chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in both legs; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient (brother-in-law). A 63- years- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided; 63-years-old at time of vaccination) via an unspecified route of administration, on 28Mar2021 11:00, at unknown dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (on 07Mar2021, unknown arm) for COVID-19 immunization had Numbness in leg (1 week after vaccination of first dose). The reporter stated that the patient received his first vaccine and started to have some side effects. His legs were numb with the first (on an unknown date in Mar2021). He then went back to get the second one and was still experiencing numbness in the legs. The reporter spoke to the patient last night and said that he has seen a doctor but has not gotten any treatment not anything at all. Further stated It happens in the mornings and in the evenings. Started like a week after the first vaccine. Then it started again, a week after the second. He was still experiencing this now, It has not gotten any better and is very concerned. He was not taking any medicine at all as Treatment. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pfizer-BioNTech COVID-19 Vaccine EUA  drive thru vaccination clinic - Patient with complex medical history including multiple allergies experienced reaction within minutes of receiving dose #1. Premedicated with benadryl and sublingual allergy med. Reaction include tingling and numbness with thickness of tongue, difficulty swallowing and chest tightness. She has NTG but has never had to use. 911 called and patient brought to ED. Seen and discharged after patient felt better.
Moderna vaccine administered on 1/20/22 had expired on 1/19/22. There was no temperature excursion.
a patient had been administered with an expired FLUZONE HIGH DOSE with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from  a other health professional.  This case involves 75 years old female patient who had been administered with an expired influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Oct-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot UJ928AA, Expiry date : 30-Jun-2023, Frequency : Total, formulation, strength was unknown) via intramuscular route in the arm not otherwise specified for Immunization and had been administered with an expired fluzone high dose with no reported adverse event (expired product administered) (latency : same day) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event a patient had been administered with an expired fluzone high dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
By 2:00 on 2/16/21 member had severe chills, by 4:00 a.m. fever of 101, body aches all over, severe headache from back of neck to top of head, in bed all day Sat with 102 fever; Sunday diahhrea and body aches and headach; Monday body aches and headache and also today. Also has lower back pain in kidney area.
SUSPECTED COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced death from covid-19 (suspected covid-19 and suspected clinical vaccination failure). On an unspecified date, Laboratory data included: COVID-19 virus test (NR: not provided) positive. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211262948- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.  V0: 20211262948- Covid-19 vaccine ad26.cov2.s- Suspected covid 19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID-19
Have about 6 in round red raised rash at injection site after 2 weeks with Moderna vaccine
myositis-ck 170 (nl 30-170);? GBS;weak muscles-legs & fever;
3 yr old received HIB #4 and H1N1 nasal mist. Was exposed to H1N1 case the day before she got vaccines. Developed hives, fevers x 3 days and began stuttering the day after vaccines given.
no adverse event has been reported; parent provided incorrect birth year for child, which led to child receiving a COVID vaccine inappropriately (child was under age 5, but received Pfizer for ages 5-11)
swelling (left) arm; stomach ache; itching; Warm; redness; pain at injection site reemerged; pain in injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in injection site), HEADACHE (headache), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling (left) arm) and ABDOMINAL PAIN UPPER (stomach ache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced INJECTION SITE PAIN (pain in injection site) and HEADACHE (headache). On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site reemerged). On 21-Mar-2021, the patient experienced ERYTHEMA (redness), ABDOMINAL PAIN UPPER (stomach ache), PRURITUS (itching) and VACCINATION SITE WARMTH (Warm). On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling (left) arm). On 19-Mar-2021, INJECTION SITE PAIN (pain in injection site) and HEADACHE (headache) had resolved. On 23-Mar-2021, ERYTHEMA (redness), PERIPHERAL SWELLING (swelling (left) arm), ABDOMINAL PAIN UPPER (stomach ache) and PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (pain at injection site reemerged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       For treatment patient consulted HCP nurse campus care
Left side of face went numb for approximately 3 weeks along with tinnitus. Numbness has subsided but tinnitus and hearing loss is still present. Severe congestion.
