chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammation of the heart; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (inflammation of the heart) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (inflammation of the heart) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (inflammation of the heart) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment  This spontaneous case reported by a consumer, concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series.. Patient had previously received a dose with Pfizer vaccine with no adverse events reported. Interchange of vaccine products was noted. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event outcome was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series.. Patient had previously received a dose with Pfizer vaccine with no adverse events reported. Interchange of vaccine products was noted. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment were reported. The event outcome was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Bronchospasms. Treated with Albuterol and Cetrtizine
Colds; Allergies; COVID vaccines side effects/feeling tired; COVID vaccines side effects/light headed; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Colds), DIZZINESS (COVID vaccines side effects/light headed), HYPERSENSITIVITY (Allergies) and FATIGUE (COVID vaccines side effects/feeling tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced DIZZINESS (COVID vaccines side effects/light headed) and FATIGUE (COVID vaccines side effects/feeling tired). On an unknown date, the patient experienced NASOPHARYNGITIS (Colds) and HYPERSENSITIVITY (Allergies). At the time of the report, NASOPHARYNGITIS (Colds), DIZZINESS (COVID vaccines side effects/light headed), HYPERSENSITIVITY (Allergies) and FATIGUE (COVID vaccines side effects/feeling tired) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  The patient had been having allergies. Patient was feeling tired and had been getting colds. The patient had received both of covid vaccines and had some side effects like feeling tired and light headed. Patient agrees to have physician contacted.    No treatment medication was reported.  The reporter's causality for the events of allergies, COVID vaccines side effects/feeling tired and light headed onset in 2021, COVID vaccines side effects/feeling tired and light headed onset in 2021 and colds was not provided for co-suspect Skyrizi.
Became pregnant; Tired and lazy; Pain in left arm for 2 days after vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Became pregnant), FATIGUE (Tired and lazy) and VACCINATION SITE PAIN (Pain in left arm for 2 days after vaccination) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 12-Nov-2021. On 26-Feb-2021, the patient experienced FATIGUE (Tired and lazy) and VACCINATION SITE PAIN (Pain in left arm for 2 days after vaccination). On 13-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Became pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Feb-2021, VACCINATION SITE PAIN (Pain in left arm for 2 days after vaccination) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Became pregnant) and FATIGUE (Tired and lazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.; Sender's Comments: This is a case of product exposure during pregnancy for this female patient who experienced tired and lazy and pain in the left arm. 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. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Lot of gas; Flu-like symptoms; Diarrhea; This spontaneous case was received on 15-Sep-2020 from a other non-helath professional (consumer) via Med Communications (reference number SEQW-01738) and concerned a 71-year-old, male patient.  The patient's medical history and concomitant medication were not reported.  On 27-Aug-2020, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, anatomical location: left deltoid, dose, route of administration: not reported) for protection against seasonal influenza. The batch number was not reported.  On an unspecified date in Sep-2020, reported as about 10 days after vaccination with Fluad Quad, the patient started to experience flu-like symptoms.  On an unspecified date in Sep-2020, reported as two days later, the patient started to experience diarrhoea and had a lot of gas.  On an unspecified date in Sep-2020, the patient started treatment with over-the-counter antidiarrhoeal for the diarrhoea.  At the time of initial reporting on 15-Sep-2020, the patient had not recovered from the event.  The reporter assessed the case as non-serious and did not provide causality assessment.  Company comment: Flatulence, influenza-like illness (reported as 'Flu-like symptoms') and diarrhoea were associated with the use of the suspect product Fluad Quad. The events occurred approx. 10-12 days after vaccination making chronology unsuggestive for flatulence and diarrhoea and compatible for influenza-like illness. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unrelated for flatulence and diarrhoea and unlikely related for influenza-like illness. (''unlikely related'' defaults to "related" in the safety database for reporting purposes); Sender's Comments: Flatulence, influenza-like illness (reported as 'Flu-like symptoms') and diarrhoea were associated with the use of the suspect product Fluad Quad. The events occurred approx. 10-12 days after vaccination making chronology unsuggestive for flatulence and diarrhoea and compatible for influenza-like illness. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as unrelated for flatulence and diarrhoea and unlikely related for influenza-like illness. (''unlikely related'' defaults to "related" in the safety database for reporting purposes)
weak, decrease appetite, cough, not sure if had fever. got worse and on 4/4/10 felt nauseated and fainted x 2 that morning with 1 episode of vomiting. denies gross body movements. taken to Hospital. W/u included blood test, CT scan brain WNL Diagnosis was Seizure. Referred to a neurologist. Pt was told everything was normal.
