chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm after his first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm after his first vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (sore arm after his first vaccine). At the time of the report, MYALGIA (sore arm after his first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  The patient donated blood and tested for Covid-19 positive vaccine antibodies.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up document received contains no new information.
Noticed a few red bumps on Lt arm at brachial site the evening of 9/7. Came ot work 9/8 felt left side of neck was swelling. The feeling began to increase around 10:30, looked inside of mouth it appeared to be swollen with increased salivation. No SOB, or difficulty swallowing at that time. Vaccine site tender, no rash or swelling at Lt Deltoid.
Patient received Fluzone and Pneumovax in left deltoid at 11:00am on 10/21/05.  Later that evening her left arm became very painful, red and swollen.  She sent to the ER that evening and then x2 on 10/22/05 with continued pain
This spontaneous report as received from a licensed practice nurse refers to a 65 year old patient. On 23-FEB-2015, the patient was vaccinated with an expired dose of ZOSTAVAX lot # J014568, expired date 18-FEB-2015. No adverse effects were reported. Additional information has been requested.
pt recvd flu vax & 3 days later devel a h/a that persisted 4 days & a fever to 103.5 7 joint pain that persisted 8 days; 4NOV92 devel a erythematous raised rash on chest extremities;
1st dose of Moderna COVID-19 vaccine was accidentally administered to a patient who had already been vaccinated with 2 doses of Pfizer COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (1st dose of Moderna COVID-19 vaccine was accidentally administered to a patient who had already been vaccinated with 2 doses of Pfizer COVID-19 vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced ACCIDENTAL OVERDOSE (1st dose of Moderna COVID-19 vaccine was accidentally administered to a patient who had already been vaccinated with 2 doses of Pfizer COVID-19 vaccine). On 09-Jun-2021, ACCIDENTAL OVERDOSE (1st dose of Moderna COVID-19 vaccine was accidentally administered to a patient who had already been vaccinated with 2 doses of Pfizer COVID-19 vaccine) 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.   No concomitant products were reported. No treatment information was provided.
About 25 minutes after my vaccine was administered,  the left side of my face went numb. My left fingers were tingling and I had a hive-like rash on my neck and left side of my face. I also had a metallic taste in my mouth. This occurred in my drive home. Upon returning home around 20 minutes post reaction, I took 1 Benadryl and started feeling improvement about 30 minutes after I took the Benadryl. I didn?t feel 100% normal until the next morning.
groin swelling; low white blood cells; This spontaneous report was received from a consumer and refers to a 15-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced groin swelling and mild white blood cell count decreased. The outcome of swelling and white blood cell count decreased was unknown. Causality assessment was not provided.
Information has been received from a physician concerning a patient, with a history of asthma, who was vaccinated with a third dose of ROTATEQ. Subsequently the patient experienced bronchospasms. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Patient had dizziness and fainting and was notified by the patient's mother.  Patient could not sit upright an was laid down.  Patient was not responsive for 5 to 10 seconds.  Patient regained consciousness and was able to give her name and reason for her visit to the pharmacy for her Covid vaccination.  911 was called and the fire department and ambulance arrived and checked vitals and advised the patient to go to the ER with them.  Patient refused to go with the ambulance and was advised by fire department and personnel to go to the ER on their own.  Patient left and was accompanied with her mother and brother.
Generalized hives 20 minutes after Varivax S.C.  Vital signs stable, no wheezing heard.  Received Epinephrine 0.3ml (1:1000) and sent to hospital ER by 911 for observation.
Information has been received from a registered nurse concerning an adult male healthcare professional who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of Varivax. He had a positive seroconversion shortly after his vaccination. Recently, a second titer was taken and the result was negative. No other symptoms were reported. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
I was getting migraine type headaches, soreness in the arm, tingling down to my fingers, and I was lethargic. I noticed some odd sensations up through my breast area. The only reason I found what was going on was because I was going in for my annual mamo gram. I had cysts in my right breast and something in the lymph node in the left breast.
Information has been received from a physician concerning a 16 year old female patient who on 17-MAY-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number not reported). On 18-MAY-2011, the patient came to the physician's office because her hands were profoundly swollen due to edema and swelling. The patient had been working with their healthcare provider to determine if the patient should go off therapy. The patient received ZYRTEC and a steroid (name unknown) as treatment for the event. At the time of the report the patient was recovering. Additional information has been requested.
p/vax pt exp chickenpox w/approx 10 lesions over entire body;pt had approx 60 lesions some fluid filled & all red & raised;pt seen by MD;
swelling and redness in arm, arm pain,  fever of 100.2, nausea,
Wrong vaccine given to pt.  Pt received TDAP instead of PENTACEL.  Unknown adverse events.
