chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on right side of chest, sensitive to touch and liquid filled; Rash on right side of chest, sensitive to touch and liquid filled; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis, apnea, and post-traumatic stress disorder (PTSD), all from unknown dates. Concomitant medications were not reported. The patient experienced rash on right side of chest, sensitive to touch and liquid filled on 17Jan2021 13:00 (reported started 2 days after vaccination). It was subsiding as of 3 days after initial appearance. The events were recovering at the time of report.   Information on the batch/lot number has been requested.
Information has been received from a healthcare professional concerning to an unknown number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of GARDASIL 9. Lots and expiration dates were unknown by the reporter. No adverse effects reported. The call was made due to a data logger. Excursion information was: Temperature and time frame: 0°C to 1°C for 2.5 hours, 9°C to 25°C (9.36C) for 8.75 hours. No previous temperature excursion. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA008768: US-009507513-1706USA008768.
shingles; nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On unspecified dates, the patient experienced shingles and nerve damage. On unspecified dates, the patient was treated by a healthcare provider for shingles and nerve damage. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Pain up my arm - left arm; Pain on my neck - left side; Discomfort in my neck - left side; Both arms hurt; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain up my arm - left arm), NECK PAIN (Pain on my neck - left side), MUSCULOSKELETAL DISCOMFORT (Discomfort in my neck - left side) and PAIN IN EXTREMITY (Both arms hurt) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain up my arm - left arm), NECK PAIN (Pain on my neck - left side), MUSCULOSKELETAL DISCOMFORT (Discomfort in my neck - left side) and PAIN IN EXTREMITY (Both arms hurt). At the time of the report, PAIN IN EXTREMITY (Pain up my arm - left arm), NECK PAIN (Pain on my neck - left side), MUSCULOSKELETAL DISCOMFORT (Discomfort in my neck - left side) and PAIN IN EXTREMITY (Both arms hurt) 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.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-062273, MOD21-062330 (E2B Linked Report).; Sender's Comments:  MOD21-062273:Linked to 2nd dose MOD-2021-057753 MOD21-062330:cross linked
Itching; Rash; Heavy fatigue; Sore arm; Large swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Large swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Sore arm), RASH (Rash) and FATIGUE (Heavy fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Medication allergies are codeine and novocaine) and Blood pressure high. Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced SWELLING (Large swelling) and PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced PRURITUS (Itching), RASH (Rash) and FATIGUE (Heavy fatigue). At the time of the report, SWELLING (Large swelling), PRURITUS (Itching), PAIN IN EXTREMITY (Sore arm), RASH (Rash) and FATIGUE (Heavy fatigue) 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.   Other concomitant medication included Prilosec. Treatment details included Hydrocortisone and Benadryl oral and topical.
This spontaneous report was received from a physician and refers to a multiple patients (children) of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with PEDVAXHIB (lot #, expiration date, strength and route of administration were not provided) for prophylaxis. The patients were vaccinated in an altered dosing schedule: "one dose at 2 months of age, one dose of at 4 months of age and one dose at 6 months of age. On an unknown date the same unspecified patients received a booster dose of PEDVAXHIB at 12 to 15 months of age. The reporter stated that the patients did not experienced any adverse events.
Doses administered to patients after temperature excursion; Refrigerator went out of range/Temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients after temperature excursion) and PRODUCT STORAGE ERROR (Refrigerator went out of range/Temperature excursion) 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 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Refrigerator went out of range/Temperature excursion). On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to patients after temperature excursion). On 03-Jan-2022, PRODUCT STORAGE ERROR (Refrigerator went out of range/Temperature excursion) had resolved. On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that refrigerator went out of range for 240 minutes as they had a temperature excursion that occurred on 03-JAN-2022at 9pm CST.The HCP also stated that the unknown of doses that were administered to unknown of patients were mix doses and were administered on 04Jan2022.  Lot number: 031H21A  and Expiration Date: 24Mar2022 4 vials were stored in the refrigerator that are un-opened and sealed but unknown of doses were administered to patients after the excursion Proposed desired Use by Date: 06Jan2021 as that was when they expire. 4 vials that are un-opened and sealed.  4 unused up vials do not have previous excursions and are un-opened and sealed.     Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: follow up received contains non-significant information.
Symptoms on 12/13/2021 including cough, shortness of breath, congestion, and lack of appetite. Hospitalized on 12/22/2021.
REALLY BIG BUMP ON HER ARM; SORE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 29-APR-2021 for covid-19 prophylaxis. On 29-APR-2021, the patient did some weeding after the shot, and later that night the patient woke up and either had chills or felt very hot (dose number in series 1). The patient experienced nausea, stomach cramps, and really bad back pain (dose number in series 1). The patient compared all events to having really severe flu. The patient was fine after one week. The patient was recovered from chills, felt very hot, nausea, stomach cramps, and really bad back pain on MAY-2021. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 17-SEP-2022 for covid-19 prophylaxis.  On an unspecified date, the patient experienced really big bump on her arm, and sore (dose number in series 2). The patient recently had the Shingles vaccines, and experienced all the side effects the second one. It was not further clarified what those other side effects were. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really big bump on her arm and sore was not reported. This report was non-serious. This case, involving the same patient is linked to 20230562076 (case for dose number in series 1). This case, from the same reporter is linked to 20230567770.
swelling @ site of inj rt thigh; rash & hives entire body; high pitched inconsolable cry >3 hr; tachycardia, diaphoresis;
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was small bowel obstruction.
Sensitive nerve endings; Sensitive Skin; Sore eyes; Headache; Body ache; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 24th February 2020, the dose was an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced nerve pain, sensitive skin, sore eye, headache and general body pain. On an unknown date, the outcome of the nerve pain, sensitive skin, sore eye, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the nerve pain, sensitive skin, sore eye, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day after receiving the 1st dose of Shingrix experienced sensitive nerve endings, sensitive skin, sore eyes, headache and body ache. This side effects lasted for one day. For tolerance of 2nd dose refer case US2020AMR039693 The reporter consented to follow up. No further details were provided.
-  Day 2 (wednesday) dizziness, weakness -  Day 3 chills, headache,  muscle acheyness
diagnosed with COVID like four weeks ago/inefficacy; diagnosed with COVID like four weeks ago/inefficacy; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID like four weeks ago/inefficacy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & started to get fever in the evening 22MAR93 & has been hot & fussy since today 24MAR93; has been given APAP & fever is dec & more active;
The evening of 3/29/21, my arm began to feel like it was on fire. I was working,  cleaning the floor with soap and water. After it started feeling like it was burning, it started to feel sluggish, like it did not want to do what I was telling it to do. The time was around 10:15pm.  The burning feeling in my arm lessened somewhat and I completed work and left. It was still feeling like it didn?t want to do what I told it to but I could force it to work.  The next morning, I couldn?t move my arm and it was painful to try to move it. That continued  for the next two days. By the third day, I could move my arm and fingers but not like normal. Full range and normal movement did not occur u til the fourth day.
Patient reports  feeling slightly lightheaded and feeling anxious, no dizziness, no flushing.  Patient reports feeling better (reports symptoms improved) Patient was seen and cleared by EMS 1. 147/93, pulse 93, Spo2 96% 2. BP140/91, pulse 83, Spo2 99%
discomfort in the injected shoulder; tingling sensation in the injected arm; nerve was hit with the injection; lot of pain in the injected shoulder; sometimes the pain shoots up her neck; tingling sensation in the hand; lot of pain in the arm and feels like a rbbit punch; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00469951) and transmitted to Sanofi on 10-Feb-2021.  This case involves a 67-year-old female patient who had nerve was hit with the injection (vaccination site nerve damage), lot of pain in the injected shoulder (arthralgia), pain shoots up her neck (neck pain), tingling sensation in the hand (paraesthesia), lot of pain in the arm and feels like a rabbit punch (pain in extremity), discomfort in the injected shoulder (vaccination site discomfort) and tingling sensation in the injected arm (vaccination site paraesthesia), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 28-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an intramuscular route in the right shoulder for prophylactic vaccination.  On 28-Oct-2020, the patient developed a non-serious had nerve was hit with the injection(vaccination site nerve damage), lot of pain in the injected shoulder (arthralgia), pain shoots up her neck (neck pain), tingling sensation in the hand (paraesthesia), lot of pain in the arm and feels like a rabbit punch (pain in extremity), discomfort in the injected shoulder (vaccination site discomfort) and tingling sensation in the injected arm (vaccination site paraesthesia), on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The details of laboratory data were not reported.  The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]). She was taking Motrin to treat her symptoms, but her doctor did not want her to continue taking Motrin since it could upset the stomach, so the doctor prescribed another pain medication, which was not helping her symptoms. Patient's doctor had suggested physical therapy or a nerve conduction study. Patient stated that she had not experienced symptoms like this with other vaccines she has received.  At the time of reporting, the patient had not recovered from all the events.  There will be no information on batch number for this case.; Sender's Comments:  00469951:
Had all four of the Pfizer shots, the Pfizer vaccines, he had taken all four of those a long time ago/tested positive; Had all four of the Pfizer shots, the Pfizer vaccines, he had taken all four of those a long time ago/tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 at 12:45 as dose 1, single (Lot number: EN6202), in left arm, on 01Mar2021 at 09:30 as dose 2, single (Lot number: EM9809), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Knee replacement" (not ongoing); "Hypertension" (unspecified if ongoing); "Allergy to bromine in pools as skin irritant" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; BISOPROLOL; OMEGA 3 PLUS [FISH OIL]. Past drug history included: Ibuprofen, reaction(s): "Allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "Had all four of the Pfizer shots, the Pfizer vaccines, he had taken all four of those a long time ago/tested positive". The event "had all four of the pfizer shots, the pfizer vaccines, he had taken all four of those a long time ago/tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from Apr2023 to Apr2023. Clinical course: This report was related to a study or programme. No investigations were provided. Patient took Pfizer shots, the Pfizer vaccines, he had taken all four of those. With his symptoms being moderate it may go on to be problematic, so his doctor wanted him to go ahead and take Paxlovid. He took Paxlovid, this was 7 days from time the time he had been cleared, so he started taking it 5 days before that, so 12 days ago he took Paxlovid. He had rebound now after he took it for 5 days his symptoms improved dramatically, and he had tested negative. He was a caregiver but not a doctor, nurse, or pharmacist, so the real concerning problem was that the person he cares for would now be without him. He tested negative which that test date was 4 days after he started taking Paxlovid, clarified to the 5th day that he tested negative. He felt fine and went on to do routine things.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181441 Same reporter/patient, different drug, different event.;US-PFIZER INC-2021229338 Same reporter/patient, same drug/different dose, different AEs, time gap.;
Estimated due date: 06/14/2021 On 12/27 I woke up with headaches, I had headaches until the 30th. On 12/28 my son was tested positive for covid. I tested negative on the 20th and 30th. My symptoms started getting worse (loss of taste and smell) and 01/06 I tested positive. 01/11 at 5PM I had my second dose. I had some body aches and fever (101.5F). chills, sweats and Tylenol and it was not making a difference. Last night around 8PM my temp was to 100.8F and today I woke up and temperature normal and body aches much better.
12-1pm - 5/6/11 - Temp 101 degrees A. Redness - size of pea. Gave TYLENOL - 2:30 - Temp 102.3 R. warm bath - 3:00pm -T - 102.3 - more TYLENOL- diarrhea - 7-8pm - ER = vomiting - 102.5 degrees. Sat. am 8:30 fine 5/7/11.
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of (Oka/Merck) VARIVAX (lot # and expiry date unspecified) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to (Oka/Merck) VARIVAX. This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS # 1503USA014263 and MARRS # 1503USA014264. Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 28-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX (dose: 0.5 ml, lot # L040421, expiry date: 15-OCT-2017) via intramuscular route, (incorrect product storage). Nurse reported that the vaccine underwent a temperature excursion of 37 degree Fahrenheit for 96 hours. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Moderate to severe muscle aches all over body.   Pain and swelling at sight of injection. Needed ibuprofen to sleep due to body aches. Pain persisted 24 hours before dulling to mild aches.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Shakiness-Medium, Additional Details: Shakiness came after the Epipen and dizziness.
Covid vaccine vial was punctured at approximately 9am on 8/25/21 and one dose was administered to a patient.  The vial was left out at room temperature for approximately 4 hours and 20 minutes.  The patient reported above was then administered the Covid vaccine from the vial that had been left at room temperature at 1:20 pm.  The vial should only be left at room temperature for max of 2 hours.
Severe urticaria on entire body unresponsive to Allegra 180 QD, Prednisone 40mg QD, Benadryl 50mg Q4hrs, Pepcid 40mg Q12hrs. Ultimately responded to Xolair injections received on 4/25/2022.
Had MMR x 2 wks ago; Now w/fine raised rash x 1 day; no fever; not real active perfered pt down;
I was not feeling well for a few days, getting progressively weaker, I had to keep sitting down. Two nights before I went to the hospital I was up all night, I could not stand. I was crawling to get anywhere throughout the house. The next day it got worse, my husband called an ambulance and I went to the hospital. Once I got there I could not stand and my blood pressure bottomed out. The ran test and found that I had bleeding in my esophagus, stomach, and upper GI. It was determined I had an upper GI bleed. I had to have a blood transfusion and was put on Protonix.
Prior to 2020, annual physical, stress test, and EKGs no Afib Annual physical examination by primary care physician (PCP) on November 23, 2020. I did not have Afib. Received my COVID 19 vaccinations in January 2021 (dates above) March 9, 2020 office visit with my PCP for a complaint of ear pain. AFib diagnosed at that time during blood pressure screening and confirmed with 12 wire EKG. April 28, 2021, PCP referred me to cardiologist. Persistent AFIB diagnosed by ECHO and stress test.
Vaccine error. Pfizer vaccine dose #1 was given to a patient under the age of 16. Patient was 14 years of age. No adverse reaction as of 03/11/2021. Will follow up with patient tomorrow and in two weeks.
Developed fever in the evening after vaccines were given earlier in the day, temp to 103, also noted to have some decreased appetite and increased fussiness. Fever did improve with anti-pyretics and symptoms had improved by the next morning, temp to 100, less fussy and still decreased appetite but with good urine output and accepting smaller feedings more frequently.