chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terribly itching rash with large, red bumps after first dose; Patient he had a rash developed and after his second dose he also had the rash develop again; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again) and VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose). At the time of the report, VACCINATION SITE RASH (Patient he had a rash developed and after his second dose he also had the rash develop again) and VACCINATION SITE ERYTHEMA (terribly itching rash with large, red bumps after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
C/O dizziness, dry mouth, sweating, and vomited X T. C/O blood shot eyes today. Two days late,r pt c/o headache x 4 days but now resolved. Pt states above symptoms resolved but states "not feeling my normal good self."
No symptoms reported no other AE; received dose of VARIVAX on 7/30/2021 and again on 9/14/2021; received dose of VARIVAX on 7/30/2021 and again on 9/14/2021; This spontaneous report was received from a nurse referring to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 30-JUL-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot# T029533 with an expiration date on 01-SEP-2022) at a dose of 0.5 milliliters subcutaneously for prophylaxis and on 14-SEP-2021, the patient received the second dose of the vaccine at a dose of 0.5  milliliters subcutaneously (schedule of product administration and product administered to patient of inappropriate age). Strength and anatomical location were not reported for the doses.   No symptoms were reported and no adverse event as well.
received a vaccine past the 30 day storage on the refrigerator; Maternal exposure during pregnancy; doses administered after 30-day Use By Date; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date), PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies.  Concurrent medical conditions included Pregnant. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Apr-2022 at 9:29 AM, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator). On 06-Apr-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (received a vaccine past the 30 day storage on the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. The vial was initially stored in the refrigerator on 25-Feb-2022. The vial was not undergone any temperature excursion.  Company comment: This is an spontaneous case of maternal exposure during pregnancy for a 30-year-old female patient, with no medical history reported, who experienced the non-serious unexpected events of Expired product administered and product storage error, after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is an spontaneous case of maternal exposure during pregnancy for a 30-year-old female patient, with no medical history reported, who experienced the non-serious unexpected events of Expired product administered and product storage error, after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported as unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The recent follow-up received on 08-JUN-2022 contains non significant information.
The subject is a 79 year old male who was found unresponsive by his wife while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted RSV Vaccine Versus An RSV Vaccine Adjuvanted Wtih Aluminum Phosphate When Administered Concomitantly With A Licensed Influenza Vaccine In High-Risk Adults > or = 65 Years Of Age, Protocol Number RSV11. The subject has received RSV vaccine or Placebo and Influenza vaccine twice with the last dose on 10/27/03. Date of first dose date was not reported. The subject was found unresponsive on 1/26/04 by his wife, 91 days post immunization. As per subject's wife, it appears that the subject went out to retrieve the mail, slipped on ice and fell. She found him unresponsive. Paramedics were unsuccessful in reviving him. He was transported to the hospital where treatment was continued but unsuccessful. Subject died on 1/26/04. The event was reported by the investigator as not related to the study vaccine. Myocardial infarction.
Disoriented, problems with balance (equilibrium was off), nauseous, fell against a wall. No tx sought. Lasted approx 36 hours
Shingles, Top of left shoulder up into hairline on left side of head, behind ear steriod injection and  antiboitic RX
Underage/ given Boostrix to patients as young as 7; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant stated that the physician informed her that the physician had given Boostrix to patients as young as 7, which led to inappropriate age at vaccine administration. The reporter consented to follow up. No further details available to Medical Assistant at the time of this call, but she consented to follow up via email.
pt recv 3 doses of Hep B vax & routine lab eval on 12JUL94 revealed a pos HBsAg w/pos anti-HBs; repeat lab eval on 20JUL94 revealed neg HBsAg; No further details were provided;
This spontaneous report as received from a other refers to unspecified number of patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis. No adverse event.; Sender's Comments: US-009507513-1708USA013504:Original Case : 1708USA013476 US-009507513-1708USA013505: Original Case: 1708USA013476 US-009507513-1708USA013503: Original Case : 1708USA013476.
Generalized weakness including angioedema since about 7-10 days, post vax, persistent to the present. Refractory to multiple medicines. Evenually fairly well controlled, but not resolved. Treated as idiopathic urticaria, but pt believes it is secondary to Fluzone.
Oct 6, went to Health clinic for a rash, prognosis contact dermatitis or shingles. Rash worsened and started prescription for Valtrex
coughing all through the night; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing all through the night) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A20A and 028L20A) for COVID-19 immunisation.     Concurrent medical conditions included Bronchitis (had cough and a sore throat) since 11-Mar-2021, Hypothyroidism since 2014 and Artificial sweetener intolerance (Aspartame). Concomitant products included PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE and ALBUTEROL [SALBUTAMOL] for Bronchitis, LEVOTHYROXINE SODIUM (SYNTHROID) from 2014 to an unknown date for Hypothyroidism.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (coughing all through the night). At the time of the report, COUGH (coughing all through the night) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 11-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative for PCR test.         Treatment information was not provided by the reporter. Action taken with mRNA-1273 in response to event was not applicable.   This case was linked to MOD-2021-044686 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Added patient details, relevant history. Added Vaccination facility information, concomitant drug and updated the outcome of event.
Developed severe pain and fever to 103.3F per pt report. On exam severe pain w/o redness, swelling, warmth at site of flu/PNEUMOVAX. Temp 99.9 po.
headache; Diarrhea; Nausea; kept falling in and out of sleep; talking continuously in her sleep; left arm was "on fire" and was red; sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore; "102 fever"; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), HEADACHE (headache) and MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Pain. Concomitant products included HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) for Pain, ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ESCITALOPRAM OXALATE (LEXAPRO), ALENDRONATE SODIUM (FOSAMAX OW), HYDROCHLOROTHIAZIDE, LABETALOL HYDROCHLORIDE (LABETALOL [LABETALOL HYDROCHLORIDE]), SPIRONOLACTONE (SPIRONOLACTONE A L), LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN D3, ALPRAZOLAM (XANAX SR) and ZOLPIDEM TARTRATE (AMBIEN CR) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore), PYREXIA ("102 fever"), CHILLS (chills) and FATIGUE (tired). On an unknown date, the patient experienced HEADACHE (headache), DIARRHEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), HEADACHE (headache), MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore), PYREXIA ("102 fever"), CHILLS (chills), FATIGUE (tired), DIARRHEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-294310 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Updated reporter address and new events diarrhea, nausea, and headache were added.
Swelling - redness, itching and burning at site. MD gave patient clindamycin - R/O cellulitis.
Injection Site Pain, Severe, 12/28-1/1, Self-Resolved Fever, 12/28-12/29, 100.5F, Self-Resolved Chills, 12/28-12/29, mild, Self-Resolved Headaches, 12/28-12/30, Severe, Self-Resolved Malaise, 12/28-12/30, Severe, Self-Resolved Myalgias, 12/28-12/30, Moderate, Self-Resolved Arthralgias, 12/28-12/30, Moderate, Self-Resolved Dizziness, 12/28-12/30, Mild, Self-Resolved Lymphadenopathy, 12/28-12/30, Mild, Self-Resolved
Patient developed fever, headache, body aches. Right side of face became painful and swollen. Gums swelled and developed white purulent spots. Patient went to ED and was admitted to hospital. IV steroids and antibiotics were administered. CBC, Culture, and CAT scan performed. Patient given narcotic pain meds and antibiotics and monitored.
Experienced a rash on the lower extremities; Had recently experienced a Shingles episode; decided not to receive the second dose until today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, shingles and incomplete course of vaccination. On an unknown date, the outcome of the rash, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported for the 1st dose. The age at the vaccination was not applicable for the 2nd dose. No patient or vaccine data was available. The patient experienced a rash on the lower extremities, after that decided not to receive the second dose until today when wanted to receive it but had recently (more than 2 years) experienced a Shingles episode. Till now patient didn't receive second dose of vaccine which led to incomplete course of vaccination. Consented to follow up.
Breakthrough case admission after 2 vaccines Moderna 5/14/21 Lot# 048B21A;  Moderna 8/9/21 Lot# 002B21A
A nurse reported a pt received vaccine on 3/9/00, he subsequently developed an injection site reaction characterized by a baseball size area of swelling, redness and tenderness.
Red swollen patches that began on left arm,  then appeared on elbow, wrist, neck, upper chest, under chin, left knee. Warm to the touch and very itchy.
I have had light spotting before my menstrual cycle every month since My vaccine which was given 8 months ago. My periods have been heavier and clotting and lasting longer. I had NO signs of perimenopause prior to the vaccine.
Overall feeling of illness, dizziness, fever,  pain in chest  shoulders and back,  chest pain when breathing-in.  These difficulties continue on still today. This was a severe adverse reaction making me incapable of working or concentrating, and causing short temperedness from the pain.
Information has been received from a Registered Nurse (R.N.) concerning, three unspecified patients (unknown ages and genders). Medical history of the patients and their concurrent conditions were not informed. It was reported that on 03-AUG-2016 the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L043214, expiration date 30-AUG-2017(concentration, dosage and therapy route were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved at the time of the report. Additional information has been requested.
Experienced numbness and swelling in left facial area, specifically swelling in left lower lip. Benadryl 50 mg P.O. administered.
Flushing upper torso and face, tingling pins and needles skin on face and arms (more left side of face) and behind ears, lips stinging (this started first) tongue tingling, felt lightheaded or unsteady (pulse was up), and headache
Has had a lot of chest and head congestion. Coughing and expectorating about 5 to 10 times per day.  Has not gone down or decrease in severity since receiving his flu shot.
TIREDNESS/INTENSE FATIGUE; moderate flu symptoms; HOT FLASHES; SWEATS THROUGHOUT THE NIGHT; light sinus pain and pressure; slight joint pain; CHILLS/CHATTERING TEETH; light muscle pain; LIGHT PAIN IN MY ARM FROM THE INJECTION; moderate headache; moderate nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy season. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced moderate flu symptoms. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced sweats throughout the night. On MAR-2021, the subject experienced light sinus pain and pressure. On MAR-2021, the subject experienced slight joint pain. On MAR-2021, the subject experienced chills/chattering teeth. On MAR-2021, the subject experienced light muscle pain. On MAR-2021, the subject experienced light pain in my arm from the injection. On MAR-2021, the subject experienced moderate headache. On MAR-2021, the subject experienced moderate nausea. On 13-MAR-2021, the subject experienced tiredness/intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue on MAR-2021. The reporter causality and company causality between JNJ-78436735 and events moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue was possible. This report was non-serious.
Mouth ulcer; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth ulcer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOUTH ULCERATION (Mouth ulcer). At the time of the report, MOUTH ULCERATION (Mouth ulcer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.   This case was linked to MOD21-071427 (E2B Linked Report).; Sender's Comments:  MOD21-071427: