chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received her Moderna booster along with influenza vaccine at the Vaccine event on Sunday 11/14. About 8 minutes after her vaccinations, pt reported feeling dryness of her buccal mucosa, along with sensation of her tongue swelling. Physical exam WNL, airway patent. HR ranging from 60-70's. Lungs clear to auscultation. No signs of respiratory distress or compromise. Pt agreed to taking Benadryl 25mg PO and drinking water. About 10 minutes after Benadryl, pt reported feeling much better, but still with some mucosal dryness. All VSS. Patient alert and oriented. We agreed that pt would seek medical attention if any symptoms worsened.
doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications or previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: Digital Data Logger), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. Other suspected therapy included the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, since it was unknown if it was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 F), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the digital data logger.  No additional adverse symptoms were reported.  This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005516: US-009507513-2001USA005520:
shingles; septic arthritis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-DEC-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from septic arthritis in the shoulder, and a painful blistering rash. As a result of these symptoms, the patient was seen and treated by medical providers, diagnosed with shingles and septic arthritis. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, septic arthritis was considered to be medically significant. The lawyer considered both events to be disability.
Went to the Emergency Room, Not breathing, CPR and Difibrilation performed. Cardiac Heart Attack. Hospitalized for 11 days 4 intensive care.
She was a little warm before going to bed, and woke up 30 mins later with a seizure. Seizure lasted for 10-20 seconds and she was not responsive afterwards (eyes open but not responsive) for about 3 mins. Her lips turned blue. We called 911 and she threw up on the ambulance. Her temperature was a little over 102 measured at hospital. She had Tylenol and temperature went down to about 100 degrees and we were discharged. We gave her Tylenol and Advil alternatively every 3-4 hrs at home. She still has low fever.
While this first vaccine gave no side effects other than a slightly sore arm, 17 days later on 4-17-2021 I suffered a TIA (Transcient Ischemic Attack). That occurred at 5:15 pm and I immediately took 4-81 mg aspirin and headed for a nearby Emergency Room. They said it was a stroke (and it did show on an MRI the next day but sub-centimeter and I was told the size of a pinhead. AT the ER the double vision in my left eye and numbness in left lips, gum and tongue were already subsiding, but the DR there gave me a Plavix and within 5 minutes I was completely back to normal (or close). I am not sure IF that first dose of vaccine had anytrhing to do with this TIA, but it might have? I had also stopped taking my 81mg aspirin several days before this TIA as I had a Periodontal appointment for insertion of an implant post and wanted to control the possible bleeding. The thoughts of my Doctor at Hospital  as well as the Neurologists was that the omission of the aspirin PROBABLY was the main cause of the temporary clotting that caused this event HOWEVER I did not tell them that I was 17 days post-Covid Pfizer vax #1 and so the possibility remains that the vaccine could have  been partially the cause of this event? As listed previously, Dr at Hospital was my Doctor and might shed some light on this and her thoughts. I felt it was important enough to report as I have heard stories of all of the vaccines possibly causing some clotting and this might fit.
On the second day, I experienced nausea, felt tired, general aches and pains, a headache, shivering, fever, stomach pain and constipation. That went on all day on the second and third days. On the fourth day, today as I write, the symptoms were reduced to stomach pain and difficult bowel movement. Some shivering and fever but much less than prior two days.
Smallpox vaccination. Within 2 days, developed single right enlarged and tender axillary node. 9 days later, pronounced erythematous ring appeared around vaccination site with cellulitis-like streaking down right shoulder to enlarged node site. Afebrile. Non-acute appearing otherwise.
This spontaneous report as received from a Doctor of pharmacy refers to a 67 years old female patient with a history of allergies and no known drug reactions. On 08-AUG-2012, the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX. The pharmacist reported that on 09-AUG-2012 the patient experienced redness and itchiness at injection site after receiving ZOSTAVAX the patient sought medical attention by calling the pharmacist. No treatment for the adverse event was given. Laboratory and diagnostics were not performed. The outcome of itchiness at injection site and redness at injection site was reported as not recovered. Additional information is not expected.
Imp having pins and needles from where injection on right shoulder. Going from their up my neck on right Side. Started out soon and now it's totally very frequent. My right legs feels weak and foot hurts to walk
Low grade fever off and on ever since the night she had the vaccine and is still having fever, chills, body aches, bone pain as well as leg pain.
Nausea; vomiting; diarrhea; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EH9899), via an unspecified route of administration at arm left on 16Dec2020 at 12:30 at single dose for immunization.  Medical history included hyperlipidemia from an unknown date and unknown if ongoing.  Concomitant medication included rosuvastatin calcium (CRESTOR) and finasteride. On 16Dec2020 at 22:30, the patient experienced nausea, vomiting and diarrhea. The patient outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 08-JUL-2015, the patient was vaccinated with an expired dose of GARDASIL (lot # H020901, expiry date 05-JUL-2015) 0.5 ml, intramuscularly. No adverse effects were reported. The outcome of expired product administered was unknown. Additional information has been requested.
Patient was given child's dose of Pfizer. Patient was supposed to get Pfizer bivalent booster teen/adult dose. Patient unable to be reached but will try again to notify that they should come in to get full dose of Pfizer bivalent vaccine.
sore throat, cough, sinus congestion, nasal congestion, post nasal drainage, sneezing, itchy eyes, ear fullness. starting on 11/8/21
Headache, nausea, vomiting, tightness in chest, coughing - in that order?.Had Moderna vaccine.
eyes rolled back, fainted, extremities stiffened and slightly shook, sweating, nausea, numbness of extremities.  pt reported that she had vomiting for 10 days following first injection.  paramedics assessed her. she left on her own with her spouse.  follow up the next day, she stated she had a headache when she went home continuing into the following day and feeling weak and fatigued the following day.
Patient presented to ER on 01/18/2021 and stated respiratory symptoms began on 01/14/2021.  Positive Covid test that day.  Patient was released from ER and admitted as inpatient to the hospital on 01/23/2021 and expired of Covid related symptoms on 02/02/2021.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 12th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
Employee presented to employee health office today. Had received 2nd COVID booster 4/25/22 at 1100 in left deltoid. States he experienced soreness around the injection site in the first few days which never went away and progressed, now affecting his left shoulder (anterior and scapula area). Shoulder pain began5/7/22. States he did not experience redness at the injection site or any other symptoms. Stated he does not have limited ROM, but that certain movements hurt. He also stated that last night he noticed his muscles felt like they were in knots across upper back into right side. States he saw PCP, Dr, yesterday due to a new right knee issue and he examined his left shoulder and told him he thought the shot may have inflamed his nerves and tendons. He states he broke down and took an Aleve last night, even though he is not supposed to due to kidney problems, to get relief.
back of my head was tingly/a constant feeling of a tingling sensation in my head almost; my motor function was off; speech had an impediment; digestive issues; mucus eyes; I felt a little out of it; tired; headaches; legs are shaky; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. On an unspecified date the patient experienced back of my head was tingly/a constant feeling of a tingling sensation in my head almost, my motor function was off, speech had an impediment, digestive issues, mucus eyes, I felt a little out of it, tired, headaches and legs are shaky. The patient called to report side effects from one of the shots and the course was reported as follows: "The side effects started mild and then went severe. The day after my shot I started experiencing digestive issues and mucus eyes. I felt a little out of it, not terrible. It lasted 5 days to a week. I felt fine for about a week and then I woke up almost two weeks after and the back of my head was tingly, my motor function was off, speech had an impediment, and I did not have control over my body, could not talk right for about 2 days. I lost control over my whole body for about 30 seconds. I still have a constant feeling of a tingling sensation in my head almost and something just is not right when I try to talk. There is a disconnect between my brain and my mouth. I am very tired, nowhere near the energy I used to have. I get random pounding headaches like someone hits me in the head with a bat, other days my legs are shaky. It is off and on. It is not constant, but it is consistent. I got rushed to the hospital but there was no sign of a stroke." The patient inquired as to how long should he expect these symptoms to last. The clinical outcomes of the events back of my head was tingly/a constant feeling of a tingling sensation in my head almost, my motor function was off, speech had an impediment, digestive issues, mucus eyes, I felt a little out of it, tired, headaches and legs are shaky were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Itching and redness over majority of body. Reported to person who gave injection, and she said to go home and take Benadryl. 50 mg Benadryl taken three times 6 hours apart. Redness is subsiding, still itchy at 8:45am on 09/15/2021
headache; mild intermittent fatigue; This is a spontaneous report from a non-contactable consumer (patient himself). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), intramuscularly in left arm on 07Feb2021 11:30 AM at single dose for COVID-19 immunization in facility type other. The patient's medical history included heart disease, type 2 diabetes mellitus, throat cancer. The patient did not have allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) at 40 mg daily, clopidogrel bisulfate (PLAVIX) at 75 mg daily, metformin at 500 mg daily, lisinopril at 5 mg daily, ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (CENTRUM FORTE) at 1 DF (Dosage Form) daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 07Feb2021 13:00, the patient experienced headache post dose x 1-2 hours (resolved after taking a short nap) and mild intermittent fatigue post dose x 4 days (recovering). The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the event headache was resolved on 07Feb2021 and recovering for the other event.   No follow-up attempts are possible. No further information is expected.
