chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection of the Anthrax vaccine under duress via lawful written and verbal order. Injected in the upper left arm. Pt experienced initial burning. The RN who administered it stated that it was from the formaldehyde that is mixed with it, followed by flu-like symptoms. Vertigo, nausea continued pain and itch 1 week post vax. Still has a ping-pong ball sized know at injection site. Starting to forget things and dropping lab specimens several times a night. Pt states
Worst headache of my life for four days. I did not work during this time. I never have headaches. This was highly unusual for me. I am a board certified OB/GYN.
9 cm circumferance raised muscle; Deltoid muscle discomfort; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCLE HYPERTROPHY (9 cm circumferance raised muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2020, the patient experienced MYALGIA (Deltoid muscle discomfort). On an unknown date, the patient experienced MUSCLE HYPERTROPHY (9 cm circumferance raised muscle) (seriousness criterion medically significant). At the time of the report, MUSCLE HYPERTROPHY (9 cm circumferance raised muscle) and MYALGIA (Deltoid muscle discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.; 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.
Unresponsive episode, transferred to local ED via Ambulance. Increased WBC, Platelets Inpatient hospital stay.
Patient was supposed to get the influenza vaccination and was instead given the Pfizer COVID-19 Booster
no signs of symptoms reported; temperature excursion on VARIVAX: product was administered to one patient after the excursion occurred; This spontaneous report was received from a nurse prescriber referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 22-AUG-2021, the patient was vaccinated with a varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T032322, expiration date: 22-SEP-2022, for prophylaxis) that had a temperature excursion. The temperature excursion was for a time frame of 36 hours at 68 degrees Fahrenheit. There was no previous temperature excursion. No signs or symptoms were reported after the administration.
Caller can no longer remember when he takes the 1st shot  / He wants to know if he did attend his 2nd dose schedule because he can no longer remember it.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. As reported "caller (Patient) can no longer remember when he took the 1st shot but he had a paper work that he should be returning on 26Feb2021 for his 2nd dose / he wanted to know if he did attend his 2nd dose schedule because he can no longer remember it." The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Mother claims that a cyst developed on her genital area the day after 2nd GARDASIL shot was given. All summer long - been tired.
slight rash on my face on that day/fades a little bit during the day but comes back; Pretty red on my face/It does not go away.; acne condition where I have little pimple/across the bridge of my nose, under my eyes, under my right jaw and on my cheek area; This spontaneous case was reported by a consumer and describes the occurrence of RASH (slight rash on my face on that day/fades a little bit during the day but comes back), ERYTHEMA (Pretty red on my face/It does not go away.) and ACNE (acne condition where I have little pimple/across the bridge of my nose, under my eyes, under my right jaw and on my cheek area) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 029L20A and Lot# 006M20A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced RASH (slight rash on my face on that day/fades a little bit during the day but comes back), ERYTHEMA (Pretty red on my face/It does not go away.) and ACNE (acne condition where I have little pimple/across the bridge of my nose, under my eyes, under my right jaw and on my cheek area). At the time of the report, RASH (slight rash on my face on that day/fades a little bit during the day but comes back), ERYTHEMA (Pretty red on my face/It does not go away.) and ACNE (acne condition where I have little pimple/across the bridge of my nose, under my eyes, under my right jaw and on my cheek area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications also includes vitamins. Treatment medications were not provided by the reporter.
Fever 101+, pain in both legs, paralysis of right leg proceeding to paralysis of both legs by 11/20/07.  Slow recovery with weakness in quads of both legs.  Continued fatigue/weakness in right leg.  Currently in physical therapy.  Has slight right leg limp.
Received first dose Moderna vaccine on 4/14/2021.  Was given second dose on 5/5/2021 and when second was due 5/14/2021
dizzy/lightheaded; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy/lightheaded) and FATIGUE (fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (knee surgery due to arthritis.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy/lightheaded) and FATIGUE (fatigue). The patient was treated with RIVAROXABAN (XARELTO) for Adverse event, at a dose of 20 mg once a day and HYDROCHLOROTHIAZIDE for Adverse event, at a dose of 12.5 mg once a day. At the time of the report, DIZZINESS (dizzy/lightheaded) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.   This case was linked to MOD-2021-403388 (Patient Link).
erythema, swelling of arm, rash (rough texture), and arm pain all the way to the elbow  which started  2 days after vaccination. Vaccine received on 4/23/21.
Rheumatoid arthritis flare ups in hips; Bruise on both sided of the hip bone; Sore spot on left arm below the elbow; booster; 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-163-4193509-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (Dose 1, Route: Intramuscular), administration date: 05Feb2021, for COVID-19 immunisation; Pfizer biontech covid-19 vaccine (Dose 2, Intramuscular), administration date: 06Mar2021, for COVID-19 immunisation. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare ups in hips"; BONE CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Bruise on both sided of the hip bone"; PAIN OF SKIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore spot on left arm below the elbow"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster". The action taken for adalimumab was unknown. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of 'Bruise on both sides of the hip bone, Rheumatoid Arthritis Flare ups in Hips and sore on left arm below the elbow' was not provided. 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 information provided, a possible causal association between the reported events rheumatoid arthritis, bone contusion, pain of skin, immunisation, and the suspect BNT162B2 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Fever that lasted for about 15 hours, headache, fatigue that lasted for about 24 hours, chills that lasted for about 10 hours, muscle pain that lasted for about 20 hours, pain at injection site.
ACUTE ST ELEVATION MI, INFERIOR WALL 9/16/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
After taste in mouth; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. This consumer (Wife) reported for a male patient (Husband) that, A male patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included meniere's disease. No known allergies. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Concomitant medication(s) included Multi Vitamins, rosuvastatin calcium (CRESTOR); furosemide (FUROSEMIDE) and sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. On 05Feb2021 15:30 patient experienced after taste in mouth, Strong immediately after vaccine. Husband had same response. NO treatment was received for event. The outcome of event after taste was recovered on an unspecified date in Feb2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021127141 Same reporter/drug/event, different patient
Long distance vision slightly blurred for 3 days.; Hands were slightly red for two days; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration in left arm on 08Feb2021 at 15:45) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced long distance vision slightly blurred for 3 days on 09Feb2021. Now fine. Hands were slightly red for two days on 09Feb2021. Now fine. Both me and my wife hands were red for the same time. No treatment received for the reported events. The outcome of the events was resolved on an unspecified 2021.
Deep chills and body aches set in about 11-12 hours after the vaccination, followed by a headache and fever. Symptoms continued until about 3am when the fever broke, but the headache and flu-like body aches continued until through the following day.
at 10 minutes....throat began to swell and close.  At 45 min, face was getting puffy.  At 2 hrs - head felt tight. At 3 hrs - heart racing, shaky, but blood pressure was normal.
15Jan91 sudden dizziness & weakness 3+ hrs when admitted to hosp et. continued on day 1 but was improved, day 2- sx completely cleared.
05/27/2022 Vaccination 07/09/2022 I started to have symptoms; congested, sneezing, more difficulty breathing, more tired.  07/10/2022  I had a low grade fever; 100.2. The evening I tested positive with a home COVID-19 test.  Dr. recommended me for Plaxovid. I started on 07/11/2022 evening. I have had 2 doses thus far.
Patient said arm starting hurting the evening after vaccination. She said it was really sore to the touch. Has not improved. Has noticed tingling, and some numbness in thumb. Sometimes gets hot. Went to chiropractor 5 times since vaccination thinking she might have hurt her arm, no improvement. She has tried ice and NSAIDS with no improvement.
Patient DOB: 11/25/2001. Received his first dose Pfizer (LOT#: EW0185 EXP: 8/2021) at 0920on 5/18/21. Patient alerted EMT. Patient stated that he felt light headed and also felt anxious. Patient stated that he had not had not eaten in the morning. EMT took patients vital signs at 0928. BP: 138/82 pulse: 75, O2: 98%. Patient was given water, juice and food. Patient was placed in zero gravity chair. Patient was asked to stay an extra 30 minutes for further observation. EMT reassessed and re-took vital signs at 0945. BP: 132/74, pulse: 76, O2: 98%. Patient stated he was feeling better and only slightly felt the symptoms. Patient was educated on worsening signs and symptoms of vaccine and when to seek EMS or urgent care. Patient verbalized understanding of education. Patient left vaccination site at 0947 before the 30 minute observation was completed. PHN educated patient that he was leaving AMA. Patient insisted on leaving and was feeling better. Patient left vaccination site unassisted and with a steady gait.
