chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Amyotrophic Lateral Sclerosis.  2/19/08 Reviewed medical records which reveal patient initially seen in neuromuscular/MDA clinic 4/2007 referred for possible motor neuron disease.  Patient symptoms began 9/2005 w/decreased dexterity of left hand which worsened progressively.  Recently started w/right hand as well w/cramping & decreased dexterity.  Had 30# wt loss over past year.  Returned to clinic 5/2007 & started Rilutek for ALS & discussed clinical trials.  Returned to clinic 8/2007 with increased weakness of arms & hands.  Neuropsychology testing was done & found to be WNL.  Returned to clinic 11/2007 w/continued loss of dexterity of hands. Reported that hand cramping began in 1999-2000 while on board ship.  These were felt to represent initial stages of ALS.  Returned to clinic 2/2008 w/progression of weakness, fatigue & awkwardness.  Now w/weakness of ankles but respiratory function preserved.  Started on lithium & continued serial labs. FINAL DX: amyotrophic lateral sclerosis. Per 60 day follow up: Progressive weakness, muscle atrophy and paralysis dut to Amyotrophic Lateral Sclerosis; loss of motor neurons as defined in: http://www.springerlink.com/content/x457214811q62412/ Received shot 1-1/27/9999 FAV038, Shot 2-2/12/99 FAV038, Shot 3-2/24/99 FAV038, Shot 4-7/29/99 FAV038, Shot 5-1/27/2000 FAV031
Patient presented with a quarter sized round shallow ulcer on his abdomen that appeared in the evening after receiving his first dose of vaccine.  Patient experienced a similar reaction after his second dose (VAERS report will be submitted).
Information has been received from a Licensed Practical Nurse concerning a 82 year old female who "at an unspecified time in the past" was vaccinated with PNEUMOVAX 23 (therapy route and lot # not reported). On 25-OCT-2010 the patient was vaccinated SQ with a dose of PNEUMOVAX 23, 0.5 ml (lot # 665924/0930Z, expired date 17-JUL-2011). The patient developed injection site reaction after receiving PNEUMOVAX 23. On 26-OCT-2010, she developed a red, hot, swollen area on her arm at the injection site that extended to her elbow. The patient was treated with antibiotics. No lab diagnostics studies performed. Patient's present status was not specified by reporter. The Licensed Practical Nurse requested a lot check for PNEUMOVAX 23 lot # 665924/0930Z. The nurse requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. No further information is available.
20SEP93 fever 9PM & achy; 21SEP93 1PM itching & hives; APAP & DPH given;
Vaccine was given Mon 3/23/09 about 12:45PM Pt started with nausea, + diarrhea that evening 4PM.  Seen in ER on (Th) 3/26/09 Given 1 liter of IV fluids Rx for ZOFRAN & PHENERGEN.
Approx 7 hours after vaccine, patient broke out in red welts on his face, and, to a lesser degree, on his legs, arms, and back, and experienced severe itching. Patient was taken to an emergency walkin clinic. The doctor at the clinic administered a shot to counteract the allergic reaction and a creme to treat the itching. The reaction subsided within three hours. The next day, patient experienced redness and mild itching on face/cheeks, but welts did not appear. Took Benadryl OTC. Redness lasted approx 12 hours, then subsided and did not return.
Your thing for the 3rd vaccine knocked me out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Your thing for the 3rd vaccine knocked me out) in a  patient of an unknown age and gender who received mRNA-1273 for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Your thing for the 3rd vaccine knocked me out). At the time of the report, VACCINATION COMPLICATION (Your thing for the 3rd vaccine knocked me out) outcome was unknown.            No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.
Delayed redness on the arm near vaccination on day 5 after shot;  treated with Claritin for five days until redness decreased as prescribed by dermatologist
Sore arm at injection site, headache, mild fever, body aches, lethargy
Lot of itchiness and redness. (No pain). Note: pt took BENADRYL and now she is fine.
Fever, inconsolable crying/shrieking, wouldn't latch, or feed. Prior to the vaccination, she was easily comforted and was latching and feeding well. Pediatrician ordered blood tests to rule out infection - these were normal.
brain fog; Rash macular; skeletal pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1; single UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset Apr2021, outcome "not recovered"; BRAIN FOG (non-serious) with onset Apr2021, outcome "not recovered"; BONE PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "skeletal pain".   Additional Information; Patient reported that he received the vaccine in Apr2021 the following day after that dose the second shot my health has been in decline brain fog rash muscular skeletal pain that continues to this day I have been working with a myraid of doctors ever since I have say this has destroyed my life I can no longer work and I am financially destroyed as well your vaccine poisoned me my life has been turned upside down I have not had any income my last pay check was 15Mar2022 it is a struggle for me each day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
They are outside of the age approved for this vaccine. Recommended in 18 years or older.
lethargy, hypotonia, shallow breathing, pallor, unresponsiveness. Admitted for 24 hour observation. Adverse reaction less than 1 hour after immunization. Final diagnosis: Vasovagal event 2 hr to crying SP immunization 12/10/07-records received for DOS 10/30-10/31/07-DC DX: Vasovagal event secondary to crying status post immunization. Admitted for observation and monitoring. Became pale and hypotonic and unable to awaken after immunizations.
A non-serious spontaneous report of administration of FLUMIST to an 11 month old male child was received from a physician. Neither medical history nor concomitant medication was reported for this patient. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
patient's right arm is extremely numb and the numbness rates as a 7 out of 10; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (patient's right arm is extremely numb and the numbness rates as a 7 out of 10) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced HYPOAESTHESIA (patient's right arm is extremely numb and the numbness rates as a 7 out of 10). At the time of the report, HYPOAESTHESIA (patient's right arm is extremely numb and the numbness rates as a 7 out of 10) outcome was unknown. Not Provided      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.   Concomitant medication was not provided. Treatment information was not provided.
Pain and swelling at injection site Pain and swelling of lymph node near left side of collarbone  Body aches
COVID-19; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MYALGIA (Body aches) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782590) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient experienced COVID-19 (COVID-19) and MYALGIA (Body aches). At the time of the report, COVID-19 (COVID-19) was resolving and MYALGIA (Body aches) outcome was unknown.     It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Treatment details were not reported by the reporter.
urinary incontinence lasting 12+ hours, too sick to even really understand what was happening lasting aprox 24 hours. Severe left flank pain lastinge about 36 hours, chest pain from breathing past 36 hours diagnosed as pleurisy) and continuing, severe shoulder pain
70 y/o female with pmhx CVA w/ right-sided deficit, htn, dm and glaucoma present to Hospital for fevers, decreased appetite and hypoglycemia. Chest XR demonstrated scattered bilateral interstitial opacities likely typical/atypical viral pneumonia. Patient was found to have BG 30's and hypotensive prior to coming to ED. EMS given glucagon en route to hospital. Oxygen sat 88 on room air, put on 2L nasal cnnula, sat mid 90's.
Stroke; Can not talk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and APHASIA (Can not talk) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported  medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization) and APHASIA (Can not talk) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA and CEREBROVASCULAR ACCIDENT. On 13-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. At the time of the report, APHASIA (Can not talk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The wife reported on behalf of her husband. On 13 Apr 2021, the patient was transported to another facility by ambulance. The wife had no information about the lot numbers and was not even and was not sure about the date of first vaccine however, she did mention it could be 03 Mar 21.  No concomitant medications were reported. Treatment information was not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
t106 p/DTP recvd; Mom states this 1st episode; no other sx noted; "Siblings tolerated vax well";
Sore and weak LEFT ARM, shoulder, back and chest. I had an X-ray and MRI that shows nothing more than desecration of collagen and tendinosis.  But, I did nothing to injure arm. Within a few weeks, the same symptoms began in my right arm. I cannot lift either arm without extreme pain.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported  treatment information was not provided.
RN note 4/19/13. Patient came to the clinic today for the following: he states that he was here yesterday, and had a tetanus shot into his left deltoid. Was fine last night. This morning when he woke up, he found the following: left inner aspect of forearm is "tingly and numb" and states that it feels like it fell asleep. Inner aspect of lower left FA is edematous, no redness. Denies pain. VS 136/91 pulse 79 afebrile at 97.0. "Feels like it had NOVOCAINE injected into it". Bilateral hand grasp is strong. No weakness on left side noted. Reports that this started at 5am. Reports having hx of carpal tunnel and MI fairly recently. Is presently enrolled in cardiac rehab, but cancelled for the day. Denies any kind of CP, angina, arm pain. Suggested using ice prn to reduce the edema, that will in turn perhaps relieve pressure on nerve that is causing the numbness.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in right arm and on 04May2023 as dose 6 (booster), single (Lot number: GJ3270) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3249), on 16Feb2021 as dose 2, single (Lot number: EL9265), on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 26Aug2023 to 31Aug2023 were taken as a result of vaccination failure, covid-19.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, sweating and shivers. On 6th April 2019, the patient experienced neck pain, shoulder pain and upset stomach. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm, neck pain, shoulder pain and upset stomach were unknown and the outcome of the sweating and shivers were not recovered/not resolved. The reporter considered the pain in arm, sweating, shivers, neck pain, shoulder pain and upset stomach to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced typical Pain around area following injection. In the middle of night, the pain increased in arm. The patient also had experienced sweat or shivers which was present on the day of reporting. On Saturday, the patient experienced body aches in base of neck and body shoulder area and also experienced sweat at night. In the noon of Saturday, the patient had stomach upset. The batch number was not reported. The patient believes that the events were related to the vaccine. The reporter agreed to follow up from GSK.
Felt exhausted the next day (10Nov2021).; Had a fever of 100.7.; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via intramuscular route of administration in the right arm on 09Nov2021(at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, the patient was diagnosed with COVID-19 prior to the vaccination. The patient had no other medical history and no known allergies. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The reporter was a Pfizer colleague and was on a phone call on 11Nov2021 with a friend of his. Reporter's friend stated that his 12-year-old son received the Pfizer COVID-19 vaccine on 09Nov2021 and had a fever of 100.7 and felt exhausted the next day on 10Nov2021. On 10Nov2021, his father stated that the patient went to the school nurse and they treated him with Tylenol and sent him home from school on 10Nov2021. The patient did not go to school on 11Nov2021 also and now at the time of reporting the patient felt back to normal per his father. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYNELOL). On 09Nov2021, the patient underwent body temperature test and the result was 100.7 (units unspecified). Since the vaccination, the patient had been tested for COVID-19. On 10Nov2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was pending. The clinical outcome of the events fever of 100.7 and felt exhausted the next day were resolved on an unknown date in Nov2021.
Severe headaches, lasting ~1+ week; Severe joint pain (~7 on scale of 1-10), lasting ~1-2 weeks
fever x 1 day 100.8-103; seen in ER @ 24hrs p/vax
Pt arrived due to a fall, but states has had a sore throat, dry cough, and pain with breathing.
Afebrile seizure activity 11/26/07-records received for DOS 11/6/07-DX: afebrile tonic clonic seizure and previously diagnosed with febrile seizures. Admitted for overnight observation. Temp in ED 98.7.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patients were administered doses of improperly stored GARDASIL lot # K007264, expiration date reported as 02-MAR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient entered observation area and upon greeting states "I feel something". Patient stated "feeling something when I swallow" denies difficulty swalling or breathing. Patient appears comfortable, Dr. speaking with patient who reports similar episode in the past mostly after a long shift at work. Patient states she has a history of SVT and usually has this response when she gets nervous. Initial BP 165/108 HR 112 02 99%. Patient reports feeling anxious and denies all other symptoms including shortness of breath or difficulty swallowing. Repeat BP 143/92 HR 95 O2 99%. Patient offered bottled water and appears to be calm at 15:20. Repeat BP 134/94 HR 83 @ 15:30. Patient speaking on her cell phone with employer re: issues at work. Patient in no apparent distress at this time. BP 139/92 HR 89 O2 98%. Patient without  complaints. Will discharge after 30 mins of observation. discharged at 15:45.
Patient STARTED EXPERIENCING NUMBNESS ON THE TIP OF HIS TONGUE AFTER THE ADMINISTRATION OF SECOND DOSE OF COVID VACCINE. HE WAITED FOR FEW MONTHS HOPING TO EVENTUALLY GET BETTER BU IT DID NOT GET BETTER. HE CALLED PHARMACY ON 12/08/21 TO REPORT THE POSSIBLE SIDE EFFECT.
This spontaneous report was received from a consumer refers to her daughter. On 02-OCT-2008 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 659199/1541U, expiration dates 26-JUN-2009). On an unknown date the patient had unspecified levels drawn and the patient's levels showed that she developed low antibodies to PNEUMOVAX 23. The reporter reported that the patient had developed low antibodies to every vaccine (unspecified of which vaccines but the reporter did mention PREVNAR) she had received on unspecified dates due to an unspecified chronic medical condition that the patient was born with. The patient was going to be receiving immunoglobulin therapy on an unspecified date for the unspecified chronic medical condition that the patient was born with. The outcome was unknown. Additional information has been requested.
excruciating pain in lt arm, hand, extending into lt side of neck; minute swelling;
R arm very red, hot, itchy - entire upper arm area - occurred couple days after shot.  Treated for local rxn - antihistamines, compresses.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter