chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse was vaccinating the client.  The client grabbed the syringe and the needle after nurse had pierced the skin but no vaccine was administered resulting in a 1/2 inch surface level scratch with minimal bleeding.  Covered scratch with a bandaid.   Needle was bent.  A new syringe and dose were then successfully administered in the opposite thigh.
Developed peripheral neuropathy, muscle weakness, pain in hands and feet, atrial fibrillation and congestive heart failure, severe swelling in legs.
FU by clinic Dr 9-27-11. TX MOTRIN 600 QID, TYL 4x/500mg, ice after heat, MOTRIN 800mg TID, VICODIN 500 at HS. Complaint of soreness, pain & increased warmth at injection site, some numbness initially in arms progressing to fingers. No streak, no significant swelling, decreased ROM (R) shoulder. Pt. to follow up with own primary health care provider & clinic Dr.
Chest pain/pressure, spread to abdominal pain, back pain. Difficulty breathing. Achiness. Headache and has developed panic attacks and anxiety. hard time sleeping due to chest pain
Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot; Twitching in the right upper eye lid; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot) and BLEPHAROSPASM (Twitching in the right upper eye lid) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20H) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, ATORVASTATIN, LOSARTAN, SPIRONOLACTONE, CARVEDILOL, AMITRIPTYLINE, FUROSEMIDE, PARACETAMOL (TYLENOL), ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), DICLOFENAC, PENTOSAN POLYSULFATE, GABAPENTIN, MELOXICAM, OMEPRAZOLE, BUSPIRONE, TOLTERODINE, ASCORBIC ACID, VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ALOPECIA (Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot) and BLEPHAROSPASM (Twitching in the right upper eye lid). At the time of the report, ALOPECIA (Loss of about 40 to 45% of hair progressively beginning 2 days after second vaccine shot) and BLEPHAROSPASM (Twitching in the right upper eye lid) outcome was unknown. Not Provided          Treatment medications were not reported
it was rpt from health care professional concerning a pt who was vax w/pneumococcal & devel localized react described as a cellulitis-like react;
01/27/2021- I had a lot of soreness at injection site, couldn't lift my arm, and it left a big red bump, very painful, I couldn't sleep, so the next morning I stayed in bed, then all the sudden I had the chills. It last for about 3 or 4 hours. The redness lasted for about a week
Nausea. Feeling like throwing up and needing to poop. Started around 230 in the morning.
Sore to touch, red, numbness down arm to thumb, ER visit 10/8/11.
This spontaneous report was received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose, route of administration and lot # were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child's left eye became swollen with redness with itching and watery eyes, and pale face.
COVID positive; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medication includes Monoclonal antibodies in Oct-2021.  HCP asked if there is an interval before receiving 3rd full dose due to being immunocompromised. It was reported that unknown dates of 1st and 2nd doses.  This is a spontaneous case concerning  a  patient of unknown age and gender, with Concurrent medical condition of Immunocompromised, who experienced the unexpected non-serious event of Covid-19. The events occurred on an unknown date after the second dose of mRNA-1273 COVID 19 Vaccine. With positive test for Covid. Underwent treatment with monoclonal antibodies. The event outcome was reported as unknown. The Concurrent medical conditions of Immunocompromised, remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a  patient of unknown age and gender, with Concurrent medical condition of Immunocompromised, who experienced the unexpected non-serious event of Covid-19. The events occurred on an unknown date after the second dose of mRNA-1273 COVID 19 Vaccine. With positive test for Covid. Underwent treatment with monoclonal antibodies. The event outcome was reported as unknown. The Concurrent medical conditions of Immunocompromised, remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
1min p/vax pt devel muscle contractions in arms, legs;lost consciousness;had incontinence, diaphoresis, heart racing, ears ringing, n, h/a;parent did not seek med attention called MD 1 day later;dx allergy to vax by phone;
Immediately following administration of Covid 19 vaccine (Pfizer), patient experienced profuse sweating , nausea and blurred vision (described as seeing stars). Medics were called and upon arrival vitals were obtained. Blood pressure was normal. Patient refused transport. Patient remained in pharmacy for about 1 hour for observation. Patient was able to  walk out.
