chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Hypersensitivity, Rash erythematous, SARS-CoV-2 test, Urticaria
Clinical narrative: rash under my breasts that is very bad and red; body hives all over the place from head to toe; 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 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) 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), for Covid-19 Immunization, reaction(s): "I never had issue"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for Covid-19 Immunization, reaction(s): "I never had issue". The following information was reported: URTICARIA (non-serious) with onset 20Sep2022, outcome "unknown", described as "body hives all over the place from head to toe"; RASH ERYTHEMATOUS (non-serious) with onset 20Sep2022, outcome "unknown", described as "rash under my breasts that is very bad and red".  Additional information: Caller received the Pfizer Covid-19 Bivalent vaccine on 12Sep at (facility name withheld). Caller reported that she has never ever had a problem with shots in her life. Yesterday 20Sep, she developed a rash under her breasts that was very bad and red, and she had body hives all over the place from head to toe. Caller was not sure if this was an adverse reaction to the vaccine, laundry detergent, soap, or something she ate. Caller provided that she received the Pfizer Covid-19 primary vaccines as well. Caller was querying what she should do about her body hives, if she should go to a dermatologist or her doctor. She was not allowed to return to work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: rash under my breasts that is very bad and red; body hives all over the place from head to toe; 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 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) 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), for Covid-19 Immunization, reaction(s): "I never had issue"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for Covid-19 Immunization, reaction(s): "I never had issue". The following information was reported: URTICARIA (non-serious) with onset 20Sep2022, outcome "unknown", described as "body hives all over the place from head to toe"; RASH ERYTHEMATOUS (non-serious) with onset 20Sep2022, outcome "unknown", described as "rash under my breasts that is very bad and red".  Additional information: Caller received the Pfizer Covid-19 Bivalent vaccine on 12Sep at (facility name withheld). Caller reported that she has never ever had a problem with shots in her life. Yesterday 20Sep, she developed a rash under her breasts that was very bad and red, and she had body hives all over the place from head to toe. Caller was not sure if this was an adverse reaction to the vaccine, laundry detergent, soap, or something she ate. Caller provided that she received the Pfizer Covid-19 primary vaccines as well. Caller was querying what she should do about her body hives, if she should go to a dermatologist or her doctor. She was not allowed to return to work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine; "Headaches" (unspecified if ongoing), notes: Other medical history: Headaches; "Sleep apnea" (unspecified if ongoing), notes: Other medical history: Sleep apnea; "Gastritis" (unspecified if ongoing), notes: Other medical history: Gastritis; "IBS" (unspecified if ongoing), notes: Other medical history: IBS. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event  covid-19 and drug ineffective and the suspect drug BNT162B2 cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chest pain, Fatigue, Headache
Clinical narrative: Myasthenia Gravis symptoms developed and Dx confirmed; debilitating fatigue; joint pain; headache; chest pain; gastro distress; second vaccination received at 6 months following first shot; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 2, single (Lot number: ER8732) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). No Covid prior vaccination. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number: 301 358A, vaccine location: Left leg), administration date: 24Mar2021, when the patient was 59-year-old, for COVID-19 Immunization. No other vaccine in four weeks. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "second vaccination received at 6 months following first shot"; MYASTHENIA GRAVIS (disability, medically significant) with onset 13Oct2021, outcome "not recovered", described as "Myasthenia Gravis symptoms developed and Dx confirmed"; CHEST PAIN (disability) with onset 13Oct2021, outcome "not recovered"; FATIGUE (disability) with onset 13Oct2021, outcome "not recovered", described as "debilitating fatigue"; ABDOMINAL DISCOMFORT (disability) with onset 13Oct2021, outcome "not recovered", described as "gastro distress"; HEADACHE (disability) with onset 13Oct2021, outcome "not recovered"; ARTHRALGIA (disability) with onset 13Oct2021, outcome "not recovered", described as "joint pain". Myasthenia Gravis symptoms developed and Dx confirmed following the second vaccination received at 6 months following first shot which caused 6 weeks (as reported) of debilitating fatigue, joint pain, headache, chest pain, gastro distress. The events "myasthenia gravis symptoms developed and dx confirmed", "debilitating fatigue", "joint pain", "headache", "chest pain" and "gastro distress" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (Covid tested post vaccination): Negative, notes: Nasal swab; Negative, notes: Nasal swab; Negative, notes: Nasal swab. Therapeutic measures were taken as a result of myasthenia gravis.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myasthenia gravis, SARS-CoV-2 test
Clinical narrative: Myasthenia Gravis symptoms developed and Dx confirmed; debilitating fatigue; joint pain; headache; chest pain; gastro distress; second vaccination received at 6 months following first shot; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 2, single (Lot number: ER8732) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). No Covid prior vaccination. No known allergies. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number: 301 358A, vaccine location: Left leg), administration date: 24Mar2021, when the patient was 59-year-old, for COVID-19 Immunization. No other vaccine in four weeks. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "second vaccination received at 6 months following first shot"; MYASTHENIA GRAVIS (disability, medically significant) with onset 13Oct2021, outcome "not recovered", described as "Myasthenia Gravis symptoms developed and Dx confirmed"; CHEST PAIN (disability) with onset 13Oct2021, outcome "not recovered"; FATIGUE (disability) with onset 13Oct2021, outcome "not recovered", described as "debilitating fatigue"; ABDOMINAL DISCOMFORT (disability) with onset 13Oct2021, outcome "not recovered", described as "gastro distress"; HEADACHE (disability) with onset 13Oct2021, outcome "not recovered"; ARTHRALGIA (disability) with onset 13Oct2021, outcome "not recovered", described as "joint pain". Myasthenia Gravis symptoms developed and Dx confirmed following the second vaccination received at 6 months following first shot which caused 6 weeks (as reported) of debilitating fatigue, joint pain, headache, chest pain, gastro distress. The events "myasthenia gravis symptoms developed and dx confirmed", "debilitating fatigue", "joint pain", "headache", "chest pain" and "gastro distress" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (Covid tested post vaccination): Negative, notes: Nasal swab; Negative, notes: Nasal swab; Negative, notes: Nasal swab. Therapeutic measures were taken as a result of myasthenia gravis.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Red itchy blotches and streaks all over her body; itchy hive-like blotches; Red itchy blotches and streaks all over her body; itchy hive-like blotches; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GJS342) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multivitamin" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: BENTYL; ELAVIL [ALLOPURINOL]; GAS-X; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6203; in left arm at 01:30 PM), administration date: 21Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EP7534; in left arm at 02:00 PM), administration date: 18Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER); in left arm at 01:15 PM), administration date: 25Sep2021, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER); Lot Number: FK9893; in left arm at 10:45 AM), administration date: 12May2022, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious), RASH PRURITIC (non-serious) all with onset 15Sep2022 at 20:00, outcome "not recovered" and all described as "Red itchy blotches and streaks all over her body; itchy hive-like blotches". The events "red itchy blotches and streaks all over her body; itchy hive-like blotches" required physician office visit. Therapeutic measures were taken as a result of rash macular, rash pruritic.  Additional Information: The patient had no known allergies. The patient had no other vaccine in four weeks. The patient was also taking an unspecified multivitamin in two weeks. 48 hours after the injection (as reported), the patient broke out in red itchy blotches and streaks all over her body (not at the injection site) - these itchy hive-like blotches come and then fade away within the hour. Then new ones appear. This is continuing to happen every day; the day of the reporting is day 7. As treatment for the events so far, topical steroid ointment for itching was administered. The patient had not been tested for COVID-19 post-vaccination.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; (17Sep2022) Negative, notes: negative test 4 days ago. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 33 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as COVID 19 Treatment from 07Sep2022 to 11Sep2022.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "autism" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: B12 [CYANOCOBALAMIN]; D3; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: fatigue 3 hours afterwards; 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 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unkown (booster), single (Batch/Lot number: unknown) at the age of 56 years 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 completed, Unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Sep2022, outcome "not recovered", described as "fatigue 3 hours afterwards". Additional information: Patient reported that he received the bivalent booster of the Pfizer COVID-19 vaccine on 19Sep2022. He began experiencing fatigue 3 hours afterwards and it was persisting. Caller would like to know how long that fatigue will last.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). An 87-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the epidemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201179633 Same patient, different product and event.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid /COVID 19 Treatment; tested positive for covid/COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EL0142), on 12Jan2021 as dose 2, single (Lot number: EL0142) and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Seasonal Allergies" (unspecified if ongoing), notes: known allergies: Seasonal Allergies. Concomitant medication(s) included: ZOLOFT, start date: 09Oct1998; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01May2022; SINGULAIR, start date: 05Jun2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid/COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: When I tested positive for covid I was eligible for Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.        Other medication details: Other medication in 2weeks product=Antidepressant, Other medication in 2weeks product=Zoloft, Other medication in 2weeks start date=09Oct1998  Other medication in 2weeks product=Antihistamine, Other medication in 2weeks product=Zyrtec, Other medication in 2weeks start date=01May2022  Other medication in 2weeks brand=Singulair, Other medication in 2weeks start date=05Jun2020  Adverse event: When I tested positive for covid I was eligible for Paxlovid. I started treatment on Sunday, 11Sep in the evening. My treatment ended the morning of Friday, 16Sep. By Monday 26Sep, I was achy, had increased coughing, increased shortness of breath, my lungs feel like they are burning, sore throat and sinus congestion. Adverse event start date: 12Sep2022 Adverse event start time: 04:00 PM AE resulted in: [None of the above] If treatment AE: Unknown  Known allergies: Seasonal Allergies  Other medical history: Asthma, Depression; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Decreased interest, Fatigue, Feeling abnormal, Headache
Clinical narrative: Brain fog; Extreme fatigue; can barely stay awake; Not wanting to do anything; Trouble with balance control; Headaches in rear of head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EW0Z0Z), in right arm for covid-19 immunisation. The patient's relevant medical history included: "PE" (unspecified if ongoing); "DVT" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB; FOLIC ACID; GABAPENTIN; HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: CW0198, Anatomical location: Arm Right,, Vaccine Administration Time: 09:00 AM), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: FL3209, Anatomical location: Arm Right, Vaccine Administration Time: 09:30 AM), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain fog"; FATIGUE (non-serious), outcome "not recovered", described as "Extreme fatigue"; HYPERSOMNIA (non-serious), outcome "not recovered", described as "can barely stay awake"; DECREASED INTEREST (non-serious), outcome "not recovered", described as "Not wanting to do anything"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Trouble with balance control"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches in rear of head". The events "brain fog", "extreme fatigue", "can barely stay awake", "not wanting to do anything", "trouble with balance control" and "headaches in rear of head" required physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, fatigue, hypersomnia, decreased interest, balance disorder, headache.  Additional information: The patient had no known allergies. Prior to vaccination, patient was not diagnosed with Covid. Post vaccination, the patient was not tested with Covid. The patient did not receive other vaccine in four weeks
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Brain fog; Extreme fatigue; can barely stay awake; Not wanting to do anything; Trouble with balance control; Headaches in rear of head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EW0Z0Z), in right arm for covid-19 immunisation. The patient's relevant medical history included: "PE" (unspecified if ongoing); "DVT" (unspecified if ongoing); "Afib" (unspecified if ongoing). Concomitant medication(s) included: CELECOXIB; FOLIC ACID; GABAPENTIN; HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: CW0198, Anatomical location: Arm Right,, Vaccine Administration Time: 09:00 AM), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Lot number: FL3209, Anatomical location: Arm Right, Vaccine Administration Time: 09:30 AM), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Brain fog"; FATIGUE (non-serious), outcome "not recovered", described as "Extreme fatigue"; HYPERSOMNIA (non-serious), outcome "not recovered", described as "can barely stay awake"; DECREASED INTEREST (non-serious), outcome "not recovered", described as "Not wanting to do anything"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Trouble with balance control"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches in rear of head". The events "brain fog", "extreme fatigue", "can barely stay awake", "not wanting to do anything", "trouble with balance control" and "headaches in rear of head" required physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, fatigue, hypersomnia, decreased interest, balance disorder, headache.  Additional information: The patient had no known allergies. Prior to vaccination, patient was not diagnosed with Covid. Post vaccination, the patient was not tested with Covid. The patient did not receive other vaccine in four weeks
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Nausea, Pain
Clinical narrative: She is feeling incredibly achy and she has a headache that doesn't go away; She is feeling incredibly achy and she has a headache that doesn't go away; received 3 vaccines and 2 boosters; Additionally, she mentioned that she is experiencing nausea that comes and goes.; 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 56-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 04, MANUFACTURER: UNKNOWN, Anatomical site : Arm), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 03, MANUFACTURER: UNKNOWN, Anatomical site : Arm), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 02, MANUFACTURER: UNKNOWN, Anatomical site : Arm), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 01, MANUFACTURER: UNKNOWN, Anatomical site : Arm), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset Sep2022, outcome "not recovered", described as "Additionally, she mentioned that she is experiencing nausea that comes and goes."; INCORRECT DOSE ADMINISTERED (non-serious) with onset 20Sep2022, outcome "unknown", described as "received 3 vaccines and 2 boosters"; PAIN (non-serious), HEADACHE (non-serious) all with onset 21Sep2022, outcome "not recovered" and all described as "She is feeling incredibly achy and she has a headache that doesn't go away". Therapeutic measures were not taken as a result of nausea, pain, headache. Additional information: Caller had "the most recent COVID vaccine" yesterday (20Sep2022). She was feeling incredibly achy, and she had a headache that didn't go away. She wanted to know if these are reported side effects from the vaccine. Additionally, she mentioned that she was experiencing nausea that comes and goes. She wanted to know if these are reported side effects from the vaccine. The patient was calling about most recent COVID vaccine. Caller did not have the name of the vaccine and said she got the vaccine last night. Unable to clarify which formulation of the vaccine. Wondering if it was normal to feel incredibly achy and has a headache that won't go away? Caller confirmed she received 3 vaccines and 2 boosters. Caller said she did not have that when asked for manufacturer, NDC, Lot, and expiration. She just went in and got the vaccines. Dosage and time was unknown and she received in her arm. NDC, Lot, and expiration was unknown for all COVID-19 vaccines. Manufacturer was unknown for all vaccines.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Experiencing symptoms of COVID and he tested positive today after a home test.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 21Sep2022, outcome "unknown", described as "Experiencing symptoms of COVID and he tested positive today after a home test.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of COVID-19.  Additional information: The reporter's husband got the COVID-19 bivalent booster vaccine 2 days ago. However, he's been experiencing symptoms of COVID and he tested positive at the time of report after a home test. The doctor prescribed Paxlovid and reporter knew it's a protease inhibitor that prevents viral replication. The reporter asked if Paxlovid will interfere with patient's immune response to the vaccine, thereby making him develop a less-strong immunity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Respiratory disorder, SARS-CoV-2 test, Sinus disorder
Clinical narrative: ongoing repository Illness; still seeing a doctor for my sinus; bronchitis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO; ADDERALL; FAMODINE; NEXIUM 1-2-3. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: Unknown, Location of injection: Arm Left), for Covid-19 immunization; Bnt162b2 (Dose 2, Batch/Lot No: Unknown, Location of injection: Arm Left), for COVID-19 immunization. The following information was reported: BRONCHITIS (hospitalization, life threatening) with onset 01Apr2022, outcome "not recovered"; RESPIRATORY DISORDER (hospitalization, life threatening) with onset 01Apr2022, outcome "not recovered", described as "ongoing repository Illness"; SINUS DISORDER (hospitalization, life threatening) with onset 01Apr2022, outcome "not recovered", described as "still seeing a doctor for my sinus". The patient was hospitalized for respiratory disorder, sinus disorder, bronchitis (hospitalization duration: 1 day(s)). The events "ongoing repository illness", "still seeing a doctor for my sinus" and "bronchitis" required physician office visit and emergency room visit. Patient had several hospitalizations occur due to bronchitis and she is a healthy 23-year-old. She have had ongoing repository Illness since early Apr2022 after her last Pfizer vaccination. Currently still seeing a doctor for her sinus and bronchial troubles (non smoker). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of respiratory disorder, sinus disorder, bronchitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Panic attack
Clinical narrative: patient anxiety symptoms went through the roof; couldn't think about going to work without having a full blown panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), outcome "not recovered", described as "patient anxiety symptoms went through the roof"; PANIC ATTACK (non-serious), outcome "unknown", described as "couldn't think about going to work without having a full blown panic attack".  Additional information: Patient was fully vaccinated as of 13Aug2021. Days after that, anxiety symptoms went through the roof. Patient couldn't think about going to work without having a full-blown panic attack. As a result, patient ended up having to quit job.Patient want to know whether Pfizer was doing anything for people who had adverse reactions to their vaccine and any studies being done since the government and drug companies are especially using us as guinea pigs  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was vaccinated, but tested positive for covid - 20Sep2022.; Patient was vaccinated, but tested positive for covid - 20Sep2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Sep2022, outcome "recovering" and all described as "Patient was vaccinated, but tested positive for covid - 20Sep2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 19:00 as dose 4 (booster), single (Lot number: FNZ908) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had initial symptoms, positive COVID test on 10Sep2022, and Start Paxlovid 14Sep2022 end Paxlovid 15Sep2022.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Dyspnoea, Fatigue, Malaise
Clinical narrative: shortness of breath; I felt like a elephant is sitting on my chest; tiredness; feeling unwell; diarrhea; runny nose; a little arm pain where the injection went in; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), 15 ug single (Batch/Lot number: unknown) 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; unknown manufacturer), for COVID-19 immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset Sep2022, outcome "unknown", described as "I felt like a elephant is sitting on my chest"; VACCINATION SITE PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "a little arm pain where the injection went in"; DIARRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "diarrhea"; MALAISE (non-serious) with onset Sep2022, outcome "unknown", described as "feeling unwell"; RHINORRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "runny nose"; DYSPNOEA (non-serious) with onset Sep2022, outcome "unknown", described as "shortness of breath"; FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "tiredness".  Additional information: 16Sep2022, the booster and had the, some of symptoms had was shortness of breath and felt like a elephant is sitting on his chest. Started having symptoms on Saturday, the 17th and 18th, on the 19th was fine, no problems on 19th. But the patient had shortness of breath, tiredness, feeling unwell, diarrhea, runny nose and a little arm pain where the injection went in.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: shortness of breath; I felt like a elephant is sitting on my chest; tiredness; feeling unwell; diarrhea; runny nose; a little arm pain where the injection went in; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 21Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose number unknown (booster), 15 ug single (Batch/Lot number: unknown) 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; unknown manufacturer), for COVID-19 immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset Sep2022, outcome "unknown", described as "I felt like a elephant is sitting on my chest"; VACCINATION SITE PAIN (non-serious) with onset Sep2022, outcome "unknown", described as "a little arm pain where the injection went in"; DIARRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "diarrhea"; MALAISE (non-serious) with onset Sep2022, outcome "unknown", described as "feeling unwell"; RHINORRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "runny nose"; DYSPNOEA (non-serious) with onset Sep2022, outcome "unknown", described as "shortness of breath"; FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "tiredness".  Additional information: 16Sep2022, the booster and had the, some of symptoms had was shortness of breath and felt like a elephant is sitting on his chest. Started having symptoms on Saturday, the 17th and 18th, on the 19th was fine, no problems on 19th. But the patient had shortness of breath, tiredness, feeling unwell, diarrhea, runny nose and a little arm pain where the injection went in.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Leg pain; Pain went to my back; Painful when walking; Felt week; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jul2021 as dose 2, single (Lot number: EW0198) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EW0196), administration date: 30Jun2021, when the patient was 47-year-old, for COVID-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset Sep2022, outcome "recovering", described as "Felt week"; PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Leg pain"; BACK PAIN (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Pain went to my back"; PAIN (non-serious) with onset Sep2022, outcome "not recovered", described as "Painful when walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, back pain, pain, asthenia.  Additional information: No fever. The weakness patient still had, but  feels better (its been 7 days).The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was not tested COVID post vaccination. The patient did not have any known allergies. Treatment included auto-adjustable positive airway pressure (APAP) & Naproxen.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: a headache and a backache/tested positive for Covid; a headache and a backache/tested positive for Covid; brain fog; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a headache and a backache/tested positive for Covid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; LETHARGY (non-serious), outcome "unknown", described as "lethargy ". The patient has had 2 Pfizer shots and 2 Pfizer boosters and she was supposed to get her third on Sunday but she tested positive for COVID. People mostly have the headache as the sign of this strain of COVID. That is why the patient was suspicious when she work up Saturday with a headache and a backache and Sunday morning as well. Even though the patient took 3 Advil and it lessened the effect she took the test and it was positive for COVID. Those are gone now. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid; Oxygen saturation: fine throughout. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.