chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning her 17 year old daughter with attention deficit/hyperactivity disorder and a history of shellfish allergy (as a child: outgrew) who in 06-NOV-2006 at 1:00PM, was vaccinated in the left deltoid (previously reported as right deltoid), IM with a first dose of GARDSIL (Lot # 653650/0640F). Her second dose of GARDASIL vaccine (Lot # 653650-0640F) was administered intramuscularly into the right deltoidon 16-January-2007, at 2:00PM. Concomitant therapy included ADDERALL. There was no illness at the time of vaccination. The nurse practitioner reported that 3 days after each dose of GARDSIL vaccine, her daughter developed diarrhea, on 09-NOV-2006 and 19-JAN-2007, respectively. The diarrhea was reported to be "relatively severe and spontaneously resolved" (dates unspecified). On 20-January-2007 at 8:00AM, on the fourth day after the second dose, the patient "developed a rash on her knees and thigh that spread during the day until she was covered in a rash from her neck to her feet." In follow-up, the nurse practitioner confirmed that the patient developed a rash four days post vaccination that covered her legs, trunk, arms and neck. She was treated with BENADRYL and it resolved. The reporter noted that the decision was made to discontinue the series so a third dose would not be given. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007.  Additional information is not expected.
Itching; Rash; Rash is hard to the touch; 3 red spots; Rash warm to the touch; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), PRURITUS (Itching) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATENOLOL, ATORVASTATIN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN POTASSIUM (LOSARTIN) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), RASH (Rash) and INJECTION SITE INDURATION (Rash is hard to the touch). On 05-Feb-2021, the patient experienced PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), PRURITUS (Itching), RASH (Rash) and INJECTION SITE INDURATION (Rash is hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Became severely lethargic for a few days with  Muscle weakness difficulty standing up. Extreme swelling and pain in the left armpit very swollen thyroid gland which lasted over a week.  Lost two days of work.  Injection site pain  Severe headache. I had a similar reaction to the 2nd dose but the booster was by far the worse.
Large reddened areas and rash progressing down patient's arm, increased warmth. Ice applied and Benadryl  25 mg. Reddened area resolved in 20 minutes.
01/04/22 presents to Family Birth Triage for "scheduled induction of labor". PMHx of "Duane radial ray syndrome, Iron deficiency"
pt recv vax 2JUL96 & became pregnant (LMP 4JUN96);lab eval on 6AUG96 revealed a negative titer of 0.9;
Consumer reports that 2 of children exp respiratory distress following 2nd immun; pt 1 was vaxed 1984 or 1985, required hospitalization tx w/steroids;
Swelling, pain, redness 6 x 8 cm (R) deltoid.
admitted to our facility due to having homicidal ideation at her group home.  Patient was started on Trileptal to assist with her difficulty with mood fluctuations.  She tolerated this medication well and noted resolution of homicidal ideation after being removed from the acute stressor and situation.  Patient did not have any significant side effects. On day of discharge patient was noting to be feeling well and back to her baseline. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Following flu shot Diagnosed with MS in 11/30/2018 and had flare-up following flu shot that required 6 weeks off work, 8 weeks on restricted duty. Symptoms left me unable to walk, see, care for myself or family. Flare-up causes optic neuritis causing permanent damage that has not resolved.
sporadic muscle twitches all over my body; felt fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: EW0171) at the age of 47 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 12May2021, outcome "not recovered", described as "sporadic muscle twitches all over my body"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "felt fatigue"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache". The events "sporadic muscle twitches all over my body", "felt fatigue" and "headache" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of muscle twitching, fatigue, headache.  Additional information: No other vaccine was taken in four weeks. The patient did not have covid prior vaccination. Covid was not tested post vaccination. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
breastfed my children; breastfed my children; developed triple positive invasive ductal carcinoma; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breastfed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TRIPLE POSITIVE BREAST CANCER (medically significant) with onset Jun2022, outcome "unknown", described as "developed triple positive invasive ductal carcinoma"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "breastfed my children". The patient underwent the following laboratory tests and procedures: Mammogram: (Dec2020) negative; Tumour marker test: (unspecified date) have no genetic markers for cancer. The clinical course was reported as follows: The patient reported that she had developed triple positive invasive ductal carcinoma that was diagnosed in Jun2022, had a negative mamogram Dec2020. She had not hit menopause she had never taken hormones and never been on birth control. She breastfed her children and had the genetics test done and have no genetic markers for cancer. She is traveling to (city and state withheld) for treatment. They have put all the pieces together and have come to the conclusion that the vaccine caused this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company does not attribute the triple positive breast cancer to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the event being intercurrent disease.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201060872 same report/drug, mother/baby case;
5 days later December 31st   Noticed weakness on my left side of my face.  Tearing on the left eye . Unable to open wide on my left lips
March 29, approximately 4:30 PM, I began to experience chills and body aches, and noticed my teeth felt sensitive when I ate dinner. March 30, upon waking: Chills and aches were gone, but by 10 AM, my teeth continued to get more and more sensitive (it felt like I had been hit on the right side of my mouth) and my gum tissue became bulbous and sore around the sore teeth (6,7,8,25,26,27) and I wondered if I cracked a tooth somehow. However, the pain radiated to the right posterior teeth, and crossed to both incisors (top and bottom) on the left side. I would describe the pain as throbbing and acutely sensitive to room temperature air, pressure, hot and cold. this happened in a very short span of time, and I was awake and not clenching or grinding my teeth. March 30, afternoon: I called my dentist. He was out of town. I posted on social media, asking if anyone has had tooth pain post vaccine. There were a handful of anecdotal stories (first hand) with a similar issue, so I decided to wait and see if my issue would resolve similarly. April 6: Pain has been intermittently severe and dull over the past week. I see my dentist this afternoon to do an evaluation. He says the tissue looks odd - almost like a herpetic lesion trying to heal, both around tooth 26 and on the palate adjacent to 8. Also, it appears there is no longer any keratinized gum tissue around 26, and the tissue had receded dramatically on this tooth. The doctor takes photos and refers me to a periodontist for a tissue graft to save the tooth. April 9 (today): I have an appointment with a periodontist next week for an evaluation. My dentist assures me the area will need a graft. Today I have less pain, but the gingival inflammation around 26 has persisted. Since I don't know the outcome at this point, I can only hope that tooth 26 can be saved with a facial graft, but that is the course of action.
Redness at site of VARIVAX injection began 9/8/08 multiple (5) vesicles around injection site.  4 cm induration at DTaP site. 20 scattered vesicles on chest and upper extremities. Scattered urticarial lesions both thighs.
States had immunization yesterday and immediately complained of headache, neck ache, arms hurting. Temperature of 103 about 6 hours last night. Gave Acetaminophen today and much improved. Today, very fussy and vomited through the night and went to doctor. Not eating or drinking. Discussed with doctor. Doctor will call parent now.
supraclavicular lymph node on the left side swollen. Onset 5 days after administration of shot.  Tender to the touch.
Pt woke up 1/1/15 with burning and itching sensation after getting vaccine on 12/31/14. Says it continued to worsen with Sat, 1/3/15, being the worst day. She started using hydrocortisone cream on 1/3/15. At this time, the rash was past her elbow. She states the full area was about 3 in by 6-7 in.  The rash started to subside on 1/4/15 and continues to improve.
fatigue, chills, headache worst symptom is severe heartburn which started approximately 20 hours after receiving the 2nd dose of Pfizer vaccine and has not responded to any medication or home treatment. Extremely painful heartburn kept me up at night and I still had it when I woke up, without eating or drinking anything.
Two deep lesions on my arm appeared overnight. I went to Urgent Care. The doctor said that they looked like week-old wounds that were healing. I went to a dermatologist and they recommended to put Vaseline on it. I didn't take any medicine and I only applied the Vaseline. They no longer look like open wounds. Currently, they look like blood blisters and they are still healing.
Pt vaccinated with Meruvax II developed fever, swollen lymph glands & aching of the knees & fingers. Treated w/Acetaminophen.
Beginning the same weekend of the second moderna vaccine (April 2021) I began to have infrequent heart palpitations and heavy menstrual cycle. Over about two months I reduced by caffiene and alcohol intake to see if the heart palpitations would subside. When they did not I contacted my PCP in June 2021. So far I have had an heart monitor which should PAC/PVC's and an echocardigram which came back normal. Heavy menstrual cycles also began the same weekend as the second vaccine. My period now lasts 6-8 days and is so heavy I can't use tampons anymore. My period used to be 4-5 days and relatively light since I am on hormonal birth control.
she feels pain in the lungs, in the body,in her head there is blood clot; she feels pain in the lungs, in the body,in her head there is blood clot; she feels pain in the lungs, in the body,in her head there is blood clot; every day she feels different; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This female patient of an unspecified age received received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. In Apr2021, the patient experienced that she feels pain in the lungs, in the body, in her head there is blood clot, every day she feels different with outcome of unknown.  The clinical course was reported as follows: The patient had the 2nd dose of the vaccine 3 or 4 weeks ago, since then she had the symptoms, she feels something's changed, and she feels pain in the lungs, in the body, in her head there is blood clot, every day she feels different. In the hospital they do tests and X-ray but results turn out normal and nothing is wrong. She had never felt this strange in her life, she didn't feel well.  Information on the lot/batch number has been requested.
5/20/21 Chest Pain, increased blood pressure, increased heart rate.  In Emergency room to evaluate.  Thought to have had a pulmonary embolism.  Positive D-Dimer.  Results negative for pulmonary embolism.  No prior history of hypertension.  Referred to cardiology due to ongoing new symptoms.  5/26/21 Sharp stabbing pains in multiple areas of Left Breast.  Continued on and off for a week and a half after beginning.  This has subsided.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-SEP-2015, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a pharmacist at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for herpes zoster. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Initial unsolicited report received from nurse on 17-Oct-2017. This case involves a female patient of unknown age who was vaccinated with a dose of FLUZONE INTRADERMAL (Batch number, expiration date, form, dose, dose in series and site of vaccination were not reported) via intradermal route on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date last year, following the vaccination, the patient developed baseball sized swollen reaction to the intramuscular, bright red swollen reaction, but then also down the arm above the elbow and up to the shoulder was swollen. The red area was also warm to touch. Laboratory data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
tested+ for covid 2/8/22.    He was on hospice and visited by hospice nurses  8/5/22 and 8/6/22 he was having fever and was on po levaquin but declined , becoming unable to take further po antiobiotics and was transferred.  He passed away on 8/7/22 at Hospice in patient facility.  He had dementia, chronic afib and heart disease.
pt recv vax 3NOV95 & 15APR96 pt to MD w/multiple lesions of erythematous papules, vesicles & pruritus;pt was initially dx w/viral exanthema versus varicella zoster virus;dx was later changed to varicella, w/50 pox lesions;pt recovered;
After 15 hours, felt rundown. Then fever started 2 hours later. Fever increased until (worst was 11pm-2am ) it hit 102 F then took Tylenol. Fever was down to 101 by 6am and likely gone by 8am. Then hours of below temperature (only checked twice, had 96 then now 97.5).  I didn't have much swelling at all and barely any pain at injection site.
Numbness left side face and headache. Called Patient at 4:30PM and stated feeling was lessening and he decided not to call MD.
Hives on the torso and upper aspect of the limbs. It didn't happen until 3 weeks after the second dose, so it could be unrelated, but it is the only thing that has changed in the patient routine and environment.
Redness around site of injections about 4 inches in circumference. Fever > 101 degrees F night of injection. Severe leg cramping and chills.
Patient accidently given 0.2mL of adult Pfizer 30mcg/0.3mL instead of peds Pfizer 10mcg/0.2mL. No known adverse events reported, or treatments needed that facility is aware of.
Same day: extreme lethargy and headache starting a few hours after injection. Lethargy 50% reduced next day and gone by 3rd day. Headache 2 days. Stomach upset  2 days. (It's worth it.)
Large local reaction: erythema and induration (approximately 5 inches in diameter). Tender. Worst at day 3; resolved after day 8. Edema at injection site >120mm not beyond elbow, erythema, tenderness.
Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AIDS and Blood pressure high.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was born on 1953. Concomitant medications taken by the patient included high blood pressure medications. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information received captured event outcome.
This is a spontaneous report received from a Pfizer-sponsored program. A 75-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in arm in Apr2016 at single dose. Medical history included Iodine contrast dye allergy 10 years earlier during a cat-scan with urticaria and swelling face on and off for 4 months. Concomitant medication included ongoing levothyroxine 50mg once daily since 20 years, and ongoing CENTRUM SILVER once daily since 20 years. The patient previously received a pneumococcal vaccine and experienced sore muscle, and flu vaccine and experienced sore muscle. The patient experienced sore muscles and redness with outcome of recovered, the top part of the arm became very red and hot for about a week after vaccination with outcome of recovered, allergic reaction with outcome of recovered, and slightly swollen on an unspecified date with outcome of unknown. The patient was admitted to the hospital 7 days after onset and was treated with cool shower and ice packs.
p/vax pt exp red blotch at inj site; classic lyme bulls eye & achiness over the body;
Information has been received from a physician concerning a 12-month-old male who was recently vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Concomitant vaccinations included a dose of varicella virus vaccine live.  Approximately one week after the vaccinations the patient developed a low grade fever and then experienced seizures.  unspecified medical attention was sought and it was reported that the patient was hospitalized for three or more days.  While he was hospitalized tests done indicate " there may have been minimal damage to the brain".  The physician suspected the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as cause.  No information was reported regarding the present status of the patient.  No product quality complaint was involved.  The physician considered the low grade fever and seizures to be disabling.  Additional information has been requested.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/17/2021 PLEURAL EFFUSION  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/17/2021 DM 2 WO COMPLICATIONS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/17/2021 PLEURAL EFFUSION
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a adult 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 influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, pain in arm and mobility decreased were recovered/resolved and the outcome of the fatigue and axillary pain were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, nausea, touch sensitivity increased, general body pain, fatigue, pain in arm, axillary pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had severe arm pain up to axillary area and down side. The patient also had more severe pain in same areas of arm/axillary. The patient was unable to raise arm for 3 days. For tolerance of next dose see case US2018183663.  Lab Comments: Lab test was done on an unknown date.
Patient states had loud noise wake her up and then a continuing ringing that had no source so she thinks it is due to vaccine a few days ago.