chrisvoncsefalvay/vaers-outcomes huggingface dataset:
90% of his body has a rash on it; breaking out in rash; it's over like 45% of his body, his toes and his legs; that's very itchy; rash all over his body; Hives covering over 50% of my body that randomly come and go; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) and a contactable consumer (patient) reported that a 37-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0168) as single dose for covid-19 immunization. Medical history included adult-onset diabetes developed just a few years ago that was controlled with a pill. He was not a insulin diabetic patient and unknown renal disorder Concomitant medication included metformin taken for diabetes; lisinopril taken for diabetes as to protect kidneys. He had his first vaccine on Friday evening of this last week and by Monday he was in the ER, 90% of his body has a rash on it, and it looked out as he poured some hot water on him, it's over like 45% of his body, his toes and his legs. He went to an urgent care, walk-in and that's very itchy and so they sent him over to look in hospital and they put him on steroids and Benadryl and anti-itchy cream (Treatment), he was missing work because he had got this rash all over his body. The event was also reported as hives covering over 50% of body that randomly come and go. Events were started from May2021. The patient underwent lab tests and procedures which included blood sugar monitor continuously which was tested on machine. The outcome of the events was unknown.
Information has been received from a 39 year old consumer with a history of Lyme disease in 1989 who on approximately 07/28/02 was vaccinated with a dose of rubella virus vaccine live (second generation). The patient was vaccinated by a nurse in the hospital following the delivery of her baby, On approximately 08/12/02, two weeks after vaccination, the patient experienced "pain in her joints and muscle, her knee felt it was exploding and she had a full rash over her body". The patient was also " extremely upset that she could be giving the baby rubella through her breast feeding. Unspecified medical attention was sought. Follow-up information from the consumer on 08/22/02 reported she had severe pain in her hands. She stated her knuckles felt like they were 'exploding" when she wakes up, and the pain sometimes travels up her arm. She also reported being unable to pick up her new baby because "the pain is bad". The patient reported being extremely upset that the hospital staff had given her this vaccine and not explaining the possible adverse reactions. It was also reported by the patient's father, who is a physician, that the patient is still experiencing arthritis fingers and knees, after being vaccinated with (rubella virus vaccine live (second generation)) post partum July 30th". Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 6th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced arm pain for one month after receiving the injection. No further details regarding the patient's experience were available at the time of report.
Initial unsolicited report received from a consumer on 17 October 2016. This case involves a female patient (age not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration was not reported) on September 2016. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination patient experienced injection site pain and a rash on arm. Laboratory data was not reported. On an unspecified date patient was treated with antibiotics as corrective treatment. Outcome of the events was not reported. Documents held by sender: none.
Patient stated he developed a dry, patchy area around the injection site a couple weeks after his first shot at this facility.
Pt recvd vax & approx 5 1/2 months p/dose 3 5JUN93 & exp jaundice;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9874), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prinzmetal angina" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "prior MI" (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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Feb2023) Negative, notes: Rebound-5 days after completing paxlovid and 2 days after a negative test; (23Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 14Feb2023 to 18Feb2023; lot number: GF3895).  No follow-up attempts are possible. No further information is expected.
shingles; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Mar2021 16:15 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included sulfa allergy and was diagnosed with COVID-19. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with anti-viral and steroid. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
An 18 month old female presented to the Emergency Dept with a 2 day history of fever, rhinorrhea, tachypnea, anorexia, and one episode of vomiting. Of note, she received a measles-mumps-rubella vaccine Priorix- 1 week prior to her presentation. The pt was diagnosed with an adverse drug reaction to the vaccine, was given acetaminophen, and was discharged in stable condition.
2 weeks, post vax, pt presented to ER with a temperature of 103F with rash over trunk. Evaluated on 7/1/00 and dx'd with febrile illness. Had erythematous vesicles on mouth and erythmatous macules over trunk only.
Within 15 minutes of shot, itching and muscle pain.  Within 45 minutes of shot muscle cramping in extremities.  Had taken 2 benadryl to ward off allergic reaction.  That evening these symptoms continued and fatigue as well as low mood occurred.  Next morning, right flank over the kidney pain-all day.  Muscle pain- all day. Fatigued.  Sunday, severe vertigo that lasted for several hours.  Remitted for 5 hours and then returned.  Dr. and Neurologist contacted.
Patient developed red infection 1 inch under injection site (itchy, red) diagnosed as infection - prescribed antibiotics.
Patient given IPV vaccine and had routine venipuncture. Approximately 7-8 minutes afterwards while patient was leaving office, she became pale, limp, unrepsonsive. Required oxygen by mask to return to normal color. Unresponsive to even deep pain for at least 10 minutes. EMS called and patient sent to local ER.  In ER, patient finally awoke--total time unresponsive ~30 minutes.
