chrisvoncsefalvay/vaers-outcomes huggingface dataset:
two weeks after vaccination, pt developed significant DVT throughout venous system of leg.   Had been extremely sedentary from msk injury sustained 3 days prior to vaccine
Facial numbness, tingling, difficulty swallowing. Flu like symptoms lasting 10 days, residual tachycardia
HPV#2 given -> pt fainted & unresponsive x about 1 min. Remained pale & sl dazed - unable to answer basic questions for 45 min in spite of positioning, juice, cool compresses. Eye fluttering again at 45 min mark so sent to ER via ambulance - there got IVF, ZOFRAN & had nl EKG & sent home by 12 noon. (Was lying down when shot given & had eaten b'fast_.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 64 years, 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 had no known allergies. The patient's 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (25Aug2022) Positive, notes: tested positive 25Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 11Aug2022 to 15Aug2022. Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Tingling in my fingers within the first 15 minutes. Tired and headaches for two weeks. tingling and arm falling asleep quickly off and on.
Evening of flu vaccine - stuffy nose. Next day nasal congestion, overall body aches, tired, lightheaded. Approx 1 week later noted left sided chest pain. 11/20 saw Occupational Med MD - numerous tests including CXR. 11/25 follow up appt at Occ Med - to follow up and have Echo stress tests scheduled for 12/12/14.
vaccination failure; shingles; itching; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic pain. Concomitant products included gabapentin.   On an unknown date, the patient received the 1st dose of Shingrix. On 13th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 13th January 2020, unknown after receiving Shingrix and 61 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix.  Additional details were provide as follows: This case was reported by the patient's husband. About three months after vaccination, the patient experienced shingles after 2nd dose, although the shingles had been mild compared to shingles she has had in the past and were on her right arm, neck, and under her left breast. The patient planned to continue follow-up with her physician on an unknown date. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) included: LEVOTHYROXIN. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SHORTLY AFTER VACCINATION, DEVELOPED DIZZINESS, BILATERAL ARMS THAT FEEL "HEAVY". RECEIVED 25MG DIPHENHYDRDAMINE BY MOUTH. RESOLVED IN ABOUT 1 HOUR
Within 10 minutes of receiving the vaccination in my left arm, I began feeling heat in my face.  I looked at my Fitbit to check my heart rate, which is normally in the high 70's or low 80's and it had exceeded 130.  I felt an itchiness in my neck and face, which was confirmed by the RN on duty that my face, neck and chest were red.  I was given 2 chewable Benadryl tablets, and observed for an additional 30 minutes, at which I was released from the facility.
The pt complained of a migraine after receiving Anthrax vaccine. Symptoms continuing into the next day.
Fever 101 degrees Severe Bodyaches Dizziness Symptoms lasted 24 hrs
My whole body has been covered in hives and whelps. It is red and burning and hot to the touch and sensitive. Urgent care gave me 5 days of steroids.
This case was reported by a physician and described the occurrence of red raised skin on arms in a 2-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On 22 October 1998 the subject received unspecified dose of Infanrix at 0.5 ml, intramuscularly in an unknown thigh. Th lot number and expiration date were not provided. The following day, on 23 October 1998, the subject developed a red, raised area on his arm down to his elbow. The event resolved on 25 October 2006. Further treatment with Infanrix was delayed. The physician was questioning if the subject should receive the next dose of Infanrix in the series. No additional information was provided.
A few minutes after receiving the vaccine, patient's husband was calling for help. The patient appeared to be passed out but woke up. An ambulance was called and she reported to the hospital.
This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient was vaccinated with live ZOSTAVAX on 21-JAN-2013. Patient route of administration and lot no. were not provided. No other co-suspects were reported. No concomitant medications were reported. On 28-JAN-2013 the patient experienced swelling of the jaw region, 8 days after onset of therapy, and swelling of tongue. It is effecting his speech No treatment information was reported. The outcome of swelling of the jaw region, swelling of tongue and it is effecting his speech was reported as not recovered/not resolved. The relatedness for swelling of the jaw region, it is effecting his speech and swelling of tongue is unknown for live ZOSTAVAX. Additional information is not expected, because consumer declined to answer any further AE questions.
Information has been received from a physician concerning a rumor of a local high school aged girl experiencing Guillain-Barre after receiving a dose of GARDASIL. The patient's outcome was unknown. The patient sought unspecified medical attention. Upon internal review, Guillain-Barre syndrome was determined to be an other important medical event. Follow-up information was received on 27-AUG-2009 from a medical assistant, who reported that they had heard this report "from a couple of mothers" (name of mother not available). It was not known if the patient was local or if she attended high school or middle school, but she was said to be in a wheelchair. The event could not be confirmed. The Health Care Professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 at 08:00 as dose 1, single (Lot number: EH9899), in left arm, on 07Jan2021 at 08:00 as dose 2, single (Lot number: EL1284), in left arm and on 09Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 incuded Paxlovid from 11Jul2022 to 15Jul2022.; Sender's Comments: As per available information the causality of the event Vaccination failure and covid-19 with suspect product BNT162B2 can not be ruled out.
Hives/rash outbreak the next day and spreading across breasts, stomach, back, armpits, pubic area, and inner thighs. Treatment includes Benadryl and Triamcinolone Acetonide Ointment  to treat Pityriasis Rosea.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23May2023 as dose 6 (booster), single (Batch/Lot number: unknown), 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chron's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benzoyl peroxide, reaction(s): "Known allergies: Benzoyl peroxide". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 ith Paxlovid from 27Aug2023 to 01Sep2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300294398 same  patient/reporter, different drug/AE;
It was warm; Discomfort at the injection site; Pain and discomfort at the injection site; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the injection site), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PAIN (Pain and discomfort at the injection site) and CHILLS (Severe chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 015M20A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the injection site), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PAIN (Pain and discomfort at the injection site) and CHILLS (Severe chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 14-Nov-2021, CHILLS (Severe chills) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the injection site), VACCINATION SITE WARMTH (It was warm) and VACCINATION SITE PAIN (Pain and discomfort at the injection site) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-047836, MOD-2021-047860 (Patient Link).
Hard to breath deep. Continuously since 3 days after the vaccine. No interaction with anyone outside the house. Everyone in the house did not go outdoors or had already been vaccinated with the second dose a month before.
extreme pain, swelling, tingling & numbness to joints to include bilat wrist, knees, ankles & feet;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 26 year old white hispanic/latino male. The patient's weight was not reported and height was 70 inches. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: The patient had allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had J&J Covid-19 vaccine early in March-May 2021 and developed Covid-19 on 26-DEC-2022 and believes that it saved him from severe illness/hospitalization/death. The patient experience loss of taste and smell, had no appetite, cough and flu-like symptoms (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000219441.; Sender's Comments: V0: 20220300887-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Arm is sore; Headache; Muscle pain, arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and MYALGIA (Muscle pain, arm is sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, Levothroxine and OMEPRAZOLE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and MYALGIA (Muscle pain, arm is sore). At the time of the report, PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a Registered Nurse via company representative regarding herself a 31 year old female patient. Currently patient had type 1 diabetes. No historical medication was reported. On 28-SEP-2015, the patient was vaccinated with PNEUMOVAX 23 Inj, intramuscular, 1 shot. No concomitant medication was reported. On 29-SEP-2015, the patient experienced persistent fever, body aches, injection site pain and heat and redness at the injection site. She also reported severe pain from her mid-back to her mid-thigh and across her spine. She sought medical attention on 29-SEP-2015 at an unspecified medical emergency room. She was treated at the facility with AUGMENTIN and KEFLEX. The outcome of persistent fever, body aches, injection site pain and heat and redness at the injection site, severe pain from her mid-back to her mid-thigh and across her spine was reported as resolved. The causality between persistent fever, body aches, injection site pain and heat and redness at the injection site, severe pain from her mid-back to her mid-thigh and across her spine and PNEUMOVAX 23 was unknown. Additional information has been requested.
Fever, dyspnea, pneumonia, cognitive changes 2nd to illness & fever, severe respiratory issues. Unable to work. Achy all over. Lungs filled with fluid.
