chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the shot developed Bells Palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and developed Bell's Palsy. The patient also stated many others also experienced Bells palsy and asked to research it. The patient further stated, some women's face never went back to normal. Additional supportive information: follow up could not be possible, as no contact details were available.
Headache, Angioedema, FATIGUE, THROAT TIGHTENING - DENIES DIFFICULTY BREATHING OR SWALLOWING
Information has been received from a consumer concerning a 15 year old daughter with no pertinent medical history reported and no known drug allergies who in June 2008, December 2008 and April 2009 was vaccinated with first, second and third doses of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. The consumer reported that in May 2009, the patient experienced headaches and dizziness after receiving GARDASIL. At the time of reporting the patient had not recovered from the events. No lab studies were performed. The patient did not seek medical attention. Additional information has been requested.
@ 5 hrs p/vax pt had a bad h/a; @ the site of inject it was sore; felt achy all over & very tired; denies any other sx;
Chest pain, trouble breathing and low body temperature for a period of 5 hours after vaccine was administered.  Recovered at ER, discharged 7 hours after vaccine was administered.
FEELING WARMTH IN LEFT LEG/BOTH FEET/HANDS; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced feeling warmth in left leg/both feet/hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling warmth in left leg/both feet/hands. This report was non-serious.
I had a sore throat that would not go away, and just didn't feel good. I went with my husband to the Urgent Care because he had tested positive at home. I initially tested negative on the rapid test but positive on the PCR test. I checked my patient portal on Sunday and saw that I was positive for COVID-19 so I called my PCP and he sent in a prescription for Paxlovid. I also was fatigued and had a headache.
Child with "limp" arm of 10/31/2014. Lower extremity weakness. Afebrile. Child taken to SCH for further evaluation of post viral or post vaccination weakness.
No other issues or concerns noted; PROQUAD was given to 17 year old patient; This spontaneous report has been received from a nurse prescriber referring to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and previous drug reactions or allergies were not reported.   On 18-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). No other issues or concerns reported (not adverse event).
Patient brought to the ED for choking while eating, recent CVA with residual dysphagia.  Found to have a cough and weakness.  Tested positive for COVID-19 1/23/2022  Chest X-ray was clear.  Admitted to the hospital for weakness.  Patient was discharged 1/28/22. Patient previously vaccinated with Moderna 3/12/21 & 04/09/21
Headache, shortness of breath, nausea. Started several hours after vaccine. No treatment used so far
full blown case of Zost 2 wks after - amin of vaccine. o- (L) letal trunk.
Left arm hurt / arm was sore; Spots that look like a burn; Blisters present at the injection site on the left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5MM97, expiry date 30th June 2020) for prophylaxis and DIPHTHERIA TOXOID + TETANUS TOXOID (TD ADSORBED) for prophylaxis.   On 27th January 2020, the patient received Shingrix, Fluarix Quadrivalent 2019-2020 season and TD ADSORBED. On 28th January 2020, 1 days after receiving Shingrix, Fluarix Quadrivalent 2019-2020 season and TD ADSORBED, the patient experienced pain in arm, rash and injection site blisters. The patient was treated with prednisone. On an unknown date, the outcome of the pain in arm, rash and injection site blisters were unknown.   It was unknown if the reporter considered the pain in arm, rash and injection site blisters to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The reporter stated that the patient left arm hurt and there were spots that look like a burn and had blisters present at the injection site on the left arm. The reporter consented to follow up.
This spontaneous report as received from a physician via Company Representative refers to a 21 month old male patient. The patient was vaccinated with 3 doses of 2 ml ROTATEQ (Dose 1 lot number 17242 was an invalid lot number for ROTATEQ; Dose 2 batch# 670237, lot# 670237/0919AA, expired on 12-DEC-2012; Dose 3 lot# 1539AA) on 12-SEP-2011, 15-NOV-2011 and 08-JAN-2012, respectively. On 22-APR-2013 the patient experienced diarrhea and dehydration. Patient tested positive for Rotavirus with unspecified lab test. Patient presented to urgent care clinic on 25-APR-2013 and was given fluids and unspecified medications. The outcome of dehydration and diarrhea was reported as recovered/resolved. The relatedness for the events was unknown for ROTATEQ. Additional information has been requested.
Seizures. There very well may have been a seizure prior to onset date that was missed because the first one noticed lasted about 45 sec and they've gotten longer each time and I am currently single parenting due to husband being deployed. The seizures start with 'zoning out' I can't get his attention and his body is limp, then his eyes roll back and face turns purple and body convulses and fists clenched. He has had 8 seizures total now and the last 2 have lasted 4 minutes.
Patient seen in acute care clinic for well baby check and administered H1N1 influenza vaccine-manufacturer unknown-. Patient immediately developed a rash over his body following vaccine administration which lasted approximately 20 minutes. No additional treatment was required and the reaction resolved.
first dose August 2019, didn't get second yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Aug-2022 Reporter's comment: The patient did not get his/her second shot yet. The patient asked that what should he/she do. Additional supportive information: Till the time of reporting the patient did not receive the second shot of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY; Dose received: 3; Complain of pain in the vaccinated arm for several days, it has progress to be worse and having pain and difficulty extending his arm even 7 days after the booster dose.; This is a spontaneous report received from contactable reporter (consumer or other non-HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Moderna covid-19 vaccine (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), both with onset an unknown date in 2021, outcome "unknown", and described as " Patient received first and second dose of Non-Pfizer vaccine and booster dose of COMIRNATY"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "complain of pain in the vaccinated arm for several days, it has progress to be worse and having pain and difficulty extending his arm even 7 days after the booster dose". It was unknown whether any therapeutic measures were taken as a result of the event pain in extremity.  Additional Information: Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
SHORTNESS OF BREATH/FELT LIKE I  COULDN'T BREATHE; ACHEY; CHILLS; EXTREMELY FATIGUED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced achey. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extremely fatigued. On APR-2021, the subject experienced headache. Laboratory data included: Blood test (NR: not provided) normal. On 17-APR-2021, the subject experienced shortness of breath/felt like i couldn't breathe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achey, headache, chills, extremely fatigued and shortness of breath/felt like i couldn't breathe was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
This is a spontaneous report from a contactable consumer (Patient). A 38-years-old non-pregnant female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0186) via an unspecified route of administration, administered in left arm on 23May2021 13:00 (at the age of 38-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Not Pregnant at time of Vaccination. Medical history included Blood clot and PE (pulmonary embolism). Patient had no known allergies. Concomitant medication(s) included Eliquis. On 24May2021 10:00, the patient experienced started a period/heavy spotting within 24 hours of vaccine after 13 days of previous period (on a 36 day cycle - period starts 23 days earlier than expected). Patient was not received any treatment. It was reported that most recent COVID-19 vaccine was administered at Pharmacy or Drug Store.  Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has been not tested for COVID-19. No covid prior vaccination and No covid tested post vaccination. Seriousness reported as non-serious. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Flu like symptoms for 12 hrs.  Body pain, exhaustion and a bit of a fever, headaches. Couple months - Apr/May2021 - Right hip - feels like inflammation, weird aching thing. If I have it in one position, it gets sore. I have a tendency for arthritis in my younger years. I changed my diet and it fine till now after the 2nd dose. Joints in fingers is painful. Hip problems now very active and when I am sitting. After 3rd booster and my finger's joints are sore.
Headache, nausea, fatigue, generalized body aches lasting for 7 days. Symptoms mostly resolved after 7 days, still feeling fatigued
Seemed to very much effect my menstruation. My period came 10 days late, then this month?s period was 2 weeks early. Very bad clotting with menstrual bleeding. I am normally very regular so this was extremely unusual.
Redness, warm, cellulitis. Will see MD on 10/11/14 8:00 am.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 13-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported not product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Hives on chest and arms; Swollen lymph nodes in neck, both still evident one month after last vaccine; Soreness on back of neck and both shoulders making arm movement painful; Soreness on back of neck and both shoulders making arm movement painful; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 09:30 (Lot number: FE3594) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: MULTIVITAMIN, CLARITIN and IBUPROFEN. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6202; Anatomical site: Right arm; Administration time: 10:00), administration date: 26Feb2021, when the patient was 62 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ENG207; Anatomical site: Left arm; Administration time: 10:00), administration date: 17Mar2021, when the patient was 62 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 13Jan2022 at 06:15, outcome "not recovered", described as "Hives on chest and arms"; LYMPHADENOPATHY (non-serious) with onset 13Jan2022 at 06:15, outcome "not recovered", described as "Swollen lymph nodes in neck, both still evident one month after last vaccine"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 13Jan2022 at 06:15, outcome "not recovered", and all described as "Soreness on back of neck and both shoulders making arm movement painful". The events "Hives on chest and arms", "Swollen lymph nodes in neck, both still evident one month after last vaccine" and "Soreness on back of neck and both shoulders making arm movement painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria, lymphadenopathy, neck pain and arthralgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Waited 8 weeks to receive second shot; Stomach is bloated; Excessive thirst; More tired; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Waited 8 weeks to receive second shot), ABDOMINAL DISTENSION (Stomach is bloated), THIRST (Excessive thirst) and FATIGUE (More tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Waited 8 weeks to receive second shot), ABDOMINAL DISTENSION (Stomach is bloated), THIRST (Excessive thirst) and FATIGUE (More tired). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Waited 8 weeks to receive second shot), ABDOMINAL DISTENSION (Stomach is bloated), THIRST (Excessive thirst) and FATIGUE (More tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reporter Patient reported that she is doing fine and told that the symptoms reported might not be for vaccine as her symptoms were because of other health issues.  patient declined for further Follow-up   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: follow up document received in which event outcome is updated.
Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (Nurse). This case involves a 31 years old male patient who experienced tender to touch, site reaction of redness of the site, pea size knot under injection site and had a site reaction, while he received vaccines PNEUMO 23 and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 18-Jun-2018, the patient received 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA (Expiry date: 14-FEB-2020) via intramuscular route in the left deltoid. On 18-Jun-2018, the patient received a dose of suspect PNEUMO 23 not produced by Sanofi Pasteur lot number not reported in unknown administration site. On 20-Jun-2018, The patient developed a non-serious tender to touch 2 days following the administration of ADACEL. On 20-Jun-2018, The patient developed a non-serious site reaction of redness of the site 2 days following the administration of ADACEL. On 20-Jun-2018, The patient developed a non-serious pea size knot under injection site 2 days following the administration of ADACEL. On an unknown date, the patient developed a non-serious had a site reaction <<Unknown latency>> following the administration of PNEUMO 23. Final diagnosis was pea size knot under injection site, site reaction of redness of the site, tender to touch and had a site reaction. Lab tests was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for site reaction of redness of the site, as Unknown for tender to touch, as Unknown for pea size knot under injection site and as Unknown for had a site reaction.
muscle aches; significant stomach pain; felt numbness and tingling around the mouth; tingling around the mouth; This is a spontaneous report from a contactable other HCP(Patient). A 58-year-old female patient received second dose BNT162B2(lot number EK9231), via an unspecified route of administration at Arm Left on 12Jan2021 11:45 at 58 years old at single dose for COVID-19 immunization. The patient medical history was Graves' disease and COVID-19. Concomitant medication included ibuprofen(MOTRIN) and diclofenac sodium. The patient previously took Percocet and Darvocet, both experienced Drug Allergy. The Historical Vaccine was first dose BNT162B2(lot number EJ1685) received on 22Dec202011:45 at 58 years old at Left arm and experienced body ache, muscle aches, feeling like coming down with the flu. While receiving the product the patient felt numbness and tingling around the mouth that went away in about 30 minutes on 12Jan2021 then the next day 13Jan2021 02:30 muscle aches and rather significant stomach pain. There was no treatment received for all the events. There was no covid tested post vaccination. There was no other vaccine in four weeks. The outcome of events numbness and tingling around the mouth was recovered on 12Jan2021 , the events muscle aches and stomach pain was recovering.
Sore arm, fatigue, headache, back ache, muscle aches, loss of appetite.
An itchy rash develop at the injection site on left arm.   In initially, the rash was red & intensely itchy.  It appeared as a bright red and has gradually faded.   During the duration of the rash of 10 days, it gradually faded and became less itchy.   I did not have any other physical symptoms.  After the 11th day of the rash, it has finally disappeared (today).
I waited 15 minutes and I left we shopped a little bit. About an hour after on the way home I got confused. By the time I got home I could not speak. My words would not come out. It happened for 30 minutes and I walked around the yard for a while then I was okay. I was really frightened. When I told my doctor what happened, he advised me he did not feel it was related to the vaccine. He advised me to start taking Baby Aspirin. The doctor did not tell me I had a mild stroke but, I feel that I did.
This case was reported by a physician via call center representative and described the occurrence of iiird nerve palsy in a 86-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension. On 7th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced iiird nerve palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the iiird nerve palsy was unknown. It was unknown if the reporter considered the iiird nerve palsy to be related to SHINGRIX. Additional details were provided as follows: The patient presented with partial third nerve palsy. The reporting physician stated that the third nerve palsy could also be related to the patient's hypertension. The reporting physician consented to follow up.