chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breakthrough COVID-19; Lack of drug effect; breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced COVID-19 (breakthrough COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with Surgery (right breast lumpectomy) for Breast cancer. At the time of the report, BREAST CANCER (breast cancer) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and COVID-19 (breakthrough COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative (Negative) negative. On 05-Sep-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Body temperature: 96.1 (Low) temperature starting going down three days before she showed symptoms of COVID-19. Her lowest temperature was 96.1 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Patient received treatment to radiation treatment.  Company comment: This report refers to a case of COVID-19 and breast cancer occurring after 2 doses of vaccination with mRNA-1273. Based on the current available information, occurrence of COVID-19 infection is assessed as lack of effect for mRNA-1273. However, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, and hence causality for COVID-19 is considered as not applicable. Very limited information regarding the event breast cancer has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of COVID-19 and breast cancer occurring after 2 doses of vaccination with mRNA-1273. Based on the current available information, occurrence of COVID-19 infection is assessed as lack of effect for mRNA-1273. However, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, and hence causality for COVID-19 is considered as not applicable. Very limited information regarding the event breast cancer has been provided at this time. Further information has been requested.
Patient received vaccine and that evening her arm was swollen and there was a raised red rash that covered about 6 inches around her upper arm. Patient said she could not raise her arm and it was very painful. Doctor recommended Ibuprofen and ice and by the next day patient said she was better.
he had sore arm; very tired; he broke out in a sweat, 24 hours later that was it; This is a spontaneous report from a contactable consumer (CEP 159558). This consumer (patient's wife; Caregiver) reported for a male patient (Husband) that, A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that on an unspecified date in 2021 he had sore arm, very tired, he broke out in a sweat, 24 hours later that was it. Reporter asked that, What is the mRNA, how does it work. Reporter said allergic to alcohol and did not provide reaction. And Does the vaccine contain alcohol? Reported stated, Thinking about getting the vaccine, but afraid to get vaccine but afraid she was allergic to one of the components. Reporter states, "I cant get near chlorine if that is what you mean. Can't even smell it, I get bleach taste in my mouth and start sneezing and sometimes gives me a headache and Sucrose, what kind of sugar is it and what the mRNA. Reporter stated that she did get the flu shot and not sure how she will take to this shot. Reporter stated she also heard it can cause vertigo. She has had bouts of vertigo. Now hearing it can cause heart inflammation in certain people. She asked, if there is any information on severe reactions, deaths. she heard in the paper that people died from the covid vaccine, didn't say which one vaccine. she did not know how many it was. Reporter stated, "my husband got the Pfizer vaccine, he did have side effects."  She said, he had sore arm and very tired. his doctor said typical.  he broke out in a sweat, 24 hours later that was it. she had one sister that took it and one did. one said to take it the other says don't and the problem it seems everyone has a problem with the second shot why isn't it approved. I take several supplements lots of C and Zinc, elderberry, mushroom complex, garlic. A whole regimen I take to build my immune system. She asked What are nanoparticles - is it relevant to the mRNA, nano technology, Any information on severe reactions, deaths. Outcome of all the events were unknown.  Information about batch/lot number has been requested.
Patient feels warm and passed out after Shingrix first shot; experimented warm but no fever; experimented warm but no fever; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix. On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling hot and dizziness. On an unknown date, the outcome of the passed out, feeling hot and dizziness were unknown.   It was unknown if the reporter considered the passed out, feeling hot and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the HCP needed information about common adverse event after Shingrix doses due there was a no-immunocompromised patient who experimented warm but no fever after Shingrix 1st shot. The patient felt warm and passed out after Shingrix. The reporter consented to follow up.
Joint and muscle pain - through back especially and shoulders that still persists Nausea, loss of appetite x1 wk, diarrhea x 6 weeks, still having some GI issues
Raised red rash area which covered the upper arm. Itchy and hot. Took Claritin and applied benedryl cream on rash site. Lasted for two weeks and then went away.
On the evening after vaccination, patient had chills, headaches, and body aches. The next morning she woke up with left eye pain, left ear pain and inability to move the left side of her face. Left sided facial paralysis diagnosed as bell's palsy
forgot to come back for their 2nd shot/ Vaccine Start Date:August 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up The reporter asked for guidance if a patient forgot to come back for their 2nd shot
A few muscle spasms in upper left arm at 11:00pm and swelling all around top half of left upper arm.
No adverse event; Administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine).    No concomitant medications were reported.  The vial was initially stored in refrigerator on 07-Jun-2022. The date for the patient vaccine administration was not known, and it was also unknown whether the patient took first, second or first and second booster doses.  It was reported that a total of 35 doses were given from 4 vials for approximately 40 patients. The dates on which vaccinations were given from 01-Apr-22, 05-Apr-22, 08-Apr-22, 06-Apr-22, 11-Apr-22, 12-Apr-22, 13-Apr-22, 14-Apr-22, 22-Apr-22, 09-Jun-22, 10-Jun-22, 13-Jun-22, 18-Jun-22, and 22-Jun-22. The vial had not undergone any temperature excursions.  No treatment medications were reported.
4/23/2021 patient noted hematuria. Negative urine culture. + hematuria on dipstick. Tx with amoxil. Still having hematuria 5/3/2021. ASO titer POSITIVE. MOnospot POSITIVE and EBV panel positive.
This case was reported by a healthcare professional and described the occurrence of sweating in a 20-year-old female subject who was vaccinated with HAVRIX 1440 for prophylaxis. Previous and/or concurrent vaccination included diphtheria and tetanus toxoids adsorbed; unknown given on 20 March 2008. Subject reported that her skin always feels sweaty when she does not eat or drink. On 20 March 2008 at 12:45 the subject received 1st dose of HAVRIX 1440 (unknown, right arm). On 20 March 2008, immediately after vaccination with HAVRIX 1440, the subject's skin was sweaty. She was given something to eat and drink and she was fine. On 20 March 2008, the event was resolved. Follow-up information received on 15 April 2008 indicated that the event was considered by the reporter to be possibly related to treatment with HAVRIX.
Vaccine receieved 12/21/20 at 10 am. Glucose in evenening 12/21/2020 120. Patient reports hypoglycemic event at 8 am 12/22/2021 - glucose of 80 followed by 3 hours of glucose of 40. Glucose then stabilized for remainder of week with no repeat events.
Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and No Treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: The reporter has stated that she is the patient, not her daughter-in-law. On 12-Jul-2021: Follow-up Information Received on 12 Jul 2021  contains No Significant Information
Information has been received from a licensed visiting nurse concerning a female over the age of 40 who on Sept 16 2004 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). On Sept 17 2004 the patient called the office complaining of high fever and left arm red and swollen like a soft ball. The patient was treated with diphenhydramine HCL. AT the time of this report, there was no follow up with the patient and it was unknown if she recovered. The nurse requested that a lot check be performed on lot 649693/0486P. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and research and was released. The nurse reported another patient who had similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649693/0486P) (WAES0409USA02238). Additional information has been requested.
This spontaneous report was received from a pharmacist of unknown age reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, some ZOSTAVAX vaccines splashed on the patient's skin of her hands (accidental exposure to product). Then, on an unspecified date (reported as: "a few days later"), the patient developed a cold sore on her lips (oral herpes). On an unknown date, the patient recovered from the oral herpes. The reporter did not assess the relatedness between the event and suspect therapy. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA004758: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA005474.
Extreme muscle pain, chilling, aching, headache , itching .  in 48 hours had a shingles outbreak on right arm.
The same night after receiving the vaccine, my arm starting swelling, itching. The next morning I woke up and the rash was there, and spread over the different areas of body. I was sweating bad, muscle pain, joint pain, and nauseated for about 3 days. I had knots in my arms. I went to the doctor last week, and she gave me a shot in the hip, it helped with the swelling.  Then I called her back and she called in a cream for me.  The other symptom remaining is the rash at the injection site, I have been putting the cream on it twice a day, taking Benadryl and Tylenol for pain
This spontaneous report was received from a medical assistant referring to a 67 year old male patient with diabetes mellitus, chronic obstructive pulmonary disease, anxiety and depression. Concomitant therapies included amlodipine, atorvastatin, alprazolam and quetiapine fumarate (SEROQUEL). The patient had a history of drug reaction or allergies to aspirin, nonsteroidal anti-inflammatory drug (NSAIDS) and lisinopril (manufacturer unknown) (MARRS# 1803USA008407). On 10-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 (strength and dosage schedule were not reported), intramuscularly, for prophylaxis (lot number: N004564, expiration date: 22-OCT-2018). On an unspecified date in 2018, the patient's whole body was immobilized (immobile) and had to get help to get up from couch since lost muscle control (motor dysfunction) and strength (asthenia) for 3 days. The patient did not seek medical attention or receive treatment. No laboratories or diagnostic tests were carried out. The outcome of immobile, asthenia and motor dysfunction was reported as recovered on an unspecified date in 2018. The reporter did not assess the relatedness between PNEUMOVAX 23 and the adverse events. Upon internal review, immobile was determined to be a medically significant event.; Sender's Comments: US-009507513-1803USA008407:
I had a headache with this vacine that I did not have with others. It lasted 2 days and it was strong. Then a few weeks later I noticed my apple watch and noticed my heart rate just went up for no reason while reason. I talked to my doctor and they ran some tests, and I was diagnosed now with afib and being treated for it, which I did not have prior to the vaccine. I don't have a history of it in my family, I dont smoke nor drink, not overweight. It came out of no where.
Skin Lesion - Information has been received from a health care professional concerning a 5 year old male patient who on 10 Mar 2000 was vaccinated with one dose of varicella virus vaccine live.  On approximatley 20 Apr 2000 the patient broke out with approximately 12 skin lesions.  It was noted that the patient was afebrile. Unspecified medical attention was sought.  Additional iformation has been requested.
cold head; cold sweats; light headed; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold head), COLD SWEAT (cold sweats), DIZZINESS (light headed), HEADACHE (headache) and MYALGIA (body aches) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold head), COLD SWEAT (cold sweats), DIZZINESS (light headed), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, NASOPHARYNGITIS (cold head), COLD SWEAT (cold sweats), DIZZINESS (light headed), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.
In the past, I have had a very mild  and intermittent case of tinnitus.  However, immediately after receiving my first Pfizer dose -- within an hour -- I noticed that my tinnitus got much, much worse and louder -- it became a constant loud hissing in both ears.  More than a week later, the tinnitus is almost debilitating --  CONSTANT and never getting any lower.    A "whooshing" sound that just won't stop.  It's maddening.    I've never had tinnitus this bad in my life and there is no reason for it to have gotten worse besides the vaccine.    It is high-pitched, and constant, and this is two weeks after receiving my dose.     It's only getting worse -- there has been no hint of quieting down.   I am very upset over this and it's obvious that my tinnitus got severe directly after I got the first Pfizer vaccine.   I've been living at home alone for the last year so it's certainly not due to loud music or anything like that.
Patient experienced hot swollen and sore after shot on 8/07/2019. she is going to see MD
Rash and swelling was noted at injection site; Rash and swelling was noted at injection site; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine [diphtheria crm197 protein] (PREVNAR 13; solution for injection in pre-filled syringe; unknown lot number and expiration date) at single dose and influenza vaccine inact sag 3v (FLUCELVAX) at an unknown dosing regimen, both via an unspecified route of administration from an unspecified date to an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient inquired if Prevnar 13 can be e given simultaneously with Flucelvax and wanted a yes or no answer only. During the call, it was mentioned that the patient received Prevnar 13 with a flu vaccine, and the patient experienced rash and swelling was noted at injection site. It was stated that there was no contraindications were noted in PI with concomitant admin of flu vaccine. The agent tried to explain that there were some information in PI that addresses concomitant admintration with flu vaccine (from studies) however caller insisting on yes/no answer and the was unable to complete explanation. The agent offered to forward her inquiry but the caller declined. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nausea Cough Shortness of breath Fatigue Headache  Loss of taste and smell Sore throat  Congestion Strange náusea  Lightheaded Eyes burning  Weight loss? Body aches
Received flu vaccine as required by workplace on Sun 9/30/18. That evening, had generalized muscle/joint pain that progressed to severe over next 2 days. All extremities/chest wall pain. More significantly, bilateral forearms felt very tight throughout and painful even at night. On the 2nd day during night, developed tingling in bilateral hands and next morning (Wed) realized I had lost grip strength. Unable to lift up my own purse or open car door. Was seen at local ED and also assessed by neurologist who was in the building. All neuro exam was negative except for weakness in grips. Advised to follow up if symptoms worsen. Over next few days, grip strength slowly came back and was able to work again.
COVID  + on 7/17; admitted to hospital on 8/4 with weakness; Three vaccines: Moderna 2/11/21 Lot# 007M20A;  Moderna 3/11/21 Lot# 002B21A;  Moderna 10/27/21 Lot# 012F21A.
Patient complained he felt tachycardic (HR was 74 BPM) he stayed for enhanced observation and stated he felt better HR was 64 BPM
feeling light headed; headaches; fatigue; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling light headed), HEADACHE (headaches), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (feeling light headed), HEADACHE (headaches), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills). At the time of the report, DIZZINESS (feeling light headed), HEADACHE (headaches), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Information was received 31-MAY-2017 from a medical assistant (see original case 1705USA005086) and refers to a 21 month old male patient. On 13-APR-2017, he was vaccinated with VARIVAX lot # M039615, expiration date 20-SEP-2018 which had undergone a temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected because follow-up information was received. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094: US-009507513-1705USA005086: US-009507513-1706USA008916: US-009507513-1706USA008917: US-009507513-1706USA008918: US-009507513-1706USA008919: US-009507513-1706USA008920: US-009507513-1706USA008921: US-009507513-1706USA008922.