chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reaction; Dose 1 taken on 28-Oct-22 and Dose 2 on 10-Nov-22; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Oct-22 and Dose 2 on 10-Nov-22) and NO ADVERSE EVENT (No adverse reaction) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 10-Nov-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Oct-22 and Dose 2 on 10-Nov-22). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Oct-22 and Dose 2 on 10-Nov-22) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 taken on 28-Oct-22 and Dose 2 on 10-Nov-22).    No concomitant products reported.  Patient got first dose of Moderna Bivalent lot 061F22A on 28 Oct 2022 0.5 ml intramuscularly in left arm, she should have received original Moderna Monovalent. She experienced no adverse effects from the shot. For her second shot she received Moderna monovalent.   No treatment products reported.   This case was linked to MOD-2022-670198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2022: Non significant follow up received
2 weeks after 1st dose - developed sever bout oif colitis -colonoscopy identified ulcerations - biopsy identified potential source as ischemic colitis.  2nd dose april 14 - delayed due to colitis.  Colonoscopy April 30.  Perineal skin inflammation and nodules after colonocopy  requiring treatment with hydrocortisone cream lasting several weeks. Lower left leg inflammation developed starting june 19 - progressively worse throughout summer.  Vascular surgery consult today resulted in confirmation of severe inflammatory reaction likely due to vaccines.  Recommended next step biopsy to determine pathology of inflammation source.
Rash on front of torso - front of neck, sides of breasts, stomach, upper thighs; general mild 'lousy' feeling
One week after receiving my first dose  of the Moderna vaccine the injection site became swollen again and fever set in.  The fever peaked 12 hours later at 100.4.  Within the next 12 hours the fever broke and the swelling and soreness at the injection site subsided.
pt reports extensive bruising still evident on 7/31/19, but states it appears to be getting better. no swelling, pain, redness, or other adverse effects reported.
pink rash 6 inches in diameter; tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (pink rash 6 inches in diameter) and FATIGUE (tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 028A21A) for COVID-19 vaccination.     No medical history were provided.  Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Immunocompromised.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced RASH ERYTHEMATOUS (pink rash 6 inches in diameter). April 2021, the patient experienced FATIGUE (tired). At the time of the report, RASH ERYTHEMATOUS (pink rash 6 inches in diameter) and FATIGUE (tired) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-289515 (Patient Link).
A non-serious spontaneous report of expired FLUMIST administered has been received from a healthcare provider concerning a 39-year-old patient. The patient a physician self administered FLUMIST before realizing the expiration date was for last season. There was no adverse event associated with this vaccination error: therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
The pt spiked a temp of 102.9, broke out in whelps to legs, arms and neck. The pt developed inconsolable crying and whining, redness and swelling to the injection site. Given Tylenol, and Benadryl. The following day the pt had developed cellulitis , swelling, warm to the touch and redness to the injection site. Treated with Keflex.
EXTREME fatigue, EXTREME weakness, some memory loss, HIGH fever (103.5) severe chills, headache, loss of appetite, off balance, vertigo Fever and chills lasted three days, all others are still happening five days after shot
I was having pain at the under side of my arm 2 days ago. This morning I woke up and a have a good sized bump, it is red, itches, and hurts a little bit.
This spontaneous report as received from a physician refers to a 3 years old patient with immunisation. The patient was vaccinated with, 1 DF GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of vaccine administered. No treatment information was reported. The outcome of inappropriate schedule of vaccine administered is unknown. Inappropriate schedule of vaccine administered is not related to GARDASIL. No further information was provided.
Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight)  Played tennis on Tue 4/13 (had diarrhea beforehand; left calf throbbed and then "popped"; had to stop immediately)  Overnight Tue/Wed upset stomach
patient was vaccinated with 2 flu shots and not 1 flu and 1 moderna. Patient did end up receiving 2 flu shots and 1 moderna on this date. 1 flu shot in each arm and moderna shot in left arm all vaccinations done IM
serologically tested negative for varicella immunology; This spontaneous report was received from a health care professional referring to an adult patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with two dose series of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 mL, administered intramuscularly for varicella immunization (strength, lot #, and expiry date were not provided).  On an unknown date, the patient experienced serologically tested negative for varicella immunology (antibody test negative). The outcome of the event was not known.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
PT STATED SHE IS NORMALLY FATIGUED AND LETHARGIC AFTER VACCINES. NORMALLY TAKES BENADRYL AFTER VACCINES. PT WAS ADMINISTERED VACCINE AND WAS IN OUR OBSERVATION AREA AND STARTED COMPLAINING OF CHEST TIGHTNESS, CLAMMY HANDS AND LIGHTHEADEDNESS. PROVIDER APPROACHED PATIENT AND PT COMPLAINED OF SOME THROAT TICKLING BUT NO BREATHING ISSUES. EMS ASSIST WAS CALLED. WHEN EMS ARRIVED TO THE PT, SHE VOMITED. EMS TRANSPORTED PT TO ER.
pt recv vax MAR99 & 2 days post vax pt exp a gen rash which was treated w/Depo-Medrol & resolved;10 days p/vax pt exp a gen sz, seen by neurologist;EEG abn;Dilantin given;sz resolved;MD did not think incident r/t vax;
she is starting to itch on vaccination arm and is moving to chest and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (she is starting to itch on vaccination arm and is moving to chest and shoulder) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (she is starting to itch on vaccination arm and is moving to chest and shoulder). At the time of the report, PRURITUS (she is starting to itch on vaccination arm and is moving to chest and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
itchy; red area the size of my palm, down from needle mark; warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red area the size of my palm, down from needle mark), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PRURITUS (itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, TELMISARTAN, ROSUVASTATIN and ESCITALOPRAM for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red area the size of my palm, down from needle mark) and VACCINATION SITE WARMTH (warm to the touch). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE ERYTHEMA (red area the size of my palm, down from needle mark), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Day after the vaccine had localized swelling to left arm and low grade fever to 100-100.9. Next day (2 days after vaccine administered) arm became very red, swollen and tender and pain with arm movement. Area of redness x 10 cm encircling 3/4 of the arm width. No more fever. Patient came to clinic on 2nd day after vaccine administered, Adverse event has NOT resolved yet.
Woke up the next morning at 4am and had paresthesia down my whole left arm. Significant tingling and could not feel ulnar nerve distribution (pinky and ring finger). This persisted for about a week, and then saw some improvement. Now at 2 months later, it still feels different than my right hand, but is manageable. Some injection site pain still at 2mo later. I expected injection site pain for a few days up to a week, but didn't expect it to last for months. It just feels different and still a little sore in my left deltoid where I received the shot.
rash-lower extremities x 2wk;rash began approx 24hr p/vax;
Pt is having alot of pain in her muscle at injection site. Day of vax there was some pain, day after vax (12/15) around  injection site was noticeably more sore. One third day there was redness around injection site and soreness was still there. Redness was gone by 12/18 but pain was still there. Pain in the arm is more noticeable if the PT uses/moves her arm. On 12/19 PT took and ibuprofen and she said some of the pain subsided but it wasnt completely gone. Pt said below injection site was also itchy but it only lasted a few days.
On December 30, 2021, I had a sore throat, and then I tested positive for omicron. Since then, in January, February, and the early part of March of 2022 I have been having a lot of heart palpitations. I had to wear a heart monitor. I also been having cognitive issues. My memory isn't as good as it used to be. I work at a multitasking, high stress management job. Now I have to really concentrate on what I'm saying because I'll forget things in mid-sentence. Sometimes my boss may ask me to do something or ask if I have already done something and I can't remember.  These heart palpitations and cognitive issues are intermittent. They just come and go. I don't have them all the time. I felt like I have symptoms of long COVID-19. My heart palpitations aren't completing gone, but they have been diminishing overtime.
I received the COVID vaccine and had a reaction. My 1st vaccine was in April 2021 and the 2nd vaccine was in April 2021. My inner ears are both closed since the end of June and have not open. I been to 3 ENT doctors, a Neurologist, my primary doctor and my inner ears are stilled closed.
2/1/2021 4" bright red splotch on shot arm, no pain, no fever faded away in two days 2/20 12:20PM #2 shot 1PM Tylenol 2 pm Fatigue+ feeling strange Restless night 2/21 tired + a bit unsteady 2/22 Redness starting on shot arm 02/25 Redness faded away. Rock-hard bowel movement. 03/1 shot arm almost itchy, almost burning tiredness linger
Patient complained of tightness in her mouth and throat with lips becoming numb and swollen.  She denied any SOB or wheezing. She had no skin rash. She had BP of 160/90 with O2 sat of 94% and pulse of 96. She had mild hand tremor. She was given benadryl 50 mg oral and monitored for 2 hours.  she was discharged home with instruction to take benadryl 25 mg in 4 hours and repeat 4 hours later. She was instructed to go to the ER if any breathing problems.
This spontaneous report was received from a registered nurse refers to a patient of unknown gender, currently 11 month old. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N013884 and expiration date 05-DEC-2018) for prophylaxis. On 13-APR-2018, ROTATEQ underwent temperature excursion at 32 degree Fahrenheit (F) to 35F (35.1F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1804USA006915: Original Case : 1804USA006915 US-009507513-1809USA013794: Original Case : 1809USA013793 US-009507513-1809USA013795: Original Case : 1809USA013793.
Diarrhea 7-8 stools/in 8 hours, frank blood, mucous in stool. Denies fever, (+) fussiness, mom noticed approx 18 hours after administration. Prior to vacc. had slightly loose, odorous stools.
PHARMACY LEFT PFIZER VIALS IN THE FREEZER FOR LONGER THAN 2 WEEKS AT THE TEMPERATURE (-25 AND -15 DEGREES C). WE GAVE DOSES OUT FROM THE VIALS,RENDERING THEM POSSIBLY LESS EFFECTIVE
Patient fainted about 5 minutes after the vaccination, he was pale, diaphoretic and stated he had numbness in both hands. He had not eaten and after the EMTs gave him a candy bar and water he was fine.
a red welt on my left arm that got to be 4cm round; sore; itchy; developed a painful labial ulcer on left side; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 11:00 (Lot number: FD8448) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Right side Frozen shoulder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "avacado allergy" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; ZOLOFT. Past drug history included: Codiene, reaction(s): "known allergies: codiene", notes: known allergies: codiene. The following information was reported: URTICARIA (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "a red welt on my left arm that got to be 4cm round"; PAIN (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "sore"; PRURITUS (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "itchy"; VULVAL ULCERATION (non-serious) with onset 03Sep2021 14:00, outcome "recovering", described as "developed a painful labial ulcer on left side". The events "a red welt on my left arm that got to be 4cm round", "sore", "itchy" and "developed a painful labial ulcer on left side" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, pain, pruritus, vulval ulceration.  Additional information: Had a red welt on my left arm that got to be 4cm round hot sore itchy then developed a painful labial ulcer on left side. AE treatment: hSV cultire  No follow-up attempts are possible. No further information is expected.
heart palpatations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpatations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PALPITATIONS (heart palpatations). At the time of the report, PALPITATIONS (heart palpatations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Patient said it started as an injection site reation and swelling almost after a week of vaccination and the inflammation caused a lymph node swelling near her shoulder. She said the swelling and inflammation subsided in the next few days but the lymph node swelling still remains. She is going to call her doctor's office.
Information has been received from a health professional concerning many patients, ages 12-15 years, who were vaccinated with GARDASOL (lot# Not provided). The reporter could not provide the exact number of patients, but estimated that every 7 out of 10 patients experienced heavy arm. On an unspecified date the patients recovered from heavy arm. The patients sought unspecified medical attention. Additional information has been requested.
her toes and feet were very cold; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (her toes and feet were very cold) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL COLDNESS (her toes and feet were very cold) and CHILLS (chills). At the time of the report, PERIPHERAL COLDNESS (her toes and feet were very cold) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment information not provided.   This case was linked to MOD21-074180 (E2B Linked Report).; Sender's Comments:  MOD21-074180:MOD-2021-074782 -2nd dose of vaccine
ear infection; sinus infection; experience extreme joint pain and rashes which seem to be related to a drug allergy; experience extreme joint pain and rashes which seem to be related to a drug allergy; got a head cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination:Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 30Dec2021, outcome "recovering", described as "got a head cold"; EAR INFECTION (non-serious), outcome "recovering", described as "ear infection"; SINUSITIS (non-serious), outcome "recovering", described as "sinus infection"; ARTHRALGIA (non-serious), RASH (non-serious), outcome "recovering" and all described as "experience extreme joint pain and rashes which seem to be related to a drug allergy". The events "got a head cold", "ear infection", "sinus infection", "experience extreme joint pain and rashes which seem to be related to a drug allergy" and "experience extreme joint pain and rashes which seem to be related to a drug allergy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, ear infection, sinusitis, arthralgia, rash.  Additional Information: if other vaccine in four weeks was no. other medications in two weeks was cephalosporin. Within 2 days of getting his first dose, my son got a head cold and its unknown whether its a reaction to vaccine or not. within 2 weeks of getting the vaccine, my son needed treatment with cephalosporin antibiotics for ear infection and sinus infection. While he is allergic to penicilin he took cephalosporins before and was fine. To-ward the end of the 7 days he began to experience extreme joint pain and rashes which seem to be related to a drug allergy. He took these before and did not have a reaction. I was not sure if it was related to the timing of the vaccine and some immune response. Treatment included steroids and ongoing use of Zyrtec and Benadryl. if covid prior vaccination and if covid tested post vaccination was yes. Device Date : 07Feb2022  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient received the following injections: 1) ProQuad (MMR/Varicella), 2) TDAP, 3) IPV, HEP B  Within approximately two minutes following these four injections, Patient asked if it was normal to feel very tired after vaccines, then slumped over in the chair she was sitting in, started convulsing and went unconscious.   The attending nurse and then the doctor who ran in to check vitals afterward did not share which vaccine or vaccine combination caused Patient to seize in a febrile seizure.
Headache started and continued for the whole day.  Actually then turned into chills, fever, cold sweats etc...
Extremely red, warm, painful arm. On day 2 much joint pain. Are still red and warm three days after shot.
After first vaccine I developed a rash under both arms that was hard pustules and then the skin became very sensitive and my breasts became sore and swollen.  I also had swelling under my injection site arm. This almost  cleared up before my 2nd vaccine except for the skin sensitivity and swelling under both arms. After the 2nd vaccine 3/3/21 within 48 hours my breasts became very swollen and painful and the under arm sensitivity became much worse. It is 2 weeks since the second dose and my breasts are still slightly swollen and tender. This is hopefully resolving, but was very painful and uncomfortable.
Fever, aches, chills, headache, exhaustion, fatigue for about 30 hours.  Very sore arm for about 5 days.
December 2021 beginning shortness of breath, prolonged fatigue, periodic headaches, joint pain in upper extremities beginning in shoulder blades, extending to forearms. Malaise, occasional confusion. Blood pressure increased during this time