chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No AE; temperature excursion / temperature: 1.1 C; This spontaneous report was received from a licensed practical nurse and refers to a 2-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # T023914, expiration date 31-MAR-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 1.1 degree Celsius (C) for 3 hours 9 minutes. No previous temperature excursion was reported. Digital data logger was not involved. No adverse event (AE) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
It's been itching; huge rash in the injection site, in their junk, in the middle of their back; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (It's been itching) and RASH (huge rash in the injection site, in their junk, in the middle of their back) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Hypothyroidism and Diabetes.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (It's been itching) and RASH (huge rash in the injection site, in their junk, in the middle of their back). At the time of the report, PRURITUS (It's been itching) and RASH (huge rash in the injection site, in their junk, in the middle of their back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Cortisone cream.
None known, immunization was outdated by 3 weeks, parent notified. Manufacturer advised re-immunization.
Chest pains (front, side, back areas of heart), heart palpitations, chronic pounding heartbeat, shortness of breath, fatigue, headaches
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired 1st dose/receiving a dose from a expired vial) and product storage error (patient's 1st had undergone a temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Sep 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 27, 2021, patient administered expired product (expired 1st dose/receiving a dose from a expired vial) and product storage error (patient's 1st had undergone a temperature excursion). On Sep 27, 2021, administered expired product (expired 1st dose/receiving a dose from a expired vial) and product storage error (patient's 1st had undergone a temperature excursion) resolved. The reporter did not provide any causality assessments, concomitant product use or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: In follow-up information, patient demographic and event included. On Sep 30, 2021: Non-significant follow-up.
Left leg tingle/pain. Went away after about 10 minutes but was unusual. Started while I was driving home and I got a slight headache.
No adverse symptoms reported; the patient was inadvertently administered an expired dose ofVAQTA (Lot: S012250, Exp: 07/07/2020) on 07/14/2020; This spontaneous report was received from a medical assistant referring to a 38-year-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 14-JUL-2020, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated(VAQTA) (lot # S012250 with expiration date 07-JUL-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered). No adverse symptoms were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient does describe beginning this a.m. a tingling/numbness sensation in both his upper extremities as well as lower extremities. Patient also describes a slight headache at the base of his skull and posterior.
Large, red swollen mass on arm, itching red bumps on mass, shot given 8/2, she came in 8/4 to report .
This is an administration error in which the patient did not report any adverse events. The patient's first covid vaccine was Janssen administered on 03/25/2021 and she received Pfizer on 06/28/2021.  Patient received 0.3 mL of Pfizer (booster) after receiving J&J as primary series before booster had been approved for the general population. On the consent form, the patient had indicated that she had never received a covid19 vaccine prior. Patient then returned on 10/31/2021 to complete the pfizer series (prior J&J vaccine still unknown by pharmacy staff) to which she did receive a 2nd dose. It was disclosed to the pharmacy today, 8/26/22, that she had originally received her first vaccine in March of 2021 resulting in 2 administration errors and patient receiving a booster at 2 separate occasions in which they were not yet approved.
Moderna Bivalent booster was incorrectly administered for primary series.  Notified patient, and 1 monovalent Moderna was given on 11/12/2022
COVID-19; COVID-19; Dose Number: 5; Dose Number: 5; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2022 at 09:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Penicillin, reaction(s): "Known allergies: Penicilin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; OFF LABEL USE (non-serious), EXTRA DOSE ADMINISTERED (non-serious), outcome "unknown" and all described as "Dose Number: 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (05May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Other medication in two weeks was No. Product: COVID 19 Treatment, treatment start date was 25Apr2022 and treatment stop date was 30Apr2022. Vaccine lot unknown reason is Misplaced/discarded. Reoccurence of Covid positive antigen tests 5 days after negative test and 6 days after last dose of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the  lack of efficacy cannot be ruled out.
Tinnitus in left ear started on March 31 in the evening.  Went to Dr.  Went for COVID test which was negative.  Took decongestant and Flonase nasal spray.   Did not help.  Still suffering with tinnitus.
This spontaneous report was received from a healthcare professional regarding unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. The reporter stated that since 01-OCT-2015 till December 2015, unspecified number of patients were vaccinated with improperly stored VARIVAX lot # L018002 expiration date 19-MAY-2017 (route, site of administration, dose unknown). The vaccine was stored at unknown temperatures exceeding 46 F for an unspecified duration. There was no previous temperature excursion. This was not part of any digital data logger. The reporter was not aware of any adverse effects. This is one of the several reports from the same reporter. Additional information has been requested.
Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Redness, swelling, pain and hot to touch at injection site; Headache; Fatigue; This spontaneous case  was received on 21-Oct-2020 from other non-health professional to agency (reference number: SEQW20-04048) with additional two documents (reference number: SEQW20-04055) received on the same day (being processed together) and concerned a 67-year-old, female patient.  The patient's concurrent conditions included diabetes type II and asthma. The patient's concomitant medications were not reported.  On 20-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) as influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient experienced redness, swelling, pain at the injection site which was hot to touch. Also, the patient started experiencing headache and fatigue.  At the time of initial reporting on 21-Oct-2020, the patient was recovering from all events. The symptoms started to wear off and the patient was doing better.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications were not reported. No alternative aetiology was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. The patient's concomitant medications were not reported. No alternative aetiology was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Janssen COVID-19 Vaccine and Moderna COVID-19 EUA resulting in adverse event. 62 y/o female PMHx HTN, morbid obesity and T2DM presented to ED c/o productive cough and SOB increasing x1 week. Dyspnea on exertion and bilateral lower extremity edema noted. Covid negative. Admitted for pneumonia, severe sepsis, pericardial effusion, and bilateral pleural effusions. Received thoracentesis finding transudative fluid , no bacterial growth, consistent with serositis presumably from recent vaccination. Responded well to steroids. Also treated with antibiotics. Discharged 12/16/21.
Patient received moderna vaccine on 4/12/21 and 5/10/21. COVID positive on 5/9/22. Presented to ER on 5/9/22. Presented as transfer from hospital for covid 19. Labs remarkable for thrombocytopenia. EKG with NSR. CXR unremarkable. Given 1 dose of remdesivir at hospital.  CT chest angio done at hospital with lingular pneumonia, no pe, bronchitis. Repeat CT chest in 2 months to ensure resolution. Patient doing well on room air, states he is feeling much better and wanting to go home. D/c'ed with augmentin and azithromycin. Discharged on 5/10/22
4/16/21 @ 12:45:  EMS transport post-vaccination (Pfizer dose #1):  patient waited 15 minutes in observation but as she stood up to leave, she stated she had a sudden severe headache.  Patient asked to lie down the ground.  BP & HR first reading was (191/102; HR 99) and upon re-check 15 minutes later was (178/91; HR 101).  She complained of chest pain; EMS was called.  Blood sugar was reported at 118.  When asked by EMS when chest pain started, patient stated "a couple days before today".
(8/1/12) itchy, redness, warm to the touch, oval in presentation in the general area of the administration. (Approx 5 in x 3 in) Pt. went to doctor and doctor gave her AUGMENTIN and BENADRYL (8/2/12).
Patient called 1/12/16 complaining about an injection site reaction of pain since the date of the administration. Patient had not seen the doctor and just called the pharmacy suggested to patient to see personal doctor.
fatigue and sleepiness for about 2 days after injection (extreme fatigue led to sleeping for 13 hours of consecutive sleep in day 2 post injection) rash, itchiness and swelling at injection site (onset 7+ days after injection and ongoing) --rash size is about  5 inches in diameter
Patient described feeling short of breath, light headed and dizzy.   Also described rapid heart rate at time and feeling like going to pass out.
vaccine involved in a temperature excursion was administered to a patient; no additional adverse event; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006595, expiration date: 10-OCT-2024, administered as prophylaxis (strength, and route of administration were not provided) (Product storage error).  It was reported that the vaccine was stored at a temperature of 57.49 Fahrenheit degrees for 1 hour and 45 minutes. No previous temperature excursions or additional adverse events were reported.
Local reaction with erythema, induration, and tenderness.  No fever, generalized aching, rash, hives.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated at a healthcare facility/office, by a physician,  for the onset of a vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
vision has decreased. Started within a week of the 2nd shot. Actually had an eye exam  2/22/21  and received a new prescription and new glasses.  First it was distance but it starting to effect close up.
He states his shoulder pain started with the first shot.; His shoulder was sore, like a Charlie's horse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 017E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-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 ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse). At the time of the report, ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-319007 (Patient Link).
When we went to bill for the vaccine, learned that this dose on 4/1/2021 was rejected as she already received 2 doses prior. She received a dose on 1/6/2021 and then on 3/3/2021;  the facility was not aware and told us to vaccinate the resident as an initial dose.
Weak; Chills; Fever; Couldn't control my urine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), URINARY INCONTINENCE (Couldn't control my urine) and ASTHENIA (Weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN C [ASCORBIC ACID], METOPROLOL, CLOPIDOGREL, LISINOPRIL, HCTZ, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and URINARY INCONTINENCE (Couldn't control my urine). On 07-Mar-2021, the patient experienced ASTHENIA (Weak). On 07-Mar-2021, CHILLS (Chills), PYREXIA (Fever), URINARY INCONTINENCE (Couldn't control my urine) and ASTHENIA (Weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore arm; Chills; Fatigue; This is a spontaneous report from a contactable consumer. An elderly non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 07Apr2021 at 08:00 at single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021, the patient experienced sore arm, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of sore arm, chills and fatigue was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (barely warm muscle at the injection site for a couple of days), DIZZINESS (Today, she started presenting little pins of headache occasionally and dizziness.), VACCINATION SITE PRURITUS (2 days after the administration, she was a little itchy at the injection site, she barely has it now), HEADACHE (Today, she started presenting little pins of headache occasionally and dizziness) and FATIGUE (Also mentioned fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 058F21A, 010M20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Ulcerative colitis (patient had been symptom free for years). Concomitant products included MESALAZINE (APRISO) for Ulcerative colitis, SIMVASTATIN and CALAMINE for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (2 days after the administration, she was a little itchy at the injection site, she barely has it now). On 07-Apr-2022, the patient experienced DIZZINESS (Today, she started presenting little pins of headache occasionally and dizziness), HEADACHE (Today, she started presenting little pins of headache occasionally and dizziness) and FATIGUE (Also mentioned fatigue). On an unknown date, the patient experienced VACCINATION SITE WARMTH (barely warm muscle at the injection site for a couple of days). At the time of the report, VACCINATION SITE WARMTH (barely warm muscle at the injection site for a couple of days) had resolved, DIZZINESS (Today, she started presenting little pins of headache occasionally and dizziness.) had not resolved, VACCINATION SITE PRURITUS (2 days after the administration, she was a little itchy at the injection site, she barely has it now) was resolving and HEADACHE (Today, she started presenting little pins of headache occasionally and dizziness) and FATIGUE (Also mentioned fatigue) outcome was unknown. The patient had no allergies. It was reported that patient had never been diagnosed/tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient received second booster dose on 04-Apr-2022. The adverse events did not cause patient to seek medical care. It was reported that some of symptoms improved. No treatment was given. This case was linked to MOD-2021-019539, MOD-2022-535387, MOD-2022-535389 (Patient Link).
syncope followed by ER visit w/ many negative tests.  persistent weakness, apathy and loss of appetite
Muscle twitching, tingling, itching all over, numbness and pain to fingers, toes
Pin prick-type pain & constant itching with red, splotchy rash on back of both thighs- 3? x 6? on both legs.  The rash come on suddenly & Itching was intense. Wore same clothing/pants all day with no issues prior to afternoon. Cortisone cream relieved discomfort and the rash did not spread.  Legs were ok the next day.