chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Strong wave of intense nausea; Minor sore arm; A spontaneous report was received from a healthcare professional (reporting on self) concerning a 66-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced minor sore arm and strong wave of intense nausea.  The patient's medical history was not provided. No concomitant medications were reported.  On 28-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection  On 28-DEC-2020, the patient experienced minor sore arm.  On 29-DEC-2020, the patient experienced strong wave of intense nausea. She did not vomit, but she had to take Zofran to help with nausea. It wiped her out for the evening. She felt fine this morning (30-DEC-2020) and went to work and again was hit by an intense nausea.   Action taken with mRNA-1273 in response to events was not reported.  The outcome for the event, minor sore arm was unknown and for strong wave of intense nausea was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.95 .  Concomitant products were not provided.  On 20-Mar-2021, excursion time was 09 AM and 10 AM  and temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic on 20-Mar. Vaccine BUD date was 08-Apr-2021. Vial was stored on cooler 1 on 20-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient received second booster dose (0.25 ml) of Moderna COVID-19 but later found not to have immunological disorder that would make him eligible to receive the booster dose. No adverse reaction to the vaccine was reported by the patient. Manufacturer was contacted regarding this occurance but no specific guidance was provided aside from ensuring patient does not receive an additional dose of the vaccine.
After receiving Tdap, Pneumovax and Influenza vaccines, patient started to experience fatigue, muscle weakness, fever and chills that evening. Weakness progressed and his brother brought him to ER on 01/21/2011. Admitted to hospital that evening. LP was attempted in ER due to fever, not successful. IVF resuscitation started, blood and urine cultures obtained, IV Primaxin started, admitted to telemetry. Antibiotics eventually changed over to PO Cipro and Flagyl. By hospital day two, weakness was resolving, tolerating physical therapy well. Had some spikes in Blood pressure which was controlled with oral medications. Neurologic exam was grossly intact. Patient scheduled to have a prostactectomy in about 2 weeks. DX: Rhabdomyolysis (Resolved)
first Pfizer dose and then received first dose of Moderna Covid-19 vaccine; over 44 days from the first Moderna dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first Pfizer dose and then received first dose of Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 44 days from the first Moderna dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first Pfizer dose and then received first dose of Moderna Covid-19 vaccine). 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 44 days from the first Moderna dose). On 01-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (first Pfizer dose and then received first dose of Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 44 days from the first Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: The reporter confirmed that the patient was not administered the 2nd dose for Moderna vaccine thus avoiding giving the patient a 3rd m-RNA dose.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 35-month-old male patient who experienced warm redness at injection site, tenderness at injection site and warm redness at injection site. At 23 months of age, the patient received a dose on 20-Apr-2010. The patient experienced warm redness at injection site, tenderness at injection site and warm redness at injection site on 21-Apr-2010. The outcome of all events is unknown. No additional information was available at the time of this report.
Day one post vaccination - dull headache, leg pain, abdominal pain, back pain - these symptoms continued for a few days, I started to feel a bit better, did not take any pain reliever medications because I didn't want to mask symptoms.   On 4/14/21, 7 days post vaccination, my leg pain in both legs worsened including numbness and a burning sensation in both feet.  Back pain continued, arm pain started in both arms with numbness in both hands however the pain on my left side with legs and arms is worse. I've had intermittent shooting pains in my left ear, left jaw, left temple and across the left side of my face. I've also experienced shoulder and neck pain. The abdominal pain is intermittent and mild. On 4/15 - 4/18 the pain in my legs was so bad that it was waking me up at night and my arm pain was occurring more frequently. I decided to go to the ER on 4/18, day 11 post vaccination, due to my concern of a possible DVT or other type of blood clot.  The ER physician's assistant did not look at my legs but did several blood tests and other tests.
Hives, startes 12 days after vaccination, initially was thought to be due to hair dye, which I have been using for years, then I thought it was food related, but nothing has changed in the diet, seen a dermatologist, started on Allegra 180 mg BID and Pepcid and steroid and Benadryl creams, still going on, 4 weeks on, did some research, turns out there are many people who are dealing with the same issue
Chest pain, hard chills, diaphoresis, fever 102; began 7-9 days after vaccination, headache, nasal congestion. 5/14 Mild perihilar interstitial prominence per CXR.
Diarrhea; The shot burned when it went in; Scratchy sensation on the throat; Runny nose; Cough; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (The shot burned when it went in), THROAT IRRITATION (Scratchy sensation on the throat), RHINORRHOEA (Runny nose), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BURNING SENSATION (The shot burned when it went in). 11-Mar-2021, the patient experienced THROAT IRRITATION (Scratchy sensation on the throat), RHINORRHOEA (Runny nose) and COUGH (Cough). On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, BURNING SENSATION (The shot burned when it went in), THROAT IRRITATION (Scratchy sensation on the throat), RHINORRHOEA (Runny nose), COUGH (Cough) and DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
About 5 minutes into sitting in my chair during the 15 minute waiting period, I felt very faint and nauseous and clammy.   I looked around for a medical person, but it was a very busy time and there were lots of people in the room.  I leaned back in my chair and just tried to take some deep breaths until the feelings went away, about 2 minutes later.   I also had a strange sensation at the time of the vaccine - I felt the liquid from the injection going in and then i had a sensation across my upper back and neck.  I was a very weird feeling. After my 15 minute period was up, the scheduler came and booked my next appointment.  I asked her if I could speak to a nurse.  I did find a nurse and report my reaction.  She asked how I felt now - which was okay, and she asked if I needed something to eat or drink, but I said no and that was it.  I asked her if I should get the 2nd vaccine and she said yes.   I have never had this reaction to any vaccine or yearly flu shot.  I am not afraid of needles.  It was very strange and I felt off for the next 3 days.
Woke up at 2am on 2/2/2021, the following day after the vaccine was given, with temperature of 99.9, muscle/joint pain, chilling and nausea.   All resolved the next day.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (Lot Number unknown) injection. The physician reported that the patient fainted after receiving Gardasil. Medical attention was sought. At the time of reporting the outcome was unknown. No further information was provided. Additional information has been requested.
pt states prior to receiving vaccine felt slightly dizzy and lightheaded then following administration of vaccine pt felt increase in dizziness and lightheadedness   pt brought back to OBS at 1032 for observation via wheelchair, stood by self to trasnfer to stretcher without difficulty vs as noted  pt placed in trendelenburg and then slowly repositioned to semi fowlers and then high fowlers and then dangle at side of bed to standing  vs as noted for same. given crackers and water feeling better  denies further dizziness   ok with being discharged home.  ambulated to exit at 1059 vs 1034 hr 70 po 97 bp 80/40  1035 tburg  hr 72 bp 104/65 po 99  1040 semifowlers  hr 72 po 98 bp 108/68  1045 hr 74 bp 123/74 po 97  1050 dangle hr 75 bp 113/71 po 97  1055 bp 111/72 hr 79 po 97  1058 standing hr 79 po 97 bp 131/82
With the 1st dose I experienced like a really bad mosquito bite at the injection site. It git red, swollen and very very itchy. About 4 inches round. My PCP recommended me to take Benadryl and it worked. About 24 hours later the symptoms started subsiding.
This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. The physician reported similar events for three patients all getting kindergarten routine immunizations. This is the second of three reports. The patient (sex and origin unknown) received a dose of PREVAR (injection) on an unknown date. Past relevant medical history and concomitant medication were not reported. On an unspecified date, the patient experienced vaccination site swollen to the size of a softball, hard, and warm to the touch. Two of the children also had hives at the site Treatment was not reported. The outcome of the events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
Seen on 1-31-08, 50-60 mm induration with erythema.
From initial information received on 11/Apr/2005 from a health are professional regarding an adverse event occurring in the USA, it was reporting that four patients (no specific identification provided) received a fourth dose of DAPTACEL, lot number C218AA, administered intra-muscularly, and a dose of IPOL, lot number not reported, as well as a dose of MMR/Measles, Mumps and Rubella vaccine lot number not reported, on an unspecified date. None of sites of administration were reported. Within two weeks, four patients developed a large local reactions with pain, tenderness, swelling and redness at unspecified site of injection. Reportedly the redness raised approximately 1 inches in diameter. It was not reported whether any of the patients recovered from these events. From additional information received on 12/Apr/2005 from an internal communication. It was reported that the four patients had a reaction to DAPTACEL vaccine but no specific patient information could be provided. From additional information received on 14/Apr/2005 from the internal communication, it was reported that one additional patient (no specific identification provided) also received a dose of DAPTACEL, lot number C218AA, on an unspecified date. An unspecified amount of time later, the patient developed entire limb swelling and also had the same reaction as the other four patients. Patient's recovery status was not reported. Follow up information received on 16/Sep/2005 and 27/Oct/2005. As per reporting physician the patients have recovered from the event. The reporting physician was contacted for the individual patient identified and he stated that he completed a report for each patient and submitted it to manufacturer. The physician was asked to resend the information, as a search in the database did not locate any additional causes from this reporter. The physician stated that he will try to complete the information again and report it to the company. Follow up information received on 04-November-2005. The reporting physician stated that he no longer had the list of patients involved in this report and therefore, would not be able to provide any additional information.
Information has been received from a 60 year old female patient who had a heart attack previously, concerning herself. Her current conditions included breast cancer, hypertension, lymphoma, swelling, heart disorder, blood cholesterol abnormal, bronchitis and drug reactions/allergies to codeine and some type of penicillin. Approximately on 04-MAR-2016 (reported as about 3 weeks ago), the patient was vaccinated with ZOSTAVAX in the left arm (dose, route, lot# and expiration date were not reported) (medication error). Concomitant medications included amlodipine besylate, atenolol, atorvastatin calcium, ezetimibe (manufacturer unknown) (reported as "Eztimide"), furosemide (manufacturer unknown), potassium (for potassium replacement), albuterol and lisinopril (manufacturer unknown) (reported as "Lisinotril"). Approximately on 05-MAR-2016 (reported as the day after she received the ZOSTAVAX), her arm had blisters, and her arms and hands started swelling up. She also had pain in both her arms. No lab diagnostics studies were performed and no treatment was given for the events. The outcome of the events was not reported. Causality assessment was not reported. Additional information has been requested.
headache, body aches, runny nose, nonproductive cough, sore throat, sinus congestion, nasal congestion, post nasal drainage.  starting on 9/26/21
Red blotch marks about 4"l X 3"w, Raised and itch. Chills. And temp 97.8°  At 5:30 A.M. Apr. 14, 2021 Lasting 6 days. Headaches the last three days  Diagnosis: "COVID ARM" by internet and a physician over the phone from the hospital.
not been getting out of bed; not eating or drinking; fever of 101.6; positive covid test; body aches; cough; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (not been getting out of bed), COUGH (cough), COVID-19 (positive covid test), DECREASED APPETITE (not eating or drinking) and MYALGIA (body aches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced COUGH (cough) and MYALGIA (body aches). On 03-Apr-2021, the patient experienced COVID-19 (positive covid test). On an unknown date, the patient experienced BED REST (not been getting out of bed), DECREASED APPETITE (not eating or drinking) and PYREXIA (fever of 101.6). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (TYLENOL COLD & FLU SEVERE) at an unspecified dose and frequency. At the time of the report, BED REST (not been getting out of bed), COUGH (cough), COVID-19 (positive covid test), DECREASED APPETITE (not eating or drinking), MYALGIA (body aches) and PYREXIA (fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 101.6 (High) got worse with a fever of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications information was provided. Treatment included Tylenol cold and severe flu. Patient did not realize he had covid prior to receiving the vaccine.
Patient reported feeling muted hearing, blurred vision, nausea, and chills. We sat her down and gave her water. Five minutes after reported symptoms she vomited and reported that she was starting to feel better. We called 911 and had EMTs come and assess her. They got a blood pressure of 120/80 and about 15 minutes after she vomited, she reported that she was feeling well enough to go home. The EMTs walked her to her vehicle and she went home.
myocardial infarction / heart attack; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction / heart attack) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MYOCARDIAL INFARCTION (myocardial infarction / heart attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 29-Aug-2021 to 30-Aug-2021 due to MYOCARDIAL INFARCTION. On 30-Aug-2021, MYOCARDIAL INFARCTION (myocardial infarction / heart attack) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided.  Treatment medication was not reported.  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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
covid-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Prednisone. Past adverse reactions to the above products included Allergy with Prednisone. Concurrent medical conditions included Blood pressure high and Overweight.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: negative (Negative) Rebound after testing negative on 27/5.         Concomitant medication was not reported. Rebound COVID-19 on 30-May-2022 and was not recovered. The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously had received a COVID-19 vaccine. The device date was 30-May-2022.  Company comment-This spontaneous case concerns a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 21st to 26th May2022. She had a rebound covid 19 after testing negative and completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 on an unknown date after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19 from 21st to 26th May2022. She had a rebound covid 19 after testing negative and completion of Paxlovid treatment. The current pandemic situation of COVID-19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
patient received vaccine  within 48 to 72 hours from time of dose patient presented to the emergency department with chest pain and an elevated troponin of 6.05.