chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had covid-19 after the second dose, and tested positive on 16Sep2021; Lack of Efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid-19 after the second dose, and tested  and DRUG INEFFECTIVE (Lack of Efficacy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced COVID-19 and DRUG INEFFECTIVE. At the time of the report, COVID-19 (had covid-19 after the second dose, and tested positive on 16Sep2021) and DRUG INEFFECTIVE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 16-Sep-2021, SARS-CoV-2 test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  It was reported that Patient also had the booster dose.  This is a spontaneous case concerning a 77-year-old, male patient with no reported medical history, who experienced the unexpected, non serious, AESI event of Covid-19 and unexpected, non serious event of drug ineffective. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days and a booster dose. The events Covid-19 and drug ineffective occurred 218 days after the second dose of mRNA-1273 vaccine administration with positive Covid-19 test result. No reported treatment medication. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Mild
Patient received PENTACEL on (L) thigh and PREVNAR on (R) thigh on 7-26-2016. Patient developed low grade fevers and papules around site of vaccine on both thighs on 7-28-2016.
Rash was all over my torso, left arm, a few spots on the right, both legs near the knees and my back. The spots were small and itchy; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old female patient (not pregnant at time of event onset or vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533) via an unspecified route of administration at right arm on 06Apr2021 10:00 (31-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination) and seasonal allergies. Concomitant medications that the patient received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and ibuprofen (both were consumed days after shot). Patient previously received cefotaxime sodium (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Rash appeared beginning on 11Apr2021 16:00 and continued to appear for about five days. Rash was all over her torso, left arm, a few spots on the right, both legs near the knees and her back. The spots were small and itchy. The itching is still prevalent on her knees but new spots have not appeared in the last 3 days. Adverse vents did not result in emergency room visit or physician office visit. The patient did not test COVID post vaccination. No therapeutic measures were taken as a result of the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from an unspecified reporter via company representative and concerns a male patient of unknown age. The patients concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not provided. On 19-FEB-2019, the patient was vaccinated with PNEUMOVAX 23 injection (lot #, expiry date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date in February 2019, the patient experienced shoulder pain and hardness at shoulder near the injection site. The outcome of reported adverse events was unknown. The causality assessment was not provided.
The Department of Health informed the HC in May 05 of the death of a medically discharged patient. The patient enlisted in Nov 04, medically discharged in Jan 05, and died on Feb 17th. The following HPI is an account of the events prior to his death as recalled by his mother during an interview in May 05. The service member a 20 year old male, who received his enlistment vaccines on 23 Nov 04. While speaking with his mom on 30 Nov he mentioned that he had a cough, and some chest pain. She state that she encourage him to seek medical attention. She state that a couple of days later, while he was running he 'passed out' and when he went to the doctor he was told it was asthma. Mom reported that while he was at home during Christmas, he reported to his family that he was experiencing some chest pain, and did have bumps on his face that cleared in Jan. Mom was unaware of which vaccines her son received but did remember that her son said that the needle was "funny." Mom does not recall if he had a scar on his arm. She state that he was discharged for stress related issues and complaints of chest pain. Mom is unaware of any other details regarding her son's illness during that time only that the chest pain persisted. When questioned about his past history of asthma, she mentioned that he had it a little in childhood but has not been bothered by it since that time. She did mention that her son felt that his pain was not related to asthma. Mom was also questioned about the waiver for a medical exam upon discharge. She state that he was told that if he requested a workup, it would delay his release and that they may not even discharge him. He received his enlistment vaccines of Hep A-Hep B, Influenza, Meningococcal, MRR, Polio, and Td on 23 Nov 04 and he received his second Hep A-Hep B on 5 Jan 05. Chest pain start 11/30/2004, dyspnea (shortness of breath) start 11/30/2004. 4/3/06 Received Autopsy Report which revealed COD as chronic myocarditis.
Patient had swollen left arm after injection with second vaccine. Patient received first vaccine at mass clinic. She had similar reaction about 24 hours after her first dose on 3/4/2021. She said it went away and about 10 days later came back. She chose to get her second dose at the pharmacy in case it happened again.  The patients arm was swollen and red at injection site and down to above her elbow.  We placed ice on it immediately after patient noticed swelling and redness. After about five minutes it appeared to be getting worse. I moved the patient to a private area and administered diphenydramine 12.5mg/ml at a dose of 50mg. Her husband agreed to drive her home and was present for the entire exchange. She complained she was feeling a bit anxious and I took her blood pressure at 12:11pm it read 194/97 her pulse was 74. Her O2 sat was at 99. I had her stay seated and drink some water.  We went through some breathing exercises and I brought another pharmacist over to talk to her and keep her distracted while I got her a granola bar. I checker her blood pressure again at 12:45pm and it had dropped to 175/93 with a pulse of 72. The swelling and redness in her arm also went down significantly. I told the patient I would check again in 15 minutes if her bp continued to drop and pulse was good I would let them go. She had calmed down a lot at this point and was felling much better. There was only slight redness, which also could have been from the cold ice pack still applied to her arm. At 12:59pm her bp was 164/92 and pulse read 66. The patient agreed to contact me if there were any other issues. They were going to eat at the restaurant next door and check in afterwards if her arm started to swell again. They purchased diphenhydramine and I advised on how to dose. I advised patient to get lots of rest and stay hydrated.
