chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: tiredness; headache; congestion; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose: 2, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose 3 (1st Booster dose), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 03May2022, outcome "not recovered", described as "congestion"; HEADACHE (non-serious) with onset 03May2022, outcome "not recovered"; FATIGUE (non-serious) with onset 03May2022, outcome "recovered" (May2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of event: This 90 year old female nurse reported that she received her second booster dose of the Pfizer Covid 19 vaccine on 02May2022. On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tiredness; headache; congestion; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose: 2, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose 3 (1st Booster dose), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 03May2022, outcome "not recovered", described as "congestion"; HEADACHE (non-serious) with onset 03May2022, outcome "not recovered"; FATIGUE (non-serious) with onset 03May2022, outcome "recovered" (May2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of event: This 90 year old female nurse reported that she received her second booster dose of the Pfizer Covid 19 vaccine on 02May2022. On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: tiredness; headache; congestion; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose: 2, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (Dose 3 (1st Booster dose), Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 03May2022, outcome "not recovered", described as "congestion"; HEADACHE (non-serious) with onset 03May2022, outcome "not recovered"; FATIGUE (non-serious) with onset 03May2022, outcome "recovered" (May2022), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Description of event: This 90 year old female nurse reported that she received her second booster dose of the Pfizer Covid 19 vaccine on 02May2022. On 03May2022 the patient developed tiredness, headache and congestion. On 08May2022, the patient tested positive for Covid 19. Her tiredness has resolved, the headache and congestion are ongoing. Event took place after use of product.  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: Fatigue, Nausea
Clinical narrative: nausea; Fatigue/tired easily with activity; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (1st booster dose, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue/tired easily with activity".  Additional information: The patient received Comirnaty second booster. Event took place after use of product. No additional history. No underlying conditions known.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Nasal congestion
Clinical narrative: congestion; sneezing; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pfizer, vaccine dose number=2; pfizer vaccine dose number=1; Moderna dose number=unknown" (unspecified if ongoing), notes: Pfizer, vaccine dose number=2; pfizer vaccine dose number=1; Moderna dose number=unknown. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", PYREXIA (non-serious), CHILLS (non-serious), COUGH (non-serious) all with onset 28Apr2022, outcome "recovered" (05May2022) and all described as "Original symptoms (fever, chills, cough) started 28Apr Positive Covid test"; COVID-19 (medically significant) with onset 29Apr2022, outcome "unknown", described as "Original symptoms (fever, chills, cough) started 28Apr Positive Covid test"; NASAL CONGESTION (non-serious) with onset 07May2022, outcome "recovering", described as "congestion"; SNEEZING (non-serious) with onset 07May2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (06May2022) Negative; (07May2022) Negative; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of nasal congestion, sneezing, pyrexia, chills, cough. Clinical course included After completing the 5-day course of Paxlovid and testing negative 2 days in a row, symptoms returned and patient tested positive again. No allergies reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sneezing
Clinical narrative: congestion; sneezing; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; Original symptoms (fever, chills, cough) started 28Apr Positive Covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pfizer, vaccine dose number=2; pfizer vaccine dose number=1; Moderna dose number=unknown" (unspecified if ongoing), notes: Pfizer, vaccine dose number=2; pfizer vaccine dose number=1; Moderna dose number=unknown. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", PYREXIA (non-serious), CHILLS (non-serious), COUGH (non-serious) all with onset 28Apr2022, outcome "recovered" (05May2022) and all described as "Original symptoms (fever, chills, cough) started 28Apr Positive Covid test"; COVID-19 (medically significant) with onset 29Apr2022, outcome "unknown", described as "Original symptoms (fever, chills, cough) started 28Apr Positive Covid test"; NASAL CONGESTION (non-serious) with onset 07May2022, outcome "recovering", described as "congestion"; SNEEZING (non-serious) with onset 07May2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (06May2022) Negative; (07May2022) Negative; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of nasal congestion, sneezing, pyrexia, chills, cough. Clinical course included After completing the 5-day course of Paxlovid and testing negative 2 days in a row, symptoms returned and patient tested positive again. No allergies reported.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris
Clinical narrative: It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 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: Bnt162b2 (Dose 1, Got both other vaccines as Pfizer also. Unlike my other two shots (the 1st was no symptoms)), for Covid-19 immunization, reaction(s): "the 1st was no symptoms"; Bnt162b2 (Dose=2, Got both other vaccines as Pfizer also. 2nd was flu-like symptoms for a day), for Covid-19 immunization, reaction(s): "2nd was flu-like symptoms for a day". The following information was reported: ANGINA PECTORIS (medically significant) with onset Oct2021, outcome "unknown", described as "It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area". Clinical course: The patient got both other vaccines as Pfizer also. Unlike other two shots (the 1st was no symptoms, and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. It felt as it was instantly spreading. Within 30 seconds, patient started to get a sharp stabbing pain in the heart area. That lasted all day every few minutes. The patient was wanted to see if get any insight from the company about patients medical problems after getting the Pfizer booster back in Oct2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, COVID-19, Cardiac stress test, Computerised tomogram
Clinical narrative: It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 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: Bnt162b2 (Dose 1, Got both other vaccines as Pfizer also. Unlike my other two shots (the 1st was no symptoms)), for Covid-19 immunization, reaction(s): "the 1st was no symptoms"; Bnt162b2 (Dose=2, Got both other vaccines as Pfizer also. 2nd was flu-like symptoms for a day), for Covid-19 immunization, reaction(s): "2nd was flu-like symptoms for a day". The following information was reported: ANGINA PECTORIS (medically significant) with onset Oct2021, outcome "unknown", described as "It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area". Clinical course: The patient got both other vaccines as Pfizer also. Unlike other two shots (the 1st was no symptoms, and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. It felt as it was instantly spreading. Within 30 seconds, patient started to get a sharp stabbing pain in the heart area. That lasted all day every few minutes. The patient was wanted to see if get any insight from the company about patients medical problems after getting the Pfizer booster back in Oct2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Vaccination failure
Clinical narrative: It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 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: Bnt162b2 (Dose 1, Got both other vaccines as Pfizer also. Unlike my other two shots (the 1st was no symptoms)), for Covid-19 immunization, reaction(s): "the 1st was no symptoms"; Bnt162b2 (Dose=2, Got both other vaccines as Pfizer also. 2nd was flu-like symptoms for a day), for Covid-19 immunization, reaction(s): "2nd was flu-like symptoms for a day". The following information was reported: ANGINA PECTORIS (medically significant) with onset Oct2021, outcome "unknown", described as "It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area". Clinical course: The patient got both other vaccines as Pfizer also. Unlike other two shots (the 1st was no symptoms, and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. It felt as it was instantly spreading. Within 30 seconds, patient started to get a sharp stabbing pain in the heart area. That lasted all day every few minutes. The patient was wanted to see if get any insight from the company about patients medical problems after getting the Pfizer booster back in Oct2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (03May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HCTZ; METOPROLOL [METOPROLOL TARTRATE]; LOSARTAN; ASPIRIN LOW; MELATONIN; CRANBERRY; VITAMIN B2 [RIBOFLAVIN]; MAGNESIUM GLYCINATE. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine"; Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pruritus, SARS-CoV-2 test
Clinical narrative: had a dull pain in my bilateral upper arms since receiving the vaccine; My right arm has significant less strength; had an episode approximately 2 weeks after receiving it where I had severe itching; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "had an episode approximately 2 weeks after receiving it where I had severe itching." (unspecified if ongoing), notes: No rash but had to take Benadryl to be able to sleep. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset Feb2022, outcome "not recovered", described as "My right arm has significant less strength"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "not recovered", described as "had a dull pain in my bilateral upper arms since receiving the vaccine"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "had an episode approximately 2 weeks after receiving it where I had severe itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, asthenia. Therapeutic measures were taken as a result of pruritus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Malaise, Pyrexia
Clinical narrative: Severe coughing; SOB; Fever 102; malaise; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 at 17:45 as dose 3 (booster), single (Lot number: FK9893) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown, Batch/Lot No: EW0185), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer Unknown, Batch/Lot No: Unknown/Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Fever 102"; DYSPNOEA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "SOB"; COUGH (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Severe coughing"; MALAISE (non-serious) with onset 07May2022 at 05:00, outcome "unknown"; ASTHENIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "weakness". The events "severe coughing", "sob", "fever 102", "malaise" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, dyspnoea, pyrexia, malaise, asthenia.  Additional information: If other vaccine in four weeks: No. If Covid prior vaccination: Yes. If Covid tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Severe coughing; SOB; Fever 102; malaise; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 at 17:45 as dose 3 (booster), single (Lot number: FK9893) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown, Batch/Lot No: EW0185), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer Unknown, Batch/Lot No: Unknown/Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Fever 102"; DYSPNOEA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "SOB"; COUGH (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Severe coughing"; MALAISE (non-serious) with onset 07May2022 at 05:00, outcome "unknown"; ASTHENIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "weakness". The events "severe coughing", "sob", "fever 102", "malaise" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, dyspnoea, pyrexia, malaise, asthenia.  Additional information: If other vaccine in four weeks: No. If Covid prior vaccination: Yes. If Covid tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 32 years 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 was not reported. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 06May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Patient had no known allergies. Patient did not receive any medications within two weeks.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Tested Covid positive; Tested Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER8730) and as dose 2, single (Lot number: EW0167) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Oct2021 as dose 3 (booster), single (Lot number: 011F21A) for covid-19 immunisation. The patient's relevant medical history included: "MCADD" (unspecified if ongoing), notes: (reason for using L-carnitine daily); "Known allergies: Dust" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing). Concomitant medication(s) included: ZINC.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 29Apr2022, outcome "not recovered" and all described as "Tested Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (29Apr2022) Positive; (30Apr2022) Positive; (04May2022) Positive; (05May2022) Positive; (06May2022) Negative; (08May2022) Negative; (09May2022) Positive, notes: Started sniffling on 09May (Day 10), and rapid test resulted positive(rebound).Tested Covid positive (Cue NAAT test) on 29Apr2022. Tested Covid positive on rapid test (iHealth) on 30Apr2022. Started Paxlovid treatment on 30Apr2022. Tested positive on rapid tests on 04May and 05May (Days 5 & 6). Tested negative on 06May and 08May (Day 7 and Day 9). Started sniffling on 09May (Day 10), and rapid test resulted positive (rebound).Therapeutic measures were taken as a result of covid-19.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 at 12:00 as dose 1, single (Lot number: EK3730), in left arm, on 11Jan2021 at 11:00 as dose 2, single (Lot number: EL3246), in left arm and on 27Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Ff2589) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: IRBESARTAN, start date: 01Jan2015; LIPITOR, start date: 01Jan2015, stop date: 22Apr2022; FAMOTIDINE, start date: 01Jan2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included: COVID-19 was treated with Paxlovid from 22Apr2022 to 27Apr2022. On 2May2022 the symptoms rebound after completing Paxlovid treatment and the patient was recovering. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 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 had no relevant medical history. The patient's concomitant medications were not reported. Patient previously received a COVID-19 Vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included no seriousness criteria reported. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient tested positive 4 days after negative test. But symptoms are mild.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "interchange of vaccine administered" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 30Apr2022, outcome "recovered" (04May2022), DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Treatment include of paxlovid from 20Apr2022 to 27Apr2022. Patient Not taken any other medications/products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Poor quality product administered, Product administration error
Clinical narrative: possibly administered an expired shot; possibly administered an expired shot; weakness of his whole body; stated that he does not feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FD1189) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, Lot No: FF8726), for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "possibly administered an expired shot"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness of his whole body"; MALAISE (non-serious), outcome "unknown", described as "stated that he does not feel well". Therapeutic measures were taken as a result of asthenia.  Additional information: The patient took the Covid shot and does not feel well. Stated that he was told that the shot may have been expired. Stated that it may be nothing and he may be recovered. Stated that his is lasting longer and he hoped to recover. Wanted to know the expiration date. Wanted to know if the Covid shot had expired. Patient Weight is 170-180. Stated that he had weakness of his whole body 1.5 weeks after the shot. Stated that it was his second dose. Stated that he is better than before but still weak. Stated that he took Advil and Tylenol for the weakness. Stated that the lot number for the first dose was FF8726. Stated that he does not have the expiration date  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1 single (Lot number: Okm20A), in right arm and on 05Mar2021 as dose 2, single (Lot number: 036A21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Rebound Covid 10 after start of Paxlovid. Device Date 10May2022, (treatment received: Paxlovid, treatment start date 25Apr2022, treatment stop date 30Apr2022).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Originally Covid caused bronchitis and that was cured with the Paxlovid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 at 22:00 as dose 1, single (Lot number: SR6733), in right arm, on 20Apr2021 at 22:00 as dose 2, single (Lot number: EW0164), in right arm, on 27Nov2021 at 19:00 as dose 3 (booster), single (Lot number: FH8030), in right arm and on 10Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19"; BRONCHITIS (non-serious) with onset 2022, outcome "recovered" (2022), described as "Originally Covid caused bronchitis and that was cured with the Paxlovid.". Therapeutic measures were taken as a result of vaccination failure, covid-19, bronchitis included Paxlovid.  Clinical Course: After I finished the Paxlovid my symptoms came back about 12 hours later. They never totally went away with the Paxlovid, but they noticeably increased when I finished. Coughing, dripping down the back of my throat, tiredness. Originally Covid caused bronchitis and that was cured with the Paxlovid.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Dec2021 at 12:00 as dose 2, single (Lot number: en5318), in left arm and as dose 3 (booster), single (Lot number: fd8448) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Caffeine" (unspecified if ongoing), notes: Known allergies: Caffeine. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course included the patient did not receive any other medications within 2 weeks of vaccination. SUSPECTED COVID-19 was treated from 25Apr2022 to 30Apr2022. On 4May2022 the symptoms includes Runny nose, stuffy nose, chest tightness (like the flu, milder case), tired, - same symptoms as before he took Paxlovid, but milder. The patient was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EN5328), in left arm, on 02Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Known allergy sulfa drug" (unspecified if ongoing), notes: sulfa drugs allergy. Concomitant medication(s) included: FAMOTIDINE, start date: 08Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 68.0
Sex: M
Vaccine: COVID19, 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 68-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: mollusks" (unspecified if ongoing), notes: known allergies: mollusks. Concomitant medication(s) included: ZOCOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Product administered at inappropriate site
Clinical narrative: COVID-19; COVID-19; vaccine location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: ff2589) at the age of 66 years, in left leg 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 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06Oct2021, outcome "unknown", described as "vaccine location=Left leg"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Inappropriate schedule of product administration, Off label use
Clinical narrative: Covid-19; Covid-19; Dose Number 4: 07Dec2021; Dose Number 4: 07Dec2021; Dose Number 4: 07Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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) and as dose 3 (booster), 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: IMMUNISATION (medically significant), OFF LABEL USE (medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "Dose Number 4: 07Dec2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03May2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Negative, notes: Tested negative on 28Apr to 01May; (03May2022) Positive; (08May2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; Dose Number 4: 07Dec2021; Dose Number 4: 07Dec2021; Dose Number 4: 07Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 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) and as dose 3 (booster), 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: IMMUNISATION (medically significant), OFF LABEL USE (medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 07Dec2021, outcome "unknown" and all described as "Dose Number 4: 07Dec2021"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03May2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Negative, notes: Tested negative on 28Apr to 01May; (03May2022) Positive; (08May2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Suspected COVID-19; SUSPECTED COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: el9262), in left arm, on 25Feb2021 as dose 2, single (Lot number: el9266), in left arm, on 26Aug2021 as dose 3 (booster), single (Lot number: fc3181), in left arm and on 31Mar2022 at 11:30 as dose 4 (booster), single (Lot number: fk9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mastocytosis emphysema" (unspecified if ongoing), notes: Mastocytosis emphysema; "Mastocytosis emphysema" (unspecified if ongoing), notes: Mastocytosis emphysema. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Suspected COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.