chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lymphadenopathy, Mammogram, SARS-CoV-2 antibody test, Ultrasound scan
Clinical narrative: swollen lymph nodes in both lower armpits; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Mar2021 11:00 (Lot number: EN6204) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Active Auto Immune Disorder" (unspecified if ongoing); "Alopetia Areata" (unspecified if ongoing); "known allergies : Fructose Malabsorption" (unspecified if ongoing); "known allergies:many foods problematic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single at 11:00 AM, lot number: EL9266, vaccine location: Right arm), administration date: 13Feb2021, when the patient was 49 years old, for Covid-19 Immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Mar2021, outcome "not recovered", described as "swollen lymph nodes in both lower armpits". The event "swollen lymph nodes in both lower armpits" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: On day 2 after second shot (07Mar2021) swollen lymph nodes in both lower armpits. Mammogram clear - ultrasound shows three enlarged lymph nodes on left lower armpit and one large enlarged lymph node on right lower armpit. Uncomfortable and very visible. Can cup the swollen area on both sides in her hand. No improvement and physician had no treatment to improve condition at this time. Benign lymph node swelling. The patient was tested negative for Nasal swab test (22Mar2021). The patient was not pregnant at the time of this report. The patient did not receive any other vaccine within four weeks of COVD vaccine. The patient did not had COVID prior vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional Information: No reporter's contact information available to you or a sub-contracted party. Start and stop date was unknown. Patient was a consumer and verbatim and event description reported as tinnitus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Overdose, Vertigo, Vision blurred
Clinical narrative: Blurry Vision; Feeling of Room Spinning; Blood Pressure Fluctuating; administration date: 04May2021, dose number: 1/other vaccine same date vaccine date: 04May2021, other vaccine same date dose number: 2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0168) as dose 2, single and intramuscular, administered in arm left, administration date 04May2021 (Lot number: er8735) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: covid prior vaccination. The patient's concomitant medications were not reported. Past drug history included: Amodiaquine?, reaction(s): "allergies". The following information was reported: OVERDOSE (non-serious) with onset 04May2021, outcome "unknown", described as "administration date: 04May2021, dose number: 1/other vaccine same date vaccine date: 04May2021, other vaccine same date dose number: 2"; VISION BLURRED (non-serious) with onset 18Jun2021, outcome "not recovered", described as "Blurry Vision"; VERTIGO (non-serious) with onset 18Jun2021, outcome "not recovered", described as "Feeling of Room Spinning"; BLOOD PRESSURE FLUCTUATION (non-serious) with onset 18Jun2021, outcome "not recovered", described as "Blood Pressure Fluctuating". It was unknown if therapeutic measures were taken as a result of vision blurred, vertigo, blood pressure fluctuation. Additional information: The vaccine facility type vaccine was other. The patient did not receive other vaccine in four weeks. The had not been covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Vaccination site pain
Clinical narrative: His arm is in agonizing pain; He has been bed ridden for the last 3 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  An elderly male patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of Covid-19 Vaccine, manufacture unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jun2021, outcome "not recovered", described as "His arm is in agonizing pain"; BEDRIDDEN (non-serious) with onset Jun2021, outcome "not recovered", described as "He has been bed ridden for the last 3 days".  Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Swap. Caller has an elderly gentleman friend who received his 2nd dose of Covid vaccine about a month ago. She called to check on him and he has been bed ridden for the last 3 days and his arm is in agonizing pain where he received the vaccine. She is wondering why, after a month, is he just now having reactions and how long could this last. Relayed information and transferred to (withheld). Faxed. Caller did not want to provide any information.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Headache; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administration date 18Jun2021 (Lot number: EW0186) at the age of 17 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; VOMITING (non-serious), outcome "unknown", described as "Vomiting".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Urticaria, Vaccination site pain
Clinical narrative: Sore at the injection site; injection arm stiff; Welt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Herniated disc" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Muscle tightness" (unspecified if ongoing); "Muscle spasms" (unspecified if ongoing); "Polycystic ovarian disease" (unspecified if ongoing); "Gastric reflux" (unspecified if ongoing); "Anaphylaxis" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Sinusitis(Frequent)" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Adenoids" (unspecified if ongoing); "Orthopedic surgery" (unspecified if ongoing); "Tonsils" (unspecified if ongoing). Concomitant medication(s) included: PERFOROMIST; IPRATROPIUM BROMIDE AND SALBUTAMOL SULFATE; TRAMADOL; BUDESONIDE;FORMOTEROL FUMARATE; LISINOPRIL; METHOCARBAMOL; METFORMIN; PANTOPRAZOLE; CETIRIZINE HCL. Past drug history included: Pneumovax. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "unknown", described as "Sore at the injection site"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 09Apr2021, outcome "unknown", described as "injection arm stiff"; URTICARIA (non-serious) with onset 09Apr2021, outcome "unknown", described as "Welt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Medication error: vaccines given to 7 patients that were in the freezer, for longer than 2 weeks.; Medication error: vaccines given to 7 patients that were in the freezer, for longer than 2 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FA6780) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "Medication error: vaccines given to 7 patients that were in the freezer, for longer than 2 weeks.".  Additional information: The reporter was originally told that the Pfizer BioNTech Covid 19 vaccine, could be kept in the freezer for one month. The reporter states that 09Jun2021, will be one month, that some of the vaccine has been in the freezer. Some vaccine, was given to patients, outside of the recommendations. As of 06Jul2021 (reported as today), the vaccine has been in the freezer for 26 days, at -7 degrees Fahrenheit, but between -18 and -5 degrees Fahrenheit, but it has been 26 days, and it has been given to some patients.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021847153 Same reporter/ AE/ drug, different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: It was beyond the 42 days window between the first and 2nd; Soreness at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 (Lot number: EW0196) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing), notes: So, with that she has cancer (Intent: History); "chemotherapy", start date: 2021, stop date: 2021. Concomitant medication(s) included: ENFORTUMAB VEDOTIN taken for chemotherapy. Vaccination history included: Bnt162b2 (dose 1, single, Anatomical site: Left Arm), administration date: 06Apr2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Jun2021, outcome "unknown", described as "It was beyond the 42 days window between the first and 2nd"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Soreness at the site of injection".  The reporter is calling on behalf of her mom,who received her Pfizer BioNtech covid vaccine back in April first dose, then started on her chemotherapy (the week she was supposed to get the 2nd shot). They didnt know how she was going to react because the chemotherapy was experimental so at the end of April they stated nothing happened so they instructed her to get the covid vaccine. She received her 2nd dose in June. It was beyond the 42 days window between the first and 2nd and the reporter was told if patient missed that window they need to start again. Reporter added, The only thing that happened was the soreness at the site of injection but nothing out of the ordinary. No fever or nothing. She has cancer (Intent: History) so she has been going through chemotherapy between that time that's why there was such a delay (Further clarification was unknown) because her oncologist wasn't sure and don't wanted to take the chance for her to take the second dose with starting of her chemotherapy  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced lymphadenopathy (swollen lymphatic system), with outcome of unknown. Additional information: The patient wanted to know if they didn't get the second dose at 3 weeks (21 days), when could they receive the second dose of the Pfizer-BioNTech COVID-19 vaccine? The patient also wanted to know why their lymphatic system swelled-up, and inquired about the  ingredients included in the vaccine (preservative in the vaccine, components of the vaccine vial made with latex, vaccine contain live virus, emergency use authorization, manufacturer and wanted to participated in the Pfizer-BioNTech COVID-19 clinical trial. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: experiencing dreaming; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Lot number: EW0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HIV Virus", start date: 1997 (ongoing), notes: Verbatim: HIV Virus; "Seizure" (ongoing), notes: Verbatim: Seizures; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: LAMIVUDINE taken for hiv infection (ongoing); PREZISTA taken for immunodeficiency (ongoing); LEVETIRACETAM taken for seizure; LAMOTRIGINE. Vaccination history included: Bnt162b2 (Batch/lot number: ER8729 , Dose 1, single, anatomical site: left arm), administration date: 19Apr2021, when the patient was 54 years old, for COVID-19 Immunisation; Pneumonia vaccine (Verbatim: a month prior in March he got the pneumonia vaccine.). The following information was reported: ABNORMAL DREAMS (non-serious) with onset May2021, outcome "not recovered", described as "experiencing dreaming". Therapeutic measures were not taken as a result of abnormal dreams.  