chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a currently 24 years old male patient. No information on patient's medical history, concurrent conditions or concomitant medication was provided. On an unknown dates (reported as "as a child"), the patient was vaccinated with undocumented, unspecified doses of M-M-R II (strength, dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient performed unspecified blood test with the result of negative titers. The outcome of negative titers and the causality between negative titers and M-M-R II were not reported. Additional information has been requested.
0.4 % normal saline vial stated as "dilutent for Haemophilus influenzae type B conjugate" was drawn up at administered IM to patient.  No adverse SX.
Left foot in extreme pain. Could not walk on it for two days. Got red did not swell
Patient received PNEUMOVAX 23 on 3/12/18. Within 24 hours the arm that was vaccinated developed a blotchy inconsistent red rash and became swollen. She had to go to the doctor on 3/14/18 where she received a steroid shot and received an antibiotic.
Tingling on face(left side), Dizziness, and throat irritation 30 minutes after administration.
Received KINRIX and MMR V on 5/15/17 during physical exam, on left thigh. Patient evaluated on 5/17/17 for cellulitis post vaccination. 8 cm erythema noted left distal injection site.
Chills, muscle aches, minor headache on the evening of.  The next day, extreme soreness on length of upper, outside right arm (injection arm), fatigue which resolved by end of day.
BLOOD IN URINE; TEMPERATURE WENT DOWN; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 841A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced temperature went down. Laboratory data included: Body temperature (NR: not provided) 97.7 F, 96.4 F. On 03-APR-2021, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in urine, and the outcome of temperature went down was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
For 3 days: injection site reaction, fatigue, headache, loss of appetite, arm soreness.  Mild to moderate.  Day 7 - 9: Moderate injection site reaction:  swelling, hot to touch, hard, 3.5 inch red circle, sore.  On going headache.
Person received #2 dose Pfizer COVID-19 vaccination January 11, 2021.  Approximately March 15, 2021 experienced eye twitching on occasion.  Approximately two weeks later she experienced ear pain.  She went to Urgent care and seen by the attending physician.  It was later, at a meeting with a colleague that it was noticed that her lip was drooping.  She contacted a primary care physician who ordered an MRI stat to R/O stroke.  MRI performed on 4/9/21 and resulted negative.  She contacted her PCP who has scheduled an appointment for her to be seen this Friday 4/16/21.  He has in the meantime ordered steriods for her to take based on her reported symptoms and unconfirmed diagnosis of Bells Palsey.
Nerve pain from my groin on both legs down to my ankles for 2 days couldn?t walk
A report was received from a healthcare professional on 6 November 2003 concerning a 73 year old female vaccinee who received expired Fluvirin on 4 November 2003. On 4 November 2003 the vaccinee received expired vaccine.  No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Hallucinating; A spontaneous report was received from a Physician concerning a male individual (other health care professional and colleague) who received his 2nd dose of Covid-19 vaccine and have experienced hallucinations.  The consumer's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of events, the consumer received his 2nd of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection.   According to physician, her colleague started hallucinating after his second shot. It is not known whether the patient had medical intervention or went to ER for treatment. Physician couldn't provide any further information as her head was fuzzy to answer any more questions.  Action taken with doses of Moderna Covid-19 vaccine was not applicable as the patient received both the doses.  The outcome of the event hallucinations was unknown.
ended up positive in covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient ended up positive in COVID-19 on Mar2021 and she got really sick. The outcome of the event was unknown.  Information about batch/lot number has been requested.
started chills and fever 12/29, stayed home 12/30 due to symptoms, previous + COVID TM 12/7/20 - Saw PCP for return to work note
no adverse event as of yet, pt received flublock and not fluzone.  Flubloc is not indicated for pts under 18
This spontaneous report was received from a licensed practical nurse and refers to a 25 months old female patient. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 31-AUG-2017 the patient was vaccinated with FLUZONE 25 (lot # UT6262MA) intramuscularly into the right thigh for prophylaxis. On 04-OCT-2017, the patient was vaccinated with first dose of VAQTA and FLUZONE 25 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 03-OCT-2018, the patient was vaccinated with improperly stored second dose of VAQTA from lot # R010954, expiry date: 27-MAY-2019 (dose and frequency were not reported) intramuscularly in the left vastus lateralis for prophylaxis. The reporter spoke with company representative and refrigeration temperature was too low. Vaccine was not active need to be revaccinated. The reporter spoke with patient's mother and explained this to her. No reaction to vaccine except some soreness at injection site (vaccination site pain), on 03-OCT-2018. The outcome of event, vaccination site pain was not reported. The relationship between the event, vaccination site pain and VAQTA was not provided. The VAQTA was exposed to a temperature below 32 degree Fahrenheit (F): 31.1 F for 8 hours and 57 minutes and 31.9 F for 9 hours and 57 minutes; exposed to temperature above 32 F: 35.0 F for 31 minutes; and exposed to temperature in range of 47F to 77F (48. 9F) for 1 hour and 42 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002051: Original Case: 1810USA002051.