patient reports that he recently contracted Bells Palsey; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (patient reports that he recently contracted Bells Palsey) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced BELL'S PALSY (patient reports that he recently contracted Bells Palsey) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (patient reports that he recently contracted Bells Palsey) outcome was unknown.            No concomitant medications were reported.  The patient reported that he received COVID-19 vaccinations primary series and booster doses The patient has had the Moderna Primary Series and has had two Moderna Booster dose. The patient reported that he recently contracted Bells Palsey.  No treatment medications were reported.  Company comment. This spontaneous case concerns a male patient (unknown age), with no medical history reported, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the expected, serious (medically significant) of Bell's palsy. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The patient reported he recently contracted Bell´s palsy. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The patient previously received a primary schedule and booster doses with mRNA - 1273. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient (unknown age), with no medical history reported, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the expected, serious (medically significant) of Bell's palsy. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The patient reported he recently contracted Bell´s palsy. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The patient previously received a primary schedule and booster doses with mRNA - 1273. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 9/6/2022 Discharge Date: 9/8/2022  PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 83 y.o. male  who presented to hospital on 9/6/2022. The patients symptoms started 1-week prior to admission the coughing got worse 3 days  prior to admission and decided to go to the ER he was found to Have COVID-19 viral pneumonia with a mild diastolic CHF-exacerbation and acute hypoxic respiratory failure. The patient required supplemental oxygen which has since been weaned off. The patient received 3 days of remdesivir and decadron while hospitalization. Will continue decadron for an additional 4 days to complete a total of 7 days of treatment. The patient has mild steroid induced hyperglycemia. He will continue his home dose of insulin, he has been receiving a reduced dose of long-acting insulin since admission.  The patient has a known history of A-fib, he has recurrent bradycardia on telemetry. Will plan for a zio patch at discharge and have him follow up with cardiology for the results. He is not currently on any rate controlling medications. An echocardiogram was completed and shows a left ventricular ejection fraction is 59% and grade II diastolic dysfunction, Grade II (pseudonormalization pattern). He was diuresed with 1 day of IV lasix and will be switched to his home dose of oral furosemide 40 mg BID. Recommend outpatient follow-up with PCP for post-hospitalization follow-up and coordination of care.
On 6/19/00, pt collapsed and was admitted to the hospital with chest pain, asthma.  20 days, post vax, pt collapsed again and was seen by private neurologist who "confirmed" reaction to MMR. 60 day follow-up dated 9/26/00 provided no additional data.
1628 itching at site of injection, Benadryl 25mg given po, 1643 little itching of ear same side as injection, 1648 itching inner eyes, monitoring patient another 15 minutes, 1703 no increase in itching, "not any different, not progressing",  denies rash, patient left after discussing with NP.
Tested positive for Covid 4 months after second dose. 104.5 fever cough stuffy nose and chest. Lips turning white. Very fatigue.
I?ve never been so sick in my life. The first dose wasn?t too bad but this time I was vomiting so violently that there was a profuse amount of blood coming out for 3 hours. I?ve never experienced a migraine but I?ve had an extremely painful and debilitating migraine since 4am. Around 10am I was dry heaving and vomiting up bile. I have excruciating back pain since 10pm last night, horrible full body chills, fever of 102, skin, and light sensitivity.
Patient received vaccine 10/01/2013. Complaint is arm is still sore, as of today 10/22/13.
Moderate muscle and whole body aches. Mild to moderate itching from head to toe. This lasted through the night. The next morning I felt a little better. Then developed a moderate cough, mild chest pains and sinus.
Swollen lymph nodes on Left underarm; Painful to move; Swelling at injection site; Low grade fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9263) via an unspecified route of administration on the left arm on 22Jan2021 16:30 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa. Concomitant medication included atomoxetine hydrochloride (STRATTERA) and bupropion hydrochloride (WELLBUTRIN). On 23Jan2021 02:30 AM, the patient experienced swollen lymph nodes on Left underarm. Painful to move. Swelling at injection site. Low grade fever and fatigue day 2 and 3. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
101 year old suffered an acute stroke due to ischemia. Patient had 5th dose of Pfizer covid-19 vaccine on December 7, 2022. Patient has never had a prior stroke event.
Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s  and chills 12 hours after injection lasting for 48 hours after. Took 800mg ibuprofen every 6 hours through 48 hours post injection with relief of myalgia?s and chills.
This pt experienced right thigh red and swollen and tender. Onset began within a few hours of Hib and Prevnar (right thigh). Very fussy, crying infant.
Bright red, hot to touch, swelling, blotchy rash covering her entire upper thigh.  Returned to doctor 10/07/2019 and was told she had a bacterial infection in the injection site under her skin. She is taking  5 milliliters of Cephalexin for a week.
