chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; A vaccine coordinator reported VARIVAX were administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U022320 with expiration date: 15-JUL-2023), for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (product storage error). It was reported that the suspect vaccine was exposed to a temperature excursion of minus 11.83 degrees Celsius for a time frame of 15 minutes. Previous temperature excursion was at 9.37 degree Celsius for a time frame of 2 hours and 30 min.   No additional adverse events (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2204USA004005:
Admin dated 1-23-14. Patient called on 2/4/14 stating outbreak occurred on total Rgt side of face.
After I administered the vaccine, the patient left the shot room and sat down with his mother on the bench. A minute or two later at most, we heard his mom yelling for us and I could see him kind of slumped over while she kept him sitting up. I ran out with an EpiPen and saw him on the bench, slumped forward but coming to - he was able to speak with us and answer questions (his name, DOB, today's date, where he was). He was dizzy and his face was pale and sweaty, but he said otherwise he was okay. We provided him water and Gatorade, which he drank and said it helped. We had them stay for 30 minutes from that point to monitor for improvement, and there were no further issues. We checked in with them before they left, and the patient said he was fine and back to normal.
At site of HEP A vaccine injection a 1 cm area of skin breakdown /  laceration with scab formation. Little or no inflammation. Seen on 10-1-08.
Now I have (what I think ) is a cold (no fever); got my booster last Thursday and had a fever for a day and a half; This spontaneous case was reported by a pharmacist and describes the occurrence of NASOPHARYNGITIS (Now I have (what I think ) is a cold (no fever)) and PYREXIA (got my booster last Thursday and had a fever for a day and a half) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Now I have (what I think ) is a cold (no fever)) and PYREXIA (got my booster last Thursday and had a fever for a day and a half). At the time of the report, NASOPHARYNGITIS (Now I have (what I think ) is a cold (no fever)) and PYREXIA (got my booster last Thursday and had a fever for a day and a half) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
dot spot on back arm, another dark spot where I bend my arm; pain; scar above my elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (dot spot on back arm, another dark spot where I bend my arm), MYALGIA (pain) and SCAR (scar above my elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa drug) and Drug allergy (allergic to pneumovax vaccine).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (dot spot on back arm, another dark spot where I bend my arm), MYALGIA (pain) and SCAR (scar above my elbow). At the time of the report, RASH MACULAR (dot spot on back arm, another dark spot where I bend my arm), MYALGIA (pain) and SCAR (scar above my elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant  Concomitant product medication was provided by reporter. Treatment for the event included paracetmol.    Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No specific follow-up information recorded.
admitted for severe sepsis and septic shock after developing leg cellulitis one month after the second dose of covid shot. required ICU care.
Tested positive for Covid virus; Tested positive for Covid virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and administered in arm, administration date 06Apr2021 (Lot number: EW0176) at the age of 60 years as dose 1, single for covid-19 immunisation. Vaccination Facility Type of first vaccine was pharmacy and of second vaccine was vaccination clinic in a stadium. The patient had no relevant medical history. There were no concomitant medications. No other vaccines were administered on Same Dates or within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Dec2021, outcome "recovering" and all described as "Tested positive for Covid virus". The event "tested positive for covid virus" was evaluated at the physician office visit (Telemedicine appointment). The event didn't require a visit to Emergency Room.. Caller states she is calling about the Pfizer adult Covid vaccine. She received both vaccines in Apr2021, and she contracted the Covid virus last week. She was still in quarantine. Caller states that Pfizer advertised that a person was 80 percent protected from getting Covid after both vaccines. Her doctor told her to take vitamins. Caller does not provide names or product information. Caller asks if a person should get the booster shot if they have natural infection? Caller asks if there have been breakthrough infections with the Pfizer Covid vaccine, as compared to the other Covid vaccines? The patient underwent the following laboratory tests and procedures: sars-cov-2 test (rapid test): (03Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On day 8 after receiving the COVID shot, I woke up with a little redness (size wise, between a dime/nickel) and a small welt on my left arm at the site of the injection. It feels a bit warm to the touch and is tender but not painful. On a scale of 1-10 of "pain" its barely a 1. On the day after the injection, my pain was mild and I'd say it was 6-7.  On day 9, today, the redness is a bit larger, not exactly round, but about the size of a quarter, so a bit larger than yesterday and welt is still there. Day 8 was the first day that I didn't receive the Check In message, ironically, so I couldn't report it there. I simply wanted to ensure that this information was shared with the appropriate individuals. It is not impacting my ability to do anything, but since it seems to be as a result of the injection, I wanted to share it.
coughing; headache; felt different; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), FEELING ABNORMAL (felt different) and HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (felt different). On 06-Mar-2021, the patient experienced COUGH (coughing) and HEADACHE (headache). At the time of the report, COUGH (coughing), FEELING ABNORMAL (felt different) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
LOCALIZED SEVERE SWELLING GREATER THAN 3CM SEVERE PAIN AND CELLULITIS.
