chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19, Weight
Clinical narrative: Long Haul Covid; Long Haul Covid; 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-163-4370040-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown), in Oct2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Heart Attack", start date: Apr2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Long Haul Covid". The patient underwent the following laboratory tests and procedures: Weight: Lost 60 Pounds. The action taken for adalimumab was unknown.  The reporter's causality for the event of long covid with Pfizer BioNTech COVID-19 Vaccine and Humira was not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the Limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Brand=Paxlovid , indication=Treatment of COVID-19; Brand=Paxlovid , indication=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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: Ff2593) at the age of 63 years, in right 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: "Osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis. Concomitant medication(s) included: ALENDRONATE, start date: 19Apr2022, stop date: 19Apr2022. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Tested negative after treatment; (2022) Positive, notes: subsequently tested positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details: [{product=COVID 19 Treatment, brand=Paxlovid ,Treatment start date=15Apr2022, Treatment stop date=19Apr2022. Indication=Treatment of COVID-19}].  Follow up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor).; Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor).; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FJ1611), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM, start date: 01Jan2021; XYZAL, start date: 01Jan2021. Past drug history included: Sudafed, reaction(s): "Known allergies: Sudafed". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: First initial positive test (at-home then confirmed by doctor). Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 17Apr2022 to 22Apr2022 (Lot number: FL4517). Initiated treatment 48 hours after first symptoms and 12 hours after first initial positive test (at-home then confirmed by doctor). Felt better within 3-4 days after starting treatment. Only side effect was horrible bitter taste in mouth for 6-8 after taking each dose. Four days after completing treated, COVID symptoms rebounded and came back with nagging cough, low grade fever, headache and congestion.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune disease" (unspecified if ongoing), notes: Immune disease, in process of determining actual disease. Concomitant medication(s) included: METHOTREXATE; HYDROXYCHLOROQUINE; LEUCOVORIN [CALCIUM FOLINATE]; FOLIC ACID; CALCIUM; VITAMIN D [COLECALCIFEROL]; ALPHA LIPOIC ACID; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Positive, notes: Took another test when symptoms recurred and got a very immediate, strong positive; (19Apr2022) weak positive, notes: got very weak positive. Therapeutic measures were not taken as a result of covid-19. Clinical course: Patient stated that, 5 days after completion of Paxlovid, I had relapse of extreme sinus congestion, runny nose and weakness, fatigue. After two days that, I had recurrence of coughing and also developed UTI at same time. Took home antigen test 2 days after completion of anti viral, and got very weak positive. Took another test when symptoms recurred and got a very immediate, strong positive.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound positive test result of COVID; Rebound positive test result of COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no known drug allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound positive test result of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. There was rebound positive test result of COVID-19 1 week after finish of Paxlovid course. The device date was reported as 27Apr2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Dose Number: 3 Batch/Lot No: Unknown./ experiencing COVID symptoms; Dose Number: 3 Batch/Lot No: Unknown./ experiencing COVID symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right 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: "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Apr2022 at 09:00, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 27Apr2022 at 09:00, outcome "not recovered" and all described as "Dose Number: 3 Batch/Lot No: Unknown./ experiencing COVID symptoms". Therapeutic measures were taken as a result of suspected covid-19.   Clinical course: Patient received Pfizer COVID-19 vaccine and had no other medications in 2 weeks. Received paxlovid as COVID-19 treatment from 22APR2022 to 26APR2022 with lot number FY4422. Patient experienced COVID symptoms again within 12 hours of taking the last dose of Paxlovid. Device Date was reported as 27Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 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 1, single (Batch/Lot number: unknown) and in Mar2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 24Apr2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were not 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Mar2022, outcome "recovered" (06Apr2022) and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; negative; positive; negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient took Paxlovid to treat a covid infection, felt better and tested negative after a week. Then a week after testing negative, patient began to feel sick and tested strongly positive for covid again for 8 or 9 days after which felt better and finally tested negative again. Patient seem to have relapsed or reinjected a week after recovering for the first round of covid. No Other medication in 2weeks.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; ON Day 10 became sick again; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 08Nov2021 at 12:00 as dose 3 (booster),single (Lot number: FH8028) at the age of 64 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "irritable bowel and diverticulosis" (unspecified if ongoing); "irritable bowel and diverticulosis" (unspecified if ongoing). Concomitant medication(s) included: LINZESS, start date: 01Dec2021 (also reported as other medication in 2weeks). The following information was reported: ILLNESS (non-serious) with onset Apr2022, outcome "recovering", described as "ON Day 10 became sick again"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Tested Positive for Covid treated with paxlovid; (Apr2022) Positive, notes: tested positive on days 11 and 12; (Apr2022) Positive, notes: Positive on Day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started on 15Apr2022 and Stopped on 24Apr2022. Therapeutic measures were not taken as a result of illness. Clinical course was reported Tested Positive for Covid treated with paxlovid. Severe symptoms Improved quickly and all symptoms were gone by Day 7. tested negative on Days 7-8-9. On Day 10 became sick again (much less severe) and tested positive on days 11 and 12.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: M
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). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had received Brand: Paxlovid as COVID 19 Treatment on 18Apr2022. Paxlovid rebound. Paxlovid completed on 22Apr2022. On Day 12 (26Apr2022) testing positive on RAT with mild symptoms.  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: Reinfection on day 14, with positive test; Reinfection on day 14, with positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EI9293), in left arm, on 03Feb2021 as dose 2, single (Lot number: EI9266), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZOLOFT; AMLODIPINE; PRAVASTATIN. Past drug history included: Compazine, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Apr2022 at 19:00, outcome "unknown" and all described as "Reinfection on day 14, with positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2022) unknown; (17Apr2022) Negative; (24Apr2022) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that, the patient received Paxlovid drug for the treatment of COVID-19 from 11Apr2022 to 16Apr2022.  Follow-Up (29Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: FF8841), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LISINOPRIL; MONTELUKAST. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Negative; (22Apr2022) positive; (27Apr2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: After completing her paxlovid meds on17Apr2022, her symptoms were gone and she tested negative on a home covid test on 18Apr2022. On 22Apr2022 she developed covid symptoms again and tested positive on a home test. She currently was still testing positive on 27Apr2022 and have cough and congestion. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: muscle aches (left arm, upper back, neck); headache; mildly nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hayfever and related allergies" (unspecified if ongoing); "Hayfever and related allergies" (unspecified if ongoing). Concomitant medication(s) included: XYZAL; MONTELUKAST SODIUM; MOMETASONE FUROATE. Vaccination history included: BNT162b2 (Lot number: 501458A, Route of administration: Intramuscular, Dose: 3, Location: Left arm), administration date: 30Oct2021, for Covid-19 immunization; BNT162b2 (Lot number: EL3247, Dose: 2), administration date: 29Mar2021, for Covid-19 immunization, reaction(s): "soreness at injection site", "headache", "Mild nausea"; BNT162b2 (Lot number: EL3247, Dose: 1), administration date: 08Mar2021, for Covid-19 immunization, reaction(s): "Sore arm at injection site", "felt jittery". The following information was reported: HEADACHE (non-serious) with onset 26Apr2022 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 26Apr2022 at 19:00, outcome "recovering", described as "mildly nauseated"; MYALGIA (non-serious) with onset 26Apr2022 at 19:00, outcome "recovering", described as "muscle aches (left arm, upper back, neck)". Therapeutic measures were taken as a result of myalgia, headache, nausea.  Additional information: The patient did not receive any other vaccine in four weeks. Prior to vaccination patient has no covid and patient not tested covid after vaccination. Patient had no known allergies. The patient received Acetaminophen to treat the events. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess jaw, Abscess neck, Carotid artery disease, Infected cyst, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "HEDS" (unspecified if ongoing); "depression" (unspecified if ongoing); "Barrett's" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: Sertraline; Famotidine; Omeprazole; Vitamin D [Colecalciferol]; Iron. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: EW0217, Location of injection: Arm Left), administration date: 06Oct2021, when the patient was 52-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 51-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 12Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: INFECTED CYST (non-serious) with onset 11Apr2022, outcome "recovered with sequelae"; ABSCESS JAW (medically significant), ABSCESS NECK (non-serious) all with onset 11Apr2022, outcome "recovered with sequelae" and all described as "abscess on left jawline/upper neck"; CAROTID ARTERY DISEASE (medically significant) with onset 11Apr2022, outcome "recovered with sequelae", described as "carotid artery". The events "carotid artery", "abscess on left jawline/upper neck" and "infected cyst" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of carotid artery disease, abscess jaw, infected cyst, abscess neck. Clinical course included Patient received treatment cephalexin. Covid prior vaccination. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccination failure; Covid 19; This is a spontaneous report received from 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 27Mar2021 as dose 1, single (Lot number: Er8732), in left arm, on 17Apr2021 as dose 2, single (Lot number: Ew0169), in left arm and on 22Sep2021 as dose 3 (booster), single (Lot number: Ew0187) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lymphoma" (unspecified if ongoing), notes: Cancer survivor (lymphoma). Concomitant medication(s) included: FLUOXETINE; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "vaccination failure"; COVID-19 (medically significant), outcome "unknown", described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID - seemed worse than initial infection. Therapeutic measures were taken as a result of covid-19. Clinical Infomation: Patient took PAXLOVID as Covid 19 treatment (Treatment start date 14Apr2022 and Treatment stop date 18Apr2022). Patient received concomitant therapy with Generic (Unspecified manufacturer).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 66 years for covid-19 immunization. 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 26Apr2022, outcome "recovering" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: Nasal Swab (Home Ag). It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Facility type vaccine was reported as Workplace clinic. It was unknown if patient received other vaccine in four weeks. It was unknown if patient had covid prior vaccination. Reported that patient went to horse show, later after 2 days the symptoms of fever, runny nose and HA (headache) has started on 26Apr2022.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Oxygen saturation decreased, Oxygenation index
Clinical narrative: symptoms of covid, tested positive on antigen home test; symptoms of covid, tested positive on antigen home test; covid cough; oxygen dropped from 96 to 92; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL1283), in left arm and on 29Jan2021 as dose 2, single (Lot number: EL3247) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: hashimoto's thyroiditis" (unspecified if ongoing), notes: Other medical history: hashimoto's thyroiditis, high pulse rate; "Other medical history: high pulse rate" (unspecified if ongoing), notes: Other medical history: hashimoto's thyroiditis, high pulse rate; "Known allergies: soy" (unspecified if ongoing), notes: Known allergies: soy, sulfa drugs, shellfish; "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: soy, sulfa drugs, shellfish; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: soy, sulfa drugs, shellfish. Concomitant medication(s) included: PROPRANOLOL, start date: 10Aug2021; ARMOUR THYROID, start date: 01Aug2015; VITAMIN D3, start date: 01Jan2020; VITAMIN C [ASCORBIC ACID], start date: 01Jan2020; METHYL FOLATE, start date: 01Oct2020. The following information was reported: OXYGEN SATURATION DECREASED (non-serious) with onset 21Mar2022, outcome "unknown", described as "oxygen dropped from 96 to 92"; DRUG INEFFECTIVE (hospitalization, medically significant) with onset 21Mar2022, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 21Mar2022, outcome "unknown" and all described as "symptoms of covid, tested positive on antigen home test"; COUGH (non-serious) with onset 24Mar2022, outcome "unknown", described as "covid cough". The patient underwent the following laboratory tests and procedures: Oxygenation index: (21Mar2022) dropped from 96 to 92, notes: oxygen dropped from 96 to 92; SARS-CoV-2 test: (15Apr2022) Positive, notes: 15Apr2022: admitted to hospital, antigen COVID test positive. no follow up PCR; (20Mar2022) Negative, notes: 20Mar2022: symptoms of COVID, tested negative; (21Mar2022) Positive, notes: 21Mar2022: symptoms of COVID, tested positive on antigen home test; (22Mar2022) confirmed COVID, notes: 22Mar2022: took PCR test at (Pharmacy withheld) confirmed COVID; (11Apr2022) Negative, notes: 11Apr2022: finally got at home negative COVID test result. Therapeutic measures were taken as a result of drug ineffective, covid-19, oxygen saturation decreased, cough.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: symptoms of covid, tested positive on antigen home test; symptoms of covid, tested positive on antigen home test; covid cough; oxygen dropped from 96 to 92; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL1283), in left arm and on 29Jan2021 as dose 2, single (Lot number: EL3247) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: hashimoto's thyroiditis" (unspecified if ongoing), notes: Other medical history: hashimoto's thyroiditis, high pulse rate; "Other medical history: high pulse rate" (unspecified if ongoing), notes: Other medical history: hashimoto's thyroiditis, high pulse rate; "Known allergies: soy" (unspecified if ongoing), notes: Known allergies: soy, sulfa drugs, shellfish; "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: soy, sulfa drugs, shellfish; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: soy, sulfa drugs, shellfish. Concomitant medication(s) included: PROPRANOLOL, start date: 10Aug2021; ARMOUR THYROID, start date: 01Aug2015; VITAMIN D3, start date: 01Jan2020; VITAMIN C [ASCORBIC ACID], start date: 01Jan2020; METHYL FOLATE, start date: 01Oct2020. The following information was reported: OXYGEN SATURATION DECREASED (non-serious) with onset 21Mar2022, outcome "unknown", described as "oxygen dropped from 96 to 92"; DRUG INEFFECTIVE (hospitalization, medically significant) with onset 21Mar2022, outcome "unknown", COVID-19 (hospitalization, medically significant) with onset 21Mar2022, outcome "unknown" and all described as "symptoms of covid, tested positive on antigen home test"; COUGH (non-serious) with onset 24Mar2022, outcome "unknown", described as "covid cough". The patient underwent the following laboratory tests and procedures: Oxygenation index: (21Mar2022) dropped from 96 to 92, notes: oxygen dropped from 96 to 92; SARS-CoV-2 test: (15Apr2022) Positive, notes: 15Apr2022: admitted to hospital, antigen COVID test positive. no follow up PCR; (20Mar2022) Negative, notes: 20Mar2022: symptoms of COVID, tested negative; (21Mar2022) Positive, notes: 21Mar2022: symptoms of COVID, tested positive on antigen home test; (22Mar2022) confirmed COVID, notes: 22Mar2022: took PCR test at (Pharmacy withheld) confirmed COVID; (11Apr2022) Negative, notes: 11Apr2022: finally got at home negative COVID test result. Therapeutic measures were taken as a result of drug ineffective, covid-19, oxygen saturation decreased, cough.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Started COVID-19 symptoms on 18Apr. Tested positive with rapid (18Apr) and PCR (19Apr) testing.; Started COVID-19 symptoms on 18Apr. Tested positive with rapid (18Apr) and PCR (19Apr) testing.; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Moderate asthma" (unspecified if ongoing); "latent TB (treated)" (unspecified if ongoing); "allergies" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; SYMBICORT; FAMOTIDINE. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: known allergies: codeine, ibuprofen, azithromycin; Ibuprofen, reaