chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given COVID Bivalent instead of COVID monovalent. Patient had previously only received one COVID vaccine. Patient has not had any adverse reactions to vaccine.
Body aches/whole body is hurting; Running fever; Fatigued/tiredness; Arm hurting; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support. A contactable 40-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0198) via unspecified route of administration, on 12Jul2021 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 13Jul2021 at 7:30 AM, the patient woke up with body aches and arm was hurting, running fever, tiredness fatigue and pains. The patient wanted to know if she can take Naproxen (ALEVE) or Paracetamol (TYLENOL) or aspirin for the pain. The outcome of the events unknown.   Information on the lot/batch number has been requested. Additional information has been requested.
Sudden reoccurrence of polymyalgia rheumatica, which has frequently been shown to reoccur after exposure to a virus
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 13 patients who were vaccinated with FLUZONE QUADRIVALENT (lot number not reported) via unknown route in unknown administration site on an unknown date. It was reported that three or possibly four opened multi-dose vials of the vaccine were stored in two separate refrigerators. During a power outage, vaccines were exposed to a maximum temp of 59 degrees for 9 hours in one refrigerator and the second refrigerator reached a maximum temp of 62 degrees for 9 hours. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
sore arm-no big deal; violent chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An elderly female patient received bnt162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Lot number and expiration date not provided.), for covid-19 immunisation, reaction(s): "violent chills", "sore arm-no big deal". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm-no big deal"; CHILLS (non-serious), outcome "unknown", described as "violent chills".  Additional Information: She's had 5 previous Covid vaccines, and all of them have been from Pfizer. With the five previous vaccinations, she felt all of them go into her arm muscle. She has managed to get the vaccines and boosters, and managed to never get Covid and she doesn't want to start now. Usually she feels it go into her muscle and she gets a bit of a sore arm-no big deal. Then about twelve hours later on the money every time, she has gotten violent chills that last about another 12 hours or so.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322049 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322048 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300322023 Same reporter, Patient / Different AE, Vaccine Dose;US-PFIZER INC-202300318101 Same reporter, Patient / Different AE, Vaccine Dose;
3 hrs after shot, body aches, nausea, body chills, fever, headache for approximately 24 hours.
(translated fr Spanish by FV)mom states p/vax pt knee became red & swollen that afternoon;MD dx'd cellulitis & prescribed ATB;redness disappeared but swelling persisted & pt did not want to walk;orthopedist saw pt & ordered bone scan
anxiety; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety) and FATIGUE (fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced FATIGUE (fatigue). On 28-Apr-2021, the patient experienced ANXIETY (anxiety). On 11-May-2021, ANXIETY (anxiety) and FATIGUE (fatigue) outcome was unknown.            Concomitant medications are thyroid medication, cholesterol medication,allergy medication. No treatment medication details was reported.    This case was linked to MOD-2021-081773 (Patient Link).
After getting my J&J booster shot, I had quite a bit of fatigue. By the 4th day, most of my symptoms were gone except extreme fatigue in the mornings which would dissipate after eating. While my blood sugar has been normal in the past, I took it to see if the fatigue was related to blood sugar problems. In the two days I have taken it, it has been 115 and 117 fasting and changes little after eating. However, the fatigue lifts after eating.
Onset of chest pain armed 8pm eve of 11/2, around 1am 11/3 developed shortness of breath. Went to ER-cardio work up, observed for 12 hrs. Dx with possible arthritis rxn related to flu vaccine, cardiac workup negative, placed on antiinflammatory meds.
Rash developed all over (big red blotches) immediately, then became SOB about 30 seconds later, then passed out, eyes rolled back per mom, then episode lasted less than 5 min.  The patient was acting normal after.  No further problems, Nebulizer treatment was given for SOB.
Chills, Fever  & Headache. Symptoms went away within 24 hours without any treatment.
Faint after MENOMUNE injection. EMS called BP 120/80 decreased respiration at time of fainting. EMS arrival, BP stable, patient alert and oriented X 3. Patient resting for 20-30 minutes, left on own with sister. Instructed to go to ER if worse. Left message for doctor.
