chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19) 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 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2020, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.  This is a regulatory authority case concerning  a  male patient of unknown age with no relevant medical history, who experienced the non-serious events of Covid-19. The events occurred approximately on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a regulatory authority case concerning  a  male patient of unknown age with no relevant medical history, who experienced the non-serious events of Covid-19. The events occurred approximately on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/30/2021 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/30/2021 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Received flu vaccine on 09/21/20 and developed a rash and hives on both arms, legs, back and neck.  Rash, pruritis and hives improve with oral BENADRYL but comes back daily.  Had shingles vaccine on 08/14/20. Has multiple food allergies.
Nauseous; The one that is distressing is I started getting this diarrhea and it had got watery, pasty, and very frequent; The one that is distressing is I started getting this diarrhea and it had got watery, pasty, and very frequent; I am pretty tired out and I was tired the first day; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL9262, Expiry date was not reported), via an unspecified route of administration on 02Feb2021 as 1st, dose single for COVID-19 immunisation. The patient medical history was not reported. The patient was taking other unspecified medications however the details were not provided (It's a long list, patient don't have it). It was reported that, the patient called you because she got the COVID shot on Tuesday morning. And by the evening, yesterday and today, patient have had a couple of symptoms. But the one that was distressing was patient started getting this diarrhea and it had got watery, pasty, and very frequent on an unspecified date in Feb2021. So, the patient pretty tired out and she was tired the first day. When she woke up yesterday and she didn't know if they were coming from, but she figured it out and it appeared that it was the reaction to the medicine or the vaccine. It was further stated that, actually, it started late Tuesday night and then it was constant yesterday, and then she woke up with very severe this happening, this diarrhea. And she didn't lay down till now and it's a little better, but it's really taken a lot out of me. Patient have been nauseous in Feb2021. The patient finally took Imodium this afternoon for the treatment of diarrhoea and distress abdominal. The patient stated that she was still experiencing diarrhea. The outcome of the event the one that is distressing is i started getting this diarrhea and it had got watery, pasty, and very frequent was not recovered and the events i am pretty tired out and i was tired the first day and nauseous was unknown.  Follow-up attempts are completed. No further information is expected.
Patient developed rash a few minutes after receiving influenza vaccine. Treated with triamcinolone 40mg IN x1. Sent home with RX for diphenhydramine 50mg Q6H PRN .
Pt recv vax on 3/16/99; on 3/17/99 pt exp cellulitis w/ edema & dec range of motion of LA
my tongue was dry; tongue swelling slightly; This is a spontaneous report from a contactable consumer.   A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) dose 1 administered in Arm Right via an unspecified route, on 18Feb2021 14:00 (Age at vaccination: 43 years old) as DOSE 1,SINGLE for covid-19 immunisation.  Medical history included urticaria, fungal infection and scoliosis.The patient experienced drug hypersensitivity previously from aspirin/salicins, monistat varieties, tobramycin/dexamethasone.The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medications in two weeks prior to the COVID vaccine.  The patient experienced tongue was dry and tongue swelling slightly on 18Feb2021 14:15. Patient was given two Benadryl thirty minutes after the vaccination.Within 2 hrs, patient felt her tongue was not swelling or dry.The outcome of the events are recovered on 18Feb2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
The day after my first injection I experienced abnormal uterine bleeding. I was over two weeks away from my usual period date. I had never experienced abnormal bleeding or irregular cycles in my life. My cycles were never overly painful. I never even needed OTC medications. My cycles had been 28-30 days since I was 13 years old. I had my second vaccine on 2/11/21 and again experienced very heavy bleeding the day after. My cycles then were coming anywhere between every 14-20 days. They progressively became very heavy and very painful. I called my OB in April 2021. They told me it could be age related. When I mentioned that it occurred the day after my Covid Vaccine (both vaccines) they told me it was unrelated. I called again in June as symptoms progressed/worsened and was told they were hearing from several other women about cycle irregularity from the vaccine but that it should normalize within a few months. My periods became heavier with shorter cycles, and by August I was also beginning to have mid-cycle heavy bleeding and constant pelvic pain. I was again told it should normalize. By October it taken a huge toll on my daily life. I was bleeding every 10ish days, heavy, and for several days. I had been missing work due to the amount of blood loss. My OB ordered full hormone levels. These were found to be normal so she then ordered a uterine ultrasound. The ultrasound showed some abnormal blood flow to my endometrium. Due to this, and in-office endometrial biopsy was performed. That came back normal. I am now faced with needing to have a hysteroscopy with D&C, potential ablation, or curative hysterectomy. I am being told I may have adenomyosis now (of which I had zero symptoms prior to vaccination) - which would require hysterectomy. My husband and I want more children but I am now being told that could be unsafe and/or not possible.
I got out of my truck and collapsed; I had a grand mal seizure, seizing for 5 plus minutes; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; Slammed my head repeatedly on the concrete during the seizure leaving my head bleeding and cuts all over me.; I leaned forward slamming on the gas colliding with another vehicle.; I don't remember starting my vehicle; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533), via an unspecified route of administration at the age of 20-year-old at arm left on 21Apr2021 22:30 at single dose for COVID-19 immunization. Medical history included epilepsy, haven't had a seizure until now for 2 years. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications included Men's Multivitamin GNC and fish oil received within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The was leaving he apartment complex to go to school after work around 7am 23Apr2021, the patient didn't remember starting he vehicle, but he leaned forward slamming on the gas colliding with another vehicle. he got out of his truck and collapsed, he had a grand mal seizure, seizing for 5 plus minutes, having to go to the emergency room, he slammed his head repeatedly on the concrete during the seizure leaving his head bleeding and cuts all over he. He was now unable to drive for 6 months and need to get an MRI an EEG and be put on medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for one day for events. Facility where the most recent COVID-19 vaccine was administered in workplace clinic. Since the vaccination, the patient hasn't been tested for COVID-19. The patient was received treatment for all events. The outcome of events was unknown. Follow-up attempts are needed. Further information is expected.
12x13cm area of Erythema, no fever, no vomiting, no fluctuance, no pain, right upper arm
Onset about 6-6:30 PM. Wheezing. Chest closed up. Used daughter's breathing nebulizer. Took BENADRYL x 1. Hives. Tingling feet. Feels numb under eyes - feels puffy but does not look puffy. Headache. Fever - not high. Not measured. 8:20AM 11/25/09. Headache more intense. Feet tingle still. Eyes feel puffy and numb under eye but not look puffy.
Day of shot, 3 hours later was in ER with kidney stone and UTI - probably unrelated and stone passed. UTI treated with Keflex.  Had fever, chills, and insomnia for a week after shot. A week after shot developed tinnitus in right ear, felt pressure burning and itching at times that would come and go. Tinnitus has moved to both ears. Has not stopped since. Heart rate at rest has been in 90's since shot. High heart rate with pain and pressure in chest along with feeling short of breath with mild amounts of activity like walking around a store.
COVID-19; COVID-19; Felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; FATIGUE (non-serious), outcome "unknown", described as "Felt tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
4 weeks of constant PVCs, irregular heart rhythm every 2nd to 5th heart beat. I went to emergency, they gave me beta blockers which I took for 5 days but they did nothing. Symptoms stopped abruptly on their own. This began 2 weeks after the second shot.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: No new information is present in source document.
Arm swollen and painful 2 months later (still) x-ray showed no infection of bone at time of injection arm bled then pain and swollen 12/14/09 Orthopedic consult records received for DOS: 11/09/09. Referred for pain in left shoulder and localized near site of vaccine injection. Rx: Voltaren gel. Assessment: left shoulder pain, likely due to irritation from flu shot .
Patient received Moderna as  first dose on 03/12/2021.  Second dose was given as Pfizer on 04/18/2021
This spontaneous report as received from a physician refers to a 12 year old female patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL,  1 shot (dose, dose number, route, lot/batch number, expiration date and indication were not reported). Other suspect therapies included TD and MENACTRA (for both dose, dose number, route, lot/batch number, expiration date and indication were not reported) given on the same day (date unspecified) together with GARDASIL . On an unknown date, briefly after being vaccinated, the patient passed out. No laboratory diagnostic studies were performed. The outcome of the event was reported as recovered/resolved within 5 minutes (reported as within 5 minutes patient was fine). The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
feeling weak muscles; chills; sleep disturbance; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient) reported for himself. An elderly male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: LL9262; Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 01Feb2021 at 14:00 pm (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received his 1st dose and after three days on 04Feb2021, the patient experienced feeling weak muscles, chills and sleep disturbance and stated that he did not know where to go after his symptoms appear. No treatment was received for the adverse event. Post the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test (Nasal Swab) which was negative on 19Jan2021. The outcome of the events was resolving.  Follow-up attempts completed. No further information expected.  Follow-up#01 (04Feb2021) and Follow-up#02 (14MAY2021): New information received from a contactable consumer (patient) reported for himself included: Updated the age group (Elderly), vaccination details (administration date: 01Feb2021 and administration time: 14:00 pm), facility type vaccine (Doctor's office/urgent care), added new events (feeling weak muscles and sleep disturbance), outcome of the events (resolving), treatment details (no), laboratory tests (SARS-COV-2 test (Nasal Swab) and details about follow-up attempts (Follow-up attempts completed. No further information expected).
Within a few hours of receiving the 2nd Moderna vaccine, patient had severe body aches, fatigue and a severe headache.  Fatigue lasted for 10 days.  The severe body aches, and severe headaches have not subsided (he's on day 35).   It is decreasing his quality of life.  He is not able to go and do things he used to be able to do.
Patient didn't receive the full dose, as some leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient didn't receive the full dose, as some leaked out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient didn't receive the full dose, as some leaked out). On 02-Oct-2021, ACCIDENTAL UNDERDOSE (Patient didn't receive the full dose, as some leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. It was reported that second shot was scheduled for 31 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 04-oct-2021 included updated reporter's information.
pt recvd vax; crying for more than 3 hrs; inc WBC; pain; adm to hosp for observation;
Adenopatia desde el axila hasta la ingle, bien doloroso y palpable
Pt with a history of varicella was exposed to his daughter who was vaccinated with varicella virus vaccine live. Subsequently the pt developed chickenpox that consisted of an unknown number of lesions. Pt's wife had a similar experience. It was noted that the consumer developed chickenpox 2-3 days after his wife and not 10-14 days that is typical of secondary transmission.
54 y.o. female a past medical history as documented below presenting to the ED for evaluation of possible allergic reaction.  She received her 1st COVID-19 vaccine just prior to arrival.  Seconds after receiving the vaccine she developed numbness/tingling to the roof of her mouth and her tongue and was advised to come to the ED for further evaluation. She denies swelling of the face, throat, lips or tongue, cough, shortness of breath or difficulty breathing. No  headache, visual changes, weakness, extremity numbness/paresthesias. Symptoms improving upon arrival to the ED. Treated with PO diphenhydramine, observed ~ 2 hours and released without incident.
Patient received 3 total dose of Pfizer Dose 1: 3/3/21 Pfizer Lot EN6202 Dose 2: 4/16/21 Pfizer Lot EW0150
The vaccines are listed as: DtaP, Tdap, and TD vaccines.  I have been experiencing pain in my neck on the side the shot was administered since the morning after receiving the injection. It's slowly getting better but still can't turn my head all the way to the left w/o significant pain.
What I noticed with my Lichen Planus (skin disorder), a week later during breakfast, I noticed I had an outbreak of lichen on the inner aspect of both my arms - wrist and front of my hands. There was also some on my upper back and where I normally had it on my lower back was exacerbated. I was having some areas of new growth on my upper legs. And that's what I noticed. That's the event that I noted is associated with the vaccine. I hadn't had any issues before hand. My doctor increased my Plaquenil to 200mg twice a daily from March until September, and I've been back down to once daily since September. I had to increase my creams for some time for my head and forearms due to the increase in the lichen planus. I had to increase the use under my arms as well but that has all diminished within the last several months. Things flared up and my cream and lotion use went from one day a week to several times a week. But were back to once a week.
Immediately after receiving the vaccine, the patient showed symptoms of acute panic attack. Pupils were dilated, skin turned pale and clammy, complains of lightheadedness and nauseas. Patient did loose consciousness for less than 1 minute, body went a little stiff during that time. The patient regained consciousness after about 1 min, showing increased respiratory rate and breathing, followed by throwing up for 10-15 minutes. No medication were administered to the patient. After about 30 minutes, the patient was feeling better and was able to leave by himself.
Falling off bike x5 on day of shots, not using scissors correctly, fall walking. Sent to Peds Neurology. Dx = Guillian Barre syndrome -  requiring IVIG.
Pain/ Aching at injection site; Redness at injection site; Swelling at injection site; Chills/ Shivering; Fever; Myalgia; Fatigue; Headache over her right eye; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 2nd May 2021, the patient received the 2nd dose of Shingrix. On 2nd May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, shivering, fever, myalgia, fatigue and headache. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and headache were not recovered/not resolved and the outcome of the shivering, myalgia and fatigue were recovered/resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, shivering, fever, myalgia, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient did not experience any adverse events following the first dose of vaccine. Upon receiving the second vaccine, the patient immediately experienced pain, redness, swelling and achiness at the injection site. Approximately 12 hours following the second vaccine, the patient had chills (shivering), fever up to 101 degrees Fahrenheit, myalgias, fatigue. On 2nd May 2021, less than a day after vaccination, the patient experienced headache. At the time of reporting, shivering, myalgias and fatigue have subsided. The patient continued to have a headache over her right eye, redness, swelling and achiness at the injection site. The reporter consented to follow up. The customer provided consent to follow-up with her directly via phone. She provided GlaxoSmithKline consent to follow-up with the pharmacy where she received the vaccine.
01/09/2021- noticed mild itching in left upper arm at site of injection.  1/10/2021- worsening itching, scratching and development of hives  and 2cm x 3cm warm edematous mass in the left upper arm. No pain and no streaking of erythema.
Developed a vesicular rash on left forearm with raised blister that weep fluid on Friday, 04/30/2021.  New blisters developed up the left arm on Saturday and Sunday, then stopped developing new blisters.
Pt recvd vax 25FEB92 & called clinic 28FEB92 stated pt eyes were crossed upon wakening 27FEB92 8AM eyes swollen; 28FEB92 lt eye was crossed toward nose, pupil was large; eye appeared swollen; MD advised to go to ER; advised no more HIB;