Additional information: Patient concomitant medication included avacruir tablet 600 mg, daily for HIV virus from 10 years, ongoing. It was reported that a couple of weeks after first injection.  Caller stated there is a summer camp of 128 kids that got sick. His first vaccine was on 19Apr2021 and his second second shot was in May2021. After the second shot within a week later he has been experiencing dreaming good, bad, and weird dreaming, start around 15May2021-20May2021, treatment - none. He was negative for the vaccine he clarified he had no antibodies and because he is immunocompromised. He clarified that he had no antibodies prior to vaccination. He has been on medication for the HIV virus for 15 years. Patient did not visit emergency room and physician office. did not have prior vaccinations.  No follow up attempts are possible. No further information is excepected
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Skin disorder
Clinical narrative: getting pains down into her bicep area ,the inner portion, in the same arm that the vaccine was given; had a big red circle that started turning dark and is getting better but it is still there.; Shooting pain in my bicep area; 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 received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "getting pains down into her bicep area ,the inner portion, in the same arm that the vaccine was given"; SKIN DISORDER (non-serious), outcome "recovering", described as "had a big red circle that started turning dark and is getting better but it is still there."; PAIN (non-serious), outcome "not recovered", described as "Shooting pain in my bicep area".  Additional information: Caller states that she had the first dose of the Pfizer COVID-19 Vaccine four weeks ago tomorrow and needs to get her second dose but not sure if she should because she was concerned because after her first dose she has been getting pains down into her bicep area ,the inner portion, in the same arm that the vaccine was given, she also had a big red circle that started turning dark and was getting better but it was still there. She was wondering if this was normal and if she should get the second dose of the vaccine. Consumer stated, Patient had some questions about the vaccine. Patient called to Pharmacist and she told me to call you guys. she got the vaccine, my first dose and it will be 4 weeks tomorrow and since I got it, I had like shooting pain in my bicep area and I am still having it now, 4 weeks later. So, I am concerned about if I should get the second dose or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Folliculitis, Hidradenitis, Poor quality product administered, Product storage error
Clinical narrative: Caller states 17 patients received the doses after the light exposure, 13 of those being second doses.; Caller states 17 patients received the doses after the light exposure, 13 of those being second doses.; Problems are Hidradenitis and Folliculitis; Problems are Hidradenitis and Folliculitis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12 year-old female patient received bnt162b2 (BNT162B2, solution for injection) (Lot number: FA6780) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hidradenitis" (unspecified if ongoing); "Folliculitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "Caller states 17 patients received the doses after the light exposure, 13 of those being second doses."; HIDRADENITIS (non-serious), FOLLICULITIS (non-serious) and all described as "Problems are Hidradenitis and Folliculitis".  Additional Information: Reporter is a nurse and they were told that the vaccines cant be exposed to light, However while in the freezer the lights were not turned off and the vaccines were exposed to light for 16 and 17 hours. Nurse wanted to know if the vaccines are still good to use. Nurse stated 17 patients received the doses after the light exposure, 13 of those being second doses. Nurse stated, It was for Covid. So, the vaccine was under the normal temperature, there was not a temperature excursion. The unit of the refrigerator unit, the light inside of unit was left on. So, the vaccine was exposed to that units of light for about 16 hour and a half so there was no temperature excursion. The temp were all within the limits. Nurse stated, Problems are Hidradenitis and Folliculitis.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856936 same reporter/drug/AE, different patient
