chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed.; Worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed. Had an outbreak also.; Wouldnt go to the doctor because "I" was embarrassed by it all; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 13Mar2021, the patient did not realize herpes was something that should be reported. With the second shot the patient had the worst smelling urine that was so golden and smelled so foul (boiled eggs) and burned when it passed. The patient had an outbreak also and had never had one in the 12 years of diagnosis. The patient was embarrassed by it all and did not go to the doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events herpes, urine that was so golden and smelled so foul (boiled eggs) and burned when it passed and urine outbreak was resolved on an unknown date in 2021; while that of the event embarrassed by it all and did not go to the doctor was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Influenza vaccine administered 11/4/14. He has since experienced near constant severe pain in the arm while impairs his normal daily activities. Pain increased with time.
Diagnosed with benign paroxysmal positional vertigo.  Emergency room visit after 36 hours.  After 48 hours, still unable to move.
Nerve damage; Lhemitte's sign symptom/Nerve zingers down trunk and into leg and arm,tilt my head forward, left side but occassionally down both legs; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve damage) and LHERMITTE'S SIGN (Lhemitte's sign symptom/Nerve zingers down trunk and into leg and arm,tilt my head forward, left side but occassionally down both legs) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Carpal tunnel syndrome since 27-Apr-2021.   On 07-Apr-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021 at 4:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LHERMITTE'S SIGN (Lhemitte's sign symptom/Nerve zingers down trunk and into leg and arm,tilt my head forward, left side but occassionally down both legs). On an unknown date, the patient experienced NERVE INJURY (Nerve damage). The patient was treated with PREDNISONE from 28-Jun-2021 to 08-Jul-2021 for Adverse event, at a dose of 1 dosage form; IBUPROFEN (IBUPAR [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form; PARACETAMOL (ACETAMINOFEN) for Adverse event, at a dose of 1 dosage form; MULTIVITAMINS [VITAMINS NOS] for Adverse event, at a dose of 1 dosage form; VITAMIN B12 NOS for Adverse event, at an unspecified dose and frequency; BIOTIN for Adverse event, at an unspecified dose and frequency; Manual therapy (therapeutic massage, hot and cold compresses, acupuncture) for Nerve injury and Manual therapy (Accupunture, hot and cold compresses, therapeutic massage) for Lhermitte's sign. At the time of the report, NERVE INJURY (Nerve damage) outcome was unknown and LHERMITTE'S SIGN (Lhemitte's sign symptom/Nerve zingers down trunk and into leg and arm,tilt my head forward, left side but occassionally down both legs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Nerve conduction studies: normal (normal) Normal, no carpel tunnel noted.         No concomitant medications were provided.  An MRI  was conducted on 7-jul-2021, but the results were not reported.   The patient reported receiving therapeutic massage on 13-may-2021  and 01-jul-2021 with no improvement. The patient received acupuncture on 20-may-2021 and 17-jun-2021 with no improvement. The patient also had chiropractor visits on 05-may-2021, 07-may-2021, 10-may-2021, 13-may-2021, 17-may-2021, 20-may-2021, 24-may-2021, 28-may-2021, 03-jun-2021, 07-jun-2021, and 10-jun-2021.   This case was linked to MOD-2021-251617 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Completed ADR Form appended; Patient demographic details, race and  ethnicity were updated. Lab test and treatment medication were added, new events were added.
