chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not able to receive second dose of Moderna vaccine until 48 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not able to receive second dose of Moderna vaccine until 48 days after first dose) in a 74-year-old female patient 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 PRODUCT DOSE OMISSION ISSUE (not able to receive second dose of Moderna vaccine until 48 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not able to receive second dose of Moderna vaccine until 48 days after first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The action taken with mRNA-1273 was not applicable.
No adverse event; Received 0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose) 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 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose) 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 UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. Patient received primary series two doses of Moderna vaccine (monovalent). Patient received two booster dose of Moderna vaccine (monovalent). No treatment medications were reported. This case contains information for the 7th of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798, US-MODERNATX, INC.-MOD-2022-648802, US-MODERNATX, INC.-MOD-2022-648805, US-MODERNATX, INC.-MOD-2022-648807, US-MODERNATX, INC.-MOD-2022-648808, US-MODERNATX, INC.-MOD-2022-648809 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:same reporter US-MODERNATX, INC.-MOD-2022-648802:same reporter US-MODERNATX, INC.-MOD-2022-648805:same reporter US-MODERNATX, INC.-MOD-2022-648807:same reporter US-MODERNATX, INC.-MOD-2022-648808:same reporter US-MODERNATX, INC.-MOD-2022-648809:same reporter
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant therapies, drug reactions or allergies provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # M014927 with expiration date 18-FEB-2019, lot # M010440 with expiration date 09-DEC-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaints (PQC) were not involved. Administered doses of vaccines were exposed to the temperature of 32 degrees Fahrenheit for 9650 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005289.
Red and hot area, 3-4 cm medial to puncture site of DTaP.
Narrative: COVID infection following COVID vaccine series 03/04, Pfizer, dose #1 03/25, Pfizer, dose #2 05/20 COVID swab, result: NOT detected 08/31 pt cc: cough, chills, myalgias, rhinorrhea, fatigue, headache exposure: unknown 08/31 COVID swab, result: detected 09/10 clinically resolved
1/17/2021  2:42 pm gave vaccine 1/17/21  2:54 pm   itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution.  BP 112/72.    Reported itchy back.  Checked back, unremarkable.   3:30, no issue ? she went home. F/u 4:30  - no issues
Pt was seen in MD office t99.7 oral gives hx of spontaneous & resolved rash, wheezing, non productive cough, stomachache, vomiting; dx gastroenteritis & acute asthmatic exacerbation given breathing tx w/Ventolin;
she had a heart valve placed in her heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: HEART VALVE OPERATION (medically significant) with onset Oct2023, outcome "unknown", described as "she had a heart valve placed in her heart".  Clinical course: The reporter was asking about the possible side effects of pfizer covid vaccine 2023-2024 related to possible heart inflammation and if possible heart inflammation is a side effect with moderna covid 19 and wondering if it is the same with pfizer covid 19. Her and her doctor have a concern with her receiving a mrna vaccine given the recent heart valve.  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.
Day 1: pacemaker activated 2 times right after receiving shot.   Arm swelled with fluid at injection site. Shooting throbbing pain from neck, shoulder  to fingers on left side.  Nausea and stomach cramps began 7 hours after receiving dose. Day 2:  7am. 101 Fever. Balloon like fluid in left arm.  Arm pain.  Joint pain in elbows and fingers on left side. Fatigue and sleepiness. Day 3:  Fever broke.  Arm pain. Swelling going down. Fatigue and sleepiness.
05/02/2021..started severe nerve pain from my right shoulder down to my elbow.                       *My Migraines have also increased !!!!!!!! Was given Gabapentin,Tizanidine, and Prednisone.                                                                                                          Sumatriptan  Tried heating pad, ice pack, icy hot. The only way I could get comfort from this horrific pain was laying down.  For 2 1/2 weeks I did nothing but lay down.   By 5/31/2021 my pain has started to let up and I can go for a longer period of time without pain.
I was in contact with my grandchild soon after her immunization as well as other family members. My nephew contracted shingles. My husband and I both have suffered from skin rashes, chronic and re-occurring hives, pressure in the head, headaches and joint pain which have not been sufficiently diagnosed by health providers. I believe these health issues may be directly related to the varicella vaccine.
Allergic reaction to Egg in shot, severe constipation, stomach ache, lack of sleep and pain spasms for 2 days and nights, then vomiting and diarrhea and rash all over body. Treated with Benadryl.
Maintenance drugs for  diabetes, high blood pressure, and hypertension loss their effectiveness.  Needed to increase dose or try other medications .  2 cyst like sores appeared.  One behind the ear and one 1 inch  below the lip.  White Styrofoam like  balls pushed thru the skin followed by bleeding for about 2 years.  Maybe 100+ best guess. No over the counter meds worked.  Got Bactrim 2 months ago.  Great improvement.
Red rash from scalp to feet; Itching from scalp to feet; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number C4NC5, expiry date 25th January 2020) for prophylaxis.   On 9th September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash and generalized pruritus. On an unknown date, the outcome of the red rash and generalized pruritus were not recovered/not resolved.   It was unknown if the reporter considered the red rash and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine intramuscularly and soon after (unknown date), he experienced red rash and itching from his scalp to his feet. These above symptoms were still present and had not resolved. The patient provided HCP (Health Care Professional) information. The reporter consented to follow up.
She experienced soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2019, the patient received the 1st dose of Shingrix. On 5th March 2019, less than a day after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination with dose of Shingrix, experienced soreness. The patient planned to follow up with physician on an unknown date. The reporter consented to follow up. For tolerence of 2nd dose, refer case US2019167113..
Site: Redness at Injection Site-Mild, Systemic: vaccine went in eye-Mild, Additional Details: when administering, needle popped off and vaccine went in immunizers eye?
Guillain-Barre syndrome; Acute motor axonal neuropathy; Spinal cord compression; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 10 March 2020, via medical records(The case was medically confirmed). As per pharmacy records, the patient had ingested Shingrix 50 MCG SUSR. As per medical records, on 11 July 2018, the patient was in hospital with hospitalization reason as guillain barre syndrome, spinal cord compression and acute motor axonal neuropathy(AMAN).
150 patients received expired vaccines; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (150 patients received expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A  e and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (150 patients received expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (150 patients received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Swelling redness pain at injection site. Dizziness nausea fatigue elevated blood pressure 188/90 an otherwise healthy female with no history of blood pressure issues.
Localized redness from inadvertent intradermal administration of Td instead of TST.
chest pain radiating to left collar bone and left neck, constant, worse when lying down, exercise.
Daughter digs at arm day after injection-when mom looks Lt arm is red from deltoid to elbow. Warm and VERY itchy. Has about a 2" knot at injection site. Mom gave BENADRYL and this helped with the itch right away. Mom continued with BENADRYL and cool compress. Mom called HD to report on 2-12-10-HD called state 2-12-10. Better-redness gone-still knot remains at Lt deltoid injection site. Mom refused follow up dose of H1N1 when due-advised mom to have all f/u vaccine given at Dr. office. Mom voiced understanding-states daughter has had reg flu before without difficulty.
following  day after receiving the vaccine  employee states developing a headache that has not been amendable to usual treatments . also intermittent  HTN and rapid heart rate.   Symptoms on going.,   lead to a 2 day hospital stay.
Had some soreness which was expected on arm with the first three arm injections; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Had some soreness which was expected on arm with the first three arm injections) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 024M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to chemicals (IV dye allergy), Drug allergy (Vicodin allergy), Blood pressure high (No recent changes in condition status), Thyroid disorder (No recent changes in condition status), High cholesterol (No recent changes in condition status), GERD (No recent changes in condition status) and Rheumatoid arthritis (No recent changes in condition status). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for Blood pressure high, OMEPRAZOLE for GERD, SIMVASTATIN for High cholesterol, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Had some soreness which was expected on arm with the first three arm injections). At the time of the report, VACCINATION SITE PAIN (Had some soreness which was expected on arm with the first three arm injections) outcome was unknown. Not Provided          Patient height was reported as 5 inch. Patient did not have any acute illness at the time of vaccination and up to one month before. Patient neither diagnosed with COVID-19 nor tested positive.  Treatment medications were not reported.   This case was linked to MOD-2022-580164, MOD-2022-585326, MOD-2022-585328, MOD-2022-580263 (Patient Link).
Left arm Pneumovax reaction severe pain mildly erythematous non swollen s warmth. TX: Keflex 500mg TID and Medrol dose pak
still dealing with the dizziness/dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (still dealing with the dizziness/dizzy spells) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (still dealing with the dizziness/dizzy spells). At the time of the report, DIZZINESS (still dealing with the dizziness/dizzy spells) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-400114 (Patient Link).
warm to touch at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th May 2019, in the left arm (batch number KC9C4, expiry date 30 March 2020), refer case US2019AMR161158).   On 31st July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 31st July 2019, less than a day after receiving Shingrix, the patient experienced injection site warmth and injection site pain. On an unknown date, the outcome of the injection site warmth was recovering/resolving and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported that, the patient experienced injection site warmth and injection site pain, after vaccination with dose of Shingrix. This case was 1 of the 2 linked cases.
Patient reported 2 days after received vaccine, she experienced throbbing in her left ear, then vertigo the day after, and flu symptoms on the 4th day after vaccine.
Information has been received from a physician concerning a male child who in approximately October 2001, was vaccinated with varicella vaccine. In November 2001, the pt had a breakthrough case of varicella. The pt was seen with 30 or less lesions that were all at the same stage with crusting visible. The pt was afebrile. The physician implied that the vaccine was administered at a much earlier date, at least more than 6 weeks prior to the pt developing varicella. Additional info has been requested.
Information has been received from a physician concerning a 17 year old female who was vaccinated with the third dose of GARDASIL on an unspecified date. On 22-MAY-2008 after receiving her third dose the patient had been experiencing headaches. The patient had sought medical attention, saw physician. At the time of report the patient's status was unknown. In follow-up, the physician indicated that on 21-NOV-2007, 22-JAN-2008 and 22-MAY-2008, the 17 year old patient was vaccinated IM with the first dose (Lot# 659055/1522U, left arm), the second dose (lot# 659657/1487U, right arm) and the third dose (lot# 659964/1978U, left arm) of GARDASIL. On 01-JUN-2008, the patient experienced dizzy and headaches. Additional information has been requested.
Dose administered to patient after more than 30 days stored in the refrigerator; Dose administered to patient after more than 30 days stored in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days stored in the refrigerator) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 088D21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Depression, High cholesterol and Dementia.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Regular medications reported included unspecified medications for hypertension, depression, high cholesterol, dementia. Patient has no history of allergies.  Off-label shot reported was patient's booster shot. Vial used was initially stored in refrigerator on 11-Jan-2022.  No treatment medications were reported.   This case was linked to MOD-2022-488503 (Patient Link).
This patient had a rash that began on the right forearm, then appeared on the right side of her face, on her ear, and behind both ears. She left school at approximately 2 PM. The mother called the doctor / ER and they said to give her Benadryl every 4 hours. It was a itchy rash on the forearm like mosquito bites; face had a poison ivy type rash; ears had a rash like poison ivy too. The patient got better with the Benadryl but without it, it comes back.
Information has been received from a nurse practitioner concerning a 65 year old female patient who in 2008 when she was 62 year old was vaccinated with a single 0.65 ml dose subcutaneously of ZOSTAVAX (Merck) (Lot # 659411/0293X). The nurse reported that this week, on approximately 24-SEP-2010 the patient presented shingles. At the time of the report, the patient was recovering from shingles. Antibody and titer test were performed and the patient got a viral sample (no result provided). The patient sought unspecified medical attention. Shingles were considered to be another important medical event by the reported because antiviral was prescribed. Additional information has been requested.
Began 2 days after injection with redness, swelling, tightness of the right arm and grouped vesicles on erythematous base covering extremities and think -very pruritic with dermatographism.