chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site discolouration
Clinical narrative: skim totally lost the pigmentation on the area that I took the first and second shot/ area without pigmentation is getting larger and its relatively large now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 15:00 (Lot number: EWO 167) as dose 1, single and administered in arm left, administration date 22May2021 15:00 (Lot number: EWO 177) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. The patient took concomitant medications. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset 02May2021 11:00, outcome "not recovered", described as "skim totally lost the pigmentation on the area that I took the first and second shot/ area without pigmentation is getting larger and its relatively large now". The event "skim totally lost the pigmentation on the area that i took the first and second shot/ area without pigmentation is getting larger and its relatively large now" 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 vaccination site discoloration. Additional information: List of other medications the patient received within 2 weeks of vaccination was Birth control pills. Reported Event: The skin totally lost the pigmentation on the area that I took the first and second shot. My second shot was 2 months ago and it seems that the area without pigmentation is getting larger and its relatively large now. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up (10Aug2021): This is a follow up-spontaneous report from a contactable Physician. This Physician reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included that: Pfizer-BioNTech Covid-19 Vaccine Follow-up Questionnaire: Yes the patient provide information regarding the reported adverse event with the use of the product. Pfizer product had no causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; After 1st dose my left side was in pain; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Jul2021 19:00 (Lot number: EW0178) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: Codeine. The following information was reported: HEADACHE (non-serious), HYPOAESTHESIA (non-serious) all with onset 08Jul2021 21:00, outcome "recovering" and all described as "Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm"; PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Jul2021 21:00, outcome "recovering" and all described as "Left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. Vaccine given in my left arm"; PAIN (non-serious) with onset 08Jul2021 21:00, outcome "unknown", described as "After 1st dose my left side was in pain". Therapeutic measures were not taken as a result of headache, hypoaesthesia, paraesthesia, pain in extremity, neck pain, pain in extremity.  Additional information: Patient did not receive any other vaccine in four weeks and not covid tested post vaccination. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient experienced left side numbness and tingling feeling. Arm, neck and leg pain. Sight headaches all on the left side. After first dose patient left side was in pain. After a few hours it became numb. Patient had a severe headache for days. This took place 7 days after the first dose. Patient received second dose of BNT162B2 (EW0177) on 22Jul2021 at 19:00 via intramuscular route, administered in right arm and after that patient had left numb on her left side and had a severe headache for 2 to 3Days.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st jab, nothing besides sore arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: EW0173) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Past drug history included: Ampicillin, reaction(s): "Known allergies: Ampicillin". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st jab, nothing besides sore arm.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. The patient was not provided information regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left lymph nodes by collar bone are swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jul2021 (Lot number: EW0181) at the age of 13 years as dose 2,single for covid-19 immunization. Relevant medical history included: "Known allergies: Tree Nuts" (unspecified if ongoing). Concomitant medication(s) included: XYZAL. Past drug history included: Pcn, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose: 1st , Time: 16:05pm, Anatomical site of Injection: left upper arm, Batch/Lot number: EWQ181), administration date: 15Jun2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Jul2021 14:15, outcome "recovering", described as "Left lymph nodes by collar bone are swollen". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient hadn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient hadn't diagnosed with COVID-19 and since the vaccination, the patient hadn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Lethargy, Pain in extremity
Clinical narrative: no sickness though, just tired the day after; sore arm; feeling run down; lethargy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jul2021 (Lot number: EW0182) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LISINOPRIL. Past drug history included: Ampicillin, reaction(s): "known allergy: ampicillin", notes: known allergies: ampicillin. Vaccination history included: Bnt162b2 (Other vaccine 4weeks lot number: EW0173, Other vaccine 4weeks dose number: 1, Other vaccine 4weeks vaccine location: Left arm), administration date: 14Jun2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: FATIGUE (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "no sickness though, just tired the day after"; PAIN IN EXTREMITY (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "sore arm"; ASTHENIA (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "feeling run down"; LETHARGY (non-serious) with onset 07Jul2021, outcome "recovered" (2021), described as "lethargy". Therapeutic measures were not taken as a result of fatigue, pain in extremity, asthenia, lethargy.  Additional information: Patient had no COVID prior vaccination. Patient was not tested COVID post vaccination. The patient was not provided information regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My left arm at injection site is still sore & aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP, Physician and Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 12:00 (Lot number: ER2613) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "recurrent episode" (unspecified if ongoing); "Mild Sleep Apnea" (ongoing); "Hypertension" (ongoing); "obesity" (unspecified if ongoing); "Primary osteoarthritis of left hip" (unspecified if ongoing); "Cervical disc disease" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipemia" (unspecified if ongoing); "Chronic LBP" (unspecified if ongoing), notes: Chronic LBP; "HLD" (unspecified if ongoing), notes: HLD; "Headache" (unspecified if ongoing); "Myalgia" (unspecified if ongoing); "Sulfa (Sulfonamide Antibiotics)" (unspecified if ongoing); "Arthritis" (ongoing); "Depression" (ongoing); "Colitis" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; B-12; SIMVASTATIN; BUSPIRONE. Past drug history included: Colesevelam, reaction(s): "Drug Allergy"; Ezetimibe, reaction(s): "Drug Allergy"; Codiene, reaction(s): "Drug allergy"; Naproxen, reaction(s): "Drug Allergy"; Divalproex. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Apr2021, outcome "not recovered", described as "My left arm at injection site is still sore & aches". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: If other vaccine in four weeks: No. AE treatment: Ice and heat. If COVID prior vaccination: No. If COVID tested post vaccination: No. Prior vaccination (within 4 weeks): None. Relevant tests: None. COVID vaccine details: Product: COVID 19, Brand: Pfizer, Lot number: EW0153, Administration date: 26Apr2021, Administration time: 11:45 AM, Dose number: 2, Vaccine location: Left arm.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye allergy
Clinical narrative: Bad allergic reaction above her eye; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing), notes: She is undergoing chemotherapy for her cancer.; "allergic to peanuts" (unspecified if ongoing), notes: she is allergic to peanuts. The patient's concomitant medications were not reported. The following information was reported: EYE ALLERGY (non-serious), outcome "unknown", described as "Bad allergic reaction above her eye". Therapeutic measures were taken as a result of eye allergy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Dizziness, Panic attack
Clinical narrative: dizzy; extreme anxiety/ Panic/Anxiety attacks; feelings of panic/ Panic/Anxiety attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Apr2021 11:30 (Lot number: ER8733) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's" (ongoing); "hypothyroidism" (ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2010 (ongoing); FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC ALLERGY; VITAMIN C ACID. Past drug history included: Amoxicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, Time: 12:00 AM, Anatomical site of injection: left arm, Route of administration: Intramuscular, lot number: ER8733), administration date: 29Mar2021, when the patient was 39 years old, for Covid-19 immunisation.  The following information was reported: DIZZINESS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "dizzy"; ANXIETY (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "extreme anxiety/ Panic/Anxiety attacks"; PANIC ATTACK (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "feelings of panic/ Panic/Anxiety attacks". The events "dizzy", "extreme anxiety/ panic/anxiety attacks" and "feelings of panic/ panic/anxiety attacks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, anxiety, panic attack.  Additional information: Vaccination facility type: Pharmacy and drug store. No other vaccine was received by patient in four weeks. Other medications in two weeks received included SYNTHROID (oral); FLONASE; ZYRTEC; MULTIVITAMIN; VITAMIN C. Patient experienced extreme anxiety affecting day to day. This began immediately after the second vaccination when she started feeling dizzy on the drive home. Feelings of panic began on drive home after 2nd dose. Since then, simple day to day activities have produced marked feelings of panic and anxiety. Patient had never experienced this before. Patient was not sure if it's an actual side affect of the COVID 19 vaccine, but wanted to report it just in case. No known causes for them. Primary care ran a blood panel to check for normal levels, but all is within range. Adverse event reported were panic/anxiety attacks. Treatment for adverse events included BUSPAR. No other cause of sudden onset and ongoing symptoms have been determined. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Panic attack
Clinical narrative: dizzy; extreme anxiety/ Panic/Anxiety attacks; feelings of panic/ Panic/Anxiety attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Apr2021 11:30 (Lot number: ER8733) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's" (ongoing); "hypothyroidism" (ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2010 (ongoing); FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC ALLERGY; VITAMIN C ACID. Past drug history included: Amoxicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, Time: 12:00 AM, Anatomical site of injection: left arm, Route of administration: Intramuscular, lot number: ER8733), administration date: 29Mar2021, when the patient was 39 years old, for Covid-19 immunisation.  The following information was reported: DIZZINESS (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "dizzy"; ANXIETY (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "extreme anxiety/ Panic/Anxiety attacks"; PANIC ATTACK (non-serious) with onset 19Apr2021 13:00, outcome "not recovered", described as "feelings of panic/ Panic/Anxiety attacks". The events "dizzy", "extreme anxiety/ panic/anxiety attacks" and "feelings of panic/ panic/anxiety attacks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, anxiety, panic attack.  Additional information: Vaccination facility type: Pharmacy and drug store. No other vaccine was received by patient in four weeks. Other medications in two weeks received included SYNTHROID (oral); FLONASE; ZYRTEC; MULTIVITAMIN; VITAMIN C. Patient experienced extreme anxiety affecting day to day. This began immediately after the second vaccination when she started feeling dizzy on the drive home. Feelings of panic began on drive home after 2nd dose. Since then, simple day to day activities have produced marked feelings of panic and anxiety. Patient had never experienced this before. Patient was not sure if it's an actual side affect of the COVID 19 vaccine, but wanted to report it just in case. No known causes for them. Primary care ran a blood panel to check for normal levels, but all is within range. Adverse event reported were panic/anxiety attacks. Treatment for adverse events included BUSPAR. No other cause of sudden onset and ongoing symptoms have been determined. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart condition; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Vomiting
Clinical narrative: Very tired; diarrhea; upset stomach; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jul2021 12:00 (Lot number: Ew0183) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing); "degenerative disc disease" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; CHLORTHALIDONE; TRAZODON; XANAX; TOPIRAMATE. Vaccination history included: Bnt162b2 (Product: COVID 19, Lot number: Ew0183, Lot unknown: False, Dose Number: 1), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 07Jul2021, outcome "recovered with sequelae" (2021), described as "Very tired"; DIARRHOEA (non-serious) with onset 07Jul2021, outcome "recovered with sequelae" (2021), described as "diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 07Jul2021, outcome "recovered with sequelae" (2021), described as "upset stomach"; VOMITING (non-serious) with onset 07Jul2021, outcome "recovered with sequelae" (2021), described as "vomiting". Therapeutic measures were not taken as a result of fatigue, diarrhoea, abdominal discomfort, vomiting.  Additional Information: Facility type vaccine was reported as, Hospital. The patient had no known allergies. No vaccine taken four weeks after covid vaccination. The patient had no covid prior vaccination. The patient was not tested positive post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Nausea; Aches; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jul2021 15:00 (Lot number: EWO196) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 2021 (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: LANSOPRAZOLE; TRAMADOLE; TYLENOL. Past drug history included: Bacitracin ointment, reaction(s): "Allergy: Bacitracin ointment", notes: Bacitracin ointment; Ciprofloxin, reaction(s): "Allergy: Ciprofloxacin", notes: Ciprofloxacin. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EWO191,, administration time=04:45 PM,, dose number=1,, vaccine location=Left arm), administration date: 23Jun2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 15Jul2021 04:00, outcome "recovering", described as "Nausea"; PAIN (non-serious) with onset 15Jul2021 04:00, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 15Jul2021 04:00, outcome "recovering", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, pain, chills.   Additional Information: It was reported that not a Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination was reported as lansoprazole; tramadole; tylenol; vitamins supple. Injection not given by this office. The patient did not provide information to you regarding the reported adverse events(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Tenderness
Clinical narrative: After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling; After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling; After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 87 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Jan2021 11:00 (Lot number: EL8982) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "when she was young , likely to schrimp that has disappeared" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; HYDROCHLOROTHIAZIDE; WARFARIN; ESTRADIOL. The following information was reported: PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling".  Additional information: After the first dose, initially right arm pain and tenderness and also in the right axilla with out lymph node swelling and after the booster dose, 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, and appearance of small spots here and there in the chest and neck regions, none so acute but uncomfortable. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swollen, near right collarbone, after second vaccine; 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), administration date 13Jul2021 (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 (First Dose), administration date: 15Jun2021, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph node swollen, near right collarbone, after second vaccine".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting; spike the fever; he has fever almost of high 104 degrees F; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 12:00 (Batch/Lot number: unknown) as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Dec2021 22:30, outcome "not recovered", described as "spike the fever; he has fever almost of high 104 degrees F"; DIARRHOEA (non-serious) with onset 29Dec2021 22:30, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 01Jan2022, outcome "unknown", described as "Vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: Reporter said her son (patient) was perfectly fine and was asymptomatic before and that right after he was okay. She reported that about 12 hours after administration (patient received his second dose at 12 pm), at 22:30-00:00, he spike a fever and developed diarrhoea. She thought the symptoms would resolve between 24-48 hours but "it's been close to 62 hours". She reported her son having a fever of 104 degree Fahrenheit last night and the diarrhoea" could not be controlled with Imodium, max dose and on the day of report in morning patient had vomiting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Overdose, Product preparation error
Clinical narrative: received undiluted doses of the Pfizer Biontech COVID 19 pediatric formulation; received undiluted doses of the Pfizer Biontech COVID 19 pediatric formulation; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2022 13:09 (Lot number: FL0007, Expiration Date: 28Feb2022) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Jan2022 13:09, outcome "unknown" and all described as "received undiluted doses of the Pfizer Biontech COVID 19 pediatric formulation"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle pain".   Additional information: The pharmacist reported the Pediatric Pfizer Covid 19 Vaccine was administered that was not mixed. He called to inquire of possible side effects after administering the Pfizer Biontech COVID 19 vaccine pediatric formulation undiluted. The NDC number of Pfizer Covid 19 Vaccine was 59267-1055-04. There were no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no Prior Vaccinations (within 4 weeks). There were no AE(s) following prior vaccinations. The vaccination facility type was reported as Pharmacy or drug store. Prior vaccinations were none. Family medical history was none. Relevant test and specific relevant test was none. Customer received undiluted dose of Pfizer Biotech Covid-19 pediatric formulation. Preparation and administration. This following case (illegible) factors: Switching from one immunizing pharmacist to another. Miscommunication, intruption, dosing multiple task at the same time, very busy and competing demands of that day. After the error was discovered the patient was observed for over an hour and these was no adverse event(s). On 05Jan2022, the reporter called to check on the patient and his mother said these was no adverse event and the child is doing well. Spoke to the child mother again on 10Jan2022 and mother said the child has not have any adverse and doing well. "The only clinical consequence known to me is muscle pain reported to me by Pfizer/Biotech".  Follow-up (31Jan2022): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter sent that included:  Updated information: Product concentration EUA tris and product indication was updated, New event 'muscle pain' added. Time of vaccination updated. Route of administration added. Additional information updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200009903 same reporter/drug/AE, different patients.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: administrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose; administrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose; sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 (Lot number: 33130BA, Expiration Date: Feb2022) at the age of 26 years as dose 2, 1.8 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 13Jan2022, outcome "unknown" and all described as "administrating a full undiluted vial (purple cap) of the Pfizer-BioNTech COVID-19 vaccine as a single dose"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "sore arm".  Additional information: The patient received a full vial of the vaccine that was undiluted. It was reported that the patient came in for 2nd dose and only reported have a sore arm after the overdose. The pharmacist provided an alternate contact for the weekly check in phone call in case she is not in the store.   Follow-up (16Feb2022): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to HCP letter sent via telephonic follow-up activity which included that:  Updated field: New reporter added, historical vaccine added, dose number and dosage updated, event sore arm added, and additional information updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200065429 same reporter, same drug, similar event, different patients.;US-PFIZER INC-202200064592 same reporter, same drug, similar event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement
Clinical narrative: After the first shot, she noticed her breasts were growing back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: BREAST ENLARGEMENT (non-serious), outcome "unknown", described as "After the first shot, she noticed her breasts were growing back".  Additional information: It was reported that, this report was not related to study or program. It was stated that Caller states she does not have her vaccine card or have this information to provide. Other products and investigation assessment not provided. She states that she called before, after her first dose and had a problem because she had been taking hormone blockers. She wasn't sure and probably should have done some research. She had been taking hormone blockers to transition. After the first shot, she noticed her breasts were growing back. She lost all of her progress for pre-op. She thinks that with the estrogen, she was losing all the progress and it is effecting her relationships. Caller states she does not have her vaccine card or have this information to provide. She states that her vaccine card was in her partner's belongings, and she was not with them any longer. She has been double vaxed and boosted and everything was ok, aside from the interference with the hormone blockers.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24Feb2022):Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: hands and arms have gone numb; got both shots in Aug and beginning at the end of Nov; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single and administration date Aug2021 (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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Nov2021, outcome "unknown", described as "got both shots in Aug and beginning at the end of Nov"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "hands and arms have gone numb". The event "hands and arms have gone numb" was evalated at the physician office visit.  