chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of rash on trunk and arms in a female subject aged between 40 and 49 years old who was vaccinated with TWINRIX (GlaxoSmithKline) and H1N1 (unspecified).  On 8 March 2010 at approximately 15:00 the subject received 1st dose of TWINRIX (unknown).  On 8 March 2010 the subject received 1st dose of H1N1 unspecified.  On 9 March 2010, 1 day after vaccination with H1N1 unspecified and TWINRIX, the subject experienced rash on trunk and arm and itching of trunk and arm which lasted for three to four days.  The subject was treated with BENADRYL.  At the time of reporting the events were resolved.  The subject received TWINRIX for travel.  The pharmacist considered the H1N1 unspecified was a co-suspect vaccine, except that the rash started at the arm that TWINRIX was administered.  The rash spread to the subject's trunk.  The pharmacist was not sure that the vaccination series should be continued.  The subject's husband received TWINRIX and did not have a reaction.  Follow-up information received from pharmacist on 28 May 2010: The subject was 37 years-old.  The pharmacist indicated that the subject did not receive H1N1 unspecified.  The events started on 08 March 2010, the same day after vaccination with TWINRIX (1 ml, right).  The events were resolved on 12 March 2010.  The pharmacist did not specify a causal relationship to vaccination with TWINRIX, but indicated that TWINRIX was the suspect product.  The vaccination series with TWINRIX was delayed until the physician continued the series at hospital.  The events did not recur following subsequent administration of TWINRIX.  The subject had not experienced adverse events following previous vaccinations.
Severe body aches starting around 7PM.m and lasting through the next morning. Fever started around 5PM. Had fever of 101.6 from 1AM through the next morning. Injection site inflamed and extremely sore starting around 8PM the day of injection. I still have all of these symptoms but slightly less severe fever of 100 degrees.
A nurse reported that a pt received an injection of 2000-2001 formula influenza virus vaccine in 2000 and subsequently, developed Guillain-Barre syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA. See cancelled report, HQ4993318DEC2000. Follow-up received on 1/2/01, indicated that the pt was an elderly female who received 1999-2000 formula influenza virus vaccine. Five to 6 months, post vax, she developed Guillain-Barre syndrome. She died.
Difficulty breathing & fast heartbeat x 1day, hoarseness, weakness, dizziness, muscle aches, soreness at shot site, chills x2days (at time of filling out report.)
Employee states her eyes started itching the next day and woke up today with swelling under both eyes, right more than left.  No drainage.  EE not sure if its allergy or vaccine related.
Full body rash I had after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body rash I had after the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Full body rash I had after the vaccine). At the time of the report, RASH (Full body rash I had after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant products reported  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021: No new information received On 07-Jul-2021: non Significant Follow-up
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 83-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, 0.3 ml single (Lot number: En6199) at the age of 83 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Additional information: caller states she had a reaction the first time she got the first one, she had a sore arm.
Patient came in on 9/21/15 for a shingle vaccine. Patient started having redness overnight and blisters 48 hours later. She was given prednisone. Everything cleared up 1 week later.
generalized pain to bilateral shoulders and legs; His B/P 160/110; nausea; headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (generalized pain to bilateral shoulders and legs), HYPERTENSION (His B/P 160/110), NAUSEA (nausea) and HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 2:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 2:12 PM, the patient experienced PAIN (generalized pain to bilateral shoulders and legs), HYPERTENSION (His B/P 160/110), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 31-Mar-2021 for Nausea, Headache, General body pain and Hypertension, at a dose of 1 dosage form. On 31-Mar-2021 at 3:00 PM, PAIN (generalized pain to bilateral shoulders and legs), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. At the time of the report, HYPERTENSION (His B/P 160/110) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood pressure measurement: 160/110 (High) 160/110 at 14:12 and 150/100 150/100 at 15:00. On 31-Mar-2021, Body temperature increased: 98.1 (normal) 98.1. On 31-Mar-2021, Heart rate: 75 (normal) 75. On 31-Mar-2021, Oxygen saturation: 96% (normal) 96%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up  received on 16-JUN-2021 contains significant information includes, Patient demographics, event outcome, vaccination Facility information.
