chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in 2017 (reported as since 20-APR-2017), the patients were vaccinated with VARIVAX (lot #: M025867 with expiration date: 24-MAY-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at following temperatures and time frames: on 20-APR-2017 at temperature greater than  6°F but less than 14°F for 2 hours and 54 minutes, on 21-APR-2017 at temperature greater than  6°F but less than 14°F for 2 hours and 44 minutes, on 22-APR-2017 at temperature greater than  6°F but less than 14°F for 3 hours and 12 minutes, on 23-APR-2017 at temperature greater than  6°F but less than 14°F for 2 hours and 49 minutes, on 02-JUN-2017 at temperature greater than  6°F  but less than 14°F for 7 hours and 51 minutes. There was no previous temperature excursion and this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours; have to go to bed and sleep for about 3 hours; Feeling weaker; Fatigue; This is a spontaneous report from two contactable consumer (patient's partner and patient). A 76-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982) via an unspecified route of administration on 04Jan2021 (76-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included sick. Other products were reported as no. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269) via an unspecified route of administration on 04Feb2021 (77-year-old at vaccination) at a single dose for COVID-19 immunization. Consumer stated, "I hope you can, what's happening is I had my COVID shot on my last one on 04Feb2021 (further clarification unknown) and before that even I was sick ( Intent: medical history) and then now it's been 4 months later. This happen to start when I felt before I had the shot. I was like feeling weaker and weaker, there was no strength and then now I am totally fatigue (the start date of the feeling of weakness and fatigue was stated as "That's going to be hard, it's probably, it was in January. I want to look at this. January, probably, in the beginning of January maybe you can say 5th or something like that"), I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours. So, I am looking to you for some help or what can I do." No treatment received. The report was reported as non-serious. The patient was still feeling weak, he was little bit better but he was still very worried about it. The outcome of event feeling weak was resolving, and of other events was unknown.   No Follow-up attempts are needed. No further information expected.
Pain in left arm at the injection site started as soon as needle was inserted. The pain from the injection site has persisted and worsened.    Pain is in left upper arm. If she tries to lift arm higher than the chest, she has a sharp pain. Yesterday started feeling pins and needles in the fingers. Now she feels that the circulation in the left hand is diminished. There is no discoloration of the skin on left arm. Denies any pain or past issues with her neck or left arm.
Break through cases after the Pfizer vaccine; break through cases after the Pfizer vaccine; Got sick with resp symptoms; Got sick with resp symptoms; missed her second shot; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that they have heard from our health department that there are more break through cases after the Pfizer vaccine. Stated that, reported just had a lady infected by her sister and nephew who came down from (Withheld) (both vaccinated with Pfizer). Family got sick with respiratory symptoms and infected her. She had her first shot couple weeks earlier and missed her second shot. She was hospitalized, they are not. The health department was sending these breakthrough specimens to CDC. Pfizer just requested a booster. Stated that, the reporter was curious whether that was for the delta variant only or for the wild type one as well. The outcome of the events was unknown.   Information about lot/ batch number is requested.; Sender's Comments: Based on known drug safety profile and as patient received only one shot of vaccine there is reasonable possibility of drug ineffective for Covid-19.
Patient received vaccine on 10/08/15. Stayed the 20mins had no ill effects. The next day the patient's arm started to turn red and swell, got warm. No pain was being experienced. Patient had the reaction the year prior and MD told her to get the vaccination again. She stated that her reaction was worse. I told her to continue to monitor the reaction and reach out to her MD or seek help if she starts having further issues.
A sore upper left arm for 48 hours. Soreness subsided after 48 hours.
L arm pain x 2 weeks; headache/fatigue/L ear pain Narrative:
arm was sore; queasy; Threw up; Trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, queasy, vomiting and difficulty sleeping. On an unknown date, the outcome of the pain in arm, queasy, vomiting and difficulty sleeping were unknown.   It was unknown if the reporter considered the pain in arm, queasy, vomiting and difficulty sleeping to be related to Shingrix.   Additional details were reported as follows; This case was reported by the patient for herself. The age at vaccination was not reported. The patient stated she received shingrix vaccine yesterday. The patient stated that her arm was sore, she feels queasy, she threw up everything she ate this morning, and she had trouble sleeping last night. The patient enquired about side effects of shingrix vaccine. The patient also mentioned that Provided information from Shingrix PI and Shingrix FAQ's, Provided medical advice disclaimer. The patient stated that referred to health care professional. Caller disconnected call before I could obtain additional information. The reporter did not consented to follow-up.
