chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient is taking dupixent 300mg qow for asthma; patient received a flu shot and now has a rash on their arm; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case received from a physician via Sales Representative.  This case involves a male patient of unknown age who received a flu shot and now has a rash on their arm and patient is taking dupixent 300mg every other week for asthma, while he was treated with dupilumab (Dupixent) via unknown device and Flu vaccine.   The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 11-Aug-2020, the patient started taking dupilumab 300mg every other week (strength, route, formulation, lot number and expiry date unknown) for asthma (product use issue) (Latency: same day). Information on batch number was not requested in context of COVID-19. On an unknown date, the patient took flu vaccine (dose, strength, form, route, frequency and batch number unknown for an unknown indication)  On an unknown date of 2020 (Latency: unknown), the patient received a flu shot and now has a rash on their arm (rash). Patient does not inject dupixent in the arm. Office wants to know if the combination of Dupixent and the flu shot caused the rash.  Action taken: Unknown for rash and not applicable for product use issue for both suspects  Corrective: Unknown for rash  Outcome: Recovered on an unknown date of 2020 for rash and not applicable for product use issue  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1/29/20: Mild arm pain at 0030, applied cold pack and took ibuprofen. At  0445, woke up with rigors, uncontrolled shaking (not just chills) and temp was 100.4.  Re-dosed with ibuprofen 600 mg (had taken  600 mg 4 hrs earlier).  Three hours later fever to 102.6, and fever persisted for 2+days. Fever persisted for the first 36 hrs despite fever reducers. Extreme muscle aches (as bad/worse than when ill with Covid), headache, fatigue, joint pain, unable to get out of bed for 48+ hrs.  See V-safe information as well for details. 12/30/20: to walk in/urgent care as recommended by my employer for Covid/influenza testing and tests all neg. Missed 3 days of work, unpaid. 1/2/2021: left arm/shoulder pain/joint pain and swelling, continued fatigue/headache but symptoms improving.
pt recv vax 12FEB97 & devel status epileptic 16FEB97;no interval sx;no prior sx or family hx of sx;
Had redness, swelling, pain lasted about 5 days and treated w/an ice pack.
Initial report received from a non-healthcare professional on 17 November 2014. A 76-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date and route of vaccination not reported), on an unspecified date. On an unspecified date, after vaccination the patient has been experiencing swollen hot to touch red area at injection site and feeling feverish, burning eyes and flushing of face. Stated symptoms "come and go" now but still having burning eyes, swelling of face, face getting hot and red with the heat radiating to her neck and back which lasts about 1 hour. The physician prescribed prednisone to the patient and is having her see an allergist. Illness at the time of vaccination was unknown and the patient had allergies to Sulfa drugs, latex and environment. Laboratory data and corrective treatment were not reported. At the time of this report, the patient was not recovered. The patient required ER visit. The case was assessed as serious upon Company's internal review due to the important medical event. List of documents held by sender: none.
Area raised, red, itchy on left arm. No treatment given. Seen in office by Dr. on Monday 02/25/2013.
Staff member said that it hurt when she received the vaccine in her right upper arm, & the pain spread up over her right shoulder close to her neck.  She said that her right arm ached, & then over the next week she could not raise her arm to get her clothes off & on. It bothered her so much that she went to the doctor on 11-05-13 & let our office know.  The doctor wants her to take pain medication & let it rest for 7 days, as well as not lifting anything greater than 30 pounds.
Patient received Afluria vaccine intramuscularly on 08-14-2020. Today 08-15-2020, the patient came into the pharmacy to say that beginning last night, she experienced a severe sore throat, severe diarrhea, and numbness in her arm from the injection site all the way down to the tips of her fingers. The numbness is not as severe today, and is only at the injection site now.
1st dose on 12/27/2022, 2nd on 1/16/2023; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number PC53Y, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe (batch number unknown, expiry date 30th June 2023) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 16th January 2023, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 16th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was 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: 15-FEB-2023 Reporter's comment: The Nurse reported that an infant received the first dose of Flulaval on 27 February 2022 and 2nd dose on 16 January 2023.  The reporter consented to follow up via postal. The Vaccine Administration Facility is the same as Primary Reporter. Additional supportive information: The patient received the 2nd dose, two weeks after the 1st dose Flulaval leading to shortening of vaccination schedule.
consumer reports exp nausea, stomach cramps, fever & loose stools p/being vaxed w/cholera vax;
Fever, frontal lobe headache, pain in left arm where vaccination was administered, which has spread to spread to left wrist, breast, and scapula. Rapid heartbeat and fatigue.
This spontaneous report as received from a medical assistant refers to a 17 year old female patient. The patient's concurrent conditions or medical history were not reported. In April 2008, in December 2012, February 2013, August 2013 and on 11-FEB-2015 the patient received the first, second, third, fourth and fifth doses, respectively, of GARDASIL, (dose, anatomical location, route. lot number and expiration date not reported). No adverse effects were reported. Additional information is not expected as the reporter did not give consent to follow up contact.
Had a few/rare heart palpitations earlier in 2021 after first and second does of Moderna vaccine.   Had no other side effects besides a sore arm after these doses.  After the booster dose on 10/29/21 I had several side effects two days after the booster which lasted about 24 hours.  Side effects included fatigue, low grade fever, body aches, and headache.  About 7-10 days after the booster I started to have heart palpitations a few times/day that increased in frequency to several times/day.  The palpitations maintained this frequency until about mid-May and they have decreased to a few times/week.  Received a booster of the Moderna vaccine on 6/21/22 and no side effects except a sore arm was noted.  Palpitations did not increase in frequency after the booster but they do remain.
Within 24-48hrs. patient spiked a fever which escalated to 107 degrees 02/12/1996 during which time Grand-Mal seizures surfaced, administered Tylenol, alternating with ibuprofen as directed, due to seizures- physician was contacted by the time patient arrived fever was 104 degrees. Child was clammy, blueish tone, lethargic and appeared to be in febrile shock.
Head started itching, eyes started to swell, hives all over started about 4pm still present at 8am next day.
Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration in left arm on 18Mar2021 16:00 (at 39-year-old) at single dose for COVID-19 immunisation. Patient's medical history was reported as none. Family medical history was none. Concomitant medications included other products from an unspecified date (reported as 2 years ago) and ongoing. No additional vaccines administered on same date of the BNT162B2. No prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced headache at 6:30 am, nausea in the afternoon. No investigation assessment. Therapeutic measures were taken as a result of the event headache, included paracetamol (TYLENOL), with good effect. The outcome of event nausea was recovered on 20Mar2021, event headache was recovered on 21Mar2021.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Headache, nausea, chills, body aches, sore throat, congestion, stomach cramps, diarrhea, vomiting, fatigue.
Headaches off and on for about two weeks. Unbelievable face pain to the point of not eating, drinking or even moving my mouth. Went to the Dentist March 2nd, and he sent me to a specialist that day because of pain. She couldn't figure out why pain was on right side and sometimes upper teeth and sometimes lower jaw. she said nerve pain. Upper mouth was numb for about a week, and slowly got better after I took antibiotic. F/U appt 3/30 pain is mild, but one tooth is now dead need root canal on 4/16/21.
Eczematous rash appeared at injection site the day after the injection. Remained for 4 months.
HEADACHE 20 HRS LATER UPSET STOMACH 20 HRS LATER VERY TIRED 20 HRS LATER INJ SITE PAIN 12 HRS LATER LOOSE BOWELS 20 HRS LATER SHIVERING-CHILLS 12:05 AM (11 HOURS AFTER)
Initial unsolicited case received from other non-health care professional on 21 Aug 2017. This case involves 17-year-old male patient who was vaccinated with a dose of MENACTRA (Batch number: U5823AA, expiry date, dose, dose in series, route and site of administration were not reported) on 16 Aug 2017 (Wednesday). The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed a rash and black and blue at injection site (skin discoloration and vaccination site reaction) approximately 8" x 4". Patient also had severe headache and dizziness. The patient had no fever. On an unknown date (Saturday) the patient went to Urgent center and was treated with cephalexin. The patient relevant lab tests were not reported. Other corrective treatment was not reported. The outcome of all the events were not reported. List of documents held by sender: none.
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
DIFFICULTY WALKING; CONDITION SEEMS TO BE WORSENING; MAJOR FATIGUE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 difficulty walking, condition seems to be worsening, and major fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the major fatigue, difficulty walking and condition seems to be worsening was not reported. This report was non-serious. This case, from the same reporter is linked to 20210935247.
It's been almost a week and the build up of how crummy I've been feeling since my second vaccination seems to just get stronger.   I feel like I may have hit a plateau. I have dealt with the tingling, the internal incessant itching, the burning and the shocks I get.  But since the last shot I received the burning has intensified. The pain seems deeper as well, like a toothache.  My hands have been really on fire for days. It's been a bit difficult to type for work. I can't sit still as the nerves from my knees down make my legs and feet feel as if they are asleep, like there's a tourniquet below the knee keeping blood flow from getting any lower.  I hated clothes with tags as they would hurt but now I can't get away with any of it, nothing with tags, if they have one, they get cut off.  Even getting goosebumps is really is painful.  And no matter what, I'm always cold. It's exhausting getting comfortable.
Headache and nausea within minutes, then about 45 min later the fatigue hit. Felt this way all weekend. Later that night into next day my at injection arm felt like I took a line drive but resolved by Monday evening.
Developed a cough, and went to Dr. on 28, December 2021.  Tested positive for covid
Moderna COVID-19 Vaccine EUA Leaning over to pick something off the floor, I fainted and fell to the floor. Unconscious a few seconds. Recovered immediately. No treatment. A friend has had the same reaction, so I thought this should be reported.
expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021.  vaccine expiration date was 11-OCT-2021.  No vial went any temperature excursions. vaccine  was administered within 2 hrs.   No adverse reactions to the vaccine reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant FU : Secondary reporter Information is updated.
pancreatitis; developed bilateral pleural effusions; ascites; splenic vein blood clot; This is a spontaneous report received from contactable reporter(s) (Physician).  An adolescent male patient received bnt162b2 (BNT162B2), administration date 15Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "kidney stone" (unspecified if ongoing), notes: Other medical history: kidney stone; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose number: 2), for Covid-19 immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose number: 1), for Covid-19 immunization. The following information was reported: PANCREATITIS (hospitalization) with onset 17Jan2022, outcome "unknown", described as "pancreatitis"; PLEURAL EFFUSION (hospitalization) with onset 17Jan2022, outcome "unknown", described as "developed bilateral pleural effusions"; ASCITES (hospitalization) with onset 17Jan2022, outcome "unknown", described as "ascites"; SPLENIC VEIN THROMBOSIS (hospitalization) with onset 17Jan2022, outcome "unknown", described as "splenic vein blood clot". The events "pancreatitis", "developed bilateral pleural effusions", "ascites" and "splenic vein blood clot" were evaluated at the emergency room visit. Clinical course: 17Jan diagnosed with pancreatitis at ER. developed bilateral pleural effusions, ascites with a splenic vein blood clot. Adverse event resulted in Emergency room/department or urgent care, Hospitalization. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Left arm warm to the touch; Little golf ball appeared in her injected arm (left); Broke out in hives all over her body; "knocked up" for the first couple of days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Broke out in hives all over her body), VACCINATION SITE WARMTH (Left arm warm to the touch), VACCINATION COMPLICATION ("knocked up" for the first couple of days) and VACCINATION SITE SWELLING (Little golf ball appeared in her injected arm (left)) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION COMPLICATION ("knocked up" for the first couple of days). On 19-Jun-2021, the patient experienced URTICARIA (Broke out in hives all over her body). On 27-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE SWELLING (Little golf ball appeared in her injected arm (left)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 19-Jun-2021 to 22-Jun-2021 for Hives, at an unspecified dose and frequency. In June 2021, VACCINATION COMPLICATION ("knocked up" for the first couple of days) had resolved. On 22-Jun-2021, URTICARIA (Broke out in hives all over her body) had resolved. In July 2021, VACCINATION SITE WARMTH (Left arm warm to the touch) and VACCINATION SITE SWELLING (Little golf ball appeared in her injected arm (left)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Patient received second dose of vaccination on 17Jul2021 - Lot number: 051C21A
Low grade fever; fatigue; myalgia; sore arm; chills; This is a spontaneous report from a non-contactable pharmacist. A 77-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on Mar2021, as dose 2, single for COVID-19 immunization. The patient Medical history included , systemic inflammatory response syndrome from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on Feb2021 as dose 1, single for COVID-19 immunization. Patient did not experience any systemic reaction after the first dose. The patient was not pregnant at the time of vaccination.The patient did not received other vaccines in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19, and COVID-19 was not tested post vaccination. It was unknown that patient took other medications in two weeks and it was also unknown that patient had known allergies. On unspecified date, after second dose the patient experienced low grade fever, fatigue, myalgia ,sore arm , chills. The patient was not received treatment for the adverse events. The outcome for the events was recovered on unspecified date.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
lost her hearing briefly for few minute this morning; Blurry vision; Fever; Nauseous/ she was sick to her stomach and she was afraid she would throw up; This is a spontaneous report from a contactable consumer. This consumer reported for a 15-year-old female patient (reporter's daughter) And This is the first case of 2 split cases.  A 15-year-old female adolescent patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729, Expiration date: 31July2021), via unspecified route, administered in right arm on 26Jun2021 09:30 am(at the age of 15-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 26Jun2021, after the vaccination in the night, the patient experienced Fever, Nauseous, she was sick to her stomach and she was afraid she would throw up. And on 27Jun2021 the patient experienced Blurry vision, lost her hearing briefly for few minutes this morning, no treatment options were used. Reported said that this is kind of a different side effect, she did read that someone had blurred vision, but she said she also lost her hearing. The event deafness assessed the as serious. The outcome of the events blurred vision was unknown, pyrexia and nausea are not recovered and deafness is recovered in 2021.  No follow-up attempts possible. No further information expected.
No adverse event; Patient received expired MMR II vaccine; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The concurrent conditions, medical history, concomitant therapies, drug reactions or allergies were not reported.  On 14-OCT-2021, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot # S028914, exportation date: 16-SEP-2021) for prophylaxis. No adverse event was reported. At the time of the report, the outcome of the event was not reported.  The causal relationship between the event and the expired suspect vaccine was not reported.