chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sudden hearing loss in her right ear /diagnosed with moderate to severe hearing loss in her right ear; tinnitus / diagnosed / with tinnitus; Dizzy / dizziness; she started to "not feel great," / suddenly felt ill / feeling ill; achy and a sore arm; This case was reported by a consumer via call center representative and described the occurrence of sudden hearing loss in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 23rd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th July 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell and pain in arm. On 27th July 2020, the patient experienced sudden hearing loss (serious criteria GSK medically significant), tinnitus and dizziness. The patient was treated with meclozine hydrochloride (Antivert (Meclozine Hydrochloride)). On 25th July 2020, the outcome of the feeling unwell and pain in arm were recovered/resolved. On 28th July 2020, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the sudden hearing loss and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the sudden hearing loss, feeling unwell, pain in arm, tinnitus and dizziness to be related to Shingrix.  Additional details were provided as follows: Consumer states that the patient received her 2nd dose of Shingrix on left arm. She states that on 24th July 2020 started to not feel great, achy and a sore arm and these resolved on 25th July 2020. On 27th July 2020 she suddenly felt ill, dizzy, tinnitus, and sudden hearing loss in her right ear.  The patient was taken to the emergency room via ambulance at that time.  She was given an Magnetic resonance imaging (MRI) that was normal, told to take antivert, and referred to an Eye Nose Throat (ENT).  Feeling ill and dizziness had resolved with these treatments.  She was later prescribed a series of ear drum injections and treated with high dose steroids.  Steroids was not coded in due to class of drug. The patient was given a COVID test, results were negative.  She states she continues to symptoms, diagnosed with moderate to severe hearing loss in her right ear with tinnitus.  The patient was going for a consultation for a hearing aid. The reporter consented to follow up.
Presented with weakness, SOB x4 days, hypoxic; DX Covid PNA, DVT, PE; CXR: Left basilar patchy opacity suspicious for PNA; Labs: D dimer: 9.52; CRP 27.91; Ferritin 2388; Meds: Maxipime, Lovenox, Decadron, Rocephin, Lovenox, Zinc, ; supplemental O2 @ 3-4 LPM NC; weaned to room air by d/c; no remdesivir due to renal concerns; Did not meet criteria for actemra
Soreness in the neck and clavicle areas (not the injection site). Mild headache all day.
Pt. called in middle of the night complaining of red ring, swelling and soreness. MD told pt. this was an allergic reaction. Treating with BENADRYL and warm compresses.
felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her scalp; heat in her chest; right side felt numb from her leg to her shoulder; hot flashes; This is a spontaneous report from a contactable consumer. A non-pregnant 39-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 19Jan2021 at 39-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history included heart murmur, Latex allergy; both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported; and no other medications were received within two weeks of the suspect vaccine. On 19Jan2021, the patient experienced: felt intense heat in her armpit lymph nodes on the right side (non-serious), streaks of heat along the back of her scalp (non-serious), heat in her chest (non-serious), right side felt numb from her leg to her shoulder (non-serious), hot flashes (non-serious). The clinical course was reported as follows: The patient, ten minutes after the vaccination, felt intense heat in her armpit lymph nodes on the right side. This was followed by streaks of heat along the back of her scalp, and heat in her chest. After about an hour, the right side felt numb from her leg to her shoulder. The patient's "body stayed that way for about 20 hours." The patient also experienced hot flashes, which was not something that she ever had before. The patient feared getting the second dose because her body felt so off after the first dose. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination with the suspect vaccine.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Started experiencing radiating numbness and tingling in lower left arm through thumb and index finger at approximately 4 p.m. (PT) 2 days following second dose of vaccine. Side effects persisted through next day at time of this report and have not improved or resolved. No changes or events have occurred that would have caused these symptoms.
PATIENT COMPLAINED HAD NAUSEA AND VOMITING FROM NEXT DAY EVENING, CAN'T KEEP ANYTHING DOWN. ALSO HAD LEFT ARM SWOLLEN AND LEFT ARM HAD BIG VISIBLE REDNESS ON IT. PATIENT VISITED THE DOCTOR, WAS PRESCRIBED SOME ONDANSETRON TABLET 8MG TO USE EVERY 8 HOURS IF NEEDED, ALSO ADVISED BY DR TO TAKE SOME BENADRYL, USE ICE PACK AND HYDRATION (PHARMACIST SUGGESTED PEDIALYTE). * ALSO PATIENT RECEIVED INFLUENZA VACCINE SAME DAY ON RIGHT ARM INTRAMUSCULAR (FLUARIX PREFILLED SYRINGE- LOT # 5J594 - EXP DATE : 05/05/18).