Pt received vaccine approx. 3:45pm. Pt ate "dum dum" pop and snack size bag of potato chips on way home. Pt c/o abd pain and tickle in throat in the car. Once home pt c/o lips felt numb; then mom noticed (L) side of face swelling - called our office at 4:16pm - gave 2tsp BENADRYL 4:30 pt's eyelids were swollen and c/o difficulty swallowing 911 called ? ER.
Information has been received from a physician concerning a preterm infant who was born after his/her mother was vaccinated with the first dose of GARDASIL on 08-MAY-2009. On 08-MAY-2009, the patient also received the first dose of RECOMBIVAX B (MSD) (dose, route, lot# not reported), the first dose of VARIVAX (Merck) (MSD) (dose, route, lot# not reported) and a dose of hepatitis A virus vaccine unactivated (manufacturer unknown) (dose, route, lot# not reported). On 14-JUL-2009, the patient received a dose of MMR II (MSD) (lot#663797/0424Y) (dose and route not reported), a dose of RECOMBIVAX B (thimerosal free, lot# 662391/0377Y), a dose of VARIVAX (Merck) (lot# 664234/0500Y) and a dose of GARDASIL (lot# 658490/0802U). Concomitant therapy included MENACTRA, DTAP (unspecified), POLIOVIRUS vaccine (unspecified) and TD. It was reported that the patient was born on 05-SEP-2009, at 34 weeks gestation. It was a preterm delivery. The preterm infant weighed 4 pounds and 6 ounces. It was reported that the baby was fine and no reported problems. The mother's experiences have been captured in WAES # 0907USA02625. Additional information is not expected.
PT CAME IN DAYS AFTER VACCINE AND SHOWED LEFT ARM. WAS RED AROUND INJECTION SITE AND WARM TO TOUCH, MILDLY ITCHY. I RECOMMENDED PT TAKE BENADRYL OR CLARITIN TO TREAT AND FOLLOW UP WITH MD.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 68-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: Initial covid symptoms began 7/8, tested positive on iHealth antigen; (13Jul2022) Negative, notes: Tested negative 7/13, symptoms absent by 7/15, (19Jul2022) weakly positive, notes: Then "Paxlovid rebound" On 7/19 mild symptoms recurred, tested weakly positive, (20Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (21Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (22Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (23Jul2022) strongly positive, notes: Tested strongly positive on 7/20-7/23, (24Jul2022) weakly positive, notes: weakly positive 7/24. Paxlovid was taken as therapeutic measures were taken as a result of drug ineffective, covid-19 from 10Jul2022 to 15Jul2022.  Clinical course: Initial covid symptoms began 08Jul, tested positive on iHealth antigen tests same day. 5 day course of Paxlovid started on 10Jul2022. Tested negative on 13Jul, symptoms absent by 15Jul. Apparently "cured." Then "Paxlovid rebound" On 19Jul mild symptoms recurred, tested weakly positive. Tested strongly positive on 20Jul-23Jul, weakly positive 24Jul. Symptoms essentially absent on 24Jul.
Mother states that patient complained about soreness at injection site and later the next day stated that her armpit was also hurting. Mother did not ask what type of pain or if it was radiating/how long.
Pruritis, painful, papular rash of hands, spreadinig to arms, then legs.
Information was received from a registered nurse, regarding unspecified patients (demographics not provided). The nurse reported that GARDASIL; ROTATEQ (case #1404USA010716); and PEDVAXHIB (case #1404USA010717) were potentially exposed to a 33F and a 24F recording, which she believed to be erroneous recordings of a digital Vaccines for Children (VFC) thermometer, and have been administered to unspecified patients (dates of administration, lot numbers, dosages and routes of administration not provided). The nurse reported that she believed that the thermometer that gave her the readings is inaccurate. She stated that her facility has a mercury thermometer that read temperatures that were in the recommended range. No adverse effect reported. Additional information has been requested.
7/29: She began to become more somnolent with left facial droop left arm weakness and left leg weakness.   tPA given at 1719 - Right MCA stroke syndrome status post IV tPA. 7/29: Mechanical thrombectomy of the right MCA with TICI 3
On 9/10/2018 I received two shots at pharmacy. FLUAD Syringe and PNEUMOVAX-23 Syringe, and had chills and fever and passed out while driving and I had 5 MI and By-Pass 1992, 3 MI and stent in 2003 I could not lift left arm where shots were, for 4 days.
Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided. Treatment details include cortisone injection for shoulder pain.
Positive for HPV; GARDASIL 9 started on 2014, only received two of three doses; This spontaneous report as received from a 30 year old female patient regarding herself. The patient was not pregnant. Information on pertinent medical history, concomitant medication and drug reactions or allergies were reported as none. On an unknown date in 2014, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, lot # and expiry date not reported) via intramuscular for prevention of human papillomavirus (HPV)/ prophylaxis. The patient had only received two of three hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations (inappropriate schedule of product administration). On an unknown date (also reported as sometime in the beginning of), the patient had C-PAP test and was tested positive for HPV (papilloma viral infection). The patient sought medical attention, spoke with the physician and was recommended for third dose of vaccination. No product quality complaint was involved. The outcome of papilloma viral infection was reported as not recovered/not resolved. Causality assessment was not provided.
(This report may have already been submitted by this nurse, but a copy can not be found so it is either being submitted for the first time or this is the second time.)  On 2-12-08 patient received #2 dose of VZV vaccine into the left upper arm. On 2-14-08 patient's mother called to report that he had significant swelling at the injection site.  Mom described the injection site as if "someone inserted a softball under his skin."  She reported that the area was "bruised, swollen, painful, hot to touch and that there was watery pus coming out of it, fever of 101.9." Mom took patient to a facility 2-14-08 where he was diagnosed with cellulitis at the injection site and placed on Augmentin and a "steroid". On 2-15-08 his temp was 100.5 and mom had given him 2 doses of the medications prescribed from the facility and she declined a follow up appointment to our office.  Patient presented to the office 2-18-08 to status his injection site.  The site had returned to normal, temp was 97.6, non-tender, with free movement of the left arm.
Received MMR and PPD on 5/10/04. PPD read as "OMM" negative on 5/12/04; no complaints. On 5/23/04 pt seen in ER for "rash to bilateral upper extremities, upper body and face. "Also states "some shortness of breath- mild." Diagnosed in ER with "adverse reaction to MMR." Taking Prednisone now for next 6 days.
Initial unsolicited report received from a non-health care professional (sales representative) on 12-Dec-2017. This case involves a patient (age and gender was not reported) who was vaccinated with 0.5 ml single dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on an unspecified date in the last few days. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, after the vaccination, patient had an anaphylactic reaction. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review case was considered as serious due to important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Patient experienced anaphylactic reaction after vaccination. Exact time to onset is not known. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were subcutaneously vaccinated with improperly stored doses of ZOSTAVAX lot # M019645, expiration date 18-JUL-2017, for prophylaxis (dose was not reported). The ZOSTAVAX were reconstituted with properly stored diluent (lot number and expiration date were unknown). No side effects were reported. Administered doses of vaccine were improperly stored for 2 hours and 30 minutes in a temperature range of 15.1 degrees Fahrenheit. There were previous temperature excursions of 14.9 degrees Fahrenheit for 9 hours and 8 degrees Fahrenheit for 3 hour and 15 minutes. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M019645, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to sterile diluent(STERILE DILUENT) and ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
Approximately 18 hours after injection, severe headache, numbness/tingling of fingers, extreme exhaustion/weakness, fainting, acute chest pain duration of 72 hours.
Child became febrile one week after vaccination. Fever lasted a month and a half and reached as high as 103.4.
she pushes on the joint, the joint itself doesn't hurt, but there is incredible discomfort; tightness in her hands, tightness is mostly in her fingers and sometimes in her feet; joint soreness and tightness in her hands; Initial information received on 12-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves adult female patient who had joint soreness and tightness in her hands (arthralgia), she pushes on the joint, the joint itself doesn't hurt, but there is incredible discomfort and tightness in her hands, tightness is mostly in her fingers (discomfort) and sometimes in her feet (musculoskeletal stiffness), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious joint soreness and tightness in her hands (arthralgia), she pushes on the joint, the joint itself doesn't hurt, but there is incredible discomfort and tightness in her hands, tightness is mostly in her fingers (discomfort) and sometimes in her feet (musculoskeletal stiffness), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was not recovered.  There will be no information available on the batch number for this case.
I noticed on Day 8 after my first shot of Moderna at the injection site, a huge red spot. I drew a line around it with a marker to check if it was growing. The injection site was still very warm to touch. The next day it grew just a big more and we drew another line around the new boundaries. By Day 10, it was gone. I called my doctor and the nurse said she had never heard of a spot forming this late.
Large red area of swelling at site of injections on left thigh. 8-9/18 large urticarial wheals on bilateral LE, left UE, cheeks, torso, injection site w/ induration and excoriation.
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30th September 2023) for prophylaxis.   On 12th September 2022, the patient received Menveo. On 12th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The nurse reported that the patient received a dose of Menveo that was inadvertently reconstituted with sterile water instead of the liquid component. No further details provided during call. The reporter consented to follow up. Additional Supportive Information: The nurse reported that the patient inadvertently received Menveo which was reconstituted with sterile water instead of the liquid component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.