chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has not had a reaction like this after any other shot  and doesn't look like a normal reaction; shot site a little raised; only reaction she has experienced has been a headache, specifically a migraine,; Extreme Joint Issues in every joint in her body; where she received the shot is still very red,; Where she received the shot is a little raised; Where she received the shot is extremely itchy; All of her tattoos seem to be welted; All of her tattoos are very itchy; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (only reaction she has experienced has been a headache, specifically a migraine,), ARTHRALGIA (Extreme Joint Issues in every joint in her body), VACCINATION SITE ERYTHEMA (where she received the shot is still very red,), VACCINATION SITE SWELLING (Where she received the shot is a little raised) and VACCINATION SITE PRURITUS (Where she received the shot is extremely itchy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced MIGRAINE (only reaction she has experienced has been a headache, specifically a migraine,), ARTHRALGIA (Extreme Joint Issues in every joint in her body), VACCINATION SITE ERYTHEMA (where she received the shot is still very red,), VACCINATION SITE SWELLING (Where she received the shot is a little raised), VACCINATION SITE PRURITUS (Where she received the shot is extremely itchy), URTICARIA (All of her tattoos seem to be welted) and PRURITUS (All of her tattoos are very itchy). On an unknown date, the patient experienced VACCINATION COMPLICATION (she has not had a reaction like this after any other shot  and doesn't look like a normal reaction) and VACCINATION SITE RASH (shot site a little raised). At the time of the report, MIGRAINE (only reaction she has experienced has been a headache, specifically a migraine,), ARTHRALGIA (Extreme Joint Issues in every joint in her body), VACCINATION SITE ERYTHEMA (where she received the shot is still very red,), VACCINATION SITE SWELLING (Where she received the shot is a little raised), VACCINATION SITE PRURITUS (Where she received the shot is extremely itchy), URTICARIA (All of her tattoos seem to be welted), PRURITUS (All of her tattoos are very itchy), VACCINATION COMPLICATION (she has not had a reaction like this after any other shot  and doesn't look like a normal reaction) and VACCINATION SITE RASH (shot site a little raised) outcome was unknown.        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.   Concomitant medications was not provided.  Treatment medications were not given.
Woke up with a red rash below the injection site on 4/18/21.  It is very warm to the touch.  No treatment was used.
Transient diarrhea, a rash, and erythema at the injection site (no induration).
Pt woke on 8/31/19 with rash about 1-2 inches which became hot, itchy, and spread to 5-6 inches with lump. Pt applied OTC antibiotic ointment.
Hospitalized for induction of labor asymptomatic COVID 19 .  Gestational hypertension, EDD 9/23/2021,  Birth 9/2021, 40w3d gestational age, wt 3.63 kg.
At 21:00, became irritable and had profuse vomiting. Hive-like lesions on arms and face. Abdomen "completely covered". ER called and then 911 and transferred to hospital. Infant became limp, eyes glassy and difficult to arouse. Given Benadryl and a steroid injection. Observed 1 1/2 hours and discharged. 2 lesions noted on stomach today. "acts ok today".
Information has been received from a nurse concerning a 12 year old female with asthma who on 09-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5mL IM. In August 2007, the patient missed her period for the month of August and developed headaches. The patient saught medical attention. She recovered from the symptoms, date not reported. On 09-OCT-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). She again developed headaches and did not have her period for the month of October. The patient still has headaches. No outcome was reported for missed periods. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 27-MAY-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistences in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
red spots on head noted by mom & progressively got worse until newborn was covered;platelet count was repeated next day w/reading of 11,000;pt adm to hosp 23JAN98 platelet count 16,000;gamma globulin given;dx thrombocytopenia purpura
Patient had previous ZOSTAVAX injection in 2016. Patient experienced redness and swelling at the injection site. Patient complained that the redness/swelling/sensitivity progressed for 2 days until he went to physician, who told the patient that he most likely experienced an infection due to the injection.
Initial and follow up information has been received from a 23 year old female consumer through the Merck Pregnancy registry and an other health professional who on approximately 23-JUN-2007 was vaccinated with 0.5 ml of a first dose GARDASIL.  There was no concomitant medication.  On 23-AUG-2007 the patient was vaccinated with second dose of GARDASIL.  On 06-SEP-2007 the patient reported that she was pregnant.  The patient's last menstrual period was 02-AUG-2007.  The estimated delivery date was 08-MAY-2007.  Unspecified medical attention was sought.  A urine test was performed (results not reported).  On 26-JUN-2008, it was reported that the patient had a pregnancy loss at 20 weeks estimated gestational age (EGA) and was then seen for a postpartum visit in January after her 20 week loss.  At the time of this report, the patient's outcome was unknown.  Upon internal review, spontaneous abortion was considered to be an other important medical event.  Additional information has been requested.
Substantial arm pain, can't lift above chest level with considerable effort; Rapid heart rate; Substantial arm pain, can't lift above chest level with considerable effort; Substantial arm pain, can't lift above chest level with considerable effort; Swollen and tender lymph nodes in right armpit; Swollen and tender lymph nodes in right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 10:15 (Lot number: 331308A) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left), administration date: 01May2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious), PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Substantial arm pain, can't lift above chest level with considerable effort"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "Rapid heart rate"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Swollen and tender lymph nodes in right armpit". Therapeutic measures were not taken as a result of mobility decreased, heart rate increased, pain in extremity, limb discomfort, axillary pain, lymphadenopathy.  Additional information: List of other medications the patient received within 2 weeks of vaccination were generic zyrtec, 1000 mg vitamin c, Fiber well. Prior to 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 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
8 days early for 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 days early for 2nd dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 days early for 2nd dose). On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 days early for 2nd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No treatment related information has been reported.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 048A21A) with no associated adverse events.
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No additional adverse event.   This is one of several reports received from the same reporter.
My monthly period started the day before I was vaccinated, June 11th,2021. It stopped on the 15th. It started again on the 22nd and hasn?t stopped. Today is July 1st, 2021.
Symptoms began with arm soreness with minor swelling around the administration area around 6-7 pm. Chills began at 11 pm lasting for half an hour followed by a fever of 102f. The fever continued during the night of 1/5/21 and early morning of 1/6/21. Woke with a strong headache in the morning at 7 am.  Headache caused dizziness and some loss of balance when walking. Had minor facial swelling with minor numbness around mouth and neck.  The fever, headache, and swelling continued throughout the day of 1/6/21. The fever broke around 7 pm on 1/6/21. Nyquil and ibuprofen were taken for fever and headache.   During the morning of 1/7/21, the fever and facial swelling had ended. The headache continued during the morning of 1/7/21 until midday. By the evening of 1/7/21, all symptoms had ceased.
body aches, chills, headache, nausea, sore arm, fever, sinus congestion, sore throat, cough, difficulty sleeping, constipation
give a Bexsero and it expired 3 days ago; This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in an unspecified number of patients who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The reporter stated that they had a nurse just gave a Bexsero vaccine and it expired the end of July, 3 days before date of reporting. The reporter's doctor would like to know if this was considered invalid. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used. The follow-up would not possible as no contact details were available. This case has been linked with the case US2022AMR115273, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR115273:Same reporter
fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (fatigue) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date of refrigeration of vaccine was 06-AUG-2021  No treatment information was reported.   This case was linked to MOD-2021-363775 (Patient Link).
Information has been received from a consumer concerning a friends' friend who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. There was no product quality complaint involved. No further information is available.
Adverse reactions body feels like it was hit; got a headache; Sore joints; This is a spontaneous report from a contactable nurse (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL0142, Expiration Date 11Jan2021, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  Medical history and concomitant medications were none.   On an unspecified date the patient experienced adverse reactions body feels like it was hit, got a headache, sore joints. The outcome of the events was unknown.  The information on the batch/lot number has been requested.
It is very tender; Swelling and puffing; It is very sore when in motion; Awaken with arthralgia right elbow; Sleepiness; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of SOMNOLENCE (Sleepiness), TENDERNESS (It is very tender), SWELLING (Swelling and puffing), PAIN (It is very sore when in motion) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, CARBINOXAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (CAPRAMIN [ACETYLSALICYLIC ACID;CAFFEINE;CARBINOXAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]), ATORVASTATIN, METOPROLOL, DOFETILIDE (TIKOSYN), RIVAROXABAN (XARELTO) and OMEPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced TENDERNESS (It is very tender), SWELLING (Swelling and puffing), PAIN (It is very sore when in motion) and ARTHRALGIA (Awaken with arthralgia right elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Feb-2021, SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue) had resolved. At the time of the report, TENDERNESS (It is very tender), SWELLING (Swelling and puffing), PAIN (It is very sore when in motion) and ARTHRALGIA (Awaken with arthralgia right elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MODERNATX, INC.-MOD-2021-020521 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-020521:Same patient, 1st dose
Pt was in extreme pain. 5 hours after receiving imz arm hurt. Went to ER crying. BP 220/81, BG 394, EKG, X-ray, and other blood work taken. Pt given pain medication.
PATIENT GOT THE VACCINE WAITED FOR 10 MIN AFTER THAT WHEN HE IS DRIVING BACK TO HOME HE MET WITH AN ACCIDENT .
Initial unsolicited report received from the healthcare professional via other company (Pfizer) 19 May 2016. Manufacturer control number: 2016248113. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu vaccine (batch number, expiry date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy. Lab data and corrective treatments were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Erythema, edema, warmth, and tenderness. Pt reports tactile fever.
The morning of the 14th woke up with numbness/tingling in feet with pain in legs, 15th tingling started in lower legs with same pain in legs, 16th tingling all the way up thighs and in hands, had palpitations numerous times through the day, felt like I was going to pass out several times, even while sitting, legs felt very fatigued   17th palpitations went away, but all other symptoms remained the same for several days. When walking up stairs, legs felt very fatigued and I would get burning in the muscles to the point I could only climb 1 flight of stairs before having to rest my legs. Tingling in my hands went away around the 25th. Tingling in upper legs went away around the same time, but the tingling in the feet and lower legs is still present today. Fatigue/weakness in legs improving. Now able to climb 2 flights of stairs with only minimal fatigue, no more burning in the muscles.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:43 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.34 for dose administered on 27-Feb-2021 and 76.41 for dose administered on 27-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 27-Feb-2021 underwent temperature excursion with temperature range of 33-36 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A administered on 27-Mar-2021 underwent temperature excursion with temperature range of 35 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.