chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a multiple patients of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies, concurrent conditions or concomitants medications were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX Vial, Lot # M019646 and expiration date: 18-JUL-2017 (dose and route of administration were not provided) for prophylaxis. On unknown dates, the pharmacist reported multiple patient complaints as itching, tingling, numbness and a ring around the injection site from the ZOSTAVAX administered from the Lot # above mentioned.  The reporter also asked whether she could have the remaining box replaced, because she did not feel comfortable giving those vaccinations. She was adviced to not discard the 4 vials still available from that box because more information about it might be needed. The outcome of  itching, tingling, numbness and a ring around the injection site was unknown. The reporter did not report the causality between the events and ZOSTAVAX. Additional information has been requested.
Patient states that she felt pain right away after getting the vaccines in her left upper arm. One vaccine was given  just bellow  ( ~1 inch below) the other.  The recollection of the Medical Assistant who gave the vaccines, stated that she thinks the Flu was more proximal and the Menacta was more distal. Patient stated that the  pain persisted and did not fell worse or better than initially. She was treated with Ibuprofen orally at her home.  The following day,  1/22/20, the area where the vaccine was administered became swollen, hot, hard, itchy and angry red and extended down her lateral arm 1/2 way to her left elbow. On 1/23/20 she returned to medical clinic where the above exam was confirmed.
patient fainted couple minutes after vaccination and fell forward from the bench and bumped his forehead but regained consciousness in few seconds and was able to talk and drink water, ambulance took him to the hospital to get his head checked but not sure about the outcome yet
Patient received Moderna lot #016M20A  in her right deltoid for her 1st dose.  She was administered Pfizer for the 2nd dose.  Patient was monitored for 30 minutes and a daily phone call will be made to  assess for adverse events.
Client went to emergency department because of sever headache for 2 days- 10 days after receiving several vaccination- one being vaccinia. Robust take to vaccinia site & small macular rash to chest- Treatment & pain meds- L.P. Discharged.
Tingling/pins & needles starting in left hand, travelling up left arm to elbow, left side of neck/face, then in left foot.  Eventually to right hand and foot.  Consistent/intense for several hours.  24-48 hours later turned into transient tingling - mostly hands and feet, but also mid section, face, on and off.  Has not resolved.
Pregnant 31 weeks at the time of administration (due date 11/12/2021). No birth weight available. Adverse events: nausea, loss of vision and increase of blood pressure that started approximately 15 minutes after receiving the injection. This lasted for approximately 12 hours and then blood pressure dropped low for the next 4 days. Severe shoulder pain (left) and complete immobility lasted for two weeks (14 days).
Headache, Myalgia, Arthralgia, Fatigue and Chills but no elevated temperature.  Narrative:
Immediate reaction at the injection site of redness; Immediate reaction at the injection site of swelling; Immediate reaction at the injection site of rash; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 31-year-old female patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 10th January 2020, the patient received Engerix B adult. On 10th January 2020, immediately after receiving Engerix B adult, the patient experienced injection site erythema, injection site swelling and injection site rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site rash to be related to Engerix B adult.  Additional details were provided as follows: The patient Engerix B adult in morning and had an immediate reaction at the injection site of redness, swelling and rash. The rash spreads across her chest.
muscle aches, chills, diarrhea, dry heaves,  could not lift left arm where the shot was given, headache, ears ringing and painful, ear aches,  severe neck pain and unable to sleep, dry cough and runny nose.  Tried several meds, hot and cold compresses, heating pad, nothing worked
Soreness and itching at injection site. Swollen lymph node on my collar bone.  Soreness in left breast.
She got her vaccine, she had no issues at all for a while.  The first problem she noticed was on 5/30/21, holiday weekend.  It felt that her ear should pop and it did not.  The following day she had a slight earache and made the side of her face hurt also.  Her husband told her to call the doctor, which she did, and she had prescribed an OTC ear drop meant to clear impacted wax and went through a course of that but it did not help.  Her hearing was very bad and could not hear so she went in to see her.  She checked her and there was no impacted wax and then she felt a little better, but did not seem to find anything wrong.  About a week later it started up again and felt like her head was full of air and that she could not hear.  She then referred her to a ENT and had a complete hearing exam and they said that she had significant hearing loss in her left ear, and everything within the ear looked fine structure wise but just was not hearing.  The doctor there did prescribe a course of steroids that may help, which she took.  She went back after 2 weeks, there was a slight improvement, but still had significant hearing loss.  She is to follow up after the first of the year, but has noticed any change in her hearing. She still cannot hear, but has a constant noise like the car window is down, the noise being so loud that it's hard to hear. She had not had problems with her hearing prior to this as she was a customer service representative.  Hearing has never been a problem for her and has had no history of ear infections, and was told that her ears look like they are in very good condition.
Same evening as injection was given Pt noticed inj site became red. By the next day the site was also hot and sore, and more red. Pt did not treat.
suspected vaccination failure; developed Myasthenia Gravis after the second Shingrix; had shingles when he received his second vaccination / he still has shingles; is very Painful; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles in February 2020) and shingles. Concurrent medical conditions included shingles.   In July 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), myasthenia gravis (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the myasthenia gravis, shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the myasthenia gravis to be related to Shingrix.  Additional details were reported as follows: The patient had shingles in July 2020 when he received his first vaccination of Shingrix in his right arm and still had shingles when he received his second vaccination of Shingrix in his left arm. He stated that he still had shingles, but it occurs intermittently and was very Painful.  He had been to his pharmacy, his doctor, the urgent care and the emergency room and had no relief. He developed Myasthenia Gravis after the second Shingrix dose.  This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR242160:Same reporter
Weak, Lethargic, No Appetite - DEATH 3/13/2021
April 14, 2021 Seen at emergency room symptoms of pericardial effusion however were mild and no echocardiogram performed to confirm, but now believe this was occurring although resolved on own. June 2, 2021 Admitted to ICU for Cardiac Tamponade and Pleural Effusion. Remained at ICU for 3 days after procedures to remove effusion and tamponade June 11, 2021 Seen at emergency room for repeat symptoms of pericardial and pleural effusion. Mild pericardial effusion confirmed - rest at home June 14, 2021 Taken to ER for increased pericardial effusion and pleural effusion. Remained in hospital through June 19, 2021 for testing and treatment
localized slightly raised area of erythema few centimeters below the injection site of the left arm. no treatment warranted at this time, only observation. rash is not pruritic or painful.
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2022-468520, MOD-2022-468523, MOD-2022-468125 (Patient Link).
Macular rash c/w RUBELLA.  Irritability, fever, poor po intake.
Red rash about 2 inches in diameter at injection site.  Sore, warm to the touch, slightly itchy.
soreness in my shoulder/right hand started experiencing a lot of pain in the joints; shoulder and hand throbbing and it keeps me up; The soreness didn't go away and has gotten worse over time; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness in my shoulder/right hand started experiencing a lot of pain in the joints), PAIN (shoulder and hand throbbing and it keeps me up) and CONDITION AGGRAVATED (The soreness didn't go away and has gotten worse over time) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, CLOPIDOGREL for Stent placement, LISINOPRIL and METOPROLOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (soreness in my shoulder/right hand started experiencing a lot of pain in the joints), PAIN (shoulder and hand throbbing and it keeps me up) and CONDITION AGGRAVATED (The soreness didn't go away and has gotten worse over time). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (soreness in my shoulder/right hand started experiencing a lot of pain in the joints), PAIN (shoulder and hand throbbing and it keeps me up) and CONDITION AGGRAVATED (The soreness didn't go away and has gotten worse over time) had not resolved.            Treatment information also include Arthritis HOT Ointment.  The soreness didn't go away and has gotten worse over time. Their right hand also started experiencing a lot of pain in the joints. The patient waited and thought it would subside but hasn't yet. The soreness really bothers them more at night compared to any other time when they have a lot of movement. When they lay on their left side at night and their right side is elevated, their shoulder and hand begin throbbing and keeps them up.   This case was linked to MOD-2021-211615 (Patient Link).
Hemolysis; feeling miserable; Back pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Hemolysis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) for Paroxysmal nocturnal haemoglobinuria.    Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (Hemolysis) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), BACK PAIN (Back pain) and PYREXIA (Fever). At the time of the report, HAEMOLYSIS (Hemolysis), FEELING ABNORMAL (feeling miserable), BACK PAIN (Back pain) and PYREXIA (Fever) had resolved. Not Provided          No concomitant medications information was reported. No treatment medications were provided. It was reported that  patient  resolved with all the symptoms after his infusion in nov 2021.Also it was reported that the patient would be following up with physician in JAN 2022.  Company comment: This is a spontaneous case concerning a male patient of unknown age, with reported medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab) and previous hemolysis after the second dose of mRNA-1273 vaccine, who experienced the serious (medically significant) unexpected event of Hemolysis. The event occurred on an unknown date after the administration of the third dose of mRNA-1273 vaccine.  At the time of the report, the outcome of the event was Recovered/Resolved. The reported medical history of Paroxysmal nocturnal hemoglobinuria remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-451867 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow-up received contains no new information.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with reported medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab) and previous hemolysis after the second dose of mRNA-1273 vaccine, who experienced the serious (medically significant) unexpected event of Hemolysis. The event occurred on an unknown date after the administration of the third dose of mRNA-1273 vaccine.  At the time of the report, the outcome of the event was Recovered/Resolved. The reported medical history of Paroxysmal nocturnal hemoglobinuria remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
vaccinated 17 year old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated 17 year old) had resolved.        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. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient was administered the 2nd dose with no adverse event reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 036A21A) with no associated AEs reported.
