chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experiencing  Chest pain and elevated troponin. Patient taken to the cath lab and treated for suspected stress induced cardiomyopathy.
anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my ear; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in right arm on 25Mar2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included post viral syndrome (chronic fatigue), dry eye, known allergies included lactose intolerance and had adverse reactions to Botox. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications in two weeks included Vitamin B, D, Magnesium, zinc, copper, omega 3. No other vaccine was received in four weeks. On 25Mar2021 (pending clarification) by 2am the patient woke up with a horrible anxiety and night sweat. Evening two the patient had some fatigue, evening three I had a flare up of nerve pain and body aches, same issues night four. By night five the patient felt like her entire body was on fire with nerve pain. Day six on 30Mar2021 the patient was extremely fatigued and had a slight ringing in her ear that remained. The patient slowly regained her strength and functioning. The events resulted in "Doctor or other healthcare professional office/clinic visit, Disability or permanent damage". No treatment was received for events. The outcome of events was recovering.   Information on the lot/ batch number has been requested.
Varicella given (R) thigh rash (R) thigh started 1/27/15 now 2 x 3 cm erythema rash (R) thigh.
My left arm has been painful and very weak since injection. It doesn?t seem to be improving with time. I know I need the 2nd shot in 6 months but not looking forward to it.
2 hrs p/vax devel total body pruritis & urticaria which lasted approx 18 hrs treated w/2 doses of PO antihistamine;
Coworker who received the shot is positive too; Coworker who received the shot is positive too; This is a spontaneous report from a contactable consumer. This consumer reporter similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history  concomitant medications were not reported. The reporter's coworker who received the shot was positive too. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513735 same reporter/product, different patient, similar event
PT RECEIVED THE VACCINE 091823, HE WAS IN THE PHARMACY 092723 FOR ANOTHER VACCINE AND MENTIONED HE WAS HAVING SOME NAUSEA THAT STARTED 2 DAYS AGO AND HE WASN'T SURE IF THAT WAS RELATED TO THE YELLOW FEVER VACCINE
Narrative: 35 y/o male received first dose of COVID-19 vaccine (Pfizer) on 4/14/2021. PMH Ischemic colitis in 2010, opioid, benzodiazepine, and cannabis abuse and dependence, GERD, Hearing Loss, PTSD. Found at home, expired 5/16/2021.
injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 03-MAR-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023035537   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter was the patient. She only had injection site pain with her first Shingrix dose.  Nothing else was reported. The reporter declined to provide HCP contact information at that time as she was switching doctors.  They might follow up with the reporter. For tolerance of 2nd dose refer linked case US2023035537, reported by same reporter.; Sender's Comments:  US-GSK-US2023035537:Same reporter
Resident expired on 2/5/21 at 03:35pm, about 25 hours after second dose of vaccine. At breakfast, resident was spitting a lot of secretions, coughing up liquids from nose and phlegm, facial swelling, which were all symptoms that he was struggling with prior to both doses of COVID vaccine, but had increased more than prior incidences on 2/5/21. Gurgling noted in upper airways, hyscolamine given, bath given to loosen secretions, morphine given. Family notified and came into facility for compassionate care visit around 1300. 1400 HR was 3 and RR was 2, but increased back to 60 and 12 within 20 minutes. Then resident expired at 1535.
I experienced a tightness in my chest, and it felt like someone was putting pressure on my chest. Which made it very painful when I was breathing.
