chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was prägnant when I received the vaccine. My daughter was born with very severe eczema. This does not run in our family, we have no health concerns, and I am healthy and ate well/took prenatal during my pregnancy. I believe this environmental toxin caused her to develop eczema.
An itchy rash appeared at my injection site about a week after the vaccine. It was a circular, red rash.
Event: Severe flu-like symptoms. Onset: 11.5 hours after injection. Symptoms: Severe chills, extreme nausea, and vomiting lasting 12 hours, followed by a general feeling of being unwell for 48 hours. This also happened after the second injection (03/20/21). This is difficult to tolerate every 6 months or so. I am a healthy person who rarely gets sick. I have had the flu only twice in my lifetime. As a former healthcare worker required to take the Hepatitis B vaccine, I also had a bad reaction to that series of injections, if that has any relevance.
pt was given a booster dose of Moderna Bivalent vaccine earlier than approved time to receive one.  She received an initial dose on 9/13/22 and received a booster dose on 12/6/22.
Patient states multiple breakout site which she believe is herpes zoster. Pain, itching, swelling, redness also at injection site. She was prescribed VALTREX on 6/13/16.
passed 42 days for 2nd dose after 1st dose; A spontaneous report, was received from a consumer concerning a 62-year-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine and had Inappropriate schedule of vaccine administered.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 13 Jan 2021, the patient got the first dose of mRNA-1273 (Lot number: Unknown) via unknown route at left arm location for prophylaxis of COVID-19 infection.  On 25 Feb 2021 patient contacted and stated that he passed 42 days for his second dose of vaccination which was on 10 Feb 2021 got delayed due to  storm and he didn't receive a call to get his 2nd dose .  On unknown date  patient experienced Inappropriate schedule of vaccine administered.  Action taken for the Inappropriate schedule of vaccine administered was unknown  The outcome for  Inappropriate schedule of vaccine administered was considered as recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
extreme fatigue, diffuse itching and painful red vasculitic type eruption on dorsum of foot and legs.
left my side paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis was recovering/resolving.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comment: This case was reported by a consumer via interactive digital media.The reporter stated patient had shot which left patient side paralyzed for a week. The patient was doing better at the time of reporting.  Additional supportive information: Follow up would not be possible since no contact details provided.
58 yr old with Crohn's colitis who presented to clinic 11/26/2009 for H1N1 shot. Had pre-existing eczema to hands but awakened 11/27 am with marked redness and sloughing to palms. Erythema extended up forearms toward antecubital area over weekend. Today-Tues-with additional skin lesions which range from papular/macular-over ant abdominal wall-to annular lesions across upper arms, post shoulders, buttocks. Some itching to lesions. No fever or chills but patient was on Prednisone taper until 3 days prior to vaccination. No prior h/o flu shot adverse reactions. No exposure to unusual chemicals or creams. No sob/chest pain. Patient has h/o CVA in past which has caused him difficulty with swallowing, no change in that previous sx.
Report of chills, fatigue and HA started next day post vaccination. Treatment include Tylenol with improvement of HA only. Outcome: Continue to work does not interfere with ADLs.
Woke up at 1 AM with shivers and high fever, 102°F. Fever drop to about 100° by 8 AM. Fever remain between 99°F and 99.7°F until approximately 2 PM, and fever returned to normal at approximately 3 PM in the afternoon or so. This was my second dose of the SHINGRIX vaccine. I had no reaction like this to the first dose which was administered six months prior.
Tylenol 3, self administered. LOA-Posterior surface from elbow to mid-tricep area with erythema and swelling 1% of body area by rule of hands. Site was palpable and soft with masses or hardness.
This spontaneous report was received from a male patient of unknown age, The patient's medical history was not reported. On 02-JUN-2014 the patient was vaccinated with ZOSTAVAX. Concomitant medications were not reported. Approximately on 03-JUN-2014 (reported as 1 or 2 days after vaccination), the patient experienced cold symptoms including a sore throat. The outcome of cold symptoms and sore throat was unknown. The causality of cold symptoms including a sore throat was not reported. This case is linked to case # 1406USA008833 (same reporter link). Additional information has been requested.
The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023; No adverse event; Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-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 19-Jun-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 (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023) 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 (Nurse is calling to report that a 45 year old patient received an expired (beyond MFG expiration date)) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-JUN-2023 and administered on 19-Jun-2023).    No concomitant medication was reported. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Bivalent BA.4-5 Blue Cap Dose was administered after Manufacturer Date of Expiry. Individual Vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 12-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Pain, itchiness, swelling, 3x3 raised redness to upper left arm. No fever, no acute distress. TX Diphenhydramine for swelling and itchiness.
I had a large, swollen lump on my left shoulder - which was bigger than a golf ball - that lasted 8 days. I went to Urgent Care. The doctor diagnosed it as lymphadenopathy cervical. I was told to apply a warm compress and to wait for it to clear.
whole body hurts; muscular type of pain in legs (feels like you've played basketball for four hours after not having; pain around kidney area in the right side of my back; major pain can't bend over and is hard to get back up; pain in arms; Left arm hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm hurt at the injection site), PAIN (whole body hurts), PAIN IN EXTREMITY (muscular type of pain in legs (feels like you've played basketball for four hours after not having), RENAL PAIN (pain around kidney area in the right side of my back) and MUSCULOSKELETAL DISCOMFORT (major pain can't bend over and is hard to get back up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurt at the injection site). On 05-May-2021, the patient experienced PAIN (whole body hurts), PAIN IN EXTREMITY (muscular type of pain in legs (feels like you've played basketball for four hours after not having), RENAL PAIN (pain around kidney area in the right side of my back), MUSCULOSKELETAL DISCOMFORT (major pain can't bend over and is hard to get back up) and PAIN IN EXTREMITY (pain in arms). At the time of the report, VACCINATION SITE PAIN (Left arm hurt at the injection site), PAIN (whole body hurts), PAIN IN EXTREMITY (muscular type of pain in legs (feels like you've played basketball for four hours after not having), RENAL PAIN (pain around kidney area in the right side of my back), MUSCULOSKELETAL DISCOMFORT (major pain can't bend over and is hard to get back up) and PAIN IN EXTREMITY (pain in arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Bad Headache; Chills; Extremely Exhausted; Queasy; A spontaneous report  was received from a (Consumer) concerning a- 23 years old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced Extremely Exhausted, Queasy, Bad Headache and Chills. The patient's medical history not included. No relevant concomitant medications were reported.   On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:010A21A) intramuscular for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient experienced events extremely exhausted and queasy. On 03 March 2021, the patient experienced events bad headache and exhausted again and had chills.   Laboratory details not provided. No treatment details included. Action taken with mRNA-1273 in response to the events was not reported.  On 27 Feb 2021, the outcome of the event Queasy was Resolved. At the time of this report, the outcome of the events Extremely Exhausted, Bad Headache and chills was unknown.
Engerix- adult was given to 19-year old; Engerix- adult was given to 19-year old; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   On 31st January 2023, the patient received Engerix B adult. On 31st January 2023, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comment: The healthcare professional reported that the patient received a dose of Engerix B adult. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The 19 years old patient received an adult Engerix B dose, which led to overdose and inappropriate age at vaccine administration.
Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 23-JAN-2012 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-OCT-2015, the patient was treated by a physician for a painful vesicular rash that was diagnosed as shingles. The patient has been prescribed doxycycline, valacyclovir hydrochloride (VALTREX), hydrocortisone, neomycin sulfate, polymyxin B sulfate (CORTISPORIN OTIC) ear drops to manage her excruciating symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a nurse refers to 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose of (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the event was unspecified. No PQC involved. Follow-up has been received from the reporting nurse, providing identifiers for the patients. This case refers to a currently 6 years old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was reported. On 16-DEC-2013, at age of 5 years old, the patient received (Oka/Merck) VARIVAX, lot# J004164, expiration date 8-APR-2015, which previously had been exposed to temperatures warmer than the recommended temperatures in the prescribing information. There were no adverse events reported. It was also stated that new thermometer was placed into the refrigerator and freezer on the first of the year and the reporting nurse was unaware of the defros cycle that occurred prior to the dew thermometer placement. This case is one of several reports from the same reporter. Additional information has been requested.
Enlarged lymph nodes under armpits, around ears, on neck and head that started growing larger over the next few weeks.
Day 2 began with headache, body aches, fever & sweats/chills.  Day 3 began ?covid arm? pain, swelling & itchy rash
Patient's daughter called at around 7:15pm to inquire which vaccine patient had received.  She claimed patient had become dizzy.  He leaned over to pick something up and fell down, receiving a gash on his arm.  She claimed that he had already received a pneumonia vaccine in the past and wanted to know if this might have been a factor precipitating patient dizziness. I explained that patient had not indicated to us at the time of signing vaccine consent form that he had received any previous pneumonia vaccine.  Explained to patient's daughter that depending on which he had received in the past, the vaccine given today would have been recommended.  She was not certain which he had received in the past.
Chills began at 11pm and stopped just before 2am. Took temperature was just above 100°F. Took Tylenol at 1am. Chills returned around 8:30am, lasted for 30 minutes, temperature was at 102°F, took Tylenol again. Another episode of chills just before 1pm, temperature was still at 102°F. Through out the rest of day temperature stayed between 100°F and 102°F. In the next morning fever is just below 100°F. Had fatigue throughout the while day and had a headache for 12 plus hours.
Numbness on the roof of my mouth, near my throat. Hot flashes, sweating, high blood pressure, the feeling of passing out, super hot throughout my body. Numbness in left cheek and upper lip. Swelling in left cheek and left eye. Dizzy.
Left deltoid area became red and itchy and muscle soreness 7 days after innoculation.  Area of redness initially plum size but grew to orange size and moved down my arm toward elbow.  Redness fading and pain gone but still itches. No adverse effect at time of vaccination other than muscle pain
The same day around 4:00 pm extremely tired didn't do anything for the same day diarrhea. For the first day i felt i was drunk. It went away  after a day. Swore on the arm. Menopaused after the first shot.
Febrile seizure 10-26-10 18:00 hour. Seen hospital ER.
pt reports she had bleeding at time of vaccination. barrier bandage removed, bandaid used instead.  Pt had swelling at injection site. This proceeded to 4 x 4.5 inch area by 10/10/21.  It was slightly darker in color than usual, slightly warm to touch, straight across bottom border.  By 10/11/21 bottom border had a sagging part likely due to gravity causing inflammation to move downward.  RPh advised pt to see dr if area gets larger, warm to touch, or if fever develops.
Both upper arms were slightly swollen and red. pt. felt achy and had fever x 1 day. No other concerns.
Fever,  chills,  whole body stretches,  headache, joint pain, very tired,  This will take a day or two to not  feel  tired. and a little  heavy breathing.
This spontaneous report as received from a physician and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of PROQUAD (Merck) lot # K010211 expiration date 17-JAN-2016, lot # L003222 expiration date 30-JUL-2016 and lot # L007228 expiration date 03-SEP-2016 (dose and route were not reported), were given to unspecified patients on unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date in November 2015, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency and route were unknown; lot number K020187 and expiration date was not provided). The following day, the patient developed redness, swelling and tenderness from the shoulder down to the elbow. The patient sought medical attention and received a steroid injection and the patient improved within a couple days and the outcome of the events were reported as recovered. The causal relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case was linked with 2018SA274273 (same reporter). This case involves 46 year old of unknown age who was accidently administered TUBERSOL (batch number: C5482AB) by intramuscular route instead of INFLUENZA VACCINE (batch number not reported) (expiration date, dose and site of administration were not reported for both the vaccine) on an unspecified date. The patients' medical history and concomitant medications were not reported. Patient had previous Positive PPD result. It was an actual medication error due to incorrect route of drug administration and Wrong vaccine administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received on 27-Sep-2018 from a pharmacist. Patient demographic updated. Previous vaccination was updated. Wrong vaccine administered event was added. List of documents held by sender: none.
chills; "headachy"; problems with balance; doesn't feel good; more pain than normal; chest pain, "not like heart pain" more like acid reflux.; a lot of fatigue; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.) and FATIGUE (a lot of fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032n20a and 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache, GERD, Vertigo and Heart attack. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, GLIMEPIRIDE (AMARYL), MECLIZINE HCL, METFORMIN, PREGABALIN, ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, LOSARTAN, PANTOPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN LOW).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.), FATIGUE (a lot of fatigue), NAUSEA (nauseous) and HEADACHE ("headachy"). On 29-Mar-2021, the patient experienced CHILLS (chills). On 30-Mar-2021, CHILLS (chills) had resolved. At the time of the report, BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.), FATIGUE (a lot of fatigue), NAUSEA (nauseous) and HEADACHE ("headachy") outcome was unknown.            Other concomitant product also include low dose aspirin, hydrochloroprol , invocana.  On 30 Mar 2021, the patient under gone lab test included blood work and urine test. However the results were unknown.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sore arm, tiredness, some shivering, nausea, rapid heart rate (80)
pt recv vax 1030AM & @ 2PM began to vomit, was lethargic & glassy eyes;vomited 6-8 times since;more alert 17JAN 11AM-taking fluids;