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 88 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Mar2021 (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 88 years as dose 1, single and intramuscular, administered in arm right, administration date 13Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "slight soreness at injection site".  Additional information: Prior vaccination and relevant tests was reported as none. Anatomical site of injection: Arm left. Drug lot number and Expiration date: EP6955 Expiry date: 30Jun2021. Only reaction was slight soreness at injection site for both her mother and herself.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 11:40 (Lot number: EW0172) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01May2021 11:40, outcome "recovered" (2021), described as "soreness of my arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior vaccination: None  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experiencing pain on his right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EV6207) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovering", described as "experiencing pain on his right arm".  Additional information: He reported that he was experiencing soreness in right arm where he had the vaccine in his left arm which started about a week and a half ago. Injected in left arm in the shoulder. Received this one on left arm in the shoulder as well. Unable to confirm if given intramuscularly. No of previous doses was none. Event did not require a visit to Emergency Room or Physician Office. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant tests was none. Patient wanted to know if this right arm pain was normal, how soon will it go away and if it will go away or will he be stuck with it. Report is related to a study or programme.  Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain in extremity, Rash macular, Vascular pain
Clinical narrative: in about 2 weeks after pain to the right arm slowly increasing; palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks; presently pain along the chest wall like neuralgic pain; appearance of small spots here and there in the chest and neck region; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 87 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EN62201) at the age of 86 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension; HYDROCHLOROTHIAZIDE; WARFARIN; ESTRADIOL. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer , Lot #EL8982: 14Jan2021 (name provided), lot number= Lot # EL8982, lot unknown= False, administrator route= Intramuscular, administration date= 14Jan2021, administration time= 11:00 AM, vaccine location= Right arm, AE- initially right arm pain and tenderness), administration date: 14Jan2021, when the patient was 87 years old, for covid-19 immunization, reaction(s): "initially right arm pain and tenderness", "initially right arm pain and tenderness", "lymph node swelling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Feb2021, outcome "recovering", described as "in about 2 weeks after pain to the right arm slowly increasing"; VASCULAR PAIN (non-serious) with onset 24Feb2021, outcome "recovering", described as "palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 24Feb2021, outcome "recovering", described as "presently pain along the chest wall like neuralgic pain"; RASH MACULAR (non-serious) with onset 24Feb2021, outcome "recovering", described as "appearance of small spots here and there in the chest and neck region". Therapeutic measures were not taken as a result of pain in extremity, vascular pain, musculoskeletal chest pain, rash macular.  Additional information: It was reported that the patient was not known allergy at present but when she was young, likely to shrimp that has disappeared. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. About 2 weeks after pain to the right arm slowly increasing, palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks, presently pain along the chest wall like neuralgic pain, and appearance of small spots here and there in the chest and neck regions, none so acute but uncomfortable.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Dermatitis allergic, Rash
Clinical narrative: Allergies: Prevnar 13 (pneumococcal13-val conj vacci) - Rash; Allergies: Prevnar 13 (pneumococcal13-val conj vacci) - Rash; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), DERMATITIS ALLERGIC (non-serious), outcome "unknown" and all described as "Allergies: Prevnar 13 (pneumococcal13-val conj vacci) - Rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hypoaesthesia oral, Oral discomfort
Clinical narrative: warm rush; numbness in/around mouth; Burning around lips; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "warm rush"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "numbness in/around mouth"; ORAL DISCOMFORT (non-serious), outcome "unknown", described as "Burning around lips"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue". Additional information: The patient stated that, she had a reaction to shot 1; warm rush and numbness in/around mouth just after she left facility. Burning around lips for 24-hrs and extreme fatigue for 2 days. Not sure if she should get second dose of Pfizer or change to another shot maker. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Patient stated a few days later a blister/patch showed up on the top of her nose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/21
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/21
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/21
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy heart abnormal, Biopsy liver abnormal, Brain natriuretic peptide increased, Cardiac failure congestive, Cardiac imaging procedure abnormal
Clinical narrative: After dose #2 (Jan 9, 2021), I began noticing decreases in my physical performance, which I think was due to decreased cardiac output. For example, pre-vaccine (Dec 2020), I could bench press 225# 6-8 times, had a max bench press of 265# and could hike at a pace of 20-22 min/mile.   By Feb 2021, these indices declined, but relatively slightly. I could bench press 225# 2-3 times, max bench press 235-240, and I was hiking at a pace of 22-24 min/mile and requiring more breaks for the same hikes.   I received by Pfizer 3rd shot, aka, booster, on Aug 26, 2021. By Sept 2021, in hindsight, by physical performance took a sudden downturn. I could no longer bench press 225# even once and I was hiking at a pace of 35-40 min/mile. By Nov, I could no longer walk from my office to an exam room without being short of breath.   By Dec 2021, I required 2 pillows to sleep, then 4 pillows, and then finally needed to sleep in a chair.   On Jan 11, 2022, I saw my primary care physician who suspected either a walking pneumonia and/or sleep apnea.  A chest X-ray was ordered for Jan 13. I received a verbal report that same day that indicated that I had mild cardiomegaly compared to prior studies but that this could be within the realm of technique differences.    I was planning on going on the ski trip the next day (Fri, Jan 14, 2022). I went on the ski trip, elevation 9,000-11,000 feet.   On Sat morning, Jan 15, 2022, I skied but struggled, especially at the bottom with returning to the chair lift. At the end of the morning skiing, around noon, I went down to one knee and was gasping for air. I check my radial pulse, twice, and it was difficult palpate. Both times, I counted over 200 beats per minute.   At the same time, by X-rays, which had been done 48 hours earlier, were released via the patient portal. I am a physician (radiation oncologist) and have experience in reading films. I saw my chest X-ray and it was clear that I had severe cardiomegaly and likely fluid as well. It was obvious to me, at this point, that I was in congestive heart failure at the time of the Jan 13, 2022 CXR and had been in some degree of CHF for several months.   I was able to make it to the rest of the group but this was not easy. They helped me return to our base where an anesthesiology friend and the 2 trainers who came on the trip examined me. My heart rate had settled in the 120-130 range and my pulse oximeter readings were 92-94%.   I returned on Mon morning, Jan 17 and went straight to Clinic, where I work.    My ECG should global conduction abnormalities.  My lab work was markedly abnormal (chemistry, CBC) with a BNP of 1700.   My echo showed bilateral ventriculmegaly with ejection fractions of 15%
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac sarcoidosis, Cardiomegaly, Chest X-ray abnormal, Conduction disorder, Dyspnoea
Clinical narrative: After dose #2 (Jan 9, 2021), I began noticing decreases in my physical performance, which I think was due to decreased cardiac output. For example, pre-vaccine (Dec 2020), I could bench press 225# 6-8 times, had a max bench press of 265# and could hike at a pace of 20-22 min/mile.   By Feb 2021, these indices declined, but relatively slightly. I could bench press 225# 2-3 times, max bench press 235-240, and I was hiking at a pace of 22-24 min/mile and requiring more breaks for the same hikes.   I received by Pfizer 3rd shot, aka, booster, on Aug 26, 2021. By Sept 2021, in hindsight, by physical performance took a sudden downturn. I could no longer bench press 225# even once and I was hiking at a pace of 35-40 min/mile. By Nov, I could no longer walk from my office to an exam room without being short of breath.   By Dec 2021, I required 2 pillows to sleep, then 4 pillows, and then finally needed to sleep in a chair.   On Jan 11, 2022, I saw my primary care physician who suspected either a walking pneumonia and/or sleep apnea.  A chest X-ray was ordered for Jan 13. I received a verbal report that same day that indicated that I had mild cardiomegaly compared to prior studies but that this could be within the realm of technique differences.    I was planning on going on the ski trip the next day (Fri, Jan 14, 2022). I went on the ski trip, elevation 9,000-11,000 feet.   On Sat morning, Jan 15, 2022, I skied but struggled, especially at the bottom with returning to the chair lift. At the end of the morning skiing, around noon, I went down to one knee and was gasping for air. I check my radial pulse, twice, and it was difficult palpate. Both times, I counted over 200 beats per minute.   At the same time, by X-rays, which had been done 48 hours earlier, were released via the patient portal. I am a physician (radiation oncologist) and have experience in reading films. I saw my chest X-ray and it was clear that I had severe cardiomegaly and likely fluid as well. It was obvious to me, at this point, that I was in congestive heart failure at the time of the Jan 13, 2022 CXR and had been in some degree of CHF for several months.   I was able to make it to the rest of the group but this was not easy. They helped me return to our base where an anesthesiology friend and the 2 trainers who came on the trip examined me. My heart rate had settled in the 120-130 range and my pulse oximeter readings were 92-94%.   I returned on Mon morning, Jan 17 and went straight to Clinic, where I work.    My ECG should global conduction abnormalities.  My lab work was markedly abnormal (chemistry, CBC) with a BNP of 1700.   My echo showed bilateral ventriculmegaly with ejection fractions of 15%