Dry scaly areas; Dry scaly areas where the rash used to be; Rash on the left arm that ran from the injection site down into the hand then spread to the leg/ had a rash all over his back; Rash all over his back; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of EXFOLIATIVE RASH (Dry scaly areas where the rash used to be), DRY SKIN (Dry scaly areas), RASH (Rash on the left arm that ran from the injection site down into the hand then spread to the leg/ had a rash all over his back), RASH (Rash all over his back) and INJECTION SITE RASH (COVID Arm) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Skin reaction (Patient had  skin allergies and he thinks that after the first shot his skin allergy has become worse.).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 29-Mar-2021, the patient experienced RASH (Rash on the left arm that ran from the injection site down into the hand then spread to the leg/ had a rash all over his back), RASH (Rash all over his back) and INJECTION SITE RASH (COVID Arm). On 02-Apr-2021, the patient experienced EXFOLIATIVE RASH (Dry scaly areas where the rash used to be). On an unknown date, the patient experienced DRY SKIN (Dry scaly areas). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) at a dose of 2- 3 days. On 01-Apr-2021, RASH (Rash on the left arm that ran from the injection site down into the hand then spread to the leg/ had a rash all over his back), RASH (Rash all over his back) and INJECTION SITE RASH (COVID Arm) outcome was unknown. At the time of the report, EXFOLIATIVE RASH (Dry scaly areas where the rash used to be) and DRY SKIN (Dry scaly areas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Jergens ultra healing lotion. Patient had taken Benadryl 30 minutes before second dose.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up case.
I know that it was a seasonal Influenza vaccine but do not know the kind or manufacturer. She had a very serious seizure on the 6th day after receiving the flu vaccine. At 11:19 AM the seizure lasted 30 minutes and she had to be given medication to bring her out of it. My granddaughter is a very healthy 4 year old and this came out of nowhere. She was transported to the emergency room and then was transferred to the PICU and she is now on the regular peds floor. She is currently still in the hospital and they are running test so I don't know the outcome as of yet.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Lost usage of her right arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Immunocompromised (Caller believes she has a weak immune system because she gets sick easily) and Sickness. Concurrent medical conditions included Lactose intolerant (Sensitivities to lactose). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Lost usage of her right arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Lost usage of her right arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: never shown positive (Negative) Has been tested but never shown positive for COVID. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that patient had received all Moderna for her vaccines and not had the card available to provide lot numbers. It was reported that patient got the second dose in last year at the end of May. Treatment medication information: The patient got a steroid shot in right shoulder from doctor and the lost usage of her right arm got better. This case was linked to MOD-2022-478203 (Patient Link).
High fever 104F with chills and sweating- has been on going since symptom on set with periods of some relief (Tylenol will bring fever down to 101 F). Nerve pain, "my nerves are on fire."   It seems to be rotating through various nerve clusters.  At first it was through his arms, then shifted to the back of his left leg, then the right, then down to his toes, then fingers. Joint pain, this was bad enough he buckled a couple times and fell the night of 02/05/2021 twice. Facial swelling, most pronounced on nose, lips, and chin.  This started 02/05/2021 at around 10:00 AM.  It has been variable in degree since it has started. Vomiting, started 02/05/2021 at around 09:30 PM.  This was after a period of nausea.  The vomitting has since slowed down, but not stopped.
Over the course of the last 9-10 months, my menstrual periods have gotten heavier and heavier to the point where I was soaking through a tampon or pad every 30 mins. I went to the OBGYN and did an ultrasound to look at the uterus and they found a thickened uterine lining and abnormal growth that they could see that resembled a polyp. Both of those things would be the cause of abnormal and heavy menstrual bleeding. I also had intensified cramping with intense pain for each period for each month. Would get worse and worse. In November, OBGYN put me on medication called Tranexamic acid to slow down the period until I could see the surgeon for surgical intervention because the medication was a temporary fix. In January 2022 I saw the OBGYN surgeon where we discussed treatment options and it was recommended that I get a total hysterectomy. February 2, 2022, they removed my uterus, fallopian tubes and cervix. Left the ovaries for hormonal control. They sent it off for pathology for the fibroid tumors and the polyp and the fallopian tubes, cervix, uterus. Found that they were fibroid tumors, and nothing was cancerous, polyp was also non-cancerous. At the time I did the ultrasound, there was no mention of the fibroid tumors so I'm not sure if they developed during all this time or if they were not spotted during the initial ultrasound. That's what was found during the hysterectomy. Before I saw the OBGYN, somewhere around that time I had an ER visit for the heavy bleeding and it made me anemic with iron deficiency.
