chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was fully vaccinated with Moderna, doses on 2/6/21, 3/6/21, and 10/26/21. Patient admitted to the hospital within three days of booster on 10/29/21 for acute CVA. Patient received IV TPA prior to arrival his initial symptoms were dizziness and eye movement issues suggestive of brainstem ischemia.  Patient was initially admitted to the ICU where he was monitored post TPA and then he was transferred to the floor.  He was seen by neurology who recommends aspirin 325 and atorvastatin 80 mg on discharge.  Echo and CTA were unremarkable.  Patient had no residual symptoms and was requesting discharge.
PATIENT BEGAN FEELING PAIN IN HIS CHEST CAVITY APPROX. JUNE 15, 2021
Left deltoid = 4x5 cm area of erythema with subcutaneous induration at site of Tdap injection; no fluctuance; tender to palpation; no streaking; no adenopathy.
My arm is bad; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 20Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Patient had second shot on Tuesday and experienced the same symptoms but this time my arm Is bad on an unspecified date.  No follow-up information needed. Information on the lot/batch number has been requested.
No additional AE/PQC reported; Pharmacist reporting a dose of VAQTA with a labeled expiry 3/6/2023 was administered to a pediatric patient on 3/8/2023. Caller reports no temperature excursion involved. No additional information available. No additional AE/PQC reported; This spontaneous report was received from a pharmacist and refers to a pediatric patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-MAR-2023, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) at a dose of 0.5 milliliter, lot #W002894, expiration date 06-MAR-2023 (formulation defaulted as intramuscular injection, anatomical location, lot # and expiration date were not reported) for prophylaxis (expired product administered). No additional adverse events was reported (no adverse event).
pt recv vax 8OCT96 & 11OCT96 mom reports pt has hives;brought to hlth dept seen by & observed red, itchy, small spotty rash gen head to toe;examined by PA;told it was allerg rxn;
Adverse reactions to the Janssen vaccine - tinnitus, blurred vision & double vision, numbness on face, heart palpitations, ocular migraines, confusion, trouble concentrating.
The shot itself was not as painful as it usually is, but it was administered in the shoulder at the top of my left arm by a man standing over me while I was seated. About 2 hours later, I reached to pick up the glass I was drinking from the table to my left, and my left shoulder felt like it was dislocated. I had to pick up my arm with my other hand and set it back down by my side. I knew it was from the vaccine, but I thought it would only be sore for a few days. I couldn't use my left arm to do normal activities like washing my hair or pulling a shirt over my head while undressing. I haven't been able to sleep on my left side and ordinary movements cause pain to shoot down my arm. After about 2.5 weeks, I was concerned because it wasn't any better -- possibly worse -- so I decided to go see an orthopedic physician. He said that maybe it was just in the muscle and gave me two prescriptions -- a pill for pain and a special cream that the pharmacy made to rub on my shoulder. More than 6 weeks after the vaccine, my shoulder was still bothering me, so I went back to see the Orthopedic physician. He has requested that I have a contrast MRI to see if the problem is in the bursa, but I haven't had the MRI yet.
Date 10/18/04 vaccine 2:00PM at 7:30PM, starting w/ fever and every muscle in my body, felt like a truck ran me over
Fever 101.5 from hour 6 to hour 34(approx) extreme nausea, extreme headache, body aches, diarrhea, racing heart. Missed 3 days of work. Nausea and diarrhea lasted 5 days. Fatigue (inability to exercise lasted 9 days.
had Covid; had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she does have allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" and all described as "had Covid". Clinical course: Patient only received one bivalent vaccine. Caller said she had covid in Jul2023. She had home tests and tested positive but since she recovered, or she assumed she recovered, with the new variant they say it can seem like had allergies and she did not have allergies so she was nervous to take the test again because she knows she could test positive again since you can possibly test positive up to 90 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) positive, notes: home tests. 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-202300278669 similar report from same reporter/different patient;US-PFIZER INC-202300279140 same patient, different dose/event;
vomiting; rash on vaccine arm and vaccine thigh - not near the shot area; fever; chills; arm hurting; arm and fingers went numb for a few minutes; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (no pregnancy) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at site of left arm at 10:00 on 07Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced arm and fingers went numb for a few minutes immediately after vaccine at 10:00 on 07Jan2021, fever, chills and arm hurting on 08Jan2021, vomiting, rash on vaccine arm and vaccine thigh - not near the shot area on 09Jan2021. Arm feeling better by end of 09Jan2021. Facility type vaccine was in Public Health Clinic facility. No other vaccine in four weeks. No other medications in two weeks. No treatment for adverse events. No COVID prior vaccination. No COVID tested post vaccination. None Known allergies. No other medical history. The outcome of events was recovering.