I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure; I have Friends that got the shingles shot 11 of them now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have Friends that got the shingles shot 11 of them now have shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via  interactive digital media. The patient got shingles shot and now he/she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This was 1 of 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter
Passing extremely large clumps/clots of blood multiple times per day.; Excessive menstrual bleeding for nearly 30 days post second vaccination shot/ Bleeding is ongoing; first dose 24May2021 and second dose 24May2021; first dose 24May2021 and second dose 24May2021; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 24May2021 14:15 (at the age of 14-year-old) as dose 2, single; dose 1 via an unspecified route of administration, administered in arm left on 24May2021 14:15 (Batch/Lot Number: EW0173) as dose 1, single, both doses for COVID-19 immunization. Medical history included allergy to peanuts, hazelnuts, soy, almonds, coconut. No concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced passing extremely large clumps/clots of blood multiple times per day, excessive menstrual bleeding for nearly 30 days post second vaccination shot/ bleeding was ongoing on 23Jun2021. Clinical course: Excessive menstrual bleeding for nearly 30 days post second vaccination shot, currently passing extremely large clumps/clots of blood multiple times per day. Bleeding was ongoing since 23Jun2021. The patient received hormones to stop bleeding as a treatment medication for the events. The reporter assessed the events as non-serious. Outcome of the events was not recovered and outcome of other events was unknown.
lt arm swelling, 2 days of parasthesia in all 5 digits & palmar aspect lt hand, & subjective weakness in lt arm/shoulder;
Receive Flu (Influenza) & 3rd HPV, at home developed mask like rash, erythematous on entire face. No fever or other systemic signs.
Fever, severe body ache, muscle pain, headache on the next day after J&J Vaccine, back pain developed afterwards within a month. Menstrual disorder bleeding almost daily since May 2021, some periods of heavy bleeding with large volume of clots; back pain and muscle ache since then. Leg tingling and pain started in August last month and developed  swelling in both lower legs (left was worse than the right) on August 24th Emergency Department, including  brushing on leg, foot, toe and both hands. P.S. I am living out of state now and in the process of seeking for consultation/evaluation.
swelling in her face; redness in both of her cheeks / redness in the left arm all the way down passed her elbow; sinuses; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling in her face), ERYTHEMA (redness in both of her cheeks / redness in the left arm all the way down passed her elbow) and SINUS DISORDER (sinuses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, LEVOTHYROXINE, AMITRIPTYLINE, METFORMIN, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MAGNESIUM, VITAMIN D NOS and POTASSIUM (POTASIUM M) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced SWELLING FACE (swelling in her face), ERYTHEMA (redness in both of her cheeks / redness in the left arm all the way down passed her elbow) and SINUS DISORDER (sinuses). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Jan-2021 for Adverse event, at a dose of UNK dosage form and PREDNISONE on 11-Jan-2021 for Sinus disorder NOS, at a dose of UNK dosage form. At the time of the report, SWELLING FACE (swelling in her face), ERYTHEMA (redness in both of her cheeks / redness in the left arm all the way down passed her elbow) and SINUS DISORDER (sinuses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included asthma inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: on 8 JUN 2021 follow up received contain no new information. Patient stated she was  doing fine and doesn't want any further FUs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Admitted with cellulitis which developed into septic shock.  COVID was + but not a factor in the current illness.
None. This was given during a clinic for people working in flood waters. Full charts weren't available. No adverse event occurred - out of licensed age range.
No other adverse effects; patient received one dose each of PROQUAD and VARIVAX/ both vaccines administered on the same day; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.   On 04-DEC-2019, the patient was vaccinated with one dose each of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (dose number and route were unknown; Lot # S021325, expiration date 05-JAN-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose number and route were unknown; Lot # S002392, expiration date 23-JAN-2021) for prophylaxis (inappropriate schedule of product administration). No other adverse effects were reported in the patient.
Arm sore, slightly red on 11/19/12 pm. After lunch on 11/20/12 redness increased & area increased swelling.
