chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; could not swallow; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm in Mar2021 (batch/lot number EP6855 and expiry date unknown) at 52 years of age as dose 1, single for covid-19 immunization at a pharmacy/drug store. The vaccine was not administered at a facility. The patient informed that she thought her 1st dose of the Pfizer COVID vaccine was on 25Mar2021 but has her patient card and written on it was 15Mar2021 or 13Mar2021 and she thinks it was 15Mar2021 which was the date of her 1st dose with lot EP6855 and states no expiry date or NDC was written on the card. The patient's medical history and concomitant medications were none. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient informed that she was calling about the Pfizer COVID vaccine and took the 1st dose back in Mar2021 and about 5 hours after she took the vaccine (Mar2021) she experienced allergic reaction and could not swallow that went on all night and she had the vaccine around 6:00 pm (also reported between 5:30 pm and 6:00 pm) and went to sleep and was fine and then at 11:00 to 12:00 at night she couldn't swallow and was up until 4:00 to 5:00 am trying to swallow and resolved in the morning (2021). The patient informed that she wanted to go to the emergency room but did not and her husband would not take her and just looked on the internet. The patient also had no physician office visit. The patient informed that her weight at the time of the Pfizer COVID vaccine (Mar2021) was like 130 pounds and now her weight (2021) was 112 pounds. The patient informed that she did take Tylenol two of them before she went to sleep. The outcome of the event could not swallow was recovered in 2021, while unknown for the other event. The patient's HCP said not to take the 2nd dose of the Pfizer COVID vaccine and said that the reaction could get worse and it has been 4 months since her first dose. The patient wanted to know if she can she take the 2nd dose of the Pfizer COVID vaccine now or was it too late since it has been 4 months since she had the 1st dose. The patient wanted to know for any reports of not being able to swallow and having this allergic reaction 5 hours after getting the Pfizer COVID Vaccine. The patient wanted to know if other people had this reaction right away and she informed that she knew most people know they have the reaction right away. The patient was informed/explained to her that the possible side effects, but no reports found specific to not being able to swallow, 5 hours after the shot. The patient was referred to HCP. The patient informed that now with the delta variant she was afraid she was not vaccinated and asked if she can mix the Pfizer COVID vaccine with a different vaccine.  Follow-up attempts are completed. No further information is expected.
Major pain in my left lower stomach before and after bowel movement.; Major pain in my left lower stomach before and after bowel movement.; This is a spontaneous report from a contactable consumer. This 37-year-old male consumer (patient) reported for himself. A 37-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736) via an unspecified route of administration in arm left on 23Apr2021 as single dose and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EWC177) via an unspecified route of administration in arm right on 14May2021 08:30 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. The patient experienced major pain in left lower stomach before and after bowel movement on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): negative on unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.   Follow-up (18Jun2021): Follow-up attempts completed. No further information expected.
Treated on day of vaccination, 1/29/21, with Solu-Medrol as tightness in throat and cough began within 1 hour of vaccine. Used son's albuterol at home, symptoms subsided.  Returned next day, 1/30/21, for returned symptoms as well as new onset itching and rash, cough, tightness in throat, itching on upper back and arms, rash on upper back. Hypertensive and tachycardia.  Treated with  Benadryl, Dexamethasone, Albuterol nebulizer treatment in clinic.  HR under 100 after nebulizer, cough greatly reduced. Prescribed Famotidine, Prednisone, Albuterol inhaler.
Headache, Fever, fatigue Narrative:  Received 2nd dose 2/17/21 and has been experiencing  tiredness, low grade (99.8-100.1F)fevers, headache, sore arm. All symptoms have subsided at this time.  Other Relevant History:
pt had unwittnessed LOC on Friday evening with "feeling funny" prior to LOC. Awoke on floor taken to ER where witnessed 45 second tonic seizure with LOC. W/I done, CT scan head, LP, MRI head, blood, urine, CSF cultures. Fever noted concurrently to 103 on 06/21. Ceftriaxone given x 2 1/2 days.
left arm is swollen and red from shoulder to above elbow. States notice swelling day after immunization.  Warm ot touch, child denies any pain.  PCP was called and he instructed to give Benadryl and apply cold packs. Parent state the same thing happened last year but did not report it.  States has only had problem with flu vaccine. Viewing immun. record received flu vaccine in 2006 in this office. no record of vaccine in 2007.
Inadvertently administered 0.3 mL of Pfizer Covid-19  5-11yr vaccine (orange top) undiluted.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was reading the whole pamphlet on Pfizer and she took the Pfizer COVID vaccine on 01Mar2021 or 08Mar2021 she believes. The patient was having some symptoms but she did not know it was from that and it still could not be from that maybe. The patient was having muscle and joint aches on an unspecified date and she always used a remedy and it would go away but with this first shot it came but then it went and came back and went again and she did not think anything else about it. The outcome of the events was unknown.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd vax & had fever 103; pain in arms, legs; admitted to hosp for vaso occlusive crisis;
high blood pressure; This is a spontaneous report from a non-contactable pharmacist. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on Feb2021 as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced high blood pressure. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Local reaction - redness, induration, and tenderness at injection site - Both (R) and (L) arms.
My eyes were swollen, rash on face and body, prednisone treatment 20 mg for 12 days and zyrtec
Undiluted dose was administered at 3:22pm, in less than 1 hour, swelling and soreness at injection site. Irritability, tiredness. Pharmacy contacted parent at 4:29pm to inform that an undiluted dose had been administered. No other advice was provided. Parents contacted primary care physician but have not yet had communication with PCP.
Redness and swelling right upper thigh-firm baseball sized bump right thigh-tender-no fever
Arm sore to move; began 02/11/2021.  Injection site extremely swollen, red, size of softball, hard and warm to touch with pain up through shoulder and into neck.  Manageable with Advil. Rash on inside of same arm.   02/12/2021 - swelling has gone down some; however, is now swollen and warm to touch from injection site to elbow; appears redder than previous day.  Consulted with RN at Facility who recommended patient follow up with PCP to rule out cellulitis.  Agreed to do so.
he contracted or tested positive for Covid-19 virus; This is a spontaneous report received from a Pfizer-sponsored program. A contactable Consumer reported for himself that, a male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his 1st dose on 17Mar2021 and was not yet scheduled for 2nd dose. He mentioned that he contracted or tested positive for Covid-19 virus yesterday. He wanted to know how he would proceed with his 2nd dose. The patient experienced he contracted or tested positive for covid-19 virus on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The event assessed as medically significant. Outcome of the event was unknown.
Wednesday 1/13/2021 I woke up feeling like nauseous, then later in the day I started to get itchy in my lower body that was coming and going (I believe I still had some allegra d in my system). On  Thursday 01/14/2021 by noon time the itching had become extreme and unbearable all over my body and felt like my skin was crawling/burning, my chest and parts of my arms were really red . I also developed a lump in my throat that kept getting bigger and felt itchy and couldn't stop clearing my throat. Around 3pm I took 10ml of Claritin. The Claritin had not really helped however the redness had gone down a lot and by 4:30 I was miserable. Informed by a provider I work with to go to urgent care. I arrived at urgent care at about 5:10 where I was treated for an allergy reaction. I was given  0.9% sodium chloride IV bolus 500mL, Methylprednisolone sod suc(PF) (SOLU-Medrol) 125mg Intravenous, Famotidine (Pepcid) 20mg/2ml injection 20mg intravenous, diphenhydramine (Benadryl) 50mg/ml injection 25mg intravenous.  The itching subsided within 30 minutes, the itchy throat/ lump was still present but was not getting worse and slowly improving.   I was discharged home and was told to pick up famotidine 20mg, otc benadryl and prednisone 50mg to take for 5 days.  got home a little after 7 and was able to eat dinner, let dog out, shower, rest  before going to bed. I did take another 10 ml of Benadryl at 10:30. Woke up without any itchy skin at 5:45 and was able to return to work this morning. I still have a slight itchy throat but it is tolerable. I took allegra d and famotidine this morning. I am holding off on the prednisone because of the immune response to vaccines from steroids. I don't want to lessen the effectiveness of the vaccine.
103 degree ferenheit fever for approximately 24 hours, severe chills and body aches.
Pt spiked to 104.1 degree fever around 6:30 pm the day after her vaccination.  She was lethargic and not wanting to eat or drink.  She did not have a rash or  difficulty breathing.  Her temperature was taken in the ear.  Her fever did respond to Ibuprofen and did not spike again.  (remained low grade on day two without medication).
seizures; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced two strokes (within a week of receiving first dose). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced two seizures after receiving second dose. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Patient received Pfizer Booster Shot and Fluzone. Patient reported pruritic rash around the neck area and arms. All vitals WNL and denies SOB. Patient reported taking Benadryl in the past and experiencing palpitations and prefers not to take any at this time. Pt was advised to go to the ER, patient declined. PCP not in Health Center. Per NP request, Doctor was called and he advised for the patient to take OTC Zyrtec or Claritin 10mg. Patient was given 10mg pill of Zyrtec and kept in observation by NP for 30 minutes. Skin was cleared at the end of the observation period, all vitals WNL. Provider advised the patient to go to the ER if symptoms return. Doctor was informed of the incident.  Patient verbalized understanding and was taken home by her husband. VAERS report completed
Patient developed Guillain Barre Syndrome with typical clinical presentation. Received IVIG treatment. The medical record received on 4/5/04 states numbness, tingling, weakness, pain in back, paraesthesia, atrophy of muscle, lower extremities, hoarseness and orthstatic hypotension.
cystitis; Headache; fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CYSTITIS (cystitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced CYSTITIS (cystitis) (seriousness criterion medically significant). At the time of the report, CYSTITIS (cystitis), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Urine analysis: abnormal (abnormal) urinalysis Blood 3 plus. In 2021, Urine analysis: abnormal (abnormal) urinalysis Blood 1 plus and nitrates (infection) Follow up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Cipro 2 courses. Concomitant  information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-105169 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hospitalized;  COVID-19 positive (9.6.21);  fully vaccinated.  Admission Date: 9/5/2021 Discharge Date:  09/07/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: TIA (transient ischemic attack) [G45.9] Chronic anticoagulation [Z79.01]   HOSPITAL COURSE:   Presents to the hospital with left upper extremity numbness and back pain, admitting provider suspected TIA, workup included an MRI, MRI of the brain was negative, based on the presentation which appears to be subacute and persistent this is more likely consistent with cervical radiculopathy. Given that family member had positive COVID test before patient's admission she was also tested for COVID, she came back positive therefore respiratory isolation placed, she was however asymptomatic, imaging of the chest was negative for pneumonia, she did not require supplemental oxygen.  She was discharged home in stable condition.  She will need to self quarantine for a total of 10 days post diagnosis of COVID.  TIA diagnosis while present on admission was worked up and ruled out Cervical radiculopathy with left upper extremity numbness is the diagnosis that the patient was considered to have when discharged COVID 19 infection positive without respiratory distress nor other manifestations Other diagnosis as above Discharge Disposition:home or self care  Active Issues Requiring Follow-up:  Suspected cervical radiculopathy with pain and numbness and multilevel degenerative disc disease of back
Patient experienced chest tightness, dizziness 15 minutes after the shot.  She sat and rested 30 minutes
she is on an antibiotic for bronchitis; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bronchitis and is on antibiotics for bronchitis. Therapeutic measures were taken for bronchitis with antibiotics. Patient was scheduled to have the second dose of the vaccine and she was on an antibiotic for bronchitis. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
One week after vaccination, I developed swelling in injection site and  I developed  a rash about 2 inches diameter from the injection site.  The temperature of the injection area was 101.7 for about two days. The rest of my body had a normal temperature.  .By the third day the temperature at the site was gone but the rash  and redness spread over arm red rash and itching continued for 5 days.
Erythematous and was warm and non tender 4" x6" at L thigh injection site.
Johnson-Johnson Covid 19 vaccine EUA- patient arrived 0845 completed paperwork and taken back guard, at 0858 client stated he was not feeling well and asked if he could lay down. Guard held his hands on shoulder to support client. Client became unconscious , code blue called , laid client to floor, client, pale, skin clammy and cold. Vital taken 0900 BP 92/60 pulse 52 resp. 20. As soon as client placed on floor he became responsive. He stated his pulse runs 52 and that was normal for him. He stated he has no medical history or medications, not diabetic. He stated he usually faints when he gets shots but it had been 20 years ago since he fainted so he thought he was over it. Stated he has fainted multiple times after shots. EMT arrived at 0904 client awake, alert and oriented, VS 112/68. EMT checked client over well. 0910 BP 147-86 HR 54. Client refused to go to hospital staff stayed with client approx. 15-20 more minutes in break room, he had beverage and snack. He stated he was much better and felt comfortable to leave,
she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine; became severely ill and 5 days later she was hospitalized; Initial information received on 04-Jan-2023 regarding an unsolicited valid serious case received from other health professional.  This case involves a 91 years old female patient who experienced she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine and became severely ill and 5 days later she was hospitalized while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, expiration date, lot number not reported) via unknown route in unknown administration site for immunization.  On 06-Oct-2022 the patient developed a serious became severely ill and 5 days later she was hospitalized (illness) latency: 1 day.   On an unknown date the patient developed a serious she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine (interstitial lung disease) (unknown latency).  Final diagnosis was (fatal) she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine.  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for the event became severely ill and 5 days later she was hospitalized and was Fatal for the event she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine. No autopsy was done. The cause of death was reported as Interstitial pneumonia.   Seriousness criteria: Event interstitial lung disease was assessed as medically significant and was leading to death. The patient was hospitalized from OCT-2022 from Illness and interstitial lung disease.; Sender's Comments: Sanofi company comment dated 04-Jan-2023: This case involves a 91 years old female patient who experienced she was hospitalized and received a diagnosis of acute interstitial pneumonia due to the influenza vaccine and became severely ill and 5 days later she was hospitalized while receiving vaccine influenza vaccine. No autopsy was done. The cause of death was reported as Interstitial pneumonia. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information regarding condition at the time of vaccination, past medical history, lifestyle history, concomitant disease or risk factor excluding other predisposing etiologies precludes comprehensive case assessment. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: acute interstitial pneumonia