"Felt sick" for 1 day. Also, injection site area of arm became red and painful for a week.  Redness also spread down the arm some.
pt in er 9/21/2008 with complaints of pain at injection site lt deltoid. dr  seen pt in er assessment: local erythema at injection site. local care to site discussed
AE-  Whole body aches, shivers, chilly, couldn't go to work, hungry but can't eat. Treatment - TYLENOL for aches and pain, working up to light meal of crackers, resting as much as possible. Outcome - at the moment patient believes it's just about peaked and will not need a doctors visit.
Pt got first HPV GARDASIL vaccine and was walking to bathroom and fainted impacting (L) cheek and chin and lower lip.
Moderna COVID-19 Vaccine EUA. Swollen Left Eyelid 1st day and on 2nd day Right Eye Swollen as well
felt vaguely itchy; mildly short of breath; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (felt vaguely itchy) and DYSPNOEA (mildly short of breath) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and TRIAMCINOLONE for an unknown indication.    On 17-Jan-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 PRURITUS (felt vaguely itchy) and DYSPNOEA (mildly short of breath). At the time of the report, PRURITUS (felt vaguely itchy) and DYSPNOEA (mildly short of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Jittery at injectionsite; Swollen at injection site; Painful again; Red at injection site; Tired; Felt crummy; Itching; Painful; Red at injection site; Woozy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woozy), NERVOUSNESS (Jittery at injectionsite), MALAISE (Felt crummy), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE PAIN (Painful) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (Woozy), MALAISE (Felt crummy), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Painful), the first episode of VACCINATION SITE ERYTHEMA (Red at injection site) and FATIGUE (Tired). On 12-Feb-2021, the patient experienced NERVOUSNESS (Jittery at injectionsite), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE PAIN (Painful again) and the second episode of VACCINATION SITE ERYTHEMA (Red at injection site). On 10-Feb-2021, DIZZINESS (Woozy), MALAISE (Felt crummy), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Painful) and FATIGUE (Tired) had resolved. At the time of the report, NERVOUSNESS (Jittery at injectionsite), VACCINATION SITE SWELLING (Swollen at injection site), VACCINATION SITE PAIN (Painful again) and the last episode of VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by Reporter.  No treatment information provided.
arm sorenss; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sorenss) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (arm sorenss). The patient was treated with PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH) at a dose of 500 mg. At the time of the report, PAIN IN EXTREMITY (arm sorenss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Pt received 2nd MMR shot on 22 Mar 11, first received 5 Jan 11. Five days after 2nd MMR shot, pt woke up with red non-itchy bumps on right forearm and all over both lower extremities. Pt states denying changing any habits. Has been using cortisone cream.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 07-FEB-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA008566: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Pt presented to ED carried by mom, states pt had an immunization 1 hour PTA and now she noted a rash and spots around his mouth and lips, mom reports lip and face swelling as well. Respirations are regular, non labored. Provider notes from ER record are as follows: "Patient is a 17 month old male presenting today with mom who reports patient began with facial and lip swelling after receiving his hepatitis B, pneumococcal, D-tap and Polio vaccinations around 9:20 AM today. Mom states patient is behind on his immunizations for his age, reporting shortly after receiving his vaccinations today, patient started with a rash on his face. She denies patient having known allergies or similar reactions in the past. She denies patient having any vomiting, diarrhea or appearing SOB. Patient is reported otherwise healthy without medical problems." Pt was given the medications prednisolone sod- phos 15 mg/5 mL oral solution 13.5 mg and diphenhydramine 12.5 mg/5 mL liquid 6.25 mg once at approximately 10:32 AM and 10:33 AM. Pt was kept in the ER and at 10:54 AM nurse noted a few more spots on arms and redness right face and eye. At 11:25 AM nurse notes "Improved rash. Redness right eye. Child is resting. Do not have a time that patient left the ER. On 4/24/17 at 2:50 PM, mom called the provider office to notify that patient had a severe allergic reaction 30 minutes after leaving office.
burning in chest and pressure. Dr  said go to ER Referred to Cardiologist   for pericarditis
2nd pfizer vaccine dose was given to pt on 07-06-2021. We found out on 07-09-2021 that vaccine expiration date was outside the recommended 31 day window. We tried to reached out to pt on 07/10 & 07/11 but we were unable to talk to reach.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: I tested negative on day 7 (of having COVID); (Mar2023) Positive, notes: I'm testing positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Mar2023 to 18Mar2023. Additional information: patient has no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
SWELLING AT INJECTION SITE AND SWELLING ON LEFT CORNER OF MOUTH AND LIP
At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone.  I had not other symptoms or complications.
Patient received Pfizer 1st dose on 7/28/21 at Pharmacy. Prior to her second dose on 8/18/21, pharmacist checked MIIS registry and found out patient had previously received Johnson & Johnson shot on March 15, 2021 at a Pharmacy. Patient was not given the 2nd dose of Pfizer shot. When asked, patient said she did not remember getting the J&J shot in March, and her signed consent form indicated she had not previously received a COVID-19 vaccine in the past. No adverse events reported.
Rash at injection site (LA), wheezing, nausea, throat tightening.
mom called 6 days p/1yr vax were given & stated pt had blisters all over mouth & a white coating on tongue & high pitched cry; instructed to take pt to MD; MD stated pt was related to MMR & tx w/Motrin
Several hours after receiving vaccine,s patient had a prolonged episode of pallor and diminished response.  06/18/2007 MR received for o/n admission for observation after developing multiple episodes of vomiting followed by pallor and lethargy several hours after vax.  Initially appeared quite ill upon arrival in the ER, but became alert, awake and smiling after IV hydration. No further episodes during admission. Impression: Vomiting, altered mental status 2' immunizations.
Pain at injection site - 72 hours Chills - 2 hours Fever - (assumed-I did not check it) about 8 hours Headache - 18 hours Body aches - 24 hours Low energy - 36 hours
Swelling of left arm, rash, itch, pain. Egg like lump in upper arm above injection site and moved down to the fold of the arm.
No known adverse effects; a dose of PNEUMOVAX was given to a patient via the intravenous route; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 16-MAR-2020, an unknown dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot number R030140 and expiration date 07-AUG-2020) was administered to the patient via the intravenous route. No known adverse effects.
I had my hair thinning and progressively getting worse on my head only. I also my primary diagnosis is Lindsey's Nails.
Pt received first dose on 4/22 and developed a rash on 4/25 on the interior aspect of the right arm. Rash area felt hot and itchy. Rash has been resolving with small rash still visible on upper aspect of right arm on 5/20. Pt cleared for 2nd Moderna dose. Pt uses they/them pronouns.
BOTH HAND ASLEEP WHEN I WOKE UP AND WHEN I OPENED MY HANDS THEY BURNED AS IF THEY WERE ON FIRE AND STILL DO THE SAME THING TODAY
The patient got the shot at 1300. At 1330 patient states she has an itchy arm,  her tongue felt  weird, and there was tingling down her legs. She said she also had a headache.  I called an ambulance as tongue swelling could lead to airway obstruction. She stated that she has bouts with anxiety. The EMTs came and stated that there was not a rash and anaphylaxis  usually occurs within 10 to 15 minutes. Around this time was 1400. Patient  purchased some benadryl. Patient refused EMTs offering to take her to the hospital. Her BP/pulse was elevated and she said she had a headache and was shaky. The EMTs left and I advised her to have someone drive her home. I called the patient at approximately 1500 and she said she was feeling better and her daughter picked her up..
tinnitus; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "recovered".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347676 Same patient, different dose number/event;
EXPOSURE TO JANSSEN COVID-19 VACCINE VIA BREAST MILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0242A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced exposure to janssen covid-19 vaccine via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure to janssen covid-19 vaccine via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210526707.
Shingles even though I had them 2 years ago/ suspected Vaccination failure; Shingles; Pain; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient had shingles even though the patient received shingles vaccine 2 years before the date of reporting. The patient had pain which was not gone. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
A non-serious, spontaneous, report of vomiting, nausea and diarrhea was received from a consumer, concerning a nine-year-old female subsequent to FLUMIST. The patients medical history includes sensitive stomach with vomiting, and seasonal and nasal allergies. Concomitant medications include fluticasone propionate since Nov-2007 for nasal allergies. The patient received FLUMIST on 28-Nov-2008, intranasal for influenza vaccination. Approximately six hours following administration, the patient experienced nausea and began vomiting about every 20 minutes throughout the night. The next day, the patient experienced diarrhea and was taken to the pediatrician office because she could not hold down water. She was given a PEDIALYTE pop and PHENERGAN by mouth. The patient recovered from the events on 29-Nov-2008. The patient's physician told the parent she did not think the events were related to FLUMIST.