Left sided chest pain, left arm/hand tingling, inspiratory/expiratory wheezes, skin flush and moist. No rash, swelling or hives. BP=151/94, P=76, RR=22. Pt. observed, supportive care, transported by EMS to ED for further evaluation and treatment.
Soreness around injection sight. Headache, low grade fever, bumpy, localized rash around the injection site
Symptoms: 1. Lightheadedness  2. Dizziness 3. Fainting  Treatment:  1. Sugar water and rest  Symptoms went away in a few hours with ample water and food. The following day all symptoms went away completely
this morning, 2/11/ 21 was fatigued., then had dizziness when gettin up to urinate, had fever  101.8 , gave him 2 tylenol  both shoulders hurting  ( he has had some shoulder ache in right shoulder for some time)
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got it at the age of 23) and pain. Previously administered products included Zovirax (back in the 80s).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUL-2023 This case was reported the patient via interactive digital media. It was painful when it got at the age of 23. In the present time the patient did not get the outbreak as often as it was when used received Zovirax back in 80s. Patient received shingles vaccine 5 years ago and wanted to confirm if it was helped as outbreaks did not came as often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
patient presented to emergency department on 11/30/21 with breathing problems patient was admitted for further management of respiratory failure with hypoxia patient was found to be covid-19 positive on 11/30/21 patient did require treatment for symptoms associated with covid-19 infection. treatment included dexamethasone  and remdesivir patient was discharged to home on 12/13/21
Five months after the second dose of the vaccine I experienced very low blood pressure and very low blood sugar. I had had a Colonoscopy prior to the episode, and I had lost some weight. My blood pressure and Diabetes medications have been adjusted. I am still very fatigued and tired after six weeks, and I am scheduled to see a Cardiologist again. I had seen him a month before. My A1C was very low but it has improved since then. My weight has stabilized. I am scheduled to have a Nuclear Stress Test in September of 2021.
Very sore arm and bruised, fever that night while sleeping, stomach hurt for 3 days, passed out while brushing bite guard next morning and sustained head and other body injuries. Due to a blizzard that day, I was taken to ER on 3/14/19 to be checked out as afraid of possibly having blood clot since my eye and cheek were black and blue, and body hurt. Vitals taken and blood tests done as well as CT scan of head and neck and x-rays of right shoulder and leg, and left hand. No blood clot or broken bones found. Recovery took a wk.
Approx 2 weeks after receiving H1N1 nasal spray began symptoms of R sided facial paralysis. ER visit 11/14/09. 12/4/2009 ED records for 11/14/2009, patient with c/o's rt facial weakness and numbness along with slurred speech. Dx Bell's Palsy 12/8/2009 Neuro consult records for 11/25/2009, reviewed MRI and noted no enhancement in the brainstem to indicate Bell's Palsy caused by MS although a small lesion could of been missed, repeat MRI with contrast along with MRI of Cervical and Thoracic spine, also Rx'd IV Solu Medrol x 5days then prednisone po, rt eye patch
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history reported.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Sore arm). The patient was treated with MULTIVITAMINS;MINERALS at an unspecified dose and frequency. At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication history not provided. No treatment details reported.
PATIENT EXPERIENCE PARALYSIS LIKE SYMPTOMS ON LEFT SIDE THE NIGHT AFTER RECEIVING FLU SHOT. HE WENT TO OFFICE WHO DIAGNOSED HIM WITH BELL'S PALSY AND WAS GIVEN A PRESCRIPTION ON 1/8/18. HE THEN WENT TO HOSPITAL AND THEY TOO DIAGNOSE HIM WITH BELL'S PALSY. THEY GAVE A PRESCRIPTION ON 1/8/18 TO TREAT HIS SYMTPOMS. PATIENT STILL HAS SOME SYMPTOMS TIL TODAY. HE IS GETTING INSURANCE AND WILL FOLLOW UP WITH A DOCTOR.
Pfizer-BioTech COVID-19 Vaccine EUA   Lightheadedness around 4 hours post vaccine.  Ears and face stinging sensation 7 hours post vaccine. Sore Arm and sore neck.
Body aches, weakness, fatigue, fever of 100.2, chills, and headache.  Symptoms lasted until 11/09/16 at approximately 4:00pm.