a patient was administered an expired dose of Acthib, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Global Medical Information (GMI) (Reference number- 00491867) and transmitted to Sanofi on 24-Feb-2021.  This case involves patient (gender and age unspecified) was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number was not provided) (Expiry date: 21-jun-2020) via unknown route in unknown administration site for prophylactic vaccination on 23-Feb-2021 (expired product administered)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Severe myalgia and joint pain. Elevated liver enzymes, decreased testosterone, increased prolactin, mild anemia, severe fatigue, nausea, depression, anxiety over a period of just over four months (Late Oct, 2003 - Early Mar, 2004).   Treatment included pain management (morphine sulphate), Pherergan for nausea, Testim 1% for hypogonaotrophism, Ativan then Klonipin for anxiety, Lexapro and Wellbutrin for depression/anxiety, methotrexate injections for joint inflammation, nortryptiline for pain management. Levitra for sexual dysfunction
This spontaneous report as received from a registered nurse and refers to multiple patients of unknown demographics. The patients' medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M038846, expiration date 26-APR-2018, for prophylaxis. The doses were stored in temperature between 9 degrees Celsius (C) to 25 C (9.7 C) for 7 hours and 20 minutes which was recorded by a digital data logger. There was no previous temperature excursion reported. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004388.
Information has been received from a consumer concerning "allot of kindergarten students" who were vaccinated with varicella virus vaccine. Subsequently they developed chickenpox. Additional information has been requested.
Tinnitus; hearing loss; Gout; Dry heaves; extreme abdominal cramping; Chills/Fever; Chills/Fever; Body Aches; Slept most of the day; Extreme sore arm; Quarter size hard lump X3weeks;; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm, at age 61 years, on 03Feb2021 (Batch/Lot Number: EL9269) as 1st DOSE, SINGLE for COVID-19 immunisation.  Relevant medical history includes hypertension, asthma, glaucoma and cataracts, and blood clot from unspecified dates. Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date.  Concomitant medications included chlorthalidone; apixaban (ELIQUIS); losartan; and verapamil, all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received ciprofloxacin (CIPRO) and vancomycin on unspecified dates and experienced known allergies. On 03Feb2021 14:00, the 1st day, patient experienced extreme sore arm; quarter size hard lump X3weeks. On 04Feb2021 14:00, second day, patient experienced chills, fever, body aches, slept most of the day. On 05Feb2021 14:00, third day, patient experienced dry heaves for 2 hours followed by extreme abdominal cramping that required the patient to lay flat for the whole day. On 06Feb2021 14:00, fourth day, patient woke up to gout in his right big toe that lasted for a week. On 08Feb2021 14:00, sixth day, patient had tinnitus in both ears and hearing loss. ENT doctor prescribed oral steroids w/ taper and when that didn't work. Patient went through 4 torturous treatments where ear drum was initially punctured and shot of steroids was inserted through the hole. That didn't work either and around the time of reporting, patient was told that she have permanent hearing loss and the tinnitus has not gone away. She is now looking at needing hearing aids and will not be subjecting herself to the second dose. Hospitalization prolonged was not involved. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a doctor's office/urgent care. The outcome of the events was not recovered.
Patient received vaccine around 5 pm. For the first two minutes after vaccination the patient seemed to be fine. Starting around that 3rd minute the patient got very dizzy and nauseous. He was then seated to prevent further NV. I asked the patient if they were breathing ok and the patient stated his breathing was fine. After about another minute the patient's eyes got glossy and the patient seemed to be out of it. I asked multiple orienting questions such as his name, where he was, and what day of the week it is. He was only able to answer the day of the week and his head was bobbing. I then called 911 as the patient became very pale and started to profusely sweat. While on the phone with the 911 operator, the patient went completely unconscious and lost control of motor functions. I was able to confirm the patient was still breathing and still had a heart rate (although rapid) and thus compressions were not given. The EMT arrived quickly to the scene and took over care of the patient. After about 20 minutes of checking vital signs, the EMT gave the patient and his family the option on whether they want to go to the hospital or not for further examination. The family decided they wanted to take the ambulance to the hospital.
Per patient: Dr. - I had a pretty bad reaction to the SHINGRIX vaccination I got at your office last Monday. I had muscle aches all over, a pounding headache and I think a fever for several hours. I had these for about 24 hours. I understand that this is a fairly common reaction to this vaccine but the paper I was given after the shot said it should be reported to agency.
Baby received shots at 9:30 AM after digitalis effect did fine all day. At 5:30pm was in exersaucer and started crying. (No fever, coughing, or choking). Turned white, lips turned white, eyes rolled back in head. No jerking. EMS at house 5 min later-vital signs normal limits. Fine since.
