chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 70-year-old female patient who received SHINGRIX. Previously administered products included BENADRYL (prior to vaccine). Concurrent medical conditions included granulomatosis with polyangiitis (diagnosed in 2001) and stent placement. Concomitant products included fluticasone propionate, ADVAIR, Fluticasone, Aspirin, Montelukast, valsartan, vitamin D, Calcium Citrate with Vitamin D, iron and risedronate sodium. On 18th March 2018, the patient received the 1st dose of SHINGRIX. On 18th March 2018, less than a day after receiving SHINGRIX, the patient experienced vertigo, weakness and nausea. On an unknown date, the outcome of the vertigo, weakness and nausea were not recovered/not resolved. The reporter considered the vertigo, weakness and nausea to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The patient received SHINGRIX on right arm. On the same day after receiving SHINGRIX, the patient experienced nausea, weakness and vertigo. The patient had denied permission to contact their physician. This case has been linked with the case US2018058870, reported by the same reporter.
Fever; aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jun2022, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 13Jun2022, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 13Jun2022, outcome "recovering". It was unknown if therapeutic measures were taken as a result of pyrexia, pain, chills.   Additional Information: The age group pf patient was 18-64 Years.   It was unknown If there was other vaccine in fourweeks, If covid prior vaccination and if covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 2 weeks (maybe less) after the vaccine I began to have some very light vaginal bleeding, spotting,  and some clots. It lasted about 10 days. I then went over 5 months without a menstrual cycle. When I did start what I believed to be my period, it was more spotting and light clotting.  A couple months later I began spotting again, this lasted for about 4-5 days. Then the bleeding became much heavier and many more clots (which is unusual for me). I have been bleeding heavier & clotting consistently for  4 more days and counting.
pt recv vax 1MAY96 & 6JUN96 pt exp Steven-Johnson's synd manifested as mucositis, conjunctivitis, diffuse vasculitis, dehydration & dysphagia;exp required an ER or MD visit;pt was subsequently hospitalized; tx w/unspecified prescription
A physician reported that a 5 month old infant received an initial dose of Prevnar vaccine at 2 months of age along with all recommended immunizations. When the infant was 4 months of age Prevnar was deferred due to decreased product availability. The infant received all other recommended vaccines at this 4 month visit. In Jan 2000, the infant was admitted to the PICU. A blood culture revealed S. pneumoniae. Within 24 hours of admission, the child died of overwhelming sepsis. The reporter noted that by the time he was notified of this case and asked microbiology to subculture the original isolate, the organism had autolysed. The original isolate had been maintained on a culture of media slant, the specimen was not lyophlized or otherwise preserved. No additional information was available as of the date of this report. Additional information received 18-Oct-2002 from reporter contained name and address of a pediatrician that cared for the child. A physician reported that a 5 month old infant received an initial dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine at 2 months of age along with "all recommended immunizations" (immunizations not specified). When the infant was 4 months of age Prevnar was deferred due to decreased product availability. The infant "received all other recommended vaccines" at this 4 month visit (immunizations not specifeid). in Jan-2002, the infant was admitted to the pediactric ICU. A blood culture revealed S. pneumoniae. Within 24 hours of admission the child died of overwhelming sepsis. The reporter noted that by the time he was notified of this case and asked Microbiology to subculture the original isolate, the organism had autlysed. The original isolate had been maintained on a culture of media slant, the specimen was not lyophlized or otherwise preserved. no additional information was available as of the date ofthis report(10/22/2002).
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: positive Positive- 6 days after finishing the medications.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided.  It was reported that an unspecified drug was administered with start date 22-May-2022 and stop date 27-May-2022, with the indication treatment of COVID-19. Device date was reported as 02-Jun-2022.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days for Covid-19. Six days after the treatment, the patient had recurrence of symptoms and tested positive for SARS-CoV-2 test. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The patient had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days for Covid-19. Six days after the treatment, the patient had recurrence of symptoms and tested positive for SARS-CoV-2 test. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Nodule formation at VP site, Mild painat 3 am at VP  4/10 turning into intense pain at 8 am 8/10 radiating down to hand.On a scale of 1-10 one being no pain 10 being worst ever. Patient experienced hot flash during intense pain became nauseous and vomited. Pain went away after 2 imnutes. Pain returned around 11:30 am. No further intense pain since. Patient still has soreness at shoulder and bicep area.
PATIENT HAS NO KNOWN SIDE EFFECTS SO FAR AS OF 04/21/2021
Patient arrived for his vaccine.  Vaccine was administered by nurse.  Patient then stated that he does not do well with shots and then he passed out.  The nurse attempted to break his fall.  He fell out of the chair and onto the floor hitting his head on the ground.  He was passed out for about 20-30 seconds.  His legs were elevated and he woke up.  VS were taken BP 137/80 HR 68 O2 sat 100%  Squad was called.  VS retaken  BP 141 HR 70 O2 sat 100%  Squad arrived.  Patient feels lightheaded.  Assisted to chair.  VS retaken  BP 114/93 HR 60 O2 sat 98 %   Patient taken to hospital.
First dose: a little tired; First dose: left arm was sore; First dose: felt the pinch when she received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:00 (Lot number: EP7534) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: Verbatim: Migraine; "She ate a piece of the candy." (unspecified if ongoing), notes: Verbatim: Her friend had traveled overseas and brought back foreign candy and she ate a piece of the candy. Within 20 minutes of eating the candy her eyes started to get itchy and the hives started. The patient's concomitant medications were not reported. Past drug history included: Keflex for Drug allergy, reaction(s): "diarrhoea", notes: Verbatim: She reports she's allergic to Keflex. She got really bad diarrhea when she took Keflex. This happened about 3 or 4 years ago. NDC/Lot/Expiry not known for Keflex. The following information was reported: FATIGUE (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "First dose: a little tired"; PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "First dose: left arm was sore"; VACCINATION SITE PAIN (non-serious) with onset 16Apr2021, outcome "recovered" (Apr2021), described as "First dose: felt the pinch when she received the vaccine".  Additional Information: When probing for information regarding her side effects with the Covid 19 vaccines she reports Patient received the first Covid 19 vaccine on 16Apr2021 and with the first dose patient was a little tired and her left arm was sore. Patient felt the pinch when she received the vaccine. It was the next day she noticed, on 17Apr2021, her tiredness and her arm soreness. The arm soreness only lasted about 2 days. The tiredness only lasted for a day. When probing medical history and concomitant medications, Patient reports she takes migraine medicine when patient needs to but she did not get a migraine with the Covid 19 vaccines. Patient declines to provide the name of the medication. No, prior vaccinations within 4 weeks and No, AE following prior vaccination. No AE require a visit to emergency room and physician office. No prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Presents for AMS, cough, fever. +COVID PTA.  Admit for acute hypoxic resp failure due to COVID pneumonia. Tx: Actemra, solumedrol, zinc,abx, increased O2 requirements; not a candidate for remdesivir. Made comfort care and expired on 8/7.
The common side effects - chills, achiness and fatigue.  No other symptoms, just those.  Lasted about 24 hours.
Tired; Body aches; Headache; Fever/feeling hot/ Warm; Shivering/Chills; Dry eyes; Trouble sleeping; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, several hours after receiving Shingrix, the patient experienced general body pain, headache, fever, shivering, eye dryness, difficulty sleeping and pain in arm. On 17th May 2019, the patient experienced tiredness. On an unknown date, the outcome of the general body pain, headache and tiredness were not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved and the outcome of the shivering, eye dryness and difficulty sleeping were unknown.   It was unknown if the reporter considered the general body pain, headache, fever, shivering, eye dryness, difficulty sleeping, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patients arm became sore soon after and lasted all day. On the day of vaccination, at 8:00 pm, the patient began to experience chills, shivering, dry eyes, and body aches. Less than a day after vaccination, the patient expereinced fever, headache and did not sleep well. The patient felt that she had a fever because she was very warm, but she did not take her temperature. The patient also had a bad headache that she described was a 7 or 8 on a scale of 1 to 10. She said that she did not sleep well last night because she woke of three times during the night feeling hot. On the day of reporting the headache was at a 2. On the day of reporting, 1 day after vaccination, she did not have chills, she felt a little achy but not as achy as day of vaccination, and she felt tired. The patient did not have a fever on the day of reporting. The reporter gave permission to contact her physician. This case has been linked to US2019073176 and US2019073187, reported by the same reporter.
run down; very sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 15:00 as dose 1, single (Lot number: HG4677) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Sep2023 at 15:00, outcome "recovered", described as "run down"; SOMNOLENCE (non-serious) with onset Sep2023 at 15:00, outcome "recovered", described as "very sleepy". Therapeutic measures were not taken as a result of fatigue, somnolence.  Additional information: The patient received no other vaccine in four weeks, Patient was very sleepy and run down 1 day post vaccination. Patient did not have covid prior vaccination and was not covid tested post vaccination.
Redness, and swelling. Hot & tender to touch next day after vaccine administered. Med: Cephalex/Ibuprofen.
ITCHING/RASH/REDNESS/NECK/BACK/ARMS ON RIGHT ARM (EMT RECOMMENDED TO CLIENT TO TAKE BENADRYL)
Metallic taste in mouth, left hand is very numb ( which is same side as injection site), but right hand is numb some too
Second Flu booster given 2 weeks early, per manufactuer  not harmful just that vaccine is not valid. No harm done to the patient. This was administered in the Flu clinic and the process for the flu clinic is we don't get into the patients chart or print MCIRs for the patients we just go by whats on the schedule and administer the immunization. Had the process been to print MCIRs this mistake would have never happened. I have brought the process of the flu clinic to my supervisors attention and hope that changes can be made to how the flu clinic works.
Days after receiving my second Pfizer Covid-19 shot in my right arm, the injection site of my first shot in my left arm began to hurt much like I had just received that shot. It was painful to the touch and also to move. This remained for a number of days even after the injection site of my second dose went away after just 1 day. I still have lingering pain in my left arm ( first dose injection site arm) I can move my arm fully to the front but can not raise it out to the side without pain. It prevents me from doing many daily activities that require movement of that arm, from putting  dishes into the cabinet, to lifting/ picking up everyday items, to gripping the doorknob to open a door. The pain has subsided but does occasionally 'sting' me with a sudden burst when using that arm.   I did not have any of these symptoms prior to receiving my second dose of Covid19 vaccine.
pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalgias, fever, chills, arthralgias.  rash lasted a little over a week and resolved on its own.
Patient experienced itching, swelling, redness, and hot to touch on the area where she has received the vaccine.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 26-JUL-2018, the patient was vaccinated with improperly stored doses of Oka-Merck PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. DILUENT MRK INJ was properly stored. No adverse effects were reported. No product quality complaint was involved. The Oka-Merck PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381:Original Case : 1808USA001261 US-009507513-1808USA004382:Original Case : 1808USA001261 US-009507513-1808USA004383:Original Case : 1808USA001261 US-009507513-1808USA004384:Original Case : 1808USA001261 US-009507513-1808USA004385:Original Case : 1808USA001261 US-009507513-1808USA004380:Original Case : 1808USA001261 US-009507513-1808USA004379:Original Case : 1808USA001261 US-009507513-1808USA004376:Original Case : 1808USA001261 US-009507513-1808USA004377:Original Case : 1808USA001261 US-009507513-1808USA004378:Original Case : 1808USA001261 US-009507513-1808USA004386:Original Case : 1808USA001261 US-009507513-1808USA004387:Original Case : 1808USA001261 US-009507513-1808USA004388:Original Case : 1808USA001261 US-009507513-1808USA004362:Original Case : 1808USA001261 US-009507513-1808USA004363:Original Case : 1808USA001261 US-009507513-1808USA004389:Original Case : 1808USA001261 US-009507513-1808USA004390:Original Case : 1808USA001261 US-009507513-1808USA004391:Original Case : 1808USA001261 US-009507513-1808USA004364:Original Case : 1808USA001261 US-009507513-1808USA004392:Original Case : 1808USA001261 US-009507513-1808USA004393:Original Case : 1808USA001261 US-009507513-1808USA004394:Original Case : 1808USA001261 US-009507513-1808USA004395:Original Case : 1808USA001261 US-009507513-1808USA004365:Original Case : 1808USA001261 US-009507513-1808USA004366:Original Case : 1808USA001261 US-009507513-1808USA004367:Original Case : 1808USA001261 US-009507513-1808USA004397:Original Case : 1808USA001261 US-009507513-1808USA004398:Original Case : 1808USA001261 US-009507513-1808USA004399:Original Case : 1808USA001261 US-009507513-1808USA004368:Original Case : 1808USA001261 US-009507513-1808USA004369:Original Case : 1808USA001261 US-009507513-1808USA004400:Original Case : 1808USA001261 US-009507513-1808USA004401:Original Case : 1808USA001261 US-009507513-1808USA004370:Original Case : 1808USA00126.
This spontaneous report as received from a physician via a field employee refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date within a few dates after receiving GARDASIL the patient experienced cervical lymphadenopathy. The cervical lymphadenopathy occurred on the same side as injection site for GARDASIL. The patient had chest X-ray and unspecified blood work. The outcome of cervical lymphadenopathy was reported as resolved in 2 week (reported as dissipated in 2 weeks). The case is linked to 1402USA007016 (same reporter link). Additional information has been requested.
burning skin; 2 days after Booster muscle spasms; twitches/nerve twitches; pins and needles hands; feet calves hamstrings; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 08:00 (Lot number: FE3592) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Reflux IBS" (unspecified if ongoing); "Known allergies: iodine contrast" (unspecified if ongoing); "Known allergies: Wheat" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: milk" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing); "Known allergies: shrimp" (unspecified if ongoing). Concomitant medication(s) included: DIVIGEL; PROGESTERONE; ARMOUR THYROID. Past drug history included: Cephalosporins for known allergies: Cephalosporins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6202, Vaccine Administration Time: 10:00 AM), administration date: 03Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El9265, Vaccine Administration Time: 10:00 AM), administration date: 10Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "burning skin"; MUSCLE SPASMS (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "2 days after Booster muscle spasms"; MUSCLE TWITCHING (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "twitches/nerve twitches"; PARAESTHESIA (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "pins and needles hands"; MUSCLE INJURY (non-serious) with onset 03Oct2021 06:30, outcome "not recovered", described as "feet calves hamstrings". The events "burning skin", "2 days after booster muscle spasms", "twitches/nerve twitches", "pins and needles hands" and "feet calves hamstrings" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin burning sensation, muscle spasms, muscle twitching, paraesthesia, muscle injury.  Additional information:Steroid dosepak was taken as treatment for adverse events.The patient didn't taken Covid prior vaccination. Patient was not tested Covid post vaccination.Patient didn't taken other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected. .