Case number PHEH2016US016932 is an initial spontaneous report received from a pharmacy technician on 28 Jun 2016. This report refers to patient of unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with Influenza vaccine ( Unknown seasonal or pandemic, manufacturer: unknown, batch number: not reported) on an unspecified date. On an unknown date, patient had unspecified allergic reaction to an unspecified flu vaccine. The outcome and causality of the event were not reported. The seriousness of the event was reported as non serious. Since the reporter contact details were not provided, no follow was possible. Hence, the case was considered as lost to follow up.
no additional AE; improperly stored temperature excursion; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On 22-APR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date was provided and also validated as 25-JUN-2022 (dose, strength, route of administration and anatomical location were not reported) for prophylaxis (improper storage of product in use). On 22-APR-2021, the data logger detected, that the involved vaccine was stored at the temperature of 6.3 degree Fahrenheit (F) for 6 hours and 30 seconds, at the temperature of 10.9 F for 7 minutes and 30 seconds, at the temperature of 6.3 F for 6 hours and 30 seconds, and at the temperature of 10.9 F for 7 minutes and 30 seconds. The data logger detected temperature excursion previously. No additional adverse event (AE) was reported (no adverse event).  This is one of the 5 linked reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008255: US-009507513-2104USA008185: US-009507513-2104USA008081: US-009507513-2104USA008022:
03/05/2021: Sore arm at injection site, fever, severe headache, severe fatigue. 03/08/2021: Symptoms subsided except for moderate fatigue; new symptom: 'brain fog.' Current: Moderate fatigue continues; 'brain fog'  with confusion is increasing in severity. Family is noticing that something is wrong. Examples: I did not know what medicines I was taking. I could not fill this form out within 20 minutes. I did not know how many pizzas to order for dinner. I signed the wrong name to a check. I had to look up how to spell the word signed.   *Dates are accurate on v-safe if needed.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: redness/itching to right deltoid post Pfizer BioNTech COVID 10 vaccine, pt denied PO Benadryl, pt alert/oriented, no change in mental status, only local reaction noted. Pt stated she wanted to drive home and would take benadryl at home if she felt the need.
Chronic itch in left upper arm, with a progression of the itch going into my left chest area. It has now progressed to an overwhelming, sharp, stabbing pain, with the itch, that is unbearable. I have been given antibiotic ointments, Cymbalta, neurotin, Benadryl, capsazin, trigger site injections, and nitro patches. There is no relief from the symptoms. My condition is becoming worse, and the emergency room was only concerned that I wasn't having a heartattack. PLEASE, I need the correct medical help. It's causing my physical activities to become quite limited. No one wants to even try an oral or intravenous antibiotic on me, because they state that they don't want to give the incorrect antibiotic if it is from the H1N1 vaccine.
3/22/21:  I woke up feeling itchy. I thought something bit me on my left arm.  (6 am) I got to work by 730 I was itching badly on my knees and top of my hands. I took 1 Benadryl but it did not help.  I thought maybe my under shirt was itchy so I took if off and I saw lots of 2" sized welts.  I took a second one by 8am and it help. I felt better.  7pm I started to feel itchy again. This time the hives were on my back. I took 2 Benadryl.  3/23/2021: 8am I started seeing hives on my arms. I took 2 Benadryl.
the next morning I lost all control of my bowels and threw up.  My body temperature was down to 92.  I got into a hot bath immediately when I realized how dangerous it was and got my temperature back up to 97.  Blood pressure 93/61 and heart 50.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. The patient's relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date in 2007, the patient was inoculated with ZOSTAVAX for routine health maintenance and prevention of shingles (strength, dose, route of administration, lot # and expiry date was not reported). On an unknown date, the patient was diagnosed with shingles (herpes zoster) despite of vaccinating with ZOSTAVAX. On an unknown date in June 2015, the patient was treated for 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 outcome of the events was unknown. Causality assessment was related.
Welts that were raised; Very itchy,rash came back and was all on my arms, super itchy; Aches, pains, the sheet on the bed could not lay on my arm, that's how bad it hurt; I was pretty miserable for a week,; Bone aches; I felt like I had the flu or COVID; Super bad rash on my upper body, especially arms; Nauseous for one day; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains, the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,) and BONE PAIN (Bone aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV disease (undetectable for 10 years) and Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for Antiretroviral therapy, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder, MELOXICAM (MOBIC) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains,the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,), BONE PAIN (Bone aches), INFLUENZA LIKE ILLNESS (I felt like I had the flu or COVID), RASH (Super bad rash on my upper body, especially arms), NAUSEA (Nauseous for one day), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. On 20-Apr-2021, NAUSEA (Nauseous for one day) had resolved. On 26-Apr-2021, URTICARIA (Welts that were raised), PRURITUS (Very itchy,rash came back and was all on my arms, super itchy), PAIN (Aches, pains,the sheet on the bed could not lay on my arm, that's how bad it hurt), FEELING ABNORMAL (I was pretty miserable for a week,), BONE PAIN (Bone aches), INFLUENZA LIKE ILLNESS (I felt like I had the flu or COVID), RASH (Super bad rash on my upper body, especially arms), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a woman in a medical office concerning a 5 year old white male who on 08/11/99 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination.  On 12/05/03, the pt developed approximately 15 red, round, raised areas on his chest, leg, head and arm.  It was noted to be itchy. The areas were in all different stages of development. Medical attention was not sought. At the time of the report, the pt outcome was unknown. Additional information has been requested.
Reaction 3" diameter Injection Site; Aching Injection Site; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Reaction 3" diameter Injection Site), VACCINATION SITE PAIN (Aching Injection Site) and HEADACHE (headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 26-Feb-2021, the patient experienced INJECTION SITE REACTION (Reaction 3" diameter Injection Site) and VACCINATION SITE PAIN (Aching Injection Site). On 26-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, INJECTION SITE REACTION (Reaction 3" diameter Injection Site) and VACCINATION SITE PAIN (Aching Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Benadryl Tablet.
This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 14th November 2018, the patient received SHINGRIX. On 14th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who herself was a physician. The patient received the SHINGRIX on an unknown arm. After the dose the patient noticed she was developing tenderness at the injection site. The patient looked at her arm and saw that the band aid and soreness were over the deltoid tendon instead of the muscle. The patient thought the vaccine was injected into the tendon, which led to vaccine administered on an inappropriate site. The pain at the time of reporting was still over the tendon, but also posterior to the deltoid.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Nurse reported that Patient received vaccine in question as a booster dose. Nurse reported that information was not available on patients first two doses and it was not known that in which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine. It was reported that patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions. Maximum Temperature is 49 degrees Fahrenheit, Minimum Temperature is 37.7 degrees Fahrenheit. The temperature excursions occurred on 4 MAR 2022, 5 MAR 2022, 7 MAR 2022, 8 MAR 2022, 9 MAR 2022, and 10 MAR 2022. Date vial moved from freezer to refrigerator was 3 MAR 2022, stored in refrigerator and Vials were not visualized. No treatment information was reported.