chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient provided image of a skin rash(reaction to covid jab); This spontaneous case was reported by a patient and describes the occurrence of RASH (Patient provided image of a skin rash(reaction to covid jab)) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced RASH (Patient provided image of a skin rash(reaction to covid jab)). At the time of the report, RASH (Patient provided image of a skin rash(reaction to covid jab)) outcome was unknown.            Patient attached photo of his arm 2 days after COVID vaccination and asking if this was normal, also his wife had it at same time. That night his wife was bad could hardly walk and very dizzy.  Both had no problems with any of the previous Covid doses. Patient received vaccination on 15-Sep-2022 Thursday. This Email was received, however country was not provided. And AE was reviewed by PV team.   This case was linked to MOD-2022-650924 (E2B Linked Report).; Sender's Comments:  MOD-2022-650924:wife case
Approximately 6 hours after receiving her vaccines, she had a seizure that lasted about 20-30 seconds. She was evaluated at the ER that day and a CT scan showed a healthy brain. Two weeks later she had an EEG done which showed no signs or propensity for epilepsy. No subsequent events or treatments have occurred.
Freezing Cold, Shaking, Fever, Next day, Hot followed by cold, two days in bed
patient received booster dose COVID-19 vaccine; Ankylosing spondylitis flare up; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4195489-00 (Agency).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk, citrate free for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "patient received booster dose COVID-19 vaccine"; ANKYLOSING SPONDYLITIS (medically significant) with onset Nov2021, outcome "unknown", described as "Ankylosing spondylitis flare up". The action taken for adalimumab was unknown.  Clinical course: There was no reported medical history. In Nov2021, the patient experienced Ankylosing Spondylitis flare up. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Nov2021 patient received booster dose COVID-19 Vaccine manufactured by Pfizer/Biontech.  The reporter's causality for the event of Ankylosing Spondylitis flare up with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event of Ankylosing Spondylitis flare up with Pfizer BioNTech Covid-19 Vaccine was possible. It was not applicable if event abate after stopping drug. Concomitant drugs, other relevant history and dates of administration were not reported.   The reporter considered "patient received booster dose covid-19 vaccine" and "ankylosing spondylitis flare up" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and possible causal association between suspect product BNT162B2 to the reported events ankylosing spondylitis aggravated cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Reporter said that they were filling out a temperature excursion assessment at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing.  It was reported that no adverse reactions were reported by any patients.  No treatment information was provided.
Approximately 6 days after receiving my RSV shot I developed what my doctor thinks is Lichen Planus both oral (palate) and dermal (neck).  The top of my mouth has redness around the periphery and is extremely painful, especially when I try to eat, drink, or brush. It feels like it was burned but I don't recall a burn and it hasn't healed in at least 5 days. Simultaneously, I developed a very itchy rash on both sides of my neck.
improperly stored vaccine administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-SEP-2021, the patient was vaccinated with improperly store rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707460, expiration date: 14-MAR-2022) and with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T026961, expiration date: 02-APR-2023) (formulation, strength, dose and frequency were not reported for both) both for prophylaxis.  The nurse reported that the vaccine experienced an excursion of 48.7 degrees Fahrenheit for 10 minutes. There was no previous temperature excursion.
Patient is a 38 yo male that was given a SHINGRIX vaccination on protocol and he does not meet the age requirement for SHINGRIX to be administered. Patient has been notified and has not experienced any adverse events.
Case completed 2 dose Covid vaccine series on 2/21/21, then was admitted to hospital for complications of Covid on 3/16/21
This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Patient noticed that she lost her sense of taste of smell about a month after receiving her second dose) and ANOSMIA (lost her sense of taste of smell about a month after receiving her second dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 023M20 A) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Patient noticed that she lost her sense of taste of smell about a month after receiving her second dose) and ANOSMIA (lost her sense of taste of smell about  a month after receiving her second dose). At the time of the report, AGEUSIA (Patient noticed that she lost her sense of taste of smell about a month after receiving her second dose) and ANOSMIA (lost her sense of taste of smell about a month after receiving her second dose) outcome was unknown. On 19 NOV 2021 the patient received her first Moderna booster dose. Lot number is 013F21A expiration date is not known. Patient received the vaccine in her left arm and the patient reports no adverse reactions or side effects. No concomitant medications were reported. The patient was told by the local Health Dept. that the loss of smell and taste was related to the Moderna Covid-19 vaccine. The patient stated that she has seen advertisements on YouTube from Doctors who offer to get patients sense of taste or smell back after taking a Covid-19 vaccine. The patient stated that this was too expensive for her to do though. No treatment information was provided. Company Comment: This spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Ageusia and Anosmia which occurred approximately a month after receiving the second dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-604305 (Patient Link). Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Ageusia and Anosmia which occurred approximately a month after receiving the second dose of mRNA-1273 vaccine. No further details on clinical course, other lab test results were reported. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the third dose of GARDASIL 2 months after the second dose of GARDASIL. The dates of administration were not available. No adverse effects reported. Additional information is not expected.