arm is getting weaker; Pain in arm/ hard to raise the arm up; difficulty sleeping at night; swelling to the side under my arm; I can't lay on on my side; pain with movement 9/10 pain scale; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm) and DISCOMFORT (I can't lay on on my side) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031AZ1A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OLMESARTAN, LEVOTHYROXINE, ATENOLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm), DISCOMFORT (I can't lay on on my side) and MYALGIA (pain with movement 9/10 pain scale). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (arm is getting weaker), PAIN IN EXTREMITY (Pain in arm/ hard to raise the arm up), INSOMNIA (difficulty sleeping at night), PERIPHERAL SWELLING (swelling to the side under my arm), DISCOMFORT (I can't lay on on my side) and MYALGIA (pain with movement 9/10 pain scale) outcome was unknown.            The patient consulted with her healthcare professional and had X-Ray and was prescribed with Tylenol. Doctor might order MRI but still for approval
While administering vaccine with a 1mm vanish point syringe, the needlee retracted after the plunger had been depressed at least half way,  but prior to administering the full volume of the dose.   A small amount of liquid was then observed running down the skin around the vaccination site.
Subsequent to receiving one dose of varicella virus vaccine live, the pt experienced a rash with what were not quite like varicella lesions.
PC 7/15/08 from patient, reports had typhoid vaccine (7/09/08) and started Chloroquine tabs Saturday (7/12/08). Then started having headache Saturday and diarrhea Mon; Diarrhea subsided, but started breaking out in fine red raised rash to abdomen. Advised patient to follow up with MD today 7/15/08. Patient called 7/16/08 rash still there; taking Benadryl. referred to PMD again. 7/17/08 MD stopped/DC Chloroquine, cont Benadryl and start cortisone cream.
Patient came to ED for evaluation of fever, diarrhea, shortness of breath.  Patient reports that her exertional dyspnea has gotten significantly worse now she is experiencing diarrhea. Patient was admitted 1/2/22 for COVID despite fully vaccinated with Moderna on 3/17/21 and 4/16/21.
Employee states 24hrs after injection she had hives, tightness in throat, itching.  12/03/09 ED notes for DOS 11/20/09. DX: Allergic reaction for H1N1 vaccine  Pt c/o rash at injection site, arms leg, hives, tightness in throat and itching. Tx: Benadryl, prednisolone and Pepcid. Pt improved and discharged home.
So, the right eye I had loss of vision and I was seen by Eye Specialists which he later referred me to another eye doctor, and that's where they injected my right eye due to having a blood clot on the right side vain of my eye. I have an appointment for next month for another injection to improve my vision.
At midnight on the day she received the vaccine, she experienced a seizure and was taken by ambulance to the ED.  She was then stable and was discharged home.  She had a second seizure at 6am and was again taken by ambulance to the ED.  She was then kept for 48 hr. observation. 7/2/08-records received for DOS 6/10-6/11/08-DC DX: Seizures, new onset. Status post Gardasil vaccination. Neurologically intact. Evening of vaccination started seeing bright lights, generalized tonic-clonic seizure, seen in ED without incident. Following morning had second seizure, generalized tonic-clonic seizure with eyes rolled up.
Itchiness all over her body; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 23-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EW0183, Expiration date: was not reported) via an unspecified route of administration, administered in right arm, on 19May2021, at 08:00 (at the age of 23-year-old), as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 19May2021, after vaccination patient experienced Itchiness all over her body. The patient stated, she does not have rash or anything, but her body has been itching for the past 10 hours. The patient stated, she does not know if that was an effect or that's normal, she would like to know. As reported, the patient got the first dose today (19May2021) this early morning and after three hours the patient experienced itchiness all over her body. The outcome of event itchiness all over her body was unknown.  No follow-up attempts are needed. No further information is expected.
Arthritis pain in back, hips, shoulders and hands; Sore arm; He is not doing anything to cause the pain; This is a program spontaneous report from a contactable consumer or other non hcp (patient himself).  A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0185; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 19May2021 08:00AM as 1st dose, single for covid-19 immunization and would scheduled to receive the second dose on 10Jun2021.  The patient's medical history included bad Arthritis, Allergic to Penicillin from an unknown date. The patient's concomitant medication included Apixaban (ELIQUIS) 25mg tablets a day patient was taking blood thinner this since he was 48-year-old. On 19 May2021 after the vaccination the patient experienced with a Sore arm, on 20May2021 then the second day after the vaccination the arthritis started for no reason and had more pain in back, hips, shoulders and hands and prior to vaccine he would had minor pain here and there, every day, but now his arthritis had really flared up badly, had to take the pain medication every day. Patient stated that He was not doing anything to cause the pain. It had stayed the same since the pain started, since patient got the vaccination, his arthritis had been getting worse. could not take arthritis medications because he had 2 blood clots for that he was on blood thinners. Patient had a type of arthritis called DISH, which was in his back and was the worst rheumatoid arthritis and osteoarthritis a person can have. Patient was in a lot of pain and took just pain killers and pain medicine as treatment as prescribed Norco by his doctor, 7.5-325 tablets to take as needed. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event pain in back, hips, shoulders and hands was not recovered, and the other events was unknown.  Follow-up (24May2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable 63-year-old male consumer (patient) reported that included patient weight, age, concomitant medication, treatment received, outcome of events.  No follow-up attempts are needed. No further information is expected.
Patient has had continuous tinnitus since receiving original COVID-19 vaccine series; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 02Jul2021 as dose 2, single (Lot number: EW0182) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ew018), administration date: 11Jun2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jul2021, outcome "not recovered", described as "Patient has had continuous tinnitus since receiving original COVID-19 vaccine series". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had covid prior vaccination and not tested positive post vaccination. No other vaccine in four weeks, no other medications in two weeks. No known allergies. Facility type vaccine was Doctor's office/urgent care.
Pfizer COVID-19 vaccine (5-11yrs) manufacturer expiration date is 8/31/2022. However, vaccine expiration date after being transferred from freezer to refrigerator is 5/17/22. Vaccine was administered on 6/1/22.
Day after vaccine I had a sore arm for 2 days and it went away. Then 8 days later I noticed a red rash the size of a silver dollar on and around the injection site.  It was slightly itchy and you could feed a bump under the skin.  It is now 4 days later and the bump has decreased but there is a slight rash still there. It seems to be getting  better.
Morning after immunizations pt developed redness and swelling by site of vaccines on left delt. Also had a fever. Doing much better today according to dad. No pain at site.
Redness starting at the shoulder continuing down to the forearm. Diagnosed as cellulitis and treated with an antibiotic.
Headache, sweating, feeling cold, loss of appetite, severe mental depression, weakness, shaky, nightmares.
Vaccinated a 16 year old; Off-Label use; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) and OFF LABEL USE (Off-Label use) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) and OFF LABEL USE (Off-Label use). On 02-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 16 year old) and OFF LABEL USE (Off-Label use) had resolved.        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.  No adverse events were reported after vaccine administration. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: The patient's race, ethnicity, pregnancy information updated and event off label use was added.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 010A21A) with no associated AEs reported.
Flushing/sweating, dizziness, and increased anxiety. Initial BP 171/108 (pulse 82). F/u BP 124/65 (pulse 74). O2 sat 100%. Patient placed in supine position and stabilized.
The day after the vaccine was given tip of left clavicle was swollen and tender.  could not do workout for eight days.  History of clavicle surgery in 2010 and 22012.  Antibiotics were given first visit to clinic, steroid injection and oral steroids given at second visit on 10.17.20.  On 10/28/20, states that he has been referred to orthopedist.  Pain is no longer felt while at rest.  Continuing to use rest and ice.
Patient said she felt "bad" and went to the hospital and said the doctors told her that her platelets were too low and has been in hospital being treated for that.
Four days post vax, mother reported fever and treated with Tylenol. Pt developed a rash all over. Advised to see physician. Pending physician diagnosis.
Parent called 8/14/08 to report RUA is red swollen, warm. Advised ibuprofen as needed.
Information has been received through the Merck pregnancy registry from a health professional concerning a 21 year old female who was vaccinated with her first dose of GARDASIL and it was subsequently discovered that the patient was pregnant. The patient's LMP=16-Nov-2007. Follow-up information has been received from a registered nurse. The patient experienced early pregnancy bleeding. The reporter was not aware of any other information that would inform the outcome of this pregnancy. Medications used during pregnancy included pre-natal vitamins (unspecified). There were no other complaints during pregnancy and labor/delivery. The prenatal labs, obstetrical procedure, serum alpha-fetoprotein test and ultrasound were performed. On 12-AUG-2008 the patient delivered a normal, health male baby weighing 7 pounds 6 ounces length 19.5 inch at 38 weeks with Apgar score "4/9/9." There were no congenital anomalies and no other complaints or abnormalities. Additional information is not expected.
Patient came to ED with shortness of breath and chest pain.  Patient admitted to hospital with Covid pneumonia and treated with remdesivir.
no adverse effects; altering dosing schedule; first dose given on 06-MAY-2013 and the second dose given on 6-JUL-2015.; This spontaneous report was received from a medical assistant, refers to a 23-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown.   The medical assistant reported that on 06-MAY-2013, the patient was vaccinated with the first dose of, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis or quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. The second dose was given on 6-JUL-2015 (inappropriate schedule of product administration).  The reporter was not certain if both doses were hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), or of the patient might have received one of each (Interchange of vaccine products). No adverse effects were reported (no adverse event).
inflammation of heart muscles/tissues; pain around heart; pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via unspecified route on 03Apr2021 single dose for covid-19 immunization at 49-year-old. Medical history included the patient was taken to ER for stroke in Jun2019. No concomitant medications. The patient previously received varenicline tartrate (CHANTIX) for quit smoking from 03Nov2019 and had stroke; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization in Mar2021 at 49-year-old. 09Aug2021, the patient had an ER visit due to pain in chest-CT Scan, EKG, Labs etc. Now on medications for inflammation of heart muscles/tissues, caused admission to hospital. Pain appeared several times throughout the day still. The patient couldn't do simple things without pain around heart. Outcome of the event inflammation of heart muscles/tissues was not resolved, outcome of the other event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.