chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site hot to the touch after 1st dose; Injection site itchy after 1st dose; Injection site red after 1st dose; Injection site swollen after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-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 VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy after 1st dose), VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red after 1st dose) outcome was unknown and VACCINATION SITE SWELLING (Injection site swollen after 1st dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided Treatment product  included Cold compress.
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil (lot# unknown) 0.5 mL IM. On an unspecified date the patient experienced an anxiety attack and fainted. Medical attention was sought. The patient recovered on the same day as the vaccination was given. No additional adverse event information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Follow-up information was received. It was reported that this was a vasovagal reaction to the needle not an adverse reaction to the vaccine. The patient often gets following any procedure. Additional information is not expected.
large, golf ball size, lump under skin, red hot and itching - not sure when the symptoms started exactly for the patient. She called me on 05/30/2022 at approximately 10:15am. I did refer her to go to a walk-in clinic due to she thought it was getting worse. I tried to call the patient when I started filling this form out but she did not answer. I do not know if patient did go to the walk in clinic or not.
Jittery, shaking hands, tight muscles in chest (confirmed that there were no palpitations). Going to take tylenol and call doctor in morning if not feeling better.
Individual report she was dizzy and almost blacked out. Started to sweat, heart rate, and oxygen dropped. Got her a wet rag, water, and helped her get into a comfortable position. She slowly came out of it and vitals went back WNL.
Initial unsolicited report received from a nurse on 19-Dec-2017. This case involves a 35 years old female patient, who was vaccinated with a dose of 0.5 ml of TYPHIM VI (batch number: N1G102M, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017, and a dose of 0.5 ml of MENACTRA (batch number: U5514AC, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017 and also a dose of 0.5 ml of STAMARIL (batch number: M51761V, expiry date, dose in series and site of administration was not reported) via intramuscular route on 11-Dec-2017. The patient's medical history included allergies to latex, allergy to codeine, allergy to BENADRYL and allergy to ROBITUSSIN. Concomitant medications were not reported. On 12-Dec-2017, one day following the vaccination (reported as the day following the vaccination), the patient experienced temp of 100.8 oral, chills, diarrhea during the night, headache, stomach pain, felt like she was punched in the stomach, and a prickly feeling to her skin widespread over her body. The patient's laboratory data included body temperature of 100.8 (unit: unknown). Corrective treatment was not reported. On an unknown date, the patient was recovered from all the events. List of documents held by sender: none.
Moderna COVID-19 Vaccine EUA. Patient got suddenly very hot, sweaty, shaky, heart palpitations, and proceeded to pass out and resulted in a head injury when head hit the floor.
After the vaccine, I had a headache, I felt off balance, my joints hurt. The headache I have, it's chronic and I am dizzy. Some days are mild, other days are very bad, both headache & dizziness. Every month I see the doctor, he said he thinks is a vaccine related and he gives me medication.
Patient had a vasovagal response. Patient observed another person feeling anxious and then he fainted. Patient immediately recovered without any further concerns.
Patient reports second dose of Pfizer on Friday.  Reports intermittent chest pain and pressure since Saturday.  Reports she was dizzy on Fri and Sat., denies that she is dizzy currently.   Denies any SOB but reports her pain does radiate into her L arm.
Patient was told by allergist ok to get vaccine even though she had a shellfish allergy. Patient received vaccine and about 10 minutes later started to report itchiness.  She was given 50mg diphenhydramine by mouth and felt better afterwards, just woozy.  She had someone come pick her up after her 30 minutes.
administered 0.5 mL- should have been 0.25 mL for booster dose
swollen left whole arm; injection site was infected; pain all over the arm moving up to the tip of left hand; injection arm soreness; injection arm numbness; Couldn't able to sleep on the left side due to pain"; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (injection arm numbness), INSOMNIA (Couldn't able to sleep on the left side due to pain"), PERIPHERAL SWELLING (swollen left whole arm), VACCINATION SITE INFECTION (injection site was infected) and PAIN (pain all over the arm moving up to the tip of left hand) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reported.  Concomitant products included LORATADINE for Allergy, FLUTICASONE PROPIONATE and BUDESONIDE;FORMOTEROL for Asthma, DULAGLUTIDE (TRULICITY) for Diabetes.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced HYPOAESTHESIA (injection arm numbness), INSOMNIA (Couldn't able to sleep on the left side due to pain") and VACCINATION SITE PAIN (injection arm soreness). On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen left whole arm), VACCINATION SITE INFECTION (injection site was infected) and PAIN (pain all over the arm moving up to the tip of left hand). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (injection arm numbness), INSOMNIA (Couldn't able to sleep on the left side due to pain"), PERIPHERAL SWELLING (swollen left whole arm), VACCINATION SITE INFECTION (injection site was infected), PAIN (pain all over the arm moving up to the tip of left hand) and VACCINATION SITE PAIN (injection arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Antibiotics treatment but not started yet.
Pt got first Moderna vaccine (Lot#036A21A) on 3/26/21 and her second Moderna on 4/23/21 (Lot# 031A21A). On 6/14/21 patient started to have C/O SOB and High Blood Pressure. Was seen here at the Clinic a couple times and then was referred to Cardiology for Follow-up. Patient now has a diagnosis of Essential Hypertension.
Patient reports "a couple days" after vaccine experienced sore/stiff neck and shoulder on and off for roughly 7 to 10 days after vaccination date. Reports limited range of motion of left arm. After 7 to 10 days diminished to mild pain and has since resolved. Of note patient reports restarting tennis around this same time - 11-14 or 11/18? - after taking extending period of time off due to neuropathy/Parkinsons diagnoses. After shoulder/neck issue resolve pt reports pain moved to lower body and he experienced lower back discomfort. He reports history of back pain/problems but says this is different. He then experienced "sensation" in left leg and knee, and eventually severe thigh pain. The left leg pain prevented him from walking for several days. He reports he is now able to walk but the pain persists. Has used ointment with lidocaine on affected areas of knee, leg and buttocks and has seen improvement. Patient has appointment to meet with MD next Thursday 12/13/18.
Information has been received from a nurse concerning a 7 year old 49 lb. 49 inch female with no pre-existing allergies, birth defects, or medical conditions, who on 07-DEC-2007 was vaccinated with a second 0.5 ml subcutaneous dose in the right anterior thigh of varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U)> Concomitant vaccination included a first dose in the left anterior thigh of hepatitis A virus vaccine inactivated (HAVRIX) (lot#AHAB225AA). There was no reported illness at the time of vaccination, and no concomitant medication. On 08-DEC-2007, within 24 hours of the vaccination, the patient developed a 103F fever, "a reddened area as large as a softball, slight swelling, and small bumps at the injection site". The reddened area was not tender to the touch. The patient's mother sought medical attention by phone and was instructed to apply a compress to the patient's right thigh and give the patient ibuprofen (ADVIL). On 09-DEC-2007, the patient was seen in follow-up. The area was improved, slightly reddened and warm. Follow up information from the nurse indicated that "immunization reaction protocols" were used, and on an unspecified date, the patient had recovered. There were no other symptoms and no other treatment was given. Additional information is not expected.
Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 3/4/2023  PRESENTING PROBLEM: Dementia with behavioral disturbance   HOSPITAL COURSE: Patient is a 93 y.o. female with PMHx of vascular dementia, CKD stage 3, hypertension and depression who presented with dementia and aggressive behavior, paranoia, delusions, and behavior disturbances to the ER.    She was being cared for by her family, but has been having outbursts and paranoid delusions. Family no longer able to care for her. They were working on placement in assisted living, but did not feel this was proper care for her dementia, and therefore brought her to the ER for evaluation. No obvious cause for delusions and attributed to progressive dementia. She was admitted to medicine for further management.    While hospitalized she had intermittent outbursts at staff. Psychiatry was consulted to assist with behavioral disturbance. Patient with limited po intake. Informational meeting with hospice and family decided to look for options with plan to sign on with Hospice.Family agreed to remove all medications not focused on comfort. Patient was continued on comfort care and patient's condition ultimately deteriorated before she passed on 3/18/23.   Death Pronouncement: Called to patient?s bedside to pronounce that patient has died. Patient was comfort care. On bedside exam no spontaneous movements were present. There was not response to verbal or tactile stimuli. Pupils were mid-dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses were palpable. No heart sounds appreciated.   Patient pronounced deceased 3/18/2023 at 1:35 AM   Family notified over phone grieving appropriately.  Hospice notified.  Funeral Home:  Death certificate to be completed by attending in am.
No side effects; PROQUAD was unknowingly administered in 2021; This spontaneous report was received from a medical assistant, concerning a currently 2 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date in 2021, the patient was unknowingly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No side effects were reported.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
Pain/swelling upper left arm.  Treated with Keflex 6/29/06.
lethargic, nausea, diarrhea, muscle aches, pain all over (like nerve endings), headache, lightheadedness, swollen glands, swollen abdomen, arm pain (at vax site), peeling skin
Extraordinarily lethargy; loss of appetite; warm temperature with no fever; body aches,"felt like someone hit me with a baseball bat in the art; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Extraordinarily lethargy), DECREASED APPETITE (loss of appetite), FEELING HOT (warm temperature with no fever) and MYALGIA (body aches,"felt like someone hit me with a baseball bat in the art) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2020. Concurrent medical conditions included CYP450 2D6 ultrarapid metaboliser status.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced LETHARGY (Extraordinarily lethargy), DECREASED APPETITE (loss of appetite), FEELING HOT (warm temperature with no fever) and MYALGIA (body aches,"felt like someone hit me with a baseball bat in the art). On 12-Apr-2021, LETHARGY (Extraordinarily lethargy), DECREASED APPETITE (loss of appetite), FEELING HOT (warm temperature with no fever) and MYALGIA (body aches,"felt like someone hit me with a baseball bat in the art) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medication included blood thinner. Treatment medication included Tylenol 1000 mg.
her Hashimoto's disease had gone; allergic reactions like hives; allergic reactions like itching; Sometimes she also experience rapid heartbeat; Her gastritis is getting worst; muscle pain; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat) and GASTRITIS (Her gastritis is getting worst) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat), GASTRITIS (Her gastritis is getting worst), MYALGIA (muscle pain) and PYREXIA (Fever). At the time of the report, CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat), GASTRITIS (Her gastritis is getting worst), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
chest tightness arm pain nausea diarrhea body aches fatigue  lost work two days
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: Tachycardia due to the epinephrine shot.  Gave her the shot after she warned me that she was having an allergic reaction, then called 911.
This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 65-year-old male patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 4ZY53, expiry date unknown) for prophylaxis. On 23rd October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 23rd October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site itching and injection site papule. The patient was treated with topical steroid NOS and antihistamine. On an unknown date, the outcome of the injection site itching and injection site papule were not recovered/not resolved.  It was unknown if the reporter considered the injection site itching and injection site papule to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient who himself was a physician. The patient has no allergies to report and has had allergy testing. The patient experiencing a local injection site reaction that was pruritic and papule-like in nature. Once the patient stops the local steroid cream and antihistamine treatment, the symptoms return. At the time of this report, the symptoms were ongoing. Lab Comments: Lab test performed on unknown date.
After given shots, patient became pale and not moving or crying in 2-5 mins. Color came back after 5 mins but very sleepy and no crying still. After 10-15 mins was more alert but still moving slowly. When left was a bit more alert and ok.  EG
Non stop going, weird verbal noise making, not focusing on events of the day, lack of self control, seems to be hyper a lot during the day, wants to change activities very frequently, won't sit for more than a few minutes to do activity books. She has not had treatment yet we are in process of getting our insurance switched over and waiting on a dr apt.
Headache; Bad chills (could not get warm); Tired; Fever of 99F; Cold sore in her mouth that seemed to be spreading; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore in her mouth that seemed to be spreading), HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 044A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ORAL HERPES (Cold sore in her mouth that seemed to be spreading). On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F). At the time of the report, ORAL HERPES (Cold sore in her mouth that seemed to be spreading), HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 99 (High) Fever of 99F..         No concomitant medications were reported.  Patient visited the dermatologist and they prescribed an ointment and pills as a treatment.   This case was linked to MOD-2021-374814, MOD-2021-374831, MOD-2021-374814 (Patient Link).
Seizure activity noted by father lasting about 2 minutes, associated with fever of 103F. Generalized jerking, lipsmacking and then became limp.
Dr says the injection site "has always remained itchy" since 1st put in (12/14/13). No lump at site. Topically a little rashy. But the itch is more the irritation. Wants to know when it will stop being itchy.
Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury.  Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR.  MD indicated vaccine reaction unlikely.
pt recvd vax & began feeling weak; pt hands & eyes became itchy; generalized hives w/ stomach pain; diarrhea & intermittent chest pain; PMD thinks pt had hypersensitive rxn to vax;
On second day arm became very sore, Motrin helped. Immunized 11 days ago; Now any use causes intense pain, hurts with gripping, no numbness; pain in deltoid; radiates to elbow
Patient stated after first pfizer shot, he felt ill and a few days later had shingles.  Rx for Acyclovir was picked up on 10-31 and gabapentin  on 11-05.  Patient came back and received second pfizer shot on 11-19 after discussion with doctors and pharmacist.
3 weeks after second dose...still extreme malaise, headache and muscle aches I have had the flu shot, and have not been around other individuals that were not also vaccinated