chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 14 year old male who received an Influenza Vaccine IM 3 yrs + 4 Valent IIV4 manufactured by Sanofi Pasteur (Lot#: UT5937KA) on 10/6/2017. He was admitted to Hospital on 10/8 for generalized rash, SIRS criteria, and hemodynamic instability, and mild joint pain. He has a past medical history significant for Juvenile idiopathic arthritis (JIA) diagnosed 8/2017 and well controlled on 100 mg Anakinra SubQ QD for previous 5 weeks. He had cellulitis S/P BACTRIM treatment 1 week (D/C Friday 10/6), healing well. He met SIRS criteria in ED, and was hypotensive with wide pulse pressure. He was given 3x boluses IVF and started on ceftriaxone 10/8 which was discontinued on 10/9 with symptomatic improvement and no source of infection. ID consulted, suspected ehrlichiosis, started on empiric doxycycline. Patient was symptomatically unchanged on 10/10; however, ferritin and CRP rose strikingly, Rheum concerned for worsening JIA complicated by Macrophage activation syndrome (MAS). Possibly JIA secondary to URI. Anakinra doubled. On 10/11 patient developed moderate transaminitis, with LDH elevated 1270; minor concern for leukemia. Symptomatically unchanged. Bone marrow biopsy was successfully performed on 10/12; pathology and cytogenetics pending, AM labs showed significant decrease in inflammatory markers, WBC and platelet levels, patient symptomatically better. Anticipate discharge on 10/13 if AM inflammatory markers are improving.
Breakthrough COVID-19 infection. This lasted 16 days. There was 48 hours of the symptoms being sever and confining me to the bed, then the next 14 days were mild symptoms. Fever 102 at the highest. I experienced fever, body aches, chills, shortness of breath.
5 hours after injection.  I started having flashes of white lights and floater in my right eye.
Patient received shot around 3:00pm on 8/14 and muscle soreness in the arm was felt that evening.  It was the next day (8/15/23) around noon that she started feeling nausea with mild fever and eventually vomited a few times.  Patient felt better later that night.  Fever was less than 100 but above 99.  She called around 6:55pm on 8/16/23 to report the symptoms.
after rec vax. Same day, in evening, started feeling aching and tired. Got into bed at midnight, started having uncontrollable chills, and shivering, temp was normal. By morning, temp is at 101. Body is sore, and can barely move. Nauseaous. Unable to take any meds for it due to nausea. In middle of the night, took peptobismol chewables to help. Now still has body aches, 101 fever, and chills and sweats, along with no sleep. Watering eyes.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (body aches). At the time of the report, CHILLS (Chills) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.
there's a pressure on head that is constant, hurt like she's going to throw up; eyes are like bloodshot, can't stay on devices; brain foggy, brain is not working properly, like has taken a bunch of Benadryl; hurt like she's going to throw up; exhausted from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (there's a pressure on head that is constant, hurt like she's going to throw up), OCULAR HYPERAEMIA (eyes are like bloodshot, can't stay on devices), FEELING ABNORMAL (brain foggy, brain is not working properly, like has taken a bunch of Benadryl), NAUSEA (hurt like she's going to throw up) and FATIGUE (exhausted from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (there's a pressure on head that is constant, hurt like she's going to throw up), OCULAR HYPERAEMIA (eyes are like bloodshot, can't stay on devices), FEELING ABNORMAL (brain foggy, brain is not working properly, like has taken a bunch of Benadryl), NAUSEA (hurt like she's going to throw up) and FATIGUE (exhausted from the vaccine). At the time of the report, HEAD DISCOMFORT (there's a pressure on head that is constant, hurt like she's going to throw up), OCULAR HYPERAEMIA (eyes are like bloodshot, can't stay on devices), FEELING ABNORMAL (brain foggy, brain is not working properly, like has taken a bunch of Benadryl), NAUSEA (hurt like she's going to throw up) and FATIGUE (exhausted from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported..   Reporter did not allow further contact
Pt reported redness and slight swelling of arm from deltoid to elbow, with no increased pain or limited mobility
Day after eyes half closing all day like sinus problem. Then for next 5 days dizzy. The worst was a feeling of weakness in the arms and legs and a feeling that the arms were somehow internally shaking. Felt unsteady on feet.....off and on for 3 weeks after vaccination.
TESTED POSITIVE FOR COVID-19 AFTER RECEIVING THE JANSSEN COVID -19 VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid-19 after receiving the janssen covid -19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 after receiving the janssen covid -19 vaccine was not reported. This report was non-serious.
Fever to 104, 3hrs after vaccination in physicians office: 12 hours after vaccination had tonic-clonic generalized seizure then lethargic with decrease oral intake: Neurology consult suspencts reaction to pertusis portion of vaccine 5/30/06 Received medical records from hospital which reveal patient experienced inconsolable screaming and febrile seizures 1 day after vaccination.  WBC 17,800, Temp 100.8. All cultures were neg & no further seizure activity noted.  Family hx of seizures in father & paternal grandmother (both related totraumatic brain injury).  Ped neuro recommended witholding further pertussis.  d/c home on 5/4/06 6/19/06 Records received from PCP whicl reveal patient had well child visit on day of vaccination/ss
Began to experience flu like s/s sore and feeling "sore all over"  Very tired. C/O pain in lt arm (client had vaccine in rt arm) pain that over a period of days spread to lt shoulder, back, hip area.  Client claims she had difficulty walking.  Pain eventually spread to rt arm and shoulder.  Client saw MD.  Blood tests were run, however, client states tests were normal.  MD unable to find cause.  Client feels her discomfort is due to flu shot.  She did discuss this with the MD.  She claims he told her it might be due to flu shot. MD told her if s/s get worse to call.  Client has not talked to MD in 1wk.  Advised client to call MD to give update on condition.
IMMEDIATLEY FELT HOT, NAUSEAU, THREW UP. PAIN FROM SHOULDER DOWN TO WRIST. MUSCLE IN ARM AS OF 04/26/22 STILL FEELS HOT AND SWOLLEN.
the patient was given higher than recommended dose because of error in mixing the vaccine with the diluent. the vaccine was only mixed with 0.8ml of the diluent instead of 1.8ml of the diluent resulting in concentrated form of the vaccine.
PATIENT REPORTED VOMITING SIX TIMES LATER THAT DAY/OVERNIGHT AFTER THE VACCINATION.  ALSO REPORTED NAUSEA, FEVER, CHILLS AND SWEATING FOR APPROXIMATELY 48 HOURS
54 hrs after injection, I had about an hour of slight, but noticeable dizziness.  When walking, I felt I was being pulled to the left.  No other symptoms were felt.   Condition went away in 90 minutes or so.
Patient less than 18 years of age received the 1st dose of Moderna'a Covid-19 Vaccine. Parent present, educated, and gave consent.
pediatric dose of Havrix administered to adult patient; pediatric dose of Havrix administered to adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HAV (Havrix 720 Junior) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.  On 15-JUN-2023, the patient received the 1st dose of Havrix 720 Junior. On 15-JUN-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced underdose (Verbatim: pediatric dose of Havrix administered to adult patient) and adult use of a child product (Verbatim: pediatric dose of Havrix administered to adult patient). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-JUL-2023 The reporter was certified medical assistant. The reporter stated that a pediatric dose of Havrix was administered to an adult patient which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Within one day of receiving the 2nd shot started having heart palpitations in the middle of the night, Went to Urgent care, not help.  Went back to hospital and a got a heartmonitor and wore that for a week. Thenon Friday, May 7th went to the emergency with sweats and almost passed out.  They kept him there for over a day, ran tests, etc.  Blood work came out fine.  He was released the following day. No answers.  One doctor there admitted that he believed it's related to the vaccine.  Now here we are, May 20th, no answers and feeling the same, but now chest pain, shortness and breath.  Never had ANY HEART PROBLEMS BEFORE THIS!
Patient called pharmacy today (3 months after vaccine given). She states that 1 week after SHINGRIX was given, that she developed a bump on her arm. Not long after, she had a itchy, scaly rash develop on her face and head. It has now spread to her entire body, head to toe. She has no pain or neuropathy from the rash. She has seen two physicians and her doctor is now having her "detox".
ON DAY NUMBER NINE PATIENT C/O CHEST PAIN WITH SHORTNESS OF BREATH, FEVER. PATIENT DX WITH PERICARDITIS. SEEN AT HOSPITAL AND DISCHARGED HAS PLANNED FOLLOW UP IN SIX WEEKS. CURRENTLY TAKING ASA 650MG Q4H X TWO WEEKS.
Pt recvd vax 10APR92 & 9 hrs later mom heard pt cry; ran into room found pt not breathing; picked pt up & body turned limp; 5mins later started to cry out still no color;
Sore upper left arm, Reduction in motuion, has gotten progressively worse, awake with pain if i turn on left side problem/pain raising left arm.
On 17th, around 12noon, I started sneezing, nasal congestion, tightness in my chest, and congestion. 08/18/2021, I took a home COVID-19 test, and it came out positive.
APPROXIMATELY 10 MINUTES AFTER VACCINE ADMINISTRATION CLIENT PASSED OUT FALLING AND HITTING HER HEAD.  CLIENT AROUSED IN A FEW SECONDS. VITAL SIGNS CHECKED. APPROXIMATELY 20 MINUTES LATER CLIENT REPORTED FEELING ANXIOUS AND CONFUSED,  CRYING,  AMBULANCE CALLED
palpitation  BP 182/86 /58  98%o2 after 10 minutes  BP 174/84/56  99%o2  #20 no more palpitations when she left for home #21 left went home against medical advice - adviced to go to hospital for evaluation
PT experienced chills, nausea, vomiting, belching, fatigue, chest pain. Given Benadryl, Allegra, pritcap(?), Zertac (?), prescription (?)
Throbbing Headache that started 7 hours after Flu-mist and and lasted 4 days.  Seen in office visit.
dizziness, coughing, stuttering, clamming skin, sweating,  feeling like my throat was closing up,  neck pain, headache
arm still hurts; Initial information regarding this unsolicited valid non-serious case was received from a consumer (patient) and transmitted to Sanofi on 01-Nov-2020.  This case was linked to cases 2020SA307964, 2020SA308110 and 2020SA308037 (same reporter)  This case involved a patient with unknown demographics whose arm still hurts (pain in extremity), while the patient received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date in October-2020 (two weeks ago, as reported), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm still hurts (pain in extremity), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not resolved for the reported event.  There will be no information available on batch number for this case.
pt. is having inflammation and  pain in left ankle; pt. is having inflammation and  pain in left ankle; feels that bones are very weak; This is a spontaneous report from a Caremark Xeljanz C&P Program (Program ID: CEP 141003). A contactable CVS/Caremark Specialty Pharmacy reported for female patient. This is a spontaneous report from a contactable other Healthcare professional.  A 36-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15May2021 (at the age of 36 years old) as a dose 2, single, for covid-19 immunization; tofacitinib citrate (XELJANZ XR), oral from 2019 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis (From 2019 to 8May2021). Patient's medical history included, rheumatoid arthritis from 2019 and ongoing. The patient's concomitant medications were not reported. Patient took first dose of bnt162b2 on 28Apr2021 dose 1, single, for covid-19 immunization. Patient reported that, her xeljanz was on therapy hold as per md instruction to discontinue 1 week before each of the covid-19/corona virus vaccine doses, so patient stopped it a week before her Pfizer corona vaccine on 28Apr2021 and then a week before 15May2021, due to missed doses patient was having inflammation and pain in left ankle (she stepped wrong and hurt her left ankle as previously reported), felt that bones are very weak, md was aware and ordered patient to resume xeljianz on monday, 24May2021. On an unspecified date, the patient experienced pt. is having inflammation and pain in left ankle and feels that bones are very weak. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Crying/fussy for remainder of day. Change in personality for 1 week. He did not smile or laugh and limited babbling for 1 week. Eczema/rash developed morning of 8/30/12.
This is a spontaneous report from a non-contactable consumer reporting for herself. This female patient of unknown age received in Jul2016 a single dose of PREVNAR 13. The patient medical history and concomitant medications were not reported. In Sep2016, in the week before this report, the patient reported that developed pneumonia. Her doctor told her that she had fluid in her left lung and it looked like pneumonia. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
ICD-10-CM ICD-9-CM   1. COVID-19 vaccine administered  Z23 V04.89   2. Pressure in left side of chest  R07.89 786.59   3. Adverse reaction to COVID-19 vaccine  T50.B95A E949.6     Reassuring evaluation today without any evidence of anaphlactic allergic reaction.  She does admit to a level of anxiety that has been present.  THat being said, even with coaching to calm nerves, doesn't have relief in left sided chest pressure.  Watched for 30 minutes in the office to see if symptoms resolved or worsened while in office.  Resolution of numbness but not of left sided chest pressure and tightness she has been feeling.  Reviewed with patients that I would like to see of getting set of labs and EKG.  Can't do this here.  Given 324 mg ASA to chew.     Called EMS for transport to hospital.   Medication Management: Patient's Medications New Prescriptions   HYDROXYZINE HYDROCHLORIDE (ATARAX) 25 MG TABLET    Take 1 tablet by mouth every 6 hours as needed for Itching. Modified Medications   No medications on file Discontinued Medications   No medications on file
Red hive at injection site. Itching at site and soreness. Progression of itching and increase in size of hive. Benadryl given every 4/6 hours. Next day at 7 pm began having itchy throat, larger hive at injection site, rapid heart beat, shaking, and feeling of nausea. Went to emergency room after taking another dose of Benadryl. Oral steroid begun for 5 days. Benadryl needed on 1/19/14 for hives on arm - same arm as injection site. "Reaction was to flu."
Whole body aches, chills, runny nose, headache, fever that lasted less than 24 hours
Information has been received from a physician concerning an 8 year old female who on 16-OCT-1998 was vaccinated with a 0.05 ml dose of varicella virus vaccine live (Oka/Merck). On 12-MAR-2007 she developed "a breakthrough of scattered vesicular lesions". Unspecified medical attention was sought. The patients recovery status is unknown. No product quality complaint was involved. Additional information has been requested.
Patient woke up on 2/19/19 with raised, red rash all over body. She sought medical treatment from her primary care Dr. and was advised to take BENADRYL. She then reported to pharmacy to choose correct BENADRYL. She took 1st BENADRYL dosage 02/19 PM. Patient was contacted 02/20/2019 to follow up, and indicated that she woke up with rash, and swelling around eyes, but no itching. She had just taken another dosage of BENDARYL, and will follow up with pharmacy later in the day.
Caller reported VARIVAX and PROQUAD were administered to a 12 month old at the same visit.  No other information provided.  No Additional AEs or PQC reported.; Caller reported VARIVAX and PROQUAD were administered to a 12 month old at the same visit.  No other information provided.  No Additional AEs or PQC reported.; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 04-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) 0.5 milliliter (ml), lot # U031561, expiration date: 06-APR-2023, administered subcutaneously (SQ) for prophylaxis (strength was not provided), and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # U015681, expiration date: 18-MAY-2023, administered subcutaneously for prophylaxis (strength was not provided) (Overdose) at the same visit. No other adverse event occurred (No adverse event).
Moderate pain, redness, swelling at vaccination site, nausea, headache, chills, fatigue
cramping in hands, not able to hold a pen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramping in hands, not able to hold a pen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (cramping in hands, not able to hold a pen). At the time of the report, MUSCLE SPASMS (cramping in hands, not able to hold a pen) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.
No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 23-APR-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA (recombinant human albumin))(PROQUAD) lot # R026351, expiration date 15-MAR-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA011917:
my arm hurt; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included OXYBUTYNIN, MAGNESIUM, ZINC, VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]), KRILL OIL, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN (LUTEIN [TOCOPHERYL ACETATE;XANTOFYL;ZEAXANTHIN]), FAMOTIDINE, PROGESTERONE and ESTRADIOL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, PAIN IN EXTREMITY (my arm hurt), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided.  The patient had a bit of a headache and body ache but nothing severe   This case was linked to MOD-2021-336727, MOD-2021-336728 (Patient Link).
Information has been received on 2/28/02 from a licensed practical nurse concerning an adult male who was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently the pt developed local site redness. It was reported that the pt had received a previous dose within "the past six months." This does not comply with the recommended dosage schedule. The pt was treated with Keflex. The reporter had questioned concerns with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.