chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no prescriptions, over the counter medications, dietary supplements, or herbal remedies  which was being taken at time of vaccination and/ or at the time of the adverse event.  The patient's past medical history included COVID-19 on 13-Jan-2022 and Premature baby 26 to 32 weeks (Premature infant of 29 week gestation).    On 15-Jul-2022 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In 2022, the patient experienced PYREXIA (Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine). At the time of the report, PYREXIA (Fever/child experienced similar symptoms during last COVID-19 Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient race was reported. No concomitant medication was reported. It was reported that patient parents shared that he experienced fever the evening after the vaccine was administered. Fever resolved by the next day after given Tylenol. Patient mom mentioned the child experienced similar symptoms during last COVID-19 Moderna vaccine.  No treatment medication was reported in first dose case of the patient.   This case was linked to MOD-2022-628903 (Patient Link).
AST  elevated; ALT elevated; This spontaneous case was reported by a nurse and describes the occurrence of ASPARTATE AMINOTRANSFERASE INCREASED (AST  elevated) and ALANINE AMINOTRANSFERASE INCREASED (ALT elevated) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to codeine.), Allergy (Allergic to antihistamine.), Hypertension and Hypercholesterolaemia. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiac disorder, LABETALOL and LOSARTAN for Hypertension, ATORVASTATIN CALCIUM (LIPITOR) for Lipids increased.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ASPARTATE AMINOTRANSFERASE INCREASED (AST  elevated) and ALANINE AMINOTRANSFERASE INCREASED (ALT elevated). On 22-Apr-2021, ASPARTATE AMINOTRANSFERASE INCREASED (AST  elevated) and ALANINE AMINOTRANSFERASE INCREASED (ALT elevated) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Alanine aminotransferase: normal (normal) ALT-18. On 20-Jan-2021, Aspartate aminotransferase: normal (normal) AST-19. On 20-Jan-2021, Haemoglobin: low (Low) A1C-5.9. On 03-Mar-2021, Alanine aminotransferase: elevated (High) ALT-58. On 03-Mar-2021, Aspartate aminotransferase: elevated (High) AST-37. On 03-Mar-2021, Haemoglobin: low (Low) A1C-6.2. On 20-Apr-2021, Alanine aminotransferase: normal (normal) ALT-18. On 20-Apr-2021, Aspartate aminotransferase: normal (normal) AST-19. On 20-Apr-2021, Haemoglobin: low (Low) A1C-5.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-215591, MOD-2021-046164.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up received contains Significant information- Updated reporter information. Updated event outcome: Recovered. Contains New medical history, New concomitant medications. New Lab test information, Contains updated product information-Route of administration, body site. Contains updated patient demographics- Height, weight, race, Ethnicity.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Rebound of covid symptoms on 25May2022 after completing paxlovid on 20May2022 with floridly positive antigen test; (22May2022) negative, notes: Rebound of covid symptoms on 25May2022 after completing paxlovid on 20May2022 with floridly positive antigen test after being faint/negative the 3 days prior to rebound symptoms; (22May2022) faint, notes: Rebound of covid symptoms on 25May2022 after completing paxlovid on 20May2022 with floridly positive antigen test after being faint/negative the 3 days prior to rebound symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: No. The patient received treatment (Conservative/supportive management) drug Paxlovid with start date 16May2022 and stop date 20May2022 for the indication of Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Rashes; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This was 2nd of two reports. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was reporting he had a delayed reaction to the COVID vaccine. He saw his allergist and primary care provider. The primary care informed him that she had 2 other patients who this has happened with and they had rashes. Unable to provide any further details about the 2 other patients. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : Same reporter/ product/ event, different patient
MILD HEADACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the subject experienced mild headache. On MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and was recovering from mild headache. This report was non-serious.
This spontaneous report as received from a nurse refers to a 12 year old patient. No information regarding the patient's medical history was provided. On 11-SEP-2013 the patient was vaccinated with VARIVAX (Merck) 1350 U, 0.5 ml subcutaneously, with valid lot # 1409AA. The vaccine had been expired on 03-SEP-2013 (reported as 06-SEP-2013 as well). No concomitant medication was reported. No adverse events were reported. No outcome was reported. The case was linked to case # 1309USA005691 (same reporter). Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chills, fever and nausea. On an unknown date, the outcome of the chills, fever and nausea were recovered/resolved. The reporter considered the chills, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced episodes of chills, fever and nausea. This lasted for definitely for 1 month and then the episodes tapered over the next month. The patient thought it was related to the vaccine. The reporter did not agree for follow up contact.
