chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to an 8-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 27-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Since receiving the moderna vaccine, I have not obtained a positive ovulation test during any of my following menstrual cycles, despite obtaining regular positive ovulation tests during my cycles preceding the vaccine, with the one exception of no positive ovulation test during the cycle in which I contracted and was recovering from covid. My menstrual cycles have also been atypical for me in terms of length and pms symptoms; my cycle historically is around 38-45 days long, but after the first dose of moderna, my cycle was only 29 days long, and after the second dose, it was only 22 days long. I had much more noticeable physical symptoms of pms such as chest/breast tenderness, intense cramping, and during my period, a heavier flow with brighter red blood. My cycle length has still remained shorter than before the vaccine, at about 31 days long.  I am continuing to track my cycles, as I?ve been doing for almost a year now, and testing for ovulation beginning on the recommended day 12 of my cycles. Additionally, I was prescribed a five pill course of Clomid beginning on day 5 of my current cycle, as an attempt to induce ovulation. As of today, day 16 of my cycle, I have not yet ovulated.
Initial report received from a healthcare professional on 27 August 2013. A 24-year-old female patient had received an intramuscular 0.5 ml dose of ADACEL vaccine (lot number C4313AA, expiry date- 3/22/15, dose number-not reported) in the right deltoid on 27 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 13 January 2013 and the estimated date of delivery was 20 October 2013. The patient's health during pregnancy, risk factors (e.g. alcohol, tobacco or recreational drugs), concomitant medications and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by the sender: none.
WITHIN A COUPLE MINUTES OF RECEIVING MODERNA VACCINATION IN HER LEFT ARM, PATIENT APPEARED TO SEIZE ON THE SAME SIDE OF HER BODY AS THE SHOT WAS GIVEN (LEFT). SHE APPEARED TO GO PALE AND STATED SHE WANTED TO LAY DOWN. SHE WAS LOWERED TO THE GROUND, 911 CALLED AND ADMINISTERED 50 MG DOSE OF BENADRYL IM. WITHIN A FEW MINUTES PATIENT APPEARED TO LOOK BETTER. CHECKED BLOOD PRESSURE 119/80 HR 142. PARAMEDICS CAME AND SHE STATED SHE WAS FINE. THE DID NOT STAY LONG TO EVALUATE HER. PATIENT CALLED FRIEND TO PICK HER UP AS WE DID NOT FEEL COMFORTABLE WITH HER DRIVING.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age. Between 05-NOV-2015 and 11-NOV-2015, the patients were vaccinated with improperly stored M-M-R II (lot # L002242, expiration date 21-JAN-2017, strength, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient started wheezing and collapsed.  She was initially treated for asthma but had never had asthma before.  She spent one night in the ICU and 4 days total in hospital.  Her left arm stopped working after the 5 day.  She was later diagnosed with Transverse Myelitis.  It is now thought that the location of her spnal cord injury caused her respiratory distress.
Within 24 hours of Shingles vaccines, I experienced a red rash from neck to torso  in addition to the mild flu symptoms (head ache, fatigue, body pain).  I did not get medical attention because the rash did not extend to my face and mouth, but I was concerned.
syncope onset within minutes of vaccination. no injuries. patient recovered within 20 minutes with no treatment needed beyond monitoring symptoms and BP. Also experienced Flushing, sweating
Shoulder joint pain after administration of flu vaccine. Patient stated that she does have arthritis, but feels this pain is from the vaccination.  Patient's symptoms did not improve and has since gone to see a physician for it.  Patient stated she is in therapy as a result.  She did not state a time course, just that it has been ongoing.
I began to feel unwell 12 hours after receiving the 2nd dose of the vaccine.  I started to notice swelling in my extremities.  My ankles, feet and legs and some on the top of my hands.  I confirmed with others in my family that I wasn't imagining the swelling.   I did reach out to my PCP and was seen on 3/25/21.
Developed redness around vaccine site 1 day after immunization. Local reaction versus ltd reaction versus cellulitis. Clinds given x 7 days.
Pt c/o lightheadedness and sweating after receiving Janssen Covid vaccine.  She was alert and oriented X3. RN escorted patient to EMS room via wheelchair. BP: 105/58, P;67, R:18. O2 Sat 98 percent on RA. Snacks and water were offered to patient. After lying down for 20 minutes, patient reported feeling better, Patient left the clinic at 1357 without any complications.