I experienced heart inflammation about two to three weeks after taking my last shop of the vaccine, the inflammation lasted for about 4 weeks.
some itching, & a couple of small hives progressing later to cover entire body w/itching hands & bottom of feet itching;pred x 6 days;IV steroids-DPH;
I got my period and all the pain came back; My periods are lasting 2 months at this point; weird bumps on my body; dose_number=1/administration_date=10Mar2021;dose_number=2/administration_date=25Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm right on 25Apr2021 12:00 PM (Age at Vaccination:47 years) at single dose for COVID-19 immunization at School or Student Health Clinic. The patient medical history included Diverticulitis, endometriosis and known allergies to Penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. The patient Concomitant medications within 2 weeks of vaccination included Elagolix Sodium (ORILISSA) taken for endometriosis from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on 10Mar2021 12:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that On 27Apr2021 12:00 PM, 2 days after I got the 2nd Pfizer vax the patient experienced I got my period and all the pain came back. My periods are lasting 2 months at this point.  ID RATHER HAVE COVID. Also..I'm getting weird bumps on my body. I'm in pain every day thanks to your vaccinations. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and treatment included Depo shot. The outcome of events was resolved.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
increased heart rate; Elevated blood pressure up to 177/110; Facial flushing; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (increased heart rate), HYPERTENSION (Elevated blood pressure up to 177/110) and FLUSHING (Facial flushing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062H20D) for COVID-19 vaccination.     Concomitant products included MELATONIN, OXITRIPTAN (5 HTP [OXITRIPTAN]), VITAMINS NOS and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced TACHYCARDIA (increased heart rate), HYPERTENSION (Elevated blood pressure up to 177/110) and FLUSHING (Facial flushing). On 18-Feb-2021, TACHYCARDIA (increased heart rate) and FLUSHING (Facial flushing) had resolved. On 25-Feb-2021, HYPERTENSION (Elevated blood pressure up to 177/110) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Blood pressure measurement: 177/110 (High) 177/110.     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.
Gardasil with non-valid lot #, howver lot # valid for Gardasil 9; This spontaneous report was received from a certified medical assistant and refers to a 12-year-old male patient. The patient's medical history or concurrent conditions were reported. The patient's illness at time of the vaccination was reported as none. His concomitant vaccines included polio vaccine inact (IPV).  On 18-FEB-2022, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (inconsistency: manufacturer reported as GlaxoSmithKline) lot # reported as T036812 with expiration date reported as 30-APR-2023, however the reported lot # occurred non-valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), but valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with expiration date 28-APR-2023 (dose was not reported), intramuscularly, in the left deltoid for prophylaxis (product lot number issue). The vaccines were administered by the certified medical assistant in a private doctor's office / hospital and were purchased with private funds and the administrator was trained.  This is one of two reports received from the same reporter regarding the same patient. ; Sender's Comments:  US-009507513-2202USA006184:
Sudden drop in blood sugar 30 minutes after eating. 12 am woke up to use bathroom minutes later woke up on the floor of the bathroom. Immediately experienced vomiting after waking up. Extreme chills and aches that were better when I got into the sauna, shivering so much I couldn?t sleep. Assumed I had a fever. At 5:30am I woke up in a sweat. Finally started to feel a little better. Was very tired all the next day. I did go to work the rest of the week after March 31st. Had to be very careful that my blood sugar didn?t drop too much. When it did I would be come shaken and dizzy. Took me until Sunday to feel like myself again.
Information has been received from a nurse via a company representative reporting on an 88 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient received an unspecified dose of PNEUMOVAX23 (route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced an allergic reaction at the injection site. The injection site became red and swollen. The patient was given BENADRYL by a health care provider and recovered within 24 hours. The causal relationship between injection site swelling and injection site redness and therapy with of PNEUMOVAX23 was not reported.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 84-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
About 30 seconds after administering Gardasil to the patient in her right deltoid, her right arm shook and she passed out in the chair she was sitting in. The nurse who administered the shot tried to arouse her by calling her name and lightly shaking her. The client became fully conscious after about 20 seconds. She did say that she had a ringing in her ears. Client also said that she sometimes passes out when she get shots.
42 YO WV FEMALE 3DAYS POST-VACCINATION INTERMITTENT CHEST PAIN; HOSPITALIZED 1DAY, CARDIAC ENZYMES, ECG, ECHO, STRESS TEST ALL NEGATIVE; CASE CLOSED BY CDC CLINICAL TEAM, FINAL DX: NON-SPECIFIC CHEST PAIN