Pt devel autoimmune hemolytic anemia following Hep B; No further details were provided;
Grape-size swelling over left jugular area had resolved by next appt on 10/23/03.
Within minutes I felt dizzy and then my heart started beating rapidly. Nurse took my blood pressure, pulse, respirations. I was held at clinic for 30 minutes. Symptoms subsided gradually and were gone in 15 minutes.
Mother reporting.  He got his vaccine, approximately 3 weeks later he came home from work, was not feeling good, laid down, went to sleep and when he woke up he was not able to walk, paralyzed on left side.  He called 9-1-1 and was taken to the ER.  In the ER he was diagnosed with a stroke, and is still in the hospital undergo rehab.  They are hoping that he is going to  make a full recovery.   He is still totally paralyzed on his left side.    He was initially admitted to the Hospital, and then transferred to rehab unit at Rehabilitation Hospital since 6/5/21.
This spontaneous report as received from a medical assistant refers to a 19 year old (also reported as 20 year old) male patient. Medical history and drug reactions or allergies were not specified. In 1995 and 2008, the patient was vaccinated with the first and the second dose of (Oka/Merck) VARIVAX injection (route, dose and lot number were not reported) for prevention of varicella. Concomitant medications were not specified. On 21-AUG-2013, the patient had a titer drawn and results were equivalent. This was clarified to be subtherapeutic (exact results and units were not provided). The patient did not seek medical attention. The outcome of had a titer drawn and results were equivalent, this was clarified to be subtherapeutic was unknown. The relatedness between the event of had a titer drawn and results were equivalent, this was clarified to be subtherapeutic was not reported. Additional information is not expected because there is no permission to contact.
From initial information received on 19Aug04 from another manf (ref HQWYE519218JUN04) regarding an adverse event occurring, it was reported by the pt's parent and a physician that a two month old male pt received an ACTHIB vaccination, an IPOL vaccination and a TRIPEDIA vaccination on 17Jun03. The lot numbers, routes and sites of admin were not reported. That same day the pt slept alot. The recovery status of the pt was unk at the time of this report. This pt had a second adverse event which is detailed in case 200402130.
became unconscious & had tonic/clonic sz for about 30 seconds & back to unconscious;was out for about 2min;p/conscious vomited small amount;taken to MD to examine;arm swollen;
Person giving me the injection gave it to me in behind my arm, above elbow in the triceps area I know it was subQ; They said it was a 30 gauge needle; A spontaneous report was received from a female nurse who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and person giving me the injection gave it to me in behind my arm, above elbow in the triceps area I know it was subQ and they said it was a 30 gauge needle.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 subcutaneously in the arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient stated she was given the vaccine injection behind her arm, above the elbow, in the triceps area, subcutaneously.  She was also suspicious of the size of the needle used. She was told it was a 30-gauge needle that was supplied by Moderna. The patient stated she was a nurse practitioner and had given over hundreds of injections during her career and was certain her injection was not intramuscular. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, person giving me the injection gave it to me in behind my arm, above elbow in the triceps area I know it was subQ and they said it was a 30 gauge needle, were considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration and Drug administration in wrong device without any associated adverse events.
30OCT recvd flu shot 13NOV got flu like s/s for 2 wks w/cough req codeine syrup; bronchial cough w/yellow sp production;
No additional AEs; improperly stored vaccine GARADASIL 9 was administered to patient; This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 19-JAN-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687291, expiration date 11-SEP-2022, injection of 0.5 ml (strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse events were reported. The reported temperature excursion was 47.8 Fahrenheit for 15 minutes. There was no previous temperature excursion reported. A digital data logger was used to capture the temperatures. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I received my 4th dose on 06/21/2022. My Influenza symptoms started in the morning around 08:00AM on 11/09/2022. I had a stuffy head, runny nose, coughing, achy face, severe head, and sneezing. On 11/13/2022 I went to the clinic where they did few tests. They did flu and COVID-19. I was positive for Influenza B. I was taking MUCINEX AM/PM before I went to the clinic. They just advised me to continue taking MUCINEX and to drink plenty of fluids. Over all it lasted for 1 month. It just subsided 1 week ago.
Arm hurting, Trouble lifting Arm; Nausea; Headache; Soreness; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness). At the time of the report, LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness). At the time of the report, LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
11/16/22 PT reported (L) arm swelling pain after vaccination on 11/2/22. Dx'd with cellulitis, Tx'd with cephalexin
Tingling that started in your feet or toes that ascended upward through her body. Tingling and weakness spreading very rapidly. Difficulty catching her breath. Choking on saliva. Respiratory failure. Paralyzed throughout her whole body. All due to the flu shot.
Rash 5 days after receiving MMR (9/1/15 MMR administered).
Hives that were very itchy and were on my legs , atomach , arms , and neck
pt devel a few lesions consistent w/chickenpox-crusted over 6d;4/12/98 new vesicular lesions appeared w/a dense cluster on rt antecubital area/few on trunk;IM atb for warmth & erythema around lesions for r/o cellulitis;hosp w/ IV atb
Tingling began in face and back of the head. Woke up the next morning with a metallic taste in mouth, numbness in mouth. Tingling and numbness persisted throughout face and head. Visited Urgent Care clinic on day 2. Prescribed prednisone to combat numbness and tingling. Began steroid this morning, day 3, no improvement. Face and head still tingle and mouth still numb.   Other side effects: lack of appetite, constant diarrhea (also began 5/11), sore arm, redness at injection site.
Four fever blisters; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Four fever blisters) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Four fever blisters). At the time of the report, ORAL HERPES (Four fever blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-022002 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022002:Crosslinked (MOD21-14971)
vaccine that was administered to a patient after temperature excursion occured; This spontaneous report has been received from a nursing assistant concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.        On 13-AUG-2020,  the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX)  formulation not provided but defaulted to subcutaneous injection, Lot # T002846 and  expiration date 23-JAN-2022  for prophylaxis (dosage regimen was not provided). The storage temperature was reported to had been at  -10.2°C for 1 hour and 53 minutes.            There was digital data logger involved and  no previous temperature excursion was reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950:AE case # 01697219 US-009507513-2008USA014798:AE case #01697207 US-009507513-2008USA014951:
LIGHT SENSITIVITY TO EYES; BLURRED VISION; VISION CHANGES; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included connective tissue disease, polyglandular failure (type 2), and raynaud's disease, and concurrent conditions included fibromyalgia, chronic hashimoto's disease, chronic lyme's disease, hypophosphatasia, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with clindamycin, codeine, lansoprazole, and glycopyrronium bromide. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced light sensitivity to eyes. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced vision changes. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from light sensitivity to eyes, blurred vision, and vision changes. This report was non-serious.
I gave patient a flu shot and a Tdap today at 11:43 pm. After that she said she felt dizzy and passed out for a few seconds. I asked employee to call 911 and the ambulance came. While waiting for the ambulance, I taped on her shoulder and she woke up and she threw up water. She said she has a fear for needle a long time ago and she overcame it but may be not this time. She also didn't have food yet. After that she rested and her husband picked her up
Moderna COVID-19 Vaccine EUA 7 days after the first injection of the Moderna vaccine, the area of my left shoulder where the vaccine was given became red, mildly sore, raised and warm.  It was an area about 4 inches long and 2 inches wide. I also experienced some discomfort in my left underarm at the same time.  My arm was sore, but not as sore as it was in the initial 24 hours after receiving the vaccine.  I did not have a fever.
Patient stated history of passing out after vaccines given or getting a procedure such as giving blood. States last time he gave blood he passed out. Patient had breakfast and half cup of apple juice prior to vaccine. Patient then taken to exam table to give vaccines. BEXERO given in right arm first then MENACTRA given after in left arm. Patient was awake and alert while receiving vaccine. Patient remained talking after vaccines given and the less than two minutes after, patient stated he wasn't feeling well. Patient became unresponsive and eyes rolled to back of head. Patient then began posturing and flinging arms, still unresponsive. Entire episode lasted less than 60 seconds. Patient awake, alert and able to answer questions immediately following. Patient diaphoretic, face and hands pale. Ice packs given x2 and legs elevated. VS: (1101a) BP 119/78, pulse 68, SPo2 93 percent. Patient pale and diaphoretic. Patient recovered for 50 minutes total. Attempts to sit patient up while recovering lead patient to feel "lightheaded." Final vital signs (1149a) BP 110/73, 60, and SPo2 95 percent. Patient appropriate in speech and coloring returned to face and hands. Patient able to transfer to wheelchair with minimal assistance. Patient Mother drove patient home.