Narrative:  Patient was seen in his home on 8/2/2021 as part of care program. Patient was afebrile with normal HR, BP, RR and temperature on the day of vaccination. COVID vaccine (Moderna) was administered. Pt seen in his home on 8/3/2021 by RN as pt was dyspneic. RN arrived and pt was febrile (100.4F), tachycardic (HR 100), tachypneic (RR 36) with decreased breath sounds. RN called squad who took patient to Medical Center where he was diagnosed with acute PE.
First night I experienced bad nausea. The next day I developed extreme tiredness, weakness, muscle aches, headache, shivering, fever (101 degrees), and swelling and redness on my arm. The red spot on my arm is about 4 inches by 2 inches and is hot to the touch. I am now at 54 hours post-vaccine and still feel lousy.
After the Moderna vaccination I experienced dizziness and was referred to The Cardiologist and it was discovered that an aortic valve needed to be replaced. I had open hart surgery 11/17/2022.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 07-MAY-2019, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R020949 and expiry date 04-MAY-2021) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005070: US-009507513-1905USA005068: US-009507513-1905USA005069:
Patient did not experience adverse events. Patient was administered Comirnaty for 12 years+ when patient is 11 years of age.
Was Bleeding; had a horrible crazy accident; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Was Bleeding) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Flu shot.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced HAEMORRHAGE (Was Bleeding) (seriousness criteria disability and medically significant) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) (seriousness criterion disability). At the time of the report, HAEMORRHAGE (Was Bleeding) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) outcome was unknown.      Relevant concomitant product usage were not reported by the reporter.  He is disabled and had a horrible crazy accident on Friday, he was bleeding and at the emergency room they put staples on his head.   Patient was taken to ER and treatment included Staples on head.  Company Comment: This case concerns an elderly male who experienced serious unexpected event of bleeding and road traffic accident on unknown date after receiving both doses of the vaccine. No relevant medical history. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns an elderly male who experienced serious unexpected event of bleeding and road traffic accident on unknown date after receiving both doses of the vaccine. No relevant medical history. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-OCT-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JUN-2014, the patient was treated at a clinic for a blistering vesicular outbreak that was diagnosed as shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On an unknown date, the patient experienced CHILLS (chills), PAIN IN EXTREMITY (aches), INFLUENZA LIKE ILLNESS (felt like with flu), PYREXIA (fever 101) and PAIN IN EXTREMITY (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), CHILLS (chills), PAIN IN EXTREMITY (aches), INFLUENZA LIKE ILLNESS (felt like with flu), PYREXIA (fever 101) and PAIN IN EXTREMITY (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: elevated (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports taking High Blood Pressure medication (NOS), Cholesterol medication (NOS) and Diuretic medication (NOS).     This case was linked to MOD-2021-031372 (Patient Link).
slightly itchy; Red area has expanded to about 3 - 3.5 inches; Warm to the touch; redness suddenly appeared at the injection site; Sore; Tired; Chills; Nauseous; Hot and cold chills; arm swelled (hard bump); tired; Joint pain; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (slightly itchy), NAUSEA (Nauseous) and CHILLS (Hot and cold chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS, ESTROGENS CONJUGATED (PREMARIN), DOXYCYCLINE, OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nauseous), CHILLS (Hot and cold chills), VACCINATION SITE SWELLING (arm swelled (hard bump)), FATIGUE (tired) and ARTHRALGIA (Joint pain). On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE ERYTHEMA (redness suddenly appeared at the injection site), VACCINATION SITE PAIN (Sore), FATIGUE (Tired) and CHILLS (Chills). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (slightly itchy) and VACCINATION SITE ERYTHEMA (Red area has expanded to about 3 - 3.5 inches). On 15-Jan-2021, DIZZINESS (Dizzy), NAUSEA (Nauseous), CHILLS (Hot and cold chills), VACCINATION SITE SWELLING (arm swelled (hard bump)), FATIGUE (tired) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PRURITUS (slightly itchy), VACCINATION SITE ERYTHEMA (redness suddenly appeared at the injection site), VACCINATION SITE PAIN (Sore), FATIGUE (Tired), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red area has expanded to about 3 - 3.5 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.