chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: PNC20, PPV
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Vaccination site induration, Vaccination site swelling
Clinical narrative: injection site pain (rigth bicep); injection site swelling; Injection site hard up to his right shoulder; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; right arms feels weak; it has a fever and sometimes gets really intense; experiencing serious pain his right shoulder; This spontaneous report was received from Consumer and refers to a 70-year-old male. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 18-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in the right bicep for prophylaxis (dose, route of administration, vaccination scheme frequency, lot number, and expiration date were not reported). The vaccination site was fine on that date.  On 19-OCT-2022 (also reported as next day), he experienced injection site swelling (vaccination site swelling), his right arm felt weak (muscular weakness), and he presented serious pain in his right bicep (vaccination site pain) and right shoulder (arthralgia). On that date, the patient also presented burning pain and a muscle sprain, it felt like it had been hit with a 2x4 (pain, ligament sprain, malaise). By that time, the vaccination site did not turn red, or nothing just turned hard up to his right shoulder (vaccination site induration). On unspecified dates in 2022, the patient's shoulder still was really in pain and the vaccination site seemed to be dissipating but the shoulder had not, he also experienced a fever that sometimes got really intense. As a self-treatment for the events, the patient had been putting lidocaine 4% (ASPERCREME) Patch XL and "Maximum Strength Lidocaine pain relief" patch 4% on his arm (covering around the vaccination site); nevertheless, they did not work. Later, the patient tried using roll-on lidocaine and icy hot therapy since he could not afford to keep buying those lidocaine patches.   At the time of reporting, the patient had not recovered from the events of vaccination site induration, pain, ligament sprain, malaise, weakness of arms, and was recovering from vaccination site pain; the outcome of the events of vaccination site swelling, arthralgia, and fever was not known. The causal relationship between the events and the suspect vaccine was not provided.
Age: 70.0
Sex: M
Vaccine: PNC20, PPV
Symptoms: Arthralgia, Injection site induration, Injection site pain, Injection site swelling, Muscle strain
Clinical narrative: injection site pain (rigth bicep); injection site swelling; Injection site hard up to his right shoulder; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; right arms feels weak; it has a fever and sometimes gets really intense; experiencing serious pain his right shoulder; This spontaneous report was received from Consumer and refers to a 70-year-old male. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 18-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in the right bicep for prophylaxis (dose, route of administration, vaccination scheme frequency, lot number, and expiration date were not reported). The vaccination site was fine on that date.  On 19-OCT-2022 (also reported as next day), he experienced injection site swelling (vaccination site swelling), his right arm felt weak (muscular weakness), and he presented serious pain in his right bicep (vaccination site pain) and right shoulder (arthralgia). On that date, the patient also presented burning pain and a muscle sprain, it felt like it had been hit with a 2x4 (pain, ligament sprain, malaise). By that time, the vaccination site did not turn red, or nothing just turned hard up to his right shoulder (vaccination site induration). On unspecified dates in 2022, the patient's shoulder still was really in pain and the vaccination site seemed to be dissipating but the shoulder had not, he also experienced a fever that sometimes got really intense. As a self-treatment for the events, the patient had been putting lidocaine 4% (ASPERCREME) Patch XL and "Maximum Strength Lidocaine pain relief" patch 4% on his arm (covering around the vaccination site); nevertheless, they did not work. Later, the patient tried using roll-on lidocaine and icy hot therapy since he could not afford to keep buying those lidocaine patches.   At the time of reporting, the patient had not recovered from the events of vaccination site induration, pain, ligament sprain, malaise, weakness of arms, and was recovering from vaccination site pain; the outcome of the events of vaccination site swelling, arthralgia, and fever was not known. The causal relationship between the events and the suspect vaccine was not provided.
Age: 70.0
Sex: M
Vaccine: PNC20, PPV
Symptoms: Muscular weakness, Pain, Product administered at inappropriate site, Pyrexia
Clinical narrative: injection site pain (rigth bicep); injection site swelling; Injection site hard up to his right shoulder; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; Described sometimes that it feels like he does not even have a right arm/clarified that it is a burning pain and a muscle sprain/it feels like it has been hit with a 2x4; right arms feels weak; it has a fever and sometimes gets really intense; experiencing serious pain his right shoulder; This spontaneous report was received from Consumer and refers to a 70-year-old male. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 18-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in the right bicep for prophylaxis (dose, route of administration, vaccination scheme frequency, lot number, and expiration date were not reported). The vaccination site was fine on that date.  On 19-OCT-2022 (also reported as next day), he experienced injection site swelling (vaccination site swelling), his right arm felt weak (muscular weakness), and he presented serious pain in his right bicep (vaccination site pain) and right shoulder (arthralgia). On that date, the patient also presented burning pain and a muscle sprain, it felt like it had been hit with a 2x4 (pain, ligament sprain, malaise). By that time, the vaccination site did not turn red, or nothing just turned hard up to his right shoulder (vaccination site induration). On unspecified dates in 2022, the patient's shoulder still was really in pain and the vaccination site seemed to be dissipating but the shoulder had not, he also experienced a fever that sometimes got really intense. As a self-treatment for the events, the patient had been putting lidocaine 4% (ASPERCREME) Patch XL and "Maximum Strength Lidocaine pain relief" patch 4% on his arm (covering around the vaccination site); nevertheless, they did not work. Later, the patient tried using roll-on lidocaine and icy hot therapy since he could not afford to keep buying those lidocaine patches.   At the time of reporting, the patient had not recovered from the events of vaccination site induration, pain, ligament sprain, malaise, weakness of arms, and was recovering from vaccination site pain; the outcome of the events of vaccination site swelling, arthralgia, and fever was not known. The causal relationship between the events and the suspect vaccine was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Pain
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=4/ vaccine brand other=Moderna; vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=4/ vaccine brand other=Moderna; vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: being negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Therapeutic measures included Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 11Dec2022 and stopped on 15Dec2022, Indication: Treatment of 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: 48.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=4/ vaccine brand other=Moderna; vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=4/ vaccine brand other=Moderna; vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: being negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Therapeutic measures included Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 11Dec2022 and stopped on 15Dec2022, Indication: Treatment of 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: 48.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech; vaccine dose number=4/ vaccine brand other=Moderna; vaccine dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: wheat" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech; vaccine dose number=4/ vaccine brand other=Moderna; vaccine dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: being negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. Therapeutic measures included Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 11Dec2022 and stopped on 15Dec2022, Indication: Treatment of 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.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aortic disorder, Condition aggravated, Pericarditis, Pruritus
Clinical narrative: Probably had pericarditis; Horrendous itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MYLANLABS-2022M1147717.  This Serious Spontaneous report was received from business partner, PFIZER, (Ref No. 202201389362) originated on 19-Dec-2022 and received by Viatris on 21-Dec-2022. This initial case, received from consumer, non health professional, involved a 78-years-old male patient who reportedly experienced pericarditis and pruritus while receiving gabapentin capsules, USP (gabapentin). Medical history, current conditions and concomitant medications were not reported. Non-company suspect medication included COVID-19 vaccine. Unknown Date: The patient initiated gabapentin capsule at a unknown dose and frequency via unknown route for an unknown indication. The patient experienced horrendous itching and probably had pericarditis. The event pericarditis was considered medically significant. 21-Oct-2022: The patient initiated COVID-19 vaccine at a unknown dose and frequency via unknown route (batch/lot number GH9697, expiration date unknown) for an unknown indication. Action taken with gabapentin was not reported. The outcome of events pericarditis and pruritus was unknown. Company Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  Viatris Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  GABAPENTIN is under agreement with Viatris  Causality assessment:  GABAPENTIN    Pericarditis, Itching Per reporter: Possible    Per Viatris: Possible; Sender's Comments: Based on the available information the causality for the reported events pericarditis and pruritus cannot be excluded for the suspect products gabapentin and COVID-19 vaccine. The impact of this report on the benefit risk profile of the Pfizer product and 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, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Probably had pericarditis; Horrendous itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MYLANLABS-2022M1147717.  This Serious Spontaneous report was received from business partner, PFIZER, (Ref No. 202201389362) originated on 19-Dec-2022 and received by Viatris on 21-Dec-2022. This initial case, received from consumer, non health professional, involved a 78-years-old male patient who reportedly experienced pericarditis and pruritus while receiving gabapentin capsules, USP (gabapentin). Medical history, current conditions and concomitant medications were not reported. Non-company suspect medication included COVID-19 vaccine. Unknown Date: The patient initiated gabapentin capsule at a unknown dose and frequency via unknown route for an unknown indication. The patient experienced horrendous itching and probably had pericarditis. The event pericarditis was considered medically significant. 21-Oct-2022: The patient initiated COVID-19 vaccine at a unknown dose and frequency via unknown route (batch/lot number GH9697, expiration date unknown) for an unknown indication. Action taken with gabapentin was not reported. The outcome of events pericarditis and pruritus was unknown. Company Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  Viatris Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  GABAPENTIN is under agreement with Viatris  Causality assessment:  GABAPENTIN    Pericarditis, Itching Per reporter: Possible    Per Viatris: Possible; Sender's Comments: Based on the available information the causality for the reported events pericarditis and pruritus cannot be excluded for the suspect products gabapentin and COVID-19 vaccine. The impact of this report on the benefit risk profile of the Pfizer product and 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, COVID19, COVID19
Symptoms: Pericarditis, Pruritus
Clinical narrative: Probably had pericarditis; Horrendous itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MYLANLABS-2022M1147717.  This Serious Spontaneous report was received from business partner, PFIZER, (Ref No. 202201389362) originated on 19-Dec-2022 and received by Viatris on 21-Dec-2022. This initial case, received from consumer, non health professional, involved a 78-years-old male patient who reportedly experienced pericarditis and pruritus while receiving gabapentin capsules, USP (gabapentin). Medical history, current conditions and concomitant medications were not reported. Non-company suspect medication included COVID-19 vaccine. Unknown Date: The patient initiated gabapentin capsule at a unknown dose and frequency via unknown route for an unknown indication. The patient experienced horrendous itching and probably had pericarditis. The event pericarditis was considered medically significant. 21-Oct-2022: The patient initiated COVID-19 vaccine at a unknown dose and frequency via unknown route (batch/lot number GH9697, expiration date unknown) for an unknown indication. Action taken with gabapentin was not reported. The outcome of events pericarditis and pruritus was unknown. Company Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  Viatris Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  GABAPENTIN is under agreement with Viatris  Causality assessment:  GABAPENTIN    Pericarditis, Itching Per reporter: Possible    Per Viatris: Possible; Sender's Comments: Based on the available information the causality for the reported events pericarditis and pruritus cannot be excluded for the suspect products gabapentin and COVID-19 vaccine. The impact of this report on the benefit risk profile of the Pfizer product and 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, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Probably had pericarditis; Horrendous itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MYLANLABS-2022M1147717.  This Serious Spontaneous report was received from business partner, PFIZER, (Ref No. 202201389362) originated on 19-Dec-2022 and received by Viatris on 21-Dec-2022. This initial case, received from consumer, non health professional, involved a 78-years-old male patient who reportedly experienced pericarditis and pruritus while receiving gabapentin capsules, USP (gabapentin). Medical history, current conditions and concomitant medications were not reported. Non-company suspect medication included COVID-19 vaccine. Unknown Date: The patient initiated gabapentin capsule at a unknown dose and frequency via unknown route for an unknown indication. The patient experienced horrendous itching and probably had pericarditis. The event pericarditis was considered medically significant. 21-Oct-2022: The patient initiated COVID-19 vaccine at a unknown dose and frequency via unknown route (batch/lot number GH9697, expiration date unknown) for an unknown indication. Action taken with gabapentin was not reported. The outcome of events pericarditis and pruritus was unknown. Company Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  Viatris Comment: Serious: Pericarditis is unlisted event whereas pruritus (Non-serious) is listed event as per company RSI of gabapentin. Causality has been assessed as possible for the events pericarditis and pruritus as contributory role of suspect drug cannot be completely excluded based on available information.  GABAPENTIN is under agreement with Viatris  Causality assessment:  GABAPENTIN    Pericarditis, Itching Per reporter: Possible    Per Viatris: Possible; Sender's Comments: Based on the available information the causality for the reported events pericarditis and pruritus cannot be excluded for the suspect products gabapentin and COVID-19 vaccine. The impact of this report on the benefit risk profile of the Pfizer product and 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: U
Vaccine: UNK, COVID19-2, COVID19-2
Symptoms: Tinnitus
Clinical narrative: I am experiencing tinnitus after my second Pfizer booster; 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 patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster unknown manufacturer), for covid-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I am experiencing tinnitus after my second Pfizer booster".  Additional information: Patient reported that for the first time in life, patient was experiencing tinnitus after patients second Pfizer booster, and patient was asking whether we have any recommendations on how to treat this side effect.  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: U
Vaccine: UNK, COVID19-2, COVID19-2
Symptoms: Tinnitus
Clinical narrative: I am experiencing tinnitus after my second Pfizer booster and it has become much worse after my 3rd booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 immunization; Bnt162b2 (Second Pfizer booster), for COVID-19 immunization, reaction(s): "tinitus". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I am experiencing tinnitus after my second Pfizer booster and it has become much worse after my 3rd booster".  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: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diagnosed with COVID yesterday; Diagnosed with COVID yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 23Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Aug2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 77 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 10Aug2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "ANA" (unspecified if ongoing), notes: ANA stands for antinuclear antibodies. It means her immune system is about gone. She was diagnosed this past summer in August.; "left branch bundle block diagnosed 12 years ago", start date: 2010 (unspecified if ongoing), notes: left branch bundle block diagnosed 12 years ago.; "heart" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: heart; "supplement" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: supplement. Concomitant medication(s) included: RANOLAZINE oral taken for cardiac disorder (ongoing); IMMUNETI taken for supplementation therapy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "unknown" and all described as "Diagnosed with COVID yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had not consumed Paxlovid yet and was calling before she took it. Lot No for third Pfizer vaccine dose was EF2593 or maybe ER2593, handwritten on vaccine card. Additional Information for Other medicines immuneti: it had vitamin c, zinc, vitamin D3, elderberry. It ias an advanced immune defense vitamin. The patient took one tablet of Ranolazine by mouth twice a day when she did not forget it. Start date: been on it for 4 years off and on. She was supposed to take it every day but had not taken it today. Caller did not like taking pills. Vaccination Facility Type: It was not a military facility. The other three vaccines were given in town and the National Guard were giving it and it felt like he hit her bone. Caller doesn't have that much fat on her body. Prior Vaccinations (within 4 weeks): Received Flu shot on same date as COVID vaccine on 10Aug2022. The patient did not go to physician's office. There was a product complaint to report. ANA stands for antinuclear antibodies. It means her immune system is about gone. She was diagnosed this past summer in August.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosed with COVID yesterday; Diagnosed with COVID yesterday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 23Mar2021 as dose 2, single (Lot number: ER2613), in right arm, on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Aug2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 77 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 10Aug2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "ANA" (unspecified if ongoing), notes: ANA stands for antinuclear antibodies. It means her immune system is about gone. She was diagnosed this past summer in August.; "left branch bundle block diagnosed 12 years ago", start date: 2010 (unspecified if ongoing), notes: left branch bundle block diagnosed 12 years ago.; "heart" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: heart; "supplement" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: supplement. Concomitant medication(s) included: RANOLAZINE oral taken for cardiac disorder (ongoing); IMMUNETI taken for supplementation therapy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "unknown" and all described as "Diagnosed with COVID yesterday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had not consumed Paxlovid yet and was calling before she took it. Lot No for third Pfizer vaccine dose was EF2593 or maybe ER2593, handwritten on vaccine card. Additional Information for Other medicines immuneti: it had vitamin c, zinc, vitamin D3, elderberry. It ias an advanced immune defense vitamin. The patient took one tablet of Ranolazine by mouth twice a day when she did not forget it. Start date: been on it for 4 years off and on. She was supposed to take it every day but had not taken it today. Caller did not like taking pills. Vaccination Facility Type: It was not a military facility. The other three vaccines were given in town and the National Guard were giving it and it felt like he hit her bone. Caller doesn't have that much fat on her body. Prior Vaccinations (within 4 weeks): Received Flu shot on same date as COVID vaccine on 10Aug2022. The patient did not go to physician's office. There was a product complaint to report. ANA stands for antinuclear antibodies. It means her immune system is about gone. She was diagnosed this past summer in August.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received Engerix B adult 20 ml and Engerix B Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The reporter consented to follow-up. This case is for 1 of 2 linked cases reported by same reporter. Additional supportive information: The patient received an expired dose of Engerix B (20 mcg/ml) in right deltoid, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022191314:Same reporter
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received Engerix B adult 20 ml and Engerix B Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The reporter consented to follow-up. This case is for 2 of 2 linked cases reported by same reporter. Additional supportive information: The patient received an expired dose of Engerix B (20 mcg/ml), which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022191313:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on DEC-2021, 2nd on 16-SEP-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number Y7D4B, expiry date 31st August 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021).   On 16th September 2022, the patient received the 2nd dose of Shingrix. On 16th September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: Information for adverse event was collected. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose one year ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about one year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix yet, which led to incomplete course of vaccination.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   On 21st December 2022, the patient received Engerix B. On 21st December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Bad stomach cramps; Sweating; Feels over heated, then gets cold; Worsening of knee and shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included open heart surgery, colon cancer, shoulder pain and knee pain.   On 19th December 2022, the patient received the 2nd dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced stomach cramps, sweating, feeling hot and cold and arthralgia. On an unknown date, the outcome of the stomach cramps, sweating, feeling hot and cold and arthralgia were unknown.   It was unknown if the reporter considered the stomach cramps, sweating, feeling hot and cold and arthralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's Comment: The reporter was the patient. The patient received Shingrix on right arm. The patient reported that he was experiencing bad stomach cramps and sweating. He felt over heated, and then he got cold. The patient also experienced worsening of knee and shoulder pain.  The reporter consented to follow up with healthcare professional.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Herpes simplex outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of herpes simplex in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2022, the patient received the 1st dose of Shingrix. On 21st December 2022, 78 days after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Dec-2022. Reporter's Comment:  The reporter stated that the patient with a herpes simplex outbreak after 1st dose of Shingrix.  The reporter stated that dose was administered on 4th October 2022. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2019, 2nd Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Dec-2022. Reporter's Comment: The reporter is the pharmacist. The patient was probably in his 50s who had his first Shingrix shot sometime in 2019 and his second Shingrix shot around the first week of October 2022 (She did not have the exact dates nor did she has his name or date of birth). The patient came in to the pharmacy seeking a third dose of Shingrix. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose late than recommended which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Jun2021, 2nd 19Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2021).   On 19th December 2022, the patient received the 2nd dose of Shingrix. On 19th December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Dec-2022. Reporter's Comment: The reporter was a pharmacy technician. The reporter provided information about patient but not about the location of the application of the second dose and neither did they provide information about vaccine. The reporter did not consent to Follow-up. Additional supportive information: The patient received 2nd dose late than recommended which led to lengthening of vaccination schedule.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 YO received Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number HNNJ7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-DEC-2022 Reporter's comment: Adverse event (AE) contained all reported information per health care professional (HCP).  The HCP gave consent for safety team follow up. Additional supportive information: 2-year-old patient received Kinrix, which led to inappropriate age at vaccine administration.