chrisvoncsefalvay/vaers-outcomes huggingface dataset:
c/o swelling of both hands with red knuckles with pain.  Referred to his private Dr. for evaluation, but office unable to see him so referred to ER
Longer, heavier, more painful menstruation Seemed to be back to normal after 6-8 months. Had return of same symptoms after COVID booster 9/2021. Symptoms continue now.
Pt recvd vax & w/in 1 minute p/vax exp a syncopal sz & fainted;
Burning forearm, hands, wrist and on top of foot and near ankles. Burning turned into itchy red splotches. Red Splotches turned into itchy large raised, red bumps/hives.  Prescribed Benadryl and Visitral.
Seen in office 4/4/08 c/o x 1 day hx L arm red itching & swelling at injection site. Afebrile. 8x9 cm erythematous area with 3-4 cm inner area with increased induration. DX vaccine reaction with cellulitis - on Keflex.
Sore arm right away and then went to a sore muscle like normal the next day and was sore for three days. What happened next, I had gone to ENT for my ear (5th) and he put me on heavy dose of Prednisone (6th). Following Tuesday, I was on Prednisone for ear. I was already really achy by then. On the third day after the Prednisone I fatigue, headaches and neck pain but I didn't have any other pain. I still couldn't hear though.  I was on this for almost 4 weeks and from them I started like I was having a hot flash and then I would get cold; sore throat; headaches heavy bones and achy muscles; earaches; fatigue; dizziness like you wouldn't believe. They were cyclical - I'd have them for a couple days and then for about a half a day I'd be a bit better and then it would start up again. The fatigues and dizziness didn't change when the other symptoms seemed to be a bit better. My hearing didn't start to clear until I went to see the 2nd ENT which was a couple of weeks down the road. I do not have the stamina I had before the vaccine - I'm not sleeping well at night and I'm always short of breath at any exertion. It is improving but it's slow. Again, the symptoms I experienced during cyclical times: Cold symptoms, runny nose, sore mouth, ringing in my ears was horrible; dizziness and short of breath - cyclical for three weeks. The Prednisone took away all my cramps and pain in my joints that I had before the vaccine. Currently: My heart feels like it's going 100 miles an hour at night in bed - chest discomfort at night. Legs blue in the shower. The week of the 28th, I was done with the Prednisone and then all the pain came back and more. I can't take an inflammatory - the pain is still there and my usual cramps came back.
4/8-4/9: arm pain, chills, chattering teeth, fever, sweating, dehydration, insomnia 4/9: fatigue, brain fog/confusion  4/8-4/22: random muscle pains mostly in legs, ankles, feet 4/17: insomnia, sweating, neck pain, nausea, dizziness, fainting, muscle pains, dehydration, anxiety/elevated heart rate -> went to ER at 4am on 4/18, tests found no abnormalities 4/17-4/22: neck pain and upper back, fatigue, muscle pains, anxiety/elevated heart rate (intermittent chest pain/sensitivity), insomnia, general discomfort overall and thus depression from not feeling normal for so long
Injection was administered in my right arm- painful, swollen, and hot lymph nodes in my right armpit
This patient received a call on 03/29/01, from the patient's parent. The parent reports the patient had her menstrual period on 02/26/01. Received MMR on 02/12/01 pregnancy is confirmed at the present. Reviewed information - no known problems after receiving MMR. The mother had spoken with OB / Gyn also. Call was made to Merck to report incident. EDC 12/03/01.
About 9:00 pm in the evening I first noticed an unusual racing of the heart while watching television. It subsided and I proceeded to bed.  About 10:30 while in bed and reading it occurred again and continued for a few minutes. It continued to wake me a couple of times in the night before stopping about 4:00 am.  No further occurrence so have not sought medical assistance.
I had extreme pelvic pain, symptoms of my menstrual cycle. I had never experienced that kind of pain before and it persisted for 3 days. I did not however start my period until a week later, not something I had experienced before. Bleeding was a lot heavier than normal as well.
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016482786) on 31-Aug-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced allergy to vaccine (allergies: influenza virus vaccines). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Mom stated PT began gasping for air, color pale; seemed as if tongue was swollen; would not take formula; no rx required; MD dx: possible rxn to DPT;
Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband.  The 2 of them drove 2 blocks away to a restaurant to eat.  Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty.  Her husband got her in the vehicle and drove to the vaccination facility,  When he arrived, she was obtunded and "out of it."  No respiratory distress, No noted rash, but some clamminess/diaphoresis.  She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits.  FNP called 911 and staff called for me.  When I arrived, patient was groggy, but responsive.  She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker).  BP 120/74.  O2 sat 97% on outdoor cold air.  Patient was able to move all extremities equally and with equal strength.  Lungs CTA, Heart regular no murmur, abdomen soft.  Patient complained of continued malaise/grogginess and nausea, no vomiting.  EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport.  I discussed ER evaluation vs. continued monitoring by me.  Patient and husband requested monitoring.  Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening.  I checked on her 5 minutes later, then 10 minutes after that.  By that time, her adult daughter had arrived.  We again discussed continue family monitoring  vs. ER.  The family wanted to take the patient home to monitor.  Patient stated "If I could just go to bed, I think I will be fine."  I called to check on the patient at 6p.  She had rested well and was improved.  She still felt a bit groggy, but otherwise was feeling better.  I called to check on the patient 1/29 at noon.  At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response.  I suspected symptoms may have been prolonged by her Beta blocker
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Apr-2021 at 4:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 4:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 41.34 years.  Concomitant product use was not provided by the reporter.  Batch number 007C21A underwent temperature excursion on 28-Apr-2021 with temperature 33 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 19-Apr-2021, beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 28-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Chills started around 10:30 the evening of the 2nd dose. After going to bed I started getting a sever headache as well as joint, muscle pain, and a shooting pain into my left hand/fingers lasting all night. Dizziness and heart racing when I got up several times to use the bathroom. The chills stopped sometime in the early morning but the fatigue, headache and muscle and joint pain lasted through out the next day. Tylenol was taking every 6 hrs and helped relieve most of the pain. I did not seek treatment. The second day out I am still feeling fatigued and slight headache but seems to be getting better.
C/o dizziness, comes in waves that started around noon today. I was advised by my doctor to wait it out & if necess. go to the Health Department. Denies rash or nausea. Instructed to go to an ER if worse.
About 6 hours after getting vaccine, I experienced extreme fatigue and passed out briefly on the bathroom floor. When I came to, I had no recollection of passing out. It was only for a minute or two. I felt better and not as tired. I felt okay the next couple of days.
On 02-11-2021, I started to feel  weird taste on the left side of my tongue which was very bothersome. The weird taste on the left side of my tongue started on my first vaccine one day before receiving my second vaccine. On 02-12-2021 I went to receive my second dose despite of how I was feeling on the left side of my tongue and hours later, my whole face drooped. I went to the ER where I was diagnosed with Bell's Palsy.  I also made an appointment to follow up with a neurologist. My symptoms of Bell's palsy lasted only three weeks.
Chicken Pox-pt had VZV on 11/18/99. Broke out with chicken pox 4-8-2007.
Excessive swelling of sting sight (right arm and interior of elbow to wrist); This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 02Apr2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included BP (blood pressure) (controlled), cholesterol (controlled), high BMI (body mass index) ("240") and insect allergies mainly bee. The patient reported that due to the history of bee sting allergy, he was prescribed EPI pen (epinephrine pen) which was first given to him 20 years ago when he had an adverse reaction and had to visit the emergency room. The patient had various encounters with stings over the years but they were minor and did not include EPI use or inordinate medical care. The patient also had an allergy to some statin drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified blood pressure and cholesterol medications within two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 02Mar2021 at 10:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 28Apr2021 at 18:00, about 3 weeks after the second shot, the patient was stung by a hornet and experienced an excessive swelling of sting sight (right arm and interior of elbow to wrist). The patient reported that this last sting was the worst reaction that he had in 20 years. The patient was advised to seek medical help if the swelling increased and if he had breathing issues. The patient stated that he did not have breathing problems and the swelling was from elbow to wrist, eventually cleared in 3 days. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures included treatment with steroid cream and anti-itch pills (unspecified) which was prescribed by the patient's provider on 29Apr2021, the day after the sting. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event excessive swelling of sting sight (right arm and interior of elbow to wrist) was resolved on 01May2021, after the duration of 3 days.
This spontaneous initial report was received from a pharmacist concerning his unknown age and gender child. The patient's medical history, current conditions and concomitant medications were not reported. The pharmacist reported that on an unspecified recent date, his child was vaccinated orally with a dose of ROTATEQ (strength, dose, frequency, lot number and expiration date were not provided), indicated for prophylaxis. The pharmacist also reported that the patient vomited shortly after receiving the vaccine dose. The patient did not received treatment for this event. At the time of this report the outcome of the vomiting was recovered, also reported as "The current status of the patient is unknown". The patient did not seek medical attention. The causal relationship between the vaccination with ROTATEQ and the vomiting event was not reported. There was no PQC involved.
SEVERE PAIN IN ARM - UNABLE TO USE SEVERE SWELLING AT INJECTION SITE RED RASH AT INJECTION SITE WARM SKIN AT INJECTION SITE FEVER OF 100.7 SEVERE HEADACHE - FATIGUE
Muscles jumping / twitching.  Mostly occurs in front thighs, but occasionally other muscles.
Breastfeeding; Big welt, rash; Big welt, rash; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J02A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-043890 (Parent-Child Link).   See case MOD-2021-043890 for details regarding the child case.; Sender's Comments: This is a case of product exposure during breastfeeding with associated AEs of urticaria and rash. Patient will continue to be contacted for further monitoring of AEs.
Patient called after 3 days of receiving vaccine that he got itching on his bottom of feet and he started to get his lip swollen. Patient started taking BENADRYL and it helped him. He got better and had no severe reaction.
pt devel itching, hives throughout body-edema of face & hands;itching & hives began several hr p/vax;to MD 12OCT96 prescription for pred & zyrtec;
Arm became sore night of vaccination.  Stayed sore for about 3 weeks.  Felt worse at night and first thing in morning.  Had a massage yesterday and arm is somewhat better today.
17 Y/O female had a reaction to the Pfizer Covid-19 IMZ, she either had a seizure or passed out. We called 911, her vitals were good when they arrived, they did take her. She was light headed after receiving the IMZ and seemed to have the reaction about 5 minutes after receiving the shot.
Fever and chills began about 6 hours after vaccine and has continued off and on for 48 hours, treated with tylenol and ibuprofen. Threw up after 8 hours. Injection site red, warm and muscle pain with continuing spread of red area on the outside part of the arm.
Pruritus aggravated; Stress; Fever; Vaccination site pain /achiness after covid vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pruritus aggravated), STRESS (Stress), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain /achiness after covid vaccine) and FATIGUE (Fatigue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included COVID-19 from January 2021 to 2021.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain /achiness after covid vaccine) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRURITUS (Pruritus aggravated) and STRESS (Stress). In 2021, PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain /achiness after covid vaccine) and FATIGUE (Fatigue) had resolved. At the time of the report, PRURITUS (Pruritus aggravated) and STRESS (Stress) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of INCREASED ITCHING DUE TO STRESS unknown onset and INCREASED ITCHING DUE TO STRESS unknown onset was not provided. The reporter's causality for the event(s) of FEVER AFTER COVID VACCINE, COVID-19, ACHINESS AFTER COVID VACCINE and FATIGUE AFTER COVID VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  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.
Initial unsolicited report received from a nurse on 15-Nov-2017 and live follow up was received on 15-Nov-2017. This case involves 53 years old female patient who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date in 2015 or 2016. She received the vaccine at a health fair at a school. The patient's medical history and concomitant medication were not reported. She was allergic to polysporin, sulfites, keflex, latex, morphine and Naprosyn. On an unspecified date, two to three weeks (Also reported as short time after the vaccination) post vaccination she developed lichen planus which was localized to the feet and legs and over time she has had flare ups with it appearing in her mouth. On an unspecified date, approximately two months after appearance of the lichen planus (Also reported as subsequently post vaccination) she developed squamous cell carcinoma (cancer) on her right lower extremity, where an outbreak of the lichen planus had been, and it was removed by a dermatologist. She stated that she was tested for hepatitis and was negative. Corrective treatment was not reported. Patient was not recovered from events. This case was considered as serious by the reporter due to medically significant event. She stated that she believes it was due to the flu vaccine. List of documents held by sender: none; Sender's Comments: The patient experienced lichen planus which was localized to the feet and legs and Squamous Cell carcinoma on her right lower extremity post vaccination with FLUZONE QUADRIVALENT. Time to onset was compatible but the events are not listed with the vaccine. Lichen planus is an autoimmune process and has multiple etiologies. Lichen planus is a benign disorder characterized by an itchy, noninfectious skin rash. Though lichen planus is a common papulosquamous disorder affecting about 1-2% of the population, neoplastic transformation of cutaneous lichen planus lesions occurs very rarely Squamous cell carcinoma might have related etiology with lichen planus. The patient had reported medical history of allergic to polysporin, sulfites, keflex, latex, morphine and naprosyn. Additional information should be obtained regarding evaluation of the events by the physician, treatment information and medical records confirming the diagnosis and its evolution. Based upon the reported information the role fo the vaccine can not be assessed.
2/10 I had pain at injection site,  mild fever and some chills, and extreme fatigue.   The  fatigue continued through mid-day, 2/15