On May 19, 2023, I tested positive for COVID-19. On Saturday, my doctor prescribed PAXLOVID. My symptoms are mild. I am isolated. I have fever, achy, fatigue.
disseminated varicella-zoster virus infection; This literature-non-study case was reported in a literature article and describes the occurrence of DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) in a 70-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) (seriousness criteria hospitalization and medically significant). At the time of the report, DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION (disseminated varicella-zoster virus infection) to be related.    No concomitant medications were reported. No treatment information was provided.  Company comment: This case concerns a 70-year-old female patient with no medical history provided who experienced serious unexpected event of Disseminated varicella zoster virus infection which required hospitalization. The event occurred after the first dose of mRNA-1273. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event nor hospitalization details was provided. Causality is confounded with patient's advanced age. The Reporter assessed the event as related to the Company product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 70-year-old female patient with no medical history provided who experienced serious unexpected event of Disseminated varicella zoster virus infection which required hospitalization. The event occurred after the first dose of mRNA-1273. The precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event nor hospitalization details was provided. Causality is confounded with patient's advanced age. The Reporter assessed the event as related to the Company product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient was given a booster dose at the age of 17. Form complete by patient had incorrect DOB listed and patient checked box indicating he was 18 or older.
Expired Havrix administered; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments: The reporter was the daughter of the patient.  The patient was given an expired Havrix vaccine (Expired Drug Used).  The reporter reported that the immunizer said it was okay that it was expired.  Caller believes the Havrix expired 30th September 2022.  The reporter will call her mother to get details and call back when she gets the lot number. The reporter gave no further information until she talks to her mother. The reporter did not give permission to contact the health care professional. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
This spontaneous report was received from a pharmacist via Poison & Drug Center (PDC) regarding a 60 year old male patient. The patient's pertinent medical conditions and concomitant medications were reported as unknown. On 09-DEC-2017, the patient was vaccinated with ZOSTAVAX lot # M032141, 1 syringe once, subcutaneous (strength was reported as unknown), expiry date: 02-OCT-2017 for prophylaxis (expired product administered). It was reported that, the patient did not experience any adverse events. There was no relevant lab data. This is one of the two reports from same reporter.
Raised erythematous welt on left bicep appeared 1 dy ago approx 1 dy after vaccinations. Treatment with CLARITIN 10mg BID and prednisone taper.
Patient received 2nd dose to early per CDC guidelines. Patient's 1st dose was 08/04/2022 and 2nd dose was 08/26/2022, this was 22 days apart.
This spontaneous report as received from a patient of unknown demographics refers to themselves. No concurrent conditions or medical history were provided. On an unknown date (reported as: more than a year ago), the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified) and patient hoped they would never get shingles. No concomitant medications were reported. On 23-MAR-2015 (reported as: of this year), the patient broke out with, according to the patient, a severe case of the shingles. Although the sores had gone away, the consumer left with scarring and was still suffering with the pain at reporting time. The patient reported the pain was unbelievable. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Developed fever, chills, mylagias, and headache on 04/14/2003. then noted 3 red itchy papules/vesicles on back, hip, and calf.
Injection reaction and cellulitis;  about 5 inches by 3 inches and dropped off vaccine by about 2-3 inches.