chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Bacteraemia, COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: DX SOB and COVID-19, 52-year-old female with a past medical history of lung cancer, chronic kidney disease, electrolyte disturbance, who initially was admitted to medical facility on September 25 for shortness of breath and the patient was found to have a COVID positive test.  She was started on treatment with remdesivir.  Also, she found to have bacteremia, 1 of 2 gram-positive cluster, was on vancomycin.  Also anticoagulation with Eliquis, vitamin C, zinc.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE (NO ADVERSE EVENT OBSERVED); This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have any illness at the time of vaccination. The patient did not have past history of similar event. The patient did not have adverse event after any previous vaccination. Patient did not have any allergy. The patient did not have any history of allergy to vaccine, drug, or food. The patient did not have any pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days, with cause. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine (no adverse event observed). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine (no adverse event observed) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211137862, 20211246432, 20211246488, 20211246559, 20211246474 and 20211245708.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE (NO ADVERSE EVENT OBSERVED); This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have any illness at the time of vaccination. The patient did not have past history of similar event. The patient did not have adverse event after any previous vaccination. Patient did not have any allergy. The patient did not have any history of allergy to vaccine, drug, or food. The patient did not have any pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days, with cause. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine (no adverse event observed). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine (no adverse event observed) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211137862, 20211246432, 20211246488, 20211246559, 20211246474 and 20211245708.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had history of allergy to unspecified vaccine, drug or food. The patient did not had any preexisting acute illness or hospitalization 30 days prior to vaccination, no past history of similar event. He did not had any illness at the time of vaccination. He did not experience any adverse event after any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: 21-SEP-2021) 0.5 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211246488, 20211246517, 20211246432, 20211246471, 20211246474, 20211246539, 20210955494, 20210955823, 20211245708 and 20211246439.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 48 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history if illness at the time of vaccination. Patient had no history of similar events. Patient had no history of allergy to vaccine, drug or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with causes. There were no any issues related to the storage of the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 21-SEP-2021) .5 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211246488, 20211246559, 20211246439, 20210955823, 20211246471, 20211246432, 20211246539 and 20211246517.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Patient hospitalized.  On oxygen.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient hospitalized.  On oxygen.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Burning sensation, Muscle spasms, Muscle tightness
Clinical narrative: muscle pains that lasted a couple weeks.; tremors; twitches; weakness in my legs; insomnia; tinnitus; brain fog; neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "muscle pains that lasted a couple weeks."; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "tremors"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitches"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "weakness in my legs"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog". The events "neuropathy", "tremors", "twitches", "weakness in my legs", "insomnia", "tinnitus" and "brain fog" were evaluated at the physician office visit. The patient went to countless doctors. The patient underwent the following laboratory tests and procedures: had done numerous tests: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Tremor
Clinical narrative: muscle pains that lasted a couple weeks.; tremors; twitches; weakness in my legs; insomnia; tinnitus; brain fog; neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "muscle pains that lasted a couple weeks."; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "tremors"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitches"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "weakness in my legs"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog". The events "neuropathy", "tremors", "twitches", "weakness in my legs", "insomnia", "tinnitus" and "brain fog" were evaluated at the physician office visit. The patient went to countless doctors. The patient underwent the following laboratory tests and procedures: had done numerous tests: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Muscle twitching, Muscular weakness, Myalgia, Neuropathy peripheral
Clinical narrative: muscle pains that lasted a couple weeks.; tremors; twitches; weakness in my legs; insomnia; tinnitus; brain fog; neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "muscle pains that lasted a couple weeks."; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "tremors"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitches"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "weakness in my legs"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog". The events "neuropathy", "tremors", "twitches", "weakness in my legs", "insomnia", "tinnitus" and "brain fog" were evaluated at the physician office visit. The patient went to countless doctors. The patient underwent the following laboratory tests and procedures: had done numerous tests: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Tremor, Vision blurred
Clinical narrative: muscle pains that lasted a couple weeks.; tremors; twitches; weakness in my legs; insomnia; tinnitus; brain fog; neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "muscle pains that lasted a couple weeks."; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "tremors"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitches"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "weakness in my legs"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog". The events "neuropathy", "tremors", "twitches", "weakness in my legs", "insomnia", "tinnitus" and "brain fog" were evaluated at the physician office visit. The patient went to countless doctors. The patient underwent the following laboratory tests and procedures: had done numerous tests: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Insomnia, Investigation, Muscle twitching, Muscular weakness
Clinical narrative: muscle pains that lasted a couple weeks.; tremors; twitches; weakness in my legs; insomnia; tinnitus; brain fog; neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "muscle pains that lasted a couple weeks."; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "tremors"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitches"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "weakness in my legs"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog". The events "neuropathy", "tremors", "twitches", "weakness in my legs", "insomnia", "tinnitus" and "brain fog" were evaluated at the physician office visit. The patient went to countless doctors. The patient underwent the following laboratory tests and procedures: had done numerous tests: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Neuropathy peripheral, Tinnitus, Tremor
Clinical narrative: muscle pains that lasted a couple weeks.; tremors; twitches; weakness in my legs; insomnia; tinnitus; brain fog; neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 2, single 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. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2021, outcome "unknown", described as "neuropathy"; MYALGIA (non-serious) with onset 01Sep2021, outcome "recovered" (Sep2021), described as "muscle pains that lasted a couple weeks."; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "tremors"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "twitches"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "weakness in my legs"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "insomnia"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog". The events "neuropathy", "tremors", "twitches", "weakness in my legs", "insomnia", "tinnitus" and "brain fog" were evaluated at the physician office visit. The patient went to countless doctors. The patient underwent the following laboratory tests and procedures: had done numerous tests: (2021) unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: pt had recent admission for COVID pneumonia and was discharged one day prior to coming back to ED with worsening symptoms of SOB and altered mental status; PMH:  A Fib, anemia, CKD, CHF, COPD, PE, DVT, DMT2; transferred to ICU; given antibiotics and vasopressors; intubated; deteriorating condition; comfort measures; family @ bedside when pt passed in the hosp
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Death, Dyspnoea, Endotracheal intubation, General physical health deterioration
Clinical narrative: pt had recent admission for COVID pneumonia and was discharged one day prior to coming back to ED with worsening symptoms of SOB and altered mental status; PMH:  A Fib, anemia, CKD, CHF, COPD, PE, DVT, DMT2; transferred to ICU; given antibiotics and vasopressors; intubated; deteriorating condition; comfort measures; family @ bedside when pt passed in the hosp
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Mental status changes
Clinical narrative: pt had recent admission for COVID pneumonia and was discharged one day prior to coming back to ED with worsening symptoms of SOB and altered mental status; PMH:  A Fib, anemia, CKD, CHF, COPD, PE, DVT, DMT2; transferred to ICU; given antibiotics and vasopressors; intubated; deteriorating condition; comfort measures; family @ bedside when pt passed in the hosp
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: The patient received third dose of vaccine; it is everyday and pain sometimes is really sharp; It is up on my shoulder where the injection site/ booster shot 2 months ago in left arm and my arm has been sore; Had pain in my arm since that time; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 (Lot number: 301558A) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; paracetamol (TYLENOL) (Batch/Lot number: unknown). Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JANUMET; JARDIANCE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021, outcome "unknown", described as "The patient received third dose of vaccine"; PAIN (non-serious) with onset 07Oct2021, outcome "not recovered", described as "it is everyday and pain sometimes is really sharp"; VACCINATION SITE PAIN (non-serious) with onset 07Oct2021, outcome "not recovered", described as "It is up on my shoulder where the injection site/ booster shot 2 months ago in left arm and my arm has been sore"; PAIN IN EXTREMITY (non-serious) with onset 07Oct2021, outcome "not recovered", described as "Had pain in my arm since that time". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for paracetamol was unknown. Therapeutic measures were taken as a result of pain, vaccination site pain, pain in extremity.  Additional information: The patient had Pfizer first two shots and then booster shot on 07Oct2021, and he had pain in arm since that time almost 2 months now. He had gone to his internist, she did try do some test, she did ultrasound and he was not sure of that, it felt like close to the bone he was not sure (Consumer was unsure of the lab test), it was his upper left arm, and it was painful every day. He had a booster in left arm and his arm had been sore right away for the last almost 2 months. That was not unusual but it has never gotten better. He had a ultrasound to figure it out, his doctor has been trying to figure it out and he cannot find who to report this to. He had a blood test, about a week ago. It was to check his potassium. The vaccine was administered in afternoon sometime. The pharmacist said to take Tylenol. He tried doing that but it did not do any good to him.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood potassium normal, Immunisation, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: The patient received third dose of vaccine; it is everyday and pain sometimes is really sharp; It is up on my shoulder where the injection site/ booster shot 2 months ago in left arm and my arm has been sore; Had pain in my arm since that time; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 (Lot number: 301558A) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; paracetamol (TYLENOL) (Batch/Lot number: unknown). Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JANUMET; JARDIANCE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021, outcome "unknown", described as "The patient received third dose of vaccine"; PAIN (non-serious) with onset 07Oct2021, outcome "not recovered", described as "it is everyday and pain sometimes is really sharp"; VACCINATION SITE PAIN (non-serious) with onset 07Oct2021, outcome "not recovered", described as "It is up on my shoulder where the injection site/ booster shot 2 months ago in left arm and my arm has been sore"; PAIN IN EXTREMITY (non-serious) with onset 07Oct2021, outcome "not recovered", described as "Had pain in my arm since that time". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for paracetamol was unknown. Therapeutic measures were taken as a result of pain, vaccination site pain, pain in extremity.  Additional information: The patient had Pfizer first two shots and then booster shot on 07Oct2021, and he had pain in arm since that time almost 2 months now. He had gone to his internist, she did try do some test, she did ultrasound and he was not sure of that, it felt like close to the bone he was not sure (Consumer was unsure of the lab test), it was his upper left arm, and it was painful every day. He had a booster in left arm and his arm had been sore right away for the last almost 2 months. That was not unusual but it has never gotten better. He had a ultrasound to figure it out, his doctor has been trying to figure it out and he cannot find who to report this to. He had a blood test, about a week ago. It was to check his potassium. The vaccine was administered in afternoon sometime. The pharmacist said to take Tylenol. He tried doing that but it did not do any good to him.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: The patient received third dose of vaccine; it is everyday and pain sometimes is really sharp; It is up on my shoulder where the injection site/ booster shot 2 months ago in left arm and my arm has been sore; Had pain in my arm since that time; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 (Lot number: 301558A) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; paracetamol (TYLENOL) (Batch/Lot number: unknown). Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JANUMET; JARDIANCE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021, outcome "unknown", described as "The patient received third dose of vaccine"; PAIN (non-serious) with onset 07Oct2021, outcome "not recovered", described as "it is everyday and pain sometimes is really sharp"; VACCINATION SITE PAIN (non-serious) with onset 07Oct2021, outcome "not recovered", described as "It is up on my shoulder where the injection site/ booster shot 2 months ago in left arm and my arm has been sore"; PAIN IN EXTREMITY (non-serious) with onset 07Oct2021, outcome "not recovered", described as "Had pain in my arm since that time". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for paracetamol was unknown. Therapeutic measures were taken as a result of pain, vaccination site pain, pain in extremity.  Additional information: The patient had Pfizer first two shots and then booster shot on 07Oct2021, and he had pain in arm since that time almost 2 months now. He had gone to his internist, she did try do some test, she did ultrasound and he was not sure of that, it felt like close to the bone he was not sure (Consumer was unsure of the lab test), it was his upper left arm, and it was painful every day. He had a booster in left arm and his arm had been sore right away for the last almost 2 months. That was not unusual but it has never gotten better. He had a ultrasound to figure it out, his doctor has been trying to figure it out and he cannot find who to report this to. He had a blood test, about a week ago. It was to check his potassium. The vaccine was administered in afternoon sometime. The pharmacist said to take Tylenol. He tried doing that but it did not do any good to him.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Booster; pain in my heart muscle/ condition getting worse, from third day my heart condition got worse; double dose(0.6 ml); shortness of breath; pain in my heart muscle/ condition getting worse, from third day my heart condition got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.6 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didnot have any reaction"; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didnot have any reaction".   The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Booster"; ANGINA PECTORIS (medically significant), CONDITION AGGRAVATED (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "pain in my heart muscle/ condition getting worse, from third day my heart condition got worse"; OVERDOSE (non-serious) with onset Nov2021, outcome "unknown", described as "double dose(0.6 ml)"; DYSPNOEA (non-serious) with onset Nov2021, outcome "not recovered", described as "shortness of breath".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Medical closure Fu - Follow up (06Dec2021) : No new information was added in narrative for the follow up as per data entry CL (due to system limitations, we are unable to route directly to Distribution).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Condition aggravated, Dyspnoea, Immunisation, Overdose
Clinical narrative: Booster; pain in my heart muscle/ condition getting worse, from third day my heart condition got worse; double dose(0.6 ml); shortness of breath; pain in my heart muscle/ condition getting worse, from third day my heart condition got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), 0.6 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didnot have any reaction"; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didnot have any reaction".   The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Booster"; ANGINA PECTORIS (medically significant), CONDITION AGGRAVATED (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "pain in my heart muscle/ condition getting worse, from third day my heart condition got worse"; OVERDOSE (non-serious) with onset Nov2021, outcome "unknown", described as "double dose(0.6 ml)"; DYSPNOEA (non-serious) with onset Nov2021, outcome "not recovered", described as "shortness of breath".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Medical closure Fu - Follow up (06Dec2021) : No new information was added in narrative for the follow up as per data entry CL (due to system limitations, we are unable to route directly to Distribution).
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Vaccine positive rechallenge
Clinical narrative: shingles; 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 66 year-old male patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FH8030) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot no. EW0172), administration date: 22Apr2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Lot no. EW0173), administration date: 13May2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "Shingles". The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Additional information: The patient queried if anybody else has reported getting shingles after Pfizer COVID-19 vaccination? He also stated: "In (name)they have articles on Shingles and COVID vaccine, I certainly reported this case to the CDC as well. There needs to be an ongoing collection of data and I don't understand the reluctance to gather the data, it could easily be tabbed as individual report as opposed to report backed up by medical doctor, I certainly went to see my medical doctor and it was diagnosed, but still you don't know if there's a connection, all I could say is that I did not have Shingles before the vaccine and certainly 2 weeks after... or weeks... or anywhere from a week to 2 weeks after the second shot I developed it, and then again after the booster, so there does seem to be something there." The patient complained about shingles not being listed as a side effect and stated "I just wonder how aggressively is your company pursuing reports of possible side effects, it doesn't sound like you or really not really you personally but your company is even interested in investigating whether or not there is a connection." 2-3 weeks after second dose, went to doctor, initially it was a mosquito bite, was not treated, it had already began to clear up. Patient did not want the pharmacy that was involved with administering the booster vaccine to be contacted, declined to provide their information.  Shingles vaccine information, NDC, Lot and Expiration Date, or manufacturer was unknown. The sample of the product was not available to be returned, if requested. It was unknown if the packaging was sealed and intact.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Immunisation
Clinical narrative: shingles; 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 66 year-old male patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FH8030) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot no. EW0172), administration date: 22Apr2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Lot no. EW0173), administration date: 13May2021, when the patient was 65 years old, for Covid-19 immunization, reaction(s): "Shingles". The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "booster"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Additional information: The patient queried if anybody else has reported getting shingles after Pfizer COVID-19 vaccination? He also stated: "In (name)they have articles on Shingles and COVID vaccine, I certainly reported this case to the CDC as well. There needs to be an ongoing collection of data and I don't understand the reluctance to gather the data, it could easily be tabbed as individual report as opposed to report backed up by medical doctor, I certainly went to see my medical doctor and it was diagnosed, but still you don't know if there's a connection, all I could say is that I did not have Shingles before the vaccine and certainly 2 weeks after... or weeks... or anywhere from a week to 2 weeks after the second shot I developed it, and then again after the booster, so there does seem to be something there." The patient complained about shingles not being listed as a side effect and stated "I just wonder how aggressively is your company pursuing reports of possible side effects, it doesn't sound like you or really not really you personally but your company is even interested in investigating whether or not there is a connection." 2-3 weeks after second dose, went to doctor, initially it was a mosquito bite, was not treated, it had already began to clear up. Patient did not want the pharmacy that was involved with administering the booster vaccine to be contacted, declined to provide their information.  Shingles vaccine information, NDC, Lot and Expiration Date, or manufacturer was unknown. The sample of the product was not available to be returned, if requested. It was unknown if the packaging was sealed and intact.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Hypertensive crisis, Joint swelling, Red blood cell sedimentation rate increased
Clinical narrative: Joint pains, swelling, increased blood pressure requiring additional medication to treat, and most recently (starting 12/13/21), diagnosis of anterior uveitis.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Iridocyclitis, Swelling
Clinical narrative: Joint pains, swelling, increased blood pressure requiring additional medication to treat, and most recently (starting 12/13/21), diagnosis of anterior uveitis.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness neurosensory, Deafness unilateral, Extra dose administered
Clinical narrative: Patient experienced onset of nasal congestion 24 hrs after the shot, then 12 hours later experienced total hearing loss in her right ear.  This has been confirmed by ENT only slight recovery over the past 3 weeks.  She now, additionally reports tinnitus in the right ear.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Patient experienced onset of nasal congestion 24 hrs after the shot, then 12 hours later experienced total hearing loss in her right ear.  This has been confirmed by ENT only slight recovery over the past 3 weeks.  She now, additionally reports tinnitus in the right ear.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness unilateral, Nasal congestion, Tinnitus
Clinical narrative: Patient experienced onset of nasal congestion 24 hrs after the shot, then 12 hours later experienced total hearing loss in her right ear.  This has been confirmed by ENT only slight recovery over the past 3 weeks.  She now, additionally reports tinnitus in the right ear.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Nausea, Rash
Clinical narrative: booster dose; nauseous; rash from the middle of my the back to middle to my belly; 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 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) (at the age of 73-years) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 immunization, reaction(s): "no adverse event"; Bnt162b2 (Dose-2), for Covid-19 immunization, reaction(s): "no adverse event". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; RASH (non-serious), outcome "unknown", described as "rash from the middle of my the back to middle to my belly".  Additional information: After receiving the Pfizer BioNTech COVID-19 vaccine adult formulation patient felt very nauseous within 5 minutes, after half an hour patient developed a rash from the middle of the back to middle to her belly and felt nauseous again on the middle of the night. At the time of report, patient asked why the first 2 could be effective but, the third one, could it be a stronger batch and not the same as the first 2 Pfizer vaccines. The patient was very curious about why there was a reaction to booster so badly and nothing from the first 2 dose. Description of Product Complaint: Description of complaint: Caller was reporting that she had a bad reaction to the Pfizer Covid booster vaccination. Caller asked if Pfizer can explain why the first 2 be effective but, the third one, could it be a stronger batch and not the same as the first 2 Pfizer vaccines. Product strength and count size dispensed: not provided. Caller declined to complete report, full details not obtained. Additional lot numbers: not provided. The sample did not provide of the product available to be returned. Packaging sealed and intact: not provided.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Nausea, Rash
Clinical narrative: booster dose; nauseous; rash from the middle of my the back to middle to my belly; 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 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) (at the age of 73-years) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 immunization, reaction(s): "no adverse event"; Bnt162b2 (Dose-2), for Covid-19 immunization, reaction(s): "no adverse event". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; RASH (non-serious), outcome "unknown", described as "rash from the middle of my the back to middle to my belly".  Additional information: After receiving the Pfizer BioNTech COVID-19 vaccine adult formulation patient felt very nauseous within 5 minutes, after half an hour patient developed a rash from the middle of the back to middle to her belly and felt nauseous again on the middle of the night. At the time of report, patient asked why the first 2 could be effective but, the third one, could it be a stronger batch and not the same as the first 2 Pfizer vaccines. The patient was very curious about why there was a reaction to booster so badly and nothing from the first 2 dose. Description of Product Complaint: Description of complaint: Caller was reporting that she had a bad reaction to the Pfizer Covid booster vaccination. Caller asked if Pfizer can explain why the first 2 be effective but, the third one, could it be a stronger batch and not the same as the first 2 Pfizer vaccines. Product strength and count size dispensed: not provided. Caller declined to complete report, full details not obtained. Additional lot numbers: not provided. The sample did not provide of the product available to be returned. Packaging sealed and intact: not provided.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Neutropenia, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted prior to this admission for covid 19 infection iso neutropenia and tested positive for covid on 11/27/21.  Patient presented to Hospital on 12/4/21 with worsening SOB and was started on 5 days of remdesivir.  Patient  was also continued on home oncologic treatment.  Patient is fully vaccinated for covid. Patient was discharged on 12/10/21.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram thorax abnormal, Dyspnoea, Lung opacity, Neutropenia
Clinical narrative: Patient was admitted prior to this admission for covid 19 infection iso neutropenia and tested positive for covid on 11/27/21.  Patient presented to Hospital on 12/4/21 with worsening SOB and was started on 5 days of remdesivir.  Patient  was also continued on home oncologic treatment.  Patient is fully vaccinated for covid. Patient was discharged on 12/10/21.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient was admitted prior to this admission for covid 19 infection iso neutropenia and tested positive for covid on 11/27/21.  Patient presented to Hospital on 12/4/21 with worsening SOB and was started on 5 days of remdesivir.  Patient  was also continued on home oncologic treatment.  Patient is fully vaccinated for covid. Patient was discharged on 12/10/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Tachycardia, Vaccine positive rechallenge
Clinical narrative: Tachycardia; Dose received:3/ dose number=3; This is a spontaneous report from a contactable reporter (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Dec2021 at 11:45 (Lot number: 32030BD) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs and "Allergy to antibiotic" (unspecified if ongoing), notes: Known allergies: Tetracyclines. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8732; Administration Time: 13:45: Anatomical location: Left Arm; Route of administration: Unspecified), administration date: 01Apr2021, when the patient was 53 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0171; Administration Time: 13:45: Anatomical location: Left Arm; Route of administration: Unspecified), administration date: 22Apr2021, when the patient was 53 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 11:45, outcome "unknown", described as "Dose received:3/ dose number=3"; TACHYCARDIA (non-serious) with onset 08Dec2021 at 00:00, outcome "recovering", described as "Tachycardia". The event "Tachycardia" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tachycardia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment for TACHYCARDIA included Bystolic (Beta Blocker).