chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) stated that some patients experienced a sore arm from the 1st dose of SHINGRIX and might not want to receive the 2nd dose of SHINGRIX. No specific patient information was provided by the HCP.
died with shingles, destroying spine and brain; died with shingles, destroying spine and brain; Suspected vaccination failure; cancer; amun system was gone; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced shingles (serious criteria death), central nervous system disorder (serious criteria death), vaccination failure (serious criteria GSK medically significant), cancer (serious criteria GSK medically significant), immune system disorder and pain. On an unknown date, the outcome of the shingles and central nervous system disorder were fatal and the outcome of the vaccination failure, cancer, immune system disorder and pain were unknown. The reported cause of death was shingles and central nervous system disorder.   It was unknown if the reporter considered the shingles, central nervous system disorder, vaccination failure, cancer, immune system disorder and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter was the patient's spouse. The patient died with shingles that got into his insides destroying his spine and brain. The patient's immune system was gone due to cancer. The patient had both shingles shots, he could not swollen, he lived 12 days and was in terrible pain. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.; Reported Cause(s) of Death: died with shingles, destroying spine and brain; died with shingles, destroying spine and brain
Information has been received from a nurse referring to an unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ. No adverse effects were reported. It was unspecified if the patients sought medical attention. Follow up information has been received on 29-APR-2015 from a healthcare worker. It was reported that more unspecified patients (unspecified number) received doses of improperly stored ROTATEQ (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested. General details and analysis were updated.
Following vax pt shook & got limp, fever shot up; dx w/URI; MD advised not to give vax if pt is ill w/URI etc;
TIRED, FATIGUED, MUSCLE/BODY ACHES, DIARREAH, NAUSEA
Rash at vaccine site about 1.5? in diameter Itchy and red Still minor symptoms 4 days out
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. It was reported that in approximately in 2013, multiple unspecified patients received doses of improperly stored GARDASIL (dose, route and lot number not reported). The reporter stated that the temperature excursion for the vaccines above occurred on an unspecified date in 2013. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Mother describes swollen arm from deltoid to elbow, redness, fever to 101.2, nausea, swollen cheeks. Unable to move left arm for 3-4 days.
Fever 99.9; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: El8982) via an unspecified route of administration, administered in Arm Right on 02Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4weeks.The patient medical history and concomitant medications were not reported. Patient had no allergies, patient didn't had covid-19 prior to vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number El3246) via unspecified route of administration on 09Feb2021 11:15 as DOSE 1, SINGLE for covid-19 immunisation. On 03Mar2021 04:00 the patient experienced fever 99.9 () (non-serious) with outcome of recovered.  The patient underwent lab tests and procedures which included body temperature: 99.9 on 03Mar2021.Patient was not tested for covid-19 to post vaccination. No treatment was received for the event. The outcome of the event pyrexia was recovered.   No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US022214, is an initial spontaneous report from a medical assistant received on 28 Oct 2015. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. The patient was administered with FLUVIRIN (batch number: 158403) intramuscular on 28 Oct 2015. After vaccination the vaccine ran back out of the injection site and down the patient arm. No adverse event was reported.
I got sick in the year 2000, I believe as a result of the flu shot. I remained severely ill from the end of the year 2000, through to the month of October 2001. At that time, the severity of the symptoms began to subside a little bit therefore I thought  that I was on the road to recovery. Then in November, for and through work, I got another flu shot. Consequently the severity of symptoms has increased, and health has been a significant struggle. This include severe muscle and joint pain, headaches, burning pain in the spine, centered around the base of the skull, persistant right sided weakness, especially in the arm and leg, right side of face is drooped and lacks muscle tone and strength of the left side. Right eyelid is also droopy. I am only able to work part time instead of full time, due to persistent pain and fatigue.
pt had rednes at injection site, with swelling (silver dollar sized) this area was warm to touch. pt stated that they also had a headache on the following day (8/25/2020) this was gone by 8/26/2020
This spontaneous report was received from a physician's assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported. On an unknown date, the patient inadvertently received an expired dose of VARIVAX lot # M019641, expiration date 24-APR-2018, subcutaneous for prophylaxis (strength and dosage schedule not reported). Concomitant therapies included sterile diluent, expiration date 18-NOV-2019 (lot number not provided). No adverse effects reported.
Information has been received from a physician's wife concerning a 64 year old female who in November 2007 and February 2008 was vaccinated with the first and second doses of GARDASIL, respectively. There was no concomitant medication. Subsequently, after receiving the second dose, the patient experienced hearing loss in the right ear. The patient sought unspecified medical attention. The patient did not experience any problems after the first dose. The patient's date of birth and vaccine were verified. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        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 medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-265450 (Patient Link).
Had Moderna 2nd dose on 3/9/21 at 11:50 AM. Fever 101.3 F at 1:30 AM on 3/10/21, took Tylenol 500 mg 2 hours later, temp down to 100.1 at 8 AM on 3/10/21, took 2nd dose of Tylenol 500 mg at 10 AM on 3/20/21. No more fever. Soreness on the site of injection 5/10 in severity at 9 PM on 3/9/21, down to 1/10 at 9 PM on 3/10/21.
Fever, vomiting, diarrhea, rapid heartrate (180 bpm resting HR), chills, extreme body aches, profuse sweating, dizziness, feeling faint.  Extreme body aches began within a couple of hours following vaccination, and other symptoms progressively worsened into the night.
On 3/14/01, mother called and said child had a temperature of 103F and increased crying through the night. No local symptoms. This lasted about 8 hours. At 08:30, the mother was instructed to start Tylenol. At 11:30, per call, baby had a normal temperature and activity was normal. Marked chart and IZ record to hold pertussis due to possible allergy.
VACCINE ERROR: First dose of COVID-19 vaccine (PFizer, lot EJ1865) was given on 12/20/2020. The second dose was given on 1/5/2020 (16 days after initial dose).  No adverse reaction was noted at the time of this submission
After a few minutes of administering the first Moderna vaccine patient reported to have blurry vision with spots, and dizziness. Within a few minutes patient became very sweaty, became pale with mild shakiness. Patient stated he ate every little before getting the vaccine. Pt also stated he was anxious and nervous. Blood pressures were taken at the beginning of the event with a reading of 86/66, heart rate 65. Cold compressions were placed on patient's forehead and arm. after 30 minutes patient felt better and symptoms resolved. Blood pressure upon leaving was 124/76 heart rate 85. Patient walked out without a problem.
Moderna  Covid 19 Vaccine EUA  Nausea , diarrhea, Joint pain, muscle aches, low grade fever, chilling
about 1am the day after the vaccine I started to get flu like symptoms aching joints and fatigue, my child was ill I thought i was getting sick because of her, my whole family tested negative for covid, I slept most of the day, the second day I was also fatigue with a sore throat and muscle fatigue and 3rd day I was normal functioning, I took ibuprofen once and it helped somewhat.
Drug ineffective; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: In Jul2022, the patient experienced COVID. The action taken for adalimumab was dosage permanently withdrawn.  Clinical course: In Jul2022, the patient experienced covid. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. There was no reported medical history. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of COVID with HUMIRA (Adalimumab) was a reasonable possibility/ probable.  The reporter's assessment of the causal relationship of "drug ineffective" and "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together; Tired; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced FATIGUE (Tired). On 04-Dec-2021, the patient experienced APHASIA (Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together). At the time of the report, APHASIA (Could not speak for about 10 minutes, could think of the words he wanted to say but could not get the words out, could not put two words together) outcome was unknown and FATIGUE (Tired) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Patient sent to ER on 10/27 r/t SOB and CP, admitted 10/27-11/2 with Dx: Sepsis, hypoxia, pneumonia. Sent back to ER for CP, SOB, and tachycardia and hospitalized 11/3-11/15 r/t pneumonia, hypoxia, CHF, A-Fib. ER visit on 11/19/21 r/t unresponsiveness. Sent to ER for hypertension and SOB and Hospitalized 11/21-12/2. Sent to ER for SOB and CP and hospitalized 12/7- present.
Service member developed symptoms of Type 1 diabetes in November 2002 (polydipsia, polyuria and weight loss). Diagnosed with Type 1 DM in December 2002 with medical discharge in 2005. The most recent vaccine service member received prior to symptoms onset of diabetes was 11/13/02, which was an influenza vaccination. Service member does not recall any unusual or prolonged local or systemic symptoms following receipt of that influenza vaccine. Patient reports the onset of polyuria and polydipsia around mid-November 2002. He attributed the increased thirst to working outside a lot. He recalls drinking increased amounts of water, Coke and Gatorade in an attempt to quench his thirst. He attributed his increased voiding to his increased fluid intake. He recalls getting up to void about 2-3 times during the night. (Service member reports an episode of "kidneys shut down" about 2-3 months prior to diagnose of diabetes. At the time, he was rehydrated in the Emergency Room and has had no subsequent problems with his renal status.) Service member reports an unexplained 15 pound weight loss around the time of diabetes diagnosis. He reports dropping from his baseline weight of 148 to the 130s. Around 11/21/02, service member noted visual changes and went on sick call. The blood glucose meter reflected his blood glucose level as HIGH ("maxed out"). When he had a serum glucose level drawn, it was elevated, and service member was given 5 units of insulin. He went to hospital Emergency Room that evening and reports his blood glucose level was in the 400s. He was hospitalized x 3 days. While hospitalized, he was started on insulin and oral medications and received diabetes self management training. Initially, it was not clear what type of diabetes this service member had. He remained on oral diabetes medications for 1 1/2 months. He was later medically boarded from the service for Type 1 diabetes mellitus. Service member felt his DM may have been related to receipt of anthrax vaccine. He received his first 5 anthrax vaccines on 11/13/1998, 11/25/1998, 12/09/1998, 06/08/1999, and 11/26/99. He denies any significant or unusual vaccination site reactions; he does recall a burning sensation with injection of each anthrax vaccine. He does not recall any unusual or prolonged systemic symptoms following anthrax vaccine receipt. He believes he may have experienced a few days of generalized body aches and malaise following receipt of each anthrax vaccine, but because he received the vaccines while preparing for deployment or while deployed, he attributed his symptoms to his increased activity and to "pushing (him)self". Service member received his 6th anthrax vaccine on 7/27/00. He denies any vaccine site reactions other than burning with injection. He recalls flu-like symptoms lasting a few days, but denies any unusual or prolonged systemic symptoms.
Immediate  radiating arm pain to my fingers, severe headache, severe body aches, fever 103, chills, nausea, extreme fatigue,  extreme continued dizziness with near syncope, today is Sunday primary doctor is closed today will be contacting
For about 12 hours I was spiking fevers of 101 degrees.   I had shaking chills and couldn't get warm even though my body felt like I was burning up.  The arthritic joints in my hands became so inflamed that I could hardly use them and over all I felt like I had a terrible case of the flu.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. No concomitant medications were reported. On 23-AUG-2016, the patient was vaccinated with GARDASIL 9 (dose, route and lot numbers were not reported) and again received the next dose one month later on 23-SEP-2016. It was reported that no apparent adverse effects were observed. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a nurse, for the Pregnancy Registry for Gardasil concerning a 23 year old female with a history of papilloma viral infection and two live births who in December 2006, was vaccinated with Gardasil.  There was no concomitant medication.  The nurse reported that the patient is now pregnant.  The patient's LMP was 24-DEC-2006 and estimated due date was 30-SEP-2007.  The patient sought unspecified medical attention.  Follow-up information from the physician's office indicated that the patient had a routine ultrasound on 31-MAY-2007 which was normal (24.6 weeks).  The patient delivered a normal male baby on 03-SEP-2007, weighing 3375 grams, 19.5 inches long.  The infant was reported to have heavy meconium at delivery but was normal with an apgar score of 8/9 and no congenital anomalies.  Additional information is not expected.
Information has been received from a health professional concerning a female patient who on 01 Nov 2006 was vaccinated with a 0.65ml dose of varicella zoster virus vaccine live (lot #652936/0981F). On approximately 01 Nov 2006, the patient developed an injection site reaction that was described as red, swollen, hot, and itchy. Unspecified medical attention was sought. The patient was told to take antihistamines and to use a cold compress. As of 06 Nov 2006, the reaction was less severe, but had not resolved. A product quality was not involved. Additional information has been requested.
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1862072, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) POSITIVE. On 09-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) POSITIVE. On 10-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.