chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature Excursion issue; The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A and o32H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received his first vaccination (unknown brand) on 9-Jan-2021 in his left arm , lot number 025L20A, expiration date was not available. no adverse events or side effects were reported, it was also reported that patient received his first vaccination (unknown brand) on 6-Feb-2021 in his left arm , lot number 016M20A, expiration date was not available. no adverse events or side effects were reported.  No concomitant medications were reported  It was reported that the nurse did not noticed the expiration date of the Moderna Covid-19 vaccine The vial was initially stored in the refrigerator on 21-Mar-2022.  No treatments were reported
Confirmed Breakthrough Case  COVID-19 (Moderna) 1 02/03/2021 Moderna 038K20A   COVID-19 (Moderna) 2 03/03/2021 Moderna 012A21A   COVID-19 (Moderna) 3 10/29/2021 Moderna 939905
Left deltoid with erythema and swelling about 4.5 cm in diameter with visible puncture from needle. Tender to touch.
Information was received from a physician via an Internet article regarding cases in litigation concerning seven women of unknown ages, who say they have suffered various physical problems, including anaphylaxis and miscarriages (dates of events unknown) after receiving GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). The details of the pregnancies were not reported. The outcome of the various physical problems, miscarriages and anaphylaxis is unknown. Upon internal review, miscarriages and anaphylaxis were determined to be medically significant. this is one of several reports from the same source. Additional information is not expected.
Vaccine given after expiration date. Expiration date confusion due to Pfizer BUD extension.
This case was reported by a consumer via call center representative and described the occurrence of loose stools in a 67-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple sclerosis and diabetes. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, 3 days after receiving SHINGRIX, the patient experienced loose stools and pain in arm. On an unknown date, the outcome of the loose stools and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the loose stools and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm approximately 2 weeks ago from the date of reporting. The patient stated that 3 days after receiving the dose he developed loose watery stools. The patient stated that he tried not eating for a couple of days and also tried a bland diet and nothing seems to be helping with the loose stools. The patient also reported soreness around the injection site on his left arm. The patient did not consent to be followed-up.
That day and the first week it was red, sore and slightly raised.  One week later it was really itchy, hot to touch, more resided and more red. I saw the doc and they put me in prednisone and Benadryl.  That was Thur 1/14.  Today it?s itching more. 3x the size and still hot.  I?m now also on an antibiotic  Very uncomfortable
No adverse event; Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))).    The concomitant medications and treatment details were not provided.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose.  It was unknown if patient experienced any symptoms after getting the vaccine.
09/01/21 The patient presents with sob. 72 year old female, who is COVID-19 positive, presents to ED complaining of sob, secondary to COVID-19 infection. Pt reports she is experiencing abdominal cramping, diarrhea, sob, cough, body aches, nausea, and pleuritic chest pain. Pt is vaccinated against COVID-19 .  Woke up short of breath. Covid positive 7-14 days ago. Chest tightness with productive cough. .  Patient tested positive for COVID-19 at on 8/19.  She has had shortness of breath, cough, diarrhea, fever and body aches.  States she has been unable to eat or drink.  Patient was vaccinated for COVID-19 in that February of 2021 with Pfizer vaccine.
Fell while coming back from the rest room to bed/Crawl back to bed/Don't know what happened after he got back to bed; Broke out in sweat; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell while coming back from the rest room to bed/Crawl back to bed/Don't know what happened after he got back to bed) and HYPERHIDROSIS (Broke out in sweat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced FALL (Fell while coming back from the rest room to bed/Crawl back to bed/Don't know what happened after he got back to bed) and HYPERHIDROSIS (Broke out in sweat). At the time of the report, FALL (Fell while coming back from the rest room to bed/Crawl back to bed/Don't know what happened after he got back to bed) and HYPERHIDROSIS (Broke out in sweat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
morbilliform rash/measles looking; Rash in most of the body/rash; Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities; Reddish; Itched a little bit towards the end; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Oct-2021. The most recent information was received on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (morbilliform rash/measles looking), RASH ERYTHEMATOUS (Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities), ERYTHEMA (Reddish), PRURITUS (Itched a little bit towards the end) and RASH (Rash in most of the body/rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced RASH MORBILLIFORM (morbilliform rash/measles looking) and RASH (Rash in most of the body/rash). In 2021, the patient experienced RASH ERYTHEMATOUS (Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities), ERYTHEMA (Reddish) and PRURITUS (Itched a little bit towards the end). On 02-Mar-2021, RASH MORBILLIFORM (morbilliform rash/measles looking) had resolved. In 2021, RASH ERYTHEMATOUS (Like a third degree sunburn without protrusion/small erythematous spots/on his neck, trunk, and extremities), ERYTHEMA (Reddish), PRURITUS (Itched a little bit towards the end) and RASH (Rash in most of the body/rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both doses on the left nondominant arm. The patient experienced events after 36 hours after vaccination and left in 4 days. Patient was not immunocompromised but is thinking on getting 3rd dose.  The patient did not take any treatments and the rash resolved after 1.5 days.  No treatment medications were provided.   This case was linked to MOD-2021-349641 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant Follow Up Appended; Reporter(HCP) Details Updated; Patient DOB Discrepancy
My right check has been experiencing numbness since shortly after the first shot. I had the second shot of Moderna a month later and the frequency and intensiveness increased. It has been six months and the numbness has extended lower on my neck. It occurs several times each day.
