chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflamed right inner ear; Fluid in the right ear; Loss of hearing in the Right  Ear; Tinnitus Right Ear; Right Ear Hurts; Tight Inner Right Ear; Metallic Taste in the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinusitis. Concurrent medical conditions included Seasonal allergy and Deviated nasal septum.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Metallic Taste in the mouth). On 09-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear) (seriousness criterion medically significant), TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear). In May 2021, the patient experienced INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear). On 08-Apr-2021, DYSGEUSIA (Metallic Taste in the mouth) had resolved. On 30-May-2021, DEAFNESS UNILATERAL (Loss of hearing in the Right  Ear), INNER EAR INFLAMMATION (Inflamed right inner ear) and MIDDLE EAR EFFUSION (Fluid in the right ear) had resolved. At the time of the report, TINNITUS (Tinnitus Right Ear), EAR PAIN (Right Ear Hurts) and EAR DISCOMFORT (Tight Inner Right Ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Acoustic stimulation tests: normal (normal) her sense of hearing had come back to normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment include Drained fluid from the Ear.  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.; Sender's Comments: 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.
Light headed and weak, head tingling feel like something moving in my head, blood pressure went up high. Still not study up and down.
I am experiencing non stop bilateral tinnitus in my ears.  It began as a subtle sound like thousands of crickets chirping and is now a high pitched, high frequency type of sound.   I had my ears cleaned by my PCP's office and wax was extracted from one ear, but the other ear was clean.  the sound diminished for approx 12 hours and then returned worse than before.  In my own research online, I have found tinnitus to be one of the adverse affects of the Pfizer vaccine.
That evening I felt off as if I was coming down with something. I had a fever the next day 3/11/21 of 99.5, significant chills and muscle aches, exhaustion, nausea, and a headache. The following day the fever was gone but I still had aches, exhaustion, nausea and a headache. The nausea lasted for about a week off and on. The headache lasted about 3 days. Exhaustion lasted about 1 week. I gradually felt better over the course of a week.
Felt tired; This case was reported by a consumer and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (years before reporting). Previously administered products included Zostavax (negative history for immunization with Zostavax (she never got the live shingles vaccine)).   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   The reporter considered the tiredness to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient stated that she didn't feel much with the first shot. She said she felt tired but it resolved within 24 hours.  The reporter did not want to answer any further questions. For tolerance of 2nd dose, refer case US2020AMR249357.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249357:Same reporter
THE EFFECTS THAT THEY HAD, WHICH DISAPPEARED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced the effects that they had, which disappeared. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the effects that they had, which disappeared. This report was non-serious.
VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE  CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.
DEATH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized for an unknown number of days and died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230120832 and 20230120898.; Sender's Comments: V0: 20230120818-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Client seen in clinic for routine Tdap referred from prework physical. Denied any immunizations in last 10 years. Wehn Tdap put into MCIR, it shows client did receive Tdap at hospital, T/C to client denies any adverse affects, denies sore arm.
FINAL DIAGNOSIS:   1. COVID-19 Infection 2. Fever 3. Fatigue/Generalized Weakness 4. Frequent Falls 5. Hypertension 6. Acute renal insufficiency         REASON FOR HOSPITALIZATION AND ADMITTING DIAGNOSIS:   Fever Weakness generalized [R53.1] Frequent falls [R29.6] COVID-19 [U07.1] Generalized weakness [R53.1]   HOSPITAL COURSE:    1. UTI Urine cultures positive for proteus. Initially started on IV rocephin,now on PO keflex   2 COVID-19 Non hypoxic, in isolation CRP level elevated, repeat,  Stop decadron today as not hypoxic MoCA testing, OT consulted   3 Acute kidney injury, creatinine slightly bumped from 1.51-1.4,  On MIVF, stable at 1.8 now   4. Failure to thrive PT/OT/CM consult. Family voiced in ER that they are unable to care for her at home. Would like testing.  Social work following, for skilled nursing facility versus home health   Fall precautions needed  Covid-19 Virus Infection Date of onset of symptoms:   Symptoms present on admission: Hypoxemia Date of covid positive test:  12/8/22 Vaccination status:   Imaging:   CXR Oxygen requirements on admission:   RA Current oxygen requirements:  RA Medical therapy: None Consultants following:  None Anticipated special isolation end date: 12/18/22   Patient stable condition. Patient to be discharged home.
pharmacist reported that a patient received a 2nd early dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix. On 19-MAY-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: pharmacist reported that a patient received a 2nd early dose of shingrix). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter did not consent to follow up. The patient received the 2nd dose of Shingrix before recommended interval, which led to shorting of vaccination schedule.
patient felt dizzy and worried of passing out.  Patient took a longer rest break and we provided a bottle of water.  Patient felt better with a longer wait period and left with her mother of under her own power.  Tried to reach out parent to follow up a few hours later but was only able to leave a message.
administered a dose of Menveo on 01Sept2021 and it expired on 20Aug2021.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 20th August 2021) for prophylaxis.   On 1st September 2021, the patient received Menveo. On 1st September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Aditional details were provided as follows: The reporter stated that, the patient was administered already expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up via email.
