chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulties breathing; terrible headache; fever; This case was reported by a consumer and described the occurrence of difficulty breathing in a 45-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7LH5G, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event (had several flu shots in the past and never experienced anything like this.).   On 15th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th November 2022, immediately after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced difficulty breathing. In November 2022, the patient experienced headache and fever. On an unknown date, the outcome of the difficulty breathing was recovering/resolving and the outcome of the headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing, headache and fever to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   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: 16-NOV-2022 Reporter's Comment: The case was reported by the patient's husband. The patient was provided the following flu vaccine at last evening Flulaval Influenza Vaccine. Immediately after receiving this vaccination she was walking out of the health center and began experiencing difficulties breathing.  She returned and the staff immediately took her vitals and continued to watch her.  After a short time she began to feel better. On the day of reporting the patient she awoke (morning) with a terrible headache and a fever.  She was still experiencing the headaches and fever this afternoon and was in contact with her doctor. The reporter said provide information with regarding this vaccine and any anticipated side effects.
general feeling of feeling ill; Fever; neck achy flare up; Knees and shoulders achy flare up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (general feeling of feeling ill), PYREXIA (Fever), NECK PAIN (neck achy flare up) and ARTHRALGIA (Knees and shoulders achy flare up) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. 4782589 and 4782589) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) modified-release tablet for Rheumatoid arthritis.    No other medical history was reported.  Concurrent medical conditions included Rheumatoid arthritis.   On 11-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 13-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-May-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (general feeling of feeling ill), PYREXIA (Fever), NECK PAIN (neck achy flare up) and ARTHRALGIA (Knees and shoulders achy flare up). At the time of the report, MALAISE (general feeling of feeling ill) and PYREXIA (Fever) outcome was unknown and NECK PAIN (neck achy flare up) and ARTHRALGIA (Knees and shoulders achy flare up) had not resolved.            Concomitant product use was not provided by the reporter.  The patient reported knees, neck and shoulders achy in the morning. Second dose of Moderna vaccine caused fever and general feeling of feeling ill.  Treatment information was not provided.  The reporter's causality for the events of Knees and shoulders achy flare up and neck achy flare up with Upadacitinib modified-release tablet was reasonable possibility. The reporter's causality for the events of fever and general feeling of feeling ill with Upadacitinib modified-release tablet was no reasonable possibility.  It was unknown if patient was enrolled in COVID-19-vaccine trial.   Reporter did not allow further contact
Information has been received from a nurse concerning a 34 year old male (in 2006) with no pertinent medical history and no known drug allergies who on unspecified dates were vaccinated with two complete series of RECOMBIVAX HB (10mcg/1mL). The dates of administration and lot numbers were unknown. The second series was administered about 10 years ago. The nurse reported that the patient had negative anti-HBs antibody after administration of two complete series of RECOMBIVAX HB. It was also reported that in 2006 a hepatitis B antibody levels test revealed that it was negative. Unspecified medical attention was sought. The patient was not recovered at this time of reporting. Additional information has been requested.
Declining health condition; Hand swollen; Cannot lift the arm; Physical activity significantly decreased; Infection; Inflammation; Arm pain/pain got worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (stent placed before receiving the vaccine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) (seriousness criterion medically significant), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patient developed arm pain for his father couple of months back next day after receiving the first dose. The pain got worsened from then making the hand swollen and physical activity significantly decreased. The reporter contacted 3 doctors to address the concern and none could figure the reason. The reporter was concerned about his father's declining health condition and mentioned that he cannot his arm. The physician recommended not to have the second dose. First Health care provider considered as Arthritis, Second now considered as Gait and third doctor diagnosed as Infection and Inflammation.  Treatment medication include Prednisone.  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.
Extreme arm pain after 5 minutes -unable to raise arm up for 2 days Fever, body aches chills approx. 12 hours after administration lasting 2 days
Pt had rash around inj site and numbness in fingers for the weekend. Pt if feeling well now but still has itchy sensation.
I had really bad shoulder joint pain and went away, headache and took Tylenol. Second shot the whole side hurt, like I have fallen on the right. Mostly on my shoulder. arm and hip and leg whichever site I had the injection on. Blood pressure is higher.
Mom placed pt in bed and dad noticed that her eyes were rolling back into her head and she was moving her eyes side to side.  Nose was twitching, lip smacking, strange cry.  Arms extended and legs flexed.  Lasted about a minute and then she fell asleep.  Mom fed her, burped her.  Mom changed diaper and she had another spell which was similar in nature.  Took her to the ER by family car and on the way she looked up a few times.  No known FH seizures.  Boodwork and LP were reassuring except for increased CRP to 17mg/L.  Monitored in the ER for a few hours then sent home.  Seen next day.  Had another similar spell when mom played her down on the changing table which lasted for 10 seconds.  Otherwise well.  Blood, urine and CSF cultures negative.  EEG unremarkable.  Head U/S showed slight asymmetry of the lateral ventricles with left greater than right, otherwise normal.  Has done fine since.
Pain, swelling which is resolving now. Patient did not feel it was necessary to see MD.
Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced a shingles outbreak after their 1st dose of vaccine. The reporter gave consent to follow up.
Severe spasms, whole mouth, shoulders, down both arms, everywhere; Chest pains; Ear infection; This is a spontaneous report from a contactable consumer. A 62-year-old-Female consumer (patient), received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ER8732, Expiration Date: 13Jul2021), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 12:45 (Age at vaccination 62 year) as SINGLE DOSE for covid-19 immunisation. Medical history included, cardiac failure. Concomitant medication(s) included hydrocortisone, neomycin sulfate, polymyxin b sulfate (ANTIBIOTIC EAR). Historical vaccine includes bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN6207, Expiration Date: 13Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 12:45 as DOSE 1, SINGLE for covid-19 immunisation. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines administered on Same Date of the Pfizer Suspect. Concomitant Products Antibiotic she did not know the name or dose but has been taking for 5 days. Caller stated she was on lots of medications, as she is in heart failure. But only provided the Antibiotic she has been taking for the last 5 days for an ear infection. This is the only new medication. She stated it was a big pill, not a capsule, by mouth. Caller did not have any further details to provide on report about the Antibiotic. On 03Apr2021 patient experienced severe spasms, whole mouth, shoulders, down both arms, everywhere, on an unspecified date in 2021 chest pains and ear infection. Therapeutic measures were taken as a result of severe spasms, whole mouth, shoulders, down both arms, everywhere took Tylenol and it has not been working. No Emergency Room visit. The patient not wanted to report her AE and be warm-transferred, thus, e-transmitted. Response received was provided disclaimer that Pfizer is unable to make treatment recommendations for individual patients and responded per EUA fact sheet under "6 OVERALL SAFETY SUMMARY". Spoke from CONS document regarding listed adverse events may not be all possible side effects as serious or unexpected side effects may occur. The outcome for event severe spasms, whole mouth, shoulders, down both arms, everywhere was not recovered, for chest pain and ear infection its unknown.   No follow-up attempts are needed. No further information is expected
Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment  Released from hospital on 4/11/21 and currently under treatment
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sensation across mouth. 7/16 chest pain, numbness-arms, feet, tingling in feet. ER-dxed w/ heart attack. Continued numbness in arms & legs, shooting pain in both, left shoulder. Cramping in L arm & hand, difficulty writing, gives out.
Red bump noted on 11/5/02-was seen 11/8/02 with multiple bumps on head, arms, chest and back. Dx chicken pox. No treatment.
Had shingles and vaccination. Now I have them again/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got Shingles vaccination and got shingles again. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
sore arm; This spontaneous report as received from a currently 70 year old male patient  consumer via company concernign himself.  There was no information about the patient's medical history, concurrent conditions or concomitant medication. In November 2020 the patient was vaccinated witha  dose of pneumococcal vaccine, polyvalent (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  Other suspect vaccine included a dose of influenza virus vaccine (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED)) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced sore arms. The outcome of sore arms was unknown. The causal relationship between the aforementioned event and with pneumococcal vaccine, polyvalent (manufacturer unknown) and  influenza virus vaccine (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED))  was unknown.
I got the vaccine on the 7th and I had an upset stomach mid to late morning on 07/09/22. Sunday morning I saw some rash on my stomach but didn't think anything of it but Monday it spread and was feeling very prickly so I called my doctor and they didn't have any appointments so I went to the urgent care and I saw someone and she said that it was shingles and she prescribed an antiviral I've been taking called valacyclovir.
Patient presented to hospital with four days chest pain, dyspnea on exertion and weakness. Work up revealed an acute submassive pulmonary embolism without evidence of deep vein thrombosis in bilateral lower extremities.
I tested positive for COVID, I saw my Dr. was given a prescription for Paxlovid.
Pt recv vax on 11/2/98; on 11/5/98 pt exp headache, lightheaded, sore throat, hoarse, popping ears, pain & tight chest, nausea, diarrhea, swollen feet, chills &fever, aches & pains
Chills, body and joint ache, fever, head ache and rash on the inner part of her arm.
Left deltoid soreness with small area information and induration. Severe headache, backache, left shoulder, left neck pain. Left sided chest pain, pain on inspiration, listless, temp 99.1.
Patient came in to get flu vaccine. Reported no history or issues with vaccines. Started looking pale, feeling dizzy. Rapid Repsonse team was called and they took it from there
Significant redness; Significant swelling; This case was reported by a physician via sales rep and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   The reporter considered the erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The physician stated he had about 3 patients with significant redness and swelling after receiving Shingrix and it has resolved on its own in a couple of days. The reporter did not consent to follow up.
20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Shingles. Allopurinol and valacyclovir prescription , welts on left neck, left ear and chest drying up but still painful, periodic shooting pain
DIED IN THREE WEEKS TIME AFTER SUFFERING TERRIBLY; COVID PNEUMONIA; THREE BLOOD CLOT IN LEGS; SIX BLOOD CLOTS IN LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media from a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date in /FEB/2020, the patient was previously treated with covid-19 vaccine from an unspecified manufacturer (form of admin, route of admin, and batch number were not reported), dose was not reported for prophylactic vaccination.(Dose number in series 1). No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.(Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following covid-19 vaccine ad26.cov2.s vaccination, the patient experienced covid, which was followed by covid pneumonia (Suspected clinical vaccination failure), six blood clots in lungs and three blood clots in legs. It was reported that the patient died in three weeks time after suffering terribly. The cause and date of death was unspecified. It was unknown whether an autopsy was performed.(Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died in three weeks time after suffering terribly on an unspecified date, and the outcome of covid pneumonia, Suspected clinical vaccination failure, six blood clots in lungs and three blood clot in legs was not reported. This report was serious (Death, and Other Medically Important Condition). This case is associated with Product Quality Complaint number 90000208090.; Sender's Comments: V0: 20211249023-covid-19 vaccine ad26.cov2.s-died in three weeks time after suffering terribly, covid pneumonia, six blood clots in lungs and three blood clot in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211249023-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH