chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Known allergies: Penicilin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative for 4 days; Negative, notes: Tested at midnight and was negative; Positive, notes: Tested the next afternoon and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid. Clinical course: Rebounded-tested negative for 4 days, started to get itchy throat and runny nose. Tested at midnight and was negative. Tested the next afternoon and was positive. Patient had not left the house in 11 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gradual headache that intensified and enlarged lymph nodes. Six days after the injection I could feel two enlarged lymph nodes at the base of my skull (occipital lymph nodes).  Nothing helps with the headache (ie. Tylenol, chiropractor, etc). Lymph nodes are still enlarged 21 days after receiving the first injection. The headache and pain in my head is debilitating and causing nausea.
Giant hive red circular about 1-1 1/2 inch in diameter on the arm. Dr said it was a severe localized reaction but swears he is not allergic.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Medical facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Medical facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Extreme body aches over the course of three days treated with ibuprofen, hot baths, and heating pads. Chills, lasting two days. Fatigue over the course of three days, increased intake of caffeine to stay awake.
patient is dead/Death NOS; after flu vaccination patient was on put on wheelchair; Initial information regarding an unsolicited valid serious case received from a consumer via social media on 04-Dec-2020.  This case involves a male patient who recieved INFLUENZA VACCINE was put on wheelchair (Wheelchair user), then died (Death).  The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after flu vaccination patient was put on wheelchair (Wheelchair user), later he died (Death).  Seriousness: event wheelchair user (disability).  Laboratory details were not reported prior to death was not reported.  It was not reported if the patient received a corrective treatment.  It was unknown if an autopsy was performed and cause of death was not reported.  There will be no information available on batch number for this case.; Sender's Comments: Sanofi company comment dated 08-Dec-2020: This case concerns a male patient who was a wheelchair user and later died after vaccination with company suspect Influenza Vaccine. The time to onset was unknown. However, patient's medical condition, concomitant medication ruling out alternate etiologies, laboratory tests were not reported. One vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: patient is dead/Death NOS
This spontaneous report as received from a physician via a company representative refers to a 2 month old male patient. On 31-DEC-2013 the patient was vaccinated with a dose PNEUMOVAX23 (lot# and route unspecified). On 31-DEC-2013, the patient received PNEUMOVAX23 by accident. No adverse effects reported. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:11 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.49 for dose administered on 03-Nov-2021. No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 22-Oct-2021 with temperature 32 degrees Fahrenheit from 08:00 AM  10:00 AM, on 27-Oct-2021 with temperature 29, 32 degrees Fahrenheit from 09:00 AM  10:00 AM and on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM.  This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021, beyond use date for the vial was reported as 29-Oct-2021, 04-Nov-2021 and 05-Nov-2021. Product moved to clinic on 22-Oct-2021, 27-Oct-2021 and 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
a patient received a 0.05 ml invalid Adacel and Fluzone Quadrivalent, no AE; Adacel and Fluzone Quadrivalent were administered after being exposed to 30 Farenheit, no AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from other health care professional.  The case is linked to the cases 2020SA209550 and 2020SA210303 (same reporter).  This case involves a 62 years old female patient who received 0.05 ml invalid dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiration date were not reported for both the vaccines), after being exposed to 30 Fahrenheit via unknown route in the right deltoid (however was not specified that which vaccine was given at this site) as prophylactic vaccination on 08-Aug-2020.  Medical history, medical treatment and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Shingles; First dose on 23Mar2021 and the second dose on 22Jun2021; This is a spontaneous report from a contactable consumer (the patient). A 90-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Jun2021 (at the age of 90-years-old) as a single dose COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 for COVID-19 immunisation and Shingrix vaccine on 13May2021 for immunisation and experienced shingles on 01Jun2021 with both of the vaccines. It was reported that the patient received first dose on 23Mar2021 and the second dose on 22Jun2021 (inappropriate schedule of vaccine administered). On 22Jul2021, the patient experienced shingles. It was reported that that in between the two doses she had to fit her number two shingle, Shingrix inoculation. She stated that she got the shingrix vaccine on 13May2021. The pharmacist told her that would be a safe date away from 23Mar2021 for the first Pfizer dose and her new date for the second dose was postponed till 22Jun2021. She stated that something went wrong, terribly wrong. She stated that this was the second attack of shingles that she has had in between 01Jun2021 was number one and yesterday was number two. It was on her face, in the same place and same symptoms only this time it was spreading very fast and the medication she was on doesn't seem to be doing anything. She has been on the medication fully for 3 days now. She wanted information like what to do, she stated there was a bulletin on a news network that she listened to and it said that the Pfizer COVID-19 has an unusually of people calling in that they had developed shingles after they had their inoculations. Even though they had protection like me. She wanted to know if that was correct. Caller asked for a web address that her family can look up on the net so they can get further information for her. Something they can find out on their computer because she was not getting any information and her doctor was on vacation and she was suffering badly from a horrible outbreak all over her face and chest. She wanted more information on if this was going to be common because within six weeks she has had exactly the same outbreak, that was really bad she cant handle this and never had shingles in her life. She was very glad to get protection by shingrix, but evidently she didn't get protection for one reason or another. She wanted to know if her immune system compromised and She wanted to know why they referred her to Pfizer medical information because there was no information to give her. She cant find out anything. Therapeutic measures were taken as a result of shingles. The outcome of event shingles was unknown.  The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
