chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; 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 72-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7139) 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: SERTRALINE; VITAMIN D [VITAMIN D NOS].  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. Patient took other medication in 2weeks. The patient had No Known allergies.
Patient states she had hives and cold chills (cold chills went away) but just currently "feels bad". She stated that she had no issues with breathing and will contact the pharmacy if symptoms worsen.
Medium soreness in upper left arm 4 days after vaccine was administered. Surprised because no soreness whatsoever the first 3 days.
5 days after the immunisation, she developed an itch, it was tender to the touch; red, hot and lumpy (similar to a bee sting). She took BENADRYL and ALEEVE-Next day it was much better. No systemic reactions.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
MMR and Varivax was ordered, but MMR and  proquad was administered. Patients mother was notified and so was the provider.
Pt vaccinated with MMR experienced generalized seizure associated with fever - otitis media 8 days after MMR administration.
Pfizer 4/14/21, 5/5/21. Positive on 7/29/22
Pt developed a fever of 102 F 5 hours after immunizations were given. RX: Tylenol.
severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000) for COVID-19 vaccination.     Concurrent medical conditions included Trigeminal neuralgia and Epilepsy. Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]) and PREGABALIN (LYRICA) for Neuropathic pain, LEVETIRACETAM for Seizures.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain) (seriousness criterion intervention required). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; PHENYTOIN (DILANTIN [PHENYTOIN]) at a dose of 300 mg and Surgery for Myalgia. At the time of the report, MYALGIA (severe pain ,difficult to brush teeth due to pain & difficult to eat due to pain & difficult to talk due to pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported severe pain and was difficult to brush her teeth, eat and talk without experiencing pain at a higher level then had been experienced prior to receiving the Moderna vaccine. Treatment also includes surgery and a sponge was placed between the nerve and vein to reduce pain which patient reported was working. Prior to surgery, he was taking high doses of pain medication as well as anti seizure medication to control epilepsy. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: 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.   This case was linked to MOD-2021-237448 (Patient Link).; Sender'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.
itching at injection site; bruising at injection site; headache; pain at injection site; redness at injection site; chills; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, chills and feeling unwell. On 1st May 2019, the patient experienced headache. On 3rd May 2019, the patient experienced injection site itching and injection site bruising. On 1st May 2019, the outcome of the chills and feeling unwell were recovered/resolved. On 2nd May 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site itching and injection site bruising were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, chills, feeling unwell, headache, injection site itching and injection site bruising to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the left arm and experienced injection site pain, injection site erythema, chills and feeling unwell, headache, injection site itching and injection site bruising. The patient has been given the consent for follow up. The outcome reported for all AES in the structured field of XML is recovering/recovered with sequel  instead of resolved.
INFLAMED JOINTS; SEVERE BODY PAIN; DIFFICULTY BREATHING; MENTAL CONFUSION; HEADACHE; MUSCLE PAIN; FEVER; SORE ARM; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, bipolar disorder, post traumatic stress disorder, and anxiety disorder, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced severe body pain. On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced mental confusion. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced muscle pain. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 17-APR-2021, the subject experienced inflamed joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-APR-2021, was recovering from difficulty breathing, had not recovered from severe body pain, muscle pain, headache, and mental confusion, and the outcome of sore arm and inflamed joints was not reported. This report was non-serious.
tested positive for COVID-19 infection; starting to experience twitching in his legs; heartbroken; starting to experience muscle pains in his legs; coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-May-2020. Concomitant products included METFORMIN, IRBESARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PRAVASTATIN, INSULIN HUMAN (INSULIN [INSULIN HUMAN]), INSULIN LISPRO (ADMELOG), TRAZODONE, GABAPENTIN, ESCITALOPRAM and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (coughing). On 03-Aug-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs). At the time of the report, COUGH (coughing), COVID-19 (tested positive for COVID-19 infection), MUSCLE TWITCHING (starting to experience twitching in his legs), FEELING ABNORMAL (heartbroken) and MYALGIA (starting to experience muscle pains in his legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2020, SARS-CoV-2 test: positive (Positive) Positive. On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no known drug of food allergies.  Patient had not taken or used any treatment medications.  The patient wears a mask and patient unsure how he became infected with COVID-19 again.  Patient was recently at a nursing home and a person there was coughing.   This case was linked to MOD-2021-275395 (Patient Link).
This report involved a cluster of three patients who experienced adverse events following administration of FLUZONE INTRADERMAL, lot number UT4163AA. The other two patients have been captured in case numbers 2012-02397 and 2012-02398. Initial report was received from a health care professional on 24 February 2012. A female patient (age and date of birth not reported) had received an injection of FLUZONE INTRADERMAL, sanofi pasteur Inc. lot number UT4163AA (route, site and date of administration not reported). One to two hours after the vaccination, the patient experienced swelling and redness that was itchy "about a 50 cent size are" that was okay by the following morning. Then two days later, the patient developed a larger area traveling down the arm that was red, warm, itchy and painful that extended about four inches from the injection site that lasted for about a week. The patient took BENADRYL at night and CLARITIN during the day to relieve the itching and inflammation as well as cold packs for the discomfort. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None. Follow up information received on 08 May 2012: Patient age was reported as 57 years at the time of event. The patient's medical history and other vaccinations included none. Product therapy dates added as 19 October 2011. Product route of administration added as subcutaneous route and site of administration added as deltoid left. Event onset dates added as 21 October 2011 and event cessation dates added as 29 October 2011.
