chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/20/22 Telephone call:  Symptomatic date: 1/20/22. Current symptoms: fever, fatigue and body aches.
On 8/22/00, mother called to report a reaction that occurred, 1 year ago. Mother states pt's left arm was very swollen, post vax, and very painful. Symptoms lasted 1 week. Mother took child to ER or walk-in medical center (unclear about this). Mother told doctor about the incident. Called doctor's office and gave date of #1 Hep-B and TD booster. Per mother, child has been dx'd with many allergies. Was tested when an infant and several years later and to be tested again this year. Will return to doctor for #2 and #3 Hep-B if doctor thinks it is alright to give same.
vertigo, dizziness, vomiting vertigo, dizziness lasted for 3 days!
Patient said she felt/heard a pop and severe pain during administration. She is still feeling pain and her arm hurts during movement.
Headaches , back pain, heightened sensations in tongue, fingertips, with numbness in the hands and feet: Bell's Palsy and GBS.
RASH ON HER WRIST; TIRED; This spontaneous report received from a patient via a company representative concerned a 70 year old female (Patient 1). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced rash on her wrist. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her wrist on MAR-2021, and the outcome of tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210342307.
Confluent redness left upper arm onto the shoulder, warm and tender. Secondary cellulitis.
servere diareeha , headake , chills, pain. since have the runs on and off.
Dizzy, low blood pressure, tingling in hands and feet. Patient was  placed in supine position, legs elevated. Oxygen was administered. BP slowly returned to normal, he was slowly transitioned from supine to sitting then standing and was able to walk out of office on his own. Event lasted about 1 hour.
pt seen by FNP  & noted flushing of face, peri-orbital edema, pain & redness @ site of inj;DPH given;BP 108/75, flushing of face had diminished as well as edema & pain in lt arm;
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter (Master case)
Warm to touch at the injection site; Hard spot at the injection site; Slight itching at the injection site; Red spot at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021 and was forwarded to Moderna on 22-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hard spot at the injection site), VACCINATION SITE PRURITUS (Slight itching at the injection site) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hard spot at the injection site), VACCINATION SITE PRURITUS (Slight itching at the injection site) and VACCINATION SITE ERYTHEMA (Red spot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hard spot at the injection site), VACCINATION SITE PRURITUS (Slight itching at the injection site) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment information was not provided
2wk p/vax 8AUG96 began having fatigue, sl fever, loss of appetite, sinus-like h/a, sl sore throat & aching;had some sx p/each of the 3 prev shots; saw MD p/2nd shot 4FEB93 & was told it would run its course;
This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Is a fever a side effect of the Moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Is a fever a side effect of the Moderna booster). At the time of the report, PYREXIA (Is a fever a side effect of the Moderna booster) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medicines were reported. No treatment medicines were reported.
Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine; Mild flu; Mild pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine), INFLUENZA (Mild flu) and VACCINATION SITE PAIN (Mild pain in the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INFLUENZA (Mild flu) and VACCINATION SITE PAIN (Mild pain in the injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine) and VACCINATION SITE PAIN (Mild pain in the injection site) outcome was unknown and INFLUENZA (Mild flu) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication information was proviided   This case was linked to MOD-2021-375208 (Patient Link).
Patient received first dose of Moderna received on 3/30, second dose received on 4/18, which is 10 days too early.
Pt vaccinated with Engerix-B felt bad all over my body, sick stomach, felt light head, arm a little stiff.
Very swollen painful injection site, fever 102.2 F, chills, muscle aches, fatigue, weakness.
Erythema Multiforme (minor) - clinical diagnosis based on morphology 10 days after first coronavirus vaccination (Moderna) patient developed targetoid papules and small plaques, primarily on the hands and slighly on the feet. Mostly dorsal surfaces.   He has no mucosal involvement.  Symptoms and signs are clear but not severe.   I prescribed topical fluocinonide 0.05% ointment.  This was two days ago, and so I do not have follow-up
"14mins post vaccination pt c/o dizziness, hot flashes/feeling warm. NO other new/abnormal sxs.  Vitals @10:02 BP 135/90, HR 68 O2 Sat 100%. Pt was monitored an additional 10 mins, given fluids.  Pt verbalized improvement to sxs.  Given ok to be released from clinic. A&Ox4. Pt stable and released from vaccination site.  ED precautions given. PMH significant for Asthma, Allergic Rhinitis, GERD, gallbladder disease, fatty liver, and diverticulosis. Pt had a recent visit to the ED 7/19 for acute on chronic abdominal pain. Current Medications: No active prescriptions for this patient."
This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave the vaccine past the 12 hours it is supposed to be outside) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave the vaccine past the 12 hours it is supposed to be outside). On 21-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Gave the vaccine past the 12 hours it is supposed to be outside) 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. No concomitant medications were provided. No treatment medications were provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 045A21A)  with no associated AEs.
Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 10-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-348333 (Patient Link).
15 year old patient inadvertently given pfizer COVID vaccine booster. Booster currently approved for age 16.
This case was reported by a other health professional via call center representative and described the occurrence of gastrointestinal disturbance in a female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced gastrointestinal disturbance (serious criteria GSK medically significant), constipation, diarrhea, vomiting, general body pain, headache, drug dose administration interval too short and off label use. On an unknown date, the outcome of the gastrointestinal disturbance, constipation, diarrhea, vomiting, general body pain, headache, drug dose administration interval too short and off label use were unknown. It was unknown if the reporter considered the gastrointestinal disturbance, constipation, diarrhea, vomiting, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported for the reporter's friend. The age at vaccination was not reported. The batch number for SHINGRIX was not provided. It was reported that patient was advised by her doctor to receive the 2nd dose of SHINGRIX one week after receiving the 1st dose, which led to shortening of vaccination schedule and might lead to off label use. The patient subsequently experienced headache, body aches, vomiting, diarrhea, constipation and digestive blocking. It was reported that the patient might be vulnerable to the vaccine reaction. It was reported that this was an anecdotal event and she did not have other details.
VACCINE HAS GOTTEN RID OF THEIR BLADDER INCONTIENCE / HELPED WITH NERVE DAMAGE; This case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included bladder incontinence and nerve damage (had from previous shingles).   In December 2020, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter wanted to provide positive feedback for the Shingrix because the vaccine had got rid of their bladder incontinence and that previous never damage from shingles was going away. The reporter consented to follow up. The case had been linked with case US2021044025, reported by the same reporter. Note: It was unknown if the vaccine was administered to more than 1 patient hence case was conservatively kept as valid with unspecified number of patients. The clarification has been raised for the same (patient's quantity).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021044025:same reporter, different patient (female)
Blisters/lesions in mouth lasting close to three months (biopsy was performed).  White and red blood cells and other areas of my labwork/bloodowork were off severely enough I was referred to both hematologist/oncologist and rheumatologist. I had severe dizziness and confusion lasting close to two months.  Pain in all my joints, but mainly in legs and hips.  Blood spots appeared on my chest, back and stomach and occurred when dizziness was present.  I  still occasionally have blisters in my mouth, but the symptoms have gotten a little better with time.
Itchy at injection site; Rash at injection site; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported.
Lethargy noted by mom @ 12 am 8/1/07. Unable to fully awaken for feeding. Slept constantly seem listless. Sxs didn't resolve until 3 pm 8/1/07. Semi-conscious state
This case was reported by a physician via sales rep and described the occurrence of intussusception in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown. It was unknown if the reporter considered the intussusception to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had seen patient that developed intesessuption after having received ROTARIX. No specific details were available. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to the cases US2019GSK048422 and US2019GSK048421, reported by same reporter.
A report has been received from a Health Professional concerning a male subject who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on 07-Nov-2015. The patient reported NOT FEELING GREAT which started on 09-Nov-2015. The outcome of the event of NOT FEELING GREAT is unknown. The report was considered to be non-serious by the company physician.
Information has been received from a physician concerning a female patient of unknown age who was enrolled in a market research. When the patient was a child (date unspecified), she was vaccinated with M-M-R (manufacturer unknown) (lot #, dose and route unspecified). On an unknown date the patient experienced hurt like a stink and she stayed with her physician. The outcome of the event was resolved with sequelae. The reporter considered the event to be related to MMR (manufacturer unknown). Additional information is not expected as the reporter was not willing to contact to discuss further.
According to child's mother, right leg swollen to the size of a grapefruit. Area red, warm to touch, area resolved in 3 days. Child was not seen in the clinic during time leg was red.
pt rcvd vax; hives after 5 days of vax; fever; rash; pt taken to ER; pt dx w/ jaundice & edema face-hands & no notes of either on ER paperwork-BC per mom;
TCustomer said they had a 1 year old patient who was scheduled to receive VARlVAX and MMRlI, but the patient received VARlVAX and PROQUAD concomitantly.Confirmed with the customer no other AE occurred/patient received each vaccine in different arms; Customer said they had a 1 year old patient who was scheduled to receive VARlVAX and MMRlI, but the patient received VARlVAX and PROQUAD concomitantly.Confirmed with the customer no other AE occurred/patient received each vaccine in different arms; Customer said they had a 1 year old patient who was scheduled to receive VARlVAX and MMRlI, but the patient received VARlVAX and PROQUAD concomitantly.Confirmed with the customer no other AE occurred/patient received each vaccine in different arms; This spontaneous report was received from a Medical Assistant and refers to a 1-year-old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 12-JUL-2021, the patient was vaccinated with 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T037643, that was verified to be valid, with an expiration date reported and verified as 06-NOV-2022) and 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (lot number T036565, that was verified to be valid, with an expiration date reported and verified as 26-APR-2022) concomitantly in different arms for prophylaxis (concentrations, dose numbers, vaccination scheme frequencies, routes and exact arm  of  each administration were not provided). It was stated that the patient was scheduled to received varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (concentration, dose number, vaccination scheme frequency, lot number and expiration date were not provided) (wrong product administered) (product prescribing issue). No additional adverse events were reported.
Patient c/o of pain at injection site after school.  Parents checked site and saw that it was swollen and red.  Woke up the morning of the 15th and it was even more swollen, red and painful.  Parents brought child ion for an appt with physician.