heart is mildly enlarged; my heart rate went to 144 bpm and I went to the ER; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history in-cluded: "two time cancer survivor", start date: 2016 (unspecified if ongoing); "obese" (unspecified if ongoing), notes: obese (251 lbs, 5 T9). The patient's concomitant medications were not reported. Vac-cination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufac-turer), for Covid-19 Immunization; Covid-19 vaccine (1st Booster; Unknown manufacturer, Primary Immunization series complete), for covid-19 Immunization.  The following information was reported: CARDIOMEGALY (medically significant), outcome "unknown", described as "heart is mildly enlarged"; HEART RATE INCREASED (medically significant), outcome "un-known", described as "my heart rate went to 144 bpm and I went to the ER". The events "heart is mild-ly enlarged" and "my heart rate went to 144 bpm and i went to the er" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: 144, notes: 144 bpm; 90. On Monday (04Apr) I received my fourth shot (second booster) at a local (name withheld). Yesterday afternoon, my heart rate went to 144 bpm and I went to the ER. The diagnosis was heart is mildly enlarged. I was given a saline iv and kept until my heart rate was in the 90 Ts.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
the patient had an unspecified "reaction" on an unspecified date; This spontaneous report was received from a medical assistant referring to a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an unspecified number of doses of Zoster Vaccine Live (ZOSTAVAX) vial 19400 plaque forming units (PFU) (dose, frequency, route, lot# and expiration date not reported) for prophylaxis.  On an unknown date, the patient experienced an unspecified adverse event. The reporter did not know the details of the event. It was unknown if the patient had received any treatment for the event. At the time of the report, the patient had recovered from the adverse event.  The causal relationship between Zoster Vaccine Live (ZOSTAVAX) and the unspecified adverse event was not reported.
lose vision in her right eye; ischemic optic neuropathy; This spontaneous case was reported by a nurse and describes the occurrence of OPTIC ISCHAEMIC NEUROPATHY (ischemic optic neuropathy) and BLINDNESS (lose vision in her right eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced OPTIC ISCHAEMIC NEUROPATHY (ischemic optic neuropathy) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced BLINDNESS (lose vision in her right eye) (seriousness criteria disability and medically significant). At the time of the report, OPTIC ISCHAEMIC NEUROPATHY (ischemic optic neuropathy) and BLINDNESS (lose vision in her right eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. patient had a small bump in the back of her right eye.; Sender's Comments: This case concerns a 66 year old female with no reported medical history who experienced Seirous , Unexpedted event of Optic Ischemic Neuropathy .which occurred 7 months  6 days after the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine)  and Blindness ( lost of viison of the right eye) which occurred on an unknown date , after vaccination with the 2nd dose . The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses  will be given. The age of the patient is a confounder for this case because age is a factor that can to possible optic ischemic neuropathy ( age above 50 ) . The benefit-risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
Broke out in hives, started in both wrists, then spread to back, BENADRYL prn hives up and down both arms, itch, not painful.
Fever. body aches, diarrhea, fatique, sore throat, runny nose. Took Nyquil, Ibprofen. Sick from work for a week.   Experienced longer term symptoms of cough, upper respiratory congestion, and fatigue for two months after COVID infection.
Patient fainted and was lowered to the floor. He came around quickly and received water to drink and stayed until feeling better-about 30 minutes.
eye swelling; a little sore in the injection site; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (3 days after the administration of the first dose of the Pfizer's COVID-19 vaccine), the patient experienced eye swelling, a little sore in the injection site but not much. The patient reported that, he was not sure if the swelling was caused by the vaccine or jalapeno peppers, he handled with his hands and then rubbed his eyes. He reported that he developed a little sore in the injection site but not much. The reporter wanted to know if he should be administered with the second dose of the Pfizer's COVID-19 vaccine considering the reaction he had in the eye and if eye swelling was a side effect reported for the administration of the Pfizer's COVID-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Medial Epicondylitis; This is a spontaneous report from a non-contactable physician, the patient. A patient of an unspecified age and gender received second dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot number: El3842) via an unspecified route of administration on 08Jan2021 as a single dose for COVID-19 Immunisation. Medical history was reported as none. The patient had previously taken trimethoprim/sulfamethoxazole (BACTRIM) on an unknown date for an unknown indication and had experienced allergy. The patient had previously received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot number: unknown) as a single dose on an unknown date for covid-19 immunisation, The patient was not diagnosed with covid-19 prior to vaccination. The patient was not tested positive since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 15Jan2021, the patient had developed medial epicondylitis one week after the vaccination. There was no change in patients activity, no stress on arm, no trauma. Even after two months it was not resolved. The patient had received NSAIDS (unspecified), compression bands, physical therapy and was taken rest as a part of therapeutic measure for the reported event medial epicondylitis. The clinical outcome of the event medial epicondylitis was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
their arm was barely sore; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "their arm was barely sore".  Additional information: First shot barely sore for about 24 hours. Second same as first for about 24 hours. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
25 min after - heart racing, couldn?t swallow,  tongue swelled, hives.  Had Benadryl and took immediately.  Called doctor and went to Er where they monitored me for several hours and took ekg.
Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight). On 13-May-2021, PYREXIA (Day after second vaccine fever lasted for 24 hours/fever of 105 degrees Farenheight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 105 (High) 105 degrees Fahrenheit.         Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-385864 (Patient Link).