Pain and swelling commenced on day 6 as reported to V-Safe- itchiness rash and frequent urination....unable to sleep throughout night on day 7 and an ER visit confirmed shingles.
pt recv vax 23JUN97 & 25JUN97 pt devel a fever of 105.5;lab eval revealed strep negative cult;
pain at injection site; swelling at injection site; fatigue; This case was reported by a non-health professional via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site swelling and fatigue. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown and the outcome of the fatigue was resolved with sequelae.   It was unknown if the reporter considered the injection site pain, injection site swelling and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient after receiving the vaccine, developed severe pain and swelling at the injection site. The patient also developed fatigue that lasted for a few days. The reporter did not have healthcare professional name or contact information at the time of the reporting. The reporter stated that he will get the information and more details and call back to Agency.
Vaccine administered. Patient reported L upper arm paresthesias ~7 min after administration. States she   had the same reaction with first dose that self resolved by end of day. Patient was monitored for 30   minutes with improvement of symptoms and no development of new or worsening symptoms. Patient was advised to   seek ER eval if she develops any throat itching or tightness, tongue swelling, shortness of breath or   vomiting.
Approximately 10 hours after injection, a sore throat and fever occurred. The sore throat persists 5 weeks later, although lessened in severity. Fatigue occurred around day 11 after the vaccine. Debilitating fatigue and weakness occurred around day 22 and persisted for 4 days, lessening to general fatigue and weakness thereafter and persisting as of date of report. Sore throat, fatigue, and weakness persist with no end date as of this report.
Information has been received from a health professional concerning a 24 year old female with fibromyalgia (since age 14) and migraines on 20-NOV-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included creatinine "supplements", multiple various vitamins (unspecified) and DEPO-PROVERA. The patient saw Rheumatologist on 21-DEC-2007 for a routine check-up and when blood was drawn. CK result came back later that day showing 19,900, patient was advised to go to the hospital. Upon admission, CK was 50,000. The patient had been exercising between the blood draws (no baseline CK level available). The patient was hospitalized for three days and received hydration. Discharge diagnosis was "enzyme deficiency". The patient had an EMG and muscle biopsy (dates unspecified) but results are not available. She was due for her second dose of GARDASIL but had canceled her appointment. Additional information has been requested.
This report describes the occurrence of Lyme disease in a 48 year old female who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. This report was received from the subject and has been verified by a physician assistant. The subject's medical history reportedly included Lyme disease, for which she "took the appropriate antibiotics." The subject smoked less than one-half pack of cigarettes per day. The subject experienced no adverse events following previous immunizations. On unspecified dates, the subject received two injections of LYMErix. The subject reported, "I recently contracted the Lyme disease again." The physician assistant reported that the subject contracted Lyme disease in August 2001, with "positive confirmatory labs." The Lyme disease resolved on an unspecified date.
A few days after the vaccine developed fever to 103, malaise, coryza, post nasal drip and a diffuse facial burning.  As of this report the sx have resolved except the facial burning, which persists.
sick for six months; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who was sick for six months (illness), after receiving INFLUENZA VACCINE.  The patient's medical history included that the patient was not allergic to eggs.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient stated that well, I disagree I had one back in 09 was sick (sickness) for six months after starting a week after the shot.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available on the batch number for this case.
HYPOTENSION 1/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
24 hr flu symptoms, as well as pain in arm that has not gone away. Nurse hit a nerve when she administered the shot.  Pain lifting arm since.
Information has been received from a female consumer, who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot # not reported) SQ. The consumer experienced an injection site reaction consisting of a large local reaction of swelling and redness. There were no Lab diagnosis/studies performed. It was reported that the consumer had not receive treatment for the adverse events. The patient did not seek medical attention. At the time of the report, the consumer had recovered. No further information is available.
Patient presented to ER with increase shortness of breath, exacerbated by ADL's. Fever of 100.4.  treated with Tylenol. Status post 4/28/22 right hemi-colectomy due to colonic intussusception. Covid positive 5/30/22. Received 2nd booster dose 4/22/22. Patient hospitalized for further evaluation of SOB with pulse ox sat dropping to 90's on room air. Please contact Hospital for any additional information. No known outcome/discharge from hospital.
Transferred from Hospital on 4/1/21 for fever and altered mental status, suspecting adverse reaction from Janssen COVID vaccine given 3/30/21, symptom onset 3/31/21 morning.  Sepsis with unknown source of infection:  This is evidenced by leukopenia, tachycardia and fever. Acute metabolic encephalopathy, likely secondary to possible sepsis versus effects of  COVID vaccine. Encephalitis and meningitis ruled out. Acute nontraumatic rhabdomyolysis: evidenced by elevated CK levels 1700 on admission, likely secondary to sepsis. Acute renal failure, hypothyroidism, transaminitis, elevated troponin likely associated with rhabdo. On sepsis protocol (vancomycin, meropenem and acyclovir)  Disc
I lost my taste / I can only taste sweet and sour; Sore throat; weird tongue sensation; a lot of pain in my upper tips; mouth very dry; I am loosing energy; I can not work; loose of mouth; lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips) and DRY MOUTH (mouth very dry) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B, 016C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips), DRY MOUTH (mouth very dry), ASTHENIA (I am loosing energy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can not work), ORAL DISCOMFORT (loose of mouth) and PAIN (lot of pain). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips), DRY MOUTH (mouth very dry), ASTHENIA (I am loosing energy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can not work), ORAL DISCOMFORT (loose of mouth) and PAIN (lot of pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took mucus relief and nasal spray as treatment medication.
administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-JAN-2023 Reporter Comment: The pharmacist reported they inadvertently administered an expired Twinrix (expired 1st January 2023) dose to a patient. The pharmacist called to inquire how to proceed. The reporter did not consent to follow up  Additional Supportive Information: The patient received an expired dose of Twinrix vaccine which led to expired vaccine used.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: pt states had facial swelling start 7/15/22.  on 7/20/22 came to pharmacy. still having some swelling. pt had been taking benadryl. unsure if vaccine related or something else. referred to provider for follow up