chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Throat clearing; fleeting hot flash; This is a spontaneous report from a non-contactable consumer. A 60-years-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration on 24Mar2021(at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The Patient was not tested for COVID-19 since the vaccination. On 24Mar2021, the patient experienced throat clearing and fleeting hot flash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported event. The clinical outcome of the Throat clearing and fleeting hot flash was recovered on unknown date.   Information about lot/batch number cannot be obtained. No further information is expected.
Myalgia; Shivering; Fatigue; Malaise; This non-serious case was reported by a consumer via call center representative and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-FEB-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myalgia (Verbatim: Myalgia), shivering (Verbatim: Shivering), fatigue (Verbatim: Fatigue) and malaise (Verbatim: Malaise). The outcome of the myalgia, shivering, fatigue and malaise were resolved.   It was unknown if the reporter considered the myalgia, shivering, fatigue and malaise to be related to Shingrix.     It was unknown if the company considered the myalgia, shivering, fatigue and malaise to be related to Shingrix.   Additional Information: GSK Receipt date: 14-APR-2023 The patient received a dose of Shingrix and experienced myalgia, shivering, fatigue, and malaise. Reporter consented to follow up.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX (lot # K008820, expiration date 19-JUN-2016, dose and route unknown). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Pregnant patient received 1st dose of Pfizer-BioNTech vaccine and experienced itchiness of hands and thighs within 15 minute observation period.  Patient received 25 mg oral diphenhydramine (Benadryl) and her symptoms resolved within another 15 minutes. est DOD unknown.
Patient reports headache with stabbing pain behind left eye which lasted a week. Right eye had blurry vision for 1-2 days. That evening had projectile vomiting and has had a touch of diarrhea off and on since then.
Pt devel a high fever 105 w/body rash, dehydration & a prod cough; pt was hospitalized x 24 hrs & tx w/mist tent, IV fluids, PCN; d/c on PCN VK dx bronchiolitis;
I got the shingles vaccine. I had bad headache, low grade fever, and fatigue for 1.5 days after the vaccine. My arm between my elbow and shoulder and injection site were very sore for about a week after the vaccine, to the point that I couldn't touch it at all.
devel mild paralysis & numbness in legs 3-4 days p/vax;hospitalized 1 wk w/dx of transverse myelitis;had inc in CSF protein;1DEC95 still has urinary incontenence & needs wheelchair for mobility;internist dx was post vax encephalomyelitis;
visible inflammation in collarbone; "felt a little warm"; dizziness; chills; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (visible inflammation in collarbone), FEELING HOT ("felt a little warm"), DIZZINESS (dizziness), CHILLS (chills) and MYALGIA (body aches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FEELING HOT ("felt a little warm"), DIZZINESS (dizziness), CHILLS (chills) and MYALGIA (body aches). On 16-Apr-2021, the patient experienced INFLAMMATION (visible inflammation in collarbone). On 16-Apr-2021, FEELING HOT ("felt a little warm"), DIZZINESS (dizziness), CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, INFLAMMATION (visible inflammation in collarbone) had not resolved. Not Provided
Child was incorrectly given an Adult Pfizer Vaccination instead of Pediatric Dose Pfizer. No adverse reaction or complication at this time.
some hearing loss; Numbness on the right of the face within five minutes of receiving treatment; tingling on right side of face; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS (some hearing loss) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050CUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced DEAFNESS (some hearing loss) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness on the right of the face within five minutes of receiving treatment) and PARAESTHESIA (tingling on right side of face). At the time of the report, DEAFNESS (some hearing loss), HYPOAESTHESIA (Numbness on the right of the face within five minutes of receiving treatment) and PARAESTHESIA (tingling on right side of face) 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 medication was provided. No laboratory data was provided. No treatment medication was given.  This case concerns a 36-year-old female with a serious unexpected event of deafness, and nonserious hypoaesthesia, and paraesthesia. Event latency within 5 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 36-year-old female with a serious unexpected event of deafness, and nonserious hypoaesthesia, and paraesthesia. Event latency within 5 minutes after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Within 12 hours I became extremely featured and within 18 hours has severe body aches resulting in bed rest for 36 hours.  My joint felt swollen and painful to move (including toes), zero appetite with associated weight loss and moderate to severe headache.
pt recv vax & days later began having pain & swelling & erythema in arm, progressing to large, painful cellulitis that looked like it may slough;saw MD as a f/u who prescribed ATB;area gradually resolved, but is still painful to touch;
delayed skin reaction to Moderna COVID-19 vaccine:  ~ 6 x 4 cm exanthema, with upper border at 6 cm from the site of inoculation
This spontaneous report was received from a vaccine coordinator and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, concomitant therapies, drug reactions or allergies was provided.   On unknown dates in 2016, between 11-NOV-2016 and 01-DEC-2016, the patients might have been vaccinated with improperly stored ROTATEQ orally, lot# M016918, expiration date: 15-FEB-2018 (dose was not reported). The administered doses of vaccine were stored in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Previously the vaccine was improperly stored in the temperature of 1.3 degrees Celsius for 11 hours 18 minutes, in the temperature of 1.4 degrees Celsius for 5 hours 32 minutes, in the temperature of 1.5 degrees Celsius for 9 hours and 42 minutes and in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Cumulatively the vaccine was stored in the temperature of 1.1 degrees Celsius for 43 hours and 18 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter.         Additional information has been requested.; Sender's Comments:  US-009507513-1612USA001131: US-009507513-1612USA009209:
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 09-FEB-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD with lot # N023967 (expiration date unknown)(Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis, reconstituted with MERCK STERILE DILUENT that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA006483.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient in her 80's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Polyethylene glycol (PEG)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Dose 2, Single), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Reported as, She was allergic to Polyethylene glycol (PEG) and remembers that when she called, someone told her that it contains 53 mg. However, she stated that she never had an adverse event when she received her first doses of the Pfizer-BioNTech COVID 19 Vaccine. Later she mentioned that she only had a sore arm but that's all. She said she was allergic to PEG on quantities greater than 1000mg. She waited between 4 to 5 months to receive her next dose of the COVID Vaccine. Patient who was in her 80's took three shots of the COVID-19 vaccine and would like to know more regarding the new booster vaccine because she had an allergic reaction with one of the ingredients in it. She also mentioned she was allergic to high doses.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201304036 Same reporter/patient/vaccine/events, different dose;US-PFIZER INC-202201304677 Same reporter/patient/vaccine/events, different dose;
Information has been received from a health profesional concerning "two patients" who were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Subsequently the patient did not show seroconversion. The nurse had no further patient information.  Unspecified medical attention was sought.  Additonal Information has been requested. FOLLOW UP Information has been received from a registered nurse who states the vaccinations were not given at her office. She reports that there is no way for her to obtain the lot numbers for the vaccine administered. No further information is expected.
chills; fever; like if the patient had been sick a few days; Phlegm/coughing up discharge of sorts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; ILLNESS (non-serious), outcome "unknown", described as "like if the patient had been sick a few days "; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Phlegm/coughing up discharge of sorts". Additional information: The patient wanted to share his/her side effects with after recent booster of the Pfizer bivalent vaccine. The patient had only been given all the prior Covid-19 vaccinations available to the patient at that time made by Moderna. This last and most recent booster was made by Pfizer and administered to the patient at his/her local (Facility name). The effects the patient had were more potent than that of Modernas prior ones. The patient had the chills, a fever and phlegm (reported as "flem") like if the patient had been sick a few days and coughing up discharge of sorts.