chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Started with positive test. Therapeutic measures were taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" 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 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.
Extreme chills first night after injection, mild headache the following day, swollen lymph node left arm second night after injection and continuation through third day after injection, injection site red on third day
can barely get up; no appetite; weakness; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (can barely get up), DECREASED APPETITE (no appetite), ASTHENIA (weakness) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced DECREASED APPETITE (no appetite), ASTHENIA (weakness) and PYREXIA (fever). On an unknown date, the patient experienced SOMNOLENCE (can barely get up). At the time of the report, SOMNOLENCE (can barely get up), DECREASED APPETITE (no appetite), ASTHENIA (weakness) and PYREXIA (fever) outcome was unknown.            Treatment Drugs: Tylenol No concomitant drugs are provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: No specific follow-up information recorded.
2 hours later tingling in both shoulders radiating down both arms and hands, eventually heaviness and numbness in both hands. Took 2 hour nap and had difficulty speaking, slurred speech, heavy tongue.
"move legs bad"; muscle pain; felt "extremely tired"; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER ("move legs bad"), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Deep vein thrombosis, Surgery (surgery on lungs-- part of lung was removed) and C-section. Concurrent medical conditions included COPD, Emphysema and Diverticulitis. Concomitant products included ATORVASTATIN, MONTELUKAST and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MOVEMENT DISORDER ("move legs bad"), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired"). On 19-Feb-2021, MOVEMENT DISORDER ("move legs bad"), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included as Advil   This case was linked to US-MODERNATX, INC.-MOD-2021-054493, US-MODERNATX, INC.-MOD-2021-056898, US-MODERNATX, INC.-MOD-2021-056977 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054493:crosslink US-MODERNATX, INC.-MOD-2021-056898:1st dose case of patient's husband US-MODERNATX, INC.-MOD-2021-056977:2nd dose case of patient's husband
Information has been received from a nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date the patient was inadvertently administered a dose of PNEUMOVAX 23 (strength, dose, route, lot# and expiration date unknown), which had been improperly stored. No adverse events were reported. This is one of two reports received from the same reporter. Additional information is not expected since the reporter would not like to be contacted.
Admitted to hospital for COVID-19 pneumonia from 2-19-2021 to 3-6-2021 followed by admission to skilled nursing facility. Had exposure to COVID-19 infected individual prior to 2-11-21, no symptoms were reported, but was tested due to exposure. Result was positive.
Headache; muscle aches; fatigue; possible fever; This is a spontaneous report from a contactable other healthcare professional (hcp) (patient). A 26-year-old female non-pregnant patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EH9833), intramuscularly on 22Dec2020 10:30 at a single dose in left arm for COVID-19 immunization. There was no medical history. Concomitant medication included fluoxetine received within 2 weeks of vaccination. There were no other vaccines received in four weeks. No known allergy. The patient experienced headache, muscle aches, fatigue, and possible fever, all on 23Dec2020 18:30. No treatment received for these events. The patient did not have COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was unknown.
Mom reports that patient had sudden onset of episode of "stiffness" tonic state x 2-3 sec.  Followed by generalized clonic-like seizure activity of about 5 sec. duration, plus eye deviation & general obtundation:  patient was afebrile at the time and siggle episode.
Patient was administered Bivalent Pfizer 5-11 vaccine instead of monovalent primary series Pfizer 5-11 vaccine. This was the patient's first dose according to parents. Patient was observed for 15 minutes with no issues. Parents were told of possible vaccine related side effects and to report any out of the ordinary adverse effects to us or their pediatrician. Parents and child left clinic on own accord with no issues.
Fatigue; Flu like sx; Headache; High fever; Diarrhea; Muscle pain; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 01May2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known allergies to seafood. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced fatigue, flu like symptoms (sx), headache, high fever, diarrhea and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was taken as a result of the events which included treatment with paracetamol (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, flu like sx, headache, high fever, diarrhea and muscle pain was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have been administered from an expired dose) in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Reporter stated that the vial was initially stored in the refrigerator on 08-Mar-2022 (5 doses) and the dates of administration of the vaccine was 29-Mar-2022 with 1 dose and 31-Mar-2022 with 4 doses and another vial was initially stored in the refrigerator on 30-Mar-2022 (2 doses) and the dates of administration of the vaccine was 05-Apr-2022 with 2 doses. And also sated that the vial did not undergo any temperature excursions and Patient did not experienced any side effects.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Vaccine administration dates were updated.
Evening of vaccine I gradually felt body aches with introduction of cold chills later in the evening - No fever but slight headache - Progressively worse throughout the night and treated with 900mg Tylenol but sleepless night - Tuesday morning body aches and nausea, threw-up once - Very weak through-out course of the day - Slept and gradually felt aches dissipate -   Wednesday injection site very sensitive and sore to touch - red circle at site
the patient had COVID; the patient had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (ongoing); "collagen disease not identified" (ongoing). Concomitant medication(s) included: METHOTREXATE taken for collagen disorder. The patient was immunosuppressed with methotrexate because she had a medical condition (collagen disease not identified). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Jun2022, outcome "not recovered", described as "the patient had COVID"; COVID-19 (medically significant) with onset 18Jun2022, outcome "not recovered", described as "the patient had COVID ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. The patient's test continued positive until time of report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given the Janssen vaccine then sat in the pharmacy to wait for the 15 minutes observation period. About 5 minutes of sitting down the patient fainted with loss of consciousness and looked pale. The patient almost fell out of the chair she was sitting in but was caught by her mother. Pharmacist rushed over to check on patient and emergency services were contacted. Patient regained consciousness within about 30 to 60 seconds of fainting. Paramedics then arrived and took the patients blood pressure. They found it was low but it regulated back to normal at later readings. The patient had multiple risk factors for fainting including, not eating that day, having anxiety about the vaccine, having worked a lot the day before, and she recently lost a significant amount of weigh. After the paramedics assessed her the patient was feeling much better and the paramedics told her she was ok to go home with her mother and she did not require further medical examination. Patient left with her mother, pharmacist followed up with the patient and she is feeling much better the next day.
Hives, hands & feet swollen, onset 26APR92, cough w/central chest discomfort onset 21APR92; sl wheeze;
Red rash that started on left shoulder and neck that radiated to upper torso. Sxs began on 2/2/21. (Had nausea, fever, body aches and chills that began day of vaccine.)
On 1/31/00, the pt was diagnosed with chicken pox, consisting of several lesions on the body. It was noted that the pt also had a cough. Follow-up information reported that the pt subsequently recovered.
Second COVID-19 vaccination; First COVID-19 vaccination; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First COVID-19 vaccination) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second COVID-19 vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First COVID-19 vaccination). On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second COVID-19 vaccination). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First COVID-19 vaccination) had resolved. On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were provided. No treatment information were provided.
PAIN IN ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for the case. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm was not reported. This report was non-serious.
Patient developed acute kidney injury 3 days after he received the vaccine.  He initially presented with emesis, myalgias and weakness and then found to have acute renal failure
The morning after receiving the first dose of the Moderna vaccine, I experienced a pressure in my left ear accompanied by both a constant low, muffled humming noise and a constant high-pitched noise. Neither have abated, though it's only been a little over 24 hours. The noises are very loud and it is hard to hear, as everything sounds muffled. It is distracting and constant.   I have no other illness, nor has anything changed in my daily routine in the past day.
This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 85-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuralgia (right side median nerve injury from prior surgery). Concurrent medical conditions included neuropathy. Concomitant products included gabapentin, Losartan, vitamin D, ANDROGEL and Metoprolol XR. On 14th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), condition aggravated, injection site pain, arthralgia, injection site itching, injection site rash and somnolence. On an unknown date, the outcome of the neuropathy, injection site pain, arthralgia and somnolence were recovered/resolved and the outcome of the condition aggravated was unknown and the outcome of the injection site itching and injection site rash were recovering/resolving. The reporter considered the neuropathy, condition aggravated, injection site pain, arthralgia, injection site itching, injection site rash and somnolence to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporting physician. The patient experienced soreness and pruritic rash on the upper right arm around where he had the SHINGRIX injection. The patient reported that the rash had improved but was still present and was about 10 by 8 centimeters in size. The patient also reported of experiencing arthralgias in both large and small joints as well as a flare up of right sided neuralgia that lasted for about 2 days. The patient related the neuralgia to a nerve injury he had related to a prior surgery. The patient reported that all events except the rash had resolved and did not require medical intervention. The contact details of the pharmacy was provided.
Resident tested positive for COVID on  01/06/2021. Resident received out patient monoclonal antibody treatment on 01/07/2021.
Sialadenitis; difficulty swallowing; herpes zoster (shingles); Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or around 10-NOV-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster (shingles), sialadenitis and difficulty swallowing. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations, and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt 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 Company's conduct, the pt have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was reported as not recovered. The causality assessment between the events and the zoster vaccine live (ZOSTAVAX) was reported as related.  The events of herpes zoster (shingles), sialadenitis and difficulty swallowing were considered to be disabling.  Upon internal review, the event of sialadenitis was determined to be medically significant.
Missed 2nd dose of Moderna vaccine on recommended interval; Lot of pain at injection site; Bruising on right shoulder/Bruising on back; Skin of back hurt; Feels like sunburn; something is moving on her back; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, HYDROXYZINE EMBONATE (HYDROXYZINE PAM) and DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and VACCINATION SITE PAIN (Lot of pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, CONTUSION (Bruising on right shoulder/Bruising on back), PAIN OF SKIN (Skin of back hurt), BURNING SENSATION (Feels like sunburn), FORMICATION (something is moving on her back) and VACCINATION SITE PAIN (Lot of pain at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine on recommended interval) had resolved.            It was reported that the patient consulted 2 dermatologists for the events.   This case was linked to MOD-2021-213234 (Dose1 case) (Patient Link).