chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node in my left armpit; Pain radiating from swollen lymph node my entire left side of upper body; pain radiating from swollen lymph node my entire left side of upper body; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 16:00 (Lot number: unknown) at the age of 37 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0185, vaccine location: Left arm, Administration time: 16:00), administration date: 19May2021, when the patient was 37 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0180, vaccine location: Left arm, Administration time: 16:00), administration date: 09Jun2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 16:00, outcome "unknown", described as "dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 11Dec2021 at 01:00, outcome "recovering", described as "Swollen lymph node in my left armpit"; LYMPH NODE PAIN (non-serious), PAIN (non-serious) all with onset 11Dec2021 at 01:00, outcome "recovering", both described as "pain radiating from swollen lymph node my entire left side of upper body". The events "Swollen lymph node in my left armpit" and "pain radiating from swollen lymph node my entire left side of upper body" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain and pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. 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.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Malaise
Clinical narrative: Booster; Not felling well at all; Difficulty breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Apr2021, for COVID-19 Immunization; Bnt162b2 (2nd Dose), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "Not felling well at all"; DYSPNOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Difficulty breathing".  Additional information:  Reporter stated, "My husband and I had a booster shot yesterday and he was not felling well at all. He was having a lot of, he did not have chest pain but difficulty breathing." If taken the Pfizer Covid-19 vaccine booster shot: Reporter stated, "It was Pfizer the booster, we got our two shots back in Apr2021."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cardiac discomfort, Headache, Muscle tightness
Clinical narrative: pain and soreness in back behind heart and in left shoulder; pain and soreness in back behind heart and in left shoulder; pricking and burning all over body; pricking and burning all over body; congestion; tightness in neck; feeling like heart is being squeezed from back; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 12:30 (Lot number: FD0809) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 3203080, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM), administration date: 04Nov2021, when the patient was 32 years old, for COVID-19 Immunization, reaction(s): "Diagnosed with Covid after first dose", "Diagnosed with Covid after first dose", "numbness in face", "pricking sensation all over body including face", "headache", "chest discomfort", "feeling like heart is being squeezed". The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 11Dec2021 08:00, outcome "not recovered" and all described as "pain and soreness in back behind heart and in left shoulder"; PARAESTHESIA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 11Dec2021 08:00, outcome "not recovered" and all described as "pricking and burning all over body"; NASAL CONGESTION (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "congestion"; MUSCLE TIGHTNESS (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "tightness in neck"; CARDIAC DISCOMFORT (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "feeling like heart is being squeezed from back"; HEADACHE (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of arthralgia, back pain, paraesthesia, skin burning sensation, nasal congestion, muscle tightness, cardiac discomfort, headache.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient did not test for COVID-19. Second dose- pricking and burning all over body, feeling like heart is being squeezed from back (has happened once so far after second dose on 10Dec), pain and soreness in back behind heart and in left shoulder, congestion, headache, tightness in neck. Patient did not received treatment for events. Device Date: 11Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Paraesthesia, Skin burning sensation
Clinical narrative: pain and soreness in back behind heart and in left shoulder; pain and soreness in back behind heart and in left shoulder; pricking and burning all over body; pricking and burning all over body; congestion; tightness in neck; feeling like heart is being squeezed from back; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 12:30 (Lot number: FD0809) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 3203080, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM), administration date: 04Nov2021, when the patient was 32 years old, for COVID-19 Immunization, reaction(s): "Diagnosed with Covid after first dose", "Diagnosed with Covid after first dose", "numbness in face", "pricking sensation all over body including face", "headache", "chest discomfort", "feeling like heart is being squeezed". The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 11Dec2021 08:00, outcome "not recovered" and all described as "pain and soreness in back behind heart and in left shoulder"; PARAESTHESIA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 11Dec2021 08:00, outcome "not recovered" and all described as "pricking and burning all over body"; NASAL CONGESTION (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "congestion"; MUSCLE TIGHTNESS (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "tightness in neck"; CARDIAC DISCOMFORT (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "feeling like heart is being squeezed from back"; HEADACHE (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of arthralgia, back pain, paraesthesia, skin burning sensation, nasal congestion, muscle tightness, cardiac discomfort, headache.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient did not test for COVID-19. Second dose- pricking and burning all over body, feeling like heart is being squeezed from back (has happened once so far after second dose on 10Dec), pain and soreness in back behind heart and in left shoulder, congestion, headache, tightness in neck. Patient did not received treatment for events. Device Date: 11Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain
Clinical narrative: Severe wide spread body aches; off label use; 1st and 2nd dose of moderna was taken; 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 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 16:00 (Lot number: FJ8757) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 011L20A, Location of injection: Arm Left, Vaccine Administration Time: 2:00PM), administration date: 12Jan2021, when the patient was 47 years old, for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: 032L20A, Location of injection: Arm Left, Vaccine Administration Time: 2:00PM), administration date: 09Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "1st and 2nd dose of moderna was taken"; IMMUNISATION (non-serious) with onset 10Dec2021 16:00, outcome "unknown", described as "dose_number=3"; PAIN (non-serious) with onset 10Dec2021 22:00, outcome "not recovered", described as "Severe wide spread body aches". Therapeutic measures were not taken as a result of pain.  Additional information The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Event resulted in None of the above, no Hospitalization Prolonged,The patient had no known allergies,The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My second was like I didn't felt great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis; MAGNESIUM; BIOTIN. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "My second was like I didn't felt great". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Tremor
Clinical narrative: shaking; chills; total body aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose,MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "shaking"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "total body aches". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101772862 same patient and drug, different dose and similar event
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain in extremity
Clinical narrative: Dose received 3; Chills in the night following vaccination.; Arm soreness through D3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: unknown) at the age of 16 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE 1, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021, outcome "unknown", described as "Dose received 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills in the night following vaccination"; PAIN IN EXTREMITY (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Arm soreness through D3". Therapeutic measures were not taken as a result of chills and pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypersomnia, Immunisation
Clinical narrative: Dose received: 3; Exhaustion; sleeping since 4 hours post vaccination through to next day.; Chills through the night after vaccination.; Joing aches; Muscle aches; Arm pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? :Yes. Concomitant medications included: FLU. Vaccination history included:  Bnt162b2 (DOSE 1 SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2 SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 12Dec2021, outcome "recovering", described as "Exhaustion"; HYPERSOMNIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "sleeping since 4 hours post vaccination through to next day"; CHILLS (non-serious) with onset 12Dec2021, outcome "recovering", described as "Chills through the night after vaccination"; ARTHRALGIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "Joing aches"; MYALGIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "Muscle aches"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021, outcome "recovering", described as "Arm pain". Therapeutic measures were not taken as a result of fatigue, hypersomnia, chills, arthralgia, myalgia and pain in extremity.  Additional Information: The patient's known allergies were reported as not applicable. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Dose received: 3; Exhaustion; sleeping since 4 hours post vaccination through to next day.; Chills through the night after vaccination.; Joing aches; Muscle aches; Arm pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Lot number: unknown) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? :Yes. Concomitant medications included: FLU. Vaccination history included:  Bnt162b2 (DOSE 1 SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2 SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 12Dec2021, outcome "recovering", described as "Exhaustion"; HYPERSOMNIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "sleeping since 4 hours post vaccination through to next day"; CHILLS (non-serious) with onset 12Dec2021, outcome "recovering", described as "Chills through the night after vaccination"; ARTHRALGIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "Joing aches"; MYALGIA (non-serious) with onset 12Dec2021, outcome "recovering", described as "Muscle aches"; PAIN IN EXTREMITY (non-serious) with onset 12Dec2021, outcome "recovering", described as "Arm pain". Therapeutic measures were not taken as a result of fatigue, hypersomnia, chills, arthralgia, myalgia and pain in extremity.  Additional Information: The patient's known allergies were reported as not applicable. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: Cough; Congestion; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 5-year-old female patient received bnt162b2 (BNT162B2), administered in right arm, administration date 09Dec2021 at 14:00 (Lot number: unknown) at the age of 5 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical site: Right arm, Administration time: 13:00, Route of administration: Unspecified), administration date: 14Nov2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: COUGH (non-serious) with onset 11Dec2021 at 12:00, outcome "recovering", described as "Cough"; NASAL CONGESTION (non-serious) with onset 11Dec2021 at 12:00, outcome "recovering", described as "Congestion". Therapeutic measures were not taken as a result of cough and nasal congestion.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash, Wound
Clinical narrative: Severe rash/open wound on left elbow.; Severe rash/open wound on left elbow.; Dose received: 3/ Dose number=3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 04Oct2021 at 10:00 (Lot number: FF8839) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3249, Anatomical site: Right arm, Administration time: 10:00), administration date: 13Jan2021, when the patient was 65 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Administration time: 10:00), administration date: 03Feb2021, when the patient was 65 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021 at 10:00, outcome "unknown", described as "Dose received: 3/ Dose number=3"; RASH (non-serious), WOUND (non-serious) all with onset 08Oct2021, outcome "recovering", and both described as "Severe rash/open wound on left elbow". The event "Severe rash/open wound on left elbow." was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash and wound.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Events lasted weeks and still healing, needed medical attention twice. After reading several articles provided to the patient by a J&J COVID team member, in which similar adverse reactions were pictured and detailed, she was confident this rash/outbreak was a result of the booster. Treatment included medications and injection for severe rash/open wound on left elbow.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Skin discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: Large injection site welt; Large injection site welt, very red; Large injection site welt, very red with heat and pain.; Large injection site welt, very red with heat; Small slight discoloration on arm.; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 23Nov2021 at 09:30 (Lot number: FH8020) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer metastatic" (unspecified if ongoing), notes: Breast Cancer metastasized to the bone. Concomitant medications included: XGEVA, start date: 12Nov2021, stop date: 12Nov2021; ALEVE; LETROZOL and CLARITIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6205, Route of Administration: Unspecified, Anatomical Location: Right arm, Time of Administration: 14:00), administration date: 02Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN8733, Route of Administration: Unspecified, Anatomical Location: Right arm, Time of Administration: 14:00), administration date: 23Mar2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 at 09:30, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE REACTION (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Large injection site welt"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Large injection site welt, very red"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 at 16:00, outcome "recovered" (an unknown date in Dec2021), described as "Large injection site welt, very red with heat and pain"; VACCINATION SITE WARMTH (non-serious) with onset 23Nov2021 at 16:00, outcome "recovered" (an unknown date in Dec2021), described as "Large injection site welt, very red with heat"; SKIN DISCOLOURATION (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Small slight discoloration on arm". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site pain, vaccination site warmth, vaccination site erythema and skin discolouration.  Additional Information: The patient did not have any physical allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The large injection site welt, very red with heat and pain expanded to 3 inch diameter. Three weeks later, the heat and pain went away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Large injection site welt; Large injection site welt, very red; Large injection site welt, very red with heat and pain.; Large injection site welt, very red with heat; Small slight discoloration on arm.; Dose received: 3; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 23Nov2021 at 09:30 (Lot number: FH8020) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer metastatic" (unspecified if ongoing), notes: Breast Cancer metastasized to the bone. Concomitant medications included: XGEVA, start date: 12Nov2021, stop date: 12Nov2021; ALEVE; LETROZOL and CLARITIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6205, Route of Administration: Unspecified, Anatomical Location: Right arm, Time of Administration: 14:00), administration date: 02Mar2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN8733, Route of Administration: Unspecified, Anatomical Location: Right arm, Time of Administration: 14:00), administration date: 23Mar2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 at 09:30, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE REACTION (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Large injection site welt"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Large injection site welt, very red"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 at 16:00, outcome "recovered" (an unknown date in Dec2021), described as "Large injection site welt, very red with heat and pain"; VACCINATION SITE WARMTH (non-serious) with onset 23Nov2021 at 16:00, outcome "recovered" (an unknown date in Dec2021), described as "Large injection site welt, very red with heat"; SKIN DISCOLOURATION (non-serious) with onset 23Nov2021 at 16:00, outcome "recovering", described as "Small slight discoloration on arm". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site pain, vaccination site warmth, vaccination site erythema and skin discolouration.  Additional Information: The patient did not have any physical allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The large injection site welt, very red with heat and pain expanded to 3 inch diameter. Three weeks later, the heat and pain went away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Vaccination site infection
Clinical narrative: The store was dirty, covid vaccine kept on desks; The store was dirty, covid vaccine kept on desks; had huge infection at the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "The store was dirty, covid vaccine kept on desks"; VACCINATION SITE INFECTION (non-serious), outcome "unknown", described as "had huge infection at the site".  Additional information: Customer Verbatim: Just receive Pfizer vaccine at (with held) and had huge infection at the site. The store was dirty, covid vaccine kept on desks.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101781361 same reporter, different patients/similar events
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Migraine, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 13Dec2021 at 09:00 (Lot number: unknown) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Migraines"; NAUSEA (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Loss of appetite"; PYREXIA (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, nausea, vomiting, decreased appetite and pyrexia. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 13Dec2021 at 09:00 (Lot number: unknown) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Migraines"; NAUSEA (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Vomiting"; DECREASED APPETITE (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Loss of appetite"; PYREXIA (non-serious) with onset 14Dec2021 at 03:00, outcome "not recovered", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, nausea, vomiting, decreased appetite and pyrexia. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 (Lot number: EW0162) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing) and no other medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous COVID-19 vaccine product also Pfizer product and lot number is ER8730, dose1, administrated in the left arm), administration date: 11Apr2021, when the patient was 16 years old, for Covid-19 Immunization. The following information was reported: MYOCARDITIS (hospitalization, disability, life threatening) with onset 31Jul2021 06:00, outcome "not recovered", described as "Myocarditis". The patient was hospitalized for myocarditis (hospitalization duration: 3 day(s)). The event "myocarditis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal Swab): (31Jul2021) negative. Therapeutic measures were taken as a result of myocarditis included Ibuprofen.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: she got the hematoma in her right arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 11Feb2021 (Lot number: EM9809, Expiration Date: Jun2021) at the age of 64 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose Lot Number: EL3302), administration date: 21Jan2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: HAEMATOMA (non-serious) with onset 11Feb2021, outcome "recovered" (Feb2021), described as "she got the hematoma in her right arm".  Additional information: The only reaction she had in 11Feb2021 when she received the vaccine, was that she had a hematoma. She got the shot in her left shoulder and she got the hematoma in her right arm. Within 4 or 5 hours, she just looked down and had this very large hematoma on her forearm. It lasted a good 10 days, at least. The patient did not remember which location in her body she received the first dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Neck pain, SARS-CoV-2 test
Clinical narrative: Headaches migraine type down into my neck; Headaches migraine type down into my neck; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 02Aug2021 at 09:00 (Lot number: unknown) at the age of 50 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Motrin, reaction: "Drug allergy", notes: Known allergies: Motrin. Vaccination history included: Covid 19 vaccine (DOSE 1 SINGLE, Lot Number: UNKNOWN, Anatomical location: Right arm, Administration time: 10:00, Manufacturer unknown), administration date: 16Jul2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 03Aug2021 at 10:00, outcome "not recovered", described as "Headaches migraine type down into my neck"; NECK PAIN (non-serious) with onset 03Aug2021 at 10:00, outcome "not recovered", described as "Headaches migraine type down into my neck". The events "Headaches migraine type down into my neck " and "Headaches migraine type down into my neck" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine and neck pain.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid and symptoms were mild; tested positive for covid and symptoms were mild; This is a spontaneous report received from contactable reporter(Consumer or other non HCP) for a sponsored program. A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Psoriatic arthritis" (ongoing); "Psoriasis" (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication included: ENBREL taken for psoriatic arthropathy. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for covid and symptoms were mild". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown results; sars-cov-2 test: (2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased
Clinical narrative: rapid heartbeat; felt wiped out and tired; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "artificial heart valve" (ongoing); "defibrillator" (ongoing); and "atrial fibrillation" (ongoing). Concomitant medication(s) included: COUMADIN taken for anticoagulant therapy (ongoing). The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "rapid heartbeat"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "felt wiped out and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In 2021 (reported as yesterday), she had a rapid heartbeat and felt wiped out and tired but said she was always in a-fib even with the defibrillator. She also mentioned that she went in and out of A-fib, and has a rapid heart rate. She would like to know if it was ok for her to get the shot since she was on COUMADIN for a blood thinner. She says she had thought she was getting Moderna, and ended up getting Pfizer, and she didn't know if she was supposed to have it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; a little bit of fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "a little bit of fatigue".   Additional information: 63-year-old consumer said he and his wife received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday. Other than sore arm and a little bit of fatigue , they did not feel any other side effects Consumer wants to know if the vaccine would still work even if they did not experience any other side effects. Consumer asked how they would know if the Pfizer-BioNTech Covid-19 Vaccine already worked on him and his wife.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: had a sore shoulder after receiving his first dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "had a sore shoulder after receiving his first dose of the vaccine".  Additional Information: The reporter is the patient's wife.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Said friends wife has been really sick since; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Said friends wife has been really sick since". Additional information: The patient is afraid to get second dose.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nerve compression
Clinical narrative: pinched nerve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE COMPRESSION (non-serious), outcome "unknown", described as "pinched nerve". The event "pinched nerve" was evaluated at the physician office visit. Therapeutic measures were taken as a result of nerve compression.  Additional information: The patient went to the doctor and was put on prednisone for his pinched nerve and was wondering if the patient can start the medication.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchy area at the injection site; 3-inch red, itchy area at the injection site; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "itchy area at the injection site"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "3-inch red, itchy area at the injection site".  Additional Information: The adverse events occurred about 9 days after her first dose. She is due for her 2nd dose of Pfizer-Biontech Covid19 vaccine, tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.