She received her flu shot at approx. 8:30AM at a flu shot clinic held away from clinic. She states she first noted symptoms at 9:15-9:30AM of itching on forearms, chest tightness and discomfort with inspiration. She came back to let us know about 9:50AM. Her skin felt clammy and she was feeling itching all over. We called 911 to get her to emergency room. BP 130/80 / O2 sat 97% / pulse 92 / R 28. 11/14/2013 phone call - feels better but still has some itching arms and legs.
significant nodular swelling up to 4-5cm; Axillary pain; tenderness; This is a spontaneous report from a Non-contactable Other HCP (Patient). A 26-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot Number: Ff8841), via an unspecified route of administration, administered in Arm Left on 30Sep2021 at 08:00 (at the age of 26-years-old) as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Sep2021 at 20:00, patient experienced axillary pain, tenderness, and significant nodular swelling up to 4-5cm. Therapeutic measures were not taken due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received ZOSTAVAX 11/4/16. Developed injection site inflammation over the next couple of days. 11/7/16-Primary doctor diagnosed as cellulitis, cephalexin prescribed. 11/8/16-Primary doctor administered penicillin injection. Condition improved as pt continued antibiotics. As of 11/17/16, pt reports that condition is approaching normal. No further treatment is required.
The client received the vaccine at 1459 and started feeling nauseous at 1415. She was given water and advised to stay additional 15 minutes for detailed observation. At 12:30, she c/o of itching and "bugs crawling under her skin." Bright red erythema spots were noted on the chest, back, and hands. BP was measured to be 126/62. No wheezing or SOB. Called EMS. EMS instructed to activate EMS, and administer epinephrine. Epi-pen was administered along with 50 mg of diphenhydramine at 1440. BP measured post Epi administration 140/60, O2 99% HR 90. No SOB or wheezing. Patient reported itching has stopped as evidenced by a decrease in erythema on patient's chest, back, and hands.  BP at 1500 was measured. 110/60, HR90, O2 99%. Paramedics arrived at 1506 and took the patient at 1508. No vitals were checked on the spot.
Headache, Myalgia, Fever, chills, fatigue, injection site pain/arm pain, rigors Narrative:  Other Relevant History:
Fever of 99.7 Vomiting Nausea Dizziness  Beginning approx 12 hours after injection and continuing 14 hours to present.
Pt developed large, reddened, swollen area at injection site. Roughly 48 hours after vaccination, pt's parent took him to ER; pt was diagnosed with cellulitis and given amoxicillin. Pt had follow up visit 4 days later at PCP's office.  At that time, swelling was reduced but not gone entirely.
Injection site shows 8cmx8cm area of redness, slightly warm area scattered through out area. Pt complained of itching earlier but no itching now.
she stated she had a friend who also had the same issue with Bell's Palsy; This is a spontaneous report from a contactable other health care professional reported for her friend. This is a report 2 of 2, for the female friend: A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection Batch/Lot number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date, unknown dose number at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reason for the patient taking Pfizer COVID vaccine was not provided. Reporter, stated that she had a friend who also had the same issue with bell's palsy on an unspecified date. The drug result of suspect was reported as related. The clinical outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event bell's palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Nausea, tiredness, muscle aches, chills, headache. Lasted for 24 hours.  Did not take temperature.  Tylenol helped.
Narrative:  Per MD note: 59yo man received COVID vaccine #1 (Pfizer) on 3/4 in the left deltoid and developed a rash in the left armpit some time later (likely >4hours). it was treated with clotrimazole so the assumption is that it looked like a  fungal rash. Of note, Surgery note form 3/9 suggest that the patient has had left axillary swelling for years. Recommendations: It is unlikely that the rash is an  allergic reaction. We have seen descriptions of axillary swelling from the vaccine which may have contributed to the rash. This is a typical reaction and would not be concerning." Rec patient to get 2nd dose.
Pt noted redness and warmth to injection site day after injection and some swelling ice applied.
1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; 1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 78 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Potts" (unspecified if ongoing), notes: Potts. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left), administration date: 12Jan2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; BNT162b2 (Dose Number: 2, Batch/Lot No: N9581, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 77-year-old, for COVID-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs"; Bnt162b2 (Dose Number: 3, Batch/Lot No: FK49894F, Location of injection: Arm Right), for COVID-19 Immunization, reaction(s): "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs", "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), HEADACHE (non-serious), COUGH (non-serious), FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2022, outcome "unknown" and all described as "1st-5th doses mild flulike: HA, SLcough,fatigue sore arm 48hrs".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380992 same patient and different drug dose/events.;
Pain and swelling at site of injection, fatigue, chills, severe body aches, headache, and a low-grade fever.
Mother noticed on 12/16 & 17/2009 child not as active.  Drinking lots of water and getting up to urinate two or three time at night.  Mother made appt. with PMD for Jan. 4, 2010.  He was told he has an infection of the pancreas and sent to Hospital for two days.  A second diagnosis of Diabetes Type 1 and sent to another Hospital for 3 days.
Nausea, Vomiting approximately 25 hours after vaccination; Nausea, Vomiting approximately 25 hours after vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies to food, medicine or other products was reported as not available. Medications taken within two weeks prior to the vaccination included medication for birth control (unspecified). 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 vaccination. On 10Apr2021 at 15:00, the patient experienced nausea, vomiting approximately 25 hours after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of nausea, vomiting approximately 25 hours after vaccination and included general care. The clinical outcome of the events nausea, vomiting approximately 25 hours after vaccination was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 10-JAN-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than two (2) weeks after receiving the ZOSTAVAX vaccine, the patient suffered a right intracerebral hemorrhage/ cerebrovascular incident which required hospitalization, rehabilitation and therapy. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, a right intracerebral hemorrhage/cerebrovascular incident was determined to be a medically significant event. A right intracerebral hemorrhage/cerebrovascular incident was considered to be disabling. Additional information has been requested.