the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.; dizziness; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VERTIGO (vertigo) and EAR DISCOMFORT (the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). On 01-Jul-2021, the patient experienced EAR DISCOMFORT (the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.). On 12-Mar-2021, DIZZINESS (dizziness) and VERTIGO (vertigo) had resolved. At the time of the report, EAR DISCOMFORT (the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant information was provided  No treatment information was provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant : causality updated
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 10:58 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 71.22. Concomitant medication of the patient was not reported. Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature range 29 to 32 degrees Fahrenheit from 09:00 am to 10:00 AM. These vials were moved to fridge on 29-Sep-2021 and 05-Oct-2021 and beyond use date for the vials was reported as 29-Oct-221 and 04-Nov-2021 respectively. The vaccines moved to clinic on 27-Oct-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures. No treatment information was provided by the reporter. This case was linked to MOD-2022-566976 (Patient Link).
Narrative:  COVID infection following COVID vaccine series 03/04, Pfizer, dose #1 03/26, dose #2 08/10 pt cc: chills, cough, diarrhea, fatigue, fever, myalgias, rhinorrhea exposure: unknown 08/11 COVID swab, result: detected
Mother states patient woke up with a very sore stiff neck and chills. Upon assessment, patient has no red areas at any vaccinated sited. Patient denies N/V/D. there is some swelling at the back of neck on the right side.
Fatigue; Malaise; Periodic migraine headaches; arm pain; Increased ringing of affected ear; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Jan2021 (Lot number: EL0142) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HIV" (unspecified if ongoing); "Autoimmune disease" (unspecified if ongoing); "meniere's diseas" (unspecified if ongoing); "Polypharmacy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 12Jan2021, outcome "unknown", described as "arm pain"; FATIGUE (non-serious) with onset 13Jan2021, outcome "recovered" (Jan2021), described as "Fatigue"; MALAISE (non-serious) with onset 12Jan2021, outcome "recovered" (Jan2021), described as "Malaise"; MIGRAINE (non-serious) with onset 12Jan2021, outcome "recovered" (Jan2021), described as "Periodic migraine headaches"; TINNITUS (non-serious) with onset Jan2021, outcome "unknown", described as "Increased ringing of affected ear".  No follow-up attempts are possible. No further information is expected.
pt c/o burning sensation of lip then lip became swollen @ 5PM 20OCT92-flu shot adm 20OCT92 930AM; states lip 3x nl; no other signs or sx; exam otherwise WNL:
Shaking violently; Pain in legs; Effected speech; Feeling off; Extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech), MALAISE (Feeling off) and FATIGUE (Extremely fatigued) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL (ZYLOPRIM), RABEPRAZOLE, ROSUVASTATIN, APIXABAN (ELIQUIS), LISINOPRIL, METOPROLOL, METFORMIN, HYDROCHLOROTHIAZIDE, MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech), MALAISE (Feeling off) and FATIGUE (Extremely fatigued). On 03-Mar-2021, TREMOR (Shaking violently), PAIN IN EXTREMITY (Pain in legs), SPEECH DISORDER (Effected speech) and MALAISE (Feeling off) had resolved. On 04-Mar-2021, FATIGUE (Extremely fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. The patient's symptoms lasted an hour and a half but the patient was extremely fatigued for rest of the day.   This case was linked to MOD21-046829 (E2B Linked Report).; Sender's Comments:  MOD21-046829:patient's wife case
Earache; diarrhea and vomiting; on menses. CDC confirmed and notified in 9/01 that the cause of death as fulminant meningococcus. Typing was C from ear drainage. Autopsy results received confirming this also.
adverse event; Initial information regarding an unsolicited valid non-serious case was received from a patient via Medical Information (Reference number- 00383487) on 07-Dec-2020.   This case involves male patient who experienced side effects of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose  of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient reported non-serious event the patient experienced side effects (latency same day).   Action taken reported as not applicable.  It was unknown the patient received any corrective treatment.  Event outcome reported as unknown for the event.  Reporter causality reported as related with respect to the event and company causality reported as Unassessable.
reports the arm she received her shot in is always sore; Arthritic like pain; This is a spontaneous report from a non-contactable consumer or other non hcp (reporter husband's grandmother). This consumer reported for 94-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 2, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that the arm she received her shot in is always sore, arthritic like pain that wasn't present before shot and not subside now 1 month post 2 doses. Event took place after use of product. The outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested.
pt recv vax 3MAR97 & 24MAR97 pt devel a pruritic, vesicular eruption (1-2mm);
BOTH HANDS BEGAN TO SWELL, VEINS IN HANDS STARTED BULGING AND HANDS TURNED ORANGE/RED COLOR UP TO WRIST ON BOTH HANDS. PT STATED THAT THIS WENT AWAY WITHIN AND HOUR.
Pt with rash that developed 10 days after imms given, skin rash all over body, 2-3 mm macular, papular eruption, non-peticheal in nature, lasting 5 days, zero+X.
I had the same immediate histamine reaction that I had from my first. I also had an intense agitation after this one and chills that were so bad, I was violently shaking. I ended up going to the ER where they determined that they believe the vaccine was delivered into a nerve and caused a very violent reaction. I get very easily over stimulated and overwhelmed because of my autism. There was talk with the doctor that the vaccine may have been harder on me because of my autism.
Started experiencing slight racing heart starting around 8:30pm day of vaccination (Wednesday the 27th of Jan) but went to bed as normal. Woke up at 1am with heart racing uncomfortably and shortness of breath, felt light-headed when standing and walking. Pulse oximeter reading at home was between 120-140 bpm. Called advice nurse, was told to either go to ER immediately or could wait 30 minutes to see if it improved. After 20 minutes no improvement, so admitted self into ER around 2am. Was told EKG appeared normal except for elevated heart rate. Began to develop throbbing headache around 3-4am. Given Benadryl and Tylenol and kept to wait for blood test results until about 5:30am. During this time heart rate decreased and headache subsided and was sent home. The next 2 days continued to feel very fatigued and experiencing shortness of breath with daily self-care activities. Returned to work on Monday (4 days after vaccination) and able to resume normal activities at work. One week following vaccination was still continuing to experience shortness of breath with light-moderate exercise (walking up slightly inclined hill). One month later continued noticing shortness of breath symptoms with moderate exercise. 6 months later experienced 3 instances of tightness in chest (felt like a panic attack almost) when driving.
Became very nauseated and vomited that night.  Nausea continued until today (4/22/08) "but getting better".  Able to eat and no further vomiting.  Left deltoid is swollen and firm around injection.  "Pain seems no different than any other shot."
Came to office 11/19/04 with spots on scalp, trunk, face x 2d. Itchy. Also spots in bueal mucosa. Comfort measures only (Benadryl PO, Aveeno oatmeal baths, cold things to drink) Dx: Breakthrough Cpox Follow up 01/25/05: Vaccination received at another facility no lot number available and manufacturer unknown.
Information has been received from a NP concerning a 26 year old female who on 9/11/00 and 12/4/00 was vaccinated with Hep-B vaccine recombinant (yeast). On 12/6/00, the pt "complained of site swelling with redness of the right deltoid". The NP reported that the pt had numbness of the right shoulder to hand, nasal congestion, pharyngitis with redness and swelling, nausea, lack of appetite, light-headedness and tingling and numbness of the right leg. The pt reported that she experienced tremors of the right leg times 3. Upon internal review, the pt's experiences were considered to be an "Other Medical Event". Unspecified medical attention was sought. Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth & Lot # for vaccine 1: report was voided.  Patient did not receive that manufacturer's product."
heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". She had a heart attack just a few days after getting a Pfizer booster. She had no heart issues. She was a healthy lady. They would never know for sure what took her from them would she have a heart attack during her sleep anyway? She thought it's very suspicious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 4 month old patient who on 13-FEB-2007 was vaccinated with a second dose of Rotateq. It was reported that the patients mother called and came into the office and stated that the patient had a bloody stool late on the 16-FEB-2007 or early on the 17-FEB-2007. The patient's mother brought the patient's diaper back in on 19-FEB-2007, and it tested positive for bloody stool. Subsequently the patient was back to normal and there was only one bloody stool. Upon internal review, the patient's bloody stool was considered to be another important medical event. Additional information has been requested.
Pt. reported severe pain in left arm several hours after FLUVIRIN shot. Pt. called on 10-25-12 and still reports pain in left arm/shoulder, but she feels it is getting better.
Expired Dose of Heplisav-B Given to Patient Under the Age of 18; Expired Dose of Heplisav-B Given to Patient Under the Age of 18; Initial Report Received on 14-Jan-2022  A medical assistant in the US (UT) reported that a 9-month old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported. Allergies were unknown.  Concomitant medications were reported as unknown.  On 26-Oct-2021, the patient received the first dose of HEPLISAV-B (Lot # 933623, expiration date 22 Aug-2021, serial # and NDC # unknown) intramuscularly in the left thigh by the medical assistant. It was realized later while going through the billing process. No adverse reactions were reported from the injection. No additional information was provided at time of reporting.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.