic respiratory failure  COVID-19 Virus Infection Severe sfepsis, POA, d/t above Respiratory alkalosis d/t above Date of onset of symptoms: 1/11/2022 Symptoms present on admission: Productive cough, weakness Date of covid positive test: 1/18/2022 Vaccination status: vaccinated J&J vaccine Imaging: CXR -right mid and lower lung suspicious for pneumonitis/atypical pneumonia Oxygen requirements on admission: 4 L NC Medical therapy:  Decadron Discharge home with oxygen and remainder of decadron course/albuterol.
After second vacination severe inflamation and pain in left shoulder persists.  Shoulder symptom primarily located over the diffuse and is aching.  Symptions exacerbated with elevation and activities.  Cortizone shot allieviated most of pain but low grade inflamation and aching persists.  Currently recieving physical therapy.  Progress has been slow.
Eleven days after administration of vaccination, patient presented with measles-like rash all over body and cold symptoms
Information has been received from a registered nurse (RN) concerning a patient who on 03-JUN-2008 was vaccinated po with the second dose of ROTATEQ. It was reported that on 03-JUN-2008 the patient spit up the second dose in the vaccine series. The RN reported on approximately 10-JUN-2008 (one week later) the patient received another po dose of ROTATEQ to replace the incomplete dose. The patient has not experienced any other known symptoms. The outcome has not been reported. A product quality complaint was not involved. Additional information has been requested.
Pt noted redness to (L) arm just before came for appointment. Noted both at influenza and Varicella site with varicella cite also a little firmer and itchy. No hives, no difficulty breathing.
Developed 2? X 1.5? red rash and several red splotches underneath injection site on left arm.
bit of soreness in arm; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media .  This case involves patient (unknown demographics) who experienced bit of soreness in arm (pain in extremity), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bit of soreness in arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.   There will be no information available on the batch number for this case.
22JUL96 swelling started rt bridge of nose, worked down to rt jaw lasting 2 days then swelling to lt bridge of nose down to lt jaw lasting 2 days;tx alcohol rub;19AUG96 PM swelling started again to lt bridge of nose & cont down to lt jaw;l
injection site started to swell at about 4:30 PM patient watched by 5:30 PM the left side of her neck, upper mouth and eye were swollen. she called her MD between 5:30 pm and 6:00 pm. he told her to take benadryl.. She took 1/2 tablet then repeated 30 minutes later. The swelling was reduce by 11:00 pm.  As of 10/8/2009 the patient reported that her arm, throat and mouth were still sore but that the swelling was gone.
Top of my chest was kind of heavy, from my chest to my throat and nose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Top of my chest was kind of heavy, from my chest to my throat and nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Top of my chest was kind of heavy, from my chest to my throat and nose). At the time of the report, CHEST DISCOMFORT (Top of my chest was kind of heavy, from my chest to my throat and nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter.
4/8 Vaccination 12:30 By 8PM, chills, fever 101.4. Took Tylenol at midnight.  4/9 I noticed baby was moving less when I woke up. I had fatigue. My watch at 10am alerted me to high HR alert; inactivity but HR was at 130's. I felt off. It happened 4xs thru the day with the apple watch during the day. I called the OB; they said to check O2 and if below 96/97 get checked out. HR was 160. We went to the ER at 4:30PM.  Low grade fever 101.9, HR to 162-165 @ rest, 94% o2 stat.
patient reporting intermittent R) arm and leg pain, arm twitching since receiving COVID-19 booster in January. Twitching has improved.
Patient's upper arm, near injection site, became swollen, red , and sore. The redness covered the upper arm. The reaction occurred the evening of receiving the immunization.  A water blister appeared at the site of the injection. The patient reported the reactions 2 days following the injection and stated the redness and soreness have reduced.
PATIENT HAS ALREADY RECIEVED 2 DOSES- 1/31/20, 5/21/20  PT WAS CHECKED BUT WAS OVERLOOKED BY IMMUNIZING PHARMACIST.  PHARMACIST REALIZED THIS WAS A THIRD DOSE RIGHT AFTER VACCINATION.  HE CONSULTED THE PATIENT AND HER DAUGHTER ABOUT GIVING A THRID DOSE.AND COMMON SIDE EFFECTS ASSOCIATED WITH THIS VACCINE.
Malaise and chills day for 1 day on day after vaccine administered. Then, a dull headache started 2 days after vaccine administered and has lasted a week (and counting).
This is a spontaneous report from a contactable nurse reported for 2 patients. This is Report 1 of 2, for a 88 years female patient. An 88-year-old female patient received PREVNAR 13 (lot number R94917, expiration date 23May2018) at 0.5 ml single dose intramuscular on 21Jul2017 for risk of pneumonia. Medical history and concomitant medications were none. In Jul2017 the patient had swelling at the injection site that resolved spontaneously.   It was described also as red, ball like, hot to touch, erythematous and resolved slowly with oral Benadryl. The patient also went to Urgent care. Final outcome was reported as recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017334556 same reporter, drug and AE, different patient.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding a patient who experienced autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced autism. Outcome was unknown. No additional information was available at the time of this report. The reporter declined to grant permission for follow up investigation.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3249), on 17Feb2021 as dose 2, single (Lot number: 9269), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive; (28Jul2022) Negative; (09Aug2022) Positive; (18Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included paxlovid from 25Jul2022 to 29Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.