chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Glomerulonephritis (inflammation of filters in kidneys); Blood in urine; fatigue; edema; swollen left eyelid; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER/BIONTECH) via an unspecified route of administration on the left arm in Feb2021 at 01:45 PM (Lot Number: EN6201) as single dose for COVID-19 immunizaiton. Medical history included inflammation, immunity, profound deafness and have familial hypertension. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. The patient was a Congenital Rubella Baby w/lifetime immunity. The patient didn't received other vaccine in four weeks. Concomitant medications included amitriptyline, atenolol and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), all taken for Congenital Rubella Baby w/lifetime immunity. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Jan2021 at 01:30 PM (Lot Number: EL9261) as single dose for COVID-19 immunizaiton. In Apr2021, the patient experienced glomerulonephritis (inflammation of filters in kidneys), blood in urine, fatigue, edema and had swollen left eyelid. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included 2 antibiotics, neither worked; ultrasound lower ab. The outcome of events was not recovered.
It was the Pfizer Vaccine. I received the vaccine at 11:30 am Sunday. At approximately 3:30 pm I started having a lot of pain in my legs (calves and feet) at first it was extreme pain that led to tingly prickly sensations. I went home, went to bed, was up all night in bed groaning because of the pain, and when I tried to stand, was unable to. I crawled to my phone and called my sister (who lives next door) who ran over. She has a wheelchair and took me to the hospital.  I was unable to walk alone for four days and the pain was not as extreme after 5 days. I am now 3 weeks out and still have numbness in my legs.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 01Feb2023 to 05Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported sore arm the evening of vaccine administered. Fever, chills, headache and very sore arm the next day (24 hours). Feeling better on the 2nd day but arm more painful and swollen. Reports red blotchey rash. Resolving by 3rd day.
Started as small pain in area of flu vaccine, then grew to serious pain in arm of vaccine during late January of 2015 and persists currently.  Unable to diagnose with neurologist and primary MD.
Mom called 15MAY92 reported that pt who recvd DTP/MMR/OPV on 13MAY92 had adverse rxn stated pt exp severe h/a, vomiting & t102-103 high fever approx 30" p/inject; parents took pt to MD who dx immun rxn;
suspected vaccination failure; has now developed Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 99-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On an unknown date, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2 doses of shingrix vaccine one and half year ago and got shingles. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
fever up to 103.3, shakes, chills, severe body aches, loss of appetite, fatigue, sore arm
also experiencing itches on gluteus and elbows; patient feels confused; itchy rash appeared on her legs, on the outside of the thighs; slight itching in her legs and back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight itching in her legs and back), RASH PRURITIC (itchy rash appeared on her legs, on the outside of the thighs), PRURITUS (also experiencing itches on gluteus and elbows) and CONFUSIONAL STATE (patient feels confused) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Candida infection. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced PRURITUS (slight itching in her legs and back). On 16-Jan-2022, the patient experienced RASH PRURITIC (itchy rash appeared on her legs, on the outside of the thighs). On an unknown date, the patient experienced PRURITUS (also experiencing itches on gluteus and elbows) and CONFUSIONAL STATE (patient feels confused). At the time of the report, PRURITUS (slight itching in her legs and back), RASH PRURITIC (itchy rash appeared on her legs, on the outside of the thighs), PRURITUS (also experiencing itches on gluteus and elbows) and CONFUSIONAL STATE (patient feels confused) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she is not sure about what caused rash, because she explained started taking a naturopathic pills for Candida around the same time as the booster, but she stop medication when she noticed about rash. No treatment has been given.   This case was linked to MOD-2022-456397 (Patient Link).
outrageously sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles multiple times and each time). Previously administered products included Antiviral  (started on an antiviral which stopped shingles each time).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: outrageously sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient received the vaccine which made him or her outrageously sick but to this point the patient thought it was been effective. It was hard to know however, because the patient did not know what his or her exposure had been. The follow-up could not be possible as no contact details were available.
devel fine pinpoint sized red raised rash on chest; buttocks devel blisters pinpoint sized next day; t101;
We inadvertently administered the vaccine past the 30-day Use by Date. According to the manufacturer the vaccine administered on June 8, 2022 from lot number 065K21A likely did not  maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Extreme dizziness/lightheadedness when standing up from a reclined position. This happened after my 2nd dose as well and lasted for several months. It started happening again after my booster dose.
myalgia; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (myalgia) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and GABAPENTIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NAUSEA (nausea). On 09-Feb-2021, the patient experienced MYALGIA (myalgia). On 09-Jan-2021, NAUSEA (nausea) outcome was unknown. On 10-Feb-2021, MYALGIA (myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment was not specified.   This case was linked to MOD-2021-297337 (Patient Link).
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones.  I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29.  There was the normal injection site soreness on the evening of the first day.
Information has been received from a consumer referring to her 16 years old daughter. The patient was not pregnant. The patient had no medical history and drug reactions or allergies. On an unknown date in 2011, the patient was vaccinated with her first dose of GARDASIL (0.5 ml, lot # and expiry date unknown, intramuscular). There was no concomitant therapy reported. In 2011, almost immediately following her first intramuscular injection, the patient experienced grand mal seizures. The patient's mother also noticed at that time that her daughter's mental acumen began declining (The patient was previously an honor student in school). On unknown dates, the patient was vaccinated with her second and third dose of GARDASIL (0.5 ml, lot # and expiry date unknown, intramuscular). On an unknown date, the patient's mother took the patient to a neurologist who ran a battery of tests including electroencephalogram (EEG), nuclear magnetic resonance imaging (MRI) and computerised tomogram (CAT scan). Subsequently, the test results determined the patient was "mentally challenged". In September 2014, the patient was hospitalized at a hospital for 2 days due to severe seizures (started in September 2014). The patient was also prescribed TEGRETOL (generic) by the neurologist to lessen seizures. The patient's mother also stated that the patient was still suffering from severe seizures. The outcome of grand mal seizures, mental acumen decline and "mentally challenged" was unknown. Causality was not provided. The events were considered to be disabling by the reporter. Upon internal review, the severe seizures and grand mal seizures were determined to be medically significant. Additional information has been requested.
A raised, red patch appeared on the same arm and spot where the vaccine was administered.  Only explanation I can think of is the vaccine.  It was there for about 48 hours.  It was only slightly itchy and irritating.   Now at day 3 it isn't raised, but still slightly red.  It's about a 2 inch x 4 inch oval.  No other symptoms were experienced.
Alerted by vaccination RN at 12:01 PM that the first 8 doses administered of the day had been given in insufficient amount. The RN stated she realized with the last patient of the morning (receiving dose #9) that the syringe was not the 3mL syringe she was used to using, and was in fact a 1mL insulin syringe. She noted that she had been drawing up the vaccine up to 5 (meaning 5 unit, equivalent to 0.05mL) rather than to 50u to give the full dose (0.5mL).  She stated she recognized her error with patient #9 and administered the correct amount (0.5mL) from a 3mL syringe she was used to using.  In addition to contacting the agency's COVID-19 provider, the patient was contacted and informed of the incident and asked to reschedule to come back in to receive the full dose (per CDC guidance) as soon as possible. Left a VM for the patient to call back. A follow-up call will be made 5/19 to follow-up. At the end of the day, when counting dose administered and factoring in the estimated amount of vaccine wasted due to insufficient dosages, there was just under 9 doses accounted for. The vaccinating RN was questioned again to see if there was any possibility any of the initial 8 patients received a full dose of the vaccine without her realizing it. She stated she did not believe she ever drew up the 1mL syringe to 50u nor administered a 0.5mL dose using the 3mL syringe, though she stated she couldn't say for sure. She said the container holding the syringes had each type divided in one compartment and separated from each other. The COVID-19 provider was informed of this information and additional guidance was requested.
Facial redness; Heat or warmness on her face; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Facial redness) and FEELING HOT (Heat or warmness on her face) in a 52-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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (Facial redness) and FEELING HOT (Heat or warmness on her face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Facial redness) and FEELING HOT (Heat or warmness on her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Chills; Feeling Achy; Flu like Symptoms; Sweating; rash all over body; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PAIN (Feeling Achy), INFLUENZA LIKE ILLNESS (Flu like Symptoms), HYPERHIDROSIS (Sweating) and RASH (rash all over body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 026A21) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease, Depression, Cholesterol, Arthritis, Penicillin allergy and Latex allergy. Concomitant products included MELOXICAM for Arthritis, PRAVASTATIN for Cholesterol, CELECOXIB (CELEXA [CELECOXIB]) for Depression, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Graves' disease.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (Chills), PAIN (Feeling Achy), INFLUENZA LIKE ILLNESS (Flu like Symptoms), HYPERHIDROSIS (Sweating) and RASH (rash all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, CHILLS (Chills), PAIN (Feeling Achy), INFLUENZA LIKE ILLNESS (Flu like Symptoms), HYPERHIDROSIS (Sweating) and RASH (rash all over body) outcome was unknown.            This case was linked to MOD-2021-079438 (Patient Link).
Congestion; fatigue; muscle aches. Tested negative for COVID on April 19, 2021. Previously had COVID in December 2020.
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration date was not reported) on the left arm on 01Feb2021 (14:00) as dose 1, single, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included contrast dye allergy, and lime and cooked lemons allergy. The patient's concomitant medications were not reported.  The patient previously took morphine, and had drug allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On an unspecified date in 2021, the patient had soreness at the injection site. The patient had received aspirin as treatment for the event. The outcome of the event was recovered on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Severe vertigo. ENT determined not inner ear but middle ear was causing it.  Imaging done (MRI, CT scan) to rule out structural causes or clot. Severe enough MDs evaluating him though he was having a stroke.
Information has been received from a physician concerning a 10 year old male who was recovering from pertussis, with penicillin allergy and sulfonamide allergy and a history of a very severe cellulitis who on 09-JUN-2009 was vaccinated with VARIVAX (Merck) (lot# 664018/0475Y, 0.5ml, subcutaneous injection). Concomitantly, the patient received a tuberculosis skin test. On 10-JUN-2009 the patient developed local injection site reaction after vaccination. The patient had red, swollen, hot, itchy area that covered most of the upper arm. The patient saw the physician for treatment, and an antibiotic was given to the patient. At the time of reporting the patient was not recovered. Follow-up information has been received from the physician concerning the 10 year old male with asthma, penicillin allergy and sulfonamide allergy and a history of a very severe cellulitis who on 09-JUN-2009 (at 4:00 PM or so) was vaccinated into left arm with a dose of VARIVAX (Merck) (lot# 664018/0475Y, 0.5ml, subcutaneous injection). At the time of vaccination the patient was "recovering from pertussis". The patient was seen by physician and recovered on an unspecified date. No further information is available.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/07/22. When error discovered facility contacted for course of action. At direction, patient outreached regarding occurrence to offer re-vaccination of dose. No adverse side effects or event as result of dose.
Began with joint pain, then chills, then fever, abd cramping and diarrhea - better after 24 hours
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration  were not reported) that underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one several reports from the same reporter. Additional information has been requested.
Myalgia, Fever, NauseaVomiting, R ARM HOT WITH REDNESS, PAIN, SWELLING Narrative:
pt devel a fever of 102 in evening same day of vax;also had dec appetite, cough & runny nose;parent stated that pt cried alot & had  a cough & temp of 102.5;pt stopped stopped breathing;
About 16 hrs after influenza vaccine adm. pt. experienced fever of 101.8 degrees oral, whole body sweating, body aches, HA, S/S improved within 7 hrs. Ret'd to work 10/15/09.
Patient presented to ED on on 9/11/21 after experiencing 3 days of abdominal pain, diarrhea, and confusion.  Patient denied any respiratory symptoms and was not found to be hypoxic. A CT abdomen/pelvis showed inflammatory changes suggesting portal colopathy/rectal varices vs proctitis, signs of cirrhosis, and a hypodense lesion in the spleen. A COVID test was done in the ED on 9/11/21, and it came back positive. Patient is fully vaccinated for COVID (s/p 3 doses of Pfizer vaccine on 2/3/21, 2/24/21, and 8/17/21). Patient was admitted for further work-up and remdesivir was started because her MD believed the diarrhea was mainly due to COVID. Lovenox was also started as VTE prophylaxis. Patient is currently on day 2 of hospitalization and is still saturating well on room air.
Rash on neck with itching and burning, throat swelling with difficulty swallowing, taken to ER given EPIPEN and other meds, reaction subsided, monitored for 3 hours in ER.
She got her vaccine, my arm was sore at the site and had a little lump.  She had fatigue the rest of the day.  She was coming out of her bathroom around 7:00 and got to the dining room and could not move either leg to take another step.  Her husband gave her a chair and called an ambulance and taken to Hospital.  She was admitted and given 3 days of intravenous steroids, blood work.   She was then admitted to a rehabilitation center at.  She was there for 14 days and then transferred now to another facility.  She is there now for rehab as well and can be there for up to 20 days.  She still can't walk and she's there to get her up and on her feet.  She can walk but has to have two people on each side of her to do so.    HOSPITALIZATION:  3 days untli 4/27/21,  4/27/21 to 5/14/21:  14 days at Rehab. 5/14/21 to  present:   Rehab facility and will be there until June.
Acute sneezing x 10 Min followed by shacking chills, temp 102, severe muscle aches, headache, sore throat lasting 16 hours
Although I had shortness of breath since my second or third shot on 11/128/21 and 7/12/22 I did not equate it to the vaccine. However it did interfere with my wok cleaning my property and generally grounds work and cleaning. I just thought I was getting old.  On March 15, 2023 I was moving snow after a severe storm the day before when I got a sudden tightening in my chest. I stopped immediately and went in side. The very next day was my yearly physical. They did an EKG after I told them what had happened and there was signs of minor damage. They ordered a stress test and when I started the test on. a incline machine, within five minutes my blood pressure shot so high they said we had to stop the stress test so an to not have me "stroke out". I was unfamiliar with the term but got the gist of it and stopped and lay down.  Since that time I have been prescribed Losartan (50 ml) and the chest pain is almost gone but after Physical therapy my bp shoots up after exercise like it did on the treadmill. My shortness of breath persists.  I never took pharmaceuticals and prided myself on having a healthy lifestye and eating habits. I wore a mask throughout Covid until April of this year.  Tested for covid before visiting family and generrally have been healthy although about 15 pounds overweight (175) up from my long standing 160lbs. since 50.
Pt developed pain, redness and swelling at the site of injected immunization. Too soon to know if recovered. Treated with antibiotics.