Bee sting like pain hour after. Extreme muscle stiffness, extreme fatigue 15 hours later . 48 hours later, edema, axillary pain, arm pain, hard red burning, hot
Severe headache, overwhelming fatigue, 102.7 temp, massive body ache, left armpit and breast extremely sore
Chest pain with sensation as though chest on fire, localized to substernal area with no radiation. Associated with sweating and difficulty breathing. Worse while fully supine and with deep inspiration, but improves while sitting up.
Patient reported numbness on Right side of face. Pharmacist referred pt to urgent care when pt stated that they did not have a primary doctor.
Pt. received varicella iz first then Gardasil in other arm . immediately said "feel dizzy" then laid pt. down on table. Pt. has a vasovagal event. No true syncope.
Not sure who the flu shot was by, my son had the Vaccine for HPV and within one month started having cramping problems and bathroom issues, took him in to doctor, and she stated he constipated and needed more fiber, and we took him home, did this and added MIRALAX to help it pass. This continued all year and kept him still having tummy issues, he increased with the frequency, started missing school or be late, missing football and baseball practice, needed to be close to a bathroom, when we took him back in 12/2016 for wellness check, we let her know and she noticed he fell low on the growth chart now and no weight gain over the past year, she gave him second HPV shot and one more flu shot, requested bone scan test and blood work. Bone scan came back 12-15 months delayed and possible markers for Crohn's and celiac. We took him to Dr in January, this led to series of test. To confirm, not only did he have Celiac and Crohn's, he was inflamed beyond any child should be without being in excruciating pain, MRI showed ulcer colitis and Irritable Bowel Disease.
pt received dtap vaccine 11/24. mom texted 11/25 that the inj site was red and swollen (office closed for Thanksgiving). spoke with mom 11/26. 11/26, she reports redness & moderate swelling from the top of pt's shoulder to nearly his elbow. reports it is hot to touch. denies fever, difficulty breathing, any other symptoms. mom reports pt occasionally acts like it's itchy, but not frequently. doesn't report pain (occasional regular soreness following vax). pt doesn't act like it's restricting his mobility. we were unable to see him in office 11/26, so recommended pt go to urgent care for evaluation.
About 20 minutes after the shot, I felt a tingling sensation down my left arm. This was later followed by numbness in my left pinky and ring finger as well as some numbness in my left forearm. The numbness/muted sensation in fingers and forearm lasted for a few days (about a week).
Headache, Myalgia, CHILLS AND NECK STIFFNESS Narrative:
Presents to the ED for SOB w/ associated cough,myalgias and HA nasal congestion/ sore throat, fever, and difficulty breathing on 8/6.tested positive for COVID on 08/16.1. COVID-19 pneumonia-Oxygen supplementation, IV empiric antibiotics .Discharge Condition:Improved Completed COVID Vacination 2/10/2021
Received vaccine on 3/25/21.  By 12 noon of the following day  (3/26/21), arm was swelling, hot to touch and red at and around the injection site.  By 1600 on 3/26/21, patient had begun to feel ill  (fatigue, headache, nausea).  By 3/27/21, the headache and the nausea had resolved but the arm was still red, hot and swollen. The whole upper arm was red.  by 3/29/21, redness is decreasing, swelling is decreasing but has not completely resolved.
Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with two doses of zoster vaccine live (Oka/Merck). The physician reported the patient received her two doses of zoster vaccine live (Oka/Merck). Subsequently, after receiving two doses of zoster vaccine live (Oka/Merck) she was diagnosed with shingles on 10-MAR-2008. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In September 2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012. No other co-suspects and no concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This case has been cross referenced with case 1210USA004308 and 1211USA000608, which concerned 2 patients which received the same expired vaccine (no adverse event was reported in these 2 cases either). Additional information is not expected.
In the middle of the night on the night of my second Covid vaccine, I woke up with intense jaw pain. It felt like my jaw exploded. For four weeks after, I was in so much pain at the jaw area by my ear and under the jaw. I had my teeth cleaned and xrayed 2 weeks after juts to make sure my teeth were healthy. They were. My mouth felt like  someone had put someone else?s teeth in my mouth. My teeth wouldn?t meet when I would bite down. My bite was totally off for 4 weeks. It?s finally feeling a lot better, but it was four weeks of pain and discomfort. I do not have a history of  grinding my teeth or any kind of jaw pain. I also visited my primary care dr and was examined. The dr was not sure why my jaw was hurting. I?m really wondering if the vaccine caused swollen lymph nodes and it affected my jaw and bite.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX. On 15th July 2018, 9 days after receiving SHINGRIX, the patient experienced shingles. In July 2018, the patient experienced muscle pain, lymph node pain, tingling skin and fatigue. On an unknown date, the outcome of the shingles, muscle pain, lymph node pain, tingling skin and fatigue were unknown. It was unknown if the reporter considered the shingles, muscle pain, lymph node pain, tingling skin and fatigue to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. In the week followed by the vaccination, the patient experienced muscle pain, sore lymph glands, tingling skin and fatigue. The patient developed a full-blown case of shingles which was diagnosed by 2 different physicians. The patient questioned if he should risk getting the 2nd shot.
felt some content out of the syringe trickle down her arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt some content out of the syringe trickle down her arm".  Response: Spoke from attached Document. Interim Recommendations for Covid-19 Vaccine Administration Errors and Deviations, under dosage "lower than authorized dose volume administered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid Booster dose 6/24/2022, the next evening, pt was tired , temp 101.0F.  Woke up next day, 6-26-22, Fever at 102. Alternated tylenol & ibuprofen . Woke at MN with acid  reflux, nausea.   No chest pain.  Some stomach pain  &   returning, Fever 104.0 F.  Next morning Fever 101.  Fatigue an headache persisting.  Nosebleed this AM.
positive with Covid; having Covid symptoms; positive with Covid; having Covid symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient (mother) received BNT162B2 (Batch/lot number: EK5730), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Patient got the vaccine administered on 18Dec2020 and after that she was diagnosed positive with Covid on 24Dec2020, so now she was having Covid symptoms obviously after the vaccine but like not due to the vaccine. Reporter was just concerned what her next dose supposed to be scheduled for 08Jan2021, was she still supposed to get the second dose or what. No treatment received. Patient was just taking vitamins. Reporter also reported that typically it was not supposed to be but was trying to get the information on enhanced immune response. Outcome of the event was unknown.; Sender's Comments: The reported positive with Covid after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
S2-L3 dermatomal vesicular rash, lasted 4 weeks, no pain.
PT received 1 cc of Td instead of 0.5 cc on 8/12/02. The PT developed fever that evening, but no local reaction. The following day, the PT still had a fever of 38-39 deg C w/no local reaction. The PT took Tylenol, which brought his temperature back to normal. The PT was called again the following day. 8/14/02, and he still did not have a fever, and he felt ok.
Patient was underage at the time of vaccination. Attempted to reach out to patient using phone number on file-no contact made.
Possible acute pericarditis 2/2 COVID booster, patient requiring hospitalization at Hospital. Cardiology and hospitalist following, originally presented to Hospital 11/18 with chest pain with radiation to the left jaw and diaphoresis, troponins negative and EKG without evidence of ischemic changes. Inflammatory markers returned elevated with evidence of trace pericardial effusion. Clinical picture most consistent with pericarditis, suspected to possibly be related to recent COVID booster. Patient had previously received three COVID vaccinations (all Moderna) without noted issue.
Patient had the first Moderna Covid vaccine on Thursday 1/21/2021.  She had a bit of sore arm on that day and the day after.  On Saturday 1/23/2021, she had a fever of 100.5 F (11AM), nausea, light headache and chills. The temperature went down after she took ibuprofen.  Patient's husband enrolled her to V-Safe to report all the adverse effects she experienced. On Sunday 1/24/2021, her temperature was 98.3F. She still had nausea and no appetite.  She and her husband watched a football game in their bedroom upstairs.  Husband noticed that his wife was pacing around the room many times. At 7Pm, Husband went downstairs for dinner but she refused to come down to eat. He went upstairs around 8pm, TV was still on. He turned off TV and went down stairs again thinking his wife felt as sleep while watching TV. He went back upstairs for bed around 10:30 PM. Husband said his wife had a deviated septum so she would snore very loudly when asleep.  He didn?t hear her snoring so he went to check on her and found her not responsive.  Husband called emergency services. Paramedic came at 10:45 and said patient was passed. Husband sent many texts to V-safe after that to report the incident. No response was received from V-safe. Patient?s doctor told her husband that she died due to cardiac arrest.
This spontaneous report as received from a pharmacy technician refers to a 5-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 12-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.