chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 & 5 Moderna; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EM6199), on 26Mar2021 as dose 2, single (Lot number: EERB732) and on 29Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 73 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24May2022 at 16:00 as dose 4 (booster), single (Lot number: 059M21A), in right arm and on 01Oct2022 at 17:00 as dose 5 (booster), single (Lot number: 055F22B), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown", described as "Dose Number: 4 & 5 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
I had headache, sore throat, cough and fatigue. It only lasted for a few day. On Jan 15th, I tested positive for COVID-19.
No Adverse event; patients received the vaccines after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date).    No concomitant medications were reported.  It was reported that, the patient received a bivalent Moderna COVID-19 vaccine after the 30-day beyond use by date of 12-Dec-2022 from 13-Dec-2022 to 17-Dec-2022.  No treatment medications were reported.  This case contains information for the 9th of 10 patients described by the reporter.
17JAN2023 constant cough, scratchy throat, lightheaded, chills. After I got back from lunch I was told I looked worse and got off my feet until end of work. 18JAN2023 I didn't feel any better. I went to manager and was told I might have COVID-19.
1st dose 4-5 years ago, 2nd not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 to 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 4-5 years ago, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-APR-2023 The pharmacist reported that a patient never received the second dose of Shingrix.   The dose was given at a different pharmacy, and the exact date of administration, as well as lot number or expiration date information was unknown.   At the time of reporting, the second dose was planned to be administered on 6th April 2023, but had not yet been given. Reporting stated she was a floating pharmacist and might not be at that location for safety follow-up, but she would let the other staff know of possible follow-up by safety. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
Information has been received from a female respiratory therapist who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009. Over the weekend after receiving the vaccine the patient experienced fever, ache and pain and redness. The symptoms had been lasting about 24-48 hours. The patient sought medical attention by telephone. At the time on the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. A standard lot check investigation was performed. All in-process quality checks for lot number 659922/1667U were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of four reports from the same source.  Additional information has been requested.
Fever, chills, weakness, muscle aches for 2 days Possible yeast infection  Some intestinal upset 2 days after
Approxiamtely three mins after patient received the MCV4 (Menquadfi) vaccine he c/o of feeling dizzy. At that time we propped his feet up in the chair, placed cool cloths on neck and face and turned on a cool fan. BP was check @2:29pm. 85/47 P-68. Patient was given a soda and some peanut butter crackers. Patients BP was checked again @2:32pm 96/57 P-64. BP was checked again @2:35pm 102/60 P-68. After 10 mins, patient stated that he was feeling better. No longer experiencing any dizziness. Advised grandmother to wait in the lobby an additional 15 mins for patient to be monitored and after that he can go. Also advised gandmother to get patient something to eat when they leave as patient stated that he had not had anything to eat all day.
Vitals : heart rate 140?s after reaction noted. After taken to ED for assessment- Temp 36.7, RR 16, Pulse 92-96, BP 115/68 and 104/66. SpO2 99-100% on room air Reaction: pale, lightheaded, said she felt like she ?was in a tunnel? after receiving vaccine, but felt better by the time she got to ED.  Impression from provider: ?Acute Vasovagal response to injection?
Headache, severe body aches, nausea, fever, cold chills, hot chills, and very fatigue over a 4 day period.
This spontaneous report as received from a registered nurse refers to a 20 month old patient of unknown gender. No medical history and drug reactions or allergies were reported. On an unknown day in August 2014, at 13 months of age, the patient was vaccinated with a dose of VARIVAX (dose, lot number and expiration date were not reported) and with MMR II (dose, lot number and expiration date were not reported). No concomitant medications were reported. The nurse stated that the Centers for Disease Control and Prevention (CDC) considered a low dose therapy of corticosteroids. The patient had started and completed a 9 day tapering dose of prednisolone (manufacturer unknown) (dose and frequency were not reported) for an unspecified reason 14 days after receiving VARIVAX and MMR II doses. In March 2015, the patient had a negative titer result for varicella immunity at 20 months of age. The outcome of antibody test negative and adverse event was unknown. The relatedness between antibody test negative and adverse event was not reported. Additional information has been requested.
Patient tested for COVID during routine admission testing for semi-private room which resulted detected.  No s/s of COVID.  Patient admitted for Hypertension.  Patient had previous infection 01/19/2021.
