chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever (99-102.5); couldn't bear weight on injected leg; high white blood cell count; high inflammatory marker count 11/5/09 Medical records received for date 10/17/09 to 10/18/09.DX: myalgia. Chief c/o parents states has fever, and refusing to bear weight L. leg after receiving vax.
In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism.  24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment.  Symptoms progressed and included severe fatigue and muscle aches.  Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues.  Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion.  He was admitted with presumption of overdose of medication, given activated charcoal.  A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time.  CK on admission, 4/11/2021, was 17,086, indicating rhabdo.  Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99.  ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4.  Over several days his mentation improved however was noted to still need light supplemental oxygenation.  Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule.  Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque.  Renal ultrasound unremarkable.  A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation.  Findings included multilobar pulmonary embolism.  Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT.  Over several days CK and Cr returned to baseline / normal levels.  He remains hospitalized and is still undergoing treatment.
Extreme fatigue; Days without sleep; Flare up of gout and in a foot that I haven't had gout pain in before; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: ER8737) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product: COVID-19, brand: Pfizer, Lot number: EN6204, Lot unknown: False, Administration date: 16Mar2021, Administration time: 01:30 PM, Vaccine location: Left arm, Dose number: 1), administration date: 16Mar2021, when the patient was 45 years old, for COVID-19 immunisation, reaction(s): "Fatigue extreme", "Sleeplessness", "Gouty pain", "Flu like symptoms". The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Extreme fatigue"; INSOMNIA (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Days without sleep"; GOUT (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Flare up of gout and in a foot that I haven't had gout pain in before"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Flu like symptoms". Therapeutic measures were not taken as a result of fatigue, insomnia, gout, influenza like illness.  No follow-up attempts are possible. No further information is expected.
low grade fever and headache, nausea , chills, exhaustion  for 7 days
This case was reported by a pharmacist via call center representative and described the occurrence of nerve damage in a 70-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. Concomitant products included Escitalopram. On 5th April 2018, the patient received the 1st dose of SHINGRIX.5 ml. On 10th April 2018, 5 days after receiving SHINGRIX, the patient experienced pain in arm, injection site swelling, muscle swelling and injected limb mobility decreased. On 12th April 2018, the patient experienced shoulder pain. In April 2018, the patient experienced nerve damage and numbness of upper extremities. The patient was treated with ibuprofen. On an unknown date, the outcome of the nerve damage, injected limb mobility decreased and shoulder pain were unknown and the outcome of the pain in arm, numbness of upper extremities, injection site swelling and muscle swelling were recovering/resolving. It was unknown if the reporter considered the nerve damage, injected limb mobility decreased and shoulder pain to be related to SHINGRIX. The reporter considered the pain in arm, numbness of upper extremities, injection site swelling and muscle swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient received SHINGRIX vaccine in the left deltoid. The patient experienced pain in the left arm and swelling of the deltoid muscle in the left arm which occurred 5 days after the dose and the patient could not lift her arm due to this.The pain radiated to the shoulder and down the arm 7 to 8 days after the dose. The patient also experienced numbness which ran down the left arm to the thumb and up through the neck. After 7 days of this pain and numbness, the patient was seen by the physician and diagnosed with nerve damage. The patient was given Ibuprofen but, did not resolve the pain. The patient was prescribed physical therapy to help with the pain and numbness. The pain and numbness had gotten some better but had not yet resolved.
have gotten Covid post-vaccination; have gotten Covid post-vaccination; This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included and concomitant medications were not reported. The patient experienced have gotten Covid post-vaccination on an unspecified date. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  Additional information:  Individual claims to have gotten Covid post-vaccination. Unsure which vaccination had been received. They also shared a post from regarding Covid break through cases: "it was expected we would see breakthrough infections, especially in places where we are seeing a lot of community transmission of the virus. In #, for example, which has the highest rates of transmission in the country, if you're vaccinated, your risk of getting COVID are equivalent to somebody who is not vaccinated here. And that is simply because there is so much more virus circulating right now in # that, even with the protection of the vaccine, you would still get infected." This may also speak to general vaccine efficacy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Itchy rash started on injection site arm and spread to neck, chest, other arm, and stomach at time of report.
