chrisvoncsefalvay/vaers-outcomes huggingface dataset:
approx 2min p/vax pt became weak, dizzy, incoherent, clammy;BP dropped from 110/70 to 60/50;pulse rate dropped 20+ points;pt c/o feeling nauseous;episode lasted approx 10-15min;
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, lot# and expiration date were not reported) intramuscularly (subcutaneous injection formulation administered by other route). No adverse symptoms were reported. No product quality complain was involved. Follow up information was received from the pharmacist on 05-OCT-2016, concerning a 18 years old female patient. On 11-AUG-2016, the patient was vaccinated with the first dose of M-M-R II (lot # L007216), by intramuscular route on the right arm. Additional information is not expected as all schedule follow up were received. Reporter information, patient information, product information, event information and narrative were updated.
This spontaneous report was received from a Nurse Practitioner concerning a patient of unknown age and gender. The patient's concurrent condition and historical drugs were not informed. On 11-SEP-2015 the patient was vaccinated with a fourth dose of PEDVAXHIB, lot # L009649, expiration date 29-NOV-2017 (dose, route and frequency were not informed). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/14/2021.
Patient was fully vaccinated, but still got COVID; Patient was fully vaccinated, but still got COVID; This is a spontaneous report from a contactable other health professional (HCP). An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number/s not reported), as dose 1, single, then as dose 2, single, both via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated, but still got COVID on an unspecified date. The patient underwent lab tests and procedures which included Sars-Cov-2 test: got covid on an unspecified date. Treatment was unknown for both events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
24hr p/vax pt devel asymptomatic urticarial rash both axilla & groin, irregular margins, small size lesions;
A few hours after the vaccine (under 3 hours,) he became lightheaded/ felt faint, his arms/hand and legs/feet began to tingle/ become numb, he became pale, he developed a significant stutter/ trouble coming up with words/ difficulty speaking; was in sinus tachycardia. He had to be hospitalized.
This spontaneous report as received from registered nurse and a pharmacist concerning a 22 year old female patient with penicillin allergy (PCN), current smoker and pertussis vaccine allergy, occupation unknown. None illness were reported at the time of vaccination. The patient's medical history included delivery of the baby (new mom). On 13-MAR-2013 21:45 PM the patient was vaccinated with PNEUMOVAX 23 dose, in the left thigh (lot # reported as H026843 exp date unknown) after being given an epidural and after delivery of the baby. The pharmacist reported that subsequently the vaccination in approximately 13-MAR-2013 the patients developed swelling and phlebitis. It was noted that in March 2013 AT 5:24 am, the patient also have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23 and also have needed to come back to the emergency room for unspecified treatment. The registered nurse reported that on 16-MAR-2013 the patient experienced swelling (also reported as subsequently vaccination), had a rash, red and warm to touch, that required an emergency room or doctor visit. The patient was discharged to home and not narcotic pain medications orally or topically were given. The outcome of swelling, having a rash, red and warm to touch was reported recovered. The outcome of phlebitis and severe pain in their legs and not been able to walk was unknown. This is one of several reports from the same reporter. Lot number H026843 is an invalid lot number for pneumococcal vaccine, polyvalent. Additional information has been requested.
shingles; Information has been received from a lawyer regarding a case in litigation concerning to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   On or about 08-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical application, lot number and expiration date were not reported) for the long-term prevention of shingles and or zoster-related conditions.   On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles, and she was treated by a healthcare provider at an urgent room. The patient had and would continue suffer ongoing injuries; significant medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies.   The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was related.
Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN5318), first dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 09:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Feb2021, the patient experienced Fatigue, slight dizziness, slight nausea, slight fever, hot and cold flashes. More fatigue then anything. The patient's lab tests included body temperature: slight fever on 02Feb2021. The outcome of the event was recovering for Fatigue, unknown for Dizziness, Nausea, Pyrexia, Hot flush.
09:35A Pt c/o of wrist discomfort pinching like pain and swelling, pt stated sensation subsided and replaced w/ itching, which slowly resolved. pt was stable and ten d/c. Initial vitalt: bp 124/90, hr 74 rr 18 O2 98% temp 97.2. d/c vitals: temp 97.2 hr 76 O2 98% rr 18 bp 126/90. Pt stable at d/c, educated and advised to seek medical medical attention if worsening s/s. 10:12A.
Hemorrhagic stroke . Admitted to the hospital on May 16 till May 20..
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies reported. On an unknown date the patients were vaccinated with improperly stored vaccinated with VARIVAX (Merck) (lot number K021484 and expiry date 03-NOV-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with vaccinated with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with vaccinated with VARIVAX (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Day /p Hep B vax-sudden onset severe generalized head pain which intensified /w any slight movement of head-did not respond to Tylenol/Advil-0 nausea, vomitting-unusual pain throughout head-diminished suddenly 24 hrs later.
Superficial redness over left hemithorax and abdomen and left thigh. Not warm, not tender, not edematous. No evidence of cellulitis. Happy child.
MIGRAINE; LETHARGY; TIRED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, lethargy, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, tired and lethargy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210331319, 20210331262, 20210331801 and 20210331202. .
Pt became faint 10 minutes or so after dosing of cv19 vaccine. Per EMS pt passed out for about 1 minute.  Pt came to stated he felt ok.  Decreased blood pressure 80/40.  pt states he had not eaten anything since 0700 blood sugar 125, pt loaded on to stretcher and transported via EMS to local hospital St. Lukes for fluids and monitoring.
Flu like symptoms that lasted a couple of days following days after vaccination. Now dealing with Pericarditis that started April 5th which caused me to miss work and I am prescribed steroid treatment and Naproxen to reduce inflammation. Still feeling consistent symptoms until this day.
The patient presents with left upper arm swelling. Pt presents with swelling to her left upper arm after flu vaccine on 10/9. D/C home with BENADRYL prescription.
PT REPORTED FEVER AND PAIN,SWELLING AND REDNESS AT INJECTION SITE
Patient had a complex febrile seizure lasted 30 minutes taken to community ER. Intubated and transferred, extubated on arrival to PICU was discharged on 6/18/07. 7/25/07-records received from facility-Assessment: complex febrile seizure, normal neurologic exam. Source of fever is esstentially a viral syndrome versus onset of bacterial pneumonia versus related to immunization. Seizure lasted 30 minutes.  Temp 102 (R) per mom. Required intubation until seen in receiving facility and subsequently extubated.
Patient developed a red mark about 2 inches by 4 inches at the injection site the day after vaccination.  Still red 3 days after vaccine.  She has taken Tylenol and denies pain unless she touches it.  No itching.
pneumonia; A spontaneous report was received from consumer, concerning an 80-Year-old female patient  who received  Moderna COVID-19 vaccine (mRNA-1273) and experienced Pneumonia and hospitalized.  The patient's medical history was not provided. concomitant product use was not provided.  On 17-Feb-2021 the patient received first dose of the mRNA-1273 vaccine (Batch number 024M20A ) in left non-dominant arm for the prophylaxis of COVID-19 infection.  On 23-Feb-2021 the patient hospitalized. the cause of hospitalization was pneumonia. Treatment included antibiotics and steroids.  Action taken with mRNA-1273 in response to event was unknown.  Outcome of the event, pneumonia was considered to be unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recvd vax; Lt leg red; pt crying; apap given & ice pack applied to site;
COVID 19 Treatment; Pfizer / BioNTech Dose Number: 3; Moderna Dose Number: 2/Dose Number: 1; Pfizer / BioNTech Dose Number: 3; Moderna Dose Number: 2/Dose Number: 1; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech Dose Number: 3; Moderna Dose Number: 2/Dose Number: 1". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: Product-COVID 19 Treatment, Brand: Paxlovid was considered as COVID 19 Treatment, start date: 20Jun2022 and stop date: 25Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sudden severe pain L foot four days after injection(10/4); sudden severe pain in R knee; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF8849, Expiry date: Unknown) via an unspecified route of administration, administered in Deltoid Left on 30Sep2021 (age at vaccination: 77years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included blood pressure measurement and hypothyroidism from an unknown date and unknown if ongoing. Patient received influenza vaccine (Lot number was not reported) administered in Right Deltoid on 08Sep2021. Historical vaccine include bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF8839, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 12:00 PM as dose 1, single and dose 2 (Lot number: EL9267) administered in Arm Left on 30Sep2021. Patient had no known allergies. Patient did not receive any other medications 2 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient was not pregnant at the time of vaccination. It was reported that developed sudden severe pain in R knee two days following injection of third Pfizer,(02Oct2021), & sudden severe pain L foot four days after injection(04Oct2021). No treatment received for the event. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Information was received from a pharmacist via a company representative regarding a patient (demographics not provided). On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage and route of administration not provided). On an unknown date, the patient developed itching following vaccination with ZOSTAVAX. The outcome of the itching following vaccination is unknown. Additional information is not expected.
On the second or third day it started with a strange overall body pain. I became very feverish, then some pain in joints that would normally be affected by the flu also happened. Followed by dizziness and weakness, sleep disruption, high fever up to 106°F. I tried using methyl prednisone 4 mg I had on hand but had an adverse reaction to that including a rash on my back so I discontinued it. I started taking acetaminophen and that helped. It took a couple of weeks before my fever stabilized around 100°F where it remains with some fluctuation downward. My normal temp is around 97.4°F and currently still fluctuates. Chronic constipation and extreme dryness of mucus membranes with a dry cough. My blood pressure and heart rate started spiking around a week ago. I?m better but not well. I also developed a UTI and was treated for it. I?m still dizzy and weak and cannot go out in the heat.
Information has been received from a healthcare worker who reported that multiple unspecified patients received doses of improperly stored PNEUMOVAX 23 (lot# K020215, expired date 15-MAY-2016, dose and route was not reported) on unspecified dates (Incorrect product storage). These vaccines were stored at 52.3 Fahrenheit (F) for 4 hours. The previous temperature excursion was 64 F for 45 minutes. No adverse event was reported. Additional information has been requested.
Caller states a nurse reported an expired dose of VAQT A adult was administered to a patient; This spontaneous report was received from a nurse referring to 28-year-old male patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.   On 17-MAY-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (concentration, number of administered dose, dosage, vaccination scheme frequency, route of administration and anatomical location were not reported; lot number T014590 and expiration date 15-APR-2021) (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Per patient's father the patient has a swollen arm where the shots were given. The area was warm and hard to the touch. The patient has redness at the injection site with purulent drainage. The patient was treated with Tylenol and damp cool cloths.
on 7/8/2019, patient received one dose of ROTATEQ (N030995) that expired on 6/17/2019; No adverse effects; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.     On 08-JUL-2019, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and frequency were not reported) lot # N030995, expiration date: 17-JUN-2019, orally for prophylaxis (expired vaccine used). There were no temperature excursions reported. There were no adverse effects reported.
1030 - patient complained syncope, the patient was alert and calm. vital signs stable (blood pressure 124/82, heart rate 82, oxygen satuartion 97%). the patient laid down and monitoring for 10 minutes. 1040 - patient was alert and calm. vital signs stable (124/82, heart rate 96). denied any discomfort, patient sent home with her mother.
Minor flu like symptoms; Low-grade fever; Headache; Fatigue; Muscle weakness in my right hand and arm; Swelling in my right foot; I have a neuromuscular disease that affects the right side of my body, and the vaccine seems to have made the disease worse; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Sep2021 14:30 (at the age of 41-year-old) (Lot Number: EW0167) as dose 2, single for COVID-19 immunization. Medical history included unknown neuromuscular disease - possibly Charcot Marie tooth or a rare form of muscular dystrophy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included lysine (LYSINE) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop dates were not reported. The patient previously took Cipro (ciprofloxacin) and experienced drug allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Aug2021 14:00 (at the age of 41-year-old) (Lot Number: EW0167) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Sep2021 14:00, the patient had had minor flu like symptoms including low-grade fever, headache, fatigue. The most concerning side effects as reported by the patient were a daily headache that does not respond to OTC pain meds, muscle weakness in her right hand and arm, and swelling in her right foot. The patient had a neuromuscular disease that affects the right side of her body, and the vaccine seemed to have made the disease worse. The patient received treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Complain of itching (no hives) lip numbness, and throat tighning.  Given 25mg benedryl po and 25mg Benedryl IM.  Transferred to ED for eval at 0938.  Discharged at 1053
10/31/22 I started having pain in the lower part of my back. I started having shooting pain down both of the back of my legs. It was extreme pain and would not cease. I went to the emergency room and was given a steroid shot. After a while, the pain eased up. I saw my PCP and she referred me to a spine doctor. The spine doctor told me it was sciatic nerve pain. The shot I was given, relieved the pain on my left leg, but it remained on my right leg. I went to physical therapy. On 3/31/23, I ended up having spine surgery on the discs that were on my sciatic nerve. On 4/13/23, I started getting right foot and ankle pain. I am wearing a boot and was told it was not related to the surgery. I had an MRI and bloodwork and no one can tell me where this pain is coming from. I am to go back in a month to see the doctor.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 20th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and influenza like illness. On an unknown date, the outcome of the general body pain and influenza like illness were recovered/resolved. It was unknown if the reporter considered the general body pain and influenza like illness to be related to SINGRIX. Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced body aches and feeling like she had the flu. The patient felt like this for about 4 days after the 1st dose of SHINGRIX. When asked if the patient reported these side effects to her doctor the reporter said no. No additional information was available.
Information has been received from a licensed practical nurse concerning a patient (age and gender not reported) who on approximately 11-OCT-2006 was vaccinated in the upper arm with a 0.5 mL dose of Pneumovax 23 (lot 651374/0485F). Subsequently, the patient developed localized swelling, redness and tenderness. The patient sought medical attention and was told to take an antihistamine and apply warm compresses to the affected area. At the time of this report, the outcome was unknown. Additional information has been requested.