chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got my booster in December 2021.  I tested positive for COVID in January 2022.  I developed a dry cough in March 2022.  Had my annual physical in April 2022.  Chest x-ray was normal.  Chest sounded normal and there was no bacteria in my lungs.  Doctor said it could be reflux or it could be a COVID side effect.  We are treating with Prilosec to see if it is reflux.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 12-month old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009088: US-009507513-2301USA009112: US-009507513-2301USA009113: US-009507513-2301USA009927: US-009507513-2302USA000400: US-009507513-2301USA010889:
Started with a sore arm and very sore shoulder blade on the side of the shot.  In the evening I had a fever:  wore two bathrobes and two pairs of socks and still couldn't get warm in bed: took Benadryl early morning to get some sleep.  Upon waking, my urine was very strong and I was slightly dizzy.  I started feeling better about 12:30 on Saturday.  I only drank water on Friday and more lemon water on Saturday to help flush my system.  Friday evening I was getting a bruise where the shot was given and got some welts around my arm from the place of the shot.  My arm was and is still very sore to touch.  The bruise is getting bigger today, Monday, but the welts are getting less; and the arm is still sore.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-FEB-2017, the pt was inoculated with ZOSTAVAX vaccine (lot number, dosage, vaccination site and route of administration not provided), as recommended for routine adult health maintenance for its intended purpose: the prevention of shingles. On an unknown date, shortly after receiving ZOSTAVAX, the pt suffered Herpes Zoster and acute ischemic left middle cerebral artery stroke. As a direct and proximate result of ZOSTAVAX, the pt's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Further, as a direct and proximate result of the Company's conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event of Acute Ischemic Left Middle Cerebral Artery Stroke was determined to be medically significant. The events of acute ischemic left middle cerebral artery stroke and herpes zoster were considered to be disabling. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Sep2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "History of cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Marijuana, reaction(s): "Known allergies: Marijuana". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2023 at 12:00, outcome "recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 05Oct2023 to 10Oct2023 as Treatment of COVID-19.   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-202300331380 same patient, different drug/event;
After vaccination my right arm went numb, then my leg, face and speech. I was taken by ambulance to hospital where they ran test and gave me magnesium and potassium and kept me overnight, they sent me home with a heart monitor and I still have it.
Swollen tongue with bumps on the edge; mouth ulcers; cracked cheeks (as if I bit my cheeks or ate sour candy).
PT REPORTED NON-STOP VOMITING THAT STARTED TUESDAY NIGHT 3/25/21 AROUND 8PM. IT DID NOT STOP UNTIL 1 AM THE NEXT DAY, 3/26/21. PT WAS DRY HEAVING EVERY HOUR ON THE HOUR UNTIL 1AM . REPORTS NO CHANGES IN DIET OR ACTIVITY TO CAUSE THE VOMITING.
About five minutes after flu vaccine injection patient started to become faint, and fell forward, but never lost consciousness. A code was called, and was found to have a regular pulse, and somewhat elevated blood pressure. He was transported to urgent care for further evaluation and monitoring. He was found with no focal neurologic deficits, rash, edema, or any other signs or symptoms except chronic right shoulder pain and mild nausea. Reported feeling back to normal after monitoring in urgent case for over an hour. Discharged back to treatment program in good condition. Dizziness & NauseaVomiting
Patient lost consciousness (semi-conscious yet not completely out like syncope) and was able to stay upright in chair with balance provided by myself.  Patient upper arms and body became rigid with yet both arms moved up and down with hands hanging down from wrists.  It really seemed like more of a seizure to me.  Patient  snorted and snored with head tilted slightly to left side.  The episode lasted about 30 to 45 seconds.  Patient became very pale and diaphoretic.  Patient took about 15 to 20 minutes to recover to the point of being able to be escorted to a car to be transported home.
received the first dose of the Pfizer vaccine and has now tested positive for Covid after this dose; received the first dose of the Pfizer vaccine and has now tested positive for Covid after this dose; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical Information Team. A 73-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that the patient received the first dose of the Pfizer vaccine and has now tested positive for COVID after this dose on an unspecified date. He was scheduled to get the second dose on 12Feb2021 and she (reporter) wanted to know if it was ok for him to proceed with the second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Information has been received from a nurse concerning a 16 year old male who in approximately 1994, "around age 3 or 4" was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, the patient was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations that same day included on dose of Menactra, one dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and one dose of hepatitis A vaccine (inactive) (MSD). Subsequently, the patient experienced swelling and itching around the injection site after his second dose of varicella virus vaccine live (Oka/Merck). The reporter noted the patient also experienced a rash about the size of his palm. It was noted the injection was "given on a Tuesday and the rash was still there by Saturday". The outcome of events was unknown. The patient sought medical attention from his mother who was a nurse at the office. Additional information has been requested.
