chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Immunisation, Musculoskeletal chest pain, Pain
Clinical narrative: Rash; Herpes zoster (Shingles); Throbbing and sharp pain at lower left rib and back; Throbbing and sharp pain at lower left rib and back; Pain increased; Dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FH8024) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; SPIRONOLACTONE; MIRTAZAPINE. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin"; Lidocaine, reaction(s): "Known allergies: Lidocaine". Vaccination history included: Bnt162b2 (dose number=2, Product=COVID 19, brand=Pfizer , lot number=ER8735, administration date=07May2021, vaccine location=Left arm), administration date: 07May2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, Product=COVID 19, brand=Pfizer , lot number=ER8735, administration date=15Apr2021, vaccine location=Left arm), administration date: 15Apr2021, when the patient was 40 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Dose number=3"; MUSCULOSKELETAL CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset 19Dec2021 12:00, outcome "not recovered" and all described as "Throbbing and sharp pain at lower left rib and back"; PAIN (non-serious) with onset 19Dec2021 12:00, outcome "not recovered", described as "Pain increased"; RASH (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Rash"; HERPES ZOSTER (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Herpes zoster (Shingles)". The events "throbbing and sharp pain at lower left rib and back", "throbbing and sharp pain at lower left rib and back", "pain increased", "rash" and "herpes zoster (shingles)" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of musculoskeletal chest pain, back pain, pain, rash, herpes zoster.  Additional information: The patient did not receive any other vaccines within 4 weeks. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; Herpes zoster (Shingles); Throbbing and sharp pain at lower left rib and back; Throbbing and sharp pain at lower left rib and back; Pain increased; Dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FH8024) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; SPIRONOLACTONE; MIRTAZAPINE. Past drug history included: Neomycin, reaction(s): "Known allergies: Neomycin"; Lidocaine, reaction(s): "Known allergies: Lidocaine". Vaccination history included: Bnt162b2 (dose number=2, Product=COVID 19, brand=Pfizer , lot number=ER8735, administration date=07May2021, vaccine location=Left arm), administration date: 07May2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (dose number=1, Product=COVID 19, brand=Pfizer , lot number=ER8735, administration date=15Apr2021, vaccine location=Left arm), administration date: 15Apr2021, when the patient was 40 years old, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Dose number=3"; MUSCULOSKELETAL CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset 19Dec2021 12:00, outcome "not recovered" and all described as "Throbbing and sharp pain at lower left rib and back"; PAIN (non-serious) with onset 19Dec2021 12:00, outcome "not recovered", described as "Pain increased"; RASH (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Rash"; HERPES ZOSTER (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Herpes zoster (Shingles)". The events "throbbing and sharp pain at lower left rib and back", "throbbing and sharp pain at lower left rib and back", "pain increased", "rash" and "herpes zoster (shingles)" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of musculoskeletal chest pain, back pain, pain, rash, herpes zoster.  Additional information: The patient did not receive any other vaccines within 4 weeks. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dyspepsia, Fatigue, Immunisation
Clinical narrative: dose_received: 3; injection site pain; tiredness; body aches; chills; nausea; heartburn; pain in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 (Lot number: FA8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 18Mar2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "recovering", described as "dose_received: 3"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 21Dec2021, outcome "recovering", described as "tiredness"; PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 21Dec2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 21Dec2021, outcome "recovering", described as "nausea"; DYSPEPSIA (non-serious) with onset 21Dec2021, outcome "recovering", described as "heartburn"; AXILLARY PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "pain in left armpit". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, fatigue, pain, chills, nausea, dyspepsia, axillary pain. No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: dose_received: 3; injection site pain; tiredness; body aches; chills; nausea; heartburn; pain in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 (Lot number: FA8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 18Mar2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "recovering", described as "dose_received: 3"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 21Dec2021, outcome "recovering", described as "tiredness"; PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 21Dec2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 21Dec2021, outcome "recovering", described as "nausea"; DYSPEPSIA (non-serious) with onset 21Dec2021, outcome "recovering", described as "heartburn"; AXILLARY PAIN (non-serious) with onset 21Dec2021, outcome "recovering", described as "pain in left armpit". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, fatigue, pain, chills, nausea, dyspepsia, axillary pain. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Immunisation, Pain
Clinical narrative: Chills; feeling out of it; fatigue; body aches; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Dec2021 19:45 (Batch/Lot number: unknown) at the age of 33 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: Bnt162b2 (Dose 2, single. Lot No: Unknown. ), for Covid-19 immunization; Bnt162b2 (Dose 1, single. Lot No: Unknown.), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 19:45, outcome "unknown", described as "Dose Number: 3"; CHILLS (non-serious) with onset 22Dec2021, outcome "recovering", described as "Chills"; FEELING ABNORMAL (non-serious) with onset 22Dec2021, outcome "recovering", described as "feeling out of it"; FATIGUE (non-serious) with onset 22Dec2021, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 22Dec2021, outcome "recovering", described as "body aches". Therapeutic measures were taken as a result of chills, feeling abnormal, fatigue, pain.  Additional information: Known allergies was none. No Covid prior vaccination and post vaccination. AE treatment was Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Pain
Clinical narrative: chills, headache, body aches; chills, headache, body aches; chills, headache, body aches; Covid-19 Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Take Synthroid daily for Hashimoto's. Concomitant medication(s) included: SYNTHROID taken for autoimmune thyroiditis. Vaccination history included: Bnt162b2 (DOSE: 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE:2, SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "chills, headache, body aches"; IMMUNISATION (non-serious), outcome "unknown", described as "Covid-19 Booster".  Additional information: Event took place after use of product.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Malaise, Urticaria
Clinical narrative: hives reaction throughout the body; Booster / 3rd dose of Pfizer vaccine; Headache; not feeling well; 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), administration date 16Dec2021 16:00 (Lot number: FL3197) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Vaccine Administration Time: 04:00 PM), administration date: 16Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0167, Vaccine Administration Time: 04:00 PM), administration date: 07May2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 16:00, outcome "unknown", described as "Booster / 3rd dose of Pfizer vaccine"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset Dec2021, outcome "unknown", described as "not feeling well"; URTICARIA (non-serious) with onset 23Dec2021 08:00, outcome "unknown", described as "hives reaction throughout the body". The events "headache", "not feeling well" and "hives reaction throughout the body" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of headache, malaise, urticaria.  Additional Information: It was reported that, the patient had headache the first day after vaccine, not feeling well for next 5 days and hives reaction throughout the body today (7th day after vaccine). The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immunisation
Clinical narrative: This is a spontaneous report received from 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 22Nov2021 10:00 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Note: Arthritis. Concomitant medication(s) included: TYLENOL; ENBREL. 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, Vaccine Administration Time: 02:00, PM), administration date: 30Apr2021, when the patient was 49 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, Vaccine Administration Time: 10:00 AM), administration date: 07Apr2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:00, outcome "unknown", described as "Booster"; BACK PAIN (non-serious) with onset 23Nov2021 01:00, outcome "not recovered", described as "Lower and Middle back pain". The event "lower and middle back pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Immunisation
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unkown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYMLOS taken for osteoporosis.The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Tymlos, it''s for Osteoporosis and I have to inject myself everyday with this".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Lymphadenopathy, Myalgia
Clinical narrative: Dose Number: 3; Fatigue; Chills; muscle soreness (entire body); swollen lymph node under left arm; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 (Lot number: 330258D) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies:Sulfa Drugs" (unspecified if ongoing); "known_allergies:Dill" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "No AEs occurred with previous two Doses"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "No AEs occurred with previous two Doses". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Dose Number: 3"; FATIGUE (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Fatigue"; CHILLS (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "muscle soreness (entire body)"; LYMPHADENOPATHY (non-serious) with onset 22Dec2021, outcome "not recovered", described as "swollen lymph node under left arm". Therapeutic measures were not taken as a result of immunisation, fatigue, chills, myalgia, lymphadenopathy.  Additional Information: The patient had fatigue, chills, muscle soreness (entire body), swollen lymph node under left arm within first 24 hours. No adverse events occurred with previous two doses. The patient had known allergies: SULFA Drugs, DILL. The patient had no other medical history. The patient had no other vaccine in four weeks. Other medications in two weeks: LEXAPRO. No treatment received for adverse events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lip swelling
Clinical narrative: lip swelling; Booster / 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 18:50 (Lot number: FE3590) at the age of 39 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Hyaluronic lip filler (juvederm ultra plus xc), start date: 01Mar2021, stop date: 01Mar2021. Vaccination history included: Bnt162b2 (Dose: 01, Lot: EL3249, Expiration: May2021), administration date: 18Jan2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot: EN6200, Expiration: Jun2021), administration date: 13Feb2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 18:50, outcome "unknown", described as "Booster / 3rd dose"; LIP SWELLING (non-serious) with onset 23Dec2021 03:00, outcome "not recovered", described as "lip swelling". Therapeutic measures were not taken as a result of lip swelling.  Additional Information: The caller was reported to be a Pfizer Employee. She was calling about the Covid vaccine for adult, it was for her. She wanted to report an adverse reaction on herself. She provided that, she had hyaluronic lip filler (was called Juvederm ultra plus xc) but that last time she had the lip filler was on 01Mar2021. It was reported that, 32 hours after the booster dose of the covid vaccine she experienced swelling in her lips. She did not experience this with the first two doses. Lip swelling started 32 hours the booster dose, clarified that lip swelling started at 3 am this morning. Confirmed she became aware today 23Dec2021, since the lip swelling started at 3am. The patient declined receiving any treatment, she had not taken anything. No investigation assessment was performed.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia
Clinical narrative: Very sore left tricep next day after receiving booster shot in left arm.; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 12:00 (Lot number: 331305A) at the age of 33 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: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729), administration date: 15Apr2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730), administration date: 25Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "booster"; MYALGIA (non-serious) with onset 23Dec2021 01:00, outcome "recovering", described as "Very sore left tricep next day after receiving booster shot in left arm.". Therapeutic measures were not taken as a result of myalgia.  Additional information: Patient did not have any other vaccine in four weeks. Patient not taken treatment to AE. Patient did not have covid prior vaccination and post vaccination patient was not tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Urticaria
Clinical narrative: Hives; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 15:00 (Lot number: FE3594) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: None, notes: Known allergies: None, Other medical history: None. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EW0172, Prev dose lot unknown: False, Prev dose administration date: 29Apr2021 , Prev dose number: 2, Prev dose vaccine location: Right arm), administration date: 29Apr2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot number: EW0158, Prev dose lot unknown: False, Prev dose administration date: 08Apr2021 , Prev dose number: 1 , Prev dose vaccine location: Right arm), administration date: 08Apr2021, when the patient was 58 years old, for Covid-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 15:00, outcome "unknown", described as "booster"; URTICARIA (non-serious) with onset 20Dec2021, outcome "recovered" (2021), described as "Hives". Therapeutic measures were taken as a result of immunisation, urticaria.  Additional information:  The patient did not receive any other vaccines within 4 weeks. Treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation
Clinical narrative: Since then vaccine 2 booster made no difference in pain levels.; Since then vaccine 2 & booster made no difference in pain levels; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Lot number: 320306D) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "cant walk without assistance", start date: 03Feb2021 (ongoing), notes: Seriousness criteria: Persistent/significant disability/incapacity, important medical event, AE required visit to: Physician offices, AE outcome: Not recovered, Treatment: Yes, If yes, Details: Biowave machine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Time (24hrs): 03:00 pm, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Batch/Lot: EL9261), administration date: 28Jan2021, when the patient was 79 years old, for Covid-19 Immunization; Bnt162b2 (Dose number: 2, Time: 03:00 pm, Anatomical site of injection: Upper left arm, Batch/Lot: EN6200), administration date: 02Mar2021, when the patient was 79 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "Since then vaccine 2 & booster made no difference in pain levels"; ARTHRALGIA (non-serious), outcome "unknown", described as "Since then vaccine 2 booster made no difference in pain levels.".   Additional information: 5 days after first vaccine of Pfizer, she woke in extreme knee pain. 05Feb2021- she have walked with a cane walker ever/since. In pain whenever she stand or mobilize. See a knee surgon (name-withheld) regularly. Have had digital photos and now bone scan Scheduled. Prescribed hydromorphine. Use Advil 600mg daily go to physical therapy 2x week for 3 months. Not effective. Ongoing. No change for 10 months. Followed 5 days of vaccine. Since then vaccine 2 booster made no difference in pain levels.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation
Clinical narrative: 3rd booster shot; shingles rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product-COVID 19,, prev dose brand-Pfizer,, prev dose brand unknown-False,, prev dose lot unknown-True,, prev dose lot unknown reason-Not, available/provided to reporter at the, time of report completion,, prev dose dose number-2), for COVID-19 immunization; Bnt162b2 (prev dose product-COVID 19,, prev dose brand-Pfizer,, prev dose brand unknown-False,, prev dose lot unknown-True,, prev dose lot unknown reason-Not, available/provided to reporter at the, time of report completion,, prev dose dose number-1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd booster shot"; HERPES ZOSTER (non-serious), outcome "recovered", described as "shingles rash". The event "shingles rash" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: It was reported that friend said her mom had some shingles rash after taking the 3rd booster shot. No other vaccine in four weeks. It was unknown if patient taken other medications in two weeks. It was unknown if patient had known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Immunisation, Pyrexia, Vomiting
Clinical narrative: Stomach pain; fever; vomiting; 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 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Dec2021 11:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immune Compromised" (unspecified if ongoing); "Phempagus Vulgaris" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE; LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not sure batch, Location of injection: Arm Right, Vaccine Administration Time: 04:45 PM), administration date: 16Apr2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 04:45 PM), administration date: 07May2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Stomach pain", "Fever", "vomiting". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 11:15, outcome "unknown", described as "Dose Number: 3"; ABDOMINAL PAIN UPPER (non-serious) with onset 22Dec2021 18:00, outcome "recovering", described as "Stomach pain"; PYREXIA (non-serious) with onset 22Dec2021 18:00, outcome "recovering", described as "fever"; VOMITING (non-serious) with onset 22Dec2021 18:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of abdominal pain upper, pyrexia, vomiting.  Additional Information: 3rd shot experiences Stomach pain, fever for over 3 days and vomiting. Prior to vaccination, patient has not been diagnosed with COVID-19. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown since the vaccination, has the patient been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858533 same patient/event, different dose of vaccine
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Immunisation, Nasopharyngitis
Clinical narrative: COVID booster; my husband same symptoms/Body ache; my husband same symptoms/Cold chills; my husband same symptoms/Cold chills; my husband same symptoms/Headache; my husband same symptoms/bad cough; my husband same symptoms/ sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2, Solution for injection), (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "COVID booster"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/Body ache"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "my husband same symptoms/Cold chills"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/Headache"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/bad cough"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/ sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated she and her husband got the COVID booster (clarified as Pfizer COVID-19 vaccine) from Pfizer on Tuesday. The reporter was not feeling good up until today like the body ache, cold chills and headache the whole 'night' (word not clear). So they wanted did a home test for COVID the PCR that you bring home and her husband was having the same symptoms, his test is negative, and the reporter test was positive. Could that be a false positive?. Paraphrased the concern: Consumer stated, Body ache, cold chills, bad cough, sore throat but reporter did not have any symptoms up until she got the booster. She just wanted to know if they could be a false positive and those are really symptoms neither just all side effects from the shot.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858979 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: COVID booster; my husband same symptoms/Body ache; my husband same symptoms/Cold chills; my husband same symptoms/Cold chills; my husband same symptoms/Headache; my husband same symptoms/bad cough; my husband same symptoms/ sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2, Solution for injection), (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "COVID booster"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/Body ache"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "my husband same symptoms/Cold chills"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/Headache"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/bad cough"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "my husband same symptoms/ sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated she and her husband got the COVID booster (clarified as Pfizer COVID-19 vaccine) from Pfizer on Tuesday. The reporter was not feeling good up until today like the body ache, cold chills and headache the whole 'night' (word not clear). So they wanted did a home test for COVID the PCR that you bring home and her husband was having the same symptoms, his test is negative, and the reporter test was positive. Could that be a false positive?. Paraphrased the concern: Consumer stated, Body ache, cold chills, bad cough, sore throat but reporter did not have any symptoms up until she got the booster. She just wanted to know if they could be a false positive and those are really symptoms neither just all side effects from the shot.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858979 same reporter/product/event, different patient
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain
Clinical narrative: booster; Pain in arm/Under that area is all red around I got the injection; red around the injection/Under that area is all red around I got the injection, I have like a red mark or the injection mark on my arm and it's kind of hurt; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 (Lot number: FH8028, Expiration Date: 28Feb2022) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE taken for anxiety. Vaccination history included: Covid-19 vaccine (Dose 1st , Lot# of First shot: EW0161., Anatomical site of administration: Left), administration date: 06May2021, when the patient was 47 years old, for COVID-19 immunization; Covid-19 vaccine (Dose 2nd, Lot# of second shot: EW0182, Anatomical site of administration: Left), administration date: 06Jun2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2021, outcome "unknown", described as "Pain in arm/Under that area is all red around I got the injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Dec2021, outcome "unknown", described as "red around the injection/Under that area is all red around I got the injection, I have like a red mark or the injection mark on my arm and it's kind of hurt". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Oedema
Clinical narrative: Swollen lymph nodes and edema in armpit on same side as injection appeared 2 days after injection; Swollen lymph nodes and edema in armpit on same side as injection appeared 2 days after injection; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 10:30 (Lot number: FL3197) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high BP" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 23Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Mar2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 10:30, outcome "unknown", described as "dose number=3"; LYMPHADENOPATHY (non-serious), OEDEMA (non-serious) all with onset 24Dec2021 04:30, outcome "not recovered" and all described as "Swollen lymph nodes and edema in armpit on same side as injection appeared 2 days after injection". Therapeutic measures were not taken as a result of lymphadenopathy, oedema.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines in 4 weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Rash pruritic
Clinical narrative: husband got the third dose of Pfizer yesterday for COVID; rash in his whole body is really itchy is starting on the leg on the upper part of leg up to all the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: 33025BD) 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, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "husband got the third dose of Pfizer yesterday for COVID"; RASH PRURITIC (non-serious) with onset Dec2021, outcome "unknown", described as "rash in his whole body is really itchy is starting on the leg on the upper part of leg up to all the neck".  Additional information: Reporter stated that reporter's husband (patient) received the third dose of Pfizer vaccine for covid on the morning of 22Dec2021. Patient experienced rash in his whole body, and was really itchy, started on the leg, on the upper part of the leg up to all the neck. Reported stated that it was pretty bad and enquired if any medication was available for the itchiness.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation
Clinical narrative: I had a booster yesterday Pfizer booster; I had a booster yesterday Pfizer booster and my under armpit is like painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "I had a booster yesterday Pfizer booster"; AXILLARY PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "I had a booster yesterday Pfizer booster and my under armpit is like painful".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Malaise, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Dec2021 (Lot number: Fd0809) at the age of 18 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: 2, Batch/Lot No: Ew0172, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05May2021, when the patient was 17 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0158, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Apr2021, when the patient was 17 years old, for Covid-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "Dose Number 3"; PAIN IN EXTREMITY (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "Left arm pain"; LYMPHADENOPATHY (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "swollen lymph nodes left under arm"; PYREXIA (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 23Dec2021 09:00, outcome "recovering", described as "general malaise". Therapeutic measures were taken as a result of pain in extremity, lymphadenopathy, pyrexia, malaise.No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: pain under the right armpit; Swelling; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 (Lot number: FF2587) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 16Apr2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 24Mar2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Dose number 3"; AXILLARY PAIN (non-serious) with onset 16Dec2021, outcome "recovered" (Dec2021), described as "pain under the right armpit"; SWELLING (non-serious) with onset 16Dec2021, outcome "recovered" (Dec2021), described as "Swelling". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: The patient had no known allergies. The patient did not received 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 had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.