chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Left arm pain; other random pains; sudden eye tearing; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:30 (Lot number: EL1283) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9889, Location of injection: Left arm, Vaccine Administration Time: 08:00 AM), administration date: 31Dec2020, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "Injection site pain". The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Chills"; TINNITUS (non-serious) with onset Jan2021, outcome "recovered" (22Jan2021), described as "Tinnitus"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Left arm pain"; PAIN (non-serious), outcome "recovering", described as "other random pains"; LACRIMATION INCREASED (non-serious), outcome "recovering", described as "sudden eye tearing". Therapeutic measures were taken as a result of lacrimation increased.  Additional Information: Facility type Vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101341429 same reporter/patient/product, different dose/event.
Someone forgot to reconstitute the dose; Someone forgot to reconstitute the dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04 Nov 2022 Reporter's Comment: The reprort from field office manager stated that they just used the last Menveo dose in the box on Wednesday. There was one powder vial remaining.  Someone might have forgot to reconstitute one dose.  Since it was the last one I'm not sure which one of the previous four patients did not receive the correct reconstituted dose.  The reporter was asking what should we do. Information in parenthesis captured upon callback to office manager.  The customer had no details regarding patients or product lot and expiration date. The reporter consent for follow up. The healthcare professionals unsure which one of 4 patients did not received proper reconstituted dose. Additional Supportive Information: The someone forgot to reconstitute the dose and only liquid administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recvd vax in rt arm 10OCT94  & called on 11OCT stating that arm was red & swollen down to elbow; referred to MD; tx w/ keflex;
VACCINE ADMINISTERED AFTER TEMPERATURE EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 25-MAR-2021, 26-MAR-2021, and 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patients experienced vaccine administered after temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after temperature excursion was not reported. This report was non-serious.
This spontaneous report was received from a Licensed Practical Nurse via a company representative, referring to an unspecified number of patients of unknown ages and genders. The medical history or concurrent conditions of the patients were not reported. Between 21-APR-2016 and 22-APR-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route, anatomical sites, lot numbers and expiration dates were not provided. The concomitant medication of the patients was not reported. Additionally, it was reported that the shipment of ZOSTAVAX was inadvertently stored in refrigerator. No adverse effect had been reported and there was not product quality complaint involved. Additional information has been requested.
severe dizziness; nausea; Blood pressure was unusually high during this period; Dehydrated; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm right on 06Apr2021 at 16:00(at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included Stage 3 kidney failure, obesity, idiopathic (likely gluten) peripheral neuropathy, and Raynaud's syndrome. Concomitant medications included pregabalin (LYRICA), losartan (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all from unknown date for unspecified indication. The past drug history was reported that patient had many drugs reaction. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm right on 16Mar2021 at 14:15(at the age of 60-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient was 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 10:00 approximately 32 hours after the vaccination, the patient experienced severe dizziness and nausea and Blood pressure was unusually high during this period. On an unknown date in Apr2021 the patient experienced dehydrated. It was reported approximately 32 hours post vaccine severe dizziness and nausea, had to return to bed. Somewhat improved approx. 8 hours later, could carefully move about. Less severe but remained approximately 6 days. Did continue 3 more days before the patient realized he was dehydrated and that was likely reason it continued. The patient had a history of drug reactions to a great number of medications. The patient was very drug sensitive. Blood pressure was unusually high during this period. The patient did not bother the physician as he never felt anything more than inconvenience after the first day of onset. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of dizziness, nausea, dehydrated and blood pressure high were resolving.   No follow-up attempts are needed. No further information is expected.
Patient gave birth following birth advised to have MMR booster as patient's titers were low. Patient given MMR vaccine following MMR vaccination by 3 days proximally on the 17th patient began to have a rash starting about the high thigh across the body and back but not extending to the arms. Described as mildly pruritic. Patient came into the facility concerned because she is a breast-feeding new mother.
Pt received Bivalent mRNA 5-11yr, Should have received bivalent 12+
RASH AT INJECTION SITE AND PAIN.  PATIENT ALSO DEVELOPED RASH IN THE ABDOMEN THE NEXT DAY.
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient Refused epi-pen.  Most likely anxiety-related event per patient and wife/observation.   EMS showed up to store within 20 minutes; patient was discharged to home and did not follow up with ER.    Spoke with wife at 5PM --patient has been fine all afternoon and went shopping after AE.
Patient given 0.2ml dose of undiluted vaccine.  No side effects or symptoms noted.
Patient reports palm-sized rash on hip after received vaccine on 1/27/14. She reported rash on 2/4/14 to pharmacy and instructed to contact MD.
4-17-12 at approx 1:45 PM gave Tdap as requested by Rx from PMD. 4-17-12 at 3:21 PM husband reported c/o numbness in (L) arm & left jaw. Edema & warmth. Advised notify PMD. BENADRYL ordered. Sx resolved by 10 PM.
Breakthrough bleeding (i'm on birth control), heavy menstrual bleeding with clots unusual for my typically short and slow cycle. Started in June. My second shot was in March. Booster shot nov 7th and very heavy breakthrough bleeding after 3 days of swollen left armpit.
The pt developed varicella lesions on waist on 05/09/2002 spreading to extremities on 05/10/2002. Afebrile, lesions were papular to vesicular and pruritic. Approx. 100 lesions noted.
Information has been received from a healthcare worker concerning a 77 year old female patient with no drug allergies or reactions who on 02-APR-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) into her left arm. Concomitant therapy included aspirin. On  02-APR-2009 the patient experienced severe bruising and pain at the injection site in the upper deltoid area of the left arm. The patient saw physician regarding the sore arm immediately after receiving the injection. At the time of the reporting, the patient was recovering. It was also reported that the patient sought medical attention via pharmacy visit. It was considered to be disabling since the patient was unable to use the left arm and still sore at the injection site. Additional information is not available.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "History of heart surgery" (not ongoing). Concomitant medication(s) included: NOVOLOG; ATORVASTATIN; CILOSTAZOL; METOPROLOL; VASCEPA; AMLODIPINE BESILATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. The patient received treatment as Paxlovid for COVID-19 from 22Jul2022 to 26Jul2022. Received Paxlovid after positive COVID test on 22Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  Medical history, concurrent conditions, or concomitant medication was not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 2012 by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2013, the patient was treated by a physician for a vesicular eruption, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
1ST day of Booster 11/23  symptoms - sore arm, lymph node pain in my left underarm, and body aches. Symptoms lasted for about 3-4 days. Then on 12/7 to present symptoms are - allergic cough (1 day) followed by allergic skin reaction that included itchy hives and rash (arms, hands, legs, feet, face, and back) and also a radiating heat that flares up throughout my body. The radiating heat is felt on the skin and internally.  Additional symptoms are fatigue, nerve pain, Chest pain, abdominal pain, joint pain, and back pain. The symptoms are non-stop and appearing ALL DAY. 24 HRS. IT FEELS LIKE MY BODY IS ON FIRE! IT IS QUITE UNCOMFORTABLE, SCARY, & CONCERNING!
C6-C7 epidural abscess, bacteremia with MSSA. IV antibiotics via PICC upon hospital discharge
(L) triceps region 3x3cm erythema lesion noted (L) axillary lymphadenopathy. Previous Anthrax: 30Jan03/14Mar03
patient developed fever, headache and sore neck within 24 hours of injection; patient developed fever, headache and sore neck within 24 hours of injection; patient developed fever, headache and sore neck within 24 hours of injection; This is a spontaneous report from a contactable physician.  A 17-year-old patient of an unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date at a single dose for immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient developed fever, headache and sore neck within 24 hours of injection. The patient never had a headache like that before.  The outcome of fever and sore neck was recovered on an unspecified date and of headache was recovering.  The physician was unsure whether it was related to Trumenba or not. Added that quite a few of his patients develop headache and fever post injection.   The batch/lot number for the vaccine, TRUMENBA, was not provided and will be requested during follow up.
DTaP given at left upper extremity 08/22/2003.  Reportedly with high fever (103F max), erythema, induration, swelling and limited range of motion within intradermal of vaccine.  Largely resolved when seen 08/29/2003 for follow up.
Patient was given an HPV vaccination at 4:22 PM, approximately 1-2 minutes later after exiting the treatment room, patient's eyes started fluttering and roll and and patient started stumbling and falling to the ground, patient was then helped to the ground. Immediately upon reaching the ground, patient's state started returning to normal and patient tried to sit up. Patient was instructed to remain on his back and his legs were elevated at this time. A code blue was called and a code team responded. Patient was evaluated by code team and a set of vital signs was taken. Patient was not recommended to go to emergency room. Approximately 7-10 minutes after event started, patient was placed in a wheelchair and given a can of soda. Patient was then monitored for another 25 minutes and approximately 35 minutes after event, patient was released and departed hospital with his parents.
11:35 PREVNAR WAS ADMINISTERED (APPROX 2 TO 3 MINS AFTER AFLURIA) 11:36 PATIENT BEGAN COMPLAINING OF HOT ,FLUSHED SENSATION IMMEDIATELY FOLLOWING BY EXCESSIVE SWEATING 11:37 PATIENT BEGINS TO SLUMP IN CHAIR AND PASSES OUT, CONTINUED BREATHING BUT UNRESPONSIVE. COMES TO AFTER  ABOUT 20 SECONDS. THESE SYMPTOMS CONTINUED ALONG WITH NAUSEA/SLIGHT VOMITING FOR ABOUT 45 MINS. 11:55 PATIENT CALLS HUSBAND TO COME PICK HER UP AND EXPLAINS WHAT HAPPENED. 12:56 HUSBAND ARRIVES AND PATIENT IS TAKEN TO VEHICLE IN A WHEEL CHAIR. 3:20 FOLLOW UP CALL TO PATIENT AND SHE WAS MUCH BETTER AND MAKING PLANS TO PICK UP HER VEHICLE. 9-25-2023  10:50AM  FOLLOW UP CALL AND PATIENT TOLD ME WAS DOING FINE.
Headache, Fever, Tachypnea & Tachycardia Narrative:
Presented with normal fever symptoms the day following the shot. However, experienced severe hives, swelling, stiffness, and joint pain around 2 weeks following the shot.
Had the first shingle shot over a year ago / can I get the second shot now?; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on a year and two months ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if he/she could get the second shot now. Follow-up would not be possible, as no contact details were available.
This is a spontaneous report from a noncontactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a rash at the injection site and described it as "itching real bad" and "very painful." The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sudden leg pain below tailbone; Joints really hurt; Pain around 17:30; Was sick day after vaccination, then ok most of day; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04May2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 05May2021, the patient was sick day after vaccination, then ok most of day. On 06May2021 at 17:30, the patient experienced sudden leg pain below tailbone, joints really hurt and had pain. The clinical outcome of the events sudden leg pain below tailbone, joints really hurt and was sick day after vaccination, then ok most of day and pain around 17:30 was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 days after receiving the second moderna vaccine my father experienced a stroke. He was transported to the emergency room  medical center where he went thru a procedure to remove a clot in his left side brain. Prior to this vaccine my father was in good health and was very active and still works and owns and operates a restaurant. He has never had any problems like this before the vaccine. One day after the vaccine he was complaining about a pain on the left side of his neck area. He was doing paperwork at approx 7:40pm when he experienced the stroke. I had to call 911.  My father is currently at the medical center recovering from the incident.
Chills; Backache; Fever; Swelling; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06May2021 at 11:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 07May2021, the patient experienced fever, chills, backache, swelling and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, backache, swelling and soreness were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (08Jul2022) Positive; (09Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: Rapid testing on 08Jul2022 showed faint positive, but was solid positive on 09Jul2022. Sore throat, nasal congestion, cough, and watery eyes flared up on 09Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient started getting bumps on his back in November. Was unsure what they were but they slowly started to spread. On December 12, 2017 I took him to the doctor to find out what they were. Diagnosis molluscum warts. Doctor treated in office with Cantharidin. Patient had a reaction to the medicine about 2 hours later started screaming and crying that his skin hurt. He ended up having a reaction to the medicine and got these horrible painful blisters all over his body we had to go to the ER. Molluscum warts are also called the pox virus. Patient would have been better off getting chicken pox instead of these horrible warts. Online research a number of parents wrote that their children ended up getting these warts after the chicken pox vaccine. These warts could last up to a year! Still recovering from the blisters but warts still popping up here and there on his body.