Adverse events experienced and are they still occurring now:  yes. reports at around midnight the day of the vaccine she began feeling body aches, HA, decreased appetite, chills, sweating w/no fever but felt warm, fatigue. states she took tylenol that helped.
Information has been received from a physician concerning a 12 month old white male who on 9/1/99 was vaccinated with MMR and Varicella. On 9/6/99, the pt experienced "an unusual total body rash characterized by fine, raised bumps which began on the arms and legs and spread to the trunk and cheeks." The pt sought unspecified medical treatment. On an unspecified date, the pt recovered. No further information is available.
absent seizure; This is a spontaneous report from a non-contactable consumer reported for her husband. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BONTECH, COVID-19 Vaccine, Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on 26May2021, as (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced absent seizure on 26May2021. It was reported that, the caller states her husband received his second dose of the Pfizer COIVD-19 vaccine today, 26May2021. and during the 15 mins wait time from after receiving the vaccine he had what she states the nurses there are calling and absent seizure. The caller states his eyes were awake but he was not responding, as she was getting ready to bring him to the ER, he became responsive so they did not go to the ER. She is wondering if there has been reports of this and what she should do next. A review of the Pfizer COVID-19 vaccine did not find information regarding seizures. The seriousness criteria of the event was reported as serious (medically significant) by the reporter. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Fever; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported for a 12-year-old female patient (reporter's daughter). A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and no reaction. It was reported that mother calling on behalf of her 12-year-old daughter received the second dose of the vaccine yesterday and has been running a fever and taking Tylenol every 4 hours since this morning. Normally she keep her home from school for 24 hours until she was fever free. Because it generated as a reaction for the shot, does that rule still apply questioned. She has had a fever this evening. she last took her temperature at 4pm and her temperature was 101.8. If she feels fine in the morning should she send her to school Or should she keep her home until her fever breaks, was she contagious questioned by mother. Outcome of the event was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Adverse reaction; extensive rash on my injection arm & on shins below each knee; Labyrinthitis; inflammation in the inner ear.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction), VESTIBULAR NEURONITIS (extensive rash on my injection arm & on shins below each knee), LABYRINTHITIS (Labyrinthitis) and INNER EAR INFLAMMATION (inflammation in the inner ear.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction), VESTIBULAR NEURONITIS (extensive rash on my injection arm & on shins below each knee), LABYRINTHITIS (Labyrinthitis) and INNER EAR INFLAMMATION (inflammation in the inner ear.). The patient was treated with VITAMIN C [ASCORBIC ACID] at a dose of 6000 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; MECLIZINE HCL ongoing since an unknown date for Vertigo, at a dose of 25 mg and LORAZEPAM (ATIVAN) for Anxiety, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Adverse reaction), VESTIBULAR NEURONITIS (extensive rash on my injection arm & on shins below each knee), LABYRINTHITIS (Labyrinthitis) and INNER EAR INFLAMMATION (inflammation in the inner ear.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Significant follow-up appended On 20-Jul-2021: Follow-up information received on 20-Jul-2021 contains no new information.
she had injected her triceps instead to be in deltoid; Injection site redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06May2021, outcome "unknown", described as "she had injected her triceps instead to be in deltoid"; VACCINATION SITE ERYTHEMA (non-serious) with onset 06May2021, outcome "unknown", described as "Injection site redness".  Additional Information: It was reported that, medical questions addressed by this program forwarded/referred to Medical Information (Live Operators Only). Customer and/or medical inquiry forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
17 year old received Pfizer booster even though it is not approved by FDA at this time.  Patient stayed in observation for recommended period of time and other adverse events occured.
Information has been received from a consumer concerning a female patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). It was reported that the patient woke up with severe lower back pain the morning after vaccination. At the time of the report the pain had migrated to her right calf muscle and had not resolved. There was no product quality complaint involved. The reporter indicated that she read this letter written by the patient to a medical advice column in the newspaper. No further information is available.
Information has been received from a registered nurse (R.N.) concerning an approximately 9-year-old male who on 27-MAR-1997 was vaccinated with a dose of Varivax (Oka/Merck) (lot number unknown). Subsequently, on an unspecified date, the patient developed a rash. The patient was evaluated by a physician but was not hospitalized. No outcome information was reported. Additional information has been received on 05-JUL-2006 from a  unspecified woman who indicated that no further information is available on this patient. No further information is expected.
Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 12:30 (Lot number: EL9267) as dose 2, single and intramuscular, administered in arm left, administration date 23Jan2021 02:30 (Lot number: EL8982) as dose 1 (single) for covid-19 immunisation. Relevant medical history included: "Sciatica", start date: 14Jan2021 (ongoing), notes: Hip replacement for AVN 13Apr2021; "Hip Pain", start date: 14Jan2021 (ongoing), notes: hip replacement for AVN 13Apr2021; "Hip Replacement", start date: 13Apr2021 (unspecified if ongoing), notes: hip replacement for AVN 13Apr2021; "AVN" (unspecified if ongoing), notes: hip replacement for AVN 13Apr2021. Concomitant medication(s) included: DIAZEPAM taken for pain in extremity; ALLEGRA (ongoing); FLONASE ALLERGY RELIEF (ongoing); PRAVASTATIN (ongoing). Prior vaccinations were none. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Mar2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 27Mar2021, outcome "unknown", described as "COVID-19". The patient had to undergo hip replacement for AVN on 13Apr2021. Pre surgical Covid test on 27Mar2021 was positive. No symptoms and barely left house for 3 weeks prior. The patient was retested for Covid on 30Mar2021and the test was negative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157379 same patient/different drug/event/dose
recurring hives and extreme itching and inflammation across entire body all day for a week straight with no resolution yet
Mild allergic reaction; Red bumps; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2022) for prophylaxis.   On 19th March 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced allergic reaction, papular rash and pruritus. On an unknown date, the outcome of the allergic reaction, papular rash and pruritus were unknown.   It was unknown if the reporter considered the allergic reaction, papular rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient had experienced a mild allergic reaction of red bumps and itching after Shingrix administration. These were the only symptoms that were mentioned by the patient to the reporter.  Patient had asked the reporter if she should get the second dose. The reporter did not consent to follow-up.
30may90 pt vax hepta B. 03jun90 pt devel stiffness in left shoulder and elbow.  sx remitted in 3-4 day. lab tests revealed anti-HBs pos and no add vax were admin.
It started in my left arm with nerve, pain and weakness. Along with chest tightness on both sides, heart palpitations, tiredness and fatigued. Prior to the vaccine, I feel like a million dollars for about 6 hours. I thought maybe my PACS had went away because I had taken my dose 2 but Later on that day, all my symptoms return. I continue to have Long COVID-19 I can't work full time anymore. I can only work 20 a week due to my illness. My doctor referred me to a Cardiologists, Neurologists, Physical Therapy, Chronic Fatigue Specialist and Acupuncture and Dietician which helped me a lot.
Headache, Fever, NauseaVomiting, Chills Narrative:
Patient presented to the ED and was subsequently hospitalized for cellulitis of lower extremity within 6 weeks of receiving covid vaccination.
Rash around site of injection; About 5 inch in diameter now;  not sure when it started but has been there for a few days at least
COVID 19 infection was confirmed on 22Sep2021; COVID 19 infection was confirmed on 22Sep2021/scratchy throat/cough; other vaccine same date vaccine date=01Apr2021; This is a spontaneous report from a contactable Pfizer colleague. A 39-years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number ER2613, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 01Apr2021 (age at vaccination: 39 years non pregnant at the time of vaccination) as DOSE 2, SINGLE, and received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number ER8734, Expiry date: unknown), via Intramuscular, administered in Arm Left on 01Apr2021 (age at vaccination: 39 years non pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. There was no medical history. Concomitant medication/ List of any other medications the patient received within 2 weeks of vaccination included ethinylestradiol, norethisterone acetate (Junel) taken for an unspecified indication. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine administered was workplace clinic. On 19Sep2021, the patient started to experience symptoms of scratchy throat and cough. Since the vaccination, patient has been tested for COVID-19. Covid test post vaccination Nasal Swab on 21Sep2021, covid test result was Positive. COVID 19 infection was confirmed on 22Sep2021. No treatment was received for events. Outcome of events drug ineffective and Covid-19 was recovering and unknown for other event.  Follow-up attempts are completed. No further information was expected.
I began to notice that you were experiencing a lot of seasonal type allergies directly after my second dose into the further months. I recently got to an ENT office where they prescribed a nasal rinse to help keep allergies down.