Exhaustion and headache by 4pm. Chills started around 6pm. Chills became violent, fever rose to 103.5. Fever didn?t respond to Tylenol, stayed 102+ from 9pm-5am. Nausea with chills from 12:30am-3am. Fever broke around 5-6am with sweats. Now fever 99.3 with headache and muscle aches at 24 hours after shot.
79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors.  She exercises regularly and has become so weak that she cannot climb stairs.  Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski.  Infectious work up has been negative, autoimmune evaluation is underway.  Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia.  The ESR dropped from 44 to 20 with hydration.  She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible.  Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.
Bad rash on the same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Bad rash on the same arm of injection) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Bad rash on the same arm of injection). The patient was treated with OXYCODONE for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Bad rash on the same arm of injection) outcome was unknown. Not Provided          No concomitant medication was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
No additional adverse events; Improper storage of product in use; This spontaneous report was received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 26-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T034829, that has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live , expiration date reported as 11-APR-2022, 1 dosage form for prophylaxis (strength and administration route were not provided) (product storage error).  The vaccine was exposed to a temperature above of less 3 Celsius degrees (C) for a time frame of 3 hours ; the vaccine did not experience previous temperature excursions. No adverse events were reported.; Sender's Comments:  US-009507513-2110USA001320: US-009507513-2110USA001321:
cramps legs/ hands; sleep sleep and sleep; pain- discomfort much; pain- discomfort much; cramps legs/ hands/sleep sleep and sleep/headache; swelling; Pain at inplants hips/ knees/ joint pain; headache; swollen glands; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) dose 2, via an unspecified route of administration on 05Feb2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 15Jan2021 as dose 1, single for covid-19 immunisation and experienced neck pain up to head, cramps legs/hands and sleep. The patient experienced pain at inplant hips and knees/ joint pain (arthralgia), sleep sleep and sleep, cramps legs and hands, cramps legs/ hands/sleep sleep and sleep/headache (disease recurrence), pain- discomfort much, swelling, swollen glands and headache on an unspecified date. The outcome of events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Approximately 3-5 min post vax client fell to floor when ready to leave lab, stating she felt dizzy. She did not loose consciousness, no pallor. After lying on floor 5-8 minutes in reception area, pt left. Pt was taken to physician approximately 45 minutes after leaving the health department. She complained of stiffness in right shoulder and neck. She was given Benadryl and told not to receive 2nd Hepatitis A vax. Also prior to receiving Hepatitis B she should take Benadryl.
The patient has been tired since the vaccine was given. The patient slept for 3 hours after vaccination and was nevertheless tired. His forehead looked hot.
Tongue thick/swollen day after with lips swollen and burning, "clearing throat a lot". Cardiac history.
The site on my left arm started to itch right away and by next morning it was hot, red, and a hard circle  has developed around it  3 to 4 inch diameter
Patient describes redness and warmth at the site of injection (reaction similar to bug bite). Potentially she had tachycardia and increased blood pressure. She iced the area. The swelling lasted about 2 days.
4 hrs after vaccine I started to feel general fatigue,  joint pain and muscle pain. It was more severe in the injection site. This has continues to get worse and at 9pm chills, fever and dry coughing began. Saturday morning the fever and chills cleared up . The fatigue has increased, but the muscle and joint pain are lessening. Dry cough continues.
Large circular red area about 3+ inches in length and 2+ inches width appeared on my arm 10 days after my vaccination. The area was warm/hot to the touch and uncomfortable when touched.  It lasted a few days before disappearing.
Presents with worsening covid symptoms, tested positive 1 week ago.  Admitted for Covid PNA. Treated with O2, abx, zinc.  The patient was admitted to the hospital, treated with IV dexamethasone, IV antibiotics,iv Remdesivir,the patient's breathing progressively, underwent 6 minutes walk study, was needing supplemental oxygen which was prescribed to have and the patient discharged home.
I pulled vaccine, confirmed it was the correct vaccine with provider, checked date and administered it to patient. I went to document it and it popped up that it had expired the day before. Re-checked date and it had expired on 8/8/21 and I gave it on 8/9/21. I immediately called my 2 supervisors and the provider to report it.  My supervisor contacted the state and they recommended the pt. come in for another Tdap. The supervisor called the patient and then patient is scheduled for a repeat Tdap tomorrow 8/11/21.
patient was given expired IPOL/ NO AE; Initial information received on 28-May-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves pediatric patient who received expired IPV (VERO) [IPOL] (batch number not reported and expiry date: 13-Mar-2021) on 28-May-2021 (expired product administered) for prophylactic vaccination by nurse.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  It was an potential medication error case due to expired vaccine used (latency: same day).  It was unknown if there were lab data/results available.   It is unknown if the patient experienced any additional symptoms/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 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.  There will be no information available on the batch number for this case.
body aches; my face is stiff and swollen¨; less pain in the left side of the face; my face it is hard to move; my face is stiff and swollen¨; ¨i feel my lips swollen like if i have injected something on them; ¨strange thinks happened on my face¨; pain and swelling on the left side of my face; lower side of my left eye started having like an eye bag; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag), EYE PAIN (less pain in the left side of the face), HYPOKINESIA (my face it is hard to move) and MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag) and FEELING ABNORMAL (¨strange thinks happened on my face¨). On 15-Apr-2021, the patient experienced EYE PAIN (less pain in the left side of the face), HYPOKINESIA (my face it is hard to move), MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨), LIP SWELLING (¨i feel my lips swollen like if i have injected something on them) and SWELLING FACE (my face is stiff and swollen¨). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (pain and swelling on the left side of my face), PERIORBITAL SWELLING (lower side of my left eye started having like an eye bag), HYPOKINESIA (my face it is hard to move), MUSCULOSKELETAL STIFFNESS (my face is stiff and swollen¨), LIP SWELLING (¨i feel my lips swollen like if i have injected something on them), MYALGIA (body aches), SWELLING FACE (my face is stiff and swollen¨) and FEELING ABNORMAL (¨strange thinks happened on my face¨) outcome was unknown and EYE PAIN (less pain in the left side of the face) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information includes ibuprofen and diphenhydramine on 14Apr2021.  Patient states that she did not have difficulty breathing, and that there were no records of this episode happening in her life.   This case was linked to US-MODERNATX, INC.-MOD-2021-078156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078156:husband
Patient received his first Moderna covid vaccine shot at about 4:00pm on 3/7/2021 and procedd to the post-vaccination observation area for his 15 minute observation period. About 10 minutes after his shot, patient alerted the an observation staff member that he was starting to feel hot. Staff member alert the pharmacist who had given him his shot and the pharmacist came over. Patient told the pharmacist he feels like he is burning up. Pharmacist took hi temperature an it in the 98 rang (can't remember the exact temp but was 98. something) Patient then then told the pharmacist that he feels like he is getting an aura of a coming seizure. The pharmacist applied an intant ice pack to the back of the patient neck and provided a bottle of cold water. Pharmacist stayed next to him talking to him and asking how he was doing and kept a hand on him in case he had a full blown seizure. Patient was awake but looked pale and seemed like he was going to fainted. Stayed like that for about 10 minutes. after about 10 minutes patient "came back". He looked back to normal and felt fine. During the process he called his wife to come get him and he was fine when she aroungs a few minutes later. Patient, wife, and pharmacist chatted for about 15 minutes before wife took him home. Patient said based on his history that it was a petit mal seizure.
1328pm pt had a syncope event. 1330 eyes rolled back hands curled in to the body. Pt was not coherent, 911 was called and pt was transferred to Hospital.
Patient vaccinated with Janssen vaccine at 1:45pm, the adverse effect started at 1:50pm. Syncopy lasted less than 20 sec, patient was assisted to floor by RN and from the seated position.  The A&O x4 within 10 sec of awakening, the SpO2 99, HR 51. Patient  was continuesly monitored for 30 min without further relapse, patient endorses active lifestyle. Upon D/C the nurses instructed the patient to call HPC or EMS as necessary.
Sore arm, arm felt heavy, tiredness, flu like symptoms, coughing up yellow phlegm, running nose, stopped up nose, swollen face and rash appeared in face diagnosed with Shingles on 07/22/2021