chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had vertigo; Patient can't hear out of his left ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Patient can't hear out of his left ear) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included MRI in May 2021.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced DEAFNESS (Patient can't hear out of his left ear) (seriousness criterion medically significant). On 03-May-2021, the patient experienced VERTIGO (Had vertigo). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC [CHLORAMPHENICOL]) in May 2021 at a dose of 1 dosage form. At the time of the report, DEAFNESS (Patient can't hear out of his left ear) and VERTIGO (Had vertigo) had not resolved.            The patient was not taking any concomitant medications.  Treatment for events included 2 steroids injections in ear.   Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is requested.   This case was linked to MOD-2021-155536 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is requested.
Extreme pain to upper R arm, predominately to R bicep area. Associated symptoms include subjective fever, body aches, headache.
12-14 hours after my second vaccine I had severe chills, body aches, headache, and felt feverish. This was only partially mitigated by acetaminophen and ibuprofen. It lasted until about 42 hours post vaccine.
Information has been received from a consumer concerning her 3 weeks old son who on 07-DEC-2007 was vaccinated with a first dose of Hib conj vaccine (OMPC) (lot # unknown). Concomitant therapy included ROTATEQ and unspecified vaccination. The reporter that her son had a bump at the injection site that would not go away. No further information was provided. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on2/18/2008. Initial and follow up information has been received from a consumer and a healthcare professional from a physician's office concerning approximately a ten week old male infant with constipation who on 07-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC) (lot # not reported). In follow up report it was indicated that on 07-DEC-2007 concomitant suspect therapy included a first dose of ROTATEQ (MSD) lot # 657673/0904U and on same day the infant received into right leg a first dose of COMVAX (OMPC) lot # 657380/0377U (route not reported.). Other concomitant therapy included DTP, poliovirus vaccine and PREVNAR. On approximately 12-DEC-2007 the patient experienced injection site bump. The patient's injection site bump persisted. In the follow up report it was reported that the physician's office was not informed about the injection site bump. Additonal information is not expected.
Sharp chest pain without prior exertion. Heart flutters, and inability to take a deep breath. Intermittent chest pains come when sitting, lying, or walking.
Patient with development of nausea and non bloody emesis x1, Patient observed for 30 min post emesis without return of symptoms . ER precautions given. Patient without symptoms at time of discharge.
patient was Diagnosed with Pulmonary Embolism after her second covid vaccine. patient symptoms were dyspnea and syncope . Patients treatment is to take Eliquis everyday.
Patient reports initially some soreness at injection site. Injection done 02/07/12. After about 1.5d, she developed redness & bruising, had sweat 2nd night. Then developed aches; fatigue; dry mouth; cramping on fingers & toes; sensation of skin crawling on back, and increased redness around upper arm - more small dilated vessels - not general erythema; not urticaria.
I noticed on day four that I was very exhausted to the pint that I wanted lie down. I didn't even want to put on my make up or even do my daily activities around the house. I decided to take my blood pressure it was 73/64. Later in the afternoon my blood pressure came up but not much. The next day I took my blood pressure, and it was very low again I called my PCP who instructed me to go to the emergency room. They ran an EKG, a Lexiscan, a radioactive CT SCAN. All test came back normal. I am still tired, not as tired as I was on previous days.
Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143
Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler.  Later that evening I took my reg asthma meds.  Sat morning still experiencing the SOB but a bad headache appeared and had some stomach aches as well.  1/9 I spoke with my Allergist who advised to take an additional Singulair and Xyzal meds on top of what I was originally taking already. 1/10 was advised to take and Allergra for the SOB along with my reg meds that evening and by the Tuesday of the next week I was finally able to get my back Asthma balanced out.
Pt explains left arm pain, redness, and tenderness below injection site. Erythematous macule 7 cm below injection site- 5cmx5cm of warm, erythematous, and tender to touch.
received partial dose; Needle not attached to the hub; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine and received partial dose.   The patient's medical history was not provided. Concomitant medications have not been provided.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient received a partial dose of the vaccine, the needle was not attached and some leaked out.   Action taken with mRNA-1273 in response to the events was unknown.  The event, partial dose received, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of out of inappropriate dose administered and needle issue for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of inappropriate dose administered and needle issue.