Day of shot felt  fine... Second day struggled through work arm and shoulder pain was about a 4.. After work  constant shooting pain in shoulder and arm 7 of 10 extremely tired nauseated. Took bath went to bed next morning felt better arm was worse more swelling and itching and pain,  about 10pm on the second day area turned bright red was very hot to touch itching and painful.
Patient complained of her "throat feeling funny" and itchy after receiving first dose of COVID-19 vaccine, Patient was taken to triage area for assessment. Vitals: B/P 162/84, HR 101, SAO2 99-100%, RR 20 @ 0740. BP 148/82, HR 104, PAO2 100%, RR 20 @ 0754-0759. Symptoms improved while patient being observed in triage, patient was given 25 mg po diphenhydramie, and released around 0800.
ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse). At the time of the report, TINNITUS (ringing of the ears/tinnitus/he would give it a 12 (on a scale of 1 to 10)/It's gotten really really loud and raging/it's gotten worse) outcome 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 treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received containing Non significant information
I was administered the 5 Moderna Covid Vaccines. The bivariant was administered on 10/26/2022. Soon after I began experiencing severe muscle soreness in my hips and shoulders. On 12/20/2022 Dr. examined me and she gave me a preliminary diagnosis of polymyalgia rheumatica (PMR). Dr. gave me a script for 15 mgs of prednisone. Dr telephoned the following morning and I was 80% better. This confirmed the PMR diagnosis I visited rheumatologist Dr and I am not on a prednisone tapering program for 12 months SED rate confirmed infection.
Fainting episode - x 5 minutes after inj. Pale, hypotension. (Sweating, weakness).
About 7:30 pm I stated to feel bad. I was freezing. My heart was beating very hard felt like it was going to jump out of my chest. I was shaking uncontrollable. I had a headache. No fever that I was aware of. Could not go to sleep. Had to go to the bathroom every 30 minutes, I think because I was so cold. The next morning I didn't feel well. The headache would not go away. My leggs started cramping really bad. I called the doctor and said I think I have blood clots. I had a ultrasound done, no blood clots. nothing wrong with me except I got the shot.  Due to the headaches I went to a specialist had a MRI on my brain and a MRA on my brain. nothing wrong with me except I got the shot. I went to see another specialist because my heart is beating unusually. I am having High blood pressure spikes and crazy dizzy spells. Had EKG and Heart Echo. Nothing wrong with me except I got the Shot.
Dry eyes; Wound infection; both eyes cataract; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4433870-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Non-Tobacco User" (unspecified if ongoing); "Abstains from Alcohol" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing); "Penicillin Allergy manifested by Rash" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; PRAMIPEXOLE; KLONOPIN; LITHIUM CARBONATE CAMBER; METFORMIN; VALTREX; CEPHALEXIN [CEFALEXIN]. Vaccination history included: BNT162b2 (First dose (1 in 1 Once)), administration date: 08Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "Dry eyes", "Wound infection"; BNT162b2 (Second dose (1 in 1 Once)), administration date: 05Apr2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "non-serious cut on right leg", "dry eyes", "infection after hit by truck", "infection after hit by truck", "staphylococcus infection". The following information was reported: CATARACT (medically significant) with onset 2022, outcome "not recovered", described as "both eyes cataract"; DRY EYE (medically significant), outcome "unknown", described as "Dry eyes"; WOUND INFECTION (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of cataract, dry eye, wound infection.  Clinical course: The patient has other concomitant therapy of Penicillin. On unknown dates, the patient experienced dry eyes, got an infection after hit by truck. In 2022, the patient experienced both eyes cataract. She was told early this year in 2022 to have a cataract surgery. Doctor had it sooner since it had gotten worse. She had it on two occasions, one eye each time. Right eye was on 13Apr2022 and left eye was on 27Apr2022. She mentioned she was given four kinds of eye drops, an anti-inflammatory, and antibiotic. She was prescribed an antibiotic and she said after seven days it cleared up pretty quickly. She held off Humira for a week after she received her Covid booster on 31Aug2021. But she said she might had been on her off week with Humira at that time as well. She was taking unspecified supplements. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with Doxycycline.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient received two doses of INFLUENZA HD with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown age and demographics who was administered two doses of influenza HD (FLUAD and Influenza USP Trival A-B high dose subvirion vaccine [Fluzone HD]) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUAD not produced by Sanofi Pasteur (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, dose, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for influenza.  On an unknown date, the patient had a non-serious event receiving two doses of influenza HD (Influenza USP trival A-B High Dose subvirion vaccine and FLUAD) with no reported adverse event (extra dose administered) (unknown latency).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received two doses of INFLUENZA HD with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received two doses of influenza hd with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Two hours after vaccination, felt severe headache and noticed right side of face swollen and pushed to the left. Eye (Rt.) was remained unclosed-unable to talk clearly-tongue felt heavy.
Two days after second injection we noticed swelling in ankles, which has not happened before. We cut back her fluid intake but the swelling persisted for two weeks. She was brought to see doctor (NP) on 17th of March which lead to no resolution. She was brought to ER on the 18th and admitted. After inpatient treatment she was released two days later and has had no subsequent issues.
Suspected vaccination failure/I got the shot and later had the shingles; Shingles; Still have a lot of nerve pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and later had shingles; the patient still had a lot of nerve pain. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
vomit; lightheaded; dizzy; super nauseous; sore arm; tired; muscle soreness; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 03Feb2021 at noon as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 03Feb2021 at noon. After 15 minutes started feeling lightheaded, dizzy and super nauseous. The nurse during the observation had her drink some water and eat a sugar candy, felt a little better and said could go home. On her way home it came back really bad, tried to eat little bit but each time she would vomit. Vomiting persisted. She could drink some water but the nausea has continued, until finally could hold something. Also experienced a sore arm, being kind of tired, muscle soreness. The main side effects are intense light headedness, dizziness, nausea. The outcome of the events nauseous and vomit was not recovered; sore arm, tired and muscle soreness was unknown while remaining outcome of the event was recovering.  Information about Lot/ Batch number has been requested. Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from an office manager regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The reporter reported that on an unknown date in 2014 an unspecified number of patients was vaccinated with VAQTA (strength, dose, frequency, product lot#, and expiry date not reported) that was improperly stored since 09-MAY-2014. This was not supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a physician's assistant concerning an approximately 17 year old female patient who was vaccinated with the first dose of GARDASIL (lot # not reported).  Subsequently the patient experienced a headache and developed mononucleosis.  Patient received the second dose of GARDASIL (lot # not reported) and subsequently experienced a headache and developed mononucleosis.  Patient sought unspecified medical attention with the physician assistant.  Patient already completed the GARDASIL series.  Patient's present status is unknown.  Additional information has been requested.
Pfizer/BioNTech start date: 27Feb2022 / Paxlovid Treatment of COVID-19 start date: 10Jul2022; Pfizer/BioNTech start date: 27Feb2022 / Paxlovid Treatment of COVID-19 start date: 10Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2022 as dose 4 (booster), single (Lot number: Fj5683) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stage 1 Triple Negative Breast Cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer/BioNTech start date: 27Feb2022 / Paxlovid Treatment of COVID-19 start date: 10Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: There were no other medication in 2weeks. The patient had a cold and sniffles yesterday and woke up this morning to test and after a negative tea it came back positive. The patient had no known allergies. Paxlovid (lot number: 2815223) taken for Treatment of COVID-19. Treatment start date was reported as 10Jul2022. Treatment stop date was reported as 15Jul2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Patient had receive dose 1 as Moderna at outside facility. Patient came to this vaccination site for dose 2 and received Pfizer instead of Moderna.  Patient was observed. Patient notified of error. No side effects were noted during observation period.
3 times during the week following the 2nd vaccine I had tongue swelling.  The third time I actually woke up in the morning with a more significant swelling.  I took a Benedryl which helped.  I did not report this to anyone else.  It did not happen immediately after the injection.
PT REPORTED HAVING A SEIZURE APPROXIMATELY 5 HOURS AFTER RECEIVING THE VACCINATION. HE REPORTS NO PRIOR HISTORY OF EPILEPSY. WAS SEEN IN EMERGENCY DEPARTMENT AND DISCHARGED SAME DAY. OTHER IMAGING PROVED INCONCLUSIVE FOR CAUSE.
Information has been received from a medical assistant concerning another female medical assistant, who while was opening a vial of ROTATEQ (Lot # 668274/09482 EXP 19-APR-2012) on 17-DEC-2010, the vaccine popped open and squirted into the medical assistant's eye. The medical assistant reported that the other medical assistant was now experiencing burning in her eye. The eye was being flushed with water. At the time of the report, the patient had not recovered. The patient was seen in the pediatrician's office where she worked. Additional information has been requested.