Left bicep still feels weak, sore, with intermittent "twitchy" throbbing pain at ~3 minute intervals.  The throbbing lasts for about 20 seconds and subsides. Pain 2/10
This spontaneous report as received from a pharmacy technician refers to a 2-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 28-FEB-2018 the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Received shot at 3:10 PM on Monday Oct 29th woke up during the night with very bad headache, took Tyneol.  In the morning every muscle ached, felt week and short of breath.  Slept most of the day.Kept breaking out with sweats and then chills, no appitite no energy to get sometime to eat.  Felt so bad I wish I would die.  Today is day 2 and I am able to get up and move around some as soon as I move I break out in a sweat.  I am hoping that this is the end
about hour and a half after vaccine felt as if swelling or numbness in face around nose and mouth (mask like distribution) no actual swelling present, sensation went away by the next morning; diarrhea for three days following vaccine, low energy - able to tolerate limited food - banana, crackers, chicken soup - worked to maintain hydration
Was bitten by a bat; Received all 3 of the pre exposure shots in the gluteal region; Case reference number US-BN-2021-002537 is a spontaneous case report initially received from a physician via regulatory authority (reference number: USBAV21-0626) on 15-Dec-2021 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient was vaccinated with three doses of RabAvert (inactivated rabies virus vaccine; batch number was not provided), all in the gluteal region, at an unknown dose, administered via intragluteal route of administration, for pre-exposure (explicitly coded as 'Vaccine administered at inappropriate site').   On an unspecified date, an unknown amount of time after the vaccination, the patient was bitten by a bat. The physician wanted to know if the patient should be treated as vaccinated or unvaccinated.    At the time of initial report, the outcome for the event animal bite was unknown.  The reporter did not provide seriousness or causality assessment.  Additional information received from Bavarian Nordic on 20-Dec-2021 included the local BN case ID.  No additional information provided.; Reporter's Comments: The female patient of unknown age was vaccinated with three doses of RabAvert, all in the gluteal region for pre-exposure, which is considered as product administered at inappropriate site. Reportedly, an unknown amount of time after the vaccination, the patient was bitten by a bat. The product administered at inappropriate site is considered as listed per convention, whilst animal bite is not listed for RabAvert according to the PI and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was unknown. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. The animal bite has been considered as not related to RabAvert, but to life circumstances. This case is considered as non-serious.; Sender's Comments: The female patient of unknown age was vaccinated with three doses of RabAvert, all in the gluteal region for pre-exposure, which is considered as product administered at inappropriate site. Reportedly, an unknown amount of time after the vaccination, the patient was bitten by a bat. The product administered at inappropriate site is considered as listed per convention, whilst animal bite is not listed for RabAvert according to the PI and Datasheet. The patient's medical history and concomitant medication details were not provided. The outcome of the event was unknown. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. The animal bite has been considered as not related to RabAvert, but to life circumstances. This case is considered as non-serious.
Felt very bad pain in my body; awful fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had it at 35 years old) and pain (Due to Shingles the patient had horrible pain and patient was contorted with pain).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Felt very bad pain in my body) and fever (Verbatim: awful fever). The outcome of the general body pain and fever were not reported.   It was unknown if the reporter considered the general body pain and fever to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2023 This case was reported by a patient via interactive digital media. The reporter stated that doctor told to get the vaccine because if the patient caught it again it could kill. The patient took first dose and felt very bad pain in body and an awful fever. The patient was afraid to take the second dose.
I have had a series of issues that lasted for a total of 10 weeks. The side effects have included non-ending migrane headaches, double vision, tongue paralysis, body ache, and loss of strength.
diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (had shingles twice when he was a teenager) and ulcerative colitis.   On 21-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: diarrhea). The outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     It was unknown if the company considered the diarrhea to be related to Shingrix.   Additional Information: GSK receipt date: 26-JUN-2023 The patient he had diarrhea for the past 4 days and was unresolved.  Sending PI. Referred to HCP. The reporter did not consent to follow-up.
Swelling from shoulder to elbow, hot to touch and painful. Also black bruising at 1 of the injection entry sites.
This spontaneous report as received from a nurse refers to a newborn patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient missed a dose of RECOMBIVAXHB lot # J007946, expiration date 24-MAR-2016 and lot J012567 expiration date 30-JAN-201, because the medication appeared gray and cloudy. Vaccination was rescheduled for the next day. No adverse event was reported. PQC involved. This is one of several reports received from the same source. Additional information has been requested.
Broke out in shingles; Body aches; Chills; Headache; Joint aches; Real fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke out in shingles), PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 25-Feb-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint aches) and FATIGUE (Real fatigue). On 28-Feb-2021, the patient experienced HERPES ZOSTER (Broke out in shingles). At the time of the report, HERPES ZOSTER (Broke out in shingles), PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint aches) and FATIGUE (Real fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Right knee pain after second dose) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Congestive heart failure, Atrial fibrillation and Gout. Concurrent medical conditions included High cholesterol. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ARTHRALGIA (Right knee pain after second dose). At the time of the report, ARTHRALGIA (Right knee pain after second dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-153684, US-MODERNATX, INC.-MOD-2021-153717 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-153684:Same reporter (1st dose case) US-MODERNATX, INC.-MOD-2021-153717:Same reporter (2nd dose case)
Headache, Arthralgia, SkinRash, NauseaVomiting, Chills, Fatigue, Injection site pain Narrative:  Other Relevant History:
At approximately 1342 HRS, patient and father presented to observation RN stated, "My arms feel heavy." Patient denied shortness of breath, chest pain, itching, or difficulty swallowing. Respirations even and unlabored. Oral mucosa inspected, appeared pink and moist. Patient smiling during assessment. Pulse Ox 99% on room air. Pulse 95 BPM, even in rate and rhythm. Patient was observed for 10 minutes. Released from observation tent. Ambulated from area accompanied by father without assistance. Gait appeared steady.
Pain at injection site; lightheadedness/dizzy; lethargic; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Mar2021 12:15 (Batch/Lot Number: UNKNOWN) at the age of 65-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Public Health Clinic. Medical history included Peanut oil allergy. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took the first dose of bnt162b2 for covid-19 immunization on 04Mar2021 12:15 PM at Left arm. The patient experienced pain at injection site, lightheadedness/dizzy, lethargic on 26Mar2021 10:30. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events recovering. Information on the lot/batch number has been requested.
itchy throat; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient (Age: 51; Unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious), outcome "unknown", described as "itchy throat". Therapeutic measures were taken as a result of throat irritation. Clinical course: The patient reported she felt an itchy throat when she got home, and she actually took Benadryl as treatment. She was asking if she can take another Benadryl before or after taking the 2nd dose.  No follow-up attempts are possible. No further information is expected.
17:10 child received vaccines, did not cry and then a few minutes later he turned red in face and started drooling and not talking. I was called into the room to assess patient and patient was quiet without any changed to baseline assessment. Left room to as Dr. to evaluate the patient and when we entered the room he told mom that his feet were itching. Upon re-assessment the child was noted to have splotchy red rash to right side of posterior neck and the bottoms of feet were red. As we continued to observe the child had additional redness to right and left side of legs, but nothing specific to injection sites. See immunization record for administration of vaccines to site. Attempt was made to administer oral BENADRYL to patient which he did not tolerate and vomited a large amount of fluid after choking, suctioning performed via bulb, tolerated well. Child cleaned and wet clothing removed. No oral BENADRYL administered. SaO2 94% and child clear bilaterally and regular heart rate. BENADRYL 15 mg IM and Epinephrine (1:1000) 0.15mg IM. With continued observation child decreased rash and redness and SaO2 return to 96%. Child transported via ambulance to ER for further evaluation and management. Clinic summary provided to parent to assist in continuation of care.
Pain at injection site after vaccine administered, then progressively worsening pain over next 12 hrs. Erythema at site, trace edema, and tingling/nerve pain along left arm.
Rash, Fever, Information has been received from a physician concerning a 13 month old female who on 1 Jul 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  It was noted no known exposure to wild type virus.  Concomitant therapy included varicella virus vaccine live (MSD).  On 10 July 2000, the patient experienced fever and on 11 Jul 2000 the patient experienced erythematous maculopapular like rash.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient was fully vaccinated as of 2/22/21. Symptomatic and testing positive as of 8/15/21