chrisvoncsefalvay/vaers-outcomes huggingface dataset:
insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia) 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 INSOMNIA (insomnia). At the time of the report, INSOMNIA (insomnia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient read on the internet that people experienced insomnia after receiving bivalent vaccine. No treatment information was reported.   Reporter did not allow further contact
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
Pfizer when mixed diluent .9mL was used instead of the correct 1.8mL Patient was given 0.3 mL Patient checked 3 days later no adverse reaction. Patient is doing fine.
BRIEF EPISODE OF DIZZINESS APPROX 5 MINUTES AFTER VACCCINATION, RESOLVED AFTER APPROX 5 MINUTES  Narrative:  BRIEF EPISODE OF DIZZINESS OF DIZZINESS 5 MINUTES AFTER VACCINE ADMINISTRATION. RESOLVED AFTER APPROX 5 MINUTES. PT BACK TO BASELINE AFTER 15 MINUTES, NO FURTHER SYMPTOMS
After the second dose I felt tired and slept majority of the day I took Aleve I started to get a rash on my right arm  but it didn't fully developed on May 17 I went to the Dr. I had a cough and he think the immune response to the 1st dose trigger my cough he prescribed Albuterol and it cleared up in 2 weeks something I also noticed after the vaccines I felt my menstrual cramps have been stronger .
Moderna COVID-19 Vaccine EUA  Left arm soreness in arm pit and around back of upper arm since soon after second shot and continuing for 3 months
On 11/11/23 pt came in and had red, slightly swollen area about 4" x5" on left arm. It was warm to the touch.
This spontaneous report as received from consumer of unknown age refers to herself. The patient's medical history included breast cancer 10 years ago. Approximately in 2013 (reported as 2 to 3 months ago), the patient was vaccinated with ZOSTAVAX, (dose unspecified). Concomitant therapies included VALTREX (Dose and manufacturer unspecified). Approximately in 2013, the patient experienced injection site tenderness. It was reported that it was the only adverse event patient experienced. It was reported that the patient's questions were only surrounding drug interaction. No medical attention sought. There was no hospitalization required for the event. There was no product quality complaint involved. The injection site tenderness has completely stopped. The outcome of injection site tenderness was reported as completely recovered (on an unspecified date). The reporters causality assessment for the event injection site tenderness with the therapy of ZOSTAVAX was not reported. Additional information has been requested.
I experienced soreness in the injection site immediately following the vaccination and persisting for another two days. Four days following the vaccination (currently ongoing),  I started experiencing body aches, fatigue, a slight headache, and an elevated temperature.
On 10/17/22, around 4:00AM I had fever, chills, and shivers. On 10/18/2022 around 8AM to 10AM I became aware of having tingling sensation in my extremities. The tingling sensation is primarily in the bottom left sole of my foot. After that day I started exercising the sensation spread from the left foot to both of my pinkies, ring fingers and both of my hands. For the hand after an hour the tingling did go away. The foot tingling is off and on. It seems to come and is pronounced when I put pressure on the foot. When I exercise it sometimes spreads to my right foot, but the tingling is predominantly on my left foot. I contacted my doctor by email, and she recommended to use ibuprofen and that did help my fever. I did that for 3 to 5 days. On 10/24/2022 I had a checkup with my doctor. The doctor ruled out prediabetes. She did a stroke test. She referred me to a neurologist. I have recovered from the fever and chills. I am still experiencing the tingling in my left foot. Sometimes when I exercise, the tingling does spread to other extremities.
PATIENT REPORTED THAT THE SITE OF INJECTION TURNED RED AND SEEMS TO BE SPREADING. THE SITE FEELS A LITTLE WARM BUT THAT SHE HAS HAD NO FEVER SINCE THE DATE OF VACCINATION AND NO OTHER SYMPTOMS. PATIENT REPORTED THAT SHE  HAS BEEN MONITORING HER TEMPERATURE SINCE SHE NOTICED THE REDNESS.  PATIENT CAME TO REPORT TO THE PHARMACY AND I ADVISED TO SEE A DOCTOR
Pt reported before shot that has had history in past of fainting after vaccinations.  After receiving the shot, had him sit in a chair next to the table for a few minutes to see if would occur again.  After about 2 minutes, pt began reporting that he felt that he was about to faint again.  He began to dry heave and passed out momentarily for 2 seconds before coming back to.  Pharmacist caught him before he fell.  Gave pt water and took blood pressure.  Patient began to feel better.  Sat for 30 minutes and then he felt fine to leave.
From initial information received on 31Jan05 from a health care professional regarding an adverse event occurring, it was reported that a 43 yr old female pt received a booster dose of Decavac, lot number U1212DA, admin IM in the left arm on 27Jun05. The following day, on 28Jan05, the pt developed a fever of 104 degrees F, as well as redness and swelling at the injection site. She notified the physician's office on 29Jan04 and was seen in the ER that night. She was treated with oral Keflex and Unisyn intravenously. She was admitted to the hospital the next day with the diagnosis of cellulitis. At the time of this report, the pt had not recovered from these events.
Vaccine administered 8/9, pt. seen next day with left upper arm swollen, red, hot, painful at injection site, no fever noted, no SOB, no difficulty swallowing. Pt. advise to treat with Ibuprofen and hot/cold compresses.
pt had numbness & soreness pt temp was 97.8;this resolved in 2 days;pt should have gotten Td;
No adverse event; Patient who received an incorrect product for their 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 22-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Patient had no relevant medical history or previous COVID-19 diagnosis and did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot AS1417B) on 03-Jan-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 19-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient who received an incorrect product for their 2nd dose).    No concomitant medication was reported.  It was reported that HCP was unsure of the exact dosage but stated that since the pink cap vial dosing was indicated as 0.2 mL, that must be the dosage the patient would have received for their 2nd dose. Patient had not reported any adverse reactions from either dose. No treatment medication was reported.
Pt was given a HIB vaccine instead of a Mennigitis (Menactra) vaccine.
Inspection for rashes, lesions, ulcers -- Pt is having 3 cm erythematous induration on left deltoid area, where he recieved VARIVAX yesterday. No abscess.
This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included pneumonia vaccine (the patient received in the past). On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, immediately after receiving SHINGRIX, the patient experienced pain. On 4th July 2018, the patient experienced cellulitis (serious criteria GSK medically significant) and erythematous rash. On an unknown date, the outcome of the cellulitis, pain and erythematous rash were recovered/resolved. It was unknown if the reporter considered the cellulitis, pain and erythematous rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. In afternoon, the patient received SHINGRIX in left arm. Immediately, the patient experienced soreness which subsided by Wednesday of that week. Three to four days after, the patient did not experience itching or hurting but experienced rash, which spread on the side of arm and it was red. The patient took blood work and blood levels found to be fine. The reporter thought that, rash could be cellulitis. The patient took an antibiotic for 10 days and the rash resolved. The rash remained for one week and all side effects resolved at the time of reporting. The patient has denied permission to contact their physician. The Pain, Red Rash and Possible Cellulitis were reported below the injection site on the side of her arm.
RASH, ITCHING, HIVES, PALPATATIONS, SOB, SWELLING OF FACE.
Expired(June 30,2021) dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a child patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number unknown, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Flulaval quadrivalent vaccine which was expired 30th June 2021. The patient had no effects at the time of reporting. The reporter consented to follow up.
mild sore arm; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 14:30 (Batch/Lot number: EN6205) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "recovered", described as "mild sore arm"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered", described as "mild nausea". Therapeutic measures were not taken as a result of pain in extremity, nausea.  Additional information: The patient had not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. The events were considered as non-serious by the reporter.   No follow-up attempts are possible. No further information is expected.
Fever , myalgia,  back spasm , fatigue,  lymp node swelling
shingles; Inappropriate schedule of vaccine; This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reported that the patient received the 1st dose of Shingrix on an unknown date last year. About 6 to 8 weeks ago, the patient developed shingles. The patient would like to get the 2nd dose, which led to incomplete course of vaccination. The healthcare professional (HCP) was the patient's son. The reporter did not had the exact date of vaccination or lot/exp.
Heavy Vaginal bleeding (not from period), bright red, moderate to severe uterine cramping that started 12 hours after vaccine. Bleeding and cramping continue 48 hours later. Tylenol decreases the cramping but does not completely resolve.
This case was reported by a healthcare professional (nurse) and described the occurrence of rotavirus in a 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 28 June 2012; hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on 28 June 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 28 June 2012. On 10 April 2012 and 28 June 2012 the subject received 1st dose and 2nd dose of ROTARIX (oral "regular dose"). On 29 October 2012, 4 months after vaccination with the 2nd dose of ROTARIX and 7 months after vaccination with the first dose of ROTARIX, the subject experienced rotavirus and vaccination failure. The subject had received 2 doses of ROTARIX and was diagnosed with rotavirus in the hospital on 29 October 2012. The subject was hospitalized for 48 hours and then released to outpatient care. Relevant test results included a stool culture obtained in the hospital and the result was positive for A rotavirus. At the time of reporting the events were unresolved. The healthcare professional (nurse) considered the events were unrelated to vaccination with ROTARIX. The nurse did not feel that the vaccine caused the infection. Follow up information received from nurse on 29 January 2013. A stool culture (rotaviral AG) was done in the hospital and the report was positive A rotavirus gastroenteritis. The nurse documented that there were no other causes of gastroenteritis present and there was no past medical history.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown age and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of GARDASIL (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014065, 1507USA014066, 1507USA014067 and 1507USA014068). Additional information has been requested.
