chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose; sweats; mild flu-like symptoms; aching; headache; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not have any pre-existing medical conditions.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache), CHILLS (chills) and ACCIDENTAL OVERDOSE (received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose). At the time of the report, HYPERHIDROSIS (sweats), INFLUENZA LIKE ILLNESS (mild flu-like symptoms), MYALGIA (aching), HEADACHE (headache) and CHILLS (chills) had resolved and ACCIDENTAL OVERDOSE (received full booster dose/non immunocompromised individual received 3rd full dose instead of half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   It was reported that the patient received 3 full doses of the Moderna COVID-19 vaccine.   The patient did not take any medications for her symptoms.   This case was linked to MOD-2022-578392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2022: Follow-up information received includes reporter details, patient details, suspect product information were updated and events were added.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dry eye, Dry mouth
Clinical narrative: Very dry mouth; eyes seem drier too; This case was received via another Manufacturer (Reference number: 202200765415) on 27-May-2022 and was forwarded to Moderna on 27-May-2022. This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (Very dry mouth) and DRY EYE (eyes seem drier too) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EN6207) on 26-Mar-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0176 Location of injection: Arm Left) on 26-Apr-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: EW0187 Location of injection: Arm Left) on 31-Aug-2021; for Drug use for unknown indication: Lamisil. Past adverse reactions to the above products included Allergy with Lamisil; and No adverse reaction with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Sjogren's syndrome. Concomitant products included LIFITEGRAST (XIIDRA) from 03-Jan-2022 to an unknown date for an unknown indication.   On 20-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 26-May-2022, the patient experienced DRY MOUTH (Very dry mouth) and DRY EYE (eyes seem drier too). At the time of the report, DRY MOUTH (Very dry mouth) and DRY EYE (eyes seem drier too) had not resolved.            The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Active Drug substance names for Paxlovid reported as COVID 19 Treatment.  It was reported that very dry mouth, & eyes seem drier too. Patient have Sjogrens Syndrome & already suffer from dry eyes & mouth, but patient think the Paxlovid made the dryness much worse. Patient had been drinking lots of water, about 10 -12 oz glasses per day.  Device Date was reported as 26-May-2022.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Dysgeusia
Clinical narrative: After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Allergy to nuts, Fruit allergy (coconut) and Hashimoto's thyroiditis. Concomitant products included ONDANSETRON from 18-May-2022 to an unknown date and OXYCODONE from 18-May-2022 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 3:00 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 25-May-2022 at 6:00 PM, the patient experienced DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.). At the time of the report, DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported the device date was 26May2022.  No treatment medications were provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Allergy to nuts, Fruit allergy (coconut) and Hashimoto's thyroiditis. Concomitant products included ONDANSETRON from 18-May-2022 to an unknown date and OXYCODONE from 18-May-2022 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 3:00 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 25-May-2022 at 6:00 PM, the patient experienced DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.). At the time of the report, DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported the device date was 26May2022.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20May2022) Positive, notes: Rebound Covid - Positive Again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took anti-viral Covid-19 Treatment of Pfizer brand. Treatment start date was 10May2022 and Stop date 5May2022. She did not had any known allergy. Other medication in 2weeks was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 022C01A), 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (22May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.The patient was treated with paxlovid for covid 19.It was unknown if the patient received any other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19, 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 57-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: tree nuts" (unspecified if ongoing), notes: tree nuts. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: still get a positive; Positive, notes: positive again; negative, notes: after 5 days. Therapeutic measures were taken as a result of covid-19.  Clinical course: Rebound effect. Felt better after 3 days. Tested negative after 5 days. On day 9 got mild symptoms and tested positive again. Now at day 12, symptoms have lessened but still get a positive result on test. Patient received treatment with Paxlovid (Lot: ga8852) from 11May2022 to 15May2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Rebound COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 01May2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(medication in 2 weeks) included: ALLEGRA, start date: 01Jan2018; ZOLOFT, start date: 02Jun2019; DEXILANT, start date: 06Jan2020. The following information was reported: COVID-19 (medically significant) with onset 22May2022, outcome "recovering", described as "Rebound COVID"; VACCINATION FAILURE (medically significant) with onset 22May2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Received antiviral medication for covid-19 treatment from 15May2022 to 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 at 15:00 as dose 1, single (Lot number: EN6203), in left arm, on 16Mar2021 at 12:00 as dose 2, single (Lot number: EN6207), in left arm and on 19Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 04Mar2018, stop date: 22May2022. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex"; Flagyl, reaction(s): "Known allergies: flagyl"; Bactrim, reaction(s): "Known allergies:bactrim"; Zithromax, reaction(s): "Known allergies: Zithromax". The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "recovered" (2022), described as "COVID 19 Treatment"; COVID-19 (medically significant) with onset May2022, outcome "recovered" (2022), described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of symptoms and positive test at day 10. Tested negative on day 6 with no symptoms; Positive, notes: Rebound of symptoms and positive test at day 10. Tested negative on day 6 with no symptoms. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Anti viral details: product-COVID 19 Treatment, brand Paxlovid, start date11May2022, stop date15May2022. Other medication details in 2weeks product were Synthroid, start date04Mar2018, stop date22May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Shoulder operation
Clinical narrative: Shoulder surgery/ Shoulder operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4401105-00 (Abbvie).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 05Jun2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Shoulder surgery/ Shoulder operation". The action taken for adalimumab was unknown.  The reporter considered "shoulder surgery/ shoulder operation" related to BNT162b2.  The reporter's causality for the event of shoulder surgery/ shoulder operation with HUMIRA (ADALIMUMAB) was not related. The reporter causality for the event of shoulder surgery/ shoulder operation with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event shoulder operation and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: a lot of allergies to things and had to take Benadryl before each dose of the Pfizer COVID-19 vaccine; 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 female patient received BNT162b2 (BNT162B2), as dose1, single (Batch/Lot number: unknown) and as dose2, 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 HYPERSENSITIVITY (medically significant), outcome "unknown", described as "a lot of allergies to things and had to take Benadryl before each dose of the Pfizer COVID-19 vaccine". Therapeutic measures were taken as a result of drug hypersensitivity.  Clinical information: Inquiry made by reporter as that she heard there may be a new formulation of the Pfizer COVID-19 vaccine that is variant specific, she would like to know if this is true and when it might be available. Informed as omicron-specific Covid vaccine is an investigational product (not authorized). Inquiry made by her regarding rceiving the primary series and a first booster dose. She states that she is trying to decide on whether or not get the second booster dose that is now authorized and would like to know how long the second booster dose provides protection against COVID-19. The caller also stated that she "a lot of allergies to things and had to take Benadryl before each dose of the Pfizer COVID-19 vaccine" The caller also stated that she was fine with each dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankle fracture, Fatigue, Knee arthroplasty, Pain, Shoulder arthroplasty
Clinical narrative: Shoulder replacement; Total knee replacement; General body pain; Tiredness; Broken ankle; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4400217-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE:1, SINGLE, route: intramuscular), for COVID-19 immunization; Bnt162b2 (DOSE:2, SINGLE, route: intramuscular), for COVID-19 immunization. The following information was reported: ANKLE FRACTURE (medically significant) with onset 2021, outcome "unknown", described as "Broken ankle"; SHOULDER ARTHROPLASTY (medically significant), outcome "unknown", described as "Shoulder replacement"; KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "Total knee replacement"; PAIN (non-serious), outcome "unknown", described as "General body pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". The action taken for upadacitinib was unknown.  Clinical course: The reporter stated that, on an unknown date, the patient experienced shoulder replacement, knee replacement after booster shot patient hurt all over and tired after booster shot. In 2021, the patient experienced Broken Ankle. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "shoulder replacement", "total knee replacement", "broken ankle", "general body pain" and "tiredness" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Shoulder arthroplasty, knee arthroplasty, ankle fracture, pain, fatigue and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 37.0
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) (Physician). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Dec2020 as dose 1, single (Lot number: 025J20A), in left arm and on 26Jan2021 as dose 2, single (Lot number: 028L20A), in right arm 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 "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Positive; (12May2022) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient underwent treatment with Paxlovid for COVID-19 from 09May2022 to 13May2022. Other medication was not received within 2 weeks. Vaccine was received. Patient tested negative on Binax home tests starting 12May, then negative on four subsequent tests in the days that followed. Symptoms resumed after 9 days of testing negative (Day 12 from original symptom onset), then tested positive again on home test soon after. Patient received second round of Paxlovid.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL1253), in right arm, on 09Feb2021 at 13:00 as dose 2, single (Lot number: EN5318), in right arm, on 01Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FC3189), in left arm and on 26Jan2022 at 13:00 as dose 4 (booster), single (Lot number: FL3197) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer of tonsil on chemo 21Dec-22Feb" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: 01Dec2021, stop date: 22May2022. Past drug history included: Simvastatin, reaction(s): "known allergies: simvastatin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (11May2022) Positive; (17May2022) Negative; (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event: Reporting a long-delay relapse: Relapse of covid 5 days after finishing paxlovid. Received chemotherapy 21Dec-22Feb. Covid symptoms and paxlovid began 11May. No symptoms and tested negative 17May; recurrent fatigue & cough 21May. Test positive 21May2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test.; Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 12:00 as dose 1, single (Lot number: EH9899), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm and on 09Aug2021 at 12:00 as dose 3 (booster), single (Lot number: EWO173) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Mar2022 at 12:00 as dose 4 (booster), single (Lot number: 026l21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "None except migraine" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL; FIORICET. Past drug history included: Morphine - rash, reaction(s): "Rash", notes: Known allergies: Morphine - rash. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (21May2022) Positive; (unspecified date) Positive; (unspecified date) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test. Recurrence of symptoms -sore throat, severe congestion, low grade temp, severe HA, fatigue prompted retest. The patient received Paxlovid for Covid-19 treatment started on 11May2022 till 15May2022, Lot number= Ga1188. Yes vaccine received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 45.0
Sex: F
Vaccine: COVID19, 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. 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: (unspecified date) Positive; (22May2022) Positive, notes: Tested positive for COVID again on 22May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The Other medication in 2weeks: Yes. The patient did not had any known allergies. The patient did not received any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 at 10:00 as dose 1, single (Lot number: EN6205), in right arm, on 23Mar2021 at 08:30 as dose 2, single (Lot number: ER8733), in right arm, on 18Oct2021 at 20:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 28Apr2022 at 17:30 as dose 4 (booster), single (Lot number: 001M21A) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor" (unspecified if ongoing), notes: Verbatim: Breast cancer survivor. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: positive rapid test on 22May after testing negative on 20May. Initial positive test was 12May; (20May2022) Negative, notes: positive rapid test on 22May after testing negative on 20May. Initial positive test was 12May; (22May2022) Positive, notes: positive rapid test on 22May after testing negative on 20May. Initial positive test was 12May. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid for covid 19 from 12May2022 to 17May2022. Patient received no other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=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.  An adult male patient received BNT162b2 (BNT162B2, solution for injection), on 04May2022 at 20:15 as dose 4 (booster), single (Lot number: Fk9895), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: O46a21a), in left arm, on 14Apr2021 as dose 2, single (Lot number: O42b21a), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: O32f21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; FLOMAX [TAMSULOSIN HYDROCHLORIDE], stop date: 10May2022; MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (21May2022) Positive, notes: Rebound, return of symptoms 5 days after dealing recovered, Still sick, pos test for Covid 12 days past start of illness, 11days after starting paxlovid. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received treatment with Paxlovid from 10May2022 to 14May2022 for the treatment of COVID-19.
Age: 58.0
Sex: M
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). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: FP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: FP6955), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [LORATADINE]. 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: (unspecified date) positive; (unspecified date) Negative; (20May2022) Positive, notes: Symptoms were gone after course of Paxlovid treatment but returned 4 days later (20May2022). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment received for covid-19 treatment from 11May2022 to 15May2022. Symptoms were gone after course of Paxlovid treatment but returned 4 days later (20May2022). Symptoms included sinus congestion, persistent cough and sore throat. Symptoms were less severe than initial symptoms (no achy feeling, no tiredness).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 at 12:00 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 54 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: "Asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporins, reaction(s): "Known allergies: Cephalosporins". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Anti-viral details: product: COVID 19 Treatment,Brand: Pfizer,Treatment start date: 20May2022,Lot number: GA5120,Indication: Treatment of COVID-19,Vaccine lot unknown reason: Unable to locate or read the details,Adverse event: Aches, headache - more than day 1 of COVID,Adverse event country: Adverse event start date: 22May2022,Adverse event start time: 10:00 PM,patient recovered was not Recovered treatment AE: No,Known allergies: Sulfa, Cephalosporins, Gluten.Other medical history: Asthma, hypothyroid, allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19, 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) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: EW0198) at the age of 59 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 included: "Overweight" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Coartem, reaction(s): "known allergies: Coartem (a malaria treatement)", notes: (a malaria treatement). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Product: COVID 19 Treatment. treatment start date: 16May2022. treatment stop date: 21May2022. Indication: Treatment of COVID-19. On the 5th and final day of the Paxlovid treatment she developed an itchy rash. Main patches were on the upper thighs, but small, more isolated spots were found on the chest, neck, back, lower legs and arms. The rash and itch were still active 48 hours after the final Paxlovid dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Ag test; Positive Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 36-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "Positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.   Clinical course: The patient was COVID exposure on 30Apr2022 then 04May mild dizziness fevers and fatigue and Ag test on 05May2022. The patient had covid tested post vaccination.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.       No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "thyroid" (unspecified if ongoing), notes: Other medical history: thyroid. The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Known allergies  Codine", notes: Known allergies: Codine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (20May2022) temperature swings 101.5 to 95.5 in minutes. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had a rebound with mild symptoms and positive test around day 9; Had a rebound with mild symptoms and positive test around day 9; 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 48-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER8T30), in right arm, on 12Apr2021 as dose 2, single (Lot number: EW0158), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "recovered" and all described as "Had a rebound with mild symptoms and positive test around day 9". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: around day 9; (May2022) negative, notes: on the 7th day. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Anti-viral details: product COVID 19 Treatment, Paxlovid, treatment start date 04May2022, treatment stop date 08May2022. other medication in 2weeks product Allupurinol. Adverse event Symptoms resolved pretty quickly, and I tested negative and was symptom-free on the 7th day. Had a rebound with mild symptoms and positive test around day 9, and didn't test negative again until around day 16.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, 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) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years, in right arm for covid-19 immunization; 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's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: Honey" (unspecified if ongoing), notes: Known allergies: Honey. Concomitant medication(s) included: LEVOTHYROXINE. The patient was not pregnant at time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Paxlovid (Lot number: GA5101) from 15May2022 to 20May2022 for the treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.