Admitted to hospital 2/6/9 for intussusception.  3/9/09 Received hospital medical records of 2/6-2/7/2009. FINAL DX: Ileocecal intussusception Records reveal patient experienced irritability, abdominal pain, curling up in a ball then sleeping immediately after.  Vomited at daycare & in evening had bloody stool.  Taken to ER where dx w/IS & enema reduced.  Admitted overnight for observation, did well & d/c to home.
Confirmed breakthrough case   COVID-19 (Moderna) 1  03/05/2021 Moderna 030A21A   COVID-19 (Moderna) 2  04/02/2021 Moderna 031B21A
This spontaneous report as received from a physician refers to a 24 year old female patient. There was reported none pertinent medical history, drug reaction or allergy. On 08-JUL-2013 the patient was vaccinated with the third dose of GARDASIL (lot # H021608, exp. date 13-AUG-2015) 0.5 ml, intramuscular for routine vaccination. Concomitant medications included "birth control". On 08-JUL-2013, "about ten hours" after receiving the dose of GARDASIL, the patient developed a headache as well as tenderness and swelling at the injection site. Physician reported that the patient was instructed to apply an ice pack to the injection site and take TYLENOL for the headache. No lab diagnostics studies were performed. On 09-JUL-2013, the patient went to the physician's office. The outcome of headache, swelling at the injection site and tenderness at the injection site was reported as recovering/resolving. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
Pt came into clinic 1 day after pneumococcal vaccine with right upper arm cellulitis to erythema 20x17cm.  Shot 12/01.
Presented for weakness, confusion, fevers. Hx of ESRD, PAD, CAD, HTN. Admitted for COVD PNA, gangrene. Tx w/abx, remdesivir, steroids, zinc, singulair, O2. 9/3 Disposition:She will be dischargedtodayto home health
PT HAD REACTION AT INJECTION SITE.  HE EXPERIENCED SOME SWELLING AND PAIN AND A RASH DEVELOPED A COUPLE DAYS AFTER RECEIVING VACCINE.  HE STATED THAT THE SWELLING HAS GONE DOWN AND THE PAIN HAS SUBSIDED.  THE RASH STILL REMAINS AND PATIENT STATED IT IS A BIT ITCHY
(Bayer aspirin 325 mg tablet, EXCEDRIN 250/250 mg tablet). 3 hours after Tdap pt experienced bilateral leg weakness that occurred for 2 days and then resolved.
pt recv vax; devel chicken pox on 7mar96;reporter felt there was no problem w/ this particular lot;
Case number PHEH2013US016736 is an initial spontaneous report received from a nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 238867). This report refers to a 23-year-old female patient. The patient's history included allergy to Penicillin and CECLOR. Concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 473011C) at a dose of one ml, intramuscularly, with first dose on 07 Sep 2011 (day 0) at left deltoid, second dose on 14 Sep 2011 (day 7) at left deltoid and third dose on 05 Oct 2011 (day 28) at left deltoid. On 14 May 2013, she had equivocal rabies titer, which was an insufficient result. She required a booster dose of rabies. Reporter assessed the case as serious (significant). Outcome of the event was not reported. No other information was provided.
Post vax, the patient developed a 4" x 2 1/2" mild erythema around the injection site with slight swelling.
2 days post vax, the pt developed significant myalgias which slowly resolved over 6 months.
first covid vaccine caused all symptoms; Obesity; Skin disorder/ spots on arms and behind ears; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (first covid vaccine caused all symptoms), OBESITY (Obesity), SKIN DISORDER (Skin disorder/ spots on arms and behind ears) and COVID-19 (COVID-19) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced IMMUNISATION REACTION (first covid vaccine caused all symptoms), OBESITY (Obesity) and SKIN DISORDER (Skin disorder/ spots on arms and behind ears). At the time of the report, IMMUNISATION REACTION (first covid vaccine caused all symptoms) had resolved, OBESITY (Obesity) had not resolved and SKIN DISORDER (Skin disorder/ spots on arms and behind ears) and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Reported that patient had some spots on arms and behind ears but mostly 95 percent healed, it was mainly cosmetic. First Covid-19 vaccine caused all symptoms besides breathing issues.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the events of spots on arms and behind ears, obesity, first covid vaccine caused all symptoms and covid-19 was not provided with Skyrizi (risankizumab).  No treatment medications were reported.  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.   This case was linked to MOD-2022-630547 (Patient Link).
Pt did not have a "adverse reaction" to smallpox innoculation.  Pt initially reported to military sickcall for rash to bilateral arms and legs and given topical treatment.  Is now diagnosed with smallpox vaccinia (auto-innoculation).  Pt is being medevaced to higher echelon of care for isolation and monitoring.
lost sense of  smell; lost sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost sense of  smell) and AGEUSIA (lost sense of taste) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced ANOSMIA (lost sense of  smell) and AGEUSIA (lost sense of taste). The patient was treated with PARACETAMOL (TYLENOL) in July 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ANOSMIA (lost sense of  smell) and AGEUSIA (lost sense of taste) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  It was reported that after the first dose, the patient had some side effects like Covid symptoms.
Chills, fever, headache, tiredness, nausea, injection site pain, muscle pain
Patient received COVID-19 vaccine dose 1 in conjunction with other vaccinations. BPA did not fire ordering provider. MA administered non COVID vaccines. RN administered COVID vaccine. I am unclear if BPA fired prior to administration, or did not fire until after.
Right sided paresthesia UE/torso/LE decreased platellar DTR on right normal strength/no weakness. Down right arm to his leg that started today. All his right side is numb to his toes he got his shot yesterday HPV#3 on his right arm no cough/cold/fever here with mom.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Period started day after booster. Period was 10 days early and lasted 9 days, next period was 7 days early and lasted 4 days, next period was 17 days early and lasted 8 days.
First itching, then rash w/hives with any skin irritation. Taking Benedryl & steroids.
chemotherapy; This spontaneous report was received from a medical assistant and refers to a 16-year-old male patient. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis.  On an unknown date, shortly after receiving the 2 doses of the vaccine, the patient started chemotherapy. The reason for chemotherapy was not specified. The outcome of the event was not reported.  The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of chemotherapy was upgraded to be medically significant.
Later the same day, developed runny nose and itchy watery eyes that lasted for a week. After that, developed what felt like sinus infection with feelings of high pressure in head and face. Also experienced migraines, congestion, earache, and popping in ears that felt like ears were "closed." These symptoms lasted for four weeks and are ongoing.
Information has been received from a physician concerning an 18 year old female who on 19-JUL-2007 was vaccinated with the first dose of GARDASIL. Per the reporter, the patient experienced bells palsy "one to two weeks after receiving GARDASIL." The patient sought unspecified medical attention. Subsequently, the patient recovered from bells palsy seven weeks after diagnosed, but could not move her mouth for three weeks. The patient refuses to receive the second and third dose of GARDASIL. No lot number was provided and no further information was provided. Additional information has been requested.
tested positive for covid; Vaccination failure; This is a spontaneous report from a contactable consumer or other non hcp. The reporter has a remote colleague (Patient). A male patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunization, received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 17Mar2021 as DOSE 2, SINGLE for covid-19 immunization, and received third dose of  bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 02Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and concomitant medication was not reported. On 29Oct2021 the patient was reported about Comirnaty. The patient tested positive for covid after having the first, second and booster dose of the covid vaccine. The patient's height/ weight/ DOB/ age were unknown. On 29Oct2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. On an unknown date he had a positive antigen test at home, sars-cov-2 test: positive. The outcome of the event was reported as unknown.  Information about lot/batch number cannot be obtained. No further information expected.