chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials were stored in the fridge for more than 30 days; No adverse event; HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.), PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy,concomitant diseases and risk factor and also unknown if received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Apr-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 17-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.), PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.) and PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days).    No concomitant information was reported. Suspect product dosage text was reported as initial booster. It was unknown if patient number 2 experienced any adverse events. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720524, US-MODERNATX, INC.-MOD-2023-720530 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720524:same reporter US-MODERNATX, INC.-MOD-2023-720530:same reporter
Headache, Myalgia, Fever, NauseaVomiting, fatigue, brain fog Narrative:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a stored improperly dose of VARIVAX (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. Additional information is not expected because reporter refused additional contact.
Injection site redness; having a little trouble on the same arm of the injection; neck pain; arm pain; stiff still; some redness about 2 inches length wise and 1.5 inches in width; pink color; A SPONTANOUS REPORT was received concerning a 68Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273)   he and his brother received the first dose of the Moderna Covid-19 vaccine yesterday morning at medical in Caller is not having an adverse event but his brother who received the vaccine in his left arm is having a little trouble on the same arm of the injection and his neck kind of bothers him. His brother's arm bothers him, stiff still, pain, some redness about 2 inches length wise and 1.5 inches in width. Pink color. He has not taken anything for his arm. Lot number reported is 029L20A for both of the patients. Caller is a 71 year old male and he takes Lisinopril, Methadone, Over the Counter Allergy relief His brother is a 68 year old male who takes Diphenhydramine, Hydroxyzine, Ibuprofen, Nortriptyline, Topiramate (stopped on Friday 19FEB2021), Lisinopril, Methadone, Sertraline, Lactulose, Docusate  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.    The outcome of the events were UNKNOWN
16 y/o patient inadvertently received 1 dose of Moderna. Patient observed for 30 minutes with no adverse effects. Follow-up call placed at 4pm and patient's mother stated that she is doing fine and still not having any issues.
Moderna vaccine given was beyond the manufacturer recommended use time of 30 days at the refrigerated temperature.
Never had shingles EVER until I got the shingles vaccine within a day; Within a day I had a hard spot from my shoulder to my elbow; not turned bright red purple; Began to blister; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced shingles, induration, skin discoloration and blister. On an unknown date, the outcome of the shingles, induration, skin discoloration and blister were unknown.   It was unknown if the reporter considered the shingles, induration, skin discoloration and blister to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The patient reported that he/she never had shingles ever until got the shingles vaccine. The patient reported that within a day after vaccination he/she had a hard spot from shoulder to elbow which was not turned bright red purple and began to blister. The follow up was not possible for this report as no contact details were reported.
Patient in office of PCP 12/11/06 in ER 12/10/06 and walk in care clinic with numbness. Referred to facility reported diagnose Guillain Barre. Per information received from annual follow recipeint has 0 impairment per treating doctor-work comp doctor. Claimant may be litigating-against manufactuer due to alleged unknown issues.
Fever, Tm 104 starting the day of vaccination (about 8 hours later). Body aches, chills, malaise, alterations of sense of taste, sense of smell. Extreme fatigue. Very mild headache. Fever lasted for 7 days in the 103 to 104 range. Current temperature is <100, but still has severe fatigue. Was seen in ER for 2 visits on 04/18/2021.   Had labs drawn, was told these were normal. Has been taking Tylenol, added ibuprofen after 6 days, and drinking diluted Gatorade.  Had video visit with me on 4/16, and then phone visits on 4/19 and 4/21.
Lost vision in my right eye, lost feeling in my leg, could hardly walk, couldn?t urinate without self cathing for 3 months, took away feeling from my bowels so it?s hard to have a bowel movement, blood sugar imbalances, severe anemia, heart jitters
About 5 minutes after vaccine administration, patient stated he felt light headed and said he was nervous about his vaccine. He passed out and hit his head on the ground. His blood pressure was measured at 69/31 and was bradycardic. He was admitted to the ED.   He has a history of anxiety, and his blood pressure was again documented at 69/37 and HR of 52.
Sat for 15 minutes following injections and seemed fine.  After about 20 minutes we went to leave and we made it about 100 feet when patient said he couldn't see.  He was very pale and I told him to put his head against my shoulder while I had my arms out to his sides just in case.  Within a few seconds he collapsed against me.  I lowered him to the floor on his left side and he came to within a few minutes.  We sat him up and had him drink water.  No further issues.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for covid-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Joint pain; Lower back intense pain; Fever; Fatigue; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) from unknown date for an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO180) via an unspecified route of administration in the left arm on 19Jul2021 at 17:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 11Aug2021 at 10:00, the patient experienced joint pain, lower back intense pain, fever, fatigue and body aches. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if patient received any treatment for the events. The clinical outcome of the events joint pain, lower back intense pain, fever, fatigue, body aches were not resolved at the time of this report.  Follow-up attempts completed. No further information expected.   Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccine Facility Information added 2. Final sentence Follow-up attempts completed. No further information expected.
she has headache but nothing more; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "she has headache but nothing more".  Additional information: The patient had headache but nothing more and wanted to make sure that she is okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 as dose 3 (booster), single (Lot number: EP6955), in left arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. No known allergies. No other medical history. The patient had no relevant medical history. Received other medication in 2 weeks. Concomitant medication(s) included: NOREL AD, start date: 28Apr2022; BENZONATATE, start date: 28Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: I tested positive on 28Apr2022; (05May2022) Positive, notes: Another positive test on 05May; (09May2022) Negative, notes: On 09May, a home test in the a.m, Another in the p.m. was negative; (11May2022) Positive, notes: On 11May, after feeling ill again, I tested positive at home, then positive at the doctors office; (14May2022) Positive, notes: An at home test today, on 14May, is positive. Therapeutic measures were taken as a result of covid-19. As reported, product: COVID 19 Treatment. Brand: Pfizer. Treatment start date: 28Apr2022. Treatment stop date: 03May2022. Lot number: FY6859. Indication: Treatment of COVID-19. Patient was tested positive on 28Apr2022, with another positive test on 05May. On 09May, a home test in the a.m. was negative, and another in the p.m. was negative. On 11May, after feeling ill again, patient was tested positive at home, then positive at the doctors office. An at home test today, on 14May, is positive.
Information has been received from a physician assistant concerning a 22 year old female with allergy to CECLOR, who on 16-AUG-2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # reported as "9725103") 0.5 ml, on 21-NOV-2007 was vaccinated intramuscularly with a second dose of GARDASIL (Lot # 654539/0742U) 0.5 ml and on 21-AUG-2008 was vaccinated intramuscularly in the left deltoid with a third dose of GARDASIL (Lot # 655604/0052X) 0.5 ml. There was no concomitant medication. The physician assistant (P.A) reported that the patient experienced a vasovagal attack after getting the third dose of GARDASIL on 21-AUG-2008. Immediately after vaccination, the P.A reported that the patient stated that she was not feeling well and was having difficulty breathing. She became pale, nauseous, very sweaty, and had bradycardia. She was laid completely flat. She did not lose conscious nor did she vomit. The patient was given ammonia inhalant and recovered in about 15-20 minutes. It was reported by the P.A that the events were considered to be serious as life threatening as the patient was having difficulty breathing. The patient remained recovered. The P.A reported that the events were "directly related" to GARDASIL. There was no product quality complaint. A Lot check has been requested. Additional information has been requested.
Patient developed zoster type rash on left side of face as well as large local raised erythematous reaction on arm which vaccine was administered.
sore in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Asthma (Chronic asthma) and Bladder disorder (Bladder problems).   On 18-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore in arm). At the time of the report, PAIN IN EXTREMITY (sore in arm) outcome was unknown.            Concomitant medications were not reported.  The patient declined to provide additional information regarding side effect.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: Follow-up received contains no new information.
Information has been received from a physician concerning a 15 year old female patient who on 14-JUL-2010 was vaccinated with the first dose of GARDASIL (lot number not provided) and with a dose of VAQTA (manufacturer unknown). The physician reported that shortly after receiving the vaccines the patient had a syncopal reaction at the front desk. The patient came around and she was fine before leaving the office. It was unspecified if the patient sought medical attention. Follow up information has been received from the physician concerning the 15 year old female student patient with no pertinent medical history, drug reactions or allergies, no adverse event following prior vaccination and no illness at time of vaccination who on 14-JUL-2010 at 10:00 was vaccinated intramuscularly into her left arm with the first dose of GARDASIL (Lot# 663454/0672Y). There was no other concomitant medication (previously reported as a dose of VAQTA (manufacturer unknown)). The physician reported that on 14-JUL-2010, in 20 minutes after she experienced syncope, she recovered. On an unspecified date, a blood glucose (BG) test was performed result was 92. The patient did not seek medical attention. No further information is available.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a small red area at the site of injection after receiving SHINGRIX. No additional details were reported.
The night after vaccine I had the chills and I went to bed. The next morning I had a temperature of 99.9 and I called work to see if I could go to work and I could. I had no other symptoms at that time and that night my nose started running and dropping constantly and the next day was Saturday and into Sunday everything was done and I didn't have any temperature on Sunday. I didn't notice any eye issues until 11/17 and I read the chart and seen something was wrong with my eye. I didn't notice it when I was working on the computer but on the single eye reading I could tell and that's when he did an extra test and found my eye was swollen and so he gave me an injection in my eye and I need to have 4 more done and get a picture of it again in January. I've worn glasses all my life but I've never had any trouble with my eyes like that before.
This spontaneous report as received from a nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # N013521, expiry date 23-JAN-2019; lot # N003993, expiry date 20-OCT-2018 and lot # M036728, expiry date 20-MAY-2018 (dose, route of administration were not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 38 minutes and from 47F to 77F for 3 hours and 14 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009203: US-009507513-1709USA010540: US-009507513-1709USA010541.
pt says his arm was sore the day after taking the vaccine but now the soreness has spread from the top of his left shoulder down to his fingers.  He says it hurts from the skin to the bone.  He cannot lay down, he has to sleep sitting upright.  he said the pain is constant but is not as bad when he sits up and when he lays down the pain is so bad he has to get back up.  He is taking aspirin for his pain.
fever; fatigue; 7 days after injection, the injection site began to itch.; rash at injection site; Had a small bump where needle was inserted; first injection the injection site was red in an oval shape around the injection area.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0183) intramuscular, administered in Arm Left on 28May2021 16:15 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0173) intramuscular, administered in Arm Right on 18Jun2021 16:15 (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies were reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior to vaccination. No COVID tested post vaccination. On 04Jun2021 07:00, 7 days after injection, the patient experienced that the injection site began to itch. On an unspecified date in 2021, she had a small bump where needle was inserted. Gradually this become larger and on day 9 after first injection the injection site was red in an oval shape around the injection are. On 04Jun2021 07:00, she had rash at injection site. On 19Jun2021, she had fever and was fatigue. No treatment was given for adverse events. The outcome of the event the injection site was red in an oval shape around the injection area was unknown. The outcome of all other events was recovered on an unknown date in 2021.    Follow-up attempts were completed. No further information was expected.
Swollen glands in the neck and under the ear; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands in the neck and under the ear) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen glands in the neck and under the ear). At the time of the report, LYMPHADENOPATHY (Swollen glands in the neck and under the ear) outcome was unknown.            no concomitant drugs and treatment medications were provided.
7 months pregnant patient, stated she has been having trouble eating breakfast due to morning sickness so she had not eaten anything. About 5 minutes after her vaccination she reports she felt sweaty and dizzy vomited a small amount and passed out for a short time. After 20-30 minutes she was feeling well enough to walk out of the store with her friend who was taking her to the hospital to be checked out on the advice of her obgyn.
Vaccine was administered on 11/07/2007.  Pt stopped by pharmacy on 12/5/07 and let me know that her arm had been very sore and stiff since the injection.  She had no bruising, swelling, bleeding, etc, just stiffness and pain.  She did not complain of pain at time of injection.  She did state that it began after the injection.
Infant started shaking her extremities and face was flushed.  Shaking like she was cold.
After administering the vaccine (Pneumovax) she turned red and started complaining of throat constriction and breathing problems. - Treatment - Epi pen.