chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site irritation
Clinical narrative: fatigue intensified; I began having body aches; incessant itching on the right side of my body (head to toe); The most intense itching was at the injection site; Itching/hives spread to left side of face, arm and torso; I felt sudden extreme fatigue; mild chest pains; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Oct2021 10:30 (Lot number: FH8028) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "HSV2" (unspecified if ongoing), notes: other medical history: hypertension, HSV2, seasonal allergies/hayfever, lichen planus; "seasonal allergies" (unspecified if ongoing), notes: other medical history: hypertension, HSV2, seasonal allergies/hayfever, lichen planus; "Hay fever" (unspecified if ongoing); "lichen planus" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [FLUTICASONE PROPIONATE]; VALTREX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 23Feb2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 02Feb2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Oct2021 13:30, outcome "not recovered", described as "I felt sudden extreme fatigue"; CHEST PAIN (non-serious) with onset 28Oct2021 13:30, outcome "not recovered", described as "mild chest pains"; CONDITION AGGRAVATED (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "fatigue intensified"; PAIN (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "I began having body aches"; PRURITUS (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "incessant itching on the right side of my body (head to toe)"; VACCINATION SITE IRRITATION (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "The most intense itching was at the injection site"; URTICARIA (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "Itching/hives spread to left side of face, arm and torso". Therapeutic measures were not taken as a result of fatigue, chest pain, condition aggravated, pain, pruritus, vaccination site irritation, urticaria.  Follow-Up (04Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hormone level abnormal, Investigation
Clinical narrative: Her hormone is wreaking havoc; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6207) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing); "Cancer" (unspecified if ongoing); "Right lower lobectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Hepatitis (Back in 1991 or 1992, had vaccination for Hepatitis. Did have a reaction in the thigh with itchiness, redness, and bumps.), for Hepatitis immunization, reaction(s): "redness", "Itchiness". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Chills"; HORMONE LEVEL ABNORMAL (non-serious), outcome "unknown", described as "Her hormone is wreaking havoc". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills.  Additional information: NDC number and expiry date was unknown. It was unknown if investigation assessment was done. After first two, day after had chills. Ten days ago, started on Spironolactone, small dose, to block the production of the aldosterone hormone. Had cancer and right lower lobectomy. Puts her at higher medical state in order to catch COVID. Her hormone was wreaking havoc. She had it when she took the first two shots. Wasn't on the heart medicine at the time of the first two COVID-19 Vaccines. When querying NDC/LOT/EXP for Entresto, Metoprolol, and Spironolactone, patient stated she needed her glasses. Spironolactone and Metoprolol are packaged in pharmacy bottles. Entresto is in a white manufacturer bottle. These medications were added after her first two COVID-19 Vaccines, but before her booster dose. there were no additional vaccines administered on same date of the Pfizer Suspect. There were no emergency room or physician office visit done. Prior Vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine were none. Back in 1991 or 1992, had vaccination for Hepatitis and had a reaction in the thigh with itchiness, redness, and bumps. Was diagnosed with a latex allergy and not sure if it was the latex or the topper of the vaccine because it was rubber.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101495467 same patient/drug, different dose/event;US-PFIZER INC-202101495468 same patient/drug, different dose/event
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for 5 days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2005006 (regulatory authority).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Sicca syndrome with other organ involvement" (unspecified if ongoing), notes: Sicca syndrome with other organ involvement; "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "migraines" (unspecified if ongoing); "partial thyroid removal" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; LIPOFEN; BOTOX; BUTALBITAL, ACETAMINOPHEN & CAFFEINE. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Sick for 5 days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body height, Chills, Diarrhoea, Faeces pale
Clinical narrative: sweaty; Underneath the rib, in her diaphragm, having pain; Diarrhea was bright yellow; Underneath, the muscles are sore; Diarrhea; Joint pain and heaviness; Vomiting; Tired; Really chilly; Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: FH8028) at the age of 60 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history includes block production of the aldosterone hormone, enlarged ventricle, Hyperaldosteronism, Conns Syndrome, diagnosed with a latex allergy, notes: Was diagnosed with a latex allergy, from an unknown date and unspecified if ongoing. Concomitant medication(s) includes metoprolol, spironolactone taken for blood aldosterone abnormal, entresto. Vaccination history includes Bnt162b2 (Dose:1, LOT: EN6207, Route: Injected into left arm), administration date: 15Mar2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): chills; Bnt162b2 (Dose: 2, LOT: ER8732, Route: Injected into left arm), administration date: 05Apr2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): chills, Legs felt heavy, Hepatitis (Back in 1991 or 1992, had vaccination for Hepatitis. Had a reaction in the thigh with itchiness, redness, and bumps.), for Immunization. On 28Oct2021 the patient had experienced Really chilly, Arm hurt, on 29Oct2021 Vomiting, Tired, on 30Oct2021 Joint pain and heaviness, on 31Oct2021 Diarrhea, On an unspecified date sweaty, underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore. Patient underwent lab tests and procedures on an unspecified date for body height with results of getting shrunk. Provides 5 feet 2.5 inches and bloodwork investigations of unknown results. The outcome of Really chilly, Diarrhea was recovered on 31Oct2021, Vomiting was recovered on 29Oct2021, Arm hurt, Tired, was recovering, Joint pain and heaviness, sweaty, Underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore was unknown   No follow-up attempts are possible. No further information is expected.  Follow-Up (08Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101495427 same patient/drug, different dose/event
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Investigation, Myalgia, Pain
Clinical narrative: sweaty; Underneath the rib, in her diaphragm, having pain; Diarrhea was bright yellow; Underneath, the muscles are sore; Diarrhea; Joint pain and heaviness; Vomiting; Tired; Really chilly; Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: FH8028) at the age of 60 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history includes block production of the aldosterone hormone, enlarged ventricle, Hyperaldosteronism, Conns Syndrome, diagnosed with a latex allergy, notes: Was diagnosed with a latex allergy, from an unknown date and unspecified if ongoing. Concomitant medication(s) includes metoprolol, spironolactone taken for blood aldosterone abnormal, entresto. Vaccination history includes Bnt162b2 (Dose:1, LOT: EN6207, Route: Injected into left arm), administration date: 15Mar2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): chills; Bnt162b2 (Dose: 2, LOT: ER8732, Route: Injected into left arm), administration date: 05Apr2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): chills, Legs felt heavy, Hepatitis (Back in 1991 or 1992, had vaccination for Hepatitis. Had a reaction in the thigh with itchiness, redness, and bumps.), for Immunization. On 28Oct2021 the patient had experienced Really chilly, Arm hurt, on 29Oct2021 Vomiting, Tired, on 30Oct2021 Joint pain and heaviness, on 31Oct2021 Diarrhea, On an unspecified date sweaty, underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore. Patient underwent lab tests and procedures on an unspecified date for body height with results of getting shrunk. Provides 5 feet 2.5 inches and bloodwork investigations of unknown results. The outcome of Really chilly, Diarrhea was recovered on 31Oct2021, Vomiting was recovered on 29Oct2021, Arm hurt, Tired, was recovering, Joint pain and heaviness, sweaty, Underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore was unknown   No follow-up attempts are possible. No further information is expected.  Follow-Up (08Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101495427 same patient/drug, different dose/event
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: sweaty; Underneath the rib, in her diaphragm, having pain; Diarrhea was bright yellow; Underneath, the muscles are sore; Diarrhea; Joint pain and heaviness; Vomiting; Tired; Really chilly; Arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: FH8028) at the age of 60 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history includes block production of the aldosterone hormone, enlarged ventricle, Hyperaldosteronism, Conns Syndrome, diagnosed with a latex allergy, notes: Was diagnosed with a latex allergy, from an unknown date and unspecified if ongoing. Concomitant medication(s) includes metoprolol, spironolactone taken for blood aldosterone abnormal, entresto. Vaccination history includes Bnt162b2 (Dose:1, LOT: EN6207, Route: Injected into left arm), administration date: 15Mar2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): chills; Bnt162b2 (Dose: 2, LOT: ER8732, Route: Injected into left arm), administration date: 05Apr2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): chills, Legs felt heavy, Hepatitis (Back in 1991 or 1992, had vaccination for Hepatitis. Had a reaction in the thigh with itchiness, redness, and bumps.), for Immunization. On 28Oct2021 the patient had experienced Really chilly, Arm hurt, on 29Oct2021 Vomiting, Tired, on 30Oct2021 Joint pain and heaviness, on 31Oct2021 Diarrhea, On an unspecified date sweaty, underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore. Patient underwent lab tests and procedures on an unspecified date for body height with results of getting shrunk. Provides 5 feet 2.5 inches and bloodwork investigations of unknown results. The outcome of Really chilly, Diarrhea was recovered on 31Oct2021, Vomiting was recovered on 29Oct2021, Arm hurt, Tired, was recovering, Joint pain and heaviness, sweaty, Underneath the rib, in her diaphragm, having pain, diarrhea was bright yellow, underneath, the muscles are sore was unknown   No follow-up attempts are possible. No further information is expected.  Follow-Up (08Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101495427 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: getting terrible heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Lot number: EL9267) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EL9264, 1st dose), administration date: Jan2021, when the patient was 91 years old, for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "getting terrible heart palpitations". Therapeutic measures were taken as a result of palpitations.  Additional information: Therapeutic measures were taken as a result of events with Magnesium.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months; spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jan2021 17:00 (Lot number: EL3248) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Weight loss" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; MELATONIN; OZEMPIC taken for weight decreased, start date: Oct2020 (ongoing); FLU VACCINE VII taken for immunisation, start date: Sep2021. Vaccination history included: Bnt162b2 (Dose 1, administration time: 05:00 PM, Lot: EK9231, vaccine location: Left arm, Route of administration: Intramuscular), administration date: 22Dec2020, when the patient was 57 years old, for covid 19 immunization. The following information was reported: RASH MACULAR (non-serious), RASH PRURITIC (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "spots that are itchy, though small, on my left leg, left arm/elbow that have persisted for months". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash macular, rash pruritic.   Additional information: Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101701174 Same patient/Vaccine, different event, different vaccine dose
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Vaccination site pain; Tiredness; headache; Muscle pain; Chills; Joint pain; Vaccination site redness; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 25Jan2021 , lot: EZ9261, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, For US Only: Vaccination Facility Type: First and second dose: Hospital, not sure of Hospital name but the hospital is in (withheld)), administration date: 25Jan2021, when the patient was 84 years old, for Covid-19 immunization; Bnt162b2 (Second dose: 17Feb2021, lot: EZ9267, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, For US Only: Vaccination Facility Type: First and second dose: Hospital, not sure of Hospital name but the hospital is in (withheld)), administration date: 17Feb2021, when the patient was 84 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Oct2021, outcome "recovering", described as "Vaccination site pain"; FATIGUE (non-serious) with onset Oct2021, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset Oct2021, outcome "recovering", described as "Muscle pain"; CHILLS (non-serious) with onset Oct2021, outcome "not recovered", described as "Chills"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Joint pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2021, outcome "recovered", described as "Vaccination site redness"; MALAISE (non-serious) with onset Oct2021, outcome "not recovered", described as "Feeling unwell".  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Vaccination site pain; Tiredness; headache; Muscle pain; Chills; Joint pain; Vaccination site redness; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: 25Jan2021 , lot: EZ9261, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, For US Only: Vaccination Facility Type: First and second dose: Hospital, not sure of Hospital name but the hospital is in (withheld)), administration date: 25Jan2021, when the patient was 84 years old, for Covid-19 immunization; Bnt162b2 (Second dose: 17Feb2021, lot: EZ9267, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, For US Only: Vaccination Facility Type: First and second dose: Hospital, not sure of Hospital name but the hospital is in (withheld)), administration date: 17Feb2021, when the patient was 84 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Oct2021, outcome "recovering", described as "Vaccination site pain"; FATIGUE (non-serious) with onset Oct2021, outcome "recovering", described as "Tiredness"; HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset Oct2021, outcome "recovering", described as "Muscle pain"; CHILLS (non-serious) with onset Oct2021, outcome "not recovered", described as "Chills"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Joint pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2021, outcome "recovered", described as "Vaccination site redness"; MALAISE (non-serious) with onset Oct2021, outcome "not recovered", described as "Feeling unwell".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Muscles and joint aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Feb2021 11:00 (Lot number: EL9263) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EL3247, Anatomical site of injection: Right arm, Administration date: 27Jan2021, Administration time: 11:00 AM), administration date: 27Jan2021, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Muscles and joint aches".  Additional information: Drug Lot Number and Expiration Date: 3rd: 30130BA. Dose: 3rd. Date: 24Aug2021. Time: 10:00 AM. Anatomical site of injection: Right Arm. Relevant test: None. Specific Relevant Test for Thromboembolic events with Thrombocytopenia was reported as None. Adverse Events: AE term: 6 days. Onset date: 24Aug2021. Onset time: 11pm. Seriousness criteria: Not serious. AE outcome: Recovered. Background  2nd shot, The patient had 12 hours of muscle and joint aches. Booster  The patient started with muscle and joint aches about 12 hours after shot. Took Tylenol. 25Aug- moderate- severe joint muscle aches all day took Tylenol. 26Aug- Awoke with severe neck and all over headache took tyenol- plus The patient had joint pain. Felt like head is nice. 27Aug- Still painful headache, joint pain a little better , took adirl. 28Aug-30Aug  Pain lessered each day , took adirl until the 29th.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Investigation, Pain in extremity, Pyrexia
Clinical narrative: tachycardia of 133bpm, tachycardia lessened over time but still persists as of submitting this report at 7:04pm, at an average of 113bpm; extreme chills; then at 9am fever of 101.1F; Arm soreness the same day of; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 16:00 (Lot number: EW0170) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "autism" (unspecified if ongoing); "Gilbert's syndrome" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Scarring in lungs" (unspecified if ongoing); "Soy and all derivatives" (unspecified if ongoing), notes: Soy and all derivatives. Concomitant medication(s) included: KLONOPIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN6206, prev dose vaccine location: Left arm, prev dose administration time: 03:00 PM), administration date: 12Mar2021, when the patient was 30 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 2, Lot Number: ER8733,, prev dose vaccine location: Left arm, prev dose administration time: 03:00 PM), administration date: 02Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: TACHYCARDIA (non-serious) with onset 02Nov2021 18:00, outcome "recovering", described as "tachycardia of 133bpm, tachycardia lessened over time but still persists as of submitting this report at 7:04pm, at an average of 113bpm"; PAIN IN EXTREMITY (non-serious) with onset 01Nov2021 18:00, outcome "recovering", described as "Arm soreness the same day of"; CHILLS (non-serious) with onset 02Nov2021 18:00, outcome "recovering", described as "extreme chills"; PYREXIA (non-serious) with onset 02Nov2021 18:00, outcome "recovering", described as "then at 9am fever of 101.1F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia, pain in extremity, chills, pyrexia. No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tachycardia
Clinical narrative: tachycardia of 133bpm, tachycardia lessened over time but still persists as of submitting this report at 7:04pm, at an average of 113bpm; extreme chills; then at 9am fever of 101.1F; Arm soreness the same day of; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 16:00 (Lot number: EW0170) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "autism" (unspecified if ongoing); "Gilbert's syndrome" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Scarring in lungs" (unspecified if ongoing); "Soy and all derivatives" (unspecified if ongoing), notes: Soy and all derivatives. Concomitant medication(s) included: KLONOPIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN6206, prev dose vaccine location: Left arm, prev dose administration time: 03:00 PM), administration date: 12Mar2021, when the patient was 30 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 2, Lot Number: ER8733,, prev dose vaccine location: Left arm, prev dose administration time: 03:00 PM), administration date: 02Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: TACHYCARDIA (non-serious) with onset 02Nov2021 18:00, outcome "recovering", described as "tachycardia of 133bpm, tachycardia lessened over time but still persists as of submitting this report at 7:04pm, at an average of 113bpm"; PAIN IN EXTREMITY (non-serious) with onset 01Nov2021 18:00, outcome "recovering", described as "Arm soreness the same day of"; CHILLS (non-serious) with onset 02Nov2021 18:00, outcome "recovering", described as "extreme chills"; PYREXIA (non-serious) with onset 02Nov2021 18:00, outcome "recovering", described as "then at 9am fever of 101.1F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia, pain in extremity, chills, pyrexia. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Soreness in left arm; severely swollen lymph nodes in left arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 08:30 (Lot number:PfizerEW0217) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 27Oct2021 as unk, single. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Pfizer EL3247, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 23Feb2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer EL3247, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM, Route of Administration: Intramuscular), administration date: 04Feb2021, when the patient was 26 years old, for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Oct2021 18:00, outcome "recovered" (Oct2021), described as "Soreness in left arm"; LYMPHADENOPATHY (non-serious) with onset 27Oct2021 18:00, outcome "recovered" (Oct2021), described as "severely swollen lymph nodes in left arm pit". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy. It was reported that prior to vaccination and since the vaccination the patient was not diagnosed with Covid 19.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Lymphadenopathy, Pain
Clinical narrative: Left armpit swollen painful starting day after injection; Left armpit swollen painful starting day after injection; Slight brain fog; Still slightly painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: 3203080) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 29Oct2021 (Batch/Lot number: unknown). The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2; Batch/Lot No: EL9266), administration date: 16Feb2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1; Batch/Lot No: EL3302), administration date: 26Jan2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 30Oct2021, outcome "recovering" and all described as "Left armpit swollen painful starting day after injection"; FEELING ABNORMAL (non-serious) with onset 30Oct2021, outcome "recovering", described as "Slight brain fog"; PAIN (non-serious) with onset 30Oct2021, outcome "recovering", described as "Still slightly painful". Therapeutic measures were taken as a result of lymphadenopathy, axillary pain, feeling abnormal, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was withheld. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was birth control, lo. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reported Event: Left armpit swollen painful starting day after injection. Still slightly painful today, 02Nov. Slight brain fog day after and 01Nov. AE Seriousness criteria not resulted in death/Life threatening/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received treatment for the adverse event with Advil. Device Date was 02Nov2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Gait disturbance
Clinical narrative: affected his heart; has to walk with a walker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization; Bnt162b2 (second dose), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "affected his heart"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "has to walk with a walker".  Additional information:Caller said that she was calling about the Pfizer booster shot. Caller said that she is trying to speak to someone about her Pfizer Booster shot, but in the phone tree the recording cut off. She got her booster shot at withheld on 25Sep2021. While reporting on herself, the caller stated that her friend's husband had the booster dose and it affected his heart and he has to walk with a walker.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Nausea, Pain
Clinical narrative: Headache; Nauseous; A little bit of the sore arm; I was extremely tired; Just start really achy; I am hungry, I want to eat but when I want to try to put food to my stomach and it makes me sick to my feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization; Bnt162b2 (Dose Number:02), for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Headache"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nauseous"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "A little bit of the sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I was extremely tired"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just start really achy"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I am hungry, I want to eat but when I want to try to put food to my stomach and it makes me sick to my feet". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Headache; Nauseous; A little bit of the sore arm; I was extremely tired; Just start really achy; I am hungry, I want to eat but when I want to try to put food to my stomach and it makes me sick to my feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization; Bnt162b2 (Dose Number:02), for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Headache"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nauseous"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "A little bit of the sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I was extremely tired"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just start really achy"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I am hungry, I want to eat but when I want to try to put food to my stomach and it makes me sick to my feet". No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Chest X-ray, Influenza, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2021 15:30 (Lot number: EL8982) at the age of 69 years as dose 1, 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 13Jan2021, outcome "recovered" (14Jan2021), described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior vaccinations: None. Concomitant drugs: None. Patients medical history: None. Specific Relevant Test for Thromboembolic events with Thrombocytopenia: None. Comments/Narrative: Patient had enclosed a brief narrative, in that knowingly, due to age his hand writing was quite poor. At this time he had not recived his booster vaccination. 1st dose- 13Jan2021: Merely a sore arm around 24 hours.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Her dad got the vaccine and now he is having heart trouble.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Her dad got the vaccine and now he is having heart trouble.".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Condition aggravated
Clinical narrative: Experiencing weird dreams specifically, sexual abhorrent dreams about men; Caller states he previously reported that he is having homoerotic dreams that he did not have before getting the vaccines; got very bad after the second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 31Oct2021 (Lot number: FF2593) at the age of 36 years 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, LOT- 301458A), administration date: 08Oct2021, when the patient was 36 years old, for Covid-19 Immunization, reaction(s): "he is having homoerotic dreams that he did not have before getting the vaccines". The following information was reported: ABNORMAL DREAMS (non-serious), outcome "not recovered", described as "Experiencing weird dreams specifically, sexual abhorrent dreams about men"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Caller states he previously reported that he is having homoerotic dreams that he did not have before getting the vaccines; got very bad after the second".  Additional information: Patient states he previously reported that he is having homoerotic dreams that he did not have before getting the vaccines. States they started after the first dose and got very bad after the second. States this has impacted his marriage, states he was really having an issue with the fantasies he was experiencing.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Oct2021 (Lot number: FP3590) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type 2 diabetes" (ongoing); "Cholesterol" (ongoing); "High blood" (ongoing); "prostrate" (ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing); SIMVASTATIN taken for blood cholesterol abnormal (ongoing); LISINOPRIL taken for hypertension (ongoing); TAMSULOSIN taken for prostate infection (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, date: 03Mar2021, Anatomical site of injection: right arm, Batch/Lot number: EN6203, 03Mar2021 sore arm for 5 days), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (Dose: 02, date: 25Mar2021, Anatomical site of injection: right arm, Batch/Lot number: ER8733, 25Mar2021 1. Sore arm for 1 day), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "sore arm", "type 2 diabetes", "head had preception problems". The following information was reported: CHILLS (non-serious) with onset 18Oct2021, outcome "recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient's medical history and Relevant tests were provided as none. No specific relevant test for thromboembolic events with Thrombocytopenia  No follow-up attempts are possible. No further information is expected.  Follow up (03Dec2021): New information received from a contactable consumer. This consumer (patient) reported in response to - Non-HCP letter follow-up activity that includes:  Historical vaccine, reporter's phone number, lab test. outcome of event.  Follow-up attempts have been completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nasopharyngitis
Clinical narrative: She said that she got hot and cold with the first 2 doses; She said that she got hot and cold with the first 2 doses; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "She said that she got hot and cold with the first 2 doses". Therapeutic measures were taken as a result of nasopharyngitis, feeling hot.  Additional Information: The patient said that she had minimal effects after the first 2 doses. She said that she got hot and cold with the first 2 doses and treated it with Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Nasopharyngitis, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: sore arm; I had a cold; it feels tight but I can breathe; it is still hurting, I may be go in to the emergency room; my throat feel strange; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 02Nov2021 14:30 (Lot number: FE3590) at the age of 66 years as dose 1, single for covid-19 immunization. Relevant medical history included: "cholesterol" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: MIRALAX taken for faeces soft; PRILOSEC [OMEPRAZOLE]; MYLANTA 11 taken for gastrooesophageal reflux disease; MYLANTA 11 taken for gastrooesophageal reflux disease; LOVASTATIN taken for blood cholesterol increased. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 02Nov2021, outcome "unknown", described as "it feels tight but I can breathe"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 02Nov2021, outcome "unknown", described as "it is still hurting, I may be go in to the emergency room; my throat feel strange"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NASOPHARYNGITIS (non-serious) with onset 02Nov2021, outcome "unknown", described as "I had a cold". Therapeutic measures were not taken as a result of chest discomfort, oropharyngeal discomfort, pain in extremity, nasopharyngitis.  Additional information: Consumer stated, "Of the Pfizer I had the first vaccine today was it normal for the, I do not see it on the list they gave me, but it was side effects that was why I am talking like that. My side effect has badden from the last two hours or more and it felt tight, but I can breathe because I was talking, I have a doctor visit assistance, but I cannot reach her, I think she was in a medical seminar on product convention, so I was reading this paper they gave me that is how I got your number. Do you have any information with quality was that a side effect or It feels like I was holding it, my lymph nodes well for my lymph node my doctor before might may be two year ago just checked in my lymph node, I had a cold, (further clarification unknown) I do not know it is like inside the 'cervix' (further clarification unknown)."  No follow-up attempts are possible. No further information is expected.