chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RabAvert vaccine administered in gluteal muscle; Case reference number US-BN-2022-002190 is a spontaneous case report initially received on 31-Aug-2022 from a consumer via Communications (reference number: USBAV22-1240) and concerns a 25-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 27-Aug-2022, the patient was exposed to a rabid bat and was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown), at an unknown dose, administered intramuscularly, in the gluteal muscle, for rabies exposure (explicitly coded as 'vaccine administered at inappropriate site'). The patient also received two shots in the arm, which were more fluid and smaller, and the reporter believed it was immunoglobulin, as reported.  On 30-Aug-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, administered intramuscularly, in the arm.  At the time of this report, it was unknown if patient experienced any adverse events.  Additional information received on 31-Aug-2022 included the local case ID.; Reporter's Comments: A 25-year-old female patient was exposed to a rabid bat and was vaccinated with the first dose of RabAvert, at an unknown dose, administered intramuscularly, in the gluteal muscle, for rabies exposure which is considered as vaccine administered at inappropriate site. Reportedly, the patient also received two shots in the arm, which were more fluid and smaller, and the reporter believed it was immunoglobulin. Three days after the first dose, the patient was vaccinated with the second dose of RabAvert, at an unknown dose, administered intramuscularly, in the arm. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if patient experienced any adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 25-year-old female patient was exposed to a rabid bat and was vaccinated with the first dose of RabAvert, at an unknown dose, administered intramuscularly, in the gluteal muscle, for rabies exposure which is considered as vaccine administered at inappropriate site. Reportedly, the patient also received two shots in the arm, which were more fluid and smaller, and the reporter believed it was immunoglobulin. Three days after the first dose, the patient was vaccinated with the second dose of RabAvert, at an unknown dose, administered intramuscularly, in the arm. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if patient experienced any adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Patient called in today stating that she started to develop fever/chills, headache, myalgias, fatigue, and increased thirst on 2-9 (2 days after receiving the typhoid and influenza injections).  She reports that symptoms have persisted, although today the headache has resolved and she is starting to feel better.
Date of Admission: 10/29/2021   Date of Death:11/4/2021   Reason for Hospital Admission (Admitting Diagnosis):  Covid-19 pneumonia   Hospital Course and Significant Findings: Patient  is a 76 Y male with a past medical history of  COPD, HTN, HFrEF (last EF 36% on TTE 2019) who presents with 1-week hx of worsening SOB in setting of recently diagnosed COVID-19.    Patient reports that he has had shortness of breath in last few years. He has a hx of COPD and was being followed by pulmonologists. However, last week after returning from a trip patient started having increasing SOB and cough productive of sputum. He reports that it has been gradually getting worse. He uses inhalers at home which minimally helped. He also took Robitussin which seemed to have greatly helped his cough. However, the SOB is now to the point that he has difficulty breathing w/movement and sometimes w/talking. These were associated w/loss of taste / smell, headache, and nausea. Patient denies vomiting, abdominal pain, diarrhea, fevers, chills, or night sweats. Patient reports he may have been exposed to COVID + patient while on a trip where he was attending mother's funeral. He and other attendees ended up being positive for COVID a few days after returning from trip.    On admission, patient started on Remdesivir (10/29-11/2), Decadron 6 mg x1 (10/29), but due to escalation of oxygen requirements, steroids were changed to Solumedrol 125 mg BID (10/29 PM-11/1 AM), Solumedrol 60 mg BID (11/1 PM-11/2), and patient given dose of Tocilizumab 8 mg/kg x1 after discussion w/pulmonology (Dr.). Pt's O2 requirements continued to increase, 11/1 requiring 10 L. 11/2 was on 7 L, but desaturated to high 80s with any movement or speech. On 11/4 AM, pt complained of significantly increased chest pain which limited his breathing, was placed on max oximizer. Status continued to decline and transitioned to max HFNC with NRB (60 L), and ICU was consulted.   On examination, pt was obtunded, unable to clear secretions, appeared dusky, satting in high 80s on HFNC w/ NRB. Anesthesia was called for intubation. Pt was intubated, bagged, transferred to ICU.   Upon arrival to ICU, pt went into PEA arrest, code blue was called. Converted to vfib, then shock administered and pt had ROSC. Central line, arterial line chest tube were placed and pressors, sedation, paralytics initiated.    Pt continued to be hypotensive with worsening O2 saturations on max pressors. Bronchoscopy revealed significant blood. Pt was severely acidotic, hypotension worsening despite pressors. Discussed w/ family pt's imminent passing and was made DNR/DNI, passed at 1500.    Complications: none
Patient's head slumped forward to chest and appeared to almost lose consciousness. Both hands appeared to lightly shake. I estimate this occurred for 30 seconds. Patient then lifted head and was responsive but her face was flushed. She denied having trouble swallowing. She agreed to water and drank two cups. She agreed to a piece of chocolate, in case she was hypoglycemic. After sitting for about 15 minutes, she felt ok to walk and left store with mother.
Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off.  Tingling pain from hairline to mid throat, from behind ear to right side of nose.  areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth,  pain in jaw like having a really bad tooth ache.  this is nine days.   I had a titanium tooth implant in the last six months.   Painful to chew food - eat soups, ice creams, soft food like bananas.
Itching on both of her arms, not at the injection site, and on her neck; This is a spontaneous report from a contactable Nurse.   A 59-year-old female patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Aug2021 (past Saturday) as dose 2, single for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not provided. On an unspecified date in 2021, after receiving the vaccination, patient experienced itching on both of her arms, not at the injection site, and on her neck since then. Nurse would like to know if that was normal or if they should be worried. As per attached cons document there will be a severe allergic reaction would usually occur with in a few minutes to one hour after getting a dose of the Pfizer vaccine. The outcome of the event was reported as unknown.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Information has been received from a lawyer regarding a case in litigation concerning a 64 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JAN-2011, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On or about 01-MAR-2017, the patient was treated by a healthcare provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Dry cough and scratchy throat5 hrs after vaccine-on 10/23 non typical asthama symtoms from climbing stairs,used albuterol inhalor- 10/24&25/2009 fever up to 103 deg. F- 10/28/2009 improving with chest congestion and mildly productive cough.
Narrative: 4/23/2021: Pt called clinic and stated she has been having excruciating migraines since she had her second COVID vaccine. Pt stated she has been vomiting because she is in so much pain. She has not migraines in 3 years. She is not taking anything right now for he migraines. PT was instructed to seek care at ER for evaluation of possible stroke due to having COVID vaccine. PT did not want to come in for care at facility and stated the recent second COVID injection triggered my dormant chronic migraine headaches which feels like I'm being stabbed in the head, once again vomiting, blurry vision, and excruciating head and neck pain. Please prescribe Fioricet today. I've been taking Motrin but need something stronger because it's barely doing nothing for me. 4/26/2022 Pt reported to going to Doctors Care for treatment and received Fioricet q4h x 5 days and Ondansetron ODT #9
1/24/12: Headache and leg weakness at school and felt faint - called office in evening and if worsening to have office visit. 1/25/12: Presents to office with headache, no dizziness and leg weakness - neuro intact positive sensation and reflexes - dc to home to monitor - later called and check. 1/26/12: Called and almost 100%.
Pt recvd HIB/DTP on 19APR91; seen in office 23APR w/erythema multiforme over the entire body x/face & palms; given 20mg of solumedrol & tavist;
- Joint (elbows, knee, thigh, shoulders) pain - fever up to 101.5 - headache - chills - sweating - body aches
chest pain and chills 2 days after vaccination.  seen in ED 2 days after for chest pain.  normal labs and EKG.  seen 6 days later in this office for continued chest pain and chills.   no previous history of chest pain
Extreme weakness,  nausea and vomiting, altered mental status, lethargy, fever, incontinence
Pt vaccinated DTP developed temp 103 approx 8 hrs p/ receiving immunization. Mom notified MD cont. giving Tylenol q4hrs as instructed, tepid bath, f/up by phone next morning, temp 101 lt thigh at site of injection red tender to touch.
Site: Swelling at Injection Site-Mild, Additional Details: Muscle appeared to spasm during administration and area around injection site was raised, after monitoring for 15 minutes, site was normal when muscle relaxed and somewhat raised when muscle was tensed.  Monitored for 30 minutes and pt reported no further issues and left pharmacy.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a red, blistery, painful rash on her chest and back on 11/14/99. The pt was diagnosed with shingles. the pt also had a runny nose for one week. The pt was treated with Tylenol, Motrin and Benadryl. Follow-up information from a physician, reported that the pt subsequently, recovered.
Eight days after shot, I developed "Covid arm", raised, red, itchy, area about 3 inches radium around injection site. It's nearly gone after one week. Not tender, somewhat raised and hard, mainly itchy. No need for remedial actions.
I had severe chills from early morning until about 5:00 pm.  I did not feel good on Sunday, so I ate very little that day and my sugar was about 42 points higher than normal.  On  Monday, I had the same breakfast and lunch that I normally have -- no changes in routine and  my sugar had jumped 60 points when checked just prior to dinner.  Today it is still abnormally high (30 points higher), even when  checked first thing in the morning. Since my sugar is pretty stable, if I watch what I eat this is extremly unusual. and occurred after the second vaccine shot. I believe the sugar readings are decreasing steadily and will see how they are today and tomorrow.
Sudden onset tinnitus in the right ear approximately 2-3 weeks after the 2nd vaccine dose.  It was a very loud & jarring  high-pitched sound (dog whistle-ish) that came on suddenly while sitting outdoors in a quiet area. The drastic intensity of the sound lasted 10-20 seconds and then turned down  where it has remained a constant high-pitched background tone that does not cease.
became unconscious after the second; movement that looks like seizures; Kidney disease; heart complications; kyphosis; Fatigued; Vomiting; This spontaneous report was received from a female patient of unknown age reporting on herself.   The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  Since unspecified dates in 2007 (reported as since 2007 or 2008), after receiving two separate doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient experienced the following events: became unconscious after the second (loss of consciousness), heart complications (cardiac disorder), fatigued, vomiting, kyphosis, movement that looks like seizures (seizure like phenomena), and kidney disease (nephropathy) (It was not clarified if the events started at the same time, in what order occurred, and after which dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) occurred). No treatment was given for the events. The outcome of the events was reported as not recovered. The causal relationship between the suspect vaccine and the events was not reported.  Upon internal review, the events loss of consciousness and seizure like phenomena were determined to be medically significant.
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient received Janssen COVID Vaccine on 03/16/2021 and she experienced fatigue after a week and she still feels fatigue
Local cellulitic reaction to left upper extremity s/p Flu shot approximately 16-18hrs after injection.  Identified by school nurse. Examined by pediatrician. Dx cellulitis. Rx'd antibiotic.
This spontaneous report was received from a certified medical assistant, refers to a 13 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. The certified medical assistant stated that on 05-JAN-2016, the patient was inadvertently vaccinated with doses of both VARIVAX (route, dosage, frequency, lot# and expiration date were not reported) and PROQUAD (route, dosage, frequency and lot# were not reported). No adverse effect was reported. It was unknown if the patient sought medical attention. No product quality complain was involved. Additional information has been requested.
Acute Pancreatic attack- sharp pain in upper left stomach radiating to upper left back, pain also in left breast lasting for approx 2 hrs and then somewhat relieved after taking Tums and phazyme.  After 12 hrs  stomach still mildly sensitive to touch and bloated.
Headache low grade fever arm range of motion decreased. Patient had vaccine on 10/7 and called 10/9 to report adverse effects. Patient stated she did not feel well since the vaccination.
PATIENT COMPLAINS OF REDNESS AND INFLAMATION AT INJECTION SITE AND PROGRESSING DOWN ARM STARTING THE DAY AFTER INJECTION
Information has been received from a physician concerning a 7 months old female with unknown drug allergies and unknown medical history who on 16-APR-2009 was vaccinated with the second dose of ROTATEQ (lot# unavailable).  On 26-MAY-2009 the patient was hospitalized after receiving the second dose of ROTATEQ because of dehydration due to Rotavirus gastroenteritis.  The hospital demographics were unspecified.  At the time of the report, the patient had recovered.  The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number (if applicable), lot number, date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information.  Additional information has been requested.
PT appeared to have fainted minutes after receiving vaccine injection. PT hit head during fall secondary to faint. Immediately after, PT's legs were raised as pressure was applied to head wound. PT became mentally aware moments after raising of legs. PT was taken to hospital by mother for treatment of head wound. No further outcomes to state at time of report.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. The box of vials was received which was frozen and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Soreness on arm seemed to wrap around under arm and armpit. Sore throat, cough
Fever of 101 F; Muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 6 patients. This is 4th of the 6 reports.   The 31-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid vaccine, lot number: unknown) via an unspecified route of administration at a single dose on an unknown date for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer - BioNTech Covid vaccine, lot number: unknown) via an unspecified route of administration at a single dose on an unknown date for Covid-19 immunization. It was stated that, 26 hours after receiving her second dose, she experienced fever of 101 F and muscle aches. Those symptoms lasted for approximately 7 hours and symptoms were relieved with one dose of Tylenol. The patient had recovered from the events of fever of 101 F and muscle aches.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Sunday 4/11 around 2 PM - noticed minor swelling in face Sunday 4/11 9 PM - Swelling worsened. Started feeling short of breath and wheezing and coughing. Hives developed on arms,  legs, and neck. Took of fexofenadine and of diphenhydramine (Benadryl). Went to sleep. Monday 4/12 7 AM - Woke up and noticed severe rash on arms and legs. Swelling on face had decreased, but still noticeable. Called and made a doctor's appointment at 10 AM. Doctor prescribed steroid injection and steroids for 9 days.
Shingrix vaccination that was reconstituted with normal saline; Shingrix vaccination that was reconstituted with normal saline; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number X006002, expiry date 08-JUL-2024) for prophylaxis.   On 15-SEP-2023, the patient received Shingrix. On 15-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix vaccination that was reconstituted with normal saline) and inappropriate dose of vaccine administered (Verbatim: Shingrix vaccination that was reconstituted with normal saline).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter was a clinic supervisor reported that the patient received Shingrix vaccination that was reconstituted with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.