chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss in both ears; This case was reported by a consumer via call center representative and described the occurrence of hearing loss bilateral in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2022, the patient received the 1st dose of Shingrix. On 12th March 2022, less than a day after receiving Shingrix, the patient experienced hearing loss bilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss bilateral was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss bilateral to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received  dose of Shingrix in left arm 5 days ago from the date of reporting and since receiving the vaccine, she had experienced hearing loss in both ears. The patient was inquiring if this was a potential side effect of receiving the vaccine.  Spoke as per package insert content, provided medical advice disclaimer, referred to health care professional and offered number to medical informer for health care professional to call. The patient provided permission to contact healthcare professional. The reporter consented to follow up.
Patient stated that about an hour after she received the vaccine she started to break out in a rash on her trunk and arms. She stated that it started to get better later that night but kept reappearing throughout the week. She said that she woke up on 4/4/21 with common symptoms of Bell's palsy. She has facial muscle weakness, pain in her jaw and pain that radiates to the back of her head, and she states that her tongue is numb. She stated that she can still taste and smell like normal. The rash is no longer there but she is still showing signs of Bell's palsy.
mom states pt had high pitched cry for over 3 hrs & cried most of noc; t101 leg sl reddened; applied cold compress; given APAp q 4 hrs;
left leg is struggling again with circulation; cant sleep; heart hurts; viens hurt so bad; Feels like choking on blood/ Feels like it skips a beat once every 30 minutes; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 25May2021 12:00 PM (Lot Number: EW0178) (at age of 22-year-old, not pregnant at time of vaccination) as single dose for covid-19 immunisation. Medical history included Hashimotos, Elhers Danlos, Raynaud's.     The patient received Other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 on 04May2021 12:00 PM (lot number: EL9269) (at age of 22-year-old) administered in Arm Left for covid-19 immunisation and experienced dizzy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took dose 2 anyway out of FOMO, first 3 days great. In May2021, start to notice the left leg was struggling again with circulation. Viens hurt so bad that she could not make it more than a mile into her daily hike. Taking tons of antioxidants, even more tumeric. Day 7 wind up in ER because her heart hurts and she could not sleep. Feels like it skips a beat once every 30 minutes. Sent home. Day 11 ER again. Feels like choking on blood. No treatment received for AE. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, was the patient did not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Event outcome was recovering.
Inflamed Lymph Nodes in Arm pit in left arm, same arm as the injection / shot. Extreme pain: feels as though there's a knife in my armpit.  48 hours after injection, still in immense pain.
Information has been received from a consumer, the patient's mother, concerning her son (a twin, who also had the same experiences reported in WAES# 0905USA01035) with penicillin allergy who some times in 1999 was vaccinated with MMR II (dose, route and lot number not reported). There was no concomitant medication. The mother stated that after receiving the vaccine the patient had 104 degree fever, was making no eye contact, excessive activity, did not speak, had stomach issues and the in May-2000 at the age of 2 1/2 year old, was diagnosed with autism. The mother reported that the patient had genetic blood work done which came back negative and he was allergic to penicillin (manufacturer unspecified) and she also reported that the patient had made progress with 40 hours of therapy a week and she was unsure if the patient received any other vaccine at the time, he received MMR II. It was unspecified if the patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Good bumps just on the left thigh; Arm was little sore; Being tired; Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder; Numb - left thigh/left calf/left shoulder; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder), HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder), NODULE (Good bumps just on the left thigh), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (Arm was little sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DISCOMFORT (Discomfort). On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder) and HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder). On an unknown date, the patient experienced NODULE (Good bumps just on the left thigh), PAIN IN EXTREMITY (Arm was little sore) and FATIGUE (Being tired). On 10-Feb-2021, PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder) and HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder) had resolved. At the time of the report, NODULE (Good bumps just on the left thigh), DISCOMFORT (Discomfort), PAIN IN EXTREMITY (Arm was little sore) and FATIGUE (Being tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not take any medications for her symptoms.
Person does not meet the FDA age eligibility for the Moderna vaccine.  Person received the first Moderna vaccine at the age of 16.
After administering the covid 19 vaccine to patient, patient was observed for 15 minutes for any adverse reaction, then patient was taken back to his room and about 30 minutes after receiving the vaccine patient experienced seizure attack, felt and hit the wall. Seizure attack lasted for less than 1 minute as per staff who was monitoring him, 911 was called. Upon my arrival patient was back to normal and sitting on the chair. 911 arrived and took over. patient was transported to nearest ER.
On 4/18/13 patient called the Pharmacy and complained of redness and itching at the site. He said it started frontal then moved to the back of the arm up to the top of the shoulder. The patient called the doctor and the doctor suggested ZYRTEC.
pt recv vax 930AM & began non stop high pitched crying @ 12PM ( 2 1/2hr later);mom gave APAP;no fever noted;crying stopped @ 5PM that day;
Nothing at first but a little over a month after getting my second injection I developed a low grade fever, chills, sore all over my body.  I do not know if these are related to the shot or not
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ4491), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "celiac" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; SYNTHROID; ROSUVASTATIN; LISINOPRIL; VITAMIN D. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative; (06May2022) Negative; (08May2022) Positive; (12May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: The patient had no known allergies. The patient received other medication in 2weeks product: Multivitamin. The patient had rebound Covid infection. Initial Covid. The patient had symptoms and positive antigen test on 01May2022 and started Paxlovid that evening. The patient completed full course of Paxlovid on 06May2022, symptoms resolved and had negative antigen test on 06May2022 and 08May2022. On 12May2022 had Covid symptoms reappear and positive antigen test.
Soon after the second vaccine I developed ringing in my ears. It's been ongoing since. And loud enough that I can hear it even when I am in my car driving.
This spontaneous report as received from the mother of the patient refers to her daughter (demographics unknown). On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot # expiration, dose, route unspecified). On an unknown date the patient experienced pain at the injection site after received the first shot of GARDASIL. Action taken was reported as discontinued. The event outcome was unknown. Additional information is not expected.
FELT LITTLE SICK; SORE ARM; FELT LITTLE TIRED; FEVER; EXTRA DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's concurrent conditions included: hypertension, vaccine intolerance, diabetes mellitus, hypoglycemia, drug allergy with ace inhibitors and calcium channel blockers and beta blockers and phenergan, and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, batch number: 1805031 expiry: 24-AUG-2021, and expiry: 07-AUG-2021) dose was not reported, administered on 17-MAR-2021, and dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for drug used for unknown indication, and metformin for drug used for unknown indication.  On 22-JUL-2021, the patient experienced extra dose of vaccine administered.On an unspecified date, the patient experienced felt little sick, sore arm, felt little tired, and fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 99.7 F, and HbA1C (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little sick, sore arm, felt little tired, and fever, and the outcome of extra dose of vaccine administered was not reported. This report was non-serious.
The next day the eye was red; had really bad pain in the left arm; pain in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in the left eye), OCULAR HYPERAEMIA (The next day the eye was red) and VACCINATION SITE PAIN (had really bad pain in the left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis since 1986.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced EYE PAIN (pain in the left eye) and VACCINATION SITE PAIN (had really bad pain in the left arm). On 11-Jul-2021, the patient experienced OCULAR HYPERAEMIA (The next day the eye was red). At the time of the report, EYE PAIN (pain in the left eye), OCULAR HYPERAEMIA (The next day the eye was red) and VACCINATION SITE PAIN (had really bad pain in the left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment information were provided.   This case was linked to MOD-2022-530641 (Patient Link).
No adverse effects; patient was  vaccinated with improperly stored PNEUMOVAX 23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 22-FEB-2019, the patient was vaccinated with an improperly stored dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # N025563 and expiration date 08-APR-2019 for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, as recorded by a data logger.There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  1905USA002678: 1905USA002684: 1905USA002685: 1905USA002686: 1905USA002687: 1905USA002688: 1905USA002689: 1905USA002690: 1905USA002691: 1905USA002692: 1905USA002693: 1905USA002694: 1905USA002695: 1905USA002696: 1905USA002679: 1905USA002680: 1905USA002697: 1905USA002698: 1905USA002699: 1905USA002700: 1905USA002701: 1905USA002702: 1905USA002703: 1905USA002704: 1905USA002705: 1905USA002706: 1905USA002707: 1905USA002708: 1905USA002709: 1905USA002710: 1905USA002711: 1905USA002683: 1905USA002712: 1905USA002681: 1905USA002682:
Pt. called today to report a dark-purple ,flat discoloration at injection site, left inner arm from 1st Jynneos vaccine. Also, a smaller discoloration in same forearm about 2 inches away from injection site, same discoloration but smaller. Advised to see PCP.
Developed increasing bladder pain 2 days after vaccination, around the same time my fever from the vaccination resolved. The bladder pain continued and by the last week of December, I saw my PCP. There was blood and leukocytes in my urine. I started a 3-day course of Bactrim. This resolved symptoms initially; however, 3 days after stopping, symptoms returned. My PCP started me on a 10-day course of Bactrim. Again, symptoms resolved, but they returned 10 days after stopping. My urologist sent for a PCR analysis of my urine and it indicated that perhaps Doxycycline would help. I am currently on Doxycycline 100mg, though some symptoms are still present.   I previously had the Astra Zeneca vaccine in Dec 2020 and Jan 2021 with no issues. I do not have a history of urinary tract infections.
Headache; Chills; Fever; Sore throat; Post nasal drip; Coughing; Sneezing; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 07May2021 at 14:15(at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 13Apr2021 at 14:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced headache, chills, fever, sore throat, post nasal drip, coughing and sneezing. 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 headache, chills, fever, sore throat, post nasal drip, coughing and sneezing were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
full body rash; weight on his chest; trouble breathing unless still; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (weight on his chest), DYSPNOEA (trouble breathing unless still) and RASH (full body rash) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHEST DISCOMFORT (weight on his chest) and DYSPNOEA (trouble breathing unless still). On 12-Apr-2021, the patient experienced RASH (full body rash). On 03-Apr-2021, CHEST DISCOMFORT (weight on his chest) and DYSPNOEA (trouble breathing unless still) had resolved. At the time of the report, RASH (full body rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient did not receive any treatment for the event.   The had an injury at work and received a tetanus shot 2 days ago and wanted to know how long to wait for second dose of mRNA-1273 (Moderna COVID-19 Vaccine).
This case was reported by a nurse and described the occurrence of exacerbation of fibromyalgia in a 46 year old female who received Engerix-B. On 1/30/04, the pt received the 2nd dose of Engerix-B (lot ENG35456A4). Following the administration of Engerix-B, on an unspecified date, in 2/04, the pt developed a "flare-up" of her fibromyalgia. The nurse considered the event to possibly be related to vaccination with Engerix-B. The nurse also reported that, "The event could have been associated with thimerosol, but it is not definite".
red arm from injection site to elbow; hot left arm from injection site to elbow; discomfort left arm; itchy left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced itchy upper limbs (Verbatim: itchy left arm). On 18-OCT-2023, the patient experienced erythema of extremities (Verbatim: red arm from injection site to elbow), extremities hot feeling of (Verbatim: hot left arm from injection site to elbow) and limb discomfort (Verbatim: discomfort left arm). The outcome of the erythema of extremities and extremities hot feeling of were resolved and the outcome of the itchy upper limbs and limb discomfort were not resolved.   It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of, itchy upper limbs and limb discomfort to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, extremities hot feeling of, itchy upper limbs and limb discomfort to be related to Shingrix.   Additional Information: GSK receipt date: 23-Oct-2023 The caller stated that she received a dose of Shingrix and less than a day after vaccination, experienced red, hot arm from injection site to elbow. In October 2023, the patient also had itchy left arm and discomfort left arm.  She later stated her family member who was a registered pharmacist told her the vaccine was given intramuscular.  Referred to health care professional.  MI phone number was provided. Did not consent to follow-up.
Pt came back to clinic complaining of watery eyes, red eyes and clear rhinorrhea. Sent to MD's office. According to the MD, this would be an unusual allergic reaction to a vaccine. I would be more suspicious of MMR causing a reaction. I think the pt can continue his Hep-B series but should be kept and observed for an hour after any future vaccinations for allergic reaction.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732) at the age of 62 years, in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunization. The patient's relevant medical history included: "Seasonal allergy to pollens" (unspecified if ongoing); "osteoporosis (no medicines yet)" (unspecified if ongoing), notes: osteoporosis (no medicines yet). Concomitant medication(s) included: CALCIUM. Past drug history included: Thimerosal, reaction(s): "known allergies: thimerosal", notes: known allergies: thimerosal. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "Torso rash over front and back a few days after vaccine, like a mild sunburn - difficult to wear certain clothing."; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious) with onset 2021, outcome "unknown", described as "making sleep and activities difficult"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "redness"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "terrible itching". Therapeutic measures were taken as a result of pruritus. Additional information: Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within 4 weeks of vaccination. Post vaccination, the patient had not been tested for COVID-19. Concomitant product included vit D supplements. All the reported events following third dose occurred on 01Dec2021, and recovered on an unknown date. Torso rash over front and back a few days after vaccine, like a mild sunburn difficult to wear certain clothing. After redness goes away, terrible itching for days - making sleep and activities difficult. Happened after each vaccine. 3rd time, The patient took Benadryl after itching started - but it made no difference at all. She had a 4th shot (2nd booster) on 28May2022 (Moderna) - torso rash again even though she suppressed fever with NSAIDs this time. Took Zyrtec. Rash progressed anyway. Still red. Even though not a 'serious' effect, it could be serious because will lead to vaccine hesitancy or reluctance in the future for her. Pharmacist advised for next time to start antihistamine a few days before vaccine to allow more time for antihistamine to work. The patient will not be going through this 4 times a year given that the 4th dose has debatable benefit anyway, had she known she would get this rash again, She would have skipped the 4th dose and waited until fall.