chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cramping with severe diarrhea, which turned into a full-blown colitis attack, which was confirmed by the CT-scan administered in the hospital. Had to start Levoflaxacin on Sunday, 4/25/21.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reaction or allergies was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). On an unknown date, about six months after vaccination with ZOSTAVAX, the patient received two blood transfusions for unspecified reasons. The outcome of the event and the causality assessment between the event and ZOSTAVAX were not provided. Upon internal review, the blood transfusions was determined to be medically significant. Additional information has been requested.
sudden onset of hearing loss in right ear; within minutes tinnitus decibel increased substantially in right ear and developed in left ear.; This is a spontaneous report from a contactable consumer (patient's parent). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 11May2021 at the age of 26 years old (Batch/Lot Number: EW0176, Expiration date: unknown) as the 2nd dose, single for COVID-19 immunization. The patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) administered in the left arm on 20Apr2021 at the age of 26 years old (Batch/Lot number: EW0171, Expiration date: unknown) for COVID-19 immunization and experienced dizziness/vertigo within a couple of hours on 20Apr2021; tinnitus (ringing in right ear) on same day; and right ear began to feel full with pressure/pain by 21Apr2021 in the morning (am), which all continued with swelling of lymph nodes and loss of hearing in right ear by 22Apr2021. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included non-alcoholic fatty liver disease, asthma, autism, appendectomy, pilonidal cyst removal, sensory integration disorder, allergies, allergy to Penicillin, and allergy to all Sulfa medications and all Cephalosporins; all from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and montelukast sodium (SINGULAIR), both taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline, amoxicillin sodium (AMOXILLIN), and hydrocodone and experienced allergy from these drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021, the patient received the second dose of Pfizer vaccine and within minutes tinnitus decibel increased substantially in right ear and developed in left ear. Tinnitus stopped in left ear and lowered to decibel level he has had since first shot in right ear. The patient was diagnosed with sudden onset of hearing loss in right ear on an unspecified date and magnetic resonance imaging (MRI) showed no tumour. All symptoms were ongoing with no prognosis of resolution. Both the events resulted in disability. The adverse events did result in a doctor or other healthcare professional office/clinic visit. The patient underwent further lab tests and procedures, which included a second hearing test with unknown results on an unspecified date. The patient received treatment for the adverse events, which included a prescription for steroid pack. The patient was not recovered from both the events.  No follow-up attempts are needed. No further information is expected.
While PT was waiting during her 15 minutes observation period post covid-19 vaccine administration PT began to experience siezure like activity lasting about 5 minutes. PT has a PMH of seizures, is compliant with her prescribed medications, and suffered a seizure a week prior. An IV was established and PT VS were monitored while PT was transported to the hospital. Prior to transport PT was COAX4 and remained stable through out transport. Run # 21-0766
On 1/21/2021 Caregivers proceed to go on rounds taking vitals and found she was with low blood pressure. They call Hospice and they certify that she had passed away.
I was administered the wrong COVID 19 vaccine.  Should have been Modera.  Was given Pfizer.
Redness, swelling at injection site approx. 4 in x 3 in. No other distal symptoms itching present at site.
Upon administration, pt. reported "seeing spots." Pt. called pharmacy 9/25 complaining of high fever, cold hands and chills. Pt. was referred to her PCP for evaluation and treatment.
Pemphigus; Nose bleeds; Globus sensation; Swelling left breast; Blood blisters in my mouth; Mouth ulcers; Skin ulcers; This is a spontaneous report from a contactable physician (Patient himself). A 56-year-old male patient received bnt162b2 (Manufacturer: Pfizer, Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 08Jan2021 09:00 (Batch/Lot Number: Ek9231) as dose 2, single for covid-19 immunisation in the hospital. Medical history included reflux from an unknown date and known allergies were none. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Manufacturer: Pfizer Formulation: Solution for injection), dose 2 single via an unknown route of administration, administered in left arm on 20Dec2020 10:45 (Batch/Lot Number: Ek5730) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not since vaccination. The patient reported that he started with some nose bleeds which he assumed was dry winter then developed shotgun 2to 3 weeks globus sensation. Then developed swelling left breast then started with blood blisters in his mouth. Then mouth ulcers. Then started with skin ulcers. All this was due to pemphigus on 15Jan2021. The patient underwent lab test which included biopsy proven with IF on 04Jun2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal association between the event pemphigus and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a physician via call center representative and described the occurrence of fever in a 43-year-old male patient who received BEXSERO (batch number 160601A, expiry date 31st July 2018). The patient's past medical history included splenectomy. Concomitant products included MENVEO and PNEUMOVAX. On 22nd February 2018, the patient received the 1st dose of BEXSERO (intramuscular). In February 2018, 12 hrs after receiving BEXSERO, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved. The reporter considered the fever and influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: On 22nd February 2018, the patient received MENVEO as concomitant medication. On 22nd February 2018, the patient received PNEUMOVAX as concomitant medication. The health care professional reported that the patient received 1st dose of BEXSERO and developed a severe fever and flu like symptoms about 12 hours after receiving the BEXSERO vaccine. The health care professional was confident that BEXSERO caused the adverse events.
Information has been received from a consumer concerning her 40 days old grandson with cystic fibrosis gene carrier and no drug reactions or allergies who on 25-OCT-2010 was administered VAQTA (manufacturer unknown) instead of RECOMBIVAX HB due to nurse's medical error. Concomitant therapy included MYLICON. Consumer did not know product name or the manufacturer of the vaccine. Mistake was discovered by the nurse and RECOMBIVAX HB was administered as well during the same visit. She noticed that her grandson fell asleep right away after receiving both vaccines. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. Patient sought medical attention via telephone. Additional information has been requested.
Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine; Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) in a 5-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer in May 2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 14-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 14-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Baby received 2nd dose of COVID-19 vaccine with 0.25 ml Moderna COVID-19 vaccine instead of Pfizer COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported Second dose of moderna was supposed to be the 2nd primary Pfizer dose for this patient. No Treatment medication was reported
Painful left arm starting 4 hours after injection, not yet resolved at 53 hours (improving). Low grade fever, chills, malaise, fatigue, joint and muscle pain, nausea, racing heart rate with mild exertion, all starting about 10 hours post vaccination, waxing and waning at 53 hours, slowly improving.
The patient's grandmother alleges that one day after administration, cellulitis appeared on patient's shoulder at the site of injection. Antibiotics were prescribed for the infection after subsequent visit(s) to prescribers for evaluation. The patient's grandmother alleges that the injection site was not sterilized properly prior to injection.
shortness of breath; vomiting; coughing; became hoarse; fever; muscle pain within hours of the injection; chills; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   The patient's past medical history included lung disorder and cardiac monitoring (the doctor had some concern over her heart so she was wearing a heart monitor for 2 weeks. No specific reason was given for the need of a heart monitor). Previously administered products included Shingrix with an associated reaction of no adverse event (first dose received within 2 to 6 months before the 2nd dose).   On 26th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 26th February 2020, less than a day after receiving Shingrix, the patient experienced muscle pain and chills. On 28th February 2020, the patient experienced vomiting, cough, hoarseness and fever. On 29th February 2020, the patient experienced shortness of breath. On an unknown date, the outcome of the muscle pain, chills, vomiting, cough, hoarseness, fever and shortness of breath were unknown.   It was unknown if the reporter considered the muscle pain, chills, vomiting, cough, hoarseness, fever and shortness of breath to be related to Shingrix.  Additional information was provided as follows: The patient started to experience muscle pain within hours of the injection.  Chills began later that day. 2 days after receiving vaccine, patient had the chills but began to vomit, cough, became hoarse and started to run a fever. On that Saturday, she started to have severe shortness of breath. On Sunday her temperature went down. On Monday, she went to the physician tor even though it felt the worse was behind her. The physician had some concern over her heart so she is wearing a heart monitor for 2 weeks. No specific reason was given for the need of a heart monitor. Emergency room visit required.
she was "shocking people" when she touched them, like static shock/I started shocking people and myself; when she pushes down on her arm it hurts.; she "could taste it when he gave it to me" talking about the vaccine.; she couldn't stop drinking coffee. She normally drinks 2 cups a day, but after receiving her vaccine, she dray 10 cups of coffee; This is a spontaneous report from a contactable consumer (patient)  A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose with no problem. She said she only knows that she "got a needle" because when she pushes down on her arm it hurts. Her concern, however, was that for the rest of the day after the shot she couldn't stop drinking coffee. She normally drinks 2 cups a day, but after receiving her vaccine, she dray 10 cups of coffee, didn't feel jittery, and went to sleep that night with no problem, and slept well. She wanted to know if this is normal. Should she get a large coffee before going to get her second dose. The patient also reported that she was "shocking people" when she touched them, like static shock. She also stated she "could taste it when he gave it to me" talking about the vaccine. She would like to know when she would get the "normal" symptoms. The patient further stated, "I had the vaccination yesterday- no problems and teeny concern of mine - after I got it I started shocking people and myself - I could taste it when he gave it to me. My concern was it made me drink a significant amount of coffee - 10 cups of coffee - didn't feel over caffeinated. Laid down and went to sleep. No ailments, don't feel bad - Had to have a cup of coffee every hour. 2 cups everyday and Pepsi. When I push in my arm is the only way that I knew I got a needle. Pfizer was my choice of vaccine from the beginning. Thank you are my heroes." The patient was informed that there was no information about avoiding caffeine around vaccination.  Cannot make a recommendation about coffee consumption, that would be a personal decision. Patient stated that she did not feel fatigued. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
3-4 mm subcutaneous swelling at immunization site, not red, not tender. No additional symptoms.
he felt ill for a long period of time after the first dose; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he felt ill for a long period of time after the first dose".  Additional information: HCP states calling on behalf of her patient who had the first dose of pfizer covid vaccine in April but did not go back to get the second shot as he felt' ill for a long period of time after the first dose' (specific symptoms unclear). Now patient wanting to travel and must follow specific travel recommendations. Patient must have completed 2 dose series of pfizer covid vaccine or get the J and J vaccine. is it safe  to take J and J after having had one dose of pfizer covid vaccine.  Follow-up attempts completed. No further information is expected.
2nd dose not given within the 2-6 months window; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional details were provided as follows: The patient did not receive 2nd dose of Shingrix withn the 2 to 6 months window. The reporter stated that, when asked for more clarifications if the 2nd dose was administered before or beyond 2 to 6 months interval, health care professional ended chat, which led to inappropriate schedule of vaccine administered. No other adverse event details provided. No Consent to follow up asked as health care professional ended chat.
Headache, mild chills, moderate body aches and fatigue. Started at 11 hours post injection and persisted through at least 19 hours post injection. Forced to telework instead of reporting in person.
Intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area reminiscent of a sunburn. Some in the arms, legs and back as well; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the arm right on 08Jun2021 at 15:30 (at the age of 12-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to chemicals (allergic to methyl isobutyl ketone), since unknown date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 03May2021 at 15:30 (at the age of 12-years-old), as a single dose for COVID-19 immunisation. On 10Jun2021 at 06:00, the patient experienced intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area reminiscent of a sunburn. Some in the arms, legs and back as well. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of intense skin rash and included treatment with unspecified steroids and unspecified allergy medicine. The clinical outcome of the event intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area, arms, legs and back was recovered on an unknown date in Jun2021.   No follow-up attempts are needed. No further information is expected.
Pain in injection site and swelling. Headcahe, joint pain, muscle pain, chills, some fatigue and temperature of 99.5 f.
Caller states before with the first and second shot he got no symptoms except a sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, before with the first and second shot he got no symptoms except a sore arm. Caller would like to know if he can go outside. Caller stated he doesn't want to make other people sick and right at the time of report he was in quarantine since he does not know if he has COVID-19 or not. Caller stated he was not going to work right now either. Caller stated he does not have a health care provider and he does not have any health insurance. Caller stated he will just be calling and going to a primary care center. Caller stated okay for someone to call him back at a later time to get more information. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
being sick ain't fun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "being sick ain't fun".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from the healthcare worker refers to a patient of unknown age and gender. No medical history, drug allergy and concurrent condition was reported. On 09-MAR-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # K005957 with the expiration date of 08-MAR-2015, 0.5 ml, subcutaneous for an unknown indication. No adverse effect was reported. No product quality complaint (PQC) involved. Additional information has been requested.