chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate numbness in both legs (especially feet), pelvic region and back pain after receiving a "flu shot". Increasing leg weakness resulting in hospital admission on 11/05. ICU and mechanical ventilation on 11/08. Plasmaphersis-11/22, IVIG-11/09, diagnose: probable Guillain- [[name]] Syndrome.  2/16/07 Received medical records from hospitalization from 11/5/06-1/12/07 which reveal patient experienced numbness of LEs from umbilicus down, low back pain & leg weakness & recurrent falls beginning almost immediately after receiving flu vax.  Seen in outlying ER & transferred to higher level care facility.  Exam revealed mild weakness of dorsiflexion bilaterally.  DTRs absent.  Diminished pinprick of LEs.  Sitnificant ataxia on finger to nose testing.  Difficulty sitting w/o support due to truncal ataxia.  Unable to stand due to severe ataxia. Declined on 3 days & required intubation.  Tx w/IVIG but continued to decline rapidly & developed flaccid quadriplegia, areflexia, bifacial weakness w/incomplete eye closure, dificulty w/[[name]] movement & tongue control.  Plasma exchange done but continued to deteriorate.  Second course of plasma exchange done & patient did improve.  Transferred to rehab hospital. Follow up EMG in 12/06 revealed severe GBS w/axonal features.  No EMG reports included.  T/C to hospital to request same. FINAL DX: Guillain [[name]] Syndrome; HTN; hyponatremia; respiratory failure; s/p trach & PEG tube; exposure keratoconjunctivitia; depression; and porrible perianal fistula. 2/22/07 Received EMG/NCS reports of 11/8/06 which revealed results c/w gen peripheral neuropathy which was neither axonal nor demyelinating in nature; report of 12/13/06 revealed evidence of a severe generalized sensorimotor peripheral neuropathy w/ a component of axonal degeneration. Follow-up: At the time of discharge from the hospital (1/12/07) patient still demonstrated "flaccid quadriplegia and areflexia" requiring ventilation support, but did not show improved pupillary response, eye movements, and tongue / [[name]] movement.
Fatigue; Muscle weakness; Muscle soreness; Painful injection site; Swelling at injection site; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration on an unknown date (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date, the patient experienced fatigue, muscle weakness and soreness, painful swelling at injection site, chills and headache. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021, the patient underwent a PCR (polymerase chain reaction) (nasal swab) test and tested negative. The clinical outcome of the events fatigue. muscle weakness and soreness, painful swelling at injection site, chills, headache was resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Mom reports after leaving the office, the patient started vomiting, his eye rolled back, and he was shaking. She took him directly to the ER and was seen at 11:11 am. He was stable, given ZOFRAN, monitored, and discharged home.
onset of heaviness of arm & tingling of fingers in the evening of 21OCT96;lt arm sx began 1-2hr later;the inj felt more painful than usual than other shots have felt;sx began by aching in upper arm, posterior shoulder;also tingling on thigh
Nausea, fatigue, muscle aches, headache and pain around injection site for first 36 hours
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jan2023) Positive, notes: started having symptoms again and tested positive for Covid again on home test kit (was negative on last day of paxlovid) - runny nose, mild cough; (16Jan2023) Negative, notes: was negative on last day of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Patient was given the 12+ Pfizer Covid bivalent booster for her initial dose in the series, instead of 12+ Pfizer Covid monovalent vaccine
lethargic slept a lot-loss of appetite starting 930PM 21JUL97 still as of 24JUL97 quite lethargic 20-21hr/24hr is sleeping;not active self when awake;went to MD 23JUL97;t99.5 ax 24JUL;
In the hours following injection I became febrile ( T- 101.6) and extremely achy with severe joint pain. Treatment consisted of acetaminophen and rest.  Fever lasted for 48 hours. Body aches continued to through the 72 hour mark.
Pain in my left arm at the joints/joint pain in the right arm; Pain in left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in my left arm at the joints/joint pain in the right arm) and VACCINATION SITE PAIN (Pain in left arm pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced ARTHRALGIA (Pain in my left arm at the joints/joint pain in the right arm) and VACCINATION SITE PAIN (Pain in left arm pain). On 10-Jan-2021, VACCINATION SITE PAIN (Pain in left arm pain) had resolved. On 13-Jan-2021, ARTHRALGIA (Pain in my left arm at the joints/joint pain in the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt was given lower dose of Pfizer vaccine (5-11) instead of full appropriate dose for age
By 2:00 P.M. Tension Headache.  By 5:00 P>M> thru 3 :00 PM next day 102 temperature.  Hands went numb.  Spine and pelvic pain.  Muscle spasms in quads and under rib pain.
