chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss in her left ear; Tinnitus in her left ear; Loss of balance; Feel exhausted; Strong headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in her left ear) and HEADACHE (Strong headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (Strong headache) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss in her left ear) (seriousness criterion medically significant), TINNITUS (Tinnitus in her left ear), BALANCE DISORDER (Loss of balance) and FATIGUE (Feel exhausted). The patient was treated with CORTISONE at an unspecified dose and frequency. On 03-Apr-2021, HEADACHE (Strong headache) had resolved. At the time of the report, DEAFNESS UNILATERAL (Hearing loss in her left ear), TINNITUS (Tinnitus in her left ear), BALANCE DISORDER (Loss of balance) and FATIGUE (Feel exhausted) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The patient experienced a strong headache that merited her transfer to the hospital. The patient reports that despite the treatment she received, she continued with the symptoms. The patient received second dose of Moderna COVID-19 vaccine on an unknown date (batch no. 007C21A).  Patient additionally received steroid injection as treatment medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received Menactra IM right arm approximately 1:00 PM on 7/18/2005.  Woke at 4:00 AM 7/19/05 with fever chills, headache and slight nausea.  Fever relieved by Tylenol but returned as it wore off.  Slight redness @ site.  Received Td at left deltoid also, at same visit.  Upon return call to client on 7/20/05, signs and symptoms resolved.
pt recv vax & now can not recv pertussis d/t inconsolable crying for 48hr requiring hosp p/DTAP was given @ 2mo on 9DEC97;
Case number PHEH2014US022524, is an initial spontaneous report received from a pharmacist on 06 Nov 2014. This report refers to a 74 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1410901) intramuscular on 13 Oct 2014. Pharmacist reported that within 4 days of vaccination she experienced muscle stiffness radiating from above injection site and down elbow. Reaction continued a week later and was unsure if reaction persists. Patient works out three times a week including arms. She is an older woman but is in great shape. Final outcome of the event, seriousness and causality assessment was not reported.
Details of pt. symptoms following her MODERNA Vaccine  Note: She has been and was perfectly healthy no health issues or symptoms of this nature until after receiving the Moderna COVID vaccination (1st dose).  26 Feb 2021 (Friday) 3:00 PM First dose Moderna vaccine given - no issues at time of vaccination. At approximately 7 hours post-dose ? severe whole body shaking, weakness, racing accelerated heart rate, difficulty walking- lasted throughout the night.  27 FEB 2021 (Saturday) Morning ? brain fog- very confused  ? NO FEVER or shaking- however weak, unbalanced on her feet and confused in the afternoon we went about normal activities  during the day so we thought she made it thru some acute reaction.  Evening ? At approximately 9 PM ? whole body shaking, chills, weak, unbalanced. Her heart rate was not as accelerated (serious) as Friday night  28 FEB 2021 (Sunday) -seemed better but still brain fog (confusion), - by afternoon did normal things did a walk to get fresh air but she seemed to have labored breathing ? ?Huffing? and slow-she seemed better after the walk.   5 PM ? sudden and unexpectedly- she started whole body shaking, chills, difficulty walking, unsteady ? lasted about 1 hour ? unsteady on her feet needed assistance to walk. I put her to bed at 7:30 pm to rest and I was afraid she would fall because unsteady and shaking legs ? she had intermittent whole body shaking, chills, weakness 1March 2021 (Monday) ? around 10 am another episode - intermittent whole body shaking & chills, generalized weakness? developed respiratory symptoms, wheezing, deep croup- like coughing, weakness 2 March 2021 (Tuesday) ? respiratory symptoms seemed to be progressing. 3 March 2021 ( Wednesday) 3 PM Doctor evaluation ? fluid in lungs ? tested for Covid & prescribed antibiotics for lungs- 250 mg AZ ( 5 day treatment)
I began itching on my back but did not show any sign of rash. It continued on my legs, and I broke out in small sores. Itching then went to my stomach, chest and thighs. My chest broke out in sores. Dr. prescribed Betamethasone. It helped clear my skin. I am on Hydroxyzine and Cetirizine with Benadryl. It is very painful when I can't stop scratching. No sign of rash, only if I scratch too hard. Now my skin has two dry dark rough patches on my left thigh and one on my left arm. My palms itch, around my ears and back hairline itch. Its miserable. It started in March.  I will say it has eased up since March with the meds. I itch all day and its difficult to sleep. I see and allergist next month and a gynecologist the 20th of this month. Its every where. ER couldn't help because there were no signs of hives or rash!
Pt received the YF vaccine. Two days later he developed fever and chills. Those resolved within 24hr. The next day, he had diarrhea and loss of appetite. Of note, his infant child had a stomach virus that was going around his daycare, and the baby also had symptoms prior to the patient developing symptoms. It took the patient 6 days to completely recover. He never had a recurrent fever. But because these symptoms are similar with a stomach virus and with a reaction to YF vaccine, we felt it was best to report this event.
Pt recv vax on 7/14/97; on 8/14/97 pt exp feeling bad (flu-like) & 3x normal value liver enzymes.
Three days after 2nd pfizer, I experienced a sharp pain (like a pulled muscle) in the heart region. Lasted two days+. My thought was my heart sac was inflamed. Also experienced shortness of breath. I googled pfizer, side effect, heart...nothing came up then. Now you do it there is all sorts for stuff for younger men.
Information has been received from a RN concerning female in her 20's who on 02May05 was vaccinated with a dose of varicella virus vaccine live. On 04May05 the pt was found to have a negative varicella titer. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Redness & swelling (3 inch x 4 inch) at injection site (upper left arm) warm to touch, pt reports mild itching.
hard to breathe; feels like he had COVID-19 all over again; body aches; fever; chills; feels tired and does not want to get up; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels tired and does not want to get up). At the time of the report, DYSPNOEA (hard to breathe), CORONAVIRUS INFECTION (feels like he had COVID-19 all over again), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels tired and does not want to get up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medication. No treatment information was provided.
Patient had pain at injection site at 8pm and took some tylenol. At 3 am patient woke up with swelling in arm, pain, and rash down to the wrist
Simultaneous response with injection. Child held breath, passed out. Complete recovery incident lasted less than 2 minutes.  Mother was very upset and wanted an ambulance called. ER visit. Discharged.
Palpitations. Started 45 minutes after injection and lasted for 7 hours. Rested for the entire time. Was just going to the ER when the palpitations stopped. 3 months and 3 days later I had palpitations again but lasted only an hour.
Information has been received from a health professional concerning a 11 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. It was reported that "several weeks ago", in approximately July 2005, the patient had 50-100 "sack field" lesions. It was noted that the patient's sibling had been vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Vertigo with nausea. Prescribed Meclizine 25mg every 8 hours by Telehealth provider, did not work after second dose so patient discontinued. Vertigo onset approximately 6:00PM and continued until  patient was able to fall asleep around 10:30PM. Patient awoke the following day on 3/17/21 with headache but vertigo had resolved.
Verbalize feeling dizziness,  was evaluated on site by EMTs and released home at 10:42 am feeling better.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. No Clinical concerns were reported
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017 at 15:12, the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000448: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704.
Within 12 hours of Adacel and Menactra, pt started having full body muscle aches, including jaw involvement, fever to 103, difficulty breathing described as not being able to take a deep breath, and headache.
An hour after I became super itchy -8:00am  12:30- chills began  1:30 body aches  6- low grade fever, fatigue  Next day- sore throat, headache, body aches, chills, fever of 104.6 I was shaking so bad from being cold  Then I had night sweats
Patient had crying for an "extended" period of time on 01/06/17, (unable to get amount from parent); Redness and puffiness of eye lids and face following admin. On 01/06/17 at 3:45pm through Saturday 01/07/17. Resolved 01/08/17. No fever or reaction at injection site.
shaking, screamed off & on for 2 days, 0 swelling, tenderness or fever.
2nd Pfizer vaccine given 14 days after 1st Pfizer vaccine. Patient monitored 15 mins-No signs & symptoms present/noted
Severe head ache, nausea, diarrhea, body aches, fatigue x 3 days.
This spontaneous report received from a nurse refers to a 13 month old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 19-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot #M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
Information has been received from a study, concerning a patient who was vaccinated with a dose of PROQUAD (Merck) (date, dose, route, lot # not reported). It was reported that 18 days after PROQUAD (Merck) was administered the patient developed a febrile illness. The subject had two days of fever up to 103 and was found dead (twenty days after PROQUAD (Merck) (date not reported) in the crib. The toxicology screen was negative except for amantadine. The chief adjudicator indicated possible viral infection (febrile) as the cause of death. According to the autopsy report, the cause of death was sudden unexpected death in childhood associated with history of febrile illness. This is one of several reports from the same source. No further information is available.
PATIENT HAD COVID-19 VACCINE ON  Dose 1 date: 01/05/2021,   Dose 2 date: 01/26/2021, AND TESTED POSITIVE TO COVID-19 TODAY 9/7/21.
