chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; adult patient decided to refuse these doses after they were drawn up for unknown reasons; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-SEP-2020 (reported as yesterday), the patient came in for next planned dose in series of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # S038698, expiration date: 01-DEC-2021 (strength and route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) subcutaneous injection, 0.5 ml, lot # S029456, expiration date: 19-SEP-2021 (strength and route of administration were not reported). The patient decided to refuse these doses after they were drawn up for unknown reasons (inappropriate schedule of product administration). No additional adverse events were reported.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored M-M-R II (dose, strength, route of administration and expiry date were not reported) lot # reported as K010211. On the same day, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # K010211, (dose, strength, route of administration and expiry date were not reported). No adverse events were reported. The reason for the temperature excursion was because daily vaccine counts cause the storage unit to have temperature fluctuations because of door opening. Lot # K01011 has been verified as non-valid lot # for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence has been received.
2 Months old infant appeared sluggish, in a deep sleep and required stimulation for 20-25 minutes.  Event occured 1 1/2 - 2 hrs after DTP/OPV immunization.
When i lift my arm, I get a quick shooting pain.  I lower my arm and raise it again.  The second time, the pain is less and I can lift it.  I thought it was normal soreness at first, but it hasn't gone away.  I got the 2nd shot a month later and now my right arm does the same thing, although not as bad.   Also, my shins just below my knees have started to hurt when I first stand up.  Just lasts a few minutes, then goes away.  I don't know if it is related, but wanted to mention it incase this has happened with other people.
Has not got second shot after 70 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not got second shot after 70 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not got second shot after 70 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not got second shot after 70 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.
Fever around 100F for 10 consecutive days, fatigue for 10 consecutive days, intermittent headache and intermittent nausea (no vomiting) for 10 consecutive days.
sore right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 007B21A, 091D21A and 025L21B) for COVID-19 prophylaxis.     The patient's past medical history included Cardiac disorder. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right arm injection site). At the time of the report, VACCINATION SITE PAIN (sore right arm injection site) outcome was unknown.            Patient received other vaccines 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient experienced sore right arm injection site after the first two doses of 19-Mar-2021 and 23-Apr-2021 and did not had any adverse reaction after later two doses of 15-Aug-2021 and 22-Jan-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727708 (E2B Linked Report). This case was linked to MOD-2023-727708 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727708:Bivalent Dose
Imm admin 9/18/03 DTaP, HIB, IPV, MMR, varicella. 9/20/03 L thigh with red rash, pain 9/22/03 L thigh painful rash 4" wide covering febrile sent home from school by nurse. 9/24/03 rash fading-Benadryl given by mother 9/22/03-ice pack placed on thigh.
SERIOUS HEART PROBLEM; This spontaneous report received from a consumer via a company representative concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy until vaccination. The patient had 3 para and 3 gravida. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced serious heart problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious heart problem was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Patient had a fever and didn't feel well. He tested positive for COVID-19 with a rapid test.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date unknown) for prophylaxis. On 18th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and injection site erythema. On 18th September 2018, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site swelling, injection site pain and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that, the patient received SHINGRIX closer to the back of her left arm and not in her deltoid, which led to vaccine administered at inappropriate site. The health care professional was not sure if this was given subcutaneous but thought it might had, which led to inappropriate route of vaccination.
