chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 47 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046376 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Lot number M046376 is an invalid lot number for hepatitis b vaccine (recombinant). Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # reported as M046376. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009238 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009238 is being deleted from our files and the case is consolidated into case # 1711USA004087 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
patient voluntarily enrolled in pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (patient voluntarily enrolled in pregnancy registry) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (a couple drinks a week maximum) and UTI (During this pregnancy resolved with antibiotic). Concurrent medical conditions included Drug hypersensitivity (Sulfa), Seasonal allergy and Asthma (Patient was without treatment for ~15 years) since 1994. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC), FISH OIL and PLANTAGO OVATA (METAMUCIL FIBER) for an unknown indication.    On 27-Jan-2021 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Mar-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (patient voluntarily enrolled in pregnancy registry). On 27-Jan-2021, EXPOSURE DURING PREGNANCY (patient voluntarily enrolled in pregnancy registry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   At 20 weeks of this pregnancy, low line placenta started and resolve at 30 weeks. On unknown data diagnostic results for glucose test, ultrasound and genetic test were normal. The patient called to enroll herself in pregnancy registry.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Internal review on 21-Jul-2021 resulted in the update of birth type, fetal outcome and narrative.
AFTER RECEIVING THE SHOT  CUSTOMER WAS WAITING FOR 15 MINUTES . CUSTOMER FELT DIZZINESS AND COLLAPSE . MEASURE  HIS BLOOD PRESSURE  AT TAHAT TIME WAS  84/62. . HE WAS ASK TO  WAIT MORE TIME AND AFTER HE WAS FEELING BETTER HE WAS LET GO HOME.
PATIENT WAS 11 YEARS OLD WHEN HE RECEIVED HIS FIRST DOSE AND HE WAS GIVEN PEDS DOSE. HE WAS 12 YEAARS OLD FOR HIS SECOND DOSE AND RECEIVED PEDIATRIC DOSE INSTEAD OF ADULT DOSE.
Sharp pain to *temple of head,* Irradic heart BP & *Pulse * Severe Swelling of Limbs Extra On the Left Side Arms got rash that was bumpy and would burn *Also Sternum to Waiste Water retention took weight 185 To 207 over night *** Still occurring Sweeting profusely, Temperature {My norm is 87.8} Heavy breath wheezing Mucus white crystallized/hard  Nebulizer air pro inhailet  high 101.8 & very low 94°  Dehydration Diarrhea stomach cramps chills
Myalgia, NauseaVomiting, BODY ACHES Narrative: PT TOOK OXYCODONE 705MG AT NIGHT, PEPTO BISMOL, ZOFRAN 4MG IN THE MORNINGAND IBUPROFEN 200 MG X2 THE NEXT MORNING.
Severe diarrhea; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. 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 vaccination. On 08Apr2021 at 23:00, the patient experienced severe diarrhea and vomiting continuing for over 12 hours and was continuing at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe diarrhea and vomiting was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Initial face sagging, full blown facial tics and paralysis set in two days later. Urgent care identified vaccine as probable cause. Neurologist believes its Ramsey Hunt Syndrome.
Stiff arm starting day after vaccine that continues to present day. On day 7-8, felt terrible for 24 hours (loss of appetite, weak). Biggest complaint is stiffness in arm. Did not take anything to treat.
This spontaneous report as received from a Registered nurse via a company representative refers to two 19 year old male patients. On an unknown dates in December 2014 (reported as "sometime last week"), the patients were vaccinated with GARDASIL 9 (lot#, strength and frequency unknown), 0.5 ml, intramuscular. The patients fainted shortly after being vaccinated with GARDASIL 9. The patients did not seek medical attention and no treatment was given for the event. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Within 8 hours I began running a fever.  Within 14 hours my body hurt so bad I couldn't get out of bed without help.  This continued for 3 days.  Day 4 I was mentally foggy.  Day 5 I was normal.  39 days after my second dose I developed severe chest pains and had to go to the emergency room where I was diagnosed with pericarditis and pleurisy.
Suspected vaccination failure; The 2 Shringrix vaccinations / got them in 2019 and he now has / Shingles; Very painful!!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The reporter was the patient's wife. The age at vaccination was not reported. In 2019, the patient received 2 Shingrix vaccinations 6 month apart and he now had a case of Shingles. The reporter stated shingles were very painful. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Persistent headache starting ~24h post vaccination.; Fatigue starting ~24h post vaccination; Pain at injection site which cleared after 24 hrs; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 13Apr2021 at 09:45 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 23Mar2021 at 09:45 as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 vaccination. On 14Apr2021 approximately 24 hours post vaccination, the patient experienced persistent headache and fatigue. On 14Apr2021, the patient had pain at injection site which cleared after 24 hours. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with acetaminophen. The clinical outcome of the events pain at injection site was recovered on 15Apr2021 after duration of 24 hours, while that of persistent headache and fatigue were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
IMMUNIZATION CLINIC NOTES:  77 y.o. female presented to Elementary School for second dose of COVID-19 vaccine. No known allergies. Patient reports history of hypertension, being treated with amlodipine. No history of asthma, COPD, use of inhaler for any conditions, or recent respiratory illness. Patient is a non-smoker. First dose of vaccine, Lot # 039K20A, administered on 2/6/2021 and patient reported no immediate symptoms during observation period after first dose. Second dose of vaccine, Lot# 013A21A, was administered on 3/5/2021 at 10:52AM to the left deltoid. Approximately 5 minutes after receiving second dose, patient reported feeling anxious and feeling like her blood pressure was increasing. Patient taken to EMS observation area. Patient observed by EMS.  Nurse assessed patient at 11:23AM. Patient was alert and oriented x 4. Manual blood pressure was 196/86. Pulse, manually palpated, was 86 and strong. SpO2 99% on room air.  Patient with flushing. No generalized hives. No itching. No swelling of face, lips, or eyes. Left deltoid injection site without erythema or swelling. Skin warm and dry. Lungs auscultated and inspiratory wheeze noted in all lung fields. No shortness of breath. No cough. No nasal congestion. No change in voice. No sensation of throat closing. No stridor.  No dizziness or syncope.  No GI symptoms.   Patient experiencing skin and respiratory symptoms. RN was asked to assess patient?s respiratory symptoms and also noted bilateral wheeze.  Patient?s symptoms post-vaccination involved more than one body system, skin and respiratory. Reviewed symptoms and standing order procedures with patient. Standing order for Medical Management of Vaccine Reactions in Adults in a Community Setting was followed. Patient was assisted to stretcher by EMS. 0.3mg epinephrine auto injector, Lot # G191202X Exp. 4/2021, was administered to the right outer thigh on 3/5/2021 at 11:39AM by RN. Patient was then transported by EMS to Medical Center.   EMERGENCY DEPARTMENT COURSE AND TREATMENT NOTE: Patient's condition remained stable during Emergency Department evaluation. Decision made to obtain prior medical records. (+)Prior records reviewed. There is low suspicion for an allergic reaction given symptoms. Patient is well appearing with a normal exam. Plan to monitor.  03/05/2021 13:13 Patient remains well appearing will discharge home.
I received my vaccine 8/14 and had normal soreness. The day after I woke up with severe soreness under my arm. When I looked at it it was a golf ball sized knot in my arm pit, was very swollen and hurt to touch. I couldn't put my arm down because it hurt so bad. I waited a day or 2 to see if it would go down and it did not. I called my doctors office and made an appt to be seen. The CRNP looked at it and said it was a reaction to the vaccine and to monitor it, and take Tylenol. If it did not go down in a week to call her. I took Tylenol as needed and would take warm showers to put heat on it. It lasted about 4 days.
heart feels like it's flipping; I cant gather my thoughts; feeling confused a lot; feeling like the walls was closing in on me; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart feels like it's flipping), THINKING ABNORMAL (I cant gather my thoughts), CONFUSIONAL STATE (feeling confused a lot) and FEELING ABNORMAL (feeling like the walls was closing in on me) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart feels like it's flipping), THINKING ABNORMAL (I cant gather my thoughts), CONFUSIONAL STATE (feeling confused a lot) and FEELING ABNORMAL (feeling like the walls was closing in on me). At the time of the report, PALPITATIONS (heart feels like it's flipping), THINKING ABNORMAL (I cant gather my thoughts), CONFUSIONAL STATE (feeling confused a lot) and FEELING ABNORMAL (feeling like the walls was closing in on me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.    Reporter did not allow further contact
Dose given past the 12 hour post puncture time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-327879.
Dizziness arm twitches, leg pain, fatigue, vertigo Narrative: employee states she was vaccinated in the left arm, the following morning her right arm was sore and she experienced "twitches" up and down her left arm and upper inner portion of her right arm in the muscle. Throbbing pain in anterior lower legs, extreme fatigue, and dizziness and vertigo
vasculitis in tissue around joints in lt hand;(size of marble) stiff joints in hands;
PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEATY FEVER; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included chemical exposure, and concurrent conditions included morphine allergy, smoker, and chantix allergy, and other pre-existing medical conditions included patient said that the symptoms were similar to what he experienced in 25-JAN-2020, he thinks that he might have had covid back then, he thinks he was asymptomatic and didn't take covid test. The patient experienced drug allergy when treated with varenicline tartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, one total administered on left arm on 22-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the patient experienced sweaty fever, felt like on fire, felt down, chills/feeling cold and On 23-JUN-2021, the patient experienced pain in the right lung and did not sleep well. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty fever, on 23-JUN-2021, was recovering from chills/feeling cold, and pain in the right lung, and the outcome of did not sleep well, felt down and felt like on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651442-Covid-19 vaccine ad26.cov2.s-Sweaty fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
1)Left upper extremity paresthesia-started 6 days after smallpox vaccination, describes as numb and tingling sensation from left mid-clavicular region to left mid-tricept area.  Lasts approximately 1-1.5 hours and has recurred 1-2 times a day. 2)Left lower extremity paresthesia-started 7 days after smallpox vaccination, lasts 5 minutes and has recurred 1-2 times a day 3)Bilateral blurred vision-intermittent episodes that started 8 days after smallpox vaccination. 4)Has also noted several expected side effects from smallpox vaccination:  flu-like symptoms, nausea, headache, supraclavicular lymphadenopathy  ****Patient has family history of multiple sclerosis.  Patient was referred to neurology and has an MRI scheduled.  Not currently on medications.
Pt was released after 15 min of monitoring.  As soon as pt got in her car 9Parking lot is 3 minutes away from vaccination site) Pt developed palpitations (HR:156/min)  Pt drove to the ER (3 blocks away from parking lot)  Pt is currently in the ER, HR between 107-119.
3/30: Left lower abdominal pain, Large gel like diarrhea. diet, 4/2 Formed diarrhea continued. 4/6 Watery diarrhea treated with Immodium. 4/9 small BM, 4/11 Watery diarrhea. 4/12 Virtual visit with Nurse Practitioner who reviewed how to handle diarrhea and constipation . 4/13 started pharmacy health rectal suppositories to avoid constipation-constipation continued with bloated abdominal. 4/14: small BM.
PATIENT RECEIVED IPV # 4. PATIENT ALREADY HAD 3 PREVIOUS DOSES FOR IPV.
3/17/21 around 09:17 face felt hot, had hives on neck and chest , heart felt like it was racing, elevated heart rate B/P 145/117, Benadryl given and transported to emergency department at facility.
woke up today with soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "woke up today with soreness at the injection site". Additional information: woke up today with soreness at the injection site.   The information on the batch/lot number for BNT162b2, BNT162b2 has been requested and will be submitted if and when received.;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. Her physician recommended and prescribed the ZOSTAVAX to the patient for long-term prevention against shingles. On or about 12-MAR-2014, the patient was inoculated with the ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-JUN-2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX vaccine, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Pt has redness around injection site (left arm), a hard knot where injection was given.  Pt also complains of "nerve pain" running down his left arm three weeks after injection (4/23/13).
Fever greater than 103, Rigors, chills, myalgias, headache, local swelling, redness, abd discomfort.
sore skin; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (sore skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN OF SKIN (sore skin). At the time of the report, PAIN OF SKIN (sore skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.