chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; improperly stored vaccine was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in July 2019 (reported as between 03-JUL-2019 and 29-JUL-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002393, expiration date 31-JAN-2021 and lot # R035225, expiration date 04-DEC-2020 (dose and route of administration were not reported) for prophylaxis and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date reported as 31-JUL-2020, but upon internal validation established as 30-JUL-2020 and lot # S008577, expiration date reported as 30-SEP-2020, but upon internal validation established as 16-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of total time in range -14 degrees Celsius to -10 degrees Celsius (-12.8 degrees Celsius) for 12 hours 3 minutes. There were no previous excursions reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA000192:
Information has been received concerning a patient who was vaccinated with a dose of Gardasil. It was reported that there may be a possible adverse event with the vaccine. The reporter did not have any specifics of the type of reaction or any other information. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Big round circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Big round circle around injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE REACTION (Big round circle around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Big round circle around injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
Pt called to report she had developed mouth sores & blisters on lips "a few days after" her vaccination. 4 days after she experienced explosive diarrhea x10 that day 4/12/2021.  Pt contacted PCP but was referred back to health center without any instructions for resolving issues. RN instructed Pt to try OTC meds for diarrhea , BRATT diet discussed, maintain hydration, warm salt water rinses for mouth sores?avoid spicy food & hard , pointy food & to wipe gently after diarrhea. Pt verbalized understanding. Pt denies any fever, abdominal discomfort or breathing issues. RN discussed V-safe with Pt to report side effects. Pt given website to sign up. Pt verbalized understanding. Pt aware to call PCP if s/s worsen or health center for any questions or concerns.
unable to sleep at night; She felt like she wanted to die; migraines; very achy; throwing up,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on 15Feb2021 at 11:30 (at the age of 65-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included irritable bowel syndrome. The patient concomitant medications were not reported. The patient previously received pneumonia vaccine on 04Jan2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced migraines, very achy, throwing up unable to sleep at night on 17Feb2021. Patient stated 10 days later I'm still having migraines, I feel like dying. She started having daily migraines. She has had a problem with migraines off and on for 4 years. She was also very achy. She wishes she could throw up. She doesn't sleep at night. She is concerned that this will happen with the second dose. The pain with the migraine is so bad. The migraines started at noon. She felt like she wanted to die. They start every afternoon. The feeling of wanting to throw up comes and goes. It is not constant. It comes in cycles. Last night she took two Ibuprofen because she could not take it anymore. The outcome of the events migraines was not recovered, very achy was recovering and other events was unknown.  No follow-up attempts are possible. No further information is expected.
A day after the first shot, I had a burning in the back of my throat for several hours. A day after the second shot, the same thing happened. I now have a burning sensation in my throat about once a week or once every other week that lasts between 6 hours and 2 to 3 days. It's not painful per se. It doesn't impede eating or drinking. It's just mildly uncomfortable. I don't have any other symptoms that go along with it.
rash at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: Fh8027) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 14Nov2021, outcome "recovering", described as "rash at site of injection". Therapeutic measures were not taken as a result of vaccination site rash. Additional information:  The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient started complaining of tingling in legs and arms and dizziness 5 minutes after vaccination. Tingling spread to hands and a headache began. BP was 160/110. EMS was called at 11am.  Dosage of 25mg of diphenhydramine was given. Patient started complaining of nausea and stated he did eat breakfast. EMS arrived at 11:07am and BP was 170/130. Patient was transported. Patient was given a shot of steroids and recovered quickly. Was discharged to be monitored at home by wife.
Chills, body aches, shivering, mild fever, pain in the arm near the injection site, feeling of being sick (similar to strong flu except that the body temperature was not too high). It lasted about 36-48 hours. Acetaminophen was taken 36 hours after first symptoms, which helped reduce the symptoms.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of GARDASIL 9 (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: M042853 (expiration date 17-JUL-2019), M044717 (expiration date: 19-JUL-2019), and N004799 (expiration date: 15-NOV-2019). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004047: US-009507513-1709USA004343: US-009507513-1709USA004344:
no symptomatic side effects were reported; administration of expired RECOMBIVAXHB to a pediatric patient; This spontaneous report was received from a medical assistant and refers to a pediatric patient of an unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 08-MAY-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) pre-filled syringe, intramuscular injection, 5/0.5 mcrg/ml, 0.5 milliliter, once, lot #U032668, expiration date: 24-APR-2023 (administration site, and route of administration were not provided) administered for prophylaxis (expired product administered). The administered vaccine did not have any temperature excursions. No symptomatic side effects were reported (no adverse event).
Lost balance and fell on left side. Alert and oriented x 3. BP 140/77 (pulse 92).
pain which spread to the back; injection site became purple; appeared a ball at the injection site and other ball between the breast and the arm; appeared a ball at the injection site and other ball between the breast and the arm; pain in both legs; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain which spread to the back), VACCINATION SITE DISCOLOURATION (injection site became purple), VACCINATION SITE MASS (appeared a ball at the injection site and other ball between the breast and the arm), BREAST MASS (appeared a ball at the injection site and other ball between the breast and the arm) and PAIN IN EXTREMITY (pain in both legs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 BACK PAIN (pain which spread to the back), VACCINATION SITE DISCOLOURATION (injection site became purple), VACCINATION SITE MASS (appeared a ball at the injection site and other ball between the breast and the arm), BREAST MASS (appeared a ball at the injection site and other ball between the breast and the arm) and PAIN IN EXTREMITY (pain in both legs). At the time of the report, BACK PAIN (pain which spread to the back), VACCINATION SITE DISCOLOURATION (injection site became purple), VACCINATION SITE MASS (appeared a ball at the injection site and other ball between the breast and the arm), BREAST MASS (appeared a ball at the injection site and other ball between the breast and the arm) and PAIN IN EXTREMITY (pain in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional info received- newevent added
Patient presented to ED for on/off SOB the past few days. Required O2 60% FiO2. Acute on chronic CHF exacerbation. Treated with Lasix. Patient is currently improved and planned discharge.
Patient had DTaP yesterday and started complaining last night that his right leg hurt and itched- this am, the right thigh was swollen and edematous with a macular pink rash down the front of the thigh - there is no fever- the pt is listless and doesn't want to eat.
Gait dysfunction, headache, tachypnea, muscle weakness in lower extremities, shakiness, flushing of face.
Pt obtained low grade fever and mild raised rash to chest, stomach and somewhat on face. Seems to itch a little bit
Pt recvd MMR vax & currently exhibited a lack of response to mumps; no further details were provided;
sx: itching around neck/behind both ears, both axillary, no rashes, denies short of breath nor chest tightness after 30 mins observation tx: Benadryl ordered by Dr.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates, unspecified number of unspecified patients received improperly stored doses of PNEUMOVAX 23 injection, prefilled syringe, lot # K020215, expiration date 15-MAY-2016 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several report from the same reporter. Additional information has been requested.
woke up with the worst tinnitus...so loud...currently still louder than what I had prior; woke up with the worst tinnitus...so loud...currently still louder than what I had prior; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female 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 19Mar2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy, legumes some food intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC); both from unknown date for unknown indication and unknown if on going. The patient previously took propylene glycol (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 05:00, the patient experienced the worst tinnitus...so loud. On unknown date in Apr2021,currently still the patient experienced louder than what she had prior. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of worst tinnitus so loud, currently still louder than what she had prior was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
She states she was well at the time and took no medications.  Approx 24 hours later SM reports she awakened with papular pruritic rash on bilateral antecubital spaces and axillae.  She also experienced pain and swelling in the rt deltoid where shot was given, myalgias, arthralgias, malaise, fatigue and abdominal cramps with no diarrhea or vomiting.  Systemic sxs and rash continued and additionally developed on the neck and under the eyes.  She took OTC BENADRYL and HC 1% cream with only temporary relief of sxs.  Rash after MMR  Lesions, papule, Pruritus.
Patient called 2 months after vaccine and states that her arm still occasionally hurts and she thinks it may be from the vaccine. She has pain in the muscle or shooting pain down to her elbow. She seemed unsure of the location or source of pain. Says that it comes and goes.
Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain; Malaise; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 22:15, the patient experienced headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs. The patient received treatment for event fever 100.6 with acetaminophen(TYLENOL). It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes of events headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs were resolving at the time of the report.   No follow-up attempts possible. No further information expected.
rash in the same area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash in the same area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (rash in the same area). At the time of the report, VACCINATION SITE RASH (rash in the same area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Left arm (shoulder and forearm) continuous muscle twitching that started the same day as the vaccine and persists now 2 days later
pt recv vax 4wk p/LMP;pt learned was pregnant;a pathologist indicated that JUN97 an ultrasound was performed & no fetal heart tones or fetal movement were noted;29JUN97 delivery was induced & a 23wk old dead fetus was delivered;
flu-like symptoms; aching; vomiting; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, pain and vomiting. On an unknown date, the outcome of the influenza-like symptoms, pain and vomiting were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain and vomiting to be related to Shingrix.  Additional information was provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported but selected as an adult as per the vaccine indication. The patient experienced vomiting, aching and flu-like symptoms after the 2nd dose of Shingrix. The events lasted for a day or two and then were resolved. The reporter did not feel comfortable while providing any additional details regarding these events for her friend. The reporter did not consent to follow up. The case is linked with the case- US2020188892  and US20201888955, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020188895:Same Report US-GLAXOSMITHKLINE-US2020188892:Same Report
bnt162b2 as third booster dose; bnt162b2 as third booster dose; I almost died; sick; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as third booster dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. The patient previously received bnt162b2 (lot number: not reported) on unspecified dates as first and second dose, single for covid-19 immunisation. The patient reported that on unspecified date, "I was sick I almost died." Outcome of all the events sick and I almost died was recovered on unspecified date.   The lot number for vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Headache, joint pain, stiffness, light-headed, fatigue, muscular pain throughout entire body.
pt recvd vax in 1986 & exp joint pain, intermittent rash & low grade fever; no further details were provided;
tightness in jaw   Narrative:  At 11:00 Patient reported to this RN mild stiffness in his jaw. This RN sought and received assistance from lead RN. Lead RN assessed and provided care as needed/illustrated below: 11:00 -- vital signs -- offered water and ice pack HR 81, BP 103/66, RR 16, 02 98=7% 11:15 -- vital signs -- Patient denied symptoms at this point HR 72, BP 106/70, RR 12 patient denied concerns before leaving vaccine clinic. Was monitored for 30 minutes.
This report was identified from a line listing obtained on request by the Company from the FDA under the Act (ref# 747828) concerning a 18 year old female patient. On 26-APR-2018, the patient was vaccinated with GARDASIL 9 (lot # N022584), expiry date: 15-JUN-2020, dose 2, intramuscular in the right arm. It was reported that second dose was given too soon, and was supposed to be given 1-2 months from the first GARDASIL 9 shot which was administered on 12-APR-2018. Merck recommended giving the 2nd injection again at least 1 month after the last injection administered and was scheduled to re-administer the second GARDASIL 9 on 29-MAY-2018.
Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:00 PM arm was sore, I was tired, not feeling well.  Went to bed, started to get chills, nausea, and vomited around 9:30 PM.  Did not sleep well.  The next day I had a headache, felt tired and wiped out.  Started to feel better around 2:00 PM .  Lost day of work was able to return to work on 1/21/2021. My arm still ached for several days.  It felt like someone had hit me in the shoulder with their fist
Localized redness and swelling in right arm (injection site), fever, nausea and vomiting. Body aches and headache.
Fever up to 102.9; severe body ache, severe joint pain (primarily back, hips, & knees); head ache; injection site - swelling with red rash (approximately 4"x6") & knot under skin.  Fever, body aches,joint pain, & head ache increased in severity within first 48 hours from injection.  Symptoms alleviated within five days of injection.  Except for injection site reation - one week for redness & swelling to subside.
Patient stated his arm was sore and hard to lift the night of injection. At work the next day it became more sore and swollen. It was also hot to the touch and red. The patient stated he was feverish and generally not feeling well. He went to urgent care and was prescribed Augmentin 875mg twice daily for 10 days to treat cellulitis. Patient missed two days of work, but stated he was feeling some better 11-21-18.