Additional information: Reporter's 12 year daughter got both shots in August and beginning at the end of November her hands and arms have gone numb. Pediatrician and Neurologist can't figure out why. Reporter need to know if it was an adverse reaction to the vaccine and how to reverse it.  No follow-up attempts are possible, No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: He reports a rash after the first dose that has not gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset Apr2021, outcome "not recovered", described as "He reports a rash after the first dose that has not gone away". The event "he reports a rash after the first dose that has not gone away" was evaluated at the physician office visit.  Additional Information: No RA Present. Reason for no lot number of covid vaccine was complainant does not have the product with them at the time of call. The reason patient took covid vaccine (Verbatim) was the thing to do and apparently not. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. Patient had a rash since he got the shot. Patient states that he had his second one on the last week of Apr2021. He reports a rash after the first dose that has not gone away. He has had it for ten months and has seen 2 dermatologists and one allergist. Asks how long will it take for the rash to go away.   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: Pain in extremity
Clinical narrative: sore arm the day after just like she did with the first two shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8735) at the age of 63 years as dose 1, single and administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement (ongoing); VALSARTAN taken for blood pressure measurement (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "sore arm the day after just like she did with the first two shots".  Additional information: The concomitant products Amlodipine: been taking a long time, probably since the 80s or something,Valsartan: been taking for years. Report was related to a study or programme. Additional information for other conditions: since the 80s probably, runs in her family. No investigation assessment. Caller states her booster shot was on 29Dec2021 at 2:40 PM (lot no.: 331308A).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: 2nd dose: made her feel really energetic; 2nd dose: made her feel really energetic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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 (Dose 1, single), for COVID-19 immunization, reaction(s): "Diarrhea", "soreness in her arm", "Fever". The following information was reported: ENERGY INCREASED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "2nd dose: made her feel really energetic".  Additional information: Reporter stated that her mother-in-law (patient) said that the 2nd dose made her like speedy gonzalez; clarified that made her really energetic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Infection, Nasopharyngitis
Clinical narrative: got infected; cold symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: INFECTION (non-serious), outcome "unknown", described as "got infected"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold symptoms".  Additional information: he got the first and second dose of the Pfizer vaccine and he is scheduled for a booster dose today. withheld mentioned that after getting both shots of the vaccine he got infected and experienced cold symptoms. the caller was not able to provide the colour of the cap.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Culture, Diagnostic aspiration, Infective tenosynovitis, Magnetic resonance imaging
Clinical narrative: rotator cuff repair infection; This is a literature report for the following literature source Adverse events following mRNA vaccine administration from a busy orthopedic practice: A series of four cases.  Follow up (17Feb2022): This is a literature report for the following literature source entitled Adverse events following mRNA vaccine administration from a busy orthopedic practice: A series of four cases , JSES Reviews, Reports, and Techniques, 2022; [DOI: 10.1016/j.xrrt.2021.12.003]. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  The initial case was missing the following minimum criteria: Unspecified event. Upon receipt of follow-up information on (17Feb2022), this case now contains all required information to be considered valid.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthroscopic rotator cuff repair", start date: Mar2020 (unspecified if ongoing); "fall" (unspecified if ongoing); "hypercholesterolemia" (ongoing); "hypertension" (ongoing); "left shoulder rotator cuff tear" (unspecified if ongoing), notes: 4.5 years ago; "right shoulder pain", start date: Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 Immunization.  The following information was reported: INFECTIVE TENOSYNOVITIS (medically significant), outcome "recovering", described as "rotator cuff repair infection". The patient underwent the following laboratory tests and procedures: c-reactive protein (normal high range 0.9): 2.2; culture: negative, notes: The cultures were held for 21 days, the final gram stain; diagnostic aspiration: unknown results; magnetic resonance imaging: a full-thickness supraspinatus tear was confirmed; demonstrated a large  loculated fluid collection, notes: in the subacromial space with disruption of the rotator cuff repair and lucency  around the previously placed anchors; red blood cell sedimentation rate (0-15): 45; white blood cell count (5.7-10.5): 7.2. Therapeutic measures were taken as a result of infective tenosynovitis; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, infective tenosynovitis cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200301423 Same article/ drug and different patient/event