I felt fatigue, I had go lie down.; I could not sleep well because of the pain; pain got worse;  I could not sleep well because of the pain; Joints started to hurt a little bit/Hips, back, legs and shoulders hurt; my temperature was 100.4 F; chills; My hips, back, legs and shoulders hurt; Face swollen; Cheeks and lips swollen; arm was a little bit sore; A spontaneous report was received from a 72-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events face swollen, cheeks and lips swollen, my joints started to hurt a little bit, my hips, back, legs and shoulders hurt, my arm was a little bit sore, pain got worse, my temperature was 100.4 f, chills, felt fatigue, had go lie down..  The patient's medical history was not provided. Concomitant medications reported were Nexium, Statin, Calcium, probiotics, iron supplements, fish oil for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route and unknown anatomical location for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the event arm was a little bit sore .   On 23 Jan 2021, the patient developed face swollen, cheeks and lips swollen.   On 27 Jan 2021, the patient experienced the events joints started to hurt a little bit,hips, back ,legs and shoulders hurt and temperature was 100.4 F.   On 29 Jan 2021, the patient experienced the events pain got worse and chills. On 31 Jan 2021, the patient experienced the event felt fatigue .   Treatment details included Benadryl, Hydroxyzine HCL 25 mg, Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event fatigue was considered resolved on 2 Feb 2021. The outcome of events face swollen, cheeks and lips swollen, joints started to hurt a little bit , hips, back ,legs and shoulders hurt, arm was a little bit sore ,pain got worse, temperature was 100.4 F and chills was unknown..; Reporter's Comments: This case concerns a 72-year-old female with NS unexpected events of swelling face, lip swelling, back pain, and 'could not sleep because of pain' and NS expected events of arthralgia, vaccination site swelling, fatigue, body temperature increased and chills. Event onset the same day as the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
Tinitus:  Resulting in severe anxiety and insomnia 2-3-2021    ENT , Audiology Exam, Rx Steroid Pack - No Improvement 2-12-2021   TMJ Diagnostics,  2-13-2021  Chiropractic treatment (muliple visits over course of 2 months) 2-14-2021  Urgent Care visit 2-19-2021  ER visit,  2-23-2021  ENT followup 2-23-2021   PCP 3-5-2021    Brain MRI  3-16-2021  PCP followup 3-17-2021  Audiologist 3-25-2021  PCP followup 3-31-2021  ENT followup 4-1-2021    PCP followup
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.  Company Comment: This is a case of Expired Product Administered concerning a 68-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 68-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events only happened after the second dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Temperature of 103 F and fever like symptoms 8/5/09. Telephone call from patients spouse stating temp now 101 F. Nausea followed by emesis of previously eaten crackers, loose stools , able to take fluids. Note, history of similar symptoms  7/14/09. PCP stated "it was a virus". condition improved. No response from client when RN left voice mail 8/6 and 8/7/09.
This spontaneous case, initially received on 20-Sep-2016, was reported by a health professional and concerns a male patient. Weight: not provided, Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received AFLURIA. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT53606. No additional suspect drugs. On an unknown date, the patient was administered AFLURIA vaccines that were out of range at 50.1F for 1 hour and 27 minutes - no adverse event (outcome: not reported, special circumstances: drug administration error without adverse event). Reporter comments: The reporter considered the event as non-serious.
About 10 minutes after vaccination, patient reported noticing some red hives over skin on upper body, was not itchy. Felt a little woozy  Was offered diphenhydramine 50mg orally by the PA, which she accepted. After taking dose, hives ameliorated and she felt well. She went back to work with no further issues reported
Given PNEUMOVAX, 9-6-2011 at approximately 8:03am. By that afternoon was beginning with pain in knees, feet and general weaknes. Got progressively worse, weak and fell once. Seen on 9-8-11 unsure etiology then - treated with IM DEPO-MEDROL and lab checked. Sx even worse 9-9-11. So weak trouble walking. Admitted labs -> Sed Rate elevated. Treated with high dose steroids with marked improvement.
Patient received Bivalent booster, but is supposed he need the Covid-19 Monovalent of primary dose. This error happen because the patient explain to us that he received primary serie doses. But he dont explain to us that the primary doses tha he received. that means that the primary serie that he received was not approved.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 01Dec2021, outcome unknown; ILLNESS (non-serious) with onset 02Dec2021, outcome unknown; PYREXIA (non-serious) with onset 02Dec2021, outcome unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.  Follow-up on 08Dec2021 included this follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
None reported on database Narrative: A 70yo male with history of CHR, DM and history of ESRD (on dialysis). Per nursing documentation of January 26, 2021, he received Covid-19 vaccine without complications and per policy and protocol, included advising the patient to stay on premise for 15 minutes. He was provided written information on side effects and how to report ADR
Pt. received MMRV and Hep A in Rt arm. Developed hives in Rt arm which quickly spread throughout entire body.
Vasovagal syncope (loss of consciousness) Tonic seizure (tensing and twitching of arms) Irregular heartbeat (per EKG) Extremely low blood pressure  I received the vaccine at a public health pop-up, drive through clinic for first responders - I accessed the vaccine through my employer as a first responder. The vaccine was administered to my left arm without complication at approximately 1:00pm (my scheduled appointment). I proceeded to the area designated for patients to be observed after receiving the vaccine and was asked to wait 15 minutes. I recall getting to the observation area then telling my spouse I felt unwell - after the event he notified me that I told him I was about to pass out and asked him to get medical help. I lost consciousness approximately 5-10 minutes following the vaccine. My husband reported that after losing consciousness I seemed to have a minor seizure, as evidenced by my head jerking and my arms and fingers "tensing and curling up".  I was sitting in the passenger seat of my car at this time, so I suffered no fall or fall related injury. Public health officials and EMT responded. They indicated to my spouse that I had experienced a vasovagal syncope episode and that I had "gone tonic"/ had a "tonic seizure".  They took my blood pressure, which was very low (I don't recall exactly but it was 80 over something). They also took my blood sugar among other things that I do not recall.  I was given oxygen and put into an ambulance. I was shaking, so they wrapped me in blankets. I believe they may have done an EKG and placed a blood pressure cuff while I was in the ambulance, but I do not recall any specifics about this. The EMT also drew my blood, placed an IV, and administered IV fluids while I was in the ambulance. I was taken by ambulance to the emergency department
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site), VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, High cholesterol (high cholesterol controlled), Blood pressure high, Prostate cancer and Lymphoma. Concurrent medical conditions included Drug allergy (sulfa drugs). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site). On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site) and VACCINATION SITE PAIN (heat, swelling and a little soreness at injection site). On 30-Mar-2021, the patient experienced PALMAR ERYTHEMA (palms of hands are reddened). On an unknown date, the patient experienced PRURITUS (redness and itciness in right armpit; itching bilateral hands) and ERYTHEMA (armpit redness). At the time of the report, VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site), VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (heat, swelling and a little soreness at injection site), PALMAR ERYTHEMA (palms of hands are reddened), PRURITUS (redness and itciness in right armpit; itching bilateral hands) and ERYTHEMA (armpit redness) outcome was unknown. Not Provided. This case was linked to US-MODERNATX, INC.-MOD-2021-062719 (E2B Linked Report). This case was linked to MOD-2021-062719, MOD-2021-062719 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062719:
Missed miscarriage. Was 4 weeks pregnant at time of second shot. Estimated delivery date of Dec 26, 2021. Heartbeat at 6 week ultrasound (May 7th). No heartbeat at 8 week ultrasound (May 20th). Pregnancy through IVF - frozen embroyo transfer on April 9th. Had D&C on May 24th.
Received vaccination 01/05/2022, diagnosed in June 2022 with breast cancer.
leg started itching real bad; leg swelled up; had a rash; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization.  Medical history includes allergic to latex. The patient's concomitant medications were not reported. It was reported that a doctor insisted she get the pneumonia shot and patient stated she had a bad effect after getting the pneumonia shot. After the pneumonia shot her leg started itching real bad, swelled up and had a rash. The patient was given medication for the pneumonia reaction and stated her leg had to be cleaned and wrapped. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Was not certain if it was cellulitis on left arm; Local reaction where the injection site stung/injection site burn; Red things on arm; swollen; First dose of Shingrix in her left arm subcutaneous; This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) and levothyroxine sodium (Synthroid).   On 5th October 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 5th October 2019, less than a day after receiving Shingrix and an unknown time after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site cellulitis, injection site stinging, injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site stinging, injection site erythema and injection site swelling were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site stinging, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient also received the Fluarix Quad 2019 -2020 in her right arm on the same date. The orthopedic Surgeon reported that his wife received Shingrix in her left arm subcutaneously rather than intramuscular in error at her pharmacy. The patient experienced a local reaction where the injection site stung and burned after receiving the Shingrix vaccine. She also had large red things on her arm that kept getting larger and were painful, red and swollen and were well defined in the arm area where she received the injection. The physician was not certain if it was cellulitis on her left arm but he was treating it with Bactrim and things were now resolving. The reporter consented to follow up. This case has been linked with US2019183586, same reporter.
Arm was sore after vaccination, but 5 days later the arm became tender and warm to the touch. The arm also developed a red area approximately 3 inche s in diameter slightly below where the vaccination was given.
STARTED 1/7/2021 WITH MODERATE  LEFT ARM PAIN,  CHILLS, NAUSEA, COLD SWEATS, MALAISE
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a 11-year-old male. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Increased blood sugar level after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Increased blood sugar level after vaccination) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032020A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Increased blood sugar level after vaccination). At the time of the report, BLOOD GLUCOSE INCREASED (Increased blood sugar level after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Tender at the injection site, body ache, by evening 102 fever, chills and more severe body ache by morning.