At about 8:30pm on 4/8/08 mom noticed ''patient" seemed to have "chills"- she wouldn't wake up. About 20 minutes later, grandmother checked on "patient". She sat up in bed, her eyes rolled back and she had another seizure. Temp. was 103.8 axillary. "Patient" was taken to ER by ambulance and was admitted for observation.  4/23/2008 MR received for DOS 4/8-9/2008 with D/C DX: Febrile Seizure after immunizations.  Infant presented to ER after 1 day hx of decreased eating and drinking, fever and 2 episodes of seizure.  Temp=104.1'F. PE otherwise WNL. PMH: none. Pt had several fever episodes while hospitalized which resolved with Motrin.  No further seizure activity
Wheezy; A spontaneous report was received from a consumer who was a 93-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed wheezing.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, approximately two days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, the patient felt that her breathing was wheezy which worsened at night.    On 04 Jan 2021, the patient's condition improved.   No treatment was received by the patient for wheezing.  Action taken with mRNA-1273 in response to the events was not reported.   The event, wheezing was considered recovering.; Reporter's Comments: This case concerns a 93-year-old male patient, who experienced a non-serious unexpected event of Wheezing. The event occurred approximately 2 days after first dose of mRNA-1273, lot # unknown. No treatment was received by the patient for wheezing. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 10-Oct-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pregnancy test: positive (Positive) Positive. On 24-Feb-2021, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter
Muscle pain in front right chest and back right below shoulder.  Lasted about 2 weeks. Treated with ibuprofen.
Info has been received from an RN concerning a child who was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced breakthrough varicella. No further info was available at the time of this report. The RN also reported that the pt's siblings developed adverse experiences (WAES0601USA01871 and WAES0601USA03298). Follow-up info was received from the RN indicating that the pt's mother did not provide any additional info regarding this pt's breakthrough chickenpox. Additional info is not expected.
Patient was administered Tdap and TWINRIX vaccinations  at Pharmacy. After the second vaccination patient complained of feeling dizzy and lightheaded and was instructed to stay seated. Patient then started to fall out of her seat and was caught from hitting her head on the ground. Patient was unconcious for ~5 seconds and awoke in slight confusion. Patient had her blood pressure read with a reading of 95/45 and EMT was eventually called after after 5 minutes. EMT arrived and assessed the patient with similar blood pressure readings and did an EKG with findings of dysarrythmias and low blood pressure. She was recommended to go to the hospital to be further evaluated, but the patient declined. Patient was released from EMT care and from the pharmacy.
Bladder comes down when she goes to the bathroom and hurts like hell; bladder disorder scheduled for surgery; Bladder comes down when she goes to the bathroom and hurts like hell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "bladder disorder" (ongoing), notes: (She had it before but it was not affecting her like now). The patient's concomitant medications were not reported. The following information was reported: BLADDER PROLAPSE (medically significant), PAIN (non-serious), outcome "not recovered" and all described as "Bladder comes down when she goes to the bathroom and hurts like hell"; BLADDER DISORDER (medically significant), outcome "not recovered", described as "bladder disorder scheduled for surgery". She was having surgery on Tuesday on her bladder. She had it before but it was not affecting her like now. They put something on her, but it kept coming down. They were going to cut in the middle and try to fix it. It started 3-4 months ago. The patient later had booster dose of BNT162B2 on an unspecified date on her arm. The patient underwent the following laboratory tests and procedures: investigation: unknown results. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt received PNEUMOVAX inj into right arm. A few hours later arm went numb. Pt was sent to ER where he was prescribed NSAID.
Within five minutes of taking first dose of vaccine I experienced adverse neurological symptoms, including numbness/ tingling (paresthesia) on left side of my body  from head to feet, including inside my throat, chest,   jaw, and left side of face. Symptom duration lasted approximately 3 hours before gradually diminishing to mild paresthesia in injection arm. Symptoms were significant but not debilitating peaking in severity approximately one hour post dose but continuing.  I felt some level of  headache and mild imbalance/ vertigo.
Pain; Fatigue extreme; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and FATIGUE (Fatigue extreme) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Fatigue extreme). At the time of the report, PAIN (Pain) outcome was unknown and FATIGUE (Fatigue extreme) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
crying x 24 hrs, shivering, fever, body rigidity, tremors, low fever x 5 days;
Diarrhea, chills, vomiting. Symptoms occurred within 3-4 hrs post vaccination.
Developed acute onset eyelid swelling, lip swelling, dyspnea with wheezing and hive like swelling at vaccine site. I self administered 8 puffs of albuterol (my prescription) and took 50 mg of oral Benadryl with improvement in wheezing and swelling at injection site. I continue with some mild unilateral right upper eyelid swelling but much improved.
This spontaneous report as received from a health care professional refers to a female patient of unknown age. Patient's current conditions and medical history was not provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (Lot# and expiration date was not known). On 08-DEC-2015, the patient visited the reporter's office to receive the second dose of GARDASIL 9. No adverse effects was reported. There were no product quality complaints. The outcome of Interchange of vaccine products was unknown. The causality for Interchange of vaccine products was not reported. Additional information has been requested.
This spontaneous report as received from registered nurse refers to multiple unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was unknown. The nurse reported that multiple unspecified patients were administered GARDASIL (dose, frequency and route unspecified) that were improperly stored. Concomitant medications were unknown. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This case is linked to #1409USA001774, #1409USA001775 and #1409USA001776 via same reporter link. Additional information has been requested.
Patient reported symptoms of chills, congestion, fatigue, and headache. headache lasted up to 4 days, and congestion is still lingering. Patient stating that also might be allergy related.
6hr p/vax pt devel an inj site rxn characterized by an 80mm by 90mm area of erythema, induration & pruritus;pt applied ice to the area & recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax;
Headache, Fever, NauseaVomiting, FATIGUE, CHILLS Narrative:
Pt. received a supplemental dose of pfizer COVID-19 on 10/4/2021 as per pts. request. Pt. received Janssen J&J COVID-19  vaccine  on 3/12/2021.    Received a phone call from Pt. on 10/13/2021 reporting that he had "A sensation on nerve track of left forearem that traveled down arm to hand"  which started on 10/9/2021, 5 days after he received his Pfizer COVID-19 vaccine.  Pt.  reports that it as not caused him to lose any mobility or function and "It is not severe but notiecable"  F/U with Pt. on 10/15/2021  and he reports "the senstion in the arm is still noticable but has improved some".  Advised  Pt. to see PCP  if symptoms worsen or persist.  Medical Director Consutled.
Fever up to 102F, myalgia, arthralgia, fatigue, nausea, vomiting, HA. Swelling of arms and subjective feeling of swelling in face. No angioedema. No hives.
pt recv vax in 1995 & 8 days later pt devel a rash on thighs & abd; No further details were provided;
Weird feeling in ears after injection, slightly dizzy and little tightness in chest. Used ice pack for comfort. Monitored until 1:07PM Chest hurting 1:33 p.m. rash developed on neck so went to  Clinic.  Nurse checked symptoms-heart racing, feeling weak. I took my clonazapam pill as advised when needed from my history of anaphylactic reactions while nurse checked with my doctor, went to ER in a wheelchair feeling dazed, tightning of legs, chest pressure,burning sensation in chest & throat, body rash. Treated with single dose of epinephrine, IV steroid, Benadryl, Pepcid.  5:30 P.M. discharge  03/05/2021 allergic reaction to vaccine/Urticaria ER 9:00AM
A report was received from a healthcare professional on 09/30/2003 concerning a female vaccinee in her mid thirties who experienced an injection site wheal with redness, swelling and warmth when receiving Fluvirin on 09/30/2003.  The vaccinee also received less than the recommended dosage.  On 09/30/2003 the vaccinee experienced welting of the injection site during Fluvirin administration.  The vaccinee received Fluvirin intramuscularly in the left deltoid.  Approximately half way through administration the injection site because red and swollen.  The administration was stopped.  The vaccinee received approximately 0.25ml Fluvirin.  The area around the injection site felt warm and looked like a "mosquito bite".  The vaccinee recovered on 09/30/2003.  There was insufficient information to determine the reporter's causality assessment.   Follow up pending. Update 1, 10/13/2003: A follow up report was received from a healthcare professional indicating that the 32 year old female vaccinee experienced an injection site wheal, eryhtema, and warmth.  The vaccinee was administered the second half of the dose on 10/01/2003 when it was certain that the redness and skin reaction had regressed.