Information has been received from a pharmacist concerning a 65 year old patient who on 27-JUN-2008 was inadvertently vaccinated with a single dose of VARIVAX (Merck) SQ instead of ZOSTAVAX (Merck) (MSD) due to human error.  The pharmacist confirmed this was not a case of product confusion.  No problems reported.  No further information is available.
Immediate hives on face, neck within 3 minutes.  Watched by doctor on site for 30 minutes.  Given Benadryl.  Hives lasted for 18 hours.  Took second Benadryl  at 6 and 12 hour mark from vaccination site. Completely cleared by 18 hours.  Advised  by doctor on site, and later by personal doctor NOT to receive 2nd or additional  vaccine shots.
VACCINE WITH AN OUT OF RANGE TEMPERATURE EXCURSION  AND WAS ADMINISTERED; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PJ3267) (expiration date 26-DEC-2022), via nasal route, on 03-NOV-2022. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.   No malfunction has been reported for FLUMIST QUADRIVALENT.    The report described a medication error for Flumist Quadrivalent and Flumist Quadrivalent. The reported term was "vaccine with an out of range temperature excursion  and was administered" (Preferred term: Product storage error).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v) and Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): vaccine with an out of range temperature excursion  and was administered.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Patient reported fatigue and aches for 2 days post vaccination. On day 11 post vaccination, she had a reaction at the injection site; red achey, warm to the touch. Also, joint pain and fatigue that lasted 5-7 days
Severe vertigo - unable to stand or walk. Occurred about 2am on 8/26/2021 when getting up to go to bathroom.  Room spinning.  Crawled back to bed and lay down. By 8am of 8/26/2021 ertigo was gone. Was left with very bad headache and stiff neck the remainder of the day, even though I alternated taking tylenol and ibuprofen all day. When I woke 7am 8/27/2021, headache was very mild. No more vertigo since original incident.
Diarrhea, fever/chills, nausea, moderate injection site soreness, headache, tired.
Per physician note, patient is diagnosed with myocarditis/pericarditis in the setting of recent COVID-19 vaccination. Patient has lupus which can cause pericarditis but the temporal sequence with the COVID booster makes pericarditis secondary to lupus less likely. Colchicine was started. Patient remains hospitalized in the ICU today.  It is not known which COVID19 booster (manufacturer) the patient received.
Onset of extreme pain in vaccinated arm about 2-3 hours after vaccine, and worsening until the following day. Had radiating pain in arm in the elbow and down to the fingers which felt like extreme tendinitis. Could not lift my arm more than a few inches without excruciating pain. The following day, the radiating pain subsided, but I still had severe muscle pain around the vaccination and could only lift my arm to shoulder level. On day 3, most of the pain was finally gone.
While we were observing patient for 15 minutes after the vaccination, patient fainted and hit her head on the floor on 6/1/21.
Presented with uncontrollable shaking, fast breathing, abdominal and flank pain.
patient reported feeling tingly  and itchy from the head to her toes. This began 15 minutes after the vaccine. pt waited 15 minutes more. Was given water and benadryl. Pt refused Epi-pen. Pt stayed and additional 30 minutes. Started feeling a little better. Had her mother come pick her up
Felt fine in morning next day, 24 hours after shot started feeling I couldn't turn head, extreme neck pain, muscle pain, lethargic, headache. Went home from work about 2 hours later and started feeling I was going to.pass out got very cold with extreme chills and shaking, fever at 102.2. An hour later 103.4, last time took temp. Terrible in and out sleep, felt like I may have to call ambulance. Fell asleep about 8 hours after I left work, slept 2 hours, woke up covered in sweat and roasting hot. Fever had broken, felt a bit better. Slept a bit, made it to work couple hours late next day, felt better as day went on, still felt like I would like to be in bed. No fever. Just a bit achy and tired. Headache still but not bad.
Covid 19, sinus, chest pain, breathing, 1 week after dose 1.; sinus; chest pain; breathing; This is a spontaneous report received from a contactable consumer. The 55-year-old non pregnant female consumer (patient) received BNT162B2 (COMIRNATY, Solution for injection, (lot number: unknown; Expiration date: not reported) on 11Apr2021 via unspecified route of administration in right arm at single dose for COVID-19 immunization. The medical history included prediabetes, high cholesterol. Patient received other medication within 2 weeks of vaccination reported as Metformin and Atorvastatin. On 17Apr2021 (one week after dose 1) patient experienced sinus, chest pain, breathing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. On 17Apr2021 post vaccination patient was tested positive for COVID-19 (Nasal Swab). Patient received treatment of Antibiotics, inhaler, steroids. It was unknown if patient visited Doctor or other healthcare professional office/clinic. The outcome of the events was reported as recovered with lasting effects.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High eye pressures in both eyes; headache; nausea; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 18th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 18 hrs after receiving Shingrix, the patient experienced headache, nausea, chills and fever. On 20th October 2020, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown and the outcome of the headache, nausea, chills and fever were recovered/resolved.   It was unknown if the reporter considered the increased intraocular pressure, headache, nausea, chills and fever to be related to Shingrix.  Additional details were reported as follows: The patient received dose Shingrix and after approximately 18 hours post injection, the patient experienced fever, chills, nausea, and headache.   The events resolved after 1 day.   The patient saw his eye doctor on 20th October 2020 for a routine eye exam and it was discovered that the patient had high eye pressures in both eyes. The reporter did not consent to follow-up.
they are not sure how much went in the patient/1 dose leaked with no reported adverse event; they are not sure how much went in the patient/1 dose leaked with no reported adverse event; Initial information received  on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and the pharmacist was not sure how much went in the patient/1 dose leaked with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On 28-Sep-2023, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and the pharmacist was not sure how much went in the patient/1 dose leaked with no reported adverse event (incorrect dose administered) and (underdose) (latency: same day) (formulation unknown) (lot U8130AA and expiry date: 06-Jan-2024) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for immunization.  It was reported that "They want to know if there any precedent for giving another dose since they are not sure how much went in the patient."  It was unknown if there were lab data/results available.   It was unknown if the patient experienced any additional symptoms/events.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a nurse refers to a 19 year old patient of unknown gender. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not reported. On 07-MAR-2016, the patient was vaccinated with an adult dose of RECOMBIVAX HB (lot # L000717, expiry date: 15-APR-2017). No adverse effects were reported. Additional information has been requested.
Vaccine given 10/12/99. Pt developed a serious rash of hives the following week for about 4 days. Started under earlobes and spread to neck front and back, chin, and across upper back.  No itching, no pain, alligator skin texture.
arm soreness; under 18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.  After receiving the vaccine patient experienced arm soreness, but had no other symptoms. Exercised to make the arm pain go away.
Severe pain in arm and muscles, headache, chills and red rash around injection site.
pt was running fever 29OCT in AM; devel chills, blueness of hands, face, rapid breathing; t15.5; CBC & cxr neg;
didn't get sore until the next morning; when I raise my arm I feel the muscle there; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 13-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (didn't get sore until the next morning) and MUSCLE DISCOMFORT (when I raise my arm I feel the muscle there) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (didn't get sore until the next morning) and MUSCLE DISCOMFORT (when I raise my arm I feel the muscle there). At the time of the report, PAIN IN EXTREMITY (didn't get sore until the next morning) and MUSCLE DISCOMFORT (when I raise my arm I feel the muscle there) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant medications included blood pressure medicine.  No treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sore at the injection site, Big area that was tender; Subcutaneous reaction; Big area that was tender and warm; itching; Hardness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness ). On 03-Mar-2021, the patient experienced SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm) and VACCINATION SITE PRURITUS (itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender). On 26-Feb-2021, VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness ) had resolved. At the time of the report, SKIN REACTION (Subcutaneous reaction), VACCINATION SITE WARMTH (Big area that was tender and warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Sore at the injection site, Big area that was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
6/15/15 7 pm (L) arm redness, warmth, edema 14 cm x 15.5 cm. Redness and induration to (L) helix. Treated with BENADRYL and cool compress.
Hospitalization: 12/22/2022 - 12/26/2022 (4 days) Presentation to the ED: cough and generalized weakness, sob.  COVID + date: 12/22/22 Treatment: remdesvir & IV steroids.  Discharge to: Home Moderna 029L20A 1/21/2021 Moderna 001A21A 2/22/2021 Moderna 076C21A 10/15/2021 Moderna 001M21A 4/16/2022
Information has been received from a 60 year old female with no medical history or allergies who on 26-FEB-2008 was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified thyroid medication, blood pressure medication, and vitamin supplements. A few weeks after vaccination, on 18-APR-2008, the patient experienced a rash on her left side underneath her breast that extended down to her waist. No product quality complaint was involved. No diagnostic laboratory tests were performed. At the time of this report, the patient had not recovered. No further information was provided. No further information is available.