chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Struggle with breathing; One week soreness in ligaments; Aches; High fever -102; Chills; Administration date 12Nov2021 at 13:30, dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 13:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYMBICORT. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: unknown, Anatomical site: Left arm, Administration time: 14:45), administration date: 31Mar2021, when the patient was 52 years old, for COVID-19 immunisation, reaction(s): "Administration date=17Mar2021, Dose 1/Administration date=31Mar2021, Dose 2"; Bnt162b2 (Dose 1, Lot number: unknown, Anatomical site: Left arm, Administration time: 13:30), administration date: 17Mar2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 13:30, outcome "unknown", described as "Administration date 12Nov2021 at 13:30, dose number: 3"; DYSPNOEA (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Struggle with breathing"; LIGAMENT PAIN (non-serious) with onset 13Nov2021 19:30, outcome "recovered" (20Nov2021), described as "One week soreness in ligaments"; PAIN (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Aches"; PYREXIA (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "High fever -102"; CHILLS (non-serious) with onset 13Nov2021 19:30, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, ligament pain, pain, pyrexia, chills.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At 30 hour, after 3rd dose patient experienced high fever -102, chills, aches, struggle with breathing and 1 week soreness in ligaments. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Immunisation, Joint swelling
Clinical narrative: Fever of 102; Severe nausea; Vomiting; Extreme chills every time I stand up; Muscle aches; Fatigue; Extreme stiffness pain; Extreme stiffness pain; Swelling in joints especially my knees; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:45 (Lot number: 30135ba) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis in knees and back" (unspecified if ongoing); "Military related PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder. Concomitant medication(s) included: NAPROXEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Rw0172, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 10May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 19Apr2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fever of 102"; NAUSEA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Vomiting"; CHILLS (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Extreme chills every time I stand up"; MYALGIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Muscle aches"; FATIGUE (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset 18Nov2021 08:30, outcome "recovering" and all described as "Extreme stiffness pain"; JOINT SWELLING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Swelling in joints especially my knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, vomiting, chills, myalgia, fatigue, musculoskeletal stiffness, pain, joint swelling.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 102; Severe nausea; Vomiting; Extreme chills every time I stand up; Muscle aches; Fatigue; Extreme stiffness pain; Extreme stiffness pain; Swelling in joints especially my knees; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:45 (Lot number: 30135ba) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis in knees and back" (unspecified if ongoing); "Military related PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder. Concomitant medication(s) included: NAPROXEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Rw0172, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 10May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 19Apr2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fever of 102"; NAUSEA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Vomiting"; CHILLS (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Extreme chills every time I stand up"; MYALGIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Muscle aches"; FATIGUE (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset 18Nov2021 08:30, outcome "recovering" and all described as "Extreme stiffness pain"; JOINT SWELLING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Swelling in joints especially my knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, vomiting, chills, myalgia, fatigue, musculoskeletal stiffness, pain, joint swelling.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever of 102; Severe nausea; Vomiting; Extreme chills every time I stand up; Muscle aches; Fatigue; Extreme stiffness pain; Extreme stiffness pain; Swelling in joints especially my knees; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 15:45 (Lot number: 30135ba) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis in knees and back" (unspecified if ongoing); "Military related PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder. Concomitant medication(s) included: NAPROXEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Rw0172, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 10May2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 19Apr2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fever of 102"; NAUSEA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Vomiting"; CHILLS (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Extreme chills every time I stand up"; MYALGIA (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Muscle aches"; FATIGUE (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious), PAIN (non-serious) all with onset 18Nov2021 08:30, outcome "recovering" and all described as "Extreme stiffness pain"; JOINT SWELLING (non-serious) with onset 18Nov2021 08:30, outcome "recovering", described as "Swelling in joints especially my knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, vomiting, chills, myalgia, fatigue, musculoskeletal stiffness, pain, joint swelling.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain, Pyrexia, Somnolence
Clinical narrative: Entire body aches; exhaustion; low grade fever; pain at injection site; unable to stay awake; Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 11:00 (Lot number: 32030BD) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: verbatim: Long hauler, COPD; "Allergy: bee stings" (unspecified if ongoing), notes: Relevant past drug history, Name of Drug as Reported: Imitrex, bee stings , Reaction: Allergy; "if_covid_prior_vaccination: Yes" (unspecified if ongoing), notes: if_covid_prior_vaccination: Yes. The patient took concomitant medications. Past drug history included: Imitrex, reaction(s): "allergy: Imitrex", notes: Relevant past drug history, Name of Drug as Reported: Imitrex, bee stings , Reaction: Allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731), administration date: 18Apr2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: OEJ1685), administration date: 22Dec2020, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "Entire body aches"; FATIGUE (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "exhaustion"; PYREXIA (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "low grade fever"; VACCINATION SITE PAIN (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "pain at injection site"; SOMNOLENCE (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "unable to stay awake"; IMMUNISATION (non-serious) with onset 09Nov2021 11:00, outcome "unknown", described as "Dose Number 3". Therapeutic measures were not taken as a result of pain, fatigue, pyrexia, vaccination site pain, somnolence, immunisation.  Additional information: Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient had received other medications within 2 weeks of vaccination. Patient was diagnosed with covid-19 prior to vaccination. Patient was not tested with covid to post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Entire body aches; exhaustion; low grade fever; pain at injection site; unable to stay awake; Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 11:00 (Lot number: 32030BD) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: verbatim: Long hauler, COPD; "Allergy: bee stings" (unspecified if ongoing), notes: Relevant past drug history, Name of Drug as Reported: Imitrex, bee stings , Reaction: Allergy; "if_covid_prior_vaccination: Yes" (unspecified if ongoing), notes: if_covid_prior_vaccination: Yes. The patient took concomitant medications. Past drug history included: Imitrex, reaction(s): "allergy: Imitrex", notes: Relevant past drug history, Name of Drug as Reported: Imitrex, bee stings , Reaction: Allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731), administration date: 18Apr2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: OEJ1685), administration date: 22Dec2020, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "Entire body aches"; FATIGUE (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "exhaustion"; PYREXIA (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "low grade fever"; VACCINATION SITE PAIN (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "pain at injection site"; SOMNOLENCE (non-serious) with onset 10Nov2021 00:30, outcome "recovered" (Nov2021), described as "unable to stay awake"; IMMUNISATION (non-serious) with onset 09Nov2021 11:00, outcome "unknown", described as "Dose Number 3". Therapeutic measures were not taken as a result of pain, fatigue, pyrexia, vaccination site pain, somnolence, immunisation.  Additional information: Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Patient had received other medications within 2 weeks of vaccination. Patient was diagnosed with covid-19 prior to vaccination. Patient was not tested with covid to post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Lymphadenopathy, Pruritus
Clinical narrative: Swollen lymph nodes on my left arm the next day, lasting for 3 days; A red dotted rash on my left inner thigh about 2inches*2inch, the dots were itchy they have lasted 3 weeks and progressively gotten better; A red dotted rash on my left inner thigh about 2inches*2inch, the dots were itchy they have lasted 3 weeks and progressively gotten better; Dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 19:00 (Lot number: 320308D) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 07Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 03Apr2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 13Mar2021, when the patient was 40 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 26Oct2021 19:00, outcome "unknown", described as "Dose_number=3"; LYMPHADENOPATHY (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Swollen lymph nodes on my left arm the next day, lasting for 3 days"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "A red dotted rash on my left inner thigh about 2inches*2inch, the dots were itchy they have lasted 3 weeks and progressively gotten better".Therapeutic measures were not taken as a result of lymphadenopathy, erythema, pruritus.Prior to vaccination, the patient  was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Swelling
Clinical narrative: Swelling; Extreme pain in left under arm.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:00 (Lot number: 32030BD) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 25Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset 19Nov2021 09:30, outcome "not recovered", described as "Swelling"; PAIN (non-serious) with onset 19Nov2021 09:30, outcome "not recovered", described as "Extreme pain in left under arm.". Therapeutic measures were not taken as a result of swelling, pain. Clinical course: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Lymphadenopathy, Mental fatigue
Clinical narrative: Left axillary lymphadenopathy; fever/rigor; fever/rigor; fatigue; mental fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:00 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LORATADINE; ACETAMINOPHEN, start date: 14Nov2021, stop date: 16Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Left arm), administration date: 28Dec2020, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "Left axillary lymphadenopathy"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 18Nov2021 20:00, outcome "recovering" and all described as "fever/rigor"; FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "fatigue"; MENTAL FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "mental fatigue". Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, chills, fatigue, mental fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left axillary lymphadenopathy; fever/rigor; fever/rigor; fatigue; mental fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:00 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LORATADINE; ACETAMINOPHEN, start date: 14Nov2021, stop date: 16Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Left arm), administration date: 28Dec2020, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "Left axillary lymphadenopathy"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 18Nov2021 20:00, outcome "recovering" and all described as "fever/rigor"; FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "fatigue"; MENTAL FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "mental fatigue". Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, chills, fatigue, mental fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate, Heart rate increased, Hypotension
Clinical narrative: one low reading blood pressure 93/70; fatigue; trouble with sleep night; Rapid heart rate for about 48 hours after vaccine (around 100) (resting heart rate usually 67-70); Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 09:00 (Lot number: FE3590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes; "osteoporosis" (unspecified if ongoing); "food poisoning" (unspecified if ongoing); "low sodium level", start date: 27Oct2021, stop date: 2021, notes: 27Oct2021 hospitalized for low sodium level (recovered) after food poisoning. Concomitant medication(s) included: ALENDRONATE; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 19Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 29Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Booster"; HEART RATE INCREASED (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "Rapid heart rate for about 48 hours after vaccine (around 100) (resting heart rate usually 67-70)"; HYPOTENSION (non-serious) with onset 20Nov2021 09:00, outcome "recovered" (Nov2021), described as "one low reading blood pressure 93/70"; FATIGUE (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "fatigue"; SLEEP DISORDER (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "trouble with sleep night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypotension, fatigue, sleep disorder.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination:  multivitamin. Since the vaccination, has the patient been tested for COVID-19: No. No known allergies.   Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Sleep disorder
Clinical narrative: one low reading blood pressure 93/70; fatigue; trouble with sleep night; Rapid heart rate for about 48 hours after vaccine (around 100) (resting heart rate usually 67-70); Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 09:00 (Lot number: FE3590) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination Yes; "osteoporosis" (unspecified if ongoing); "food poisoning" (unspecified if ongoing); "low sodium level", start date: 27Oct2021, stop date: 2021, notes: 27Oct2021 hospitalized for low sodium level (recovered) after food poisoning. Concomitant medication(s) included: ALENDRONATE; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 19Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 29Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Booster"; HEART RATE INCREASED (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "Rapid heart rate for about 48 hours after vaccine (around 100) (resting heart rate usually 67-70)"; HYPOTENSION (non-serious) with onset 20Nov2021 09:00, outcome "recovered" (Nov2021), described as "one low reading blood pressure 93/70"; FATIGUE (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "fatigue"; SLEEP DISORDER (non-serious) with onset 19Nov2021 19:30, outcome "recovered" (Nov2021), described as "trouble with sleep night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypotension, fatigue, sleep disorder.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination:  multivitamin. Since the vaccination, has the patient been tested for COVID-19: No. No known allergies.   Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Swollen axillary nodes and supraclavicular; Dose Number:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 12:00 (Lot number: FG3527) at the age of 37 years as dose 3 (booster), 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, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Mar2021, when the patient was 36 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EWQ169, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Apr2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 12:00, outcome "unknown", described as "Dose Number:3"; SWELLING (non-serious) with onset 19Nov2021 12:00, outcome "not recovered", described as "Swollen axillary nodes and supraclavicular". Therapeutic measures were not taken as a result of swelling.  No follow-up attempts are possible. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Influenza like illness, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: raised red rash; itchy; Vax 2 - Normal (flu-type) symptoms; sore to touch; location same arm as injection; Vax 3 - Normal (flu-type) symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Nov2021 11:45 (Lot number: FH8028) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; AMLODIPINE BESILATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8736, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 22Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Normal (flu-type) symptoms".  The following information was reported: IMMUNISATION (non-serious) with onset 14Nov2021 11:45, outcome "unknown", described as "Vax 3 - Normal (flu-type) symptoms"; RASH ERYTHEMATOUS (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "raised red rash"; PRURITUS (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "itchy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "Vax 2 - Normal (flu-type) symptoms"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 16:00, outcome "not recovered", described as "sore to touch; location same arm as injection". Therapeutic measures were not taken as a result of rash erythematous, pruritus, influenza like illness, pain in extremity.  Additional Information:  Patient covid prior vaccination was unknown. Covid tested post vaccination and known allergies was no. Device Date: 19Nov2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: I got the Pfizer booster; he is having a very bad fever;  I have high fever really bad; 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), administration date 20Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunization; Covid-19 vaccine (Dose 2 (Primary Immunization series complete but unknown manufacturer)), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "I got the Pfizer booster"; PYREXIA (non-serious) with onset 20Nov2021, outcome "unknown", described as "he is having a very bad fever; I have high fever really bad".  Additional information:Transferring agent stated, I have a caller on the other line. He said he got the booster shot (Captured as unspecified shot) and he is having a very bad fever. So, he also wanted to know if he can take allergy tablets (Unspecified medications). So, I already provided him the number of Pfizer Medical Information department as well." Call was transferred. Consumer stated, Yesterday I got the Pfizer booster. I have high fever bad. The guy who gave it to me said I could not get an allergy shot. I just need to know if I can take allergy pills (unspecified medications), you know, like Benadryl or any of them. Is there any problem there?". Proprietary medicinal product name: Benadryl.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Listless, Vaccination site pain
Clinical narrative: general listlesness; R arm soreness approx. 12-36 hours post-dose; fatigue; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm right, administration date 08Nov2021 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, administration date 23Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Nov2021, outcome unknown, described as DOSE 3 (BOOSTER), SINGLE; LISTLESS (non-serious) with onset 09Nov2021, outcome recovered(2021), described as general listlesness; VACCINATION SITE PAIN (non-serious) with onset 09Nov2021, outcome recovered(2021), described as R arm soreness approx. 12-36 hours post-dose; FATIGUE (non-serious) with onset 09Nov2021, outcome recovered(2021), described as fatigue. Therapeutic measures were not taken as a result of listless, vaccination site pain, fatigue.  Additional information: Prior to vaccination, the patient was not 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: no. Known allergies were reported as No. The patient received Flu vaccine as other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Confusional state, Immunisation, Tinnitus
Clinical narrative: My blood pressure was 144/ 75 with a pulse of 122; in evening my blood pressure was still 129/71 with my pulse up to 114 and then say at 11:22 it was 115/ 72 and my pulse this morning was 88; Ringing in my ear; Unable to focus and confused; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Lot number: EW0183, Expiration Date: Nov2021) at the age of 61 years as dose 3 (booster), single for covid-19 immunization.   Relevant medical history included: "I suffered a stroke a brain bleed" (unspecified if ongoing); "I usually have low blood pressure" (unspecified if ongoing). There patient received different concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 2021, for COVID-19 immunization, reaction(s): "very tired", "I was hot", "not feeling good"; Bnt162b2 (dose 2, single), administration date: 2021, for COVID-19 immunization.  The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "My blood pressure was 144/ 75 with a pulse of 122; in evening my blood pressure was still 129/71 with my pulse up to 114 and then say at 11:22 it was 115/ 72 and my pulse this morning was 88"; TINNITUS (non-serious) with onset Nov2021, outcome "unknown", described as "Ringing in my ear"; CONFUSIONAL STATE (non-serious) with onset Nov2021, outcome "unknown", described as "Unable to focus and confused"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No investigation assessment were done. Regarding prior vaccination (4 weeks): Consumer stated, that she did the first two and then this one. It was over 8 months. No other vaccines. Consumer stated that she took different medication and she does not know them all. Consumer stated, "The reason that she was concerned because she suffered a stroke a brain bleed (history) and usually had low blood pressure, her numbers were usually low for it to be this high. It really concerns because that's not good for her. So, that was her main concern.   Follow-up attempts were completed. No further information was expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Immunisation, Pruritus, Rash
Clinical narrative: a rash began to appear on my right hip area; it was itchy; red; It was all over my backside/The rash is up to my neck/shoulders now,; hot/angry; booster dose; 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), administered in arm left, administration date 03Nov2021 15:15 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "Allergies." (unspecified if ongoing); "known allergies: Ceftin spores" (unspecified if ongoing), notes: known allergies: Ceftin spores. Concomitant medication(s) included: FLU, administration date 21Oct2021. Past drug history included: Doxycycline, reaction(s): "known allergies: doxycycline". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Phizer,, prev_dose_brand_unknown=False,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Una, ble to locate or read the details,, prev_dose_administration_date=01May2021, prev_dose_dose_number=2,, prev_dose_vaccine_location=Left, arm},), administration date: 01May2021, when the patient was 39 years old, for Covid-19 Immunization; Bnt162b2 ({prev_dose_product=COVID 19,, prev_dose_brand=Phizer,, prev_dose_brand_unknown=False,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Una, ble to locate or read the details,, prev_dose_administration_date=03Apr2021, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left, arm}]), administration date: 03Apr2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021 15:15, outcome "unknown", described as "booster dose"; RASH (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "a rash began to appear on my right hip area"; PRURITUS (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "it was itchy"; ERYTHEMA (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "red"; RASH (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "It was all over my backside/The rash is up to my neck/shoulders now,"; FEELING HOT (non-serious) with onset 06Nov2021 20:00, outcome "recovered with sequelae", described as "hot/angry". The events "a rash began to appear on my right hip area", "it was itchy", "red", "it was all over my backside/the rash is up to my neck/shoulders now," and "hot/angry" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash, pruritus, erythema, rash, feeling hot. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Mouth swelling, Pain, Pyrexia
Clinical narrative: booster dose; slight fever; body aches; chills; Tenderness; very little swelling around the mouth where she received dermal fillers; she gets reactions after every vaccine given to her; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: EW0175) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "received dermal fillers", start date: May2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 30Mar2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "she gets reactions after every vaccine given to her"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735), administration date: 24Apr2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "she gets reactions after every vaccine given to her". The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "booster dose"; PYREXIA (non-serious) with onset 20Nov2021, outcome "recovered", described as "slight fever"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovered", described as "chills"; TENDERNESS (non-serious) with onset 20Nov2021, outcome "recovered", described as "Tenderness"; MOUTH SWELLING (non-serious) with onset 20Nov2021, outcome "recovered", described as "very little swelling around the mouth where she received dermal fillers"; VACCINATION COMPLICATION (non-serious) with onset 20Nov2021, outcome "recovered", described as "she gets reactions after every vaccine given to her". Therapeutic measures were taken as a result of pyrexia, pain. Therapeutic measures were not taken as a result of chills, tenderness, vaccination complication.  Additional information: patient reported tenderness and very little swelling around the mouth where she received dermal fillers on May2021. the swelling and tenderness resolved in less than 24 hours. she mentioned that she gets reactions after every vaccine given to her. No treatment received. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. She mentioned that she gets reactions after every vaccine given to her. she ran a slight fever and had body aches and chills. motrin helped with the pain and fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.