Headache, Myalgia, & NauseaVomiting Narrative: dose 1- day 1-2 sorearm dose 2- day 1-4 sorearm; day 2-ha; bodyache;fatige;nausea
Severe pitting edema in both ankles,   Muscle weakness in both legs, fatigue, mental confusion  resulting in difficult communication and comprehension, short term memory  problems resulting in lost of cellphone,, and not remembering if wife took her cancer medicine.    Note: this was booster shot.
PT STATED THAT SHE INITIALLY HAD A SMALL REACTION AT INJECTION SITE BUT THAT IT WENT AWAY UNTIL A WEEK LATER AND THEN IT LOOKED LIKE A WELP ON HER UPPER ARM. IT WAS TENDER, HOT AND A LITTLE ITCHY. PT ALSO SAID THAT SHE BLEED FOR 2 DAYS AFTERWARDS.. BLED ENOUGH TO HAVE TO CHANGE BANDAIDS MULTIPLE TIMES AND THEN IT STOPPED. PT TREATED THE RASH WITH HYDROCORTISONE CREAM AND IT WENT AWAY.
The very next day I had a significant loss in my taste; The very next day I had a significant loss in my  smell.; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 14:15 (at the age of 49 years old) (Batch/Lot Number: EM9810) as single dose for COVID-19 immunisation. Medical history included none and the patient has no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), levothyroxine sodium (SYNTHROID), trazodone. No other vaccines were received in four weeks. The very next day of vaccination on 04Feb2021 at 12:00 PM she had a significant loss in taste and smell. The events resulted in Doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The patient was not tested for Covid-10 prior vaccination and was tested negative post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Feb2021. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. Next day pain was in the right lung, severe, (could not take a breath). Next day the pain and discomfort traveled dow my right leg, extreme cramps, soreness, etc. The next day it was my left lung in severe pain. By Monday my breathing is very shallow and my cough is much worse, each cough produces its own package of phlem. Breathing is diffiicult  I HAVE AN APPOINTMENT TO RECEIVE SECOND SHOT ON FEB. 24. I DO NOT THINK I SHOULD
Flushing; Dizzy; Tongue was swollen; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FLUSHING (Flushing), DIZZINESS (Dizzy), SWOLLEN TONGUE (Tongue was swollen) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for an unknown indication.     No Medical History information was reported.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FLUSHING (Flushing), DIZZINESS (Dizzy), SWOLLEN TONGUE (Tongue was swollen) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and NAPROXEN at a dose of 500 milligram twice a day. At the time of the report, FLUSHING (Flushing), DIZZINESS (Dizzy), SWOLLEN TONGUE (Tongue was swollen) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Heart rate: (High) went to the ER for her heart rate since it was elevated in 130-140s.     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.
Patient reports confusion and foggy memory one day after vaccine. Patient states "On Sunday I couldn't remember anything that happened on Saturday." Symptoms resolved by Monday.
a 14  year old was administered a PROQUAD vaccine; No aditional AE details; This spontaneous report was received from a healthcare professional and refers to a 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, (strength, dose, dose number, route and site of vaccination, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) details was provided (no adverse event).
pt recv vax 17JAN96 & 25JAN96 pt devel 12 gen lesions;no further details were provided;
Patient received her first HPV vaccine today and immediately described  discomfort in her jaw and glands in neck. Patient also described a "filter" in front of her eyes as well as noises in her ears. When patient stated that her mouth was dry and her throat was "tight" and sore, nurse sent family to emergency room 6 minutes away. Patient did not state that she could not breathe but did not want to take any unnecessary chances. At emergency room, doctor diagnosed patient with an systemic allergic histamine reaction. Patient had started to feel somewhat better while being assessed by doctor. Once patient was treated with Benadryl, patient's condition resolved.
Headache, pain at site not able to use shoulder, nausea, chills, aches.
Patient received her 1st booster on 5/3/22 and I administered her 2nd booster on 7/28/22, so the timing was too soon. Patient has not had an adverse reaction to date.
Patient reported that he had nasal bleeding the same night he received the vaccine and that this is something new and that he never has nose bleeds. He then had a nose bleed again the following day but it was not as bad. He also reported flu-like symptoms but i explained that is a possible side effect of the vaccine and those should subside. I explained to call the pharmacy back or seek medical attention if the nose bleed returns or gets worse. He stated that the nose bleed was not as bad today but thought he should report the event to the pharmacy.
Patient administered vaccine that expired 4/1/2022. Incorrect expiration of 6/12/2022 recorded with this lot# next to data entry station.