Patient admitted with abdominal pain for several weeks, and found to have a portal vein thrombosis on CT. She also had mildly abnormal liver function tests. Her symptoms came on a few days after a MVA at the end of December. She was also found to be anemic with AKI. She was started on IV heparin. Her AKI has resolved. She has since transitioned to apixaban and should complete 3 months of anticoagulation for what should be viewed as a provoked portal vein thrombosis. She also became positive for Covid-19 during this hospitalization - developed mild symptoms of sore throat and a cough, but no SOB or hypoxia. Her symptoms resolved within two days. Treated for all hospital problems and discharged home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
arm started to itch and became red; red splotches on her arm; arm was a little puffy but not painful; On a pain scale of 1-10, the pain was 0.5.; arm was a pinkish color; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm started to itch and became red), ERYTHEMA (red splotches on her arm), PERIPHERAL SWELLING (arm was a little puffy but not painful), SKIN DISCOLOURATION (arm was a pinkish color) and PAIN ASSESSMENT (On a pain scale of 1-10, the pain was 0.5.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-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) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced SKIN DISCOLOURATION (arm was a pinkish color). On 16-Apr-2021, the patient experienced PRURITUS (arm started to itch and became red), ERYTHEMA (red splotches on her arm), PERIPHERAL SWELLING (arm was a little puffy but not painful) and PAIN ASSESSMENT (On a pain scale of 1-10, the pain was 0.5.). At the time of the report, PRURITUS (arm started to itch and became red), ERYTHEMA (red splotches on her arm), PERIPHERAL SWELLING (arm was a little puffy but not painful), SKIN DISCOLOURATION (arm was a pinkish color) and PAIN ASSESSMENT (On a pain scale of 1-10, the pain was 0.5.) outcome was unknown. Not Provided          Treatment information not provided. List of concomitant medication were not given.
Mother calls in on telehealth visit in regards to some concern regarding the area where child got some Immunizations on 8-10-20. Patient received his 4 year old shots and he did fine. Mother states went home and there were no issues. No fever, cough. Asymtomatic. However on 8-11-20 she noticed he had redness and a bit of fussiness in the area of the left thigh. Mother notes the redness is not getting any bigger however does Feel a little bit swollen. Mother states hers never had any type of reactions in the past. Patient is walking around fine without any issues. Polio, MMR, DTAP, Varicella in the past; Kinnrix, ProQuad,1st done.
Redness to anterior right shoulder and into axilla. Slight right axilla lymph node swelling. Rash right shoulder. Moist heat, alternate with ice, maximum 20 mins. Keflex 500mg X 10 dys.
Child was on Pulmicort .025% nebulizer treatment for 3 weeks BID prior to vaccination. Also the baby was on Albuterol nebulizer treatment. Baby was suffering from Asthma and was on and off medication for 4 months prior to the vaccination. Baby weighed 23 pounds at the time of vaccination. I suspect that the baby had a reaction to the vaccination. She had mumps and many complications as described below. I would like your honest evaluation whether my baby had a serious reaction to the vaccination. IF so, what could be the reason, is it because she was on inhaled steroid treatment before the vaccinations. My baby seems to have recovered completely at this point. SX: 02/25/05 (7)days after vaccination fever of 100-102 degrees lasted 5 days, 03/01/05 itching and red rash all over the body lasted for 3 days. 03/04/05 (2 weeks after vaccination) swelling under the jaw on the left side started and the baby has mild fever of 99 degrees. 03/06/05 swelling became large, like mumps, and fever increased to 100 degrees. I have suspected mumps. 03/07/05 swelling became larger baby could not turn head. Fever increased to 101 degrees, DR was consulted and suggested a salivary gland swelling could be cervical adenitis and started antibiotics " augmentin" Baby had a very difficult night, she cried alot and very miserable while moving her head. Baby drinking about 40% of normal amount of food. 03/08/2005 Dr saw baby again fever 102 degrees. Swelling looked bigger but lookded like less painful and the baby was not crying much anymore.
REGEN-COV] use for COVID-19 under Emergency Use Authorization (EUA): The rash is diffuse. The rash is characterized by itchiness and redness. Associated with: new medication -no outdoor activity, no possible plant contact, no new detergents/soaps/colognes/body washes, no new bedding or clothing, no known allergens. Pertinent negatives include no congestion, cough, diarrhea, fatigue, fever, joint pain, shortness of breath, sore throat or vomiting. Treatments tried: Benadryl. The treatment provided no relief. Of note, patient Covid positive as of 7/31, underwent new REGEN-COV infusion on 8/4. Interestingly, patient had first Pfizer COVID vaccine on 7/23/21
Information has been received from a health professional concerning a 16 month old female with a penicillin allergy and a history of ear infections who on 14-OCT-2005 and 07-FEB-2006 was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. "Since 13-FEB-2006" the patient has been extremely irritable, crying, having a decreased appetite, gas and seems to be in pain. The onset date of symptoms was also reported as 07-FEB-2006. An X-ray was done (results not provided). The patient was seen in the office, but treatment was not yet recommended. At the time of this report the patient was not recovered. No product quality complaint was involved. Additional information has been requested.
I got the vaccine yesterday and last night I started having a very bad headache along with fatigue. As the night progressed, I started having chest pain/heaviness, body aches, dizziness, fever of 102 for over 4 hours while taking Acetaminophen, chills, and an elevated heart rate.
Mild headache began after second dose, continued and a week later i was in urgent care with terrible pain in the left temple, left temple painful to touch, left side of face painful to touch.  Pain in jaw, neck, trouble eating, talking, pain in back of head, nubness, burning and sometimes stabbing pain.
3 hours inconsolable crying. Large "golf ball size" welts on the thighs.
passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine