chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right hand flares up after taking booster Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Right hand flares up after taking booster Moderna shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Right hand flares up after taking booster Moderna shot). At the time of the report, CONDITION AGGRAVATED (Right hand flares up after taking booster Moderna shot) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of right hand flares up after taking booster Moderna shot was not provided for Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No adverse effects reported.; she received her first dose of GARDASIL 9, and second dose of GARDASIL 9 on unspecified dates in 2016. The consumer reports that she is "now in the pharmacy to receive the third dose of GARDASIL 9 late"; This spontaneous report was received from a female patient of unknown age and refers to herself. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date in 2016, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # L023230, expiration date 28-JUL-2017 and lot # L044475, expiration date 12-MAY-2017, accordingly (exact dose and route of administration were not reported) for prophylaxis.  On 30-JUL-2019 (reported as now), the consumer reports that she was in the pharmacy to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) late. No adverse effects reported.
The day after extremely painful. Last night it was throbbing. Not as painful has developed bad rash on her arm that has spread a little up her arm.
issues with their mouth; blisters under her mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MOUTH INJURY (issues with their mouth) and BLISTER (blisters under her mouth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOUTH INJURY (issues with their mouth) and BLISTER (blisters under her mouth). At the time of the report, MOUTH INJURY (issues with their mouth) and BLISTER (blisters under her mouth) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included antivirals, antibiotics, steroids in three four different times.
hospitalized 7AUG95 w/szs; dx'd w/infantile spasms & remains under care of neurologist
Fever, chills, erythema/tenderness at site of injection at deltoid with lymphangitis extending into left axilla.
ASYSTOLE; PASSED AWAY; This spontaneous report received from a physician concerned their mother-in-law, an 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 was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was in a nursing home, but was hospitalized for pyelonephritis.  The patient was not allowed back into the nursing home without a negative COVID test and the vaccine.  After discharge from the hospital, the patient's COVID test came back negative, and upon arrival to the nursing home, the patient received the Janssen COVID-19 vaccine.  Within 30 minutes, the patient was unresponsive and transported back to the hospital.  On arrival to the hospital, the patient was asystole.  She was treated at the hospital until 13-MAR-2021, when she passed away.   Asystole was reported as fatal.  Additionally, cause of death was reported as "cause unknown", therefore, an additional serious adverse event of "passed away" was captured.  An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 13-MAR-2021. This report was serious (Death and Hospitalization).; Sender's Comments: V0:  An female of unknown age became unresponsive 30 minutes after, experienced asystole on the same day as, and died of unknown causes 2 days after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection; route of administration and batch number unknown) for prophylactic vaccination while in a nursing home.  Medical history and concomitant medications were not reported. The patient was the mother-in-law of the reporter, an internal medicine physician. The patient had no complaints for 30 minutes after receiving the vaccine, then became unresponsive; she was transported to a hospital where she was noted to be asystolic upon arrival. Treatment and hospital course were not provided.  The patient died 2 days after receiving the vaccine, and cause of death was unknown; outcome of asystole was reported as fatal.  An autopsy was not performed. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: ASYSTOLE; UNKNOWN CAUSE OF DEATH
fatigue, HA day 1 post vaccination.  Treatment: BC powder with improvement.  Outcome. Did not interfere with ADLs.
RASHES NOTED ALL OVER BODY. TOOK BENADRYL BUT DID NOT HELP. TOOK MEDROL DOSEPACK AND RASH SEEMED BETTER BUT GOTTEN WORSE AGAIN.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), LEVOTHYROXINE, ATORVASTATIN, ANASTROZOLE, HYDROCODONE and NABUMETONE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            The patient did not receive any treatment.
Sore Arm After the First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm After the First Vaccine) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm After the First Vaccine). On 12-Mar-2021, VACCINATION SITE PAIN (Sore Arm After the First Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090334, US-MODERNATX, INC.-MOD-2021-090629 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090334:Cross linked US-MODERNATX, INC.-MOD-2021-090629:cross linked dose 1
Chronic dry cough and bronchoconstriction  starting immediately after 1st dose, continuing until the 2nd dose and worsening after second dose.
Post first vax, seven days later she experienced a chronic muscle ache at the injection site. There was no treatment.
Client received Dtap inadvertently and should have received Tdap. No adverse reactions noted. Notified parent about incident and aware of vaccine error.
9x13cm area of redness and swelling and central induration over DTaP/ IPV site. MMR at periphery of erythema. No lymph nodes.
no adverse event; expired dose; This spontaneous report was received from a consumer and referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     On 13-APR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 dose, lot # s024844, expiration date was 01-APR-2021) orally for prophylaxis.  Follow up information was received from a nurse on 04-MAY-2021. The details of the reporter and patient were updated. This was a 6-month-old (also reported as 7 months old) male patient. On 13-APR-2021, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S024844) which was expired. The provider and the patient's mother were aware that. That dose remained effective. The patient was not reimmunized and remaining doses were removed from the office supply. No further vaccination needed. No digital data logger was involved.
Approximately 2 hours after vaccination, child developed fever of 103.  Since immunization was given at school, child sent home and referred to private physician.
arm became red in area of vax, eventually spread (3-4 days) to cover area from shoulder to elbow;skin hot, itchy;arm swollen;low grade fever;tx w/hot pact ATB;gradually subsided over 2wk;
rash with severe pain, burning and itching all over the anterior abdominal wall on the right side / diagnosed with herpes zoster and postherpetic trigeminal neuralgia; rash with severe pain, burning and itching all over the anterior abdominal wall on the right side / diagnosed with herpes zoster and postherpetic trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or around 24-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from a rash with severe pain, burning and itching all over the anterior abdominal wall on the right side. The patient was diagnosed with herpes zoster and post herpetic trigeminal neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered/not resolved. The reporter felt both events were related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
1st dose 07Sep2021, additional dose on 17Sep2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 20th January 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 17th September 2021, the patient received the 2nd dose of Shingrix. On 17th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows: On 7th September 2021, the patient received 1st dose of Shingrix. The patient was administered with the first dose of Shingrix vaccine but the dose was not documented in system and an additional dose was administered at an interval shorter than the recommended, which led to shortening of vaccination schedule. The reporter stated that the patient was doing fine and had not had any issues. The reporter consented to follow up.
Complained of itching at and around injection site and 10 minutes, post vax, hives appeared around injection site and disappeared, 5 hours later. Benadryl was recommended but employee didn't take any since symptoms resolved. No other symptoms occurred.
Swollen Injected Arm from shoulder to elbow after 3rd shot; Red Injected Arm from shoulder to elbow after 3rd shot; Sores on the arm from shoulder to elbow after 3rd shot; Sores were bleeding from shoulder to elbow after 3rd shot; Warm to touch from shoulder to elbow after 3rd shot; Felt weak in that arm from shoulder to elbow after 3rd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Swollen Injected Arm from shoulder to elbow after 3rd shot), VACCINATION SITE ERYTHEMA (Red Injected Arm from shoulder to elbow after 3rd shot), VACCINATION SITE ULCER (Sores on the arm from shoulder to elbow after 3rd shot), SKIN ULCER HAEMORRHAGE (Sores were bleeding from shoulder to elbow after 3rd shot) and VACCINATION SITE WARMTH (Warm to touch from shoulder to elbow after 3rd shot) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On an unknown date, the patient received 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 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen Injected Arm from shoulder to elbow after 3rd shot), VACCINATION SITE ERYTHEMA (Red Injected Arm from shoulder to elbow after 3rd shot), VACCINATION SITE ULCER (Sores on the arm from shoulder to elbow after 3rd shot), SKIN ULCER HAEMORRHAGE (Sores were bleeding from shoulder to elbow after 3rd shot), VACCINATION SITE WARMTH (Warm to touch from shoulder to elbow after 3rd shot) and VACCINATION SITE MOVEMENT IMPAIRMENT (Felt weak in that arm from shoulder to elbow after 3rd shot). At the time of the report, VACCINATION SITE SWELLING (Swollen Injected Arm from shoulder to elbow after 3rd shot), VACCINATION SITE ERYTHEMA (Red Injected Arm from shoulder to elbow after 3rd shot), VACCINATION SITE ULCER (Sores on the arm from shoulder to elbow after 3rd shot), SKIN ULCER HAEMORRHAGE (Sores were bleeding from shoulder to elbow after 3rd shot), VACCINATION SITE WARMTH (Warm to touch from shoulder to elbow after 3rd shot) and VACCINATION SITE MOVEMENT IMPAIRMENT (Felt weak in that arm from shoulder to elbow after 3rd shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use 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)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, 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 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use 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 (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medications were reported.   Beyond use date was reported as 08-Jan-2023. All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.   No treatment details were reported.  This case contains information for the 15 out of 15 patients as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566:Master case
This spontaneous report as received from a certified nurse assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored ROTATEQ, orally, lot # L038536, expiry date 19-AUG-2017 (strength and dose were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.