chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; felt sick again; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she'll fish" (unspecified if ongoing), notes: known allergies: Penicillin she'll fish. Concomitant medication(s) included: HORIZANT. Past drug history included: Penicillin, reaction(s): "known allergies: Penicillin", notes: known allergies: Penicillin. The following information was reported: ILLNESS (non-serious) with onset 14May2022, outcome "recovering", described as "felt sick again"; OROPHARYNGEAL PAIN (non-serious) with onset 14May2022, outcome "recovering", described as "sore throat"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of oropharyngeal pain, illness.  Clinical Information: Other medication in 2weeks was yes. Anti-viral details was, Product=COVID 19 Treatment, Brand was paxlovid, Treatment start date was  05May2022. Treatment stop date was 09May2022. Other medication in 2weeks product was Horizant. After a few days sore throat and felt sick again. Adverse event start date was 14May2022.If patient recovered was Recovering. If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have an underlying rosacea. However, since receiving the 1?st 2 Covid vaccines, I have developed a chronic inflammatory skin condition requiring 2 IM steroid injections and 1 course of oral steroids. Elevated ANA - worked up for lupus but rheumatologist does not think it is that.  I have also developed  strong inflammatory reactions to surgical & N-95 masks with associated hives. Patch testing negative for allergic reaction to masks but a skin biopsy after mask wear indicated  allergic reaction. Facial redness / hives definitely associated with mask wear but in addition to that I have developed a chronic redness  / rash on face : have many pictures to support this.  I saw rheumatologist last week who ordered additional blood work, revisited an allergist today who recommends follow up with Dermatology.  I have a scheduled visit with my dermatologist this week for continued follow up..
Information has been received from a physician concerning a patient who was vaccinated with a dose of hepatitis B Virus vaccine rHBsAg (yeast) (manufacturer unknown). Subsequently the patient experienced an adverse reaction. It was unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
headache; This is a spontaneous report from a contactable healthcare professional (hcp) (patient). A 39-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine) second dose (lot number: EK9231) on 09Jan2021 in left deltoid, intramuscularly at a single dose for prophylaxis. Medical history included Heart Disease (VSD asymptomatic). The patient previously took first dose of bnt162b2 (lot number: EH 9899) on 18Dec2020 for COVID-19 prophylaxis. The patient's concomitant medications were not reported. The patient had a test for SARS - CoV2: 27Dec2020: negative, none of symptoms; 28Dec2020: negative; 29Dec2020: positive: all PCRS. On 28Dec2020, the patient also had headache + cough. The patient was diagnosed positive COVID by PCR on 29Dec2020. The patient experienced 30 degree of severe symptoms headache on an unspecified date in Jan2021 continued daily as of 19Jan2021. The reported issue occurred after use of the product. No treatment received for headache. The outcome of event headache was not recovered.
Mother reported slight rash and redness to face about 15 min after pt received vaccines. Nurse practitioner, RN, and MD were notified. V/S taken and were stable. Providers determined there was no harm to pt.
Covid Arm Redness, itching, swelling & weeping around the injection site. Started approx 1 month after vaccination.
Unknown type of COVID-19 vaccine.  Death in less than 24 hours. Unknown if vaccine related.
Narrative: 90yo male Pt under the care of hospice with a h/o Parkinsons disease, HTN, dysphagia, CHF, COPD, mild cognitive impairment who presented to the ED from his medical foster home for treatment with IV fluids and treatment after testing positive for COVID. Pt admitted to inpt hospice. Did not qualify for monoclonal antibodies (EUA) since a hospice patient. Pt died during inpt hospice on 1/9/2022. Death was caused by: Complications from COVID-19 infection, patient was comfort care in hospice care. Pt had received covid vaccines on 1/7/21 & 2/4/21. Covid vaccine failure after only two doses 10 months prior.
pt recv vax;(hypotensive? approx 30 seconds), hyporesponsive episode
Two days after the first does I developed chest pressure, palpitations and shortness of breath. These symptoms lasted about a week and the shortness of breath continued with exertion for a few weeks more.  A week after the vaccine I developed a rash on my arms and legs that lasted about a month
p/vax pt devel irregular red rash & itching on arms, neck & chest, 6/21/99 similar rash on legs, abd, back & hives on neck & thighs;
Initial information received from a healthcare professional on 25 October 2012. A 48-year-old male patient with the history of type 2 diabetes and seasonal allergies and concomitant medication were reported as Janumet (Metformin and Sitagliptin), ASA (81mg) and vitamins; had received 2nd intradermal dose of FLUZONE intradermal (lot number UT4473AA) in the left deltoid on 24 October 2012 at 2:30 pm. The patient had no known drug allergy. On 24 October 2012, 6 hours after vaccination i.e. at 8:30 pm the patient developed achiness, headache, chills and sweats. The lab investigations were not reported. The patient self-medicated with ALEVE and had little relief. The patient's outcome was unknown. Documents held by sender: none.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: L#EL8987), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Meniere's ear" (unspecified if ongoing), notes: We both were diagnosed with the Meniere's ear 20 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number: dose 1, single, lot number: EL9266), administration date: 2021, for Covid-19 immunization. The following information was reported: VESTIBULAR DISORDER (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "Diagnosed with Vestibular  this has occurred with my husband. Received vaccine on the same day"; VERTIGO (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae"; VISUAL IMPAIRMENT (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "effects vision"; BALANCE DISORDER (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "lose of balance"; VOMITING (hospitalization) with onset 23Feb2021, 25 days after the suspect product(s) administration, outcome "recovered with sequelae", described as "throwing up". Vertigo, throwing up lose of balance, effects vision. Diagnosed with Vestibular this has occurred with reporters husband. Received vaccine on the same day. They both were diagnosed with the Meniere's ear 20 years ago. Have never had any flare up until after taking vaccine. The patient was hospitalized for vertigo, vomiting, balance disorder, visual impairment, vestibular disorder (hospitalization duration: 3 day(s)). The events "vertigo", "throwing up", "lose of balance", "effects vision" and "diagnosed with vestibular  this has occurred with my husband. received vaccine on the same day" required emergency room visit/department or urgent care, Hospitalization. Therapeutic measures were taken as a result of vertigo, vomiting, balance disorder, visual impairment, vestibular disorder. Adverse event treatment was physical therapy.
approx 24hr p/vax devel nausea, lethargy & a rash on trunk only;sx cleared p/48hr;
Client noted itching at site of inject day after vaccine given. Did not notice at arm until 1-24-12 (six days after inject). At that time noted area warm to touch, slightly pink, and raised. 1-24-12 came to clinic noted raised area approx 70 mm x 90 mm, warm to touch, very slightly darker than normal skin color on upper raised area.
Not eating, not sleeping, not drinking, fever of 103.6. Diarrhea, upset, cranky, stomach seem like in pain. Every three hrs been giving him Motrin then Tylenol swiching back in forth for the past 7 days. Fever has not gone down.
Sudden onset of fainting sensation . Followed by dizziness moderate shortness of breath lightheaded ness panic tingling in hands feet top of head headache distress.
I were positive for COVID-19 on 11FEB2023, I had a cough that's all. I was prescribed PAXLOVID, I started to lose the cough very fast about a day or 2. I did have a rebound of COVID and I was prescribed steroids.
The pt's eyelids swelled and began to itch. He was given Benadryl IM-symptom improved with in 40 minutes.
Chest pain; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 19Apr2021 as dose 1, single for COVID-19 immunization. The patient relevant medical history and concomitant medications were not reported. On 20Apr2021 morning, the patient had chest pain. The patient wanted to know if she should panic and if chest pain was a side effect of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizziness, Headache, Myalgia, Fever &  ErythemaMultiform  Narrative:
She said every thing hurt( she had muscle pain); Swelling; Rash is itchy/ Rash of her right arm/Itchiness; Arm Hardness; hotness in arm/ rash is hot; hotness in arm; spent the next couple of days in bed; she experienced shivering; Feeling cold; Redness just below the injection site; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   The patient's past medical history included shingles (had 2 episodes of Shingles when she was in her 30's). Previously administered products included Zostavax (1st dose received in 8th December 2014).   On 18th February 2022, the patient received the 1st dose of Shingrix .5 ml. On 18th February 2022, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, erythema and pain in arm. On 19th February 2022, the patient experienced muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the shivering, erythema, swelling, itchy rash, induration, heat rash and extremities hot feeling of were not recovered/not resolved and the outcome of the feeling cold, pain in arm, muscle pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, erythema, pain in arm, muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in right deltoid and that night she experienced shivering, feeling cold, a sore arm, and redness just below the injection site.  The following day she said every thing hurt( she had muscle pain), and that she spent the next couple of days in bed.  The patient also noticed a rash, itchiness, swelling, hotness, and hardness of her right arm. The patient had measured the size of her rash and stated it was 3 inches in diameter, but it had increased yesterday on 21st February 2022) to 4 inches across and 5 inches in length. On the day of reporting she stated that she no longer had pain, and she felt better, but the the rash continues and it was hot and itchy around the edges. She had not yet measured the size of the rash but stated that it was almost wrapping around her arm Gave medical advice disclaimer. Spoke per content. Spoke per PI (package insert). Referred to health care professional.  The reporter consented to follow-up with HCP (health care Professional). The reporter consented to follow-up.
Headache started within hours of vaccine dose given. Headache intermittent throughout the day for 1.5 weeks. Treated supportively with Motrin and rest. Resolved after 1.5 weeks.  Also report of right eye drainage, clear, present for 5 days.  Currently resolved.
Received Tdap and HPV4 vaccines on 9-26-07, same day developed a burning rash on the left side of neck and chest.  Has been afebrile and attending school. Presented in office today, 10-05-2007, with c/o rash and burning. Has a H/O varicella disease as a small child and varicella vaccine on 6-1-1998. Has raised blisters with red base, lesions vertically descend from neck to left side of chest.  Dr. diagnosed Pt with Shingles.
Itchy large rash down back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy large rash down back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced RASH PRURITIC (Itchy large rash down back). At the time of the report, RASH PRURITIC (Itchy large rash down back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.
Firstly - As a hospital employee, I received Moderna 031L2OA in the arm. Your form doesn't allow me to say that. After 19 years of no period, I started menstruating every 7-14 days over a 3 month period! Severe cramping down in my uterus (as if back in high school), usual effects of menstruating (cramping,  bloating,...). Nineteen years of NO cycles!   Thought I had gynecological cancer, went thru ultrasounds and biopsies. I AM FURIOUS that a potential link between these vaccines and screwing up menstrual cycles were back and may and NOTHING WAS EVER ANNOUNCED HERE! Even now, on December 18th, has there been anything reported. Get off your butts and start taking care the public. You aren't even asking the question! Since I've gone public in late October telling everyone, there are at least  4 people who have had menstruation screwups including another "dry" 50-year old who started bleeding after 10 years in my primary's office. And you wonder why people don't trust you or these shots? YOU ARE THE PROBLEM.  It also appears that younger women are losing early-stage pregnancies and experiencing very heavy menstrual cycles. But of course, our government won't share that information either. If I were a young woman, I would in no way take these shots. And what about the poor people who can't afford to get medical testing and now have to live with similar issues? I will be happy to produce my insurance reports and tests as proof of the anguish and pain I had to go through alone in this. I will not be a sheep any longer.  How dare you push people to get a drug and doesn't even provide full disclosure of risks and side effects. And a visit with an optician this week, he said he's seeing double the people coming in his office with double vision and wondering if this too is a side effect of the vaccines.   You are failures and not to be trusted.
given vaccine about 6 PM from Pharmacy  Arm was itching by the time I got to the grocery store-within 15 minutes BUT THE WORST WAS YET TO COME WHEN I WOKE UP NEXT MORNING & MY LEFT ARM WAS RED, SWOLLEN, HARD FROM INSIDE ELBOW UP TO RIGHT BELOW SHOT ENTRANCE--ABOUT 6 INCHES BY 6 INCHES / BUT DUMMY ME DID NOT GO TO ER UNTILL THE 8th of Sept where they gave me prescription for Prednisone-20 mg-twice daily for 5 days. Today (09/21/19) arm is looking normal.
Pfizer vaccine dose 2 was given in subcutaneous tissue rather than  deltoid muscle.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 16:00 (Lot number: EN6205) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "heart condition" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Feb2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: the patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The event was reported as non-serious.   No follow-up attempts are possible. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), on 02Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "Known allergies: garlic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Sep2023 to 11Sep2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
12 hours post vaccination had chills and body aches, restless sleep. The morning after whioe body soreness, tired, nauseous, pain at injection site, headache. Took 1000 mg Tylenol at 11 am and 7 pm. Day 2 Body aches, tired. Currently 12 weeks pregnant as of 2nd dose date.
6/24/03 Pt complained achy feeling 3-4 hours (18:00-19:00) after administration of Adult Hep B vaccine. Complained of chest pressure during night. 6/25/03 today complained of aches and general malaise. No fever. BP 144/104.
patient was administrated/ recall on May 17 2021/ recall cate 10feb2021; patient was administrated/ recall on May 17 2021/ recall cate 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 17th May 2021, the patient received Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169129:Same reporter US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The reporter stated that a patient was administered a dose of VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) that was improperly stored. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
8 x 6" red swollen left deltoid area with normal range or motion. Treatment-Tylenol.
03/16/2021: Planned total laparoscopic hysterectomy bilateral salpingo-oophorectomy and cystoscopy possible total abdominal hysterectomy because of recent D&C (Dec. 2020) that showed complex atypical hyperplasia on pathology.
A report has been received from a Pharmacist concerning a female subject, who had been receiving Nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The patient experienced expired FLUMIST Quadrivalent. The outcome of the event of expired FLUMIST Quadrivalent administered was unknown. The report was considered to be non-serious. Summary of insignificant follow-up information received by AstraZeneca/Medimmune on 15-JAN-2015 from pharmacist. No new information to add. Corrected report 21-OCT-2015. Key ingredient updated.
pain in her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series, manufacturer unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm."  Additional Information: It was reported that the caller was a consumer who asked how many milligrams were in the booster shot what were the ingredients. Asked about the percentage of people calling reporting side effects due to the booster shoot in the last 2 weeks. The caller mentioned that the next date after the vaccine she presented pain in her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.