had a box of last year's flu vaccine that got administered to a couple of employees; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported that they had a box of last year's flu vaccine (already expired) that got administered to a couple of employees, which led to expired vaccine used. Pharmacist would assume that they would need to be revaccinated with this year's formulation but was there a timeframe they must wait to get the current year's vaccine. They were supposed to be returned earlier in the year, but accidentally fell under the radar and were mixed in with this year's new flu, and then unintentionally administered to employees. No further information was reported. The reported consented to follow up.
patient is immunocompromised; 1st dose 5/23/2019, wants to get 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of immunocompromised in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immunocompromised (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the immunocompromised and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immunocompromised to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The registered pharmacist reported that the patient 45 years old had received her first dose of Shingrix and was immunocompromised. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The patient wanted to get 2nd dose of Shingrix. The patient enquired about how to proceed with the schedule. The reporter did not consent to follow up.
Stomach pain / sharp pain in the stomach; A spontaneous report was received from a consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach pain / sharp pain in the stomach.  The patient medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced Stomach pain/sharp pain in the stomach.  Treatment for the event included Stomach-Aid.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event stomach pain/sharp pain in the stomach was not resolved.; Reporter's Comments: This case concerns a 89 year old female patient, who experienced a unexpected event of stomach pain, 4 days after receiving first dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.
sore upper arm; Injection site soreness; mild headache; red spots on the tops of her hands, it's a little bit tingly, red spots on her palms, they stop at the wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore upper arm), VACCINATION SITE PAIN (Injection site soreness), HEADACHE (mild headache) and ERYTHEMA (red spots on the tops of her hands, it's a little bit tingly, red spots on her palms, they stop at the wrist) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore upper arm), VACCINATION SITE PAIN (Injection site soreness), HEADACHE (mild headache) and ERYTHEMA (red spots on the tops of her hands, it's a little bit tingly, red spots on her palms, they stop at the wrist). At the time of the report, PAIN IN EXTREMITY (sore upper arm), VACCINATION SITE PAIN (Injection site soreness), HEADACHE (mild headache) and ERYTHEMA (red spots on the tops of her hands, it's a little bit tingly, red spots on her palms, they stop at the wrist) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided. Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-083524, US-MODERNATX, INC.-MOD-2021-083552 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083524:Husband's case US-MODERNATX, INC.-MOD-2021-083552:wife 's case
Developed shingles 5 days after 2nd dose; This is a spontaneous report from a contactable consumer (patient) other hcp.   A 47-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ew0179 Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 08May2021 08:00 (age at vaccination 47-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. the patient received first dose of BNT162b2 (BNT162B2, Lot number: Ew0150 and Expiration date: unknown), administered in Arm Left on 19Apr2021 08:00 AM as first dose single doe for COVID-19 immunisation. Medical history included evans syndrome, rubber sensitivity, CVID (immunodeficiency common variable). The patient previously took doxycycline and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. Concomitant medication(s) included curcuma longa root (TURMERIC CURCUMIN), zingiber officinale root (GINGER ROOT [ZINGIBER OFFICINALE ROOT]) taken for an unknown indication from unknown dates and unknown if ongoing. On 13May2021, the patient experienced developed shingles 5 days after 2nd dose. adverse event result in patient visited Doctor or other healthcare professional office, clinic visit. Therapeutic measures were taken as a result of developed shingles 5 days after 2nd dose tried Valtrex. Developed shingles 5 days after 2nd dose. patient understand that this is not an allergic/anaphylactic reaction. she think this needs to be taken into consideration. The outcome of event was recovering.   Information on Lot/Batch number was available. Additional information has been requested
Vaccination series completed 3/6/21 and 3/27/21.  Tested positive for COVID-19 incidentally on 5/27/21 during a previous admission at this hospital. Was discharged from that admission on 5/28/21 to a nursing facility. Presented to ED from nursing facility on 6/3/21 with hypotension and hyperglycemia, BG 823. Found to be in DKA.-- arterial pH 7.32, lactate 5.2. BP 104/57, HR 75, on 2L NC O2 with sat 100%. Unclear if COVID infection contributing to current presentation No specific treatment for COVID currently, supportive care for now.