chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the Shingrix vaccine and I had shingles at the time; This case was reported by a consumer via interactive digital media and described the occurrence of off label use in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. Patient received the shingrix vaccine and had shingles at the time of vaccination, which led to off label use. Patient was asking how serious was this. No further information was reported. Follow up was not possible as no contact details were provided.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 8/10/2022 &  2/13/2023 -- RECURRENCE OF SAME SYMPTOMS
GENERALIZED DIFFUSE MACULOPAPULAR RASH,  MILD FEVER/FATIGUE/CHILLS
Information has been received from a consumer concerning her 1 year old daughter who in 1/2000 was vaccinated with 1 dose of varicella vaccine. On about 2/8/00, 2 weeks, post vax, the pt developed 20 to 30 pox on her belly. She sought unspecified medical attention. No further information is available.
12/26/21  Patient presents with fever (102), cough, congestion and body aches that started today. No known exposure. Was with family yesterday. She is vaccinated. Physical Exam. Constitutional: General: She is not in acute distress. Appearance: She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Head: Normocephalic. Right Ear: Tympanic membrane, ear canal and external ear normal. Left Ear: Tympanic membrane, ear canal and external ear normal.     Nose: Congestion and rhinorrhea (clear) present.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Uvula midline. No oropharyngeal exudate or posterior oropharyngeal erythema.
Fatigue, extreme weakness, trouble walking, and trouble getting dressed that lasted about 6 hours.   Note:patient form was uploaded and I put the wrong lot number on it. I put the 1st dose lot number and It should be the same as the lot number above. sorry.
with only mild GI symptoms as a reaction; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient of  received BNT162B2 (Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Unknown) via an unspecified route of administration on 15APR2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date the patient experienced only mild GI symptoms as a reaction. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433455 same reporter/drug/event, different patient.;US-PFIZER INC-2021433454 same reporter/drug/event, different patient.
Hives over much of both the arms and legs as well as on the waist.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Concomitant medication included simvastatin (SIMVASTATIN) taken for high cholesterol from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Apr2021 at 22:00, approximately two and a half days (60 hours) after the second shot, the patient experienced hives over much of both his arms and legs as well as his waist. The patient reported that these continued until the patient took medication to treat the hives. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives and included treatment with a 6-day prescription of methylprednisolone 4mg. The clinical outcome of the event hives was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Registered Nurse referring to a female patient of unknown age. No concurrent or historical conditions were reported. On unknown dates, the patient was vaccinated with the first two doses of oral ROTATEQ (lot numbers and expiration dates were not provided) dose, route and anatomical location were unknown. On an unspecified date, the patient was inadvertently administered her third dose of oral ROTATEQ (Lot number reported as L022447, expiration date 26-FEB-2017) at age 13 months. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weakness
Severe feminist in both ears 24/7 with dizziness. Dr. prescribed z pack and a week later thinking it might be allergy related he gave me Flonase.  I have had no relief and experience insomnia, anxiety, dizziness and tinnitus 24/7.
Missed miscarriage diagnosed on 4/12/2022. Timeline: last menstrual period on 1/29/2022, Covid vaccine Moderna booster on 2/5/2022, positive pregnancy test on 2/25/22, missed miscarriage date based on ultrasound was 3/9/2022 (5 weeks 4 days gestation). Ultrasound on 4/4/2022 confirmed pregnancy was only at 5 weeks and 4 days, ultrasound on 4/12/2022 confirmed no progress to pregnancy and was still measuring at 5 weeks and 4 days. Treatment selected was a D&C (Dilation and Curettage) surgery which was completed on 4/14/2022.
Patient received vaccine and was standing in waiting area and had witnessed syncopal episode and fall.  Hit back of head and had laceration.  Patient slow to arose and provider from urgent care called to evaluate.  Awakened and able to answer questions.  Appeared laceration would need sutures/staples.  Ambulance called for and transported.
I woke up one morning with a rash on my left torso. I called my doctor. The nurse practitioner diagnosed it as Shingles. I was prescribed an antiviral for seven days.  I experienced some tiredness and achiness as well. There was itchiness from the rash that occurred but it gradually went away. Though the rash itself took 4 weeks to completely go away.
Within 12 hours- Severe chills for 2 hours, then turned into fever of 102. Took motrin at 4 am (four hours after effects started.) Headache and achy. Fever continued for 20 hours. Took Nyquil that night.  5th day at 11pm, developed itchy rash on forearms, spreading to torso and shoulders. Started down back. Took benedryl and used caladryl lotion on rash.  Tired for 4 days.
first dose in 2020, second in 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was self-reported by the patient for himself. The age at vaccination was not reported. The patient stated that he received first dose of Shingrix in 2020 and second dose in January 2022, which led to lengthening of vaccination schedule. The reporter provided very limited information. The reporter disconnected the call and therefore agent could not ask caller's mailing address, consent for follow-up, Health Care Professional contact information, lot/ expiry date of the shot, and date/route of administration.
gave 4 doses that were expired; vial was initially stored in the refrigerator on 12-Jul-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12-Jul-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12-Jul-2022). On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No temperature excursions was reported.  The vial was initially stored in the refrigerator on 12-Jul-2022.  No treatment medication was reported.
COVID arm - large rash on upper left arm area below the injection site. Erythema, pruritus, rash.
generalized rash;27JAN95 f/u urticaria over trunk, arms, legs, up to neck;recovered;
presented w/ 1+ - 2+ edema in rt arm extending to rt elbow w/erythema & tenderness;some inflammation of axillary lymph nodes;pt seen by PA, prescribed keflex; & instructed to use ice packs;
biopsy confirmed leukocytoclastic vasculitis developed within 2 weeks of 2nd Pfizer Shot; required hospitalization, prolonged course of steroids
This spontaneous report was received from a nurse and refers to a 6 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-NOV-2017, the patient was vaccinated with the improperly stored doses of ROTATEQ (dose and route of administration were not reported) (lot # N014980 and expiration date: 16-NOV-2018) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit or colder for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1711USA003900: US-009507513-1711USA011245: US-009507513-1711USA011243:
States he felt congested and feverish prior to flu mist administration.  Temp was taken prior to flu mist was 98.8 by medical rep.  Went to another medical rep for the flu mist administration and answered all questions on the flu mist questionnaire as no.  After being administered the flu mist, states he progressively felt worse until Sunday night about 7 PM, he headed to the ER.  Stated his chest was further congested and he was feeling even more feverish.  At ER, he was diagnosed with an upper respiratory infection and told to go home and drink fluids and rest.  By Tuesday Dec 11th, was feeling better.
shortness of breath; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain).  At the time of the report, DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient only had mild tenderness at injection site after her first dose; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 14Aug2021 (Lot number: FA7485) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: 2006 (ongoing); "Vertigo", start date: 2010 (ongoing); "Fibromyalgia", start date: 2007 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "patient only had mild tenderness at injection site after her first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any prior vaccination (within 4 weeks). Reporter considered the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
rash on right leg, than spread on left leg; red rash; itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on right leg, than spread on left leg), RASH ERYTHEMATOUS (red rash) and RASH PRURITIC (itchy rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006C21A.) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE and VITAMIN D NOS for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 05-May-2021, the patient experienced RASH (rash on right leg, than spread on left leg), RASH ERYTHEMATOUS (red rash) and RASH PRURITIC (itchy rash). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (rash on right leg, than spread on left leg), RASH ERYTHEMATOUS (red rash) and RASH PRURITIC (itchy rash) outcome was unknown.            Treatment includes Hydrocortisone Cream
Erythematous papulo-vesicular lesions consistant wtih chicken pox on chest, back, abdomen, and thighs.
Febrile 104.2 for  36 hours.   Chills. Sweating.  Inappetant
2/5/21 patient had dermal filler of bilateral periorbital/cheek areas in Palo Alto.  3/23/21 received first dose of COVID-19 vaccine 4/10/21 woke up with left facial swelling, redness and tenderness. Took 2 motrins and Claritin. 4/11/21 felt worse, spread to right face. Went to ED, treated with cefriaxone for possible cellulitis. Discharged on keflex 500 mg PO QID x 7 days. After discharge she took 2 Advils for temperature 100.4. 4/12/21 worse with increase in facial swelling and pain. Took 2 advils. Seen in allergy clinic, diagnosed with Delayed Inflammatory Reaction of dermal fillers after Moderna vaccine. Started prednisone 50 mg taper course and zyrtec 20 mg BID. 4/13/21 significant improvement with decrease in facial swelling and pain after 2 doses of prednisone.
urticarial rash one day p/vax; although 5 days prior to shots, was seen w/t102;
Patient reports it started as a tingling, pain  and burning in the elbow and travelled up the shoulder and up the chest and to the heart. Pain felt like a cardio thump . Grabbed the epi. Sitting forward. Talked Dr. Doctor stated to sit back and uncross legs. Initiated slow breathing. Pain subsided to a tolerable amount. Not short of breath but tachycardic. Still dizzy. Stayed an hour sitting position, after injection. Felt there was an irritating sensation around the heart. Left and walked back to clinic. 10 minutes after arriving to the clinic, dizziness, flushing , came back and irritation around the heart was still noticed but tolerable. 2 minutes after, voice started cracking and drank some water. Intensity of dizziness increased and overall symptoms also intensified. Returned to COVID immunization clinic 15 minutes later. Patient was moved to direct observation in a chair. Given oral benadryl. Instructed to stay and would evaluate if new interventions would be deemed necessary.  Benadryl helped. Symptoms were relieved in 15 mins. Patient has been in the clinic under direct observation for about 3.5 hours.
I had an upper respiratory infection, white blisters on my throat, minimal cough, I had fluid in my ears. I took an at home COVID-19 test that came back negative. I had a telehealth visit with my NP who prescribed AUGMENTIN that I started taking that day and I am now finally feeling better.
Throat tightening, speech difficulty, profound weakness 12 minutes after vaccinaton. Epi-Pen administered left thigh Brought to ER-given solumedrol, benadryl, Pepcid Inj.  and Fluids. Observed 2 hours. Complete recovery- advised not to receive another Moderna COVID Vaccine and given possible allergen list (Polysorbate and PEG)
Sore arm/Achy /Pain in arm; Warm/Feeling of warmth; arm was red from the injection site/red arm; Itched; Rash; painful rash / Raised rash; Unable to sleep; Scabs; Red bumps; Itchy bumps; Burned; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, 1 day after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site itching, injection site rash, papular rash, sleeplessness, scab, red rash, itchy rash and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the left arm at around 5:30pm. Less than an hour, the patient experienced sore arm. The patient stated that, her arm was red from the injection site down to her elbow and approximately four inches in width, the redness changed to a rash which she described as raised, red bumps that itch. The patient could not sleep for a week because it was so painful. The patient stated that, the area involved has reduced in size and is appearing to resolve. There was discrepancy between the outcome reported in the structured field and the outcome reported in the source document (recovered or recovered with sequel) for all events.
This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009323: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
I got Covid 19. The primary symptom was cough, sinus drainage bronchitis, temperature of 102 on one morning. And it felt like the bone in my knees hurt and then the bottom center of my back hurt and it felt like the bone also. Overall it was mild and short lived. I went to the doctor and they sent me to have a Covid test.
Massive migration, body aches, nausea, dizziness, pasted out hitting head.
Period late by 3 days with more intense cramps than usual; Period late by 3 days with more intense cramps than usual; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), DYSMENORRHOEA (non-serious) all with onset Oct2023, outcome "unknown" and all described as "Period late by 3 days with more intense cramps than usual".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) thigh 3 x 3 cms red warm/cellulitis surrounding vaccine site placed on AUGMENTIN.
9/17/2008 PM of injection, pt reported increased pulse rate, heart fluttering, sweaty and clammy with some chest pain and pain up (L) side of neck into jaw x approx. 5 hrs. Then it subsided without any preventative interventions. Since has had sl. incidents then last pm another full blown episode x 2hrs- Pt sent to Cardiologist.
Treatment of COVID-19; Treatment of COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Dec2020 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Seriousness criteria not Results in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect: No. On 28Apr2022 patient experienced Starting feeling sick again after feeling much better, Worse shortness of breath and cough, Extremely fatigued and headaches. Outcome of event at the time of last observation was Not resolved. The patient received COVID-19 treatment with Paxlovid (Date of start of drug: 12Apr2022, Date of last administration: 17Apr2022). The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. The patient received Ventolin treatment for the adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.