8/5/11 per after shot - low gd temp (fever) "clumsy" - not able to climb stairs - up at noc - very agitated, crying, fever-101.6.
ON SATURDAY, 02/19/2022 THE NAMED PATIENT CAME WITH HIS MOM TO GET PFIZER COVID SHOT. HE GOT THE SHOT AROUND 10.20AM. AFTER LIKE 5 MINS WAITING OUTSIDE. THE PATIENTS MOM WAS SEEN HOLDING THE PATIENT.MY ATTENTION WAS CALLED IMMEDIATELY AND WE BROUGHT HIM BACK INTO THE CONSULTATION AREA WHERE HE WAS MADE TO LYE ON THE FLOOR. HIS EYES WAS ROLLING AND HE HAD NO ENERGY  AT ALL . HE COMPLAINED OF HEADACHE AND DIZZINESS. 911 WAS CALLED AND THEY CAME AND CHECKED HIM. AFTER LIKE 10 MINS, HE WAS OK AND TOLD THE MOM HE WANTED TO GO HOME. THE MOM REFUSED GOING TO THE HOSPITAL BECAUSE THEY DID NOT HAVE INSURANCE
11;45 Mom put her light on had shortness of breathe, needed a Nirtro pill. Didn?t give much relief. Was given Ativan for anxiety & Diltiazm for blood pressure.. not much relief, was given oxygen. Then LASIK for fluid build up.  Passed about 6;20 A.M. on the 9th.
Presented to ED on 7/19 for respiratory distress. COVID + in February, 2 weeks before admission and on admission. On Chemo therapy since December 2021. Admitted on Vapotherm to maintain O2 level. 7/28 critical care consulted and patient was intubated for acute onset chronic hypoxic respiratory failure. Sputum culture on 7/22 showed pulmonary aspergillus. Treated with cresemba for funagal infection and broad spectrum antibiotics and COVID treatment. Became infected with pseudomonas which was treated with cefepime. Developed right-sided tension pneumothorax which was relieved by chest tube placed to wall suction.Final sputum culture showed extended spectrum cephalosporin resistant pseudomomas aerginosa. Pressor requirments included norepinephrine, epinephrine, vasopressin to maintain mean arterial pressure greater than 65. Ventilator settings increased to 100% FiO2. Cefepime changed to meropenum on 8/4, however patinet was in multi organ failure from septic shock. Changed from full code to intubate only. Due to continued deterioration family decided on comfort care on 8/4.
Within minutes baby had breathing problems and was given a breathing treatment in Dr. office. Days later developed irritability, crying for no apparent reason, vomiting to violent throwing up then seizures to hospital ER to coma like state. Hospitalized 12 days. Subdural hematoma and retinal hemorrhage and fractured rib.  9/14/07 Reviewed hospital medical records which reveal patient experienced abnormal behavior w/abnormal crying s/p being cared for by father while mother was at work.  Reported emesis x 3.  Seen by pcp 5/15 for cough & URI.  In ER, bruising noted on left face, mandible & chest. Right SDH w/left shift by CT scan. Admitted 5/18-5/30/2007.  Intubated & admitted to PICU until 5/23 when transferred to floor on RA.  Hemodynamically stable but had seizures.  Neurosurgery, ophthalmology & neurology consult done.  No surgery required, medically managed.  Found to have diffuse bilateral retinal hemorrhages & preretinal hemorrhage involving macula of right eye.  Referred to CPS & d/c to CPS.  It was felt child would have developmental delays & referral was made.  D/C to CPS on anticonvulsant, thickened formula & left eye patching. FINAL DX: Shaken baby syndrome; SDH; bilateral retinal hemorrhages; preretinal hemorrhages; non accidental trauma. 11/6/07 Reviewed pcp medical records which reveal patient had cough x 1 wk on day of vax along with umbilical hernia, skin bumps, dry skin & scratching at face. Dx w/bronchiolitis on day of vax.  Tx w/nebs.  Returned to clinic on 5/15 much improved.  Dx w/GERD at that time secondary to overfeeding.  Seen in Neurology clinic 7/26/07 s/p hospitalization as described above & started weaning off antiseizure med.  1/11/08 Received birth records which reveal mother w/PNC, chlamidya in 2nd trimester & no complications during pregnancy.  Apgars 7/9 at 1/5 min.  Patient w/mild jaundice at birth w/no phototx required.  Received Hep B 2/22/2007, lot #0640F.
Patient states the day following vaccine his " Left breast swelled up, turned purple and black and was very painful" and is now only "the size of a half dollar and stopped hurting 2 days ago".    This information was gathered from a Phone encounter.  Patient states he did not report this or seek any medical assistance.
rash all over body; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported (reporter's mother) that:  A 80-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm on 20Feb2021 15:00 (At the age of 80 years) as DOSE 2,SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient was allergic to penicillin from an unknown date and unknown if ongoing. Patient had not taken any prior vaccination within 4 weeks. The patient's concomitant medications were not reported. On unspecified date, patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration (At the age of 80 years) as DOSE 1, SINGLE for covid-19 immunisation.The patient experienced rash all over body on an unspecified date. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vomiting - diarrhea - bloody stool. Dx with intussusception.
daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat
Other than local soreness with each AVA, he denied any medical problems.  In 1999 he reported tingling in his left thigh, constant for a day or 5.  This was followed by 5 days of no problems before it returned for one week before finally subsiding.  At the end of 99 and beginning of 2000 he noticed tingling involving the whole left side of his head, and that his left eye would want to droop.  He did seek medical attention and reported a negative work up.  He then began to notice weakness in his left thigh.  He noted a sudden onset while at work and a couple of days later he began to notice back pain and headaches.  Reported everything went down hill from there.  He also noted shoulder pain at around the same time and initially thought it was related to his shoulder injury but stated that the pain was more intense this time.  Currently he states that all of his joints are painful, with occasional swelling of right great toe, and both wrists.  He also notes all muscles as being painful.  He states he is stiff in the arm and this may last hours and that he has to move around to loosen up.  Nothing makes pain worse or better.  He also reports headaches and problems sleeping.  Prior to his immunizations he would be able to do a 2 mile run in 13-15 minutes with a PT score of 280-300.  Currently he can't walk and at times requires crutches to get around.  7/15/08 Reviewed case summary & medical records from 1986 to 6/2008.   FINAL DX: fibromyalgia unrelated to vaccinations Records reveal patient experienced multiple sports related injuries, tension HA, URI, muscle strains, back pain, flu s/s, shoulder dislocation w/right axillary neuropathy r/t sports injury, shin splints, elevated BP, benign positional vertigo, CTS, ganglion cyst all prior to vaccinations in 1998-99.  Migraines, sore throat, persistent shoulder pain, upper back, neck & LBP, insomnia, dizziness, hearing loss, 2001 c/o of intermittent numbness all over, adjustment disorder w/depression & anxiety.  2002 referred to pain clinic for chronic upper & lower back pain, medically retired, dx chronic myalgia.  2005 referred to rheum clinic for polyarthritis intermittently since 1998 & dx w/fibrositis.  2006 rheum dx w/fibromyalgia.
She got her vaccine, had no problems, the next night started itching.  She kept itching every day all over her body.  2 weeks later she went on a cruise and got hot, took Zyrtec and was staying calm but could tell a difference.  When she got home she kept itching, and about a month later she went to the doctor.  (son is a doctor who told her that they would not do anything).  Got a steroid pack and antibiotics and calmed it done but did not go away.  She then kept itching, and went to a dermatologist and they did a skin biopsy.  It feels like gun BB's under her skin.  Extends to her back, chest, and a little on her stomach.  The biopsy showed that it is  Grover's disease, which she has found can be caused by the vaccine. She was given a topical ointment, and has to use some lotion on top of that, Cerave, and was given another antibiotics to use if it's unbearable, but has held off on that as she does not want to put things into her body that she doesn't have to.  She has noticed that when she works out and gets sweaty that the rash gets worse.    Was told that it will take 6-12 months for it to go away.    Had the normal reactions with the first two, tiredness, vomiting within 3 minutes of vaccine but went away after a couple of days, no rash.  She could not lift her arm real well, but nothing like the 3rd one.   Slept for first 2 days, and then was fine.
Severe joint and muscle pain; Severe joint and muscle pain; It woke me up; 99.8 with a gram of Tylenol on board; This is a spontaneous report from a non-contactable nurse, the patient.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included sertraline, cefixime (FLEXERIL), and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 07Jan2021 01:00 AM, the patient experienced severe joint and muscle pain. The patient was woken up even after taking cefixime which usually knocks the patient out (as reported). The patient had a temperature of 99.8 with a gram of paracetamol on board (as reported). The patient reported that she did not receive any treatment for the events. Since vaccination, the patient had not been tested for COVID-19. The outcome of the events severe joint, muscle pain, was woken and temperature of 99.8, were all recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report as received from a certified medical assistant refers to a 4 month old male patient with no pertinent medical history. On 26-FEB-2014, the patient was vaccinated with a dose of ROTATEQ (dose and lot # not reported) orally and on 25-APR-2014, the patient inadvertently received an incomplete dose of ROTATEQ (dose and lot # not reported) orally, due to vomiting immediately after administration. The outcome of vomiting was unknown. Additional information has been requested.
Patient received vaccine and 5 minutes into 15 minute waiting observation felt that he was cold, reported that he has chills and felt the need to vomit. Patient was visibly sweating. Patient refused to have pharmacist on duty call 911. Stated he started feeling better. Patient was observed for 25 minutes total and left with partner stating he felt well.
Pain in left chest. Started as throbbing off and on, lasted for a few days. Changed to a sharp knife-like pain that lasted for a few days. It wasn't continual, but lasted for more than five days.
Muscle/body aches from the bottom of my ribcage to the base of my neck; Muscle/body aches from the bottom of my ribcage to the base of my neck; Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest; My nerves felt like they were on fire in my entire upper body; Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest; This is a spontaneous report from a contactable other hcp (patient).  A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ff2588), dose 1 via an unspecified route of administration, administered in the right arm on 17Sep2021 at 08:30 (at the age of 29 years old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy or drug store. Medical history included obesity and known allergies: sodium benzoate, raw fruits and vegetables. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE) er 20 mg/ as needed taken for an unspecified indication, start and stop date were not reported. Patient did not received other vaccines in 4 weeks. Patient did not have COVID prior vaccination. Patient did not tested COVID post vaccination. On 18Sep2021, at 02:00, patient experienced muscle/body aches from the bottom of her ribcage to the base of her neck. Chest pain- her heart was pounding hard against her chest like it was about to beat out of her chest. Her nerves felt like they were on fire in her entire upper body where she was experiencing the muscle/body aches. This lasted from about 2:00 am until 6:00 am- ibuprofen was taken to help alleviate the symptoms which for the most part subsided next day. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the right arm on 08Oct2021 at 08:30 (at the age of 29 years old) (Batch/Lot Number: ff2589) as DOSE 2, SINGLE for covid-19 immunization. Therapeutic measures were taken as a result of all the events (ibuprofen). The outcome of all the events was recovered/resolved with sequel with the stop date reported as 18Sep2021 at 06:00.  Follow-up attempts are completed. No further information is expected.
Patient completed the vaccines and became lightheaded with 2 minutes of unresponsiveness. Vital signs monitored. Patient alert and talking within 2 minutes and vital signs stable within 10 minutes. Monitored and checked by physician. Released in 40 minutes wth no other reactions.
received only the adjuvant of shingrix; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number J2Y4L, expiry date 18-AUG-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant of shingrix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-Jul-2023 A nurse reported that a patient received only the adjuvant of shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea
Patient felt lightheaded and dizzy. She was unsteady on her feet. Symptoms began within 5 minutes of receiving vaccine.
Client reported dizziness to nurse while in observation area. Client successfully made to trash can without incident where client threw up. Client was assessed by doctor. Client was encouraged to eat crackers and drink fluids when able. Client complied. Client denied discomfort, dizziness, light headedness or nausea at time information was gathered. Client is now stable.
Systemic: Nausea-Mild, Systemic: Vomiting-Mild; symptoms  lasted 1 day
Pt called 9-14-11 to report of red itchy splotches in face area. Denied SOB, or trouble breathing or swelling in throat, nose area. Mom said gave BENADRYL last night & it seemed to help.