Red area at shot site starting approximately 9 hours 1.5 inches, increasing to 2.5 in 24hrs to approximately 3 in  at 36 hrs. Itchy at 42 hrs. Welt red inside right elbow  3-4 in at 6hr, lighter 48hr. Torso pink painted look plus red rash 10 hr -48hr fever 100 F with Ibuprofen 800
child noted to have red maculopapular rash to left cheek and neck and around injection site (L)arm 5 minutes past immunization.  Also, few whelps around injection site(L)arm.  Baby evaluated per B. Nail, FNP.  Benadry 1 1/2 tsp PO given.  20 minutes after Benadryl rash faded.
anaphylaxis; Literature report:.  This literature marketed report as received from a physician refers to a 19-year-old female patient. Information about medical history, concomitant therapy and concurrent conditions was unknown. The patient experienced throat swelling and pruritus which rapidly progressed to facial flushing and scattered non-injection site urticaria within 15 minutes of receiving varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis.   Symptoms resolved within one hour after treatment with antihistamine and the patient was referred to allergy clinic. The patient underwent skin testing to varicella virus vaccine live (Oka/Merck) (VARIVAX), bovine and porcine gelatin, and neomycin. Full strength skin prick testing (SPT) was negative to all. Intradermal testing (IDT) with 0.2ml of 1:10 varicella virus vaccine live (Oka/Merck) (VARIVAX) was positive as was 0.2ml of 1:100 gelatin. IDT to 1:100 gelatins of the control subject were negative. Four weeks post-vaccination, patient's varicella zoster virus (VZV) IgG titers remained negative.   Allergy work-up concluded that anaphylaxis was secondary to gelatin. Positive IDT to varicella virus vaccine live (Oka/Merck) (VARIVAX) 1:10 dilution indicated the vaccine contains sufficient gelatin to trigger mast cell degranulation in the patient. Anaphylaxis remains a rare adverse event following vaccine administration and gelatin must be considered as a culprit following live virus vaccination.   Upon internal review, the event anaphylaxis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
After receiving the vaccine, I felt sick to my stomach, and I had a hard time breathing. So I went to the hospital, and the doctors did a lung x-ray which looked bad. Then they did a lung scan and thought it looked like I had covid, but the results showed I had pneumonia. I was hospitalized for 4 days.
Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot no., route and site of administration were not reported). On an unspecified date the patient experienced what was assumed to be shingles rash. It was unknown if the patient sought medical attention or not. The patient's outcome was unknown at the time of reporting. Additional information has been requested.
The patient was scheduled to receive the second dose of the series on 1/25/21 and received it on 1/19/21. The patient reported injection site soreness lasting 24 hours.
For 18, I've months shortness of breath, extreme shortness of breath; symptoms started after 2nd shot; Patient received 0.25 ml of second dose of Morderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath), IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Feb-2021, the patient experienced UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine). On an unknown date, the patient experienced DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) and IMMUNISATION REACTION (symptoms started after 2nd shot). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) had not resolved and IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) outcome was unknown.            It was reported that patient had months shortness of breath, extreme shortness of breath, slowly got worsen symptoms started after 2nd shot.   This case was linked to MOD-2022-675668 (Patient Link).
Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation
Severe joint pain to the point I couldn't care for myself. Developed Polymyalgia Rheumatica. I have to take Prednisone for a long period of time to keep pain down-which has bad side effects for me.
Patient presented to vaccine clinic to receive her first dose of Moderna COVID-19 vaccine. Due to her self reported history of anaphylaxis from bee stings she remained in observation for 30 minutes post injection. After being observed for 30 minutes patient reported itching on her arms, face, and head. She also reported tingling of her tongue. No visible hives, respirations within normal limits, unlabored, with open airway. Patient also reported a headache and explained that she was very sensitive to many medications. Provider recommended presenting to the the emergency department with symptoms, or staying in her car near medical facility for at least an hour post injection. Provider also recommended having someone come to pick up the patient so that she was not driving herself alone and seek medical attention if symptoms worsen.