chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
SYMPTOMS: RASH ON LEFT ARM AND LEFT SIDE OF NECK IT COMES AND GOES. STINGING FEELING ALL OVER BODY WHEN I HURRY TO DO SOMETHING OR DO PHYSICAL TRAINING. LUMPS AROUND MY TESTICLES. LACK OF SEX DRIVE. FATIGUE AND MOOD SWINGS.
indurated red swollen warm area @ site of inj lasted 5 days then resolved;extended from shoulder to elbow for 2-3 days;
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with PEDVAXHIB (lot# was not reported). Nurse reported that the patient received PEDVAXHIB, improperly stored in a plastic syringe, exposed to 36F to 45F for a maximum of 24 hours. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a several unspecified patients of unknown age. On 21-MAY-2014, several patients received M-M-R II (lot # J006955, expiration date: 07-JUN-2015) 0.5 ml, subcutaneous. They received M-M-R II post not support excursion date 21-MAY-2014 (dose stored at 17 Celsius degree for 21.5 hours). No patients have expressed any adverse effects. None of patients sought medical attention. Additional information has been requested.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant product use was not provided by the reporter.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  Treatment information was not provided.  This case contains information for the 58th patient out of 190 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
1 cc and a half [dose]; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (1 cc and a half [dose]) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1.5 ml. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (1 cc and a half [dose]). At the time of the report, ACCIDENTAL OVERDOSE (1 cc and a half [dose]) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Medical history and age was added.
On 10/24 - Right arm became swollen, then on 10/25 - her arm was red and warm to the touch which spread downward. BENADRYL was given which improved the symptoms. By 10/27 the symptoms had resolved.
No Adverse Event; 5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration 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. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Dec-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. On 30-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        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 (5 Adult Patients received expired Booster of Moderna COVID-19 vaccines on 30DEC2022 beyond MFG Expiration Date).    No concomitant medication information provided. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was 30-Dec-2022.  The vial did not undergo any temperature excursions. No treatment information provided. This case contains information for the 1st of 5 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-695101, US-MODERNATX, INC.-MOD-2023-695127, US-MODERNATX, INC.-MOD-2023-695166, US-MODERNATX, INC.-MOD-2023-695188 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695166:4 of 5 adult patient US-MODERNATX, INC.-MOD-2023-695188:5 of 5 adult patient US-MODERNATX, INC.-MOD-2023-695101:2 of 5 adult patient US-MODERNATX, INC.-MOD-2023-695127:3 of 5 adult patient
Shoulder pain around injection site, starting approx 11/22/15 still sore on 12/2/15.
Covid 19 Pedi Pfizer vaccine was administered to a 9 year old patient after dilution time was expired. Vaccine was opened on Friday morning at 10:08 am and given on Monday afternoon at around 4:30pm.
6FEB97 rapid fever, febrile sz, so evaluated w/CBC/LP/head Ct -nl;no source of infect;hosp x 24hr;
Patient admitted to hospital with respiratory failure due to hypoxia, bilateral PE and LLE DVT.
Expired Fluzone QIV was administered to 4 patients, no AE; The patients received 5 ml of vaccine, no AE; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involves 4 patients (unknown demographics) who were administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered and overdose).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a 5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, Suspension for injection) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used and overdose (latency same day).  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 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.  There will ne no information available on batch number for this case.
Significant bruise that appeared soon after injection and still significant almost two weeks later; red bumpy blotch that feels hot to the touch, sore arm almost two weeks after shot; injection site now itching
Increased sleep day of vaccines and next day (24 hours), then extremely irritable and inconsolable for 24 hours with only 30 minutes of sleep in 24 hours. Admitted for spinal tap and sepsis evaluation. Improved immediately after spinal tap per parents.
cannot swallow; her throat is killing her; allergic reaction; swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (cannot swallow), OROPHARYNGEAL PAIN (her throat is killing her), HYPERSENSITIVITY (allergic reaction) and LYMPHADENOPATHY (swollen glands) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced DYSPHAGIA (cannot swallow), OROPHARYNGEAL PAIN (her throat is killing her), HYPERSENSITIVITY (allergic reaction) and LYMPHADENOPATHY (swollen glands). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 UNK. At the time of the report, DYSPHAGIA (cannot swallow), OROPHARYNGEAL PAIN (her throat is killing her), HYPERSENSITIVITY (allergic reaction) and LYMPHADENOPATHY (swollen glands) outcome was unknown.            Concomitant medication was not provided.
