chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Booster; Joint pain; Muscle pain; I have infringement and I couldn''t rotate it because cuff causing my shoulders; Vaccine triggered my stupid problem with the rotated cuff and infringement; I have the little bit of sinus but it seems to triggered the pain out of the blue; Muscle spasms at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster) single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "voice incomprehensive" (unspecified if ongoing); "shoulder movement" (unspecified if ongoing); "voice distortion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "I have infringement and I couldn''t rotate it because cuff causing my shoulders; Vaccine triggered my stupid problem with the rotated cuff and infringement"; SINUS PAIN (non-serious), outcome "unknown", described as "I have the little bit of sinus but it seems to triggered the pain out of the blue"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle spasms at the injection site".  Additional information: Patient completed 3 doses of the Pfizer, have joint pain, muscle pain, patient think in September did third dose (Booster dose). Patient was retired other health provider (Hence reporter type captured in the tab). Patient have a problem with whatever have and then infringement and couldn't rotate it because cuff causing my shoulders. I haven't had it because of that I had to retire, so I haven't had this problem in 9 years but when I had the vaccine I have the little bit of sinus but it seems to triggered the pain out of the blue, and I am having little muscle spasms at the injection site. Is it possible that the vaccine triggered my stupid problem with the rotated cuff and infringement because it just it's been going on for a couple of weeks, should not realize that third dose. Will it just, Is this possible that it triggered I haven't had a problem in years, then out of the blue. I was reviewing the side effects and I am having a problem; It really triggered after my booster.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Immunisation, Interchange of vaccine products, Magnetic resonance imaging
Clinical narrative: nausea; headaches; Off Label use; Interchange of vaccine products; booster dose; 9d post PFE boost saw return of dizziness when upright.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Moderna (Dose Number: 2), administration date: Feb2021; Moderna (Dose Number: 1), administration date: Feb2021. The following information was reported: OFF LABEL USE (non-serious) with onset 05Nov2021, outcome "unknown", described as "Off Label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 05Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "booster dose"; DIZZINESS (non-serious) with onset Nov2021, outcome "not recovered", described as "9d post PFE boost saw return of dizziness when upright."; NAUSEA (non-serious), outcome "unknown", described as "nausea"; HEADACHE (non-serious), outcome "unknown", described as "headaches". The event "9d post pfe boost saw return of dizziness when upright." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: facility type vaccine: Pharmacy or Drug Store. Note patient on blood thinners. Also, nausea, headaches, kaleidoscope vision. All were new symptoms. At some point after MDRN vaccine pt fell, struck head got MRI, no findings. Post Pfizer boost saw return of dizziness when upright. This was a return of symptoms after 8 weeks of normalcy. Contact person was pt daughter and a nurse and is willing to provide more details on the case.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Off label use
Clinical narrative: nausea; headaches; Off Label use; Interchange of vaccine products; booster dose; 9d post PFE boost saw return of dizziness when upright.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Moderna (Dose Number: 2), administration date: Feb2021; Moderna (Dose Number: 1), administration date: Feb2021. The following information was reported: OFF LABEL USE (non-serious) with onset 05Nov2021, outcome "unknown", described as "Off Label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 05Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "booster dose"; DIZZINESS (non-serious) with onset Nov2021, outcome "not recovered", described as "9d post PFE boost saw return of dizziness when upright."; NAUSEA (non-serious), outcome "unknown", described as "nausea"; HEADACHE (non-serious), outcome "unknown", described as "headaches". The event "9d post pfe boost saw return of dizziness when upright." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: facility type vaccine: Pharmacy or Drug Store. Note patient on blood thinners. Also, nausea, headaches, kaleidoscope vision. All were new symptoms. At some point after MDRN vaccine pt fell, struck head got MRI, no findings. Post Pfizer boost saw return of dizziness when upright. This was a return of symptoms after 8 weeks of normalcy. Contact person was pt daughter and a nurse and is willing to provide more details on the case.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymph node pain, Pain, Vaccination site pain
Clinical narrative: Injection site soreness the day after; general achiness and exhaustion; exhaustion; tenderness under right arm - lymphnodes; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2), for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 15Nov2021, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 16Nov2021, outcome recovered (Nov2021); PAIN (non-serious) with onset 16Nov2021, outcome recovered (Nov2021); FATIGUE (non-serious) with onset 16Nov2021, outcome recovered (Nov2021); LYMPH NODE PAIN (non-serious) with onset 16Nov2021, outcome recovered (Nov2021). Therapeutic measures were not taken as a result of vaccination site pain, pain, fatigue, lymph node pain. The patient didn't receive any other vaccine within 4 weeks prior to covid19 vaccine. Prior to vaccination, the patient was not diagnosed with covid19 and since the vaccination, the patient was not tested for covid19. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation
Clinical narrative: 3rd Booster on 10Sep2021; never felt right / felt bad continuously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Multiple Sclerosis (ongoing); anxiety (unspecified if ongoing); migraines (unspecified if ongoing); pain (unspecified if ongoing); urinary incontinence (unspecified if ongoing); nephrolithiasis (unspecified if ongoing); degenerative disc disease (unspecified if ongoing); spasms (unspecified if ongoing); dizziness (unspecified if ongoing). Concomitant medication(s) included OCREVUS; DIAZEPAM; NEURONTIN; FLEXERIL; DETROL; ADDERALL; HYDROCODONE; MECLIZINE; ROBAXIN; TIZANIDINE; ESTRACE VAGINAL; LEVOFLOXACIN. Vaccination history included: Bnt162b2 (Dose: 2), administration date: 22Jul2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1), administration date: 30Jun2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported FEELING ABNORMAL (non-serious) with onset 2021, outcome unknown; IMMUNISATION (non-serious) with onset 10Sep2021, outcome unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: two family members that had injuries from the Pfizer covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: INJURY (non-serious), outcome "unknown", described as "two family members that had injuries from the Pfizer covid 19".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Interchange of vaccine products, Off label use
Clinical narrative: Recieved first dose on 19Jan2021, recieved second dose of moderna covid-19 vaccine; Recieved first dose on 19Jan2021, recieved second dose of moderna covid-19 vaccine; take pfizer for a booster; wide awake; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s) MOD21-164358 (Moderna). A 78-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Bladder infection (unspecified if ongoing); Triglycerides (unspecified if ongoing). Concomitant medication(s) included FIBRATE taken for blood triglycerides. Vaccination history included Moderna covid-19 vaccine (First dose, Expiration date: 03Jul2021, Received the vaccine in the left upper arm), administration date: 19Jan2021, when the patient was 78 years old, for COVID-19 Immunization; Moderna covid-19 vaccine (Second dose, Lot number: 024M20A, Expiration date: 03Aug2021, Received the vaccine in the left upper arm), administration date: 15Feb2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 13Nov2021, outcome unknown; IMMUNISATION (non-serious) with onset 13Nov2021, outcome unknown; INSOMNIA (non-serious) with onset Nov2021, outcome unknown. Therapeutic measures were taken as a result of insomnia.  Patient reports she was afraid to get the Moderna COVID-19 booster because she didn't want to go through that again. Her sister suggested take Pfizer for a booster, so received Pfizer 13Nov2021, and was again wide awake. Not sure if going to last. Plans to call Pfizer. Safety follow-up consent provided for patient and HCP. There was no product complaint associated with this case. Patient was not pregnant at the time of vaccination.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lymph node pain, Lymphadenopathy, Vaccination site erythema
Clinical narrative: Red at injection site; Chills; Very swollen and painful lymph node in armpit of left arm injected; Very swollen and painful lymph node in armpit of left arm injected; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 16:00 (Batch/Lot number: unknown) at the age of 49 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: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 19Apr2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 29Mar2021, when the patient was 48 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Nov2021 16:00, outcome "unknown", described as "booster"; VACCINATION SITE ERYTHEMA (non-serious) with onset 15Nov2021, outcome "recovering", described as "Red at injection site"; CHILLS (non-serious) with onset 15Nov2021, outcome "recovering", described as "Chills"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 15Nov2021, outcome "recovering" and all described as "Very swollen and painful lymph node in armpit of left arm injected". Therapeutic measures were not taken as a result of vaccination site erythema, chills, lymphadenopathy, lymph node pain.  Additional Information:Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Device Date: 17Nov2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Sore arm right after receiving vaccine. In the middle of the night, soreness went down arm into the hand.; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 18:00 (Lot number: FH8030) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 06Nov2021; TRI FEMYNOR. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin allergy", notes: Known allergies: Amoxicillin allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Vaccine Administration Time: 05:15 PM, Route of Administration: Intramuscular), administration date: 07Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Vaccine Administration Time: 05:15 PM, Route of Administration: Intramuscular), administration date: 17Mar2021, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 18:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021 20:00, outcome "recovered" (2021), described as "Sore arm right after receiving vaccine. In the middle of the night, soreness went down arm into the hand.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: Got booster; Rash; 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 female 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: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Got booster"; RASH (non-serious), outcome "unknown", described as "Rash". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Neck pain, Off label use, Pain in extremity
Clinical narrative: Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Pain in my right arm Elbow Shoulder Fingers Wrist Neck; Dose received: 3; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:00 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfates" (unspecified if ongoing), notes: known allergies: Sulfates. Concomitant medication(s) included: ZOLOFT. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose 1, Single), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Dose 2, Single), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Aug2021 16:00, outcome "unknown", described as "Dose received: 3"; OFF LABEL USE (non-serious) with onset 20Aug2021 16:00, outcome "unknown", described as "Off label use"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 01Sep2021, outcome "unknown" and all described as "Pain in my right arm Elbow Shoulder Fingers Wrist Neck". The event "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck", "pain in my right arm elbow shoulder fingers wrist neck" and "pain in my right arm elbow shoulder fingers wrist neck" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, arthralgia, arthralgia, pain in extremity, arthralgia, neck pain.  Additional information: Vaccine facility type was pharmacy or drug store. No other vaccines received in four weeks. Other medications in wo weeks included zoloft, pindenol. No covid prior vaccination. No covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 15:15 (Lot number: FK5618) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Nov2021 16:00, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient had no allergy. Case is reported as non-serious. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Limb discomfort, Vaccination site pain
Clinical narrative: He received his booster vaccine on 12Oct2021; arm at the injection site down deep is sore and it has remained sore; a problem with lifting his left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 (Lot number: FE3590) at the age of 72 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 (Dose: 01, EN5318), administration date: 30Jan2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "None"; Bnt162b2 (Dose: 02, Lot: EN6201), administration date: 21Feb2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "None". The following information was reported: IMMUNISATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "He received his booster vaccine on 12Oct2021"; VACCINATION SITE PAIN (non-serious) with onset 12Oct2021, outcome "not recovered", described as "arm at the injection site down deep is sore and it has remained sore"; LIMB DISCOMFORT (non-serious) with onset 12Oct2021, outcome "not recovered", described as "a problem with lifting his left arm". Therapeutic measures were taken as a result of vaccination site pain, limb discomfort.  Additional information: History of previous immunization with the Pfizer vaccine considered as suspect included Pfizer Covid Vaccines. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No relevant medical history (including any illness at time of vaccination). No relevant family medical history to adverse event. No relevant tests done. Time the Vaccination Was Given: Afternoon 15:00-16:00. Treatment included Tylenol.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Immunisation
Clinical narrative: felt yucky; Chills; fever; fatigue; body aches; headache; golf balls sized red circle at injection site; swollen injection site; hard at injection site; Booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Hypothyroidism (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (dose 1), for covid-19 immunisation; Bnt162b2 (dose 2), for covid-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome unknown; FEELING ABNORMAL (non-serious) with onset 16Nov2021, outcome unknown; CHILLS (non-serious) with onset 16Nov2021, outcome unknown; PYREXIA (non-serious) with onset 16Nov2021, outcome unknown; FATIGUE (non-serious) with onset 16Nov2021, outcome unknown; PAIN (non-serious) with onset 16Nov2021, outcome unknown; HEADACHE (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE SWELLING (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 16Nov2021, outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: felt yucky; Chills; fever; fatigue; body aches; headache; golf balls sized red circle at injection site; swollen injection site; hard at injection site; Booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Hypothyroidism (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (dose 1), for covid-19 immunisation; Bnt162b2 (dose 2), for covid-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome unknown; FEELING ABNORMAL (non-serious) with onset 16Nov2021, outcome unknown; CHILLS (non-serious) with onset 16Nov2021, outcome unknown; PYREXIA (non-serious) with onset 16Nov2021, outcome unknown; FATIGUE (non-serious) with onset 16Nov2021, outcome unknown; PAIN (non-serious) with onset 16Nov2021, outcome unknown; HEADACHE (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE ERYTHEMA (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE SWELLING (non-serious) with onset 16Nov2021, outcome unknown; VACCINATION SITE MASS (non-serious) with onset 16Nov2021, outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder, Confusional state, Feeling abnormal, Headache, Immunisation
Clinical narrative: a sense of confusion the entire day; head felt strange; bones felt weak; booster; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 12:00 (Lot number: FF8839) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included No. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. upon request), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. upon request), for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 16Nov2021 12:00, outcome unknown; CONFUSIONAL STATE (non-serious) with onset 17Nov2021, outcome recovering; HEADACHE (non-serious) with onset 16Nov2021, outcome recovering; FEELING ABNORMAL (non-serious) with onset 17Nov2021, outcome recovering; BONE DISORDER (non-serious) with onset 17Nov2021, outcome recovering. Therapeutic measures were not taken as a result of confusional state, headache, feeling abnormal, and bone disorder.  The patient did not receive other vaccine in four weeks and other medications in two weeks. She got headache with the booster short on 16Nov2021. On 17Nov2021, she had headache and a sense of confusion the entire day, her head felt strange, her bones felt weak. The patient did not received treatment for the events. The patient was not diagnosed with covid-19 prior vaccination. The patient has not been tested positive for Covid-19, post vaccination. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Very sore arm (injection arm); low grade fever; chills; body aches (especially back, neck and legs); headache; fatigue; dose_received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 09:00 (Lot number: FF8841) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; KEFLEX [CEFALEXIN MONOHYDRATE]. Vaccination history included: Bnt162b2 (dose- 2, lot number=EL3247, route=Intramuscular, location=left arm), administration date: 17Feb2021, when the patient was 45 years old, for Covid-19 immunization; Bnt162b2 (dose-1, lot number=EL3247, route=Other, location=left arm), administration date: 27Jan2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "dose_received: 3"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Very sore arm (injection arm)"; PYREXIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "low grade fever"; CHILLS (non-serious) with onset 18Nov2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "body aches (especially back, neck and legs)"; HEADACHE (non-serious) with onset 18Nov2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, pain, headache, fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received Synthorid, Keflex any other medications within 2 weeks of vaccination. Prior to the vaccination, the 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
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm (injection arm); low grade fever; chills; body aches (especially back, neck and legs); headache; fatigue; dose_received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 09:00 (Lot number: FF8841) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; KEFLEX [CEFALEXIN MONOHYDRATE]. Vaccination history included: Bnt162b2 (dose- 2, lot number=EL3247, route=Intramuscular, location=left arm), administration date: 17Feb2021, when the patient was 45 years old, for Covid-19 immunization; Bnt162b2 (dose-1, lot number=EL3247, route=Other, location=left arm), administration date: 27Jan2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "dose_received: 3"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Very sore arm (injection arm)"; PYREXIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "low grade fever"; CHILLS (non-serious) with onset 18Nov2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "body aches (especially back, neck and legs)"; HEADACHE (non-serious) with onset 18Nov2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, pain, headache, fatigue.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received Synthorid, Keflex any other medications within 2 weeks of vaccination. Prior to the vaccination, the 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
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Myalgia, Pyrexia
Clinical narrative: low grade fever; fatigue; muscle pain; booster dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: 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: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "muscle pain"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster dose".  Additional information: After receiving the booster dose, the patient experienced low grade fever, fatigue, and muscle pain. The adverse events resolved within 2 days. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Immunisation
Clinical narrative: experienced "Covid Toes" in which they had blisters on their toes. experienced milder blisters for just a couple of days after dose #3.; dose #3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "chemotherapy" (unspecified if ongoing); "Mastectomy" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing), notes: Neuropathy of Feet and, Hands. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer , DOSE 1), administration date: Feb2021, for COVID-19 Immunization; Bnt162b2 (Product: COVID 19, Brand: Pfizer , DOSE 2), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "dose #3"; BLISTER (non-serious), outcome "recovered", described as "experienced "Covid Toes" in which they had blisters on their toes. experienced milder blisters for just a couple of days after dose #3.". Therapeutic measures were not taken as a result of blister.  Additional information: The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain in extremity
Clinical narrative: arm soreness; chills; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 11:00 (Lot number: EW1096) at the age of 54 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 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 11:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "arm soreness"; CHILLS (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 17Nov2021 19:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, chills, fatigue.  additional information: the patient had no known allergies. other medical history none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not receive any other medication within 2 weeks of COVID vaccination. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for Covid post vaccination. facility type vaccine: Workplace clinic.  Follow-up attempts are completed. No further information
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Immunisation, Limb discomfort
Clinical narrative: losing his balance; Seem to be losing balance was reported as worsened; booster; feet are a little crooked; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: FF2590, Expiration Date: 31Dec2021) at the age of 72 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 (First dose, Date of administration-05Mar2021, lot: ENG199 or EN6199, caller clarifies he does think the lot is EN6199., Route of administration: Left Upper arm), administration date: 05Mar2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Second dose: 02APR2021, lot number: EP6955, NDC: Unknown, Expiration: Unknown, Route of administration: Left or right upper arm), administration date: 02Apr2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "booster"; BALANCE DISORDER (non-serious) with onset 13Nov2021, outcome "not recovered", described as "losing his balance"; CONDITION AGGRAVATED (non-serious) with onset 13Nov2021, outcome "unknown", described as "Seem to be losing balance was reported as worsened"; LIMB DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "feet are a little crooked".  Additional information: The patient had no side effects after receiving the first and second dose Pfizer Covid 19 Vaccine. He got his first and second dose of the covid vaccine without experiencing any side effects. He said he got his booster dose last 12Nov2021 and a day after, he started losing his balance and "getting a little bit worse" so far.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain, Product use issue
Clinical narrative: Fatigue; Achiness; Booster; other_vaccine_same_date_product=Flu Shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 18Nov2021 (Batch/Lot number: unknown), single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available to reporter at the time of report completion), administration date: Mar2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021, outcome unknown; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome unknown; FATIGUE (non-serious) with onset 20Nov2021, outcome recovered (Nov2021); PAIN (non-serious) with onset 20Nov2021, outcome recovered (Nov2021). It was unknown if therapeutic measures were taken as a result of fatigue, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sudden body temperature drop.; Uncontrollable shaking; body felt cold; woke up groggy but ok; Dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 10:00 (Lot number: FH 8030 or FM) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary Fibrosis" (unspecified if ongoing), notes: Pulmonary Fibrosis; "penicillin" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "latex" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM [DILTIAZEM HYDROCHLORIDE]; FUROSEMIDE; POTASSIUM; FLU VACCINE VII, administration date Oct2021. Past drug history included: Iodine, reaction(s): "Known Allergy: Iodine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER 8729, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 02May2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 04Apr2021, when the patient was 78 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 10:00, outcome "unknown", described as "Dose number 3"; BODY TEMPERATURE DECREASED (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Sudden body temperature drop."; TREMOR (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Uncontrollable shaking"; FEELING COLD (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "body felt cold"; SOMNOLENCE (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "woke up groggy but ok". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature decreased, tremor, somnolence. Therapeutic measures were taken as a result of feeling cold.  Additional information: Sudden body temperature drop. Uncontrollable shaking, body felt cold as tho suddenly in sub zero temp. Inside entire time added more clothing not enough then added heating pad direct to body and fell asleep. Woke up groggy but OK. AE resulted in: None of the above. If covid tested post vaccination: No, Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, List of any other medications the patient received within 2 weeks of vaccination: Diltiazem 240mg, Furosemide 40mg, Potassium 10meq,  Follow-up attempts are completed. No further information is expected.