On 5/5/03 Pt received DTaP, LD/IM and MMR Larm/SQ. On 5/6/03 in AM grandmother noted pt's left upper arm to be red, warm, swollen and hard (as stated by grandmother). No other Sx's since vaccinations received. Warm moist compresses applied and Tylenol given for comfort by grandmother as needed. Pt denies any complaints of pain to left arm today. Area of erythema 6 cm long x 5 cm wide. Area swollen and semi-firm. No other Sxs noted today.
heart showed calcification; light headedness; Itching; Redness; Bothers Ear rings a lot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), DISCOMFORT (Bothers Ear rings a lot), ARTERIOSCLEROSIS CORONARY ARTERY (heart showed calcification) and DIZZINESS (light headedness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 04-Mar-2021, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), DISCOMFORT (Bothers Ear rings a lot) and DIZZINESS (light headedness). On an unknown date, the patient experienced ARTERIOSCLEROSIS CORONARY ARTERY (heart showed calcification). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness), DISCOMFORT (Bothers Ear rings a lot), ARTERIOSCLEROSIS CORONARY ARTERY (heart showed calcification) and DIZZINESS (light headedness) outcome was unknown.            Concomitant medication was not provided by the reporter. Treatment details included Applied scented oil on the arm.
Neck was numb after 1st booster; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Neck was numb after 1st booster) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 019B21A and 014M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included Neuropathy (feet and legs, from kneed down) in 2012. Concurrent medical conditions included Drug allergy (Aspirin) and Type II diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPOAESTHESIA (Neck was numb after 1st booster). At the time of the report, HYPOAESTHESIA (Neck was numb after 1st booster) had not resolved.      Other concomitant medication included Mylan 26 Units (1 a day). It was reported that, the 1 week after receiving the vaccine, neck was numb after 1st booster.  No treatment medication was reported.  This case was linked to MOD-2022-648121 (Patient Link).
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-month-old female patient who received HBV (Engerix B pediatric) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 6th June 2022, the patient received Engerix B pediatric. On 6th June 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: The reporter administered an expired dose of ENGERIX B PEDS to a patient. No symptoms reporter. Reporter did not provide prescriber information for follow up. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered an expired dose of the Engerix B pediatric which led to expired vaccine used.
Body aches; Fatigue; Feeling cold occurred about 2 weeks after 2nd shot and again last night (4/9/21). Symptoms disappeared by next day; This is a spontaneous report from a contactable consumer, the patient. An 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 19:30 as a single dose for COVID-19 immunisation. Medical history included bronchiectasis and acid reflux (esophageal). The patient had no known allergies to medications, food or other products. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) and Ipratropium bromide (DUONEB) all for unknown indications, from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 22Feb2021 at 16:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 the patient experienced body aches, fatigue, feeling cold occurred about 2 weeks after 2nd shot and again last night (09Apr2021). Symptoms disappeared by next day. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, fatigue, feeling cold occurred about 2 weeks after 2nd shot and again last night (09Apr2021) were recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
45 min after vaccination I got the chills. Throughout the night (within a few hours of vaccine) I had chills and extreme soreness to arm. Next morning I woke up with chills, terrible headache/migraine, high fever up to 103.3, cough, aches, neck and back pain, nausea, and vomited one time. No Tylenol or Motrin would break my fever all day long.
Fever 103 10/2/06, ataxia, c/o eye hurting, c/o upper thigh pain.
Patient was vaccinated with first shot of Pfizer, he was previously vaccinated with both doses of Moderna back in March.
Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic doctor told me it was not related to the vaccine and it could be inflammation and suggested to make an appointment with my cardiologist, I wanted to let you know what I experienced, I respect my health professional's opinion.
Intense left arm pain awakening me from sleep, fever 101.4, unable to hold down food or water, slept for almost 24 hours, could not go into work on 1/8/21.
Within 10 minutes of receiving FLUVIRIN 2011-2012 patient complained of headache/pressure & her throat tightening. Patient was given 1 dose of EPIPEN 0.3 mg.
On May 3rd I broke out in a rash on the inside of both legs under the knee area.  The rash is raised from the skin and pink in color.  It itches and burns.
Parent called clinic at approximately 5pm to report that patient was experiencing inflamed painful axillary "lymph nodes" and small "red spots" about the size of a pencil eraser on her torso front and back. Spot were not fluid filled or pruritus but patient reports they are very painful. Clinic manager called the parent the next day. Parent indicated that symptoms were not getting any worse and may be getting better. Parent agreed to call Clinic Manager in the event that the symptoms did not resolve in the next 1-2 days.
Information has been received from a physician concerning a 62 year old male patient with left hemiplegia and a history of stroke several years ago who on 06/07/2006 was vaccinated IM in the the left upper arm with his second dose of pneumococcal 23v polysaccharide vaccine (lot #650835/0966P, batch #nb29850). A few hours post vaccination the patient developed an injection site reaction with redness and warmth. In the evening the symptoms worsened and he developed swelling of the whole arm down to the fingers. Voltaren bandings and cooling were administered. It was noted that the patient's first vaccination in 1999 was well tolerated. At the time of the report his symptoms were ongoing. No product quality complaint was involved. Additional information has been requested. Other business partner numbers included E2006-092996. The reporter considered injection site reaction, redness, sensation of heat, and large arm swelling to be other important medical events. (OMIC)
This is a spontaneous report from a contactable nurse. This nurse reported that a 12-year-old male patient, had received PREVNAR on unknown date and other vaccines in the past. Relevant medical history and concomitant medication were unknown The patient has now undergone a bone marrow transplant on unknown date. The clinical outcome of the event is unknown.
Received expired second dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received- Patient, product and reporter HP details added,
pt recv vax;became nauseated & began v;v persisted 8-10 hrs;afebrile;tenderness at inject site;to MD who felt unrelated to vax;24 hrs later no longer v & is reported to be feeling better;no oth side effects devel;
patient was administered DT today instead of Td, with no reported adverse evet; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 79 years old female patient who was administered DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE today instead of td, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-APR-2023 (latency: same day) the reporter reported a non-serious patient was administered dt today instead of td, with no reported adverse evet (wrong product administered) in the right deltoid (with lot C5864AA, dose 0.5 mL, 1X, expiry date 07-APR-2023, unknown strength, formulation, route) for wound treatment.  No relevant lab data was reported.  Action taken: Not Applicable.  Outcome: Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mom called our nurse advice line and reported that right bicep had a area "the same diameter as an orange" that was red and itchy; no fever; no hives; had immunizations on 2/5/08.  Nurse followed immunization protocol.
experiencing their arm being sore and swollen; experiencing their arm being sore and swollen; itchiness; redness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (experiencing their arm being sore and swollen), PERIPHERAL SWELLING (experiencing their arm being sore and swollen), PRURITUS (itchiness) and ERYTHEMA (redness) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (experiencing their arm being sore and swollen), PERIPHERAL SWELLING (experiencing their arm being sore and swollen), PRURITUS (itchiness) and ERYTHEMA (redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experiencing their arm being sore and swollen), PERIPHERAL SWELLING (experiencing their arm being sore and swollen), PRURITUS (itchiness) and ERYTHEMA (redness) outcome was unknown.            No concomitant product reported by reporter. From few days ago, patient was having some reactions due to the vaccine.  Patient had put hydrocortisone in affected area as treatment medication.
got shingles vaccine and got shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got the vaccine a few years back and developed shingles 8 months later. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sever hip and lower back pain requiring tele visit with who then sent me to  urgent care. Sever pain and discomfort lasted for 6 days straight with no relief from NSAIDS, heat, or ice, or muscle relaxers. Pain persisted non stop for 6 days and was excruciating. For females viewing this, worse than back labor that wouldn?t stop. Urgent care informed me joint pain was from vaccine.
This spontaneous report was received from a medical student (a certified medical assistant) referring to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies. On 28-MAR-2017, the patient was vaccinated with ROTATEQ oral (lot # M018958 and expiration date 03-MAR-2018) for an unknown indication (dose and strength were not reported). This vaccine had a temperature excursion of 50 Fahrenheit degrees (°F) (the range was from 47 °F to 77 °F) for 48 hours.  No previous temperature excursions were reported and a data logger was involved. No adverse effects were reported and no further information was provided. The reporter also mentioned that the products were not administered to other patients since the time of the excursion. Additional information has been requested.
Pt reports inability to swallow liquids or solids immediately after injection until seen in ED the following day, cough and shortness of breath 9 hours after vaccination. Also w/ fever.
This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with ROTATEQ suspension 2 (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.