This case was reported by a other health professional and described the occurrence of inappropriate age at vacine administration in a 13-month-old patient who received FLUARIX QIV. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receivng FLUARIX, the patient experienced inapprorpiate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: FLUARIX QIV was given to a 13 months old.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient came in today to inform of us about one rash that appeared on the upper arm two days after the vaccination. Patient followed up with urgent care MD today and was given topical steroid ( as per patient)
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Scheduled for additional dose of Moderna due to being immunocompromised/on long term immunosuppression therapy. A full dose was needed, but half dose was given..
This spontaneous report was received from the patient's son, who was also the physician via a company representative and refers to a female patient of an unknown age. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis reported as prevention of shingles. After two months of the vaccination, at an unknown date, the patient experienced a "shingles outbreak". At the time of reporting, it was unknown whether the patient recovered or not from the adverse event. The causal relationship between the adverse event and the therapy with ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
pt recv vax JUL95 & MAY97 pt devel a rash;
About 4 hours after, went to walk my dog. Felt dizzy and leaned in elevator, passed out and woke up to my dog licking Me. Could not see clear enough to call my roommate, could not hear, and could not walk major loss of mobility. Lasted about 3-4 minutes and then called doctor who said go to ER
Patient came to ED with increased chest congestion, shortness of breath, cough, and generalized weakness.  Patient was admitted to the hospital and treated with remdesivir.
Hematochezia - Child exclusively breastfed. First dose ROTATEQ administered 10/6/17 and onset hematochezia 10/16/17 initially thought to be sensitivity to mom's diet. Mom's diet restricted (even though allergy testing revealed no obvious allergy, only slight sensitivity to cow's milk) and bloody stools resolved. Second dose ROTATEQ administered 12/5/17 and hematochezia returned 12/6/17 without any change to mom's diet.
Information has been received fro a physician's assistant concerning a 24 year old female, with a penicillin allergy and no medical history, who on 03-JAN-2007 was vaccinated with a first 1 ml intramuscular dose of Recombivax HB (Lot# 653391/0186F). There was no concomitant medication. On 03-JAN-2007 about 45 minutes after vaccination with Recombivax, the patient developed nausea and abdominal cramping. The patient vomited twice and had diarrhea. No treatment was given. After several hours of rest the patient seemed to be recovering. There were no laboratory or diagnostic tests performed. Unspecified medial attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient has had extreme nausea since getting her second dose.  Said she has been gagging frequently.  Patient reported adverse event to the pharmacy on 8/21/21.  I suggested she see her PCP.
Headache, Myalgia, Fever, NauseaVomiting, menstruation, fatigue Narrative: Employee reports within 4 hours after receiving the second dose of the vaccine, they began experiencing injection site pain/discomfort. Reports did not see a doctor did not take any medications, and has fully recovered.
BRIEF GENERALIZED SEIZURE AFTER DTP AND ORAL POLIO VACCINE #1. SPONTANEOUS RECOVERY. PT PRESENTLY WELL.
REDNESS, ITCHING AND SWELLING AT THE SITE OF INJECTION WHICH RESOLVED AFTER 2-3 DAYS.
This spontaneous case reported by a consumer, describes the occurrence of decreased appetite (loss of appetite), pain (body aches), pyrexia (fever) and chills in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031M20A and 039A21A) for COVID-19 immunization. Concomitant products included vitamins (NOS) for an unknown indication. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Apr 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced decreased appetite (loss of appetite), pain (body aches), pyrexia (fever) and chills. At the time of the report, decreased appetite (loss of appetite), pain (body aches), pyrexia (fever) and chills outcome: unknown.
Inconsolable crying, abnormal behavior, staring episodes, irritability, decreased smiling/ change in affect, fever last 3-4 days. Worse second day.
PENNY-SIZED SOLID RED CIRCLES UP LEFT AND RIGHT SIDE OF BODY AND ON FLANK AREA. NO ITCHING OR PAIN ASSOCIATED. PATIENT MENTIONED THAT HE WORKS OUTSIDE FREQUENTLY AND THE REACTION COULD BE ASSOCIATED WITH THAT.
pt hospitalized 9/20/07-9/25/07 for RLQ pain, developed right T12 HZV rash on 9/27/07-tx'd with Acyclovir 1gm q 8 hr x 7d. Dx. Herpes zoster. 10/5/07 Reviewed hospital medical records which reveal patient experienced right sided abdominal pain & difficulty sleeping 9/19 while out of town.  Saw pcp on 9/20 & admitted 9/20-9/25/2007.  Urinary catheter inserted w/large residual.  Tx w/oral antibiotics.  Abdominal pain resolved.  FINAL DX: acute abdominal pain of unknown etiology; bladder outlet obstruction; hyponatremia. 11/9/07 Received pcp medical records which included vax record.  Confirms lot # as reported.  Seen s/p hospitalization on 9/26 & had developed right T12 HXV rash evening before with pain.  Tx w/antiviral & pain med.  Returned to pcp 10/3 still having pain.  Tx w/neurontin.  Returned to pcp 10/11.  Pain improved w/neurontin & pain med & was to start tapering both off as tolerated.  Returned to pcp  10/31 w/increased pain & med increased. FINAL DX: Zoster infection w/post herpetic pain. Per 60 day follow up: R thoracic post herpetic neuritis. 1/12/2010 Right lumbar postherpetic neurolgia on gabapentin.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 19:15 as dose 1, single (Lot number: EL9262), in left arm and on 02Mar2021 at 16:15 as dose 2, single (Lot number: EN6198) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "crohns" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "dry eye" (unspecified if ongoing). Concomitant medication(s) included: PRESERVISION, start date: Jan2009; SIMVASTIN, start date: Jan2007. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Antiviral details Product-COVID 19 Treatment, Treatment start date-29May2022, Treatment stop date-10Jun2022, Indication-Treatment of COVID-19. Other medication details, Other medication in 2 weeks product-Prednisone, Other medication in 2 weeks start date-21Apr2022, Other medication in 2 weeks stop date-03Jun2022, Other medication in 2 weeks product-B-100 Complex, Other medication in 2 weeks brand-Nature Made, Other medication in 2 weeks product-Triamterene/HCTZ, Other medication in 2 weeks product-Caltrate 600 +D, Other medication in 2 weeks product-fenofibrate 48mg. Adverse event runny nose, plugged ear off and on, hoarse voice, minor throat scratch. Adverse events start date 10Jun2022, Adverse event start time 07:45 AM. If patient recovered Not recovered, If treatment ae no.  No follow-up attempts are needed. No further information is expected.
it feels like arthritis; ARM IS SORE; Arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (ARM IS SORE), VACCINATION SITE SWELLING (Arm swelling) and VACCINATION COMPLICATION (it feels like arthritis) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (ARM IS SORE) and VACCINATION SITE SWELLING (Arm swelling). On an unknown date, the patient experienced VACCINATION COMPLICATION (it feels like arthritis). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (ARM IS SORE), VACCINATION SITE SWELLING (Arm swelling) and VACCINATION COMPLICATION (it feels like arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.
Patient received a lower dose than what is recommended for dose 2 in a primary COVID vaccine series.  She received the Moderna Bivalent Booster vaccine for 6mon-5yrs, which is a lower dose than the Moderna Bivalent vaccine for 6mon and older (Primary series).  Therefore, patient received a lower dose than recommended.
About 3 hours after the injection I started to develop upper Left arm and shoulder pain. Later that night I couldn?t lift my arm without terrible pain. I was unable to sleep despite taking Advil 800mg and heat and ice. The next day 1/7 wasn?t any better. On 1/8 I woke up and noticed the left shoulder area was red and warm to the touch. A little over 2 inches in diameter. I went to my Dr office and they diagnosed cellulitis and prescribed Keflex 500mg  3 times a day. I just took the first dose on 1/8/2021 at 2:45pm.