This spontaneous report was received from a pharmacist, concerning a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately November 2017 (reported as "about four months ago"), the patient was vaccinated with ZOSTAVAX, subcutaneously, for shingles prevention (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced a "boil" at the injection site (Injection site abscess). The pharmacist reported that it was about the size of a pencil eraser, was not painful and was not a rash. It was unknown by the reporter if the patient received treatment for the event or if lab diagnostics or studies were performed. The patient was not recovered from the event by the time of the reporting. The reporter did not assess the causal relationship between vaccination with ZOSTAVAX and the event.
Body aches, headaches, fatigue, cough, nasal congestion  Extra Strength Tylenol  saw physician at urgent care and he determined it was viral  Lasted 7 days? with fatigue following
Pt experienced temperature of 103, lethargy, body achiness, general malaise starting on 06/16 and lasting for 4 days. Pt also experienced right and left deltoid soreness.
About 5 days, post vax, the pt developed neck pain radiating into his left scapula, left deltoid and left axilla. No symptoms in the days immediately following the administration of the vaccine. Still symptomatic.
Began with a rash all over my back and shoulders on Monday evening. On Tuesday the injection site became swollen and red. Rash progressively got worse. Tuesday night began feeling pain in lower right quadrant. Wednesday woke up with tightness in chest and lump in the throat. Went to Urgent care approx. at 1:00 pm, they transported me to Emergency room where they did complete work up on heart, gallbladder, kidney and pancreas. Thought it was allergic reaction to vaccine. Prescribed steroids, BENADRYL and baby aspirin.
Patient came to me two weeks after the vaccination and complained that at the same day after she got her shot, she came back home and noticed from what she described: "the vaccine  drained off my arm". She said she noticed some drops of uncolored liquid on her arm and it started itching really bad. She applied some cold to the arm which helped her a little. She had the itchie feeling for the next couple days. She also spoke to her physician a couple days later and he recommended her to revaccinate the same strain over again. Right now patient is ok, she has no bruises or rashes at this moment. She will come back to the pharmacy in couple weeks to have another flu shot.
varicella rash; This spontaneous report was received from a physician and refers to a patient of unknown age and gender with heart disease congenital. Te patient's medical history and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced a new varicela rash(rash vesicular). The outcome of rash vesicular was unknown.     The reporter considered rash vesicular to be related to varicella virus vaccine live (Oka/Merck)(VARIVAX).
Patient received peds 5-11 dose when should've received the full adult dose having been age 12 at time of vaccination
EXTREMELY THIRSTY; THROAT FEELS DRY; SOMETHING WRONG WITH STOMACH; FEELS LIKE A HANGOVER; EYES LIKE CRIED ENDLESSLY; SWEAT; FEELING EMOTIONAL; NOT FEELING GOOD AND SICK; CHILLS; HEADACHES; FELT GIGGLY LIKE DOPAMINE RUSH; UNABLE TO SLEEP; SLEEPY; FEELING WARM (HOT); SLEPT ALL DAY AND NIGHT; HEAVY ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-AUG-2021, the patient experienced felt giggly like dopamine rush. On 05-AUG-2021, the patient experienced unable to sleep. On 05-AUG-2021, the patient experienced sleepy. On 05-AUG-2021, the patient experienced feeling warm (hot). On 05-AUG-2021, the patient experienced slept all day and night. On 05-AUG-2021, the patient experienced heavy arm. On 06-AUG-2021, the patient experienced extremely thirsty. On 06-AUG-2021, the patient experienced throat feels dry. On 06-AUG-2021, the patient experienced something wrong with stomach. On 06-AUG-2021, the patient experienced feels like a hangover. On 06-AUG-2021, the patient experienced eyes like cried endlessly. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced feeling emotional. On 06-AUG-2021, the patient experienced not feeling good and sick. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt giggly like dopamine rush, unable to sleep, sleepy, feeling warm (hot), extremely thirsty, throat feels dry, something wrong with stomach, feels like a hangover, eyes like cried endlessly, sweat, feeling emotional, slept all day and night, heavy arm, not feeling good and sick, chills, and headaches on 07-AUG-2021. This report was non-serious.
Loss of taste; loss of appetite; Nausea; vomiting; body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA, DECREASED APPETITE, NAUSEA, VOMITING, and MYALGIA in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy to lettuce and cucumber.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced AGEUSIA, DECREASED APPETITE, NAUSEA, VOMITING, MYALGIA, and PYREXIA. At the time of the report, AGEUSIA, DECREASED APPETITE, NAUSEA, and VOMITING had not resolved and MYALGIA and PYREXIA had resolved.            It was reported that the patient had no pre-existing conditions. No concomitant medications were provided. No treatment medications were provided.  This case concerns a 32-year-old female patient with no relevant medical history who experienced non-serious unexpected events of Decreased appetite, Ageusia, and non-serious expected events of Nausea, Vomiting, Myalgia, and Pyrexia. The events occurred within a week following vaccination with the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, Decreased appetite, Ageusia, Nausea, and Vomiting were still ongoing whereas Myalgia and Pyrexia had resolved. No further information regarding clinical course of the events was provided at this time. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
At the time of the incident (3:00 A.M.) I was experiencing chills, a fever, and nightmares. When I went to the bathroom I fainted. Once I regained consciousness and got to  a standing position I fainted a second time after I took a few steps.
diffuse itchy rash developed 2-3d after vaccine. telephone call to office the following day. Rash is already improving. Has not yet taken OTC antihistamines
States 8 days after vaccine had clavicle lymph node  in vaccination arm left.  Her arm also started to get sore again.  Things resolved itself in a few days.
Swelling, redness, pain starting about 7 hours after injection. Applied ice and took ADVIL for four days until it abated. Swelling and redness from shoulder to elbow. Pain an 8 on scale from 1 to 10.
tested covid positive; tested covid positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 11-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), in Oct2021 as dose 1, single (Lot number: FK5618) and on 09Dec2021 as dose 2, single (Lot number: FL0007) at the age of 10 years 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) all with onset 22Jun2022, outcome "recovering" and all described as "tested covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Additional Information: The patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. No treatment was received for the adverse events.  No follow-up attempts are possible. No further information is expected.
Chills, aches, shakes Fever - reaching 102 for a few hours. These 4 symptoms lasting approximately 24 hours.  Severe Fatigue Headache Stomach cramping  No appetite  Diarrhea - starting 48 hours after receiving the vaccine, still occurring 5 days after receiving the vaccine.
Patient was given Pfizer as second dose in error.  Pt should have received Moderna second dose.     No patient adverse reaction at the vaccination site noted.
Severe Cold; for 36 hours I couldn't stand on my feet; Severe Sweating; slightly headache; Severe Chills/Shivering; I am still sick; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Cold"; WEIGHT BEARING DIFFICULTY (non-serious) with onset 07Apr2021, outcome "not recovered", described as "for 36 hours I couldn't stand on my feet"; ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "I am still sick"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Sweating"; HEADACHE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "slightly headache"; CHILLS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Chills/Shivering". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient went to the doctor like about 10 days after (last Friday, she didn't knew what the date, was 8, the 9th of April) and the symptoms; very severe chills, shivering and cold, sweat, happened 7 days (7April2021) after she took the shot. Before that there was slight headache and like fatigue. It was reported that patient took Pfizer 1st shot two weeks ago, and was still sick. The patient was still suffering chills, headache, cold and sweating all over. The patient wondered how long it was going to last. The patient stated that it was its little bit better. The shivering was not that severe. The patient reported that she would not go for the 2nd shot.  No follow-up attempts are possible. No further information is expected.
6 month-old was supposed to receive Pentacel but the lyopilized ActHIB component was mixed with Quadracel rather than DTap-IPV diluent from the Pentacel package, no AE; 6 month-old received lyopilized ActHIB component mixed with Quadracel rather than DTap-IPV diluent from the Pentacel package, no AE; Initial information received on 29-Apr-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 6 months old female patient who was supposed to receive her DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], immunization. But when it was reconstituted, the lyopilized Act-Hib (lot U6622AA, expiry date: 16-Feb-2021) was mixed with [DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5688AA, expiry date: 26-Nov-2021) rather than the Dtap-IPV diluent from the pentacel package on 29-Apr-2020 via intramuscular route in the left thigh for prophylactic vaccination.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique and inappropriate age vaccine administration.  No adverse event reported at the time of reporting.  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 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.
Same as first time; sharp, repeated headache; muscle pain, tiredness that evening and next day. Less upset stomach took TYLENOL as first time, better in 48 hours.
Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN 5318), dose 1 via an unspecified route of administration, administered in left upper arm on 25Jan2021 at 12:45 as single dose for covid-19 immunization. Medical history included cardiac disorder, hypertension, type 2 diabetes mellitus, hypothyroidism, drug hypersensitivity and allergies to Ace inhibitors. Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. On 25Jan2021, at 04:00 pm patient experienced prolonged headaches, nausea and abdominal pain. On 01Feb2021, the patient underwent lab tests and procedures which included sars-cov-2 test as negative. No covid prior vaccination. The treatment medications for the events included Zofran. The patient was recovered from the all events.