chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 11-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (which had the lot # M004116, expiration date 12-OCT-2017). Subsequently, on 16-NOV-2016, the patient received the second dose of GARDASIL 9 (which had the lot # M016193, expiration date 24-APR-2018) both for prophylaxis (anatomical site of vaccinations was not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. there was no product quality complaint involved. Additional information has been requested.
Sharp head ache at all various times of the day.  Onset is sharp and seems to go away if I rub where it hurts.  As short as 30 seconds up to 30 minutes.
Pt came in for booster dose. Had wrong date on her vaccination card for second dose. She received booster dose. First dose was given on 4/8/21 and second dose 7/7/21.
They have given a patient ADACEL vaccine which was not suitable for use due to temperature excursion no adverse event; Initial information was received on 13-Jul-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a unknown age/gender of patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] vaccine which was not suitable for use due to temperature excursion no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, a patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength: standard)at dose of 0.5 ml total once (1x) (lot number: U7627AA, expiration date: 16-Dec-2024, route, administration site: Unknown) for immunization (immunisation) which was not suitable for use due to temperature excursion no adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event they have given a patient adacel vaccine which was not suitable for use due to temperature excursion no adverse event.  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 guidelines. 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.
I awoke feeling moderately well, went to the conference I was there to attend, halfway through the conference I started to feel unwell and left. Once I got back to my room, I tested with a home COVID-19 test that came back positive, I have a fever, congestion with bloody crusting, cough, fatigue. My fever finally broke by day five and I was testing negative by that day also. My wife and I stayed in quarantine the whole time we were overseas for the conference. Once home we tested positive for the flu in December, and I was able to finally able to get relief from the sinus issue. I am still dealing with a fogginess and fatigue since having COVID-19.
Patient described severe myalgia all over - especially in feet and legs. She said she has been stuck in bed since the afternoon of the day of vaccination. She is just now feeling up to ambulating.
Cellulitus at the site of the immunization, redness and warm to the touch.  Blood sugar also spiked to 405.
Rash at injection site.  On 4/9/12 examined by OHS and rash present at injection site with 7 vesicles.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 03-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 416 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Seriousness Criteria: Other Medically Significant (OMIC). Initial report received on 7/3/06 from a health care professional. A 17 year old female pt had received an ID, left forearm injection of Tubersol 5 TU, lot C23649AA); and an IM, left deltoid, first dose injection of Menactra lot U2107AA. On 7/3/06, within 5 minutes after receiving the tuberculin test, the pt "became pale and passed out for a few seconds". Her blood pressure was 80/60. The pt had no past medical history. Other medications included birth control pills. At the time of this report, recovery status was unknown. Additional info was not provided.
At 1:20pm Patient felt a little flushed and felt little pressure like face is blowing up. Vital was taken BP:150/83, HR:73, Oxygen:97. No EMS. Patient report might have high blood pressure. Patient was observed another 10mins and nurse retake vital BP: 123/83. Patient felt better and cleared by nurse.
Angio edema of face occurring 2 1/2 days after 2nd dose of Japenese Encephalitis vaccine with urticaria of hands at same time.
Patient stated that her right arm was sore from the shot and it radiate pain to her elbow for 7 days.  Patient experienced sight fever.
Hives/Rash; Facial swelling; This is a spontaneous report from non-contactable consumer, the patient. A 62-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 28Feb2021, as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, fibrocystic breast, tonsils surgery, caesarean, myomectomy, sensitivity to dairy/some fruit, feathers/wool/pets and seasonal allergy. Concomitant medications included ALLERCLEAR; glucosamine (MANUFACTURER UNKNOWN); EMERGEN C IMMUNE PLUS; guaifenesin (MUCINEX) all from an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021, the patient experienced hives/rash and facial swelling. The patient was treated with methylprednisolone for all the events. The clinical outcome of hives/rash and facial swelling was resolving. No follow-up attempts are needed. No further information is expected.
Patient presented with left arm erythema and bruising.  She states it started with "little red splotches" late day 1 post vaccination and then the redness spread day 3 post vaccination.  Arm condition is currently stable with mild arm soreness.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 30 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Pt presented 10 minutes after received Yellow Fever vaccine w/n/v, photophobia, blurring vision, h/a. Pt encouraged PO hydration, 24 hour siq, 800 mg iboprophin po tid prn, f/u in am
I had my vaccination on 09/16/2022. I started to experience a headache. and scratchy throat on 03/27/2023. Then on 03/28/2023 I started to experience brain fog coughing and sore throat. On 03/29/2023 I had extreme fatigue and chest congestions. My headache was worse and I had a low-grade fever. On 03/29/2023 I tested COVID-19 Positive. I was informed to take Zinc Vitamin D  AdvilTurmeric to quarantine and plenty of rest. The doctor recommended against Paxlovid.
Patient began to have itchy throat and tingling lips. 25 mg PO Benedryl given. Symptoms subsided within 10-15 minutes.
Noticed a couple of spots of hives, they state it was hives and that the itching sensation moves across their body, and it is not continuous.; skin irritation; Developed more itchiness on their under arm area, around their neck and their groin. The itching got progressively worse; Headache for 3 days, like migraine around the temples, on both sides; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Noticed a couple of spots of hives, they state it was hives and that the itching sensation moves across their body, and it is not continuous.), PRURITUS (Developed more itchiness on their under arm area, around their neck and their groin. The itching got progressively worse), SKIN IRRITATION (skin irritation), MIGRAINE (Headache for 3 days, like migraine around the temples, on both sides) and CHILLS (chills) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 004C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced PRURITUS (Developed more itchiness on their under arm area, around their neck and their groin. The itching got progressively worse). On an unknown date, the patient experienced URTICARIA (Noticed a couple of spots of hives, they state it was hives and that the itching sensation moves across their body, and it is not continuous.), SKIN IRRITATION (skin irritation), MIGRAINE (Headache for 3 days, like migraine around the temples, on both sides) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (Noticed a couple of spots of hives, they state it was hives and that the itching sensation moves across their body, and it is not continuous.) and PRURITUS (Developed more itchiness on their under arm area, around their neck and their groin. The itching got progressively worse) had not resolved, SKIN IRRITATION (skin irritation) outcome was unknown and MIGRAINE (Headache for 3 days, like migraine around the temples, on both sides) and CHILLS (chills) had resolved.            Concomitant product used was not provided by the reporter.  Patient used antihistamines to reduce the itching and that while they were working or working out, it went away, but, if he was not doing anything it came back. They were also looking into some possible soy allergy or another irritant in their environment. Patient stated he was consuming a meal replacement (Soylent) and stopped the last 2 days with no decrease in the itching. Around 01-02Dec2021 they first noticed some itching, not major.
Some dose leaked out of the injection site after given. Moderna was contacted and the recommendation is to repeat the dose when less then authorized dose was given for any reason (syringe malfunction, patient pulled out, etc.) for the booster (0.25ml). Patient was consulted by both pharmacist and Moderna with the recommendation and decided to repeat the dose, so it was given.
She presents to the Occupational Health Clinic on 5/8/2018 for evaluation of a rash, history of receiving the Varicella vaccination on April 24, 2018. The vaccine was administer subcutaneously in her right arm. Thursday, May 3, she developed discomfort at the injection site and mild erythema. On Friday she had symptoms of general malaise including fever and chills; she did not take her temperature. On Saturday she felt generally worse with weakness and diffuse joint pain. On Sunday she sought treatment in the Emergency Department for her persistent symptoms. In addition she felt lightheaded and dizzy, she was having diarrheal stools. Impression at the time of the ED evaluation included a viral syndrome; possible cellulitis at the injection site. An ultrasound of the area of the vaccination site did not reveal an abscess; lab work was within normal limits. She was provided with a prescription for KEFLEX for potential soft tissue infection. Today 5/8/2018 she has a rash along her anterior chest, arms and upper back. She has itching along the areas of the rash and her scalp. Her supervisor recommended evaluation in Occupational Health to rule out a potential contagious rash. She reports continued general malaise, she has not had a fever or chills. She reports she has not taken the KEFLEX today.
PT CAME IN 6 DAYS AFTER HIS VACCINATION WITH A PRESCRIPTION WRITTEN FOR AN ANTIBIOTIC AND PREDNISONE.  HIS ARM WAS VERY RED AND SWOLLEN WHERE HE RECEIVED THE VACCINATION.
Patient said started on Saturday (day of vaccine) with pain at injection site & muscle pains, then progressed to pain shooting down arm, difficulty breathing, dizziness, throbbing pain in arm. On sunday, he had tonugue stinging & numbness, as well as lips and left jaw numb. He went to walk in clinic and they sent him to ER to be evaluated. At ER MRI and cat scan were performed to rule out stroke. Stroke was ruled out. Patient states today (1/27/21) that he feels better and most adverse effects resolved except still some pain in arm.
My left arm has gotten progressively worse since the last shot. It hurts like heck all of the time and I have lost range of motion. It's really bad and super painful. It is getting worse.
Patient received 0.3mL; A spontaneous report was received from pharmacist concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine and the patient received 0.3mL.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient was given 0.3 ml dose of the vaccine instead of 0.5 ml. No treatment information was provided. The patient had no adverse reactions.  Action taken with mRNA-1273 in response to the event was not reported.   The event, patient received 0.3mL, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 49 year-old, female patient, who experienced an event of incorrect dose administered after receiving her first dose of COVID-19 vaccine. No adverse events were reported.
Expired Havrix administered; 11 YO received Adult Havrix; 11 YO received Adult Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 22nd December 2022, the patient received Havrix adult. On 22nd December 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used, overdose and adult product administered to child. On an unknown date, the outcome of the expired vaccine used, overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The patient received an expired adult dose of Havrix at 13 years of age. The reporter did not have patient initials available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.  Additional supportive information: The patient received an adult dose of Havrix beyond expiry date, which led to expired vaccine used, overdose and adult product administered to child.
A cellulitis-like reaction at the injection site a week after administration. The injection site is red, swollen, firm, hot to the touch, and burning. It reaction site is the size of a grapefruit.
Mother called to report pt c/o "loosing vision on both sides." Parent to take pt to primary care provider (Dominican Health Clinic) for eval. Mother called back after eval & reported pt was dx with migrain headaches and was given Rx.
Woke up the morning after receiving the shot with a fever and body aches.  Lasted all day and also woke up the second day after the shot with a fever and tiredness.
Was symptom free from Lyme for 2 years. Lyme symptoms flared up day after vaccine and cont in addition to chest pain and breathing difficulties. Heavy fatigue, joint pains, breathing difficulties progressing. Following up with MD this week.
At injection site in a circular area about 4 inches in diameter, arm was hot, hard, itchy, red with a rash. It lasted for about 2 days; starting on Saturday morning 10/9/2021 and continuing Through Sunday 10/10/2021. Applied an OTC  anti-itch cream which helped.
Patient  had recently turned 12 and was given a Pediatric dose at an elementary school clinic.
pt experiencing chest pain after receiving second dose of COVID 19 vaccine on 5/26/21. Pharmacist and staff suggested contacting 911 to have an ambulance come, but patient's mother wanted to take him to Hospital for children which is nearby. Pt had chest pain 1-2 days after first dose and had EKG done 5/24/21. MD cleared patient to have vaccine.
1 -1/2 hrs after receiving vaccine patient developed swelling at site, diffuse urticaria, and noisy breathing. He was given ATARAX then EPI PEN which helped. He was taken to the E.D. The impression at the E.D. was that the allergic reaction had resolved at the time of discharge, patient to use BENADRYL and ATARAX over next 24 hrs.
This is a spontaneous report from a contactable consumer (patient, reported for self). A 68-years-old (non pregnant) female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EN 6202), via an unspecified route of administration, administered in Left arm on 24Feb2021 at 20:00 (At 68-years-old) as single dose for COVID-19 immunization.  Medical history included Vaginal yeast infection on and unspecified date. Patient had no known allergies. Other medical history : Not much. Concomitant medications (other medications in two weeks) included fluoxetine hydrochloride (PROZAC); quetiapine fumarate (SEROQUEL); levothyroxine (LEVOTHYROXINE), Vitamins taken for an unspecified indication at unspecified dose, start and stop date were not reported. Patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 01Mar2021 (Monday) at 07:00, starting on four days after receiving the first vaccine patient started getting a yeast infection. Patient reported that she was not sexually active and not on hormones. Patient was retired. Patient reported that she was told this could be from the vaccine due to it lowering her immune system as it begins to work. Patient reported that she has had only had one vaginal yeast infection in her whole life, and mentions she does not know why she got this, and wondered if it could be related to the vaccine at all. Also, within a few minutes after receiving the first vaccine, patient experienced heart racing and it felt like when one goes to the dentist and receive novocaine and heart speeds up. The paramedics came over and checked her heart rate (high) and blood pressure (high) and waited for about30 minutes and talked with the patient, then rechecked the patient and it was okay. Patient received treatment for the reported adverse events. Patient reported to have purchased over-the-counter medicine that was taking care of it. Patient mentioned that her second vaccine was set for the 18Mar. No COVID tested post vaccination. Seriousness of the events yeast infection, lowering my immune system, heartracing, heart rate (high) and blood pressure (high) were non-serious. Outcome of the events were reported as recovering. No Follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated by an urgent care for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. Additional information has been requested.