4/6/2023 About noon I experienced a fever, body aches, and sore throat.  Tested with an At Home COVID-19 Test, positive. Fever and Body aches continued about the same, with sore throat getting worse with a cough developing on 4/7. Fever and subsided after 2 days.  Cough was getting worse until I spoke to doctor on 4/10 who proscribed Benzonatate capsules.  Symptoms gradually got better until about 4/21.  Some congestion lingers to time of reporting.
Patient was given the Pfizer Covid Bivalent injection for her 2nd dose of the series. No known patient reaction at this time.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 09:15 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 at 09:45 as dose 2, single (Lot number: ER8729), in left arm and on 10Dec2021 at 18:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 62 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity. Concomitant medication(s) included: VITAMIN C;  ZINC GLUCONATE; VITAMIN D3; PRESERVISION AREDS 2. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) positive, notes: Tested positive for Covid-19 on 29Jun2022 PM; (04Jul2022) negative, notes: tested negative on 04Jul2022, 05Jul2022, and 06Jul2022; (05Jul2022) negative, notes: tested negative on 04Jul2022, 05Jul2022, and 06Jul2022; (06Jul2022) negative, notes: tested negative on 04Jul2022, 05Jul2022, and 06Jul2022; (11Jul2022) positive, notes: tested positive 11Jul2022 AM. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid, Treatment start date: 30Jun2022, Treatment stop date: 04Jul2022. Tested positive for Covid-19 on 29Jun2022 PM, chills, headache, fatigue, doctor prescribed Paxlovid 30Jun2022, tested negative on 04Jul2022, 05Jul2022, and 06Jul2022. Symptoms (different than first time now head cold symptoms) appeared 10Jul2022 PM, tested positive 11Jul2022.
Pain in left shoulder; shooting pain from left shoulder to chest; Felt like stabbing in my chest hurt to breathe; This is a spontaneous report from a non-contactable other hcp. A adult female patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3302 and Expiration date was not provided), via other, administered in Arm Left on 28Jan2021 12:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included , covid-19; if covid prior vaccination: Yes, known allergies: Nuts, Patient's received single dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL0140 and Expiration date was not provided), via Intramuscular, administered in Arm Left on 06Jan2021 10:00 as 1ST DOSE, SINGLE for covid-19 immunisation. There were no concomitant medications. On 28Jan2021 18:00 the patient experienced pain in left shoulder, shooting pain from left shoulder to chest, felt like stabbing in my chest hurt to breathe. The outcome of event was Not recovered/Not resolved.  No follow-up attempts are possible. No further information is expected.
sicker; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got sicker than hell after receiving the shot but stated that it was still better than getting shingles. This case is linked to case US2021AMR198950 reported for the same patient (2nd dose).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198950:same patient 2nd dose
I experienced a small itchy/red rash on the forearm of the arm I was vaccinated. My identical twin sister, who has the autoimmune disorder also experienced an allergic reaction but more severe. She experienced hives 5-6 days following her Maderna vaccine
I was experiencing some chest pains. I went to see my doctor, who ordered test, I have had a series of stress test that involved radiation while going through the test. I am awaiting the results of the stress test. I had a pelvic ultrasound that showed a mass on my uterus. I have an MRI schedule, January 23, to determine if it is just a fibroid. I have an appointment for an endoscopy of my bladder to determine where the blood (hematuria) in my urine is coming from.
Visions problems after first dose; Blurry/it became bad really fast/trouble reading the batch number from the vaccination card with his reading glasses; foggy; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Visions problems after first dose), VISION BLURRED (Blurry/it became bad really fast/trouble reading the batch number from the vaccination card with his reading glasses) and FEELING ABNORMAL (foggy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included INSULIN HUMAN (HUMULIN-R), INSULIN DETEMIR (LEVEMIR), LISINOPRIL, ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 04-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 VISION BLURRED (Visions problems after first dose), VISION BLURRED (Blurry/it became bad really fast/trouble reading the batch number from the vaccination card with his reading glasses) and FEELING ABNORMAL (foggy). At the time of the report, VISION BLURRED (Visions problems after first dose), VISION BLURRED (Blurry/it became bad really fast/trouble reading the batch number from the vaccination card with his reading glasses) and FEELING ABNORMAL (foggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.