On September 30, 2021, approximately one month after receiving my second dose of the Pfizer Covid-19 vaccination, I had a period. I had been in menopause and my last period before September 30 ,2021, occurred in November 2019.  I had a full period for a week and this was not vaginal bleeding.   A week before I had the period, my breasts became full and tender...so much so that I was googling "breast pain, breast soreness, post menopausal".  This tells me that what I experienced was hormonal in nature and not just bleeding. This wasn't spotting either...it was as if something in my body that controlled ovulation clicked back on.  The period lasted one week and was exactly like my former regular periods.  I fully believe that the Pfizer vaccine "kicked" me out of menopause and I have many questions.  Am I fertile again? Could I get pregnant? Am I producing estrogen again (hence the sore breasts before the period)? Will I go through menopause again? Will I experience hot flashes, crashing estrogen levels? How could I have a period if my estrogen levels were low?  It seems to me that there had to be significant estrogen production to create sore breasts. My classic PMS symptoms were back as well, including feeling extremely emotional and crying at the drop of a hat.  I have only had one period since becoming fully vaccinated.  At this point, I do not know if I will have another one.
After 4-5 hours of the 2nd dose of Moderna I start to get pain in the arms and legs, feel weir at night time like light headache, dizziness and uncomfortable in breathing that wake me up at the middle of the night. Blood pressure elevated higher than normal. After a week the arm's pain getting better,but the legs' pain gets worse. Since then my legs pain and join pain getting worse and worse, its hurts with activities and no pain at rest while seat or lay down. I've been through many doctors visits including the Urgent Care, ER, Neurology and rheumatology doctors and had many kinds of testing and found nothing wrong with my heart, lung, blood clots in the legs, Both of my legs are just progressively getting worse,both legs are getting more pain and weaker, that make me hard to lift them up for walking. I almost can't work now. I also feel so tired, dizzy and headache for 2-3 days each time that come and go since the 2nd dose of the vaccine. I'll have the MRI tests on 06/05/2021 and 06/06/2021.
This case was reported by a physician via call center representative and described the occurrence of myalgia in a 68-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 myalgia, fever and pain in arm. On an unknown date, the outcome of the myalgia, fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the myalgia, fever and pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for his friend. The patient received a dose of SHINGRIX and had a severe reaction to her dose including severe myalgia, Fever of 102 degree F and sore arm for 3 to 4 days.  The physician classifies the reaction to a dose of SHINGRIX as a grade 3 reaction. The physician did not know where the patient had received SHINGRIX since the patient was in a different location than his. The physician denied consent to be follow up. Lab Comments: On an unknown date, the patient had performed Body temperature.
Left arm sore immediately following vaccine.  Tires and not feeling well overall.  Left arm sore and shoulder, back and even hip hurt all night.  Off and on chills and awake all night.  The next day left arm started turning red and by Monday had spread from shoulder down to elbow.  Arm is sore and very hot.
Fever of 103.1 taken rectally so far on and off for 3 days.
Symptoms included facial burning and throat swelling. Exam of mouth, throat, neck revealed swollen throat and hoarseness. No shortness of breath, no wheezing, no cough. Lungs clear to auscultation. She was given IV BENADRYL and Methylprednisolone - one dose of each. Symptoms improved and she was discharged with tapering dose of Prednisone.
Chills, body ache, head ache, exhaustion, fogginess, loss of appetite
DOSE # 2 Felt fine for over 15 hours, then felt immediate exhaustion. Chills and cold for 5 hours Aching all over. Joints hurts, Then Fever of 100 for a few hours Dizziness All resolved within 24 hours except dizziness.  This last 2 days.
Received a rash at the site of injection on day 8  (4/10/21) after 1st dose.  Site was warm, hard, and slightly itchy.  Also seem to be very tired again.  Initial side effects included very tired, headache, chills, achy.  Initial side effects were gone within 3 days of injection.
PT SATES SHE EXPERIENCED COVID ARM AFTER BIVALENT BOOSTER. STATES SORENESS, SWELLING, ITCHING, AND PAIN. USED APAP AND BENADRYL TO TREAT. STILL EXPERIENCING MINOR SYMPTOMS
Noticed a lump on her leg when changing her diaper that morning. Was thinking it was an insect bite (possibly a tick), it was hot and red so I took her to the doctor. It was 10 days after her vaccine and I wasn't even thinking it could be that until the doctor that read her records noted that she was just seen for her check up. It was then that I realized it was at the injection site because it was in a slightly different spot than usual. Dr. treated her for cellulitis and recommended we follow up with her doctor on Monday and see which vaccine it was. Her leg didn't seem to be getting any better so they switched her antibiotic. She did respond to this one. In the meantime she was at the urgent care on Saturday and on Sunday her twin brother had a lump on his other leg. When I took them both on Monday I found out that it was the Varicella injection site where they were infected. Something is not right!!
Injection site warm to touch, large induration at injection site.  Extremely itchiness at injection site.
This spontaneous report as received from an office manager refers to a patient of an unknown gender and age. The patient's concurrent conditions and medical history were not reported. On 30-OCT-2015, 05-JAN-2016 and 18-APR-2016, the patient was vaccinated with the first second and third dose of GARDASIL 9 (strength, dose lot and expirations dates were not provided). After that, on 01-SEP-2016, a fourth dose of 0.5 ml of GARDASIL 9 (lot # K010215, expiration date 05-MAY-2017) was administered to the patient (product use issue). There were no concomitant medications and adverse effects reported. No temperature exclusion occurred and no product quality complain was involved. Additional information has been requested.
He became ill  September 26, 2021. He was tested for COVID-19 with a positive result.  Passed away on October 12, 2021
Patient developed fever and rash on 3-17-18. Was examined by MD on 3-19-18. Aural temperature of 99.8. Has lesions consistent with chicken pox. Lesions in various stages (some scabbed, some red papules, some pustules on red base) on trunk, and a few on face and extremities. Rash began on back. As above, younger sister had similar rash 2 weeks ago, now resolved.
Client received 2 doses of other COVID vaccine and requested a booster dose of Moderna vaccine. Administered dose of Moderna COVID vaccine. After client left realized that a full 0.5 ml dose of Moderna was administered instead of 0.25 ml booster dose.
Patient administered pediarix instead of dtap; received additional doses of Hep B and IPV; found with chart/vaccine review
dejavu symptoms throughout the week after the dose.  On Thursday Morning approximately 2.5 days after the dose, I had a seizure in my sleep at approximately 4am.
After receiving the second Moderna vaccine I awoke 7.5 hours later feeling extremely ill with wracking chills, aching all over and joints feeling like I had been severely beaten.  This lasted for 24 hours.  The next day, I had nausea/vomiting and was very weak.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Had flu shot on Nov. 1st and on Nov 3rd c/o feeling sluggish, beefy tongue, reddened eyes, and "weird" feeling in her mouth. Went to PCP and had EKG with an AHR of 40 BPM. Referred to a cardiologist.
dose one of Shingrix in Spring 2019 / not yet had dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in spring 2019).   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 reporter reported for himself. 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. No address available at time of the report. The reporter consented to follow up.
On  Morning of 17th September, found to be partially blinded in left eye. Clotting in retinal vein discovered by ophthalmologist, as well as macular hemorrhage.
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and route were not reported). Concomitant medications were unknown. On an unknown date (reported as several years ago), the patient experienced swelling, redness and rash that lasted for 2 days. The outcome of the events was reported as recovered/resolved. The causality of the events was not reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information is not expected as reporter contact details were not reported.
Had the delta-variant; Had the delta-variant; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for three patients. This is the second of three reports. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm on 05Feb2021 (at the age of 76-year-old, Lot number: EL9269) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 26Feb2021 (Lot number: EL9266) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing diabetic. Prior vaccinations (within 4 weeks) and additional vaccines administered on same date of the Pfizer suspect were none. Concomitant medication included ongoing metformin for diabetic. The patient had the delta-variant in Sep2021. Patient had both doses of the Pfizer-Covid 19 Vaccine. However, he had the delta-variant. He had the same symptoms as the reporting consumer 2-3 days after she did. The reporting consumer explained she started to have covid symptoms on 08Sep2021. She had a stuffy nose, stuffy ears, slight fever, drainage, and sore throat. At first she thought it was just sinus issues, but her covid test had come back positive. She had tiredness, loose stools, headache, stuffiness, stuffiness in nose and ears really bad. She was assuming she had the delta variant. She explained her husband, the patient, had these same symptoms. Patient started to experience these events 2-3 days after she did. Events did not require a visit to emergency room or physician office, but had a tele-medicine appointment. Lab data included Covid test was positive in Sep2021. Outcome of events was unknown. This report was assessed by the reporting consumer as non-serious.   Follow-up attempts are completed. No further information is expected. Linked Report(s): US-PFIZER INC-202101294617 same reporter/drug/AE, different patient; US-PFIZER INC-202101299154 same reporter/drug/AE, different patient.
Developed asthma attack while in observation area. Severe, tight cough and wheezing
The next day after receiving vaccination I experience muscle aches-extreme fatigue-excrushating pain in both legs-head aches-ash on my face
sore; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adolescent female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore".  Additional information: Causality: Related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Acetaminophen (2 x 500 mg) were taken 2 and 8 hours after the injection. About 11 hours after injection (9:00 pm) there were chills/shivers for about 6 hours. Temperature was 97.6. General fatigue and malaise the next day. Again at 9:00 pm there was less severe chills/shivers for about 2 hours. No other effects after that. Minor soreness at the injection site.  Perhaps minor reaction but I thought it would be beneficial to report.
Rheumatoid flare-up that started in her hands and moved to her feet; Swollen joints/joints are swollen; Red and swollen joints; A spontaneous report  was received from a consumer, concerning an 81-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed rheumatoid flare-up, red/erythema and swollen joints/ joint swelling.  The patient's medical history included rheumatoid arthritis.  Products known to have been used by the patient, within two weeks prior to the event were not provided.  On 16 Feb 2021, the patient received first dose of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of the events, the patient received their second dose of mRNA-1273 (batch number: unknown) on right arm for prophylaxis of COVID-19 infection.  On 14 Mar 2021, one day after vaccination, the patient experienced rheumatoid flare-up which started in her hands and moved to her feet which was considered as serious (medically significant). On 20 Mar 2021, the patient's joints were swollen and red.     Treatment for the event is not provided.   Action taken with mrna-1273 in response to the events was not provided  The outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Elderly age and medical history of rheumatoid arthritis  are considered confounders.