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Exercise tolerance decreased, Full blood count abnormal
Clinical narrative: After dose #2 (Jan 9, 2021), I began noticing decreases in my physical performance, which I think was due to decreased cardiac output. For example, pre-vaccine (Dec 2020), I could bench press 225# 6-8 times, had a max bench press of 265# and could hike at a pace of 20-22 min/mile.   By Feb 2021, these indices declined, but relatively slightly. I could bench press 225# 2-3 times, max bench press 235-240, and I was hiking at a pace of 22-24 min/mile and requiring more breaks for the same hikes.   I received by Pfizer 3rd shot, aka, booster, on Aug 26, 2021. By Sept 2021, in hindsight, by physical performance took a sudden downturn. I could no longer bench press 225# even once and I was hiking at a pace of 35-40 min/mile. By Nov, I could no longer walk from my office to an exam room without being short of breath.   By Dec 2021, I required 2 pillows to sleep, then 4 pillows, and then finally needed to sleep in a chair.   On Jan 11, 2022, I saw my primary care physician who suspected either a walking pneumonia and/or sleep apnea.  A chest X-ray was ordered for Jan 13. I received a verbal report that same day that indicated that I had mild cardiomegaly compared to prior studies but that this could be within the realm of technique differences.    I was planning on going on the ski trip the next day (Fri, Jan 14, 2022). I went on the ski trip, elevation 9,000-11,000 feet.   On Sat morning, Jan 15, 2022, I skied but struggled, especially at the bottom with returning to the chair lift. At the end of the morning skiing, around noon, I went down to one knee and was gasping for air. I check my radial pulse, twice, and it was difficult palpate. Both times, I counted over 200 beats per minute.   At the same time, by X-rays, which had been done 48 hours earlier, were released via the patient portal. I am a physician (radiation oncologist) and have experience in reading films. I saw my chest X-ray and it was clear that I had severe cardiomegaly and likely fluid as well. It was obvious to me, at this point, that I was in congestive heart failure at the time of the Jan 13, 2022 CXR and had been in some degree of CHF for several months.   I was able to make it to the rest of the group but this was not easy. They helped me return to our base where an anesthesiology friend and the 2 trainers who came on the trip examined me. My heart rate had settled in the 120-130 range and my pulse oximeter readings were 92-94%.   I returned on Mon morning, Jan 17 and went straight to Clinic, where I work.    My ECG should global conduction abnormalities.  My lab work was markedly abnormal (chemistry, CBC) with a BNP of 1700.   My echo showed bilateral ventriculmegaly with ejection fractions of 15%
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Giant cell myocarditis, Granulomatous liver disease, Heart rate abnormal, Insomnia, Laboratory test abnormal
Clinical narrative: After dose #2 (Jan 9, 2021), I began noticing decreases in my physical performance, which I think was due to decreased cardiac output. For example, pre-vaccine (Dec 2020), I could bench press 225# 6-8 times, had a max bench press of 265# and could hike at a pace of 20-22 min/mile.   By Feb 2021, these indices declined, but relatively slightly. I could bench press 225# 2-3 times, max bench press 235-240, and I was hiking at a pace of 22-24 min/mile and requiring more breaks for the same hikes.   I received by Pfizer 3rd shot, aka, booster, on Aug 26, 2021. By Sept 2021, in hindsight, by physical performance took a sudden downturn. I could no longer bench press 225# even once and I was hiking at a pace of 35-40 min/mile. By Nov, I could no longer walk from my office to an exam room without being short of breath.   By Dec 2021, I required 2 pillows to sleep, then 4 pillows, and then finally needed to sleep in a chair.   On Jan 11, 2022, I saw my primary care physician who suspected either a walking pneumonia and/or sleep apnea.  A chest X-ray was ordered for Jan 13. I received a verbal report that same day that indicated that I had mild cardiomegaly compared to prior studies but that this could be within the realm of technique differences.    I was planning on going on the ski trip the next day (Fri, Jan 14, 2022). I went on the ski trip, elevation 9,000-11,000 feet.   On Sat morning, Jan 15, 2022, I skied but struggled, especially at the bottom with returning to the chair lift. At the end of the morning skiing, around noon, I went down to one knee and was gasping for air. I check my radial pulse, twice, and it was difficult palpate. Both times, I counted over 200 beats per minute.   At the same time, by X-rays, which had been done 48 hours earlier, were released via the patient portal. I am a physician (radiation oncologist) and have experience in reading films. I saw my chest X-ray and it was clear that I had severe cardiomegaly and likely fluid as well. It was obvious to me, at this point, that I was in congestive heart failure at the time of the Jan 13, 2022 CXR and had been in some degree of CHF for several months.   I was able to make it to the rest of the group but this was not easy. They helped me return to our base where an anesthesiology friend and the 2 trainers who came on the trip examined me. My heart rate had settled in the 120-130 range and my pulse oximeter readings were 92-94%.   I returned on Mon morning, Jan 17 and went straight to Clinic, where I work.    My ECG should global conduction abnormalities.  My lab work was markedly abnormal (chemistry, CBC) with a BNP of 1700.   My echo showed bilateral ventriculmegaly with ejection fractions of 15%
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Liver sarcoidosis, Palpatory finding abnormal, Positron emission tomogram abnormal
Clinical narrative: After dose #2 (Jan 9, 2021), I began noticing decreases in my physical performance, which I think was due to decreased cardiac output. For example, pre-vaccine (Dec 2020), I could bench press 225# 6-8 times, had a max bench press of 265# and could hike at a pace of 20-22 min/mile.   By Feb 2021, these indices declined, but relatively slightly. I could bench press 225# 2-3 times, max bench press 235-240, and I was hiking at a pace of 22-24 min/mile and requiring more breaks for the same hikes.   I received by Pfizer 3rd shot, aka, booster, on Aug 26, 2021. By Sept 2021, in hindsight, by physical performance took a sudden downturn. I could no longer bench press 225# even once and I was hiking at a pace of 35-40 min/mile. By Nov, I could no longer walk from my office to an exam room without being short of breath.   By Dec 2021, I required 2 pillows to sleep, then 4 pillows, and then finally needed to sleep in a chair.   On Jan 11, 2022, I saw my primary care physician who suspected either a walking pneumonia and/or sleep apnea.  A chest X-ray was ordered for Jan 13. I received a verbal report that same day that indicated that I had mild cardiomegaly compared to prior studies but that this could be within the realm of technique differences.    I was planning on going on the ski trip the next day (Fri, Jan 14, 2022). I went on the ski trip, elevation 9,000-11,000 feet.   On Sat morning, Jan 15, 2022, I skied but struggled, especially at the bottom with returning to the chair lift. At the end of the morning skiing, around noon, I went down to one knee and was gasping for air. I check my radial pulse, twice, and it was difficult palpate. Both times, I counted over 200 beats per minute.   At the same time, by X-rays, which had been done 48 hours earlier, were released via the patient portal. I am a physician (radiation oncologist) and have experience in reading films. I saw my chest X-ray and it was clear that I had severe cardiomegaly and likely fluid as well. It was obvious to me, at this point, that I was in congestive heart failure at the time of the Jan 13, 2022 CXR and had been in some degree of CHF for several months.   I was able to make it to the rest of the group but this was not easy. They helped me return to our base where an anesthesiology friend and the 2 trainers who came on the trip examined me. My heart rate had settled in the 120-130 range and my pulse oximeter readings were 92-94%.   I returned on Mon morning, Jan 17 and went straight to Clinic, where I work.    My ECG should global conduction abnormalities.  My lab work was markedly abnormal (chemistry, CBC) with a BNP of 1700.   My echo showed bilateral ventriculmegaly with ejection fractions of 15%
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/21
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose increased, Diabetes mellitus, Fatigue, Somnolence
Clinical narrative: Immediately after getting first covid vaccine 9/23/2021 I felt weak, tired and extremely sleepy. Second covid shot 10/21/2021 I notice that I was having a hard time maintaining my weight. I lost ten pounds in one week after second shot went from 191 to roughly 179 pounds in weight. I never lost my appetite but I was constantly loosing weight.  I went to a nurse practitioner sometime in November 2021, test where ran I was diagnosed with diabetes and a blood sugar over 400. This was the fastest appointment that I could get.   2nd opinion Test were ran and I was diagnosed with type 1 diabetes   3rd opinion went to see an actual endocrinologist
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Immediately after getting first covid vaccine 9/23/2021 I felt weak, tired and extremely sleepy. Second covid shot 10/21/2021 I notice that I was having a hard time maintaining my weight. I lost ten pounds in one week after second shot went from 191 to roughly 179 pounds in weight. I never lost my appetite but I was constantly loosing weight.  I went to a nurse practitioner sometime in November 2021, test where ran I was diagnosed with diabetes and a blood sugar over 400. This was the fastest appointment that I could get.   2nd opinion Test were ran and I was diagnosed with type 1 diabetes   3rd opinion went to see an actual endocrinologist
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Cardiac disorder, Electrocardiogram ambulatory, Feeling abnormal
Clinical narrative: Gastrointestinal issues, migraines, fever and flu like symptoms, heart issues/palpitations, head fog, body aches, breathing issues, elevated inflammation and white blood cell count