chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has experienced  massive headaches nonstop; she experienced is a blinding headache; This is a spontaneous report received from a contactable Pharmacist (patient). A 62-year- old pharmacist received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Batch/Lot Number: EW0181), via an unspecified route of administration in the left arm on 29Jun2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Time the vaccination was given as sometime in the evening, about 19:00 or maybe a little earlier, 18:30. Medical history was reported as none. Concomitant medications were not reported. The patient stated she was in a clinical trial last year, 2020, for the Astra Zeneca Vaccine and received the active Astra Zeneca Vaccine. The patient stated no one recognizes the Astra Zeneca Vaccine here. An Airline told the caller they would not fly her and she was considered not vaccinated. In order to secure a CDC Card, the caller had to go and have the Pfizer Covid 19 Vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Had first dose of the Pfizer COVID-19 vaccine on 29Jun2021. Since then she had experienced massive headaches nonstop. She had read from the internet that there had been reports of headaches but what she experienced was a blinding headache. For two or three days the patient had been running a blinding headache. The patient's headache was not subsiding. The patient had taken Aspirin and Tylenol. The patient stated, today is Friday, 02Jul2021, on Wednesday, 30Jun2021 and Thursday 01Jul2021, the patient was incapacitated sitting at home and trying to put an ice pack. The patient rotated warm packs and ice packs. The patient could not function. When asked if the headache had improved, persisted or worsened the patient replied the headache was just as it is, its blinding. The headache had not improved even after taking the over the counter pain pills. The outcome of events was not resolved.  Additional Information: Description of Product Complaint: Tylenol (Lot: P108696, NDC: 0363-0519-12, Expiration: Jan2020, Additional lot numbers: P108696) The patient reported a blinding headache after receiving the first dose Pfizer Covid 19 Vaccine. The patient stated the headache has continued even after taking over the counter pain medication. The patient stated the headache had continued and the patient has taken Tylenol. The patient stated she needed to put on glasses to read the information on the Tylenol bottle.   Description of Product Complaint: Aspirin (Lot: P121168, expiration: Jul2022, NDC: 0363-0563-32, Additional lot numbers: P121168) The patient reported a blinding headache after receiving the first dose Pfizer Covid 19 Vaccine. The patient stated the headache had continued even after taking over the counter pain medication. The patient stated the headache had continued and the patient had taken Aspirin.  Follow up needed, further information has been requested.
15JUL92 recvd 1st dose of Engerix-B & 2 days later devel lightheadedness;
The pt screamed, unconsolable almost for about 30 mins immediately receiving injections. The sites were red and swollen. The next day the pt had a high temperature of 103.6 deg. F. and remained fussy.
This case was reported by a healthcare professional and described the occurrence of hives in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine recombinant (unknown manufacturer). Concurrent vaccination included combined diphtheria, tetanus, pertussis (A or W not known) vaccine (manufacturer unspecified) given on the same date as hepatitis B vaccine. On an unspecified date (from 1993 to 1997) the subject received unspecified dose of Hepatitis B vaccine. At an unspecified time after vaccination with hepatitis B, the subject experienced hives. At the time of reporting the event was resolved. The healthcare professional considered the event was resolved. The subject experienced hives. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with Hepatitis B vaccine. Follow-up information received via the reporter on 15 January 2009 indicated that they were not sure if the hepatitis B vaccine administered to the subject between 1993-1997 was GlaxoSmithKline vaccine as was originally reported. No additional information was provided.
Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!
2 inch red raised area at injection site with extreme soreness entire left arm all the way down to pinky finger.
presents with itchy rash and palpitations after getting her 1stnd COVID-19 vaccine today.  Patient reports that she has a history of 16 different allergies and has had anaphylaxis before so she carries an EpiPen with her.  She denies any difficulty breathing for "throat closing up".  She states that she did feel some palpitations and chest tightness earlier but this has improved.  She states that her skin feels itchy.  She states that her heart rate feels high.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 06-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Facial drooping & numbness, was diagnosed with Bells Palsy at hosp. Went to neurologist a couple days later he admitted me to overlook. By then lost feeling in my feet, legs, arms, hands and had trouble understanding & focusing.
Area of redness extending out from original area of vaccination by about 2 inches, rash initially spreading down arm from vaccination location progressing to itching over entire body and face.
When my daughter received her vaccinations the nurse let me know that she might have a side effect that will appear in two weeks, most likely redness around the area. Today is 2 weeks to the day that she got her vaccinations and woke up cranky, with redness around the area where her vaccine was injected and was unable to hold herself up with her legs. She has been a perfect walker for at least two months now and I knew something was wrong. She would move around bent over with her hands on the floor unable to stand fully without pain.
Case number PHEH2013US011412 is an initial spontaneous report received from a health care professional on 22 May 2013, and with a follow up report received from nurse on 12 Jul 2013. This report refers to an 11 year old female patient. The patient's medical history and concomitant medications were not reported. The patient received an intramuscular dose of 0.5 ml MENVEO (batch number: 12013) on 23 Mar 2013. It was reported that the patient possibly received MenA lyophilized conjugate of MENVEO diluted with sterile water instead of being reconstituted with MenCYW-135 liquid conjugate. It was reported that a box of MENVEO was found with one full dose and one vial of powder, but without diluent. No adverse reaction was reported following maladministration. No further information was provided. Follow up report received from nurse on 12 Jul 2013. Updated patient demographics, batch number and vaccination date.
Needed to catch breath; Loose stool; Arm was sore; Horrible chills; Fever of 99 F; Headache; Body aches; A spontaneous report was received from a consumer who was a 66-year-old, female, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm was sore, horrible chills, fever of 99F, headache, body aches, loose stool, and felt like needed to catch breath.  The patient's medical history included asthma, and COVID-19. Concomitant medications were not reported.  On 08 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, one day after vaccine administration, the patient's arm was sore, she had chills, fever of 99F, headache, and body aches.   On 10 Jan 2021, her previous symptoms resolved but she began to experience loose stool, and felt like she needed to catch her breath. The patient made an appointment with a respirator specialist.  On 11 Jan 2021, her gastrointestinal symptoms went away.  On 12 Jan 2021, the patient's breathing issues were better but she continued to have pain in her arm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, sore arm was considered not resolved; outcome of the events, chills, fever of 99F, headache, body aches, were resolved on 10 Jan 2021; outcome of the event, loose stool, was resolved on 11 Jan 2021; outcome of the event, felt like needed to catch breath, were resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old, female patient with medical history of asthma and COVID-19, who experienced expected event of pain, chills, pyrexia, headache, myalgia and unexpected event of diarrhea and dyspnea. The event occurred 2 days after the first dose of mRNA-1273 (Lot number: 027L20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Thyrotoxicosis starting approx 10 weeks after receiving 2nd Pfizer vaccination. Presented for evaluation approx 15 weeks after 2nd vaccine thyrotoxicosis - tachycardia (resting HR 120's), 12lb weight loss, tremors, heat intolerance treated with methimazole x 4 weeks
Possible Oculo-Repsiratory Syndrom as described in studies in early 2000s.  Vaccine at 7pm, went to sleep a bit after 8pm. Woke up at midnight - eye discharge, chest a bit tight, throat a bit hoarse.  Took 200mg ibuprofen and hot shower and went back to bed. Woke up again at 7am - swelling of eyelids and green eye discharge OU, voice hoarse (no throat pain), mild nasal congestion with no discharge, slight wheeze on deep breath, slight urge to for soft cough a couple of times, lethargic / tired, mild pain at injection site.  Did not take temperature. COVID-19 test (at home Elisa) negative.  Feeling a bit better now at 11am at time of reporting.  Patient (I) wear KN-95 most of the time so unlikely other viral or bacterial infection.
Pt was given an adult dose of Hepatitis A vaccine (1.0cc) rather than pediatric/adolescent dose. CDC contacted. Their response "We do not expect to see a serious reaction. Second dose (pediatric Hepatitis A) should be given in six months."
Patient had sore arm after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had sore arm after receiving 1st dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE PAIN (Patient had sore arm after receiving 1st dose of vaccine). At the time of the report, VACCINATION SITE PAIN (Patient had sore arm after receiving 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Upon internal review on 21-May-2021, the age was corrected to unknown.
This spontaneous report as received from a nurse refers to a "handful" of parents. On an unknown date patients was vaccinated with VARIVAX (Merck) (strength, dose, frequency, route, lot # and indication were not provided). At the practice, over the past year, a "handful" of parents have reported that their child had developed chicken pox after administration of their first dose of VARIVAX (Merck). Nurse had no specific information to share regarding patients, dosing information, or any other details. She further stated that this was word-of mouth, as the parents only called the office with the reports and there was no physical assessment done. No other information available. This is one of several reports received from the same source. Additional information has been requested.
No additional AEs reported; post-expiry stability data of an expired dose of PNEUMOVAX23; This spontaneous report was received from a registered nurse referring to a 67-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 23-DEC-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S005856, expiration date 03-DEC-2020, 0.5 milliliter; route was not reported) for prophylaxis (expired product administered). No adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); ; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Massive itching on legs, ankle, back, upper arms and central chest,   Itching reduced by taking Eucerin, Triachmcinlone, and anti-histamines OTC.  Ultimately controlled by Steroid Shots.  Itching would spike a week or two after each injection.
Patient daughter completed the interview as they are a patient at Hospital. Wife stated patient is not aware of how exposure occurred, she has continue to practice safety protocols. Wife informed patients oxygen levels were greatly diminished before hospital admission.
body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011ML(orC)0A) 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) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (body aches) and PYREXIA (fever). At the time of the report, MYALGIA (body aches) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
At approximately 0545 AM on 2/4/21, i started experiencing a severe pain/ tingling in my left arm by the administration site of the vaccine with a sudden pounding then contact headache with lightheaded ness . The pain and light headedness resolved around approximately 12pm. The headache lessen over the next 24-48 hours. Over the counter of Tylenol was taken along with NSAID later in the day.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported for 5 patients. This report refers to the male (other guest's husband) she was at dinner with.  A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Aug2021, after vaccination, the patient was tested positive for COVID. This consumer reported stated she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who didn't. She clarified she still has immunity obviously, and she doesn't want to get another shot. The consumer clarifies the female person who was coughing her brains but was wearing a mask and was sitting across from the reporting consumer. This person's husband had COVID and didn't know it but was cured. His symptoms resolved in 2 days but was shedding the virus apparently. She clarifies this person's husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Apparently, the male that had COVID that week was still shedding the virus because the other male guest at the dinner was in the hospital for 2 weeks. The reporting consumer confirms they all three people at the dinner with her tested positive for COVID. The patient had recovered from the event on unknown date in 2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
pt recvd vax w/in 2 hrs, became very fussy & crying alot; rt thigh became swollen & indurated; faint erythema & warmth; no fever;
Patient reported pain after admin of flu shot. Admin - 10/28/11. Reported - 11/16/11.
Approximately after 45 mins of giving the vaccine, he started to feel numbness on the right side of the face. Including the temple, part of the eye and right cheek. 4 days have passed and at the moment he still has that same symptoms. The Clinic cannot treat him, they told him to go to the Emergency Room.
Pt. was only 5 months and 19 days old when she first got the flu vaccine (too young). Age of patient at time of event: 5 months 19 days.
HYPOXIA 9/25/2021 CEREBRAL EMBOLISM  CARDIOGENIC SHOCK 3/15/2022 CEREBRAL EMBOLISM  HYPOXIA 9/25/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE  CARDIOGENIC SHOCK 3/15/2022 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE  HYPOXIA 9/25/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 3/15/2022 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  HYPOXIA 9/25/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 3/15/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
pt recv vax 13DEC93 & in MAR94 rubella titer was neg; No further details were provided;
positive again on Day 10; positive again on Day 10; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "positive again on Day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Rebound COVID-19 infection on Day 10. Tested negative on Day 5 and 6. Developed symptoms and tested positive again on Day 10; (unspecified date) Negative, notes: Rebound COVID-19 infection on Day 10. Tested negative on Day 5 and 6. Developed symptoms and tested positive again on Day 10; (unspecified date) Positive, notes: Rebound COVID-19 infection on Day 10. Tested negative on Day 5 and 6. Developed symptoms and tested positive again on Day 10; (2022) Positive, notes: COVID 19 Treatment tested positive again on Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medications within two weeks of vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.