chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Cough, Fatigue, Headache, Rhinorrhoea, Sinus congestion
Clinical narrative: runny nose; coughing; My sinuses are blocked and I blow my nose a lot; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), COUGH (coughing), SINUS CONGESTION (My sinuses are blocked and I blow my nose a lot), HEADACHE (headache) and FATIGUE (fatigue) in a 35-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced RHINORRHOEA (runny nose), COUGH (coughing), SINUS CONGESTION (My sinuses are blocked and I blow my nose a lot), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, RHINORRHOEA (runny nose), COUGH (coughing), SINUS CONGESTION (My sinuses are blocked and I blow my nose a lot), HEADACHE (headache) and FATIGUE (fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment were not provided.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Every day I just noticed like new spots and they're very itchy; Broke out in a diffused Rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Every day I just noticed like new spots and they're very itchy) and RASH (Broke out in a diffused Rash) in a 35-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer (The last dose she received was Moderna everything else was Pfizer and 1st dose was in 2020 or 2021.). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 21-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 21-Oct-2023, the patient experienced PRURITUS (Every day I just noticed like new spots and they're very itchy) and RASH (Broke out in a diffused Rash). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL DM) at a dose of 2 dosage form once a day. At the time of the report, PRURITUS (Every day I just noticed like new spots and they're very itchy) and RASH (Broke out in a diffused Rash) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient was taking concomitant Synthroid for 20 years. Patient received the Spikevax vaccine which was fourth or fifth dose and a couple of hours later broke out in a diffused Rash. The patient noticed that the rash was more like all the ankle and wrist. For the first actually sign was like the wrist of the arm, where the vaccine was given and then noticed it in ankles. Every day new spots were noticed and they're very itchy. The last dose was Moderna everything else was Pfizer, the patient received 1st dose in 2020 or 2021.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller also reported that her husband who also got the Spikevax same day as she did. 19Oct2023 only had a little sore arm from the injection.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Caller also reported that her husband who also got the Spikevax same day as she did. 19Oct2023 only had a little sore arm from the injection.) in an 85-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: RSV (14 -15 days before the Spikevax) in October 2023 and flu vaccine (14 -15 days before the Spikevax) in October 2023. Past adverse reactions to the above products included No adverse event with RSV and flu vaccine.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (Caller also reported that her husband who also got the Spikevax same day as she did. 19Oct2023 only had a little sore arm from the injection.). In October 2023, PAIN IN EXTREMITY (Caller also reported that her husband who also got the Spikevax same day as she did. 19Oct2023 only had a little sore arm from the injection.) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Dehydration, Ear pain, Fatigue, Feeling hot
Clinical narrative: no appetite; ill; earache; high blood pressure; dehydrated; No fever, but felt very warm; headache; rash; nausea; fatigue; body aches; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure) and DEHYDRATION (dehydrated) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccines (Dose 1) on 29-Mar-2021, Moderna COVID-19 vaccines (Dose 2) on 26-Apr-2021 and Moderna COVID-19 vaccines (Dose 3) on 28-Dec-2021; for Product used for unknown indication: Flu vaccine (3 weeks prior). Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna COVID-19 vaccines, Moderna COVID-19 vaccines and Moderna COVID-19 vaccines.    On 18-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), DEHYDRATION (dehydrated), FEELING HOT (No fever, but felt very warm), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) had not resolved and DEHYDRATION (dehydrated) and FEELING HOT (No fever, but felt very warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Blood pressure measurement: 165.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that she saw her doctor on 20-Oct-2023 and started taking blood pressure medication.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Hypertension, Malaise, Nausea, No reaction on previous exposure to drug, Pain
Clinical narrative: no appetite; ill; earache; high blood pressure; dehydrated; No fever, but felt very warm; headache; rash; nausea; fatigue; body aches; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure) and DEHYDRATION (dehydrated) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccines (Dose 1) on 29-Mar-2021, Moderna COVID-19 vaccines (Dose 2) on 26-Apr-2021 and Moderna COVID-19 vaccines (Dose 3) on 28-Dec-2021; for Product used for unknown indication: Flu vaccine (3 weeks prior). Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna COVID-19 vaccines, Moderna COVID-19 vaccines and Moderna COVID-19 vaccines.    On 18-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), DEHYDRATION (dehydrated), FEELING HOT (No fever, but felt very warm), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) had not resolved and DEHYDRATION (dehydrated) and FEELING HOT (No fever, but felt very warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Blood pressure measurement: 165.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that she saw her doctor on 20-Oct-2023 and started taking blood pressure medication.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: no appetite; ill; earache; high blood pressure; dehydrated; No fever, but felt very warm; headache; rash; nausea; fatigue; body aches; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure) and DEHYDRATION (dehydrated) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccines (Dose 1) on 29-Mar-2021, Moderna COVID-19 vaccines (Dose 2) on 26-Apr-2021 and Moderna COVID-19 vaccines (Dose 3) on 28-Dec-2021; for Product used for unknown indication: Flu vaccine (3 weeks prior). Past adverse reactions to the above products included No adverse event with Flu vaccine, Moderna COVID-19 vaccines, Moderna COVID-19 vaccines and Moderna COVID-19 vaccines.    On 18-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Oct-2023, the patient experienced DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), DEHYDRATION (dehydrated), FEELING HOT (No fever, but felt very warm), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, DECREASED APPETITE (no appetite), MALAISE (ill), EAR PAIN (earache), HYPERTENSION (high blood pressure), HEADACHE (headache), RASH (rash), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) had not resolved and DEHYDRATION (dehydrated) and FEELING HOT (No fever, but felt very warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2023, Blood pressure measurement: 165.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that she saw her doctor on 20-Oct-2023 and started taking blood pressure medication.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right 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 included: "Throat cancer" (unspecified if ongoing). The patient's concomitant medications were not= reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023- 2024 FORMULA)), on 25Sep2023 at 18:30 as dose 2, single (Lot number: HG4629) at the age of 66 years, in left arm for covid-19 immunisation; for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 1, single (Lot number: GJ3275), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Aspartate aminotransferase, Blood creatinine, Bronchoalveolar lavage
Clinical narrative: testing positive for COVID/ COVID-19; testing positive for COVID/ COVID-19; diffuse alveolar hemorrhage/ DAH secondary to COVID-19; Microscopic polyangiitis/ pulmonary-limited MPA following a COVID-19 infection/ diagnosis of MPA; This is a literature report.  Here, authors describe a rare case of diffuse alveolar hemorrhage secondary to pulmonary-limited microscopic polyangiitis (MPA) following a COVID-19 infection. A 47-year-old female with medical history of hypertension, fully vaccinated for COVID-19 presented with shortness of breath, cough, fever and hemoptysis. Patient reported that she developed hemoptysis several days after testing positive for COVID. Upon arrival, patient was found to be severely hypoxic with SpO2 60% on room air, improved to SpO2 98% on 2L O2. COVID-19 PCR was positive. Labs were notable for Hgb 7.1 g/dL, PLT 101 K/mcL, Cr 1.15 mg/dL, AST 40 units/L, ALT 35 units/L, CRP 179.2 mg/L and procalcitonin 0.20 ng/mL. Chest imaging showed bilateral diffuse reticulated ground glass opacities, with no pulmonary embolism. Patient was initiated on Decadron 6mg daily dose with Remdesivir for COVID-19 as well as intravenous piperacillin/tazobactam for possible superimposed pneumonia. However, due to worsening pulmonary infiltrates with no significant improvement in hypoxia and hemoptysis, bronchoscopy was performed which demonstrated sequential bloodier aliquots of saline on serial bronchoalveolar lavages (BAL) consistent with diffuse alveolar hemorrhage (DAH). All cultures from BAL were negative. Patient was started on pulse-dose methylprednisolone 1g daily for 3 days with taper pending clinical improvement and vasculitis work up. Patient's ANCA antibodies returned highly positive in perinuclear pattern with MPO antigen positivity, most consistent with diagnosis of MPA. Patient was started on Rituximab immunosuppressive therapy and was discharged home on Prednisone with rapid clinical improvement. DAH secondary to COVID-19 can be an early sign of underlying autoimmune vasculitides and should prompt evaluation for potential rheumatologic disorders.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug bnt162b2 and event, Pulmonary alveolar hemorrhage cannot be excluded. Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug, and the events Covid 19, vaccination failure 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: F
Vaccine: COVID19
Symptoms: C-reactive protein, COVID-19, Chest X-ray, Haemoglobin, Microscopic polyangiitis
Clinical narrative: testing positive for COVID/ COVID-19; testing positive for COVID/ COVID-19; diffuse alveolar hemorrhage/ DAH secondary to COVID-19; Microscopic polyangiitis/ pulmonary-limited MPA following a COVID-19 infection/ diagnosis of MPA; This is a literature report.  Here, authors describe a rare case of diffuse alveolar hemorrhage secondary to pulmonary-limited microscopic polyangiitis (MPA) following a COVID-19 infection. A 47-year-old female with medical history of hypertension, fully vaccinated for COVID-19 presented with shortness of breath, cough, fever and hemoptysis. Patient reported that she developed hemoptysis several days after testing positive for COVID. Upon arrival, patient was found to be severely hypoxic with SpO2 60% on room air, improved to SpO2 98% on 2L O2. COVID-19 PCR was positive. Labs were notable for Hgb 7.1 g/dL, PLT 101 K/mcL, Cr 1.15 mg/dL, AST 40 units/L, ALT 35 units/L, CRP 179.2 mg/L and procalcitonin 0.20 ng/mL. Chest imaging showed bilateral diffuse reticulated ground glass opacities, with no pulmonary embolism. Patient was initiated on Decadron 6mg daily dose with Remdesivir for COVID-19 as well as intravenous piperacillin/tazobactam for possible superimposed pneumonia. However, due to worsening pulmonary infiltrates with no significant improvement in hypoxia and hemoptysis, bronchoscopy was performed which demonstrated sequential bloodier aliquots of saline on serial bronchoalveolar lavages (BAL) consistent with diffuse alveolar hemorrhage (DAH). All cultures from BAL were negative. Patient was started on pulse-dose methylprednisolone 1g daily for 3 days with taper pending clinical improvement and vasculitis work up. Patient's ANCA antibodies returned highly positive in perinuclear pattern with MPO antigen positivity, most consistent with diagnosis of MPA. Patient was started on Rituximab immunosuppressive therapy and was discharged home on Prednisone with rapid clinical improvement. DAH secondary to COVID-19 can be an early sign of underlying autoimmune vasculitides and should prompt evaluation for potential rheumatologic disorders.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug bnt162b2 and event, Pulmonary alveolar hemorrhage cannot be excluded. Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug, and the events Covid 19, vaccination failure 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: F
Vaccine: COVID19
Symptoms: Platelet count, Procalcitonin, Pulmonary alveolar haemorrhage, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive for COVID/ COVID-19; testing positive for COVID/ COVID-19; diffuse alveolar hemorrhage/ DAH secondary to COVID-19; Microscopic polyangiitis/ pulmonary-limited MPA following a COVID-19 infection/ diagnosis of MPA; This is a literature report.  Here, authors describe a rare case of diffuse alveolar hemorrhage secondary to pulmonary-limited microscopic polyangiitis (MPA) following a COVID-19 infection. A 47-year-old female with medical history of hypertension, fully vaccinated for COVID-19 presented with shortness of breath, cough, fever and hemoptysis. Patient reported that she developed hemoptysis several days after testing positive for COVID. Upon arrival, patient was found to be severely hypoxic with SpO2 60% on room air, improved to SpO2 98% on 2L O2. COVID-19 PCR was positive. Labs were notable for Hgb 7.1 g/dL, PLT 101 K/mcL, Cr 1.15 mg/dL, AST 40 units/L, ALT 35 units/L, CRP 179.2 mg/L and procalcitonin 0.20 ng/mL. Chest imaging showed bilateral diffuse reticulated ground glass opacities, with no pulmonary embolism. Patient was initiated on Decadron 6mg daily dose with Remdesivir for COVID-19 as well as intravenous piperacillin/tazobactam for possible superimposed pneumonia. However, due to worsening pulmonary infiltrates with no significant improvement in hypoxia and hemoptysis, bronchoscopy was performed which demonstrated sequential bloodier aliquots of saline on serial bronchoalveolar lavages (BAL) consistent with diffuse alveolar hemorrhage (DAH). All cultures from BAL were negative. Patient was started on pulse-dose methylprednisolone 1g daily for 3 days with taper pending clinical improvement and vasculitis work up. Patient's ANCA antibodies returned highly positive in perinuclear pattern with MPO antigen positivity, most consistent with diagnosis of MPA. Patient was started on Rituximab immunosuppressive therapy and was discharged home on Prednisone with rapid clinical improvement. DAH secondary to COVID-19 can be an early sign of underlying autoimmune vasculitides and should prompt evaluation for potential rheumatologic disorders.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug bnt162b2 and event, Pulmonary alveolar hemorrhage cannot be excluded. Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug, and the events Covid 19, vaccination failure 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: F
Vaccine: COVID19
Symptoms: Insomnia, Pain
Clinical narrative: she had the same reactions as I did / side pain all over my body; she had the same reactions as I did / she had the same reactions as I did / could not sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: HG4664), in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset Oct2023, outcome "recovering", described as "she had the same reactions as I did / she had the same reactions as I did / could not sleep"; PAIN (non-serious) with onset Oct2023, outcome "recovering", described as "she had the same reactions as I did / side pain all over my body". Therapeutic measures were not taken as a result of pain, insomnia.  Additional information: On Wednesday, patient and reporter received the vaccine for the COVID-19 the name of these vaccines it is a Comirnaty, new one they just released one month ago. Reporter stated that patient also had same reactions as he did but she was feeling better now. Patient did not received other vaccine administered on the same date.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336340 Same reporter/vaccine/event, different patient;
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 22Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Known allergies:Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), administration date: 21Apr2023, when the patient was 70-year-old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as COVID 19 Treatment from 13Oct2023 till 18Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 "Treatment of COVID-19". 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
Symptoms: Haematuria
Clinical narrative: Patient urinating blood; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HAEMATURIA (non-serious) with onset 23Oct2023 at 07:00, outcome "unknown", described as "Patient urinating blood". The event "patient urinating blood" required physician office visit. It was unknown if therapeutic measures were taken as a result of haematuria.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: broke out in a red rash, not terrible, it is about 2 inches or like 3 inches and it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "not recovered", described as "broke out in a red rash, not terrible, it is about 2 inches or like 3 inches and it itches". Additional information: Consumer stated, "I am 79 years old and I got the RSV Shot (As consumer was not sure about the name) last Saturday, so it is been a week, and I broke out in a red rash, not terrible, it is about 2 inches or like 3 inches and it itches and that is not going away." The consumer does not know what shot they used. When paraphrased, patient broke out with a rash the very next day, that is not terrible. Patient was not sure if it is a side effect and wanted to know if it was normal.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: nausea; Fever; chills; sweating; muscle pain; joint pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "muscle pain"; NAUSEA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "sweating". Therapeutic measures were not taken as a result of nausea, pyrexia, chills, hyperhidrosis, myalgia, arthralgia.  Additional information: Fever, chills, sweating, muscle pain, joint pain, nausea were still ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pyrexia
Clinical narrative: nausea; Fever; chills; sweating; muscle pain; joint pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 14:30 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "muscle pain"; NAUSEA (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 20Oct2023 at 16:30, outcome "not recovered", described as "sweating". Therapeutic measures were not taken as a result of nausea, pyrexia, chills, hyperhidrosis, myalgia, arthralgia.  Additional information: Fever, chills, sweating, muscle pain, joint pain, nausea were still ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Malaise, Pain in extremity
Clinical narrative: tested positive; tested positive; she did not feel well the next day; she got so sick but it only lasted 1 day; she had pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, 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), for COVID-19 immunization; Bnt162b2 (dose 2, single), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), single), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (dose 4 (booster), single), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 12Oct2023, outcome "unknown", described as "she did not feel well the next day"; ILLNESS (non-serious) with onset Oct2023, outcome "recovered" (Oct2023), described as "she got so sick but it only lasted 1 day"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "she had pain in the arm"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Positive, notes: she felt horrible and she tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: On 11Oct2023, patient got her 5th COVID vaccine called Comirnaty. She stated she only got Pfizer vaccines. Patient did not feel well the next day, reporter stated she got so sick but it only lasted 1 day. Aside from that she had pain in the arm. Reported stated on that Monday morning, she felt horrible and she tested positive. Her doctor ordered Paxlovid and her symptoms irradiated. Reporter stated this was her first time getting COVID. Reporter wanted to know if the vaccine caused her to test positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; she did not feel well the next day; she got so sick but it only lasted 1 day; she had pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, 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), for COVID-19 immunization; Bnt162b2 (dose 2, single), for COVID-19 immunization; Bnt162b2 (dose 3 (booster), single), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (dose 4 (booster), single), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 12Oct2023, outcome "unknown", described as "she did not feel well the next day"; ILLNESS (non-serious) with onset Oct2023, outcome "recovered" (Oct2023), described as "she got so sick but it only lasted 1 day"; PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "she had pain in the arm"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Positive, notes: she felt horrible and she tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: On 11Oct2023, patient got her 5th COVID vaccine called Comirnaty. She stated she only got Pfizer vaccines. Patient did not feel well the next day, reporter stated she got so sick but it only lasted 1 day. Aside from that she had pain in the arm. Reported stated on that Monday morning, she felt horrible and she tested positive. Her doctor ordered Paxlovid and her symptoms irradiated. Reporter stated this was her first time getting COVID. Reporter wanted to know if the vaccine caused her to test positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain; slight swelling; redness; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "nodules on lung and thyroid" (unspecified if ongoing); "nodules on lung and thyroid" (unspecified if ongoing); "high BP" (unspecified if ongoing); "GAD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "migraines" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "sleep disorder" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "anemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "OSA" (unspecified if ongoing); "OSFED" (unspecified if ongoing); "OSFED" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: prior vaccination; "Known allergies: shellfish" (unspecified if ongoing); "Known allergies: IV contrast dye" (unspecified if ongoing); "Known allergies: sensitive to gluten and iodine" (unspecified if ongoing), notes: Known allergies: sensitive to gluten and iodine. Concomitant medications included: SERTRALINE; OMEPRAZOLE; VYVANSE; WELLBUTRIN XL. Past drug history included: Iodine, reaction(s): "Known allergies: sensitive to iodine". 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; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 20Oct2023 at 22:00, outcome "not recovered"; ERYTHEMA (non-serious) with onset 20Oct2023 at 22:00, outcome "not recovered", described as "redness"; SWELLING (non-serious) with onset 20Oct2023 at 22:00, outcome "not recovered", described as "slight swelling". The events "pain", "slight swelling" and "redness" required physician office visit. Therapeutic measures were not taken as a result of pain, swelling, erythema.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: 3 days of fever; extensive body aches; fatigue; injection site swelling and soreness; injection site swelling and soreness; redness- size of a lemon. Redness lasted 7 days; could not lift arm w/o discomfort for 7 days; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 12Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Dtap (although DTap Booster in Aug2013 had adverse effect, as if my brain was on LSD. Filed a CDC report at that time. Will NOT get another.), administration date: Aug2013, for immunization, reaction(s): "brain was on LSD". The following information was reported: PYREXIA (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "3 days of fever"; LIMB DISCOMFORT (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "could not lift arm w/o discomfort for 7 days"; PAIN (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "extensive body aches"; FATIGUE (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023); VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023) and all described as "injection site swelling and soreness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "redness- size of a lemon. Redness lasted 7 days". Therapeutic measures were not taken as a result of pyrexia, pain, fatigue, vaccination site pain, vaccination site swelling, vaccination site erythema, limb discomfort. Additional information: The patient had no known allergies. Vaccine was administered at doctor's office/urgent care. The redness lasted 7 days, soreness too, and could not lift arm w/o discomfort for 7 days. As reported, the patient recovered with lasting effects for all events.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pyrexia
Clinical narrative: 3 days of fever; extensive body aches; fatigue; injection site swelling and soreness; injection site swelling and soreness; redness- size of a lemon. Redness lasted 7 days; could not lift arm w/o discomfort for 7 days; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 12Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Dtap (although DTap Booster in Aug2013 had adverse effect, as if my brain was on LSD. Filed a CDC report at that time. Will NOT get another.), administration date: Aug2013, for immunization, reaction(s): "brain was on LSD". The following information was reported: PYREXIA (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "3 days of fever"; LIMB DISCOMFORT (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "could not lift arm w/o discomfort for 7 days"; PAIN (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "extensive body aches"; FATIGUE (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023); VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023) and all described as "injection site swelling and soreness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 12Oct2023 at 18:00, outcome "recovered with sequelae" (23Oct2023), described as "redness- size of a lemon. Redness lasted 7 days". Therapeutic measures were not taken as a result of pyrexia, pain, fatigue, vaccination site pain, vaccination site swelling, vaccination site erythema, limb discomfort. Additional information: The patient had no known allergies. Vaccine was administered at doctor's office/urgent care. The redness lasted 7 days, soreness too, and could not lift arm w/o discomfort for 7 days. As reported, the patient recovered with lasting effects for all events.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 66.0
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) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), 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 covid-19, drug ineffective included Paxlovid form 11Oct2023 to 15Oct2023   The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.