This initial spontaneous report was received from a nurse (medical assistant) referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 10-FEB-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) injection (lot # K007451 with expiration date 21-NOV-2015; dose, route and albumin status were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Pt. developed large red area around injection site -MOC describes as the size of a tennis ball.
sore arm, swelling/"knot" at injection stie; this has resolved. But still experiencing pain/limited range of motion 3 weeks post vaccine Narrative:  pain and limited ROM of arm; she is seeking care through her pcp; xray of her arm has been ordered by her pcp
"I was told I have arthritis, osteoarthritis and I never had all that before."; "I was told I have arthritis, osteoarthritis and I never had all that before."; " I had so much pain in my hips and groins"; "shoulder pain."; "I could barely walk."; "aches and pains"; "I still have a hurting feeling in the left arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm"), ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before.") and MOBILITY DECREASED ("I could barely walk.") in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm") and MOBILITY DECREASED ("I could barely walk."). On an unknown date, the patient experienced ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), PAIN (" I had so much pain in my hips and groins") and ARTHRALGIA ("shoulder pain."). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm"), ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), MOBILITY DECREASED ("I could barely walk."), PAIN (" I had so much pain in my hips and groins") and ARTHRALGIA ("shoulder pain.") outcome was unknown. Not Provided
No symptoms reported. No additional AE; Staff calling on behalf of a medical assistant.  Per employee, medical assistant had an 18 month old female patient come in to the HCP's office today and the provider wanted to administer the second dose of VAQTA, 2 days prior to being the full; This spontaneous report was received from a medical assistant, referring to a 18-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-OCT-2023, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis, 2 days prior to being the full 6 months from the first dose (inappropriate schedule of product administration). The reporter consulted with the provider and the provider stated that there was a 4-day cushion window between the doses and that it was still a valid dose. Medical assistant was uncomfortable to administer it, but administered the vaccine and the immunization registry accepted it as a valid dose. No symptoms reported. No additional adverse event (AE).
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 13:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High blood pressure and cholesterol" (unspecified if ongoing); "High blood pressure and cholesterol" (unspecified if ongoing); "recently diagnosed with diabetes" (unspecified if ongoing); "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19. Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN. The following information was reported: ALOPECIA (medically significant) with onset 20Jan2022 13:15, outcome "not recovered", described as "As with contacting Covid in Nov2020, 6 months after receiving Covid vaccination, I've experienced significant hair loss 6 months after the vaccine". Therapeutic measures were not taken as a result of alopecia. Clinical Course: Prior to vaccination, patient was diagnosed with COVID-19. She was experienced significant hair loss and an still continuing to lose hair. Her hair was at approximately half the volume as it was prior to the vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt had 5 yr check up 2/23/15. Seen in ofc 3/6/15 for stye. Guillain-Barre diagnosed 3/11 - 3/12/15.
Sore arm at injection site; lethargic; Decreased appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FK5618) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Nov2021, outcome "recovering", described as "Sore arm at injection site"; LETHARGY (non-serious) with onset 12Nov2021, outcome "recovering", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 12Nov2021, outcome "recovering", described as "Decreased appetite". Therapeutic measures were taken as a result of vaccination site pain, lethargy, decreased appetite.  Additional Information: Seriousness criteria not Results in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drugstore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No covid prior vaccination was reported. Patient not tested covid post vaccination. No known allergies were reported. Treatment received for the adverse event was with motrin. Awareness Date was and device timestamp was reported as 12Nov2021.  No follow-up attempts are possible. No further information is expected.
He got his vaccine, he had a sore arm, moderately sore, and it came the next day and lasted for 2 days.  He had just had his face injected on 12/23/20 with Bellafil facial injection filler and the filler itself disappeared.  He has had this filler many times prior and this had never happened to it.  It was noticeable at the time of the vaccine, but started disappearing a couple days after the vaccine, but did really notice it within a week, and within 2-3 weeks it was like he had never had it.  The filler is guaranteed for 5 years and did not last but a few weeks.    He notified the people regarding the filler and they said that they had never had that reported before, and asked them to replace it, which they would not do so.  He had to wait a year and 3 months to have it readministered.  It did last at that time.    He did have subsequent COVID vaccines and did not have any problems with the facial fillings after the first one.  He has had 6 subsequent COVID vaccines with no reactions.  He had all Moderna vaccines up until the last one which was a Pfizer, in 10/23.
Pain that felt like a muscle spasm initially and progressed from left of spine in upper back to around ribs to under arm and across chest, including numbness and itching , progressed to a few red, non-draining lesions noted on the chest and back along the painful areas.  Progression of pain led to an urgent care visit on 2/10/21 at which Shingles was diagnosed and Valtrex, muscle relaxer, and lidocaine gel were ordered for the lesions that were noted.
SORE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, the batch number will not be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and mild headache was not reported. This report was non-serious.
My husband and I were visiting friends. They had a started feeling like they had a scratchy throat but thought it was allergies. It wasn't until the third day that we tested for COVID-19 and theirs came back positive. We drove back home to immediately. I tested again once I got home with a home COVID-19 test it wasn't until the second day that we were back home that I tested positive. I called my doctor, discussed my symptoms, received a prescription for Paxlovid and am on day four. I have very mild symptoms, I feel like I have had a very mild cold.
