chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Inappropriate dose of Vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia (stopped statins for paxlovid tx)" (unspecified if ongoing), notes: notes: stopped statins for paxlovid tx. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of Vaccine administered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: D0: Sx, negative rapid test; (2022) Positive, notes: D1: Sx, positive Cue test, strong positive LFT; (2022) Strong positive, notes: D2: Sx worsened, fever/chills/cough, strong positive LFT; (2022) Weak positive, notes: D3: Sx maintained, fever/chills/cough, weak positive LFT; (2022) Negative, notes: D4: Sx improving significantly, negative LFT; (2022) D5: Sx resolved, negative Cue,, notes: D5: Sx resolved, negative Cue, negative LFT, final day of Paxlovid; (2022) Positive, notes: D11: LFT Positive (today). Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received treatment for COVID-19 from 01May2022 to 05May2022. No known allergies.  No follow-up attempts are possible. No further information is expected.
urine is darker than normal; This case was reported by a consumer via interactive digital media and described the occurrence of urine discoloration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2021, the patient received Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced urine discoloration. On an unknown date, the outcome of the urine discoloration was unknown.   It was unknown if the reporter considered the urine discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient got the Shingrix shot 2 days ago from the day of reporting and since the patient's urine was darker than normal.  The reporter asked was this a side effect of the vaccine.
One day post vax, 11/20/98, the pt experienced redness, warmth and swelling at the site of injection. Reportedly the pt recovered from this experience. From additional information received on 11/16/98, it was reported "Reviewed, no additional information at this time".
Headache; arm pain (felt sore); felt groggy; super tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain (felt sore)), SOMNOLENCE (felt groggy), FATIGUE (super tired) and HEADACHE (Headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain (felt sore)), SOMNOLENCE (felt groggy) and FATIGUE (super tired). On 04-Feb-2021, the patient experienced HEADACHE (Headache). On 04-Feb-2021, SOMNOLENCE (felt groggy) and FATIGUE (super tired) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain (felt sore)) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
lethargy & dec po intake, inc amt of sleep, 12hr p/shot on 25OCT96, examined 26OCT96 by MD;no fever, no vomiting, no sz;
Immunocompromised patient received a booster dose instead of a third primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third primary dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J primary shot (primary shot) in March 2021. Past adverse reactions to the above products included No adverse event with J&J primary shot. Concurrent medical conditions included Immunocompromised.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In January 2022, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third primary dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received a booster dose instead of a third primary dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Ulna nerve pain down into finger (OT / brace); Feels like an electric shock; Still painful; Extraordinarily uncomfortable; Hard to do things, affects daily activities; Numbness in finger tip; Not much use of pinky finger; This case was reported by a consumer via call center representative and described the occurrence of neuralgia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased. On an unknown date, the outcome of the neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased to be related to Shingrix.     Additional Information: GSK receipt date: 26-JAN-2023 Reporter comment: The reporter was a patient. The patient about 3 to 4 days after receiving the first dose of Shingrix, the patient reports that she had ulna nerve pain in her right arm, which is the arm she received the vaccine in, down into her pinky finger.  The Patient reports that the pain "feels like an electric shock going down her arm like hitting your funny bone". The Patient reports it is now 5 months later after receiving the first dose of Shingrix and it is still painful, extraordinarily uncomfortable, it is hard to do things, she has numbness in her fingertip, she does not have much use of her pinky finger on her right hand, (Multiple AE's Filed), and if affects her daily activities. The patient has seen her PCP (primary care physician) and a hand specialist.  The hand specialist sent her to occupational therapy where she received a brace to wear, which she says helps, and was also given exercises to do. The reporter did not consent to follow up Note: TTO for all event conservatively capture as a 3 days because as a same pain which is described as origin of pain is further elaborated as nerve pain can cause numbness also query raised for the same.
central epithelial defect; neurotrophic keratopathy; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 11-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severely painful impaired vision, redness in left eye and decreased visual acuity. The patient was diagnosed with neurotrophic keratopathy and central epithelial defect. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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 zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events neurotrophic keratopathy and central epithelial defect was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events neurotrophic keratopathy and central epithelial defect to be disability.   Upon internal review, central epithelial defect was determined to be medically significant.
A few minutes after receiving the shot, the patient claimed to be experiencing lightheadedness and wanted to lie down.  He was noticeably sweating.  When asked if he felt like fainting, he explained he gets this way when he is near needles, like when he gets a vaccine or receives a new tattoo.  The patient asked for a trash can to vomit in and did so when one was provided.  After monitoring the patient for a few minutes and giving him a bottle of water to drink from, the patient said he started to feel better.  After the 15 minutes post-vaccination monitoring window was reached, the patient said he was OK to go home.  He walked to the bathroom with no assistance needed.  The patient was advised to check his blood pressure before leaving and to contact a doctor if his symptoms return.
drug ineffective/contracted covid.  after first shot; contracted covid.  after first shot; This is a spontaneous report received from a Pfizer sponsored program via non-contactable consumer. This is the first of 2 reports from the same reporter for same patient. A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unknown date, the patient was contracted COVID after first shot. The patient was waited for the 6 weeks and was wondering about giving second dose of COVID Vaccine. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021454576 same drug and patient, different event and drug dose
Extreme Hair loss/bad hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Extreme Hair loss/bad hair loss) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced ALOPECIA (Extreme Hair loss/bad hair loss) (seriousness criterion hospitalization). At the time of the report, ALOPECIA (Extreme Hair loss/bad hair loss) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   A week after receiving first dose, patient began to fall out in big clumps. Patient once had long thick hair, 8 months later her hair was so bald. Patient had to wear a wig. It came out in clumps of hair which had never happened in her life. On 16-Feb-2021, received second dose.  No treatment information was provided.  Company comment: 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. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant follow up - verbatam added; Sender's Comments: 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. Further information has been requested.
itchiness on the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness on the injection site.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included POTASSIUM for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness on the injection site.). At the time of the report, VACCINATION SITE PRURITUS (itchiness on the injection site.) outcome was unknown.            other concomitant medications were reported are fluid pill and blood pressure medicine for an unknown indication.  No treatment information provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: TCR-NNI(NO NEW INFORMATION); Sender's Comments: 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.
Moderna dose given to a 17 year old when only approved for 18+.  No adverse events reported.
SEVERE BREAK OUT OF HIVES AND RASH FOR FOUR CONSECUTIVE DAYS. THEY COVERED 2/3 OF HIS BODY AT SOME TIMES. THE HIVES WOULD MOVE AROUND HIS BODY. THEY STARTED ON HIS TRUNK AND SPREAD OUT TO HIS FACE, HANDS, AND ANKLES BY THE THIRD DAY. VERY ITCHY.
pt devel burning soreness in lt shoulder 8hrs p/inj; woke up w/extreme pain & tenderness in lt shoulder & enlarged gland @ base of shoulder site of a marble very tender & painful;localized rxn to Rabies vax
Upper lip localized angioedema; oral mucositis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 16-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose Number: 1; Batch/Lot No: not known), administration date: 21Feb2022, when the patient was 14-year-old, for Covid-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 2; Batch/Lot No: not known), for Covid-19 Immunization. No other vaccine in four weeks, no other medications in two weeks. No known allergies. None other medical history. Unknown if covid prior vaccination and no covid tested post vaccination. The following information was reported: ANGIOEDEMA (medically significant) with onset 09Sep2023 at 19:00, outcome "recovering", described as "Upper lip localized angioedema"; STOMATITIS (non-serious) with onset 09Sep2023 at 19:00, outcome "recovering", described as "oral mucositis". The events "upper lip localized angioedema" and "oral mucositis" required physician office visit. Therapeutic measures were taken as a result of angioedema, stomatitis. HSV testing.   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, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 and the reported event "Upper lip localized angioedema". 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.
This is a spontaneous report from a contactable nurse. This Nurse reported similar events for 3 patients on behalf of a physician. This is the third of 3 reports. A patient of unspecified age and gender received meningococcal group B Rlp2086 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported.  On 07Jun2018, the patient woke-up with pain, chills, tired and nausea. At the time of the report the outcome of the events was unknown. Pfizer is a Marketing Authorization Holder of Meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018288752 Same reporter/drugs/events different patients.;US-PFIZER INC-2018288886 Same reporter/drugs/events different patients.
I received Pfizer vaccine 1st shot January 31st, February 2nd I tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 31Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Feb2021, the patient was tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Feb2021. The clinical outcome of the events was unknown.     Follow-up#1 (05May2021): This is a follow-up spontaneous report from a contactable consumer. This contactable female consumer (patient) reported for herself: no new significant information has been received.   Follow-up#2 (04May2021): This is a follow-up spontaneous report from a contactable consumer. This female contactable consumer (patient) reported for herself: no new significant information has been received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
receiving a dose from an expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose from an expired vial) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026c21a, 032L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose from an expired vial). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (receiving a dose from an expired vial) had resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-376983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received contains Non significant information. On 08-Nov-2021: Follow-up received contain No New information.
I have been experiencing rebound Covid symptoms after my five day treatment with Paxlovid. I felt pretty good, during and shortly after. About the second day post treatment I started having the same s; I have been experiencing rebound Covid symptoms after my five day treatment with Paxlovid. I felt pretty good, during and shortly after. About the second day post treatment I started having the same s; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Past history of Lyme carditis, with several bouts of heart block since." (unspecified if ongoing); "Past history of Lyme carditis, with several bouts of heart block since." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer / biontech (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 04May2022, outcome "not recovered" and all described as "I have been experiencing rebound Covid symptoms after my five day treatment with Paxlovid. I felt pretty good, during and shortly after. About the second day post treatment I started having the same s". Therapeutic measures were not taken as a result of covid-19, drug ineffective. Adverse event: Patient has been experiencing rebound Covid symptoms after his five day treatment with Paxlovid. Patient felt pretty good, during and shortly after. About the second day post treatment he started having the same symptoms as before treatment. On day 11, today he was feeling much worse. We need direction from the manufacturer and the CDC as to how to go about dealing with these current symptoms. There is nothing published as of yet, besides several news media coverage of this happening. Should I seek a different treatment, or a repeat dose of Paxlovid?. No Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.