Starting 05/22/2022, I felt like I had a sinus/allergy issue. On 05/23/2022, I woke up in the middle of the night with a sore throat and bad body aches. I tested on 05/24/2022 and it was positive, and had a temp later that day of 100.8. My tonsils were "on fire" and painful. So, I called my doctor and they prescribed PAXLOVID to take for 5 days. I self isolated for 5 days and wore a mask for 5 days (10 total days). During the night for the first 5 days of the breakthrough case I had shooting pain down my hips and legs. By 05/31/2022, I felt fine and tested myself for COVID and it was negative. Then on 06/04/2022, I felt like I was getting another allergy/sinus problem: Nasal congestion and sneezing. Then 06/05/2022, I developed coughing and re-tested myself for COVID and it was positive. So, I called my doctors office this morning (06/06/2022) to see what to do and they told me to self isolate for 5 days and wear a mask for 5 days (for a total of 10 days) but I have no fever and no body aches. I just have allergy type symptoms: rough sounding voice, post nasal drip and nasal congestion.
Information has been received on 20-FEB-2017 from a medical assistant regarding two 4 year old patients of unknown gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On 20-FEB-2017 the patients were vaccinated with VARIVAX lot # M037642 expiration 01-SEP-2018 (dose and route not reported) for prophylaxis after supported temperature excursion. The vaccine was stored at 15.4F for 1 hour and 45 minutes. There was no previous temperature excursion. The call was made because of a data logger. No adverse events were reported. No further information was reported. On 20-FEB-2017, 1 day after onset of therapy the patient experienced incorrect product storage and no adverse event.  The outcome of incorrect product storage and no adverse event is unknown.  The reporter considered incorrect product storage to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009195:
Information has been received from a registered nurse, concerning a 87 years old male patient, who on 28-AUG-2012 was vaccinated with a dose of improperly stored ZOSTAVAX (dose and route not reported) (lot # 0567AE, Exp: 04-APR-2013 - in validation process). The nurse reported that ZOSTAVAX that was administered to the patient had been delivered after being in transit from Company for 5 days; The nurse stated that it was stored in a truck over the weekend, and she does not know the temperature the ZOSTAVAX was exposed to during that time. No adverse effect had been observed or reported. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and polymyalgia. On an unknown date, the outcome of the general body pain and polymyalgia were recovered/resolved. It was unknown if the reporter considered the general body pain and polymyalgia to be related to SHINGRIX. Additional information was reported as follows: The patient had general pain and myalgia all over his body. The reporter could not remember any other details at the time of reporting. The nurse agreed to be followed up. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK137701.
The patient is a 4 year, 11 month old female who presents with a complaint of Rash. The patient is accompanied to the office visit today by their mother, The rash has been occurring for 1 day(s). The rash is present at the abdomen, back and elbow. Symptoms of the rash have included itching. Note for "Rash" Note: Patient comes for a rash since last night. The rash was discovered because of itches. She has no fever and her appetite is decreased. There has been no vomiting or diarrhea. She has a runny nose and a cough.
Patient received vaccines and reported feeling queasy prior to leaving clinic. Upon assessment patient with NAD noted. O2 sat 99% on RA. Pulse 100 BPM. Blood glucose 108.  Pt given water and crackers and reports feeling better at 2:53 pm. Pt escorted to vehicle by staff member and left in care of Father.
ALLERGIC REACTION- PATIENT RECEIVED A RED WELT OR HIVE ABOUT 6 INCHES BELOW SIGHT OF INJECTION. PHYSICIAN PRESCRIBED TOPICAL STEROID AND NURSE RECOMMENDED PTN TAKE ORAL ANTIHISTAMINE. Pneumonia vax was also given on same date. Reaction occured on left arm.