Information has been received from a certificated medical assistant concerning a male patient whose 12 year old male brother on 28-JUN-2010 at 11:30 am was vaccinated with the second dose of VARIVAX (Merck) (lot # 665575/1229Y, in the left deltoid) IM. His brother's concomitant therapy included the first dose of MENACTRA (unspecified, sanofi, lot # U3465AA, IM) in the right deltoid and the sixth dose of BOOSTRIX (lot # AC52B061EA, IM) in the left deltoid on 28-JUN-2010 at 11:30 am. On 26-JUN-2010 the patient had rash. He and his brother were both in hot tub during the previous week. The outcome was not reported. Additional information is not expected. The patient's brother's information has been captured in WAES # 1006USA04371.
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
On 12/29/18  patient reported muscle weakness and pain. Patient was diagnosed with influenza 12/28/19 at an urgent care facility. Pain and weakness thought to be from active influenza infection at time of reporting. On 2/4/19 patient states arm is still sore and visited PCP.
The nurse administered 0.5ml of TD (lot TD-92, expiration date 10/28/2004) vaccine to a patient intradermally (left forearm), instead of administering PPD, on 07/16/2004.  The patient came back on Monday, 07/19/2004, for the follow up appointment.  The reaction site was pink to red, 35mm across and 45mm up/down.  The patient developed the adverse reaction on Saturday, 07/17/2004, patient told the doctor that her arm was itchy and she was taking Tylenol over the weekend.  The patient felt much better on Monday, 07/19/2004.
Hives beginning on left thigh near Kinrix vac site, spreading to both cheeks, right thigh and left arm.  Given 15mg diphenhydramine PO, hives diminished. Patient was up to date with CDC vaccine schedule - this was the first time she had ever received a ProQuad or Kinrix.
I developed tinnitus and that what the first symptoms I noticed and my PCP sent me to a ENT doctor. The ENT confirmed that I was not hearing all that well in that ear and told me that there was not much they could do about it.
Subsequently the pt experienced a case of breakthrough chickenpox with and unspecified number of lesions. The pt sought medical attention.
I had a lemon/orange size raised area raised about 2/3/ inches on my arm around site ewhere had hot. It hurt and had pain under my left arm pit. Lasted about 2 weeks before gone and pain subsided. Still have pain in that area when I rub my hands over area where given shot. Swelling has all gone away.
Initial report received on Dec 20 2005 from the patients parent. A 13 year old male patient with a history of Angelman's syndrome diagnosed at age two and seizures received an injection of Fluzone SV 2005-2006, lot number unknown, route and site of administration unknown, on Nov 16 2005. Illness at the time of vaccination was none. Per the reporter, the patient seizure activity had been controlled with medications, and his last seizure had occurred in March 2005. On Nov 22 2005, seizure activity began and gradually worsened. He experienced three seizures on that day. The parent administered Diastat, and the seizure activity stopped. On Nov 24 2005, the patient had two seizures. An ear infection was suspected, and the patient was prescribed Amoxicillin. Examination by the patients physician on Nov 26 2005, following two additional seizures, revealed no ear infections. On Dec 2 2005, the patient was examined in an ER after having continued seizure activity. he was administered Dilantin and admitted to the hospital. Total number of seizures on that day were 18. Additional medications used in treatment were Depakote, Topamax, Klonopin and Zarontin. Per the reporter, a videography test determined that the patient had continuous seizures from Dec 6 2005 to Dec 7 2005. At the time of this report, the patient remained hospitalized and had not recovered.
Pt states one hour after the shot, my arm started itching. Then it started getting red and swelling. It hurts when I use my arm. Keflex and Benadryl.
Information has been received from a nurse (clinic coordinator) concerning unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients received doses of improperly stored ROTATEQ (lot #L044476 with expiration date 07-SEP-2017, dose and route were not reported). The doses of ROTATEQ underwent temperature excursions at 34.8 F for 6 hour 25 minutes and 14.6 F for 5 hours 45 minutes respectively. Previous temperature excursion was as followings: 47 F for 45 min, 48 F for 45 min, 49 F for 30 min, 50 F for 45 min and 50 F for 3 hour 15 min. Data logger was involved. Product quality complaint (PQC) was not involved. This is one of several reports from the same source. Additional information has been requested.
08/10/2013 Moderate Other. Pt's father asked about serious RXN and denied at time of administration once syncope occurred. Pt's father stated that he had a similar RXN to first HPV vaccine. EMS responded to RXN and assisted pt.