Patient received GARDASIL and MENACTRA vaccine, patient fainted and had two seizures. Seizure activity lasting for approx. few seconds each. Petit mal activity.
Fever of 102.5 degrees lasting about 30 hrs; joint pain; Headache; This is a spontaneous report from a contactable other health professional. A 58-year-old female patient received BNT162B2, (Solution for injection, Batch/Lot: EL3249), in right arm via intramuscular on 02Feb2021 10:30 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 on 12Jan2021 for COVID-19 immunization, lot number: EK9231, administration time: 10:45 AM, route: Intramuscular, vaccine location: Right arm, dose number: one. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had event fever of 102.5 degrees lasting about 30 hrs, joint pain, headache on 02Feb2021 at 08:45 PM. The treatment was not received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.5 degrees. The outcome of the events was recovering.
Information has been received from a physician concerning an 8 month old unimmunized patient who 3 year old pre-school sibling was vaccinated with a dose of varicella virus vaccine live. The pt's sibling developed a breakthrough rash that was diagnosed as varicella. It was reported that the sibling passed it on the pt. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The pt's sibling experienced varicella following vaccination with varicella virus vaccine live. (WAES0411USA00089). Additional information has been requested.
Information has been received from a physician concerning a 12-month-old male who on 03-NOV-2006 was vaccinated with a 0.5 ml dose of MMR II (Lot # 654477/0973F). On 22-MAR-2007, the patient experienced a zoster-like rash. Unspecified medical attention was sought. The outcome at the time of this report was not recovered. No additional information available. There was no product quality complaint. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of skin irritation in a 61-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. Previously administered products included ZOSTAVAX (In December 2016 received ZOSTAVAX). Concurrent medical conditions included neuropathy and type II diabetes mellitus. On 8th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 9th November 2018, 1 days after receiving SHINGRIX and 9 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced skin irritation. On an unknown date, the outcome of the skin irritation was not recovered/not resolved. It was unknown if the reporter considered the skin irritation to be related to SHINGRIX and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient had the flu shot on his left arm and SHINGRIX vaccine on his right shoulder. The patient received he noticed an irritation on his skin that felt like an intense sunburn. The irritation started on his left thigh and hamstring on Friday then moved to his chest on Saturday. On Sunday and Monday he had the irritation on his chest and back. On the reporting date, he had the irritation under both of his arms. The patient claimed that the irritation was more extensive on the reporting date and the issue was still unresolved. The patient had consented to follow up. The patient had provided contact details of the nurse.
Started with severe muscle cramps and progressed to fevers, chills, wheezing, cough, weakness, fatigue lasting 3+ weeks (still going on).
This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 67-year-old female patient who received SHINGRIX. Concurrent medical conditions included osteoporosis. Concomitant products included EFFEXOR, Levothyroxine, Probiotics, PROLIA and Vitamin D3. On 19th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 20th March 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness, pain in arm, swelling arm and general body pain. On an unknown date, the outcome of the tiredness, pain in arm, swelling arm and general body pain were not recovered/not resolved. It was unknown if the reporter considered the tiredness, pain in arm and general body pain to be related to SHINGRIX. Additional information was received as follows: On an unknown date, the patient planned to follow-up with her physician.
Numbness in her mouth and tongue; Numbness in her mouth and tongue; This is a spontaneous report from a Pfizer. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was experiencing numbness in her mouth and tongue after she received the first dose of Covid-19 Vaccine. Outcome of the events was unknown.  Information about Lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Developed tinnitus and a migraine the morning after the shot. I have never had migraines. On the day after second Moderna shot I had another migraine, the tinnitus seemed to worsen over time and is one-sided on the left and constant. I then had an MRI of brain and ear canal due to lack of history of above, and it was normal.  I have constant tinnitus and occasional migraines, both of which developed the day after the first shot.
Seizure; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient's grandmother). A 16-year-old female patient received bnt162b2 (Pfizer COVID vaccine), via an unspecified route of administration, administered in arm on 24Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included epilepsy from 2016 to an unknown date. There were no concomitant medications. The patient experienced seizure on 25Mar2021 03:00 with outcome of recovering. It was added that the patient did not have a seizure for 3 years and took her off after 2 years. She had not been on seizure medications for 4-5 years. She had been seizure free and had not been to her neurologist for 4-5 years. Epileptic but never had a seizure for the past 6 years. She is going back to the same doctor. She was diagnosed as being epileptic 5 years prior. Time the vaccination was given: 14:00-14:30. Her neurologist is informed not to get second dose. NO ER required. The patient went to the doctor. Last Friday, she had an EEG and results are unknown now. They have not had follow up appointment yet to get results. The patient underwent lab tests and procedures which included electroencephalogram: results are unknown on an unspecified date.   Information on the lot/batch number has been requested.
Patient stated pain about 1 hour after, starting to notice a swollen circle with warmth within a few hours swelling had extended further down her right arm. woke up sunday morning and top of right arm was fully swollen and worse than night before. proceeded to hospital
2 hrs. after receiving vaccines, pt. had a headache, vomited x 2, felt faint and phonophobia.