chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Neuralgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: NEURALGIA (non-serious) with onset 2022, outcome "unknown", described as "There is a patient who has developed neuralgia/neurological issues"; MUSCULAR WEAKNESS (non-serious) with onset 2022, outcome "unknown", described as "muscle weakness after receiving their third dose". Additional information: Additional information: Pharmacy student had called to see if there was any data on how many patients who have received the adult formulation of the Pfizer BioNTech COVID 19 vaccine have developed neuralgia or muscle weakness after receiving the third dose. There was a patient who has developed neuralgia and muscle weakness after receiving their third dose approximately a month ago. The age and gender of the patient was unknown by the caller. (She believes it was the gray cap formulation because it was given a month ago but knows for certain it was an adult formulation of the vaccine.) What was the incidence or rate at which patients develop neuralgia or muscle weakness after receiving the third dose of the Pfizer BioNTech COVID 19 vaccine, gray cap formulation?. States they are just looking for a percentage of how often this has been reported to see if they can rule it out for the patient.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). A female patient received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Since then Ive developed a few hard/ swollen lymph nodes in my neck.". The event "since then ive developed a few hard/ swollen lymph nodes in my neck." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: : In Feb2022, patient received 3rd dose of the Pfizer covid-19 vaccine. Since then, she developed a few hard/ swollen lymph nodes in my neck. She had been to a handful of doctors and had an MRI in July to confirm.  All the articles she read said these should go away but they're still large and hard in Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; FISH OIL; PREGNENOLONE; IRON; IODINE; B12 [CYANOCOBALAMIN]; ASHWAGANDHA; VITEX AGNUS CASTUS. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: FH8027), administration date: 12May2021, when the patient was 40-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: ER8731), administration date: 21Apr2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, nasal congestion, pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was treated with Paxlovid.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Cough, Nasal congestion, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; FISH OIL; PREGNENOLONE; IRON; IODINE; B12 [CYANOCOBALAMIN]; ASHWAGANDHA; VITEX AGNUS CASTUS. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: FH8027), administration date: 12May2021, when the patient was 40-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: ER8731), administration date: 21Apr2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, nasal congestion, pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was treated with Paxlovid.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; FISH OIL; PREGNENOLONE; IRON; IODINE; B12 [CYANOCOBALAMIN]; ASHWAGANDHA; VITEX AGNUS CASTUS. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot number: FH8027), administration date: 12May2021, when the patient was 40-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: ER8731), administration date: 21Apr2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, cough, nasal congestion, pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was treated with Paxlovid.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: Positive COVID test; Positive COVID test; fever of 102F; coughing; congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER8731), on 12May2021 as dose 2, single (Lot number: EW0172) and on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; IODINE; FISH OIL; PREGNENOLONE; ASHWAGANDHA; VITEX AGNUS CASTUS; IRON; B12-VITAMIIN. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Positive COVID test"; PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "positive covid test", "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive, notes: Nasal Swab; Body temperature: (17Aug2022) 102F, notes: fever. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough, nasal congestion, pain. AE treatment included with Paxlovid. Facility type vaccine was workplace clinic. No other vaccine in four weeks. No covid prior vaccination. Covid was tested post vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Cough, Nasal congestion, Pain
Clinical narrative: Positive COVID test; Positive COVID test; fever of 102F; coughing; congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER8731), on 12May2021 as dose 2, single (Lot number: EW0172) and on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; IODINE; FISH OIL; PREGNENOLONE; ASHWAGANDHA; VITEX AGNUS CASTUS; IRON; B12-VITAMIIN. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Positive COVID test"; PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "positive covid test", "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive, notes: Nasal Swab; Body temperature: (17Aug2022) 102F, notes: fever. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough, nasal congestion, pain. AE treatment included with Paxlovid. Facility type vaccine was workplace clinic. No other vaccine in four weeks. No covid prior vaccination. Covid was tested post vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; fever of 102F; coughing; congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: ER8731), on 12May2021 as dose 2, single (Lot number: EW0172) and on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; DHEA; ZINC; IODINE; FISH OIL; PREGNENOLONE; ASHWAGANDHA; VITEX AGNUS CASTUS; IRON; B12-VITAMIIN. Past drug history included: Marcaine, reaction(s): "Known allergies: Marcaine"; Lidocaine, reaction(s): "Known allergies: lidocaine"; Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "unknown" and all described as "Positive COVID test"; PAIN (non-serious) with onset 17Aug2022, outcome "unknown", described as "body aches"; NASAL CONGESTION (non-serious) with onset 17Aug2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 17Aug2022, outcome "unknown", described as "coughing"; PYREXIA (non-serious) with onset 17Aug2022, outcome "unknown", described as "fever of 102F". The events "positive covid test", "fever of 102f", "coughing", "congestion" and "body aches" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive, notes: Nasal Swab; Body temperature: (17Aug2022) 102F, notes: fever. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough, nasal congestion, pain. AE treatment included with Paxlovid. Facility type vaccine was workplace clinic. No other vaccine in four weeks. No covid prior vaccination. Covid was tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Bursitis, Gait inability, Osteoarthritis, Pain
Clinical narrative: couldn't get up; severe pain in my right hip; can't move or walk; osteoarthritis; severe iliopsoas bursitis; severe iliopsoas bursitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 at 10:45 as dose 3 (booster), single (Lot number: FJL1991) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose lot number=EWO196,, prev dose administration date=01Jul2021,, prev dose administration time=10:00 AM,, prev dose dose number=2,, prev dose vaccine location=Left arm,), administration date: 01Jul2021, when the patient was 41-year-old, for COVID-19 Immunization; BNT162b2 (prev dose lot number=ewo191,, prev dose administration date=10Jun2021,, prev dose administration time=10:00 AM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 10Jun2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: GAIT INABILITY (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "can't move or walk"; BEDRIDDEN (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "couldn't get up"; OSTEOARTHRITIS (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered"; BURSITIS (disability, medically significant), TENDONITIS (disability, medically significant) all with onset 08Jul2022 at 05:00, outcome "not recovered" and all described as "severe iliopsoas bursitis"; PAIN (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "severe pain in my right hip". The events "couldn't get up", "severe pain in my right hip", "can't move or walk", "osteoarthritis" and "severe iliopsoas bursitis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bedridden, pain, gait inability, osteoarthritis, bursitis, tendonitis.  Clinical course: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Patient had not received no other vaccines with in four weeks. Third day i couldn't get up, severe pain in my right hip, can't move or walk. Diagnosed with osteoarthritis and severe iliopsoas bursitis. Patient received treatment with corticosteroids. Facility type vaccine was at pharmacy or drug store.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: couldn't get up; severe pain in my right hip; can't move or walk; osteoarthritis; severe iliopsoas bursitis; severe iliopsoas bursitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 05Jul2022 at 10:45 as dose 3 (booster), single (Lot number: FJL1991) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose lot number=EWO196,, prev dose administration date=01Jul2021,, prev dose administration time=10:00 AM,, prev dose dose number=2,, prev dose vaccine location=Left arm,), administration date: 01Jul2021, when the patient was 41-year-old, for COVID-19 Immunization; BNT162b2 (prev dose lot number=ewo191,, prev dose administration date=10Jun2021,, prev dose administration time=10:00 AM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 10Jun2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: GAIT INABILITY (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "can't move or walk"; BEDRIDDEN (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "couldn't get up"; OSTEOARTHRITIS (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered"; BURSITIS (disability, medically significant), TENDONITIS (disability, medically significant) all with onset 08Jul2022 at 05:00, outcome "not recovered" and all described as "severe iliopsoas bursitis"; PAIN (disability, medically significant) with onset 08Jul2022 at 05:00, outcome "not recovered", described as "severe pain in my right hip". The events "couldn't get up", "severe pain in my right hip", "can't move or walk", "osteoarthritis" and "severe iliopsoas bursitis" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bedridden, pain, gait inability, osteoarthritis, bursitis, tendonitis.  Clinical course: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Patient had not received no other vaccines with in four weeks. Third day i couldn't get up, severe pain in my right hip, can't move or walk. Diagnosed with osteoarthritis and severe iliopsoas bursitis. Patient received treatment with corticosteroids. Facility type vaccine was at pharmacy or drug store.   Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 at 09:30 as dose 1, single (Lot number: EW0187) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LISINOPRIL; VITAMIN C [ASCORBIC ACID]; B COMPLEX [VITAMIN B COMPLEX]. The following information was reported: ASTHENIA (non-serious) with onset 23May2021, outcome "not recovered", described as "I have no energy and no strength"; PYREXIA (non-serious) with onset 23May2021, outcome "not recovered", described as "ran a fever on and off since the vaccine". The events "i have no energy and no strength" and "ran a fever on and off since the vaccine" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, pyrexia. Additional information: facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. He had no energy and no strength. He had ran a fever on and off since the vaccine. He had seen multiple doctors and no one knows what to do. Ae treatment: various antibiotics, high dose vit c. No covid prior vaccination. Covid test post vaccination: Covid test type post vaccination: Nasal Swab, Covid test date: 10Aug2022, Covid test result: Negative.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated for COVID-19 with Paxlovid. It was reported that patient had Rebound of covid infection after a negative test result. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: ew0182), in left arm, on 04Jun2021 as dose 2, single (Lot number: ew0178), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: tj8760) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diet controlled diabetes-glucose intolerance" (unspecified if ongoing), notes: Diet controlled diabetes-glucose intolerance; "Diet controlled diabetes-glucose intolerance" (unspecified if ongoing), notes: Diet controlled diabetes-glucose intolerance; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: COQ 10, start date: Jan2010, stop date: 08Aug2022; D3, start date: Jan2015, stop date: 08Aug2022; ROSUVASTATIN, start date: Jan2010, stop date: 08Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, latency 10 days 20 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: re-bound COVID 4th day after treatment. presented with head congestion followed by positive test after testing negative. Anti viral details: Product: COVID 19 Treatment, Paxlovid, treatment start on 08Aug2022 and stop date was 12Aug2022.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), on 19Mar2021 as dose 2, single (Lot number: EN6208), on 07Oct2021 as dose 3 (booster), single (Lot number: 30145819) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "non-alcoholic fatty liver" (unspecified if ongoing), notes: non-alcoholic fatty liver disease. Concomitant medication(s) included: AMLODIPINE, start date: Mar2021; FLUTICASONE, start date: May2022; ROSUVASTATIN, start date: May2022; OMEGA-3-ACID ETHYL ESTER, start date: Mar2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: repeat of COVID symptoms; Positive, notes: testing positive 11 days after Paxlovid dose ended. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies to patient. The patient received Paxlovid as a treatment for COVID-19 from 04Aug2022 to 09Aug2022. sore arm when vaccinated, repeat of COVID symptoms and testing positive 11 days after Paxlovid dose ended.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Non-alcoholic fatty liver disease" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Mar2021; OMEGA-3-ACID ETHYL ESTER, start date: Mar2021. Past drug history included: Bnt162b2, start date: 07Oct2021, stop date: 07Oct2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 3 (BOOSTER), SINGLE; Lot Number: 30145819; Bnt162b2, start date: 19Mar2021, stop date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 2, SINGLE; Lot Number: EN6208; Bnt162b2, start date: 26Feb2021, stop date: 26Feb2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 1, SINGLE; Lot Number: EN6203; Bnt162b2, start date: 07Oct2021, stop date: 07Oct2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 3 (BOOSTER), SINGLE; Lot Number: 30145819; Bnt162b2, start date: 19Mar2021, stop date: 19Mar2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 2, SINGLE; Lot Number: EN6208; Bnt162b2, start date: 26Feb2021, stop date: 26Feb2021, for Covid-19 Immunization, reaction(s): "Treatment of COVID-19", notes: DOSE 1, SINGLE; Lot Number: EN6203. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Mar2022, outcome "unknown", described as "sore arm when vaccinated". Additional information: The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ME/CFS/PEM" (unspecified if ongoing), notes: ME/CFS/PEM; "ME/CFS/PEM" (unspecified if ongoing), notes: ME/CFS/PEM; "ME/CFS/PEM" (unspecified if ongoing), notes: ME/CFS/PEM. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had not received any other vaccine within 2 weeks of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive;(unspecified date) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After 2 days of testing negative, the patient felt a sore throat and tired. The patient was tested positive again on 16Aug2022 at 12:00 PM. The patient had received Paxlovid from 09Aug2022 to 13Aug2022 for the treatment of COVID-19. The device date was mentioned as 19Aug2022. The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 at 14:00 as dose 1, single (Lot number: EL3249), in right arm, on 04Feb2021 at 14:00 as dose 2, single (Lot number: EL3302), in right arm, on 05Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 27Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 64 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR oral, start date: 02Mar2015, stop date: 06Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with oral, Paxlovid from 06Aug2022 to 11Aug2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Primary Sjogren's syndrome" (unspecified if ongoing); "dysautonomia" (unspecified if ongoing); "IBS" (unspecified if ongoing); "secondary inflammatory arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "post concussion syndrome" (unspecified if ongoing); "Known allergies: Whey protein" (unspecified if ongoing); "detergent fragrances" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Aug2022) Negative, notes: Positive rapid antigen test 48hrs after negative test; (19Aug2022) Positive, notes: Positive rapid antigen test 48hrs after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received no Other medication in 2 weeks. Patient received treatment with paxlovid from 09Aug2022 to 14Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in two weeks. The patient received Paxlovid for COVID 19 Treatment, Treatment start date is 17Aug2022, Treatment stop date is 19Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 12:00 as dose 1, single (Lot number: EN6205), in right arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: ER8733), in left arm, on 28Oct2021 at 16:30 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 12Apr2022 at 12:45 as dose 4 (booster), single (Lot number: FJ4991) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral aneurysm" (unspecified if ongoing); "Pituitary gland microadenoma" (unspecified if ongoing), notes: Pituitary gland microadenoma. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL], start date: Jan2011. Past drug history included: Morphine, reaction(s): "known_allergies Morphine", notes: known_allergies Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Jul2022, outcome "recovered" (18Aug2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive; (18Aug2022) Negative; (31Jul2022) Positive; (07Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment included the patient COVID-19 PCR test was positive on 31Jul2022. The nurse practitioner at # prescribed me Paxlovid for 5 days which she completed the regime on 05Aug2022. On 07Aug2022, She took another COVID-19 PCR test, the result was negative. On 12Aug2022 she took another covid (antigen) and tested positive, so she had a rebound event. She primary care doctor prescribed me a 2nd round of Paxlovid for 5 more days. On 18Aug2022 I took another COVID (antigen) test and tested negative. 2nd round of Paxlovid treatment was received for the adverse event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 06Aug2022, outcome "unknown", described as "COVID-19"; COVID-19 (medically significant) with onset 06Aug2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2022) Positive; (20Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Clinical course: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was unknown. The patient previously received a COVID-19 Vaccine. Adverse event: Rebound COVID positive, initially positive 06Aug and treated with paxlovid x 5 days, symptoms restarted 19Aug and tested positive 20Aug  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient had no known allergies. She did not receive any other medications in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 13:00 as dose 1, single (Lot number: EN6204), in right arm, on 30Mar2021 at 13:00 as dose 2, single (Lot number: EN6198), in right arm, on 28Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 16May2022 at 13:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient reported Known allergies: No, other medical history: None.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 18Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lactose, reaction(s): "Known allergies: Lactose". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID rebound 4 days after completing Paxlovid.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: severe jaw pain to the point she couldn't open her mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:30 as dose 1 (orange cap), single (Lot number: FK5127) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN JAW (hospitalization, disability, medically significant) with onset 08Nov2021, outcome "recovered" (Nov2021), described as "severe jaw pain to the point she couldn't open her mouth". The patient was hospitalized for pain in jaw (hospitalization duration: 4 day(s)). The event "severe jaw pain to the point she couldn't open her mouth" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pain in jaw with ERP and CBT, OT.  Clinical information: The patient had no known allergies. Patient not had covid prior vaccination. Patient had tested for covid post vaccination. No other vaccine in four weeks. After the first dose, she experienced severe jaw pain to the point she couldn't open her mouth, but this resolved within a week or so. Event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage.