chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
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) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm 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: "GERD" (unspecified if ongoing), notes: other medical history: GERD; "Paroxysmal A Fib" (unspecified if ongoing), notes: other medical history: Paroxysmal A Fib. Concomitant medication(s) included: PANTOPRAZOLE; METOPROLOL. Patient had no known allergies. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Yes the report is about covid treatment. Other medication was taken in 2 weeks. Paxlovid was taken as COVID 19 Treatment which start on 22Sep2022 and stopped on 26Sep2022. On 01Oct2022 rebound COVID 19 symptoms 5 days after completing paxlovid.   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 events and the suspect drug BNT162B2 cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 49 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025J20A), on 04Feb2021 as dose 2, single (Lot number: 016M20A) and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "insomnia" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; SUVOREXANT; VITAMIN D3; RYBELSUS; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Nov2021, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" 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 vaccination failure, covid-19.  Clinical information: Patient received other medication in two weeks. Patient received anti viral treatment for COVID 19 with Paxlovid from 19Sep2022 till 24Sep2022. Patient taken multivitamin as concomitant. There were no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: MOD22-025425 (Moderna).  A male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 12Oct2021 as dose 3 (booster), single (Lot number: EW0186) for COVID-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing); "Digestion" (unspecified if ongoing). Concomitant medications included: LOSARTAN taken for blood pressure; SIMVASTATIN taken for cholesterol; SERTRALINE taken for antidepressant; OMEPRAZOLE taken for digestion; VITAMIN D3. Vaccination history included: BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Lot number: EN6201), administration date: 10Feb2021, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Manufacturer: Pfizer, Lot number: EN6198), administration date: 03Mar2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "mild headache".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200076049 same patient/event, different dose number;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: right leg lymphedema; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot: EL9264), administration date: 17Feb2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot: EN6205), administration date: 17Mar2021, when the patient was 73-year-old, for COVID-19 immunization. The following information was reported: LYMPHOEDEMA (non-serious) with onset Mar2022, outcome "recovering", described as "right leg lymphedema". Therapeutic measures were taken as a result of lymphoedema. Additional information: patient does not see NDC/EXP on the vaccine card, the booster information was handwritten on the bottom which he got that at (specialty pharmacy name) (name withheld), there are also two unknown codes A53 and L2. Treatment for the lymphedema has been massage treatment and using a compression stocking, thigh high, on his right leg lymphedema. The lymphedema has gotten better. He has worn the compression stocking on his right leg continuously since the stockings were received in April, he has been using it daily.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Lot number: ER8729) at the age of 34 years, in right arm 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 11Sep2022 to 16Sep2022. Clinical course: The patient had no known allergies.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: chills; felt so bad so went back to bed all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hip problem" (unspecified if ongoing), notes: hip problem before the Pfizer covid vaccines/ hip problem the last few years. The patient's concomitant medications were not reported. Past drug history included: Cortisone for hip problem. The following information was reported: CHILLS (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt so bad so went back to bed all day". Additional information: 1st vaccine, patient had chills and got up in the morning and the chills were so bad she was going to take a shower and could not take a shower because she just had felt so bad so went back to bed all day (as reported). Family Medical History Relevant to AE(s): None.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel good with the 2nd covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Lot number: EN6198) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hip problem" (ongoing), notes: hip problem had two prior cortisone shots and hip problem was before the Pfizer covid vaccines. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL926), administration date: 29Jan2021, when the patient was 75-year-old, for Covid-19 Immunization, reaction(s): "Chills", "she just had felt so bad so went back to bed all day". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "did not feel good with the 2nd covid vaccine".  Additional information: Hip problem was not something that just started recently. She also got a shot of cortisone and another shot and does not know if that one was cortisone also because she went to a different doctor and they gave her a shot that appeared to be like cortisone and she went to facility the second time and they gave her a shot and she was not sure if it was cortisone or hydronic and has no name for the shot. Had no lots, expiry dates or NDC numbers for the cortisone shot or the other shot she does not know the name of and states the cortisone shot did not work.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201203569 same reporter/patient/product, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Body surface area, Erythrodermic psoriasis, Hepatitis C virus test, Psoriasis
Clinical narrative: erythrodermic psoriasis; Acute exacerbation of psoriasis after COVID-19 Pfizer vaccination;  This is a literature report for the following literature source(s): A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 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 (DOSE 1, Single), for covid-19 immunisation. The following information was reported: ERYTHRODERMIC PSORIASIS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering"; PSORIASIS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "Acute exacerbation of psoriasis after COVID-19 Pfizer vaccination". The patient underwent the following laboratory tests and procedures: Body surface area: greater than 80; Hepatitis C virus test: Positive. Therapeutic measures were taken as a result of erythrodermic psoriasis, psoriasis. Sender's Comments: Based on the available information in the case, the causal association between the events erythrodermic psoriasis, psoriasis and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
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 a non-contactable reporter(s) (Pharmacist).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 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 and concomitant medications were not reported. The patient tested positive in Covid-19 test on an unspecified date and received oral PAXLOVID as COVID 19 treatment from 13Sep2022 to 18Sep2022. The patient was initially treated on 13Sep2022 x 5 days and then tested negative on 18Sep2022. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: gj5342) at the age of 73 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), 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 was not reported. Concomitant medication(s) included: ELIQUIS, start date: Sep2021; TAMSULOSIN, start date: Jun2022; FINASTERIDE, start date: Jun2022; METOPROLOL, start date: Sep2021. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" 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. Additional information: The patient received Paxlovid as treatment from 23Sep2022 to 27Sep2022.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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), on 29Dec2020 as dose 1, single (Lot number: Eh9899), in right arm, on 19Jan2021 as dose 2, single (Lot number: EL1283), in right arm and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Valley Fever" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive, notes: COVID 19 Treatment; (01Oct2022) Negative; (04Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient was given Paxlovid as treatment on 23Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
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 contactable reporter(s) (Consumer or other non HCP).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes a Pfizer brand Covid-19 treatment from 01Oct2022 to unspecified date in Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Cluster headache, Fatigue, Feeling abnormal, Headache
Clinical narrative: My head feels foggy more than headachy; My head feels foggy more than headachy; intermittent tiredness/fatigue; had heaviness in my legs over the weekend; Feels weird. Her head feels weird; stuffiness and maybe some sinus issues; cluster headaches; 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 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 11:50 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bladder infection" (unspecified if ongoing); "hand issue" (unspecified if ongoing), notes: she was having hand issues( "unrelated to the vaccine, from a previous hand issue"). The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Inflammation", notes: Pharmacist told her she could take some Meloxicam for inflammation prior to taking the vaccine. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "Feels weird. Her head feels weird"; HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 2022, outcome "unknown" and all described as "My head feels foggy more than headachy"; CLUSTER HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "cluster headaches"; LIMB DISCOMFORT (non-serious) with onset 2022, outcome "recovered" (2022), described as "had heaviness in my legs over the weekend"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "intermittent tiredness/fatigue"; NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "stuffiness and maybe some sinus issues". Relevant laboratory tests and procedures are available in the appropriate section. 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
Symptoms: Limb discomfort, Nasal congestion
Clinical narrative: My head feels foggy more than headachy; My head feels foggy more than headachy; intermittent tiredness/fatigue; had heaviness in my legs over the weekend; Feels weird. Her head feels weird; stuffiness and maybe some sinus issues; cluster headaches; 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 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 11:50 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bladder infection" (unspecified if ongoing); "hand issue" (unspecified if ongoing), notes: she was having hand issues( "unrelated to the vaccine, from a previous hand issue"). The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Inflammation", notes: Pharmacist told her she could take some Meloxicam for inflammation prior to taking the vaccine. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "Feels weird. Her head feels weird"; HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 2022, outcome "unknown" and all described as "My head feels foggy more than headachy"; CLUSTER HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "cluster headaches"; LIMB DISCOMFORT (non-serious) with onset 2022, outcome "recovered" (2022), described as "had heaviness in my legs over the weekend"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "intermittent tiredness/fatigue"; NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "stuffiness and maybe some sinus issues". Relevant laboratory tests and procedures are available in the appropriate section. 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: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm 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), outcome "not recovered" and all described as "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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Neutrophil count, Neutrophil count decreased, White blood cell count, White blood cell count decreased
Clinical narrative: white blood count has dropped/white blood count was down/WBC were 2.5; Neutrophils were 1.0; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 82-year-old female patient received palbociclib (IBRANCE), at 100 mg; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. 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; Covid-19 vaccine (dose 3; manufacturer unknown), for Covid-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "white blood count has dropped/white blood count was down/WBC were 2.5"; NEUTROPHIL COUNT DECREASED (non-serious), outcome "unknown", described as "Neutrophils were 1.0". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for palbociclib was unknown.  Additional information: The patient stated that her white blood count has dropped since taking Ibrance and she got her Pfizer booster week ago and she was asking if that could possibly have caused it to drop. Her white blood count has dropped a little. She did get the booster with variant 2 weeks ago and wondered if that could also drop her white count. Her white count was a little low today but, doctor said he was going to retake blood count Friday and it might be back up by then and wondered if it was from taking the Ibrance drug. Patient just reordered the Ibrance and didn't think it would be a problem with taking the Ibrance. Patient was off this week from the Ibrance.  All of a sudden, it came to her mind that she had that booster. She clarified that she does have the exact name of the booster, just that it is the Pfizer booster with variant. She stated this might not have anything to do with the Ibrance. She went to get blood work today and her blood count was a little low, her WBC were 2.5 and her Neutrophils were 1.0, and the normal range is 1.8 to 7.7.  She forgot to mention to her oncologist that she had the booster two weeks ago. She was curious to see if the vaccine could lower her white blood cell counts. She was having her blood retested on Friday. She was wondering if the Pfizer Covid booster could be causing her white blood cell counts to be dropping and not the Ibrance. She has been on Ibrance since May (year unspecified) and its been very successful.  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: 32.0
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 a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: testing negative and finishing Paxlovid anti-viral pills. 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore right arm; slight fever; slight fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 50 years, in right arm for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM; ATORVASTATIN; LUNESTA; ALLEGRA 12 HOUR; PRILOSEC [OMEPRAZOLE]. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FH8030, Location of injection: Arm Right), administration date: 30Nov2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 49-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 49-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Sore right arm"; FATIGUE (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "slight fatigue"; PYREXIA (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "slight fever". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, fatigue.  Additional information: The patient did not have COVID-19 prior to vaccination, and was not tested for COVID-19 post-vaccination. No other vaccine was received in four weeks. The patient was also taking multivitamins in two weeks.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Approximately 1 week after getting BV vaccine, all long COVID symptoms disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Aug2021 (unspecified if ongoing), notes: If COVID prior vaccination: Yes, long term covid symptoms, including fatigue, brain fog.; "COVID-19" (unspecified if ongoing), notes: long term covid symptoms, including fatigue, brain fog. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Single , Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Single , Manufacturer unknown), for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Sep2022, outcome "unknown", described as "Approximately 1 week after getting BV vaccine, all long COVID symptoms disappeared". Therapeutic measures were not taken as a result of therapeutic response unexpected.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID yesterday; tested positive for COVID yesterday; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 42-year-old 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022, outcome "unknown" and all described as "tested positive for COVID yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: She (reporter) and her husband both tested positive for COVID yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: she (reporter) and her husband (patient) both tested positive for COVID yesterday and were both prescribed Paxlovid at their request but haven't started taking it yet. They were triple vaccinated with the Pfizer COVID19 vaccines and have had COVID 4 or 5 times in between their vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204632 same reporter/vaccine/event, different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Inflammation, SARS-CoV-2 test
Clinical narrative: tested positive for COVID yesterday; tested positive for COVID yesterday; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 42-year-old 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022, outcome "unknown" and all described as "tested positive for COVID yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: She (reporter) and her husband both tested positive for COVID yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: she (reporter) and her husband (patient) both tested positive for COVID yesterday and were both prescribed Paxlovid at their request but haven't started taking it yet. They were triple vaccinated with the Pfizer COVID19 vaccines and have had COVID 4 or 5 times in between their vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201204632 same reporter/vaccine/event, different patient;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis
Clinical narrative: hot flashes; excessive sweating; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 2, Batch/Lot No: EW0170), administration date: 20Apr2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (dose 1, Batch/Lot No: ER8732), administration date: 30Mar2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 26Feb2022, outcome "recovered" (2022), described as "excessive sweating"; HOT FLUSH (non-serious) with onset 26Feb2022, outcome "recovered" (2022), described as "hot flashes". Therapeutic measures were not taken as a result of hot flush, hyperhidrosis.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Myalgia, Pain in extremity
Clinical narrative: had pain in my left arm; The pain feels like a knife in my shoulder joint; arm muscle is painful; arm muscle is painful at night and keeps me awake.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Bladder leakage" (unspecified if ongoing), notes: Bladder leakage; "Known allergies: IVP dye" (unspecified if ongoing), notes: Known allergies: IVP dye. The patient's concomitant medications were not reported. Past drug history included: Known allergies: doxycycline, reaction(s): "Known allergies: doxycycline". 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: ARTHRALGIA (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "The pain feels like a knife in my shoulder joint"; MYALGIA (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "arm muscle is painful"; INSOMNIA (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "arm muscle is painful at night and keeps me awake."; PAIN IN EXTREMITY (non-serious) with onset 27Jun2022 at 11:00, outcome "not recovered", described as "had pain in my left arm". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, myalgia, insomnia. Additional information: The patient did not have COVID prior to vaccination and not tested for COVID post vaccination. The patient received her 4th COVID vaccine dose (Pfizer) on 04Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Right arm very sore; Overall aches/sore; Slight headache; Slight fatigue; Slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in right arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IUD NOS; IVERMECTIN; NEXIUM 1-2-3; B12 [CYANOCOBALAMIN]; COLLAGEN; TURMERIC [CURCUMA LONGA]; OMEGA 100; ALLEGRA 12 HOUR. Vaccination history included: pfizer/biontech (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Right), administration date: 15Dec2021, for COVID-19 immunization; pfizer/biontech (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 30Mar2021, for COVID-19 immunization; pfizer/biontech (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 09Mar2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Overall aches/sore"; PAIN IN EXTREMITY (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Right arm very sore"; FATIGUE (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Slight fatigue"; PYREXIA (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Slight fever"; HEADACHE (non-serious) with onset 04Oct2022 at 08:30, outcome "not recovered", described as "Slight headache". Therapeutic measures were not taken as a result of pain in extremity, pain, headache, fatigue, pyrexia.  Additional information: Report was non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the following other medications within 2 weeks of vaccination: IUD, Ivermectin cream (rosacea), Nexium, Allegra, Probiotic, B12, Collagen, Turmeric, Omega. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 21Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 58 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 10 days before I was diagnosed with COVID I had the new bivalent booster dose and I still got COVID; 10 days before I was diagnosed with COVID I had the new bivalent booster dose and I still got COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "10 days before I was diagnosed with COVID I had the new bivalent booster dose and I still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Feb2022 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: No known allergies. COVID 19 Treatment was Paxlovid from 20Sep2022 to 25Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. 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.
Sex: F
Vaccine: COVID19, COVID19
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster) , single, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies: Red Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have other medications in 2 weeks. The patient was treated with Paxlovid from 19Sep2022 to 24Sep2022. It was reported that the patient was healthy.
Sex: M
Vaccine: COVID19, COVID19
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).  A 46-year-old male patient 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 had no relevant medical history. There were no concomitant medications. 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; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: it was reported that patient had return of symptoms 7 days after last dose of Paxlovid. Rapid test showed positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3, (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FENOFIBRATE, start date: 01Apr2020, stop date: 04Oct2022; AMLODIPINE BESILATE, start date: 01Jan2019, stop date: 04Oct2022; DICLOFENAC, start date: 01Apr2018, stop date: 04Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid from 23Sep2022 to 27Sep2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.