chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: neomycin" (unspecified if ongoing); "digestive issues (food allergies)/sinusitis (food allergies)" (unspecified if ongoing); "sinusitis (food allergies)" (unspecified if ongoing); "eustacian tube inflammation" (unspecified if ongoing); "Uticaria from eye drops" (unspecified if ongoing), notes: other medical history: Uticaria from eye drops; "Known allergies: other antibiotics topical" (unspecified if ongoing); "digestive issues (food allergies)" (unspecified if ongoing); "Known allergies: additives in eye drops" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, prev dose lot number: EN6208, prev dose administration time: 11:45 AM, prev dose vaccine location: Right arm), administration date: 11Mar2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Vaccination site pain", "Arthralgia", "Pain in extremity", "Headache", "Visual impairment"; BNT162b2 (DOSE 2, SINGLE, prev dose lot number: ER8737, prev dose vaccine location: Right arm), administration date: 01Apr2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Vaccination site pain", "Arthralgia", "Pain in extremity", "Headache", "Visual impairment". The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "recovered", described as "intermittent visual focus disturbances 5-6 hours"; MALAISE (non-serious), outcome "recovered", described as "general malaise 6 hours"; VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious), outcome "recovered" and all described as "First 4 doses upon injection shooting pain down arm to wrist"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "pain in arm 4-5 hours/shooting pain, Down arm to wrist"; HEADACHE (non-serious), outcome "recovered", described as "pounding headache 3-4 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of visual impairment, malaise, vaccination site pain, arthralgia, pain in extremity, headache. Additional information: Facility type vaccine was pharmacy or drug Store. No other vaccine in four weeks and no covid prior vaccination. First 4 doses upon injection shooting pain, down arm to wrist, continued pain in arm 4-5 Hours, pounding headache 3-4 hours, intermittent visual focus disturbances 5-6 Hours, general malaise 6 hours. No follow-up attempts are possible. No further information is expected.
Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked); Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked); Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked); This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)), UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)). On an unknown date, the patient experienced NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)). At the time of the report, DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)), UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)) and UNDERDOSE (Administration error: the needle leaked while administering the bivalent vaccine (unknown what volume leaked)).    It was reported that patient mentioned that 4 weeks ago she received the Moderna bivalent booster but the needle leaked while administering the vaccine unknown what volume leaked.  It was unknown if patient experienced any AE after the vaccine. It was unknown if any treatment was given for any symptom or if patient was under any concomitant or regular medication.
a sore arm after receiving her COVID 19 vaccine booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "a sore arm after receiving her COVID 19 vaccine booster shot". Additional information: Patient reports a sore arm after receiving her COVID 19 vaccine booster shot. It was better now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
w/in 8hr of vax pt exp pain in calf muscles, then moving to both knees;following day sx worse;no relief w/ASA consumption;sx gradually resolved over 4 days;presently totally asymptomatic;
Pt received Varicella vaccine on 9-21-98 & 4-7-09. Diagnosed with varicella on 6-17-11 at clinic and confirmed by doctor in our office on 6-20-11.
local reaction: 24 hrs post vaccination she developed swelling with pruritus, 48 hours post vaccination (when the patient was evaluated) she had pruritus, 2 cm of erythema, significant tenderness to palpation, calor and corresponding mild axillary lymphadenopathy. no consitutional symptoms were reported.
The morning after I received the vaccine I developed a rash and intermittent hives.  Whenever I scratch the areas the hives develop .  They come and go.  This started as a raised hive around the vaccination area then moved to other areas.  I am still having this issue after 16 days .  I have not gone to the doctor and have been taking benydryl for relief
Had well teen exam on 6/1/15 & received MMR on 6/11/15 developed pneumonia (seen in clinic) w/presenting malaise, fever, vomiting. Persistent fever 6/17/15 & seen in ER w/worsening pneumonia. No rash.
Pt devel elevated temp 9PM day of immun; c/o discomfort, soreness, & stiffness all over extremities & in chest next AM; Temp elevated to 104 night of immun;
Fever; Nausea; Fatigue; Redness at injection site; Itchiness at the site of injection; Tender at the site injection; Warm to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection), INJECTION SITE WARMTH (Warm to the touch at injection site) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection) and INJECTION SITE WARMTH (Warm to the touch at injection site). On 01-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE PAIN (Tender at the site injection), INJECTION SITE WARMTH (Warm to the touch at injection site), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  The treatment Medication was Tylenol.
The pt developed a rash on her torso, arms and legs. She had the shot at approx. 14:30 and the rash and itching started approx. 20:00. Went to the doctor and said it could be related to sulfa antibiotic taken the previous week and was referred to an allergist.
Muscle soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 19:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN)  and lisinopril (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 11:00, the patient experienced muscle soreness at injection site that lasted approx. 24 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event muscle soreness at injection site was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacy sales representative concerning a female who on approx. 10/22/01 was vaccinated with pneumococcal vaccine 23 polyvalent. A few days later, in 10/01, the pt was hospitalized for a "infection". The same source also provided information regarding other persons' experiences with pneumococcal vaccine 23 polyvalent (WAES 01110031). Additional information has been requested.
Patient reports 100 F fever, redness and swelling of arm from elbow to neck, fatigue
This spontaneous report was received from a 60 years-old female patient, reporting on herself. The patient's did not have pertinent medical history. Her concurrent conditions included drug reaction or allergy to penicillin. Concomitant medications included losartan potassium (manufacturer unknown). On 17-APR-2017, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose and route of administration were not provided) in combination with a sterile diluent (manufacturer unknown) (lot #, expiration date, strength and dose were not provided); the shot was administered in the fatty part of the upper left arm, for shingles prevention. After that, her left arm became swollen, and a red welt was developed around the injection site. The patient also stated that she was experiencing a little bit of soreness on the lymph gland on the side where the shot was administered. The patient sought medical attention by speaking with her physician but no laboratory diagnostics studies were performed. At the reporting time, the patient had not recovered from the peripheral swelling, injection site erythema and lymph node pain. The relatedness between the peripheral swelling, injection site erythema and lymph node pain and the vaccine was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
fingers really swollen; tight chest; Wheezing; headache; Rash on body; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age of 44-years-old) as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and celiac disease. The patient had a history of allergy to sulfamethoxazole, trimethoprim (BACTRIUM), penicillin, nitrofurantoin (MACROBID) and gluten. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 15.30, the patient experienced headache within 30 minutes and rash on body that night then next day morning woke up to fingers really swollen, tight chest and wheezing. The patient received benadryl and advil as treatment advised by doctor for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the rash, headache, finger swollen, tight chest and wheezing was not resolved.   No follow-up attempts are needed. No further information expected.
3rd HPV vaccine on 12/27/22 and two weeks later 1/14/23 had a rash all over my chest and back, had profound fatigue and joint pain. 1/17/23 - still with rash
Patient was unknowingly about 12 weeks pregnancy at time of immunization. She only found out about pregnancy on 12/25/18 and is due 3/7/19. She is currently in prenatal care but no other details about health of pregnancy are known.
Moderna vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED  I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 5/13/2021 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Patient stated that he woke up on 2-23-22  and adjusted his pillow with his left arm and began having shooting pain that radiated up and down his left arm and neck. He said that one day later his arm  became numb and he rubbed it with green alcohol.  He stated that his arm is no longer numb, but stings when he moves it up and down, but doesn't hurt at rest. He has not gone for  medical attention at this time.  He said he is going to wait to see if pain improves.
Information has been received from an Advanced Registered Nurse Practitioner concerning a 15 year old female patient with drug reactions/allergies to amoxicillin and sulfa medicines, who on 18-DEC-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 662304/1013Y) and on 12-MAR-2010, the patient was vaccinated with the second dose of GARDASIL (lot number 665266/1378Y). There was no concomitant medication. On 12-MAR-2010 the patient experienced extreme left neck pain with tricep tingling at the injection site of her left arm. The patient also had limited range of motion of her neck and left arm. The patient was taking ibuprofen for the discomfort. On 16-MAR-2010, the patient visited the doctor. The patient had no adverse symptoms after the first dose of GARDASIL. At the time of the report, the patient had not recovered. No laboratory diagnostics studies were performed. Follow up information has been received from a Nurse Practitioner who stated that the patient did not receive any concomitant vaccinations when GARDASIL vaccinations were administered. The Nurse Practitioner spoke to the patient's mother on 19-MAR-2010 and the patient was doing better. The patient had an increase in motion in her neck and arm. The patient was treated with "heat and ibuprofen". Additional information has been requested.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-APR-2016, The patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L033548 with expiration date 14-MAY-2017 (strength and dose number were not provided). The patient's concomitant medications were not reported. The office manager stated that, the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. ROTATEQ was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-JAN-2018, The patient was inadvertently vaccinated with a dose of PROQUAD injection, 0.5 ml, by subcutaneous route, lot number N002325, expiration date 19-JUL-2018, with M-M-R II lot number M040558, expiration date 03-OCT-2018 (strength, dose and route of administration were not reported) both for prophylaxis. It was reconstituted with sterile diluent (STERILE DILUENT) lot number # M044949, expiration date 18-JUN-2019. No adverse effects reported.
It started with swollen lymph nodes all over my body and also since them I have not had menstrual cycle since vaccine. I also have been experiencing rapid weight gain.  I'm seeing a gynecologist, Rheumatologist, and endocrinologist.  I have taken progesterone to see if it would kick start my periods again but it has not.
Vaccine was given at 4:38pm 2-3-23, per provider at site, best to wait to call patient next day to confirm any symptoms or adverse reactions noted. Attempted to call patient 3x today, no answer or VM option. Day of, after administration of vaccine patient was asked to wait 15 mins to ensure no adverse reactions, patient left with no symptoms/adverse reactions. Attempted to call patient by reaching mother, however no answer or VM option. I made two attempts on 2-3-23 @ 8:49am and again at 8:50am. Will continue trying later in the day.
Redness and swelling on right thigh that has resolved. Small pea sized knot located under the skin on right thigh 19 days later that mother states has decreased in size.
1/2 dollar size welt on (L) deltoid. Welt was red, tender and hard. Treatment: watched until gone - Gone by Friday 9/4/09.
Havrix expired 2021 was given patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date July 2021) for prophylaxis.   On 12th January 2022, the patient received Havrix. On 12th January 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The case was reported by the Pharmacist's technician. The age at vaccination was not reported. The patient was indivertibly given an expired dose of Havrix, which led to expired vaccine used. No information was available about the patient involved and lot number of the vaccine at the time of reporting. The reporter consented to follow up via email.
Swollen Itchy Eye lids creating a crusty scab that burns; Swollen Itchy Eye lids creating a crusty scab that burns; Swollen Itchy Eye lids creating a crusty scab that burns; Swollen Itchy Eye lids creating a crusty scab that burns; Itchy scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0177) at the age of 33 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient did not have COVID-19 prior to the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of the BNT162B2 vaccine. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0165, Location of injection: Arm Left), administration date: 11May2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (medically significant), EYELIDS PRURITUS (medically significant), EYE IRRITATION (non-serious), SCAB (non-serious) all with onset 01Jun2021, outcome "not recovered" and all described as "Swollen Itchy Eye lids creating a crusty scab that burns"; PRURITUS (non-serious) with onset 01Jun2021, outcome "not recovered", described as "Itchy scalp". The events "swollen itchy eye lids creating a crusty scab that burns" and "itchy scalp" were evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling of eyelid, eyelids pruritus, eye irritation, scab, pruritus. Clinical Course: Treatment included two doses of steroids and steroid creams. The patient was not tested for COVID-19 post vaccination.   Follow-up (17Dec2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient received ZOSTAVAX vial 19400 PFU (lot number, expiry date, route and dose were not reported) instead of VARIVAX. No adverse symptoms reported. Additional information has been requested.
Slept for 24hrs straight.  Green mucus fecal matter in diaper.
I am a registered nurse at Medical Center.  I have received the flu vaccine every year since 2007, without any reaction. This year, after my Administrator On Duty gave me the shot about 2 hours after, I started getting swollen eyes and a sore throat. I called the pharmacy, they said to call our AOD. She then told me to call our employee health nurse, who does not get into the office until about 7:30 AM. As the morning proceeded, My symptoms started getting worse, and I felt like I couldn't catch my breath. Once I saw our employee health nurse, she advised me to go to the ER for treatment. Once in the ER, they administered a bolus of fluid for my heart rate (150s), as well as, Benadryl IV, Epinephrine sub Q, and dexamethasone IV.
Local hyperemia erythema on rt upper thigh extending 10cm from injection sight warm to touch from inner thigh to outer thigh