fatigue; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (Fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MOMETASONE FUROATE (NASONEX), OMEPRAZOLE, METFORMIN, ROSUVASTATIN CALCIUM (CRESTOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATENOLOL for an unknown indication.    On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, FATIGUE (fatigue) had resolved and HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            Treatment medication includes Antibiotics
pt recvd vax; delayed local rxn 4 days p/ dose 1; red raised area 10 x 16 mm; small local rxn p/ dose 2;
No additional AE; temperature excursion on PROQUAD; This spontaneous report has been received from a medical assistant referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported.    On 10-MAY-2021, the patient was vaccinated with temperature excursion dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, route of administration and anatomical location were not provided, lot number U002535 has been verified to be a valid lot number, expiration date reported as 24-JUL-2022) for prophylaxis (product storage error). The vaccine underwent temperature excursion at -10.8 degree Celsius (C) for 1 hours 45 minutes. It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2105USA003786: US-009507513-2105USA004015: US-009507513-2106USA001126:
Information has been received from a physician's office concerning a 20 year old female, who on 14-MAY-2007 was vaccinated with a dose of Gardasil. Subsequently. on the same day as the vaccination the patient experienced pain in her arm. It was noted that the injection was given to the patient in the wrong position of the arm said to be too interiorly. The patient sought unspecified medical attention. At the time of the report, the patients outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Soreness at the injection site; Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (wine twice a night) in August 2020 and Pregnancy (Live, full-term birth No complications) in August 2019. Concurrent medical conditions included Food allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) from 24-Nov-2020 to an unknown date for an unknown indication.    On 29-Dec-2020 at 9:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Aug-2020 and the estimated date of delivery was 18-May-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 29-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) 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.   Treatment medication use was not provided by the reporter. Patient have already done all the screening, first trimester and second trimester screening for my baby, so far everything is looking good.  Company Comment: This is a case of product exposure during pregnancy and Injection site pain. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2020: No specific follow-up information recorded. On 29-Dec-2020: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy and Injection site pain. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Received vaccine 2/2/21 at 9 PM, began feeling major pain and swelling at injection site at around 12 AM. Took 500 mg Tylenol  On 2/3/21 around 3 PM began feeling extremely fatigued and had a migraine. At around 5 PM began feeling nauseous and dizzy and at around 7 PM began to have body aches. Took temperature later at 11 PM and got 100.8 F. Believe I had above 101 earlier in the day. Took 1000 mg tylenol before bed. Throughout the night woke up multiple times drenched in sweat and had hot and cold chills. Arm pain is getting better though.
ADMIN HPV AND TDAP VACCINE, WITHIN ONE MIN OF ADMIN CHILD FAINTED INTO FATHERS ARMS, PT OBSERVED FOR 15 ADDITIONAL MIN WITH NO PROBLEMS. VITALS WNL. This is in follo-up to report (s) previously submitted on 10/12/2007. Information has been received from a registered nurse concerning a 15 year old female with no medical history or allergies who on 18-JUN-2007 was vaccinated IM into the left deltoid with a first 0.5 ml dose of GARDASIL (lot# 657622/0388U). Concomitant medication given IM into the left deltoid included the first dose of ADACEL (batch c2632AA). Approximately one minute after getting the vaccine the patient fainted for a few seconds. The patient was observed in the office for 15 minutes and fully recovered. Unspecified medical attention was sought and no treatment was needed. No diagnostic laboratory studies were performed. It was reported that the patient was vaccinated with a second dose of the vaccine on 20-AUG-2007 amd experienced no events. No quality complaint was involved. Additional information is not expected.
PATIENT WAS ADMINISTERED FLU SHOT AND LEFT PHARMACY ARE WITH HER MOM.  SHE FELT DIZZY AND BEGIN TO FAINT.  HER MOM HELD HER AS SHE FELL TO FLOOR.  SHE DID NOT HIT HER HEAD AND DID NOT LOOSE CONSCIOUSNESS.  SHE FELT QUEEZY. SHE WAS EVALUATED BY EMS AT STORE AND WAS RELEASED TO GO HOME FROM STORE. I CALLED AND CHECKED ON HER AT 5:38 PM THIS AFTERNOON AND HER MOM REPORTED SHE WAS FEELING FINE AND WATCHING TELEVISION IN HER ROOM
High fever; Chills; Shaking; Extreme muscle pain; Painful swollen lymph node in armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 08:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 20:00, the patient experienced shaking, high fever, chills, extreme muscle pain and painful swollen lymph node in armpit. The events did not result in 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 the events shaking, high fever, chills, extreme muscle pain and painful swollen lymph node in armpit was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Beginning in mid-April, I had conjunctivitis a few different days over the course of about three weeks. All occurrences happened after starting Lexapro for depression and anxiety on April 10th. The conjunctivitis was usually accompanied by a mild headache, for which I took Tylenol. I was also experiencing mild heart palpitations most mornings. On April 29th, the conjunctivitis got very intense and was accompanied by severe photophobia, blurred vision, and heart palpitations beginning in the afternoon. I eventually ended up going to the ER around 11:00pm that night. At the ER, I was given an EKG, urine and blood tests, all of which came back normal. I was diagnosed with allergic conjunctivitis, given a Benadryl and told to start Zyrtec. The blurred vision did not resolve and I was unable to drive to work. The photophobia still remained and looking at screens was painful. On May 4th, I had a virtual visit with my primary care physician where we decided to take ease me off of the Lexapro. This resolved the heart palpitations once I was fully off of the medication. Also on May 4th, I visited my eye doctor, who prescribed steroid eye drops for 10 days for allergic conjunctivitis, which eventually cleared up the  blurred vision after several days, allowing me to return to work on May 10th. A follow-up with my primary care physician on May 24th resulted in marking Lexapro as an allergy. She offered trying a different anti-depressant, but I declined for now. Since then, all severe symptoms have resolved, but my eyes are still dry and I have been trying various eye drops ever since. I visited an allergist and my eye doctor in July, and the allergist performed a skin test. All seasonal allergens and cats came back negative. The eye doctor found I'm still experiencing some allergic conjunctivitis in my left eye, and both eyes are moderately dry. He suggested trying a few different treatments for dry eyes and getting a new glasses prescription, which I am in the middle of now. The new glasses seem to be helping some, but the dry eyes are still persisting.
Fever of 101.8 which led to runny nose, cough, loss of appetite and hospitalization for severe dehydration and ear infection.
Patient was given undiluted Pediatric Pfizer 0.2ml IM right deltoid. Nurse was unaware of event until after patient left Clinic. Patient was observed for 15 minutes with no reaction. Nurse reported event to Nurse Supervisor @ 2:53pm. Nurse Supervisor reported to Clinical Director @ 2:56 pm, then State Nursing Director @ 3:00pm. Pfizer was called @ 3:05pm and guidance received for patient treatment @ 3:50pm. MD was called  and given/ faxed report from Pfizer. Nurse Supervisor then called patient's father using Services. Parent informed of event and possible complications, patient doing well as stated by father. Father verbalized understanding.
Rash located all over the body and feet. Fever noted (102 deg. F.) pm of day of immunization. Noticed the rash the next morning with itching. Dissipated on 03/15/20002 as well as rash. Restarted on 03/17/2002 pm on face and chest, no fever.
Patient complains of pain at injection site, pain shooting up her neck for 2 weeks following vaccine, tingling sensation at injection site, pain that continues at injection site and has limited her adls/iadls
Pt states 24 hours after injection, site began to get painful with a burning sensation and itchy.
Patient received an adult dose of the Hep A vaccine- Vaqta. Patients father was notified and to watch for adverse reaction that were stated on the VIS given at time of injection. Father reported patient is feeling fine and no symptoms/ side effects noted. Advised father to watch patient for 24 hours for adverse side effects.
4 Days after vaccine, mild to increasing  dizziness, vertigo, ringing in ears (tinnitus), resulting in going to hospital 1 week after first vaccine with extreme dizziness, vomiting, tinnitus. Loss of hearing in left ear going from no hearing to minimal hearing over 10 weeks.  2 hospital visits (one 7 days after first vaccine, 2nd one 4 weeks after 2nd vaccine. Prescribed Meclizine. 10 weeks since first vaccine. Still experiencing extreme dizziness, vertigo, tinnitus, loss of hearing in left ear. First vaccine 01/22/2021 Second vaccine 02/12/2021
Vaccine administered patient became faint. Lost consciousness and was rigid. Regained consciousness in less than a minute. Said was fine we kept him on site for 15 more minutes.
3/29/21 ER HPI: 68 y.o. female who presents with 3 day history of left anterior chest pain.  The pain radiates into her back.  Pain has been constant and severe at times.  It has no relieving or exacerbating factors.  Patient denies fever chills cough dyspnea diaphoresis nausea or vomiting.  She denies prior similar history.  Patient has taken nothing for the pain 4/2/21 ER presentation - flexed to clinic 4/2/21 Clinic HPI: 68 y.o. female who presents today for suspected shingles vs laceration that is infection on her L posterior back. She was seen in the ER for anterior chest wall pain on 03/29 which had started 3 days prior and then saw Dr. again yesterday for follow-up.  He gave her a steroid shot and treated her with oral prednisone.  In the ER, patient had elevated D-dimer but this was thought to be from her renal insufficiency.  She had no other symptoms that suggested pulmonary embolism.  No CT angiography of chest was done due to renal insufficiency.The rest of her workup was negative. Rash broke out the day she saw Dr. but didn't mention it to him at that visit. There was no rash on her anterior chest wall where she was hurting at the time.
Erythematous papular rash (B) thigh (site of injections) within 24 hours of administration -> looks allergic. Not infections treatment as allergic dermatitis.