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was retrieved via a search of scientific literature on 22 October 2013. Verbatim from the article: "A 3-month-old healthy female infant presented to the dermatology clinic with a 1 month history of blisters which began on her feet. The blisters developed 3 days after she received her routine 2 month immunizations (oral polio, DPT, HIB, and hepatitis B). The blisters had been increasing in both number and size and had spread to the patient's hands. She had no prior history of skin disorders and no family history of atopy. Physical examination revealed a well-appearing infant girl who was noted to have multiple 0.25 to 1 cm tense bullae on erythematous bases. The lesions were clustered most intensely on the ventral surfaces of the palms and soles, but also were present on the lateral digits and the dorsal hands and feet. Solitary lesions were also noted on her arms and legs. No lesions were noted on the patient's trunk, face, or perineum. Punch biopsies were performed of the lesional and perilesional skin from the dorsal right foot for both standard histologic analysis and for immunofluorescence studies. Laboratory evaluation including a complete blood count with differential was within normal limits, with the exception of a mild peripheral eosinophilia (8%). Hematoxylin and eosin staining clearly demonstrated a subepidermal bullous dermatosis with an intense mixed inflammatory infiltrate containing numerous eosinophils within the dermis. Periodic acid-Schiff stain for fungi was negative. Gram's stain was negative. Direct immunofluorescence of perilesional skin revealed linear staining of IgG along the basement membrane zone. Staining of complement component C3 was also seen in the same distribution. Staining for IgA, IgM, and fibrinogen was negative, and no circulating anti-basement membrane zone antibodies were detected in the patient's serum. The mother's serum was tested and found to be devoid of circulating anti-basement membrane zone antibodies. Neither salt-split skin testing or immunoblot assay was performed. After a potent CYCLOCRT ointment was applied, her blisters resolved completely at 6 weeks with only mild postinflammatory hyperpigmentation and no textural changes. One year after resolution of her lesions the patient has had no further outbreaks and has continued the recommended schedule for routine childhood immunizations." Documents held by sender: none.
heart racing; This is a spontaneous report received from a contactable male consumer. This 53- year- old male consumer reported for himself that: A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0171 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 21Apr2021 14:20 (age at vaccination was 53-year-old) as DOSE 1, single dose for covid-19 immunisation. Medical history included ongoing diabetic, ongoing breathing problems, heart stent from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no adverse events following prior vaccinations. The patient had no additional administered vaccines and no vaccines administered on same date with the Pfizer vaccine considered as suspect. He had his first Covid 19 vaccine yesterday, on 21Apr2021 21:00 patient experienced heart racing. He did not know that the Covid 19 vaccine could cause that. He reports his heart started to race right away after receiving the Covid 19 vaccine. He did not check his heartrate, he just knows that it was fast. It's also irritating to him because he has a history of heart issues. He didn't know he would get this particular side effect. He thought, he has to go to the emergency department, but his heart rate slowed down around 9:00PM last night, 21Apr2021. The patient had no relevant tests. The patient did not visit emergency room and physician office. The outcome of the event was recovered on 21Apr2021.  No follow-up attempts are needed. No further information is expected.
Immediate headache that lasted 5 days although I took ibuprofen,  fatigue, nausea, joint pain in left arm, back, hip, knees . Itchy left arm about 2 days after that has continued to this day.
I noticed a welt that formed at the injection site. It is warm to the touch and if pressure is applied there is some discomfort/pain. I noticed the welt the morning after I got the 2nd dose of COVID19 shot. I have no known allergies.
1st shot hurt too much; Got one shot because the 1st hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received 1st  dose of Shingles which hurt too much and therefore the patient did not receive next shot, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Moderna 2/24/2021, 3/25/2021, 11/8/2021. Positive on 7/12/2022.
Patient got a FLUZONE High Dose shot on 11/6/13 at pharmacy. She already had one flu shot on 10/1/13 at Dr's office too. It was a duplication. Patient did not have any side effects and did not need any treatment of any kind.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that dosesof VAQTA (dose, route and lot# not reported) that were exposed to a supported temperature excursion that occurred on 29-JUL-2014 had been administered to unspecified patients on unspecified dates. The reporter reported that she had not been informed of any adverse effects. It ws unknown if the patients sought medical attention or not. At the time of report, the status of patients was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Started with a fever within a few hours of getting vaccines. Then the next morning parents noticed a rash that looked like hives on abdomen and in inguinal area.
Warmth, swelling and erythema (5x5x3cm) on bilat upper extremities at site of vacccination.
Left arm pain at injection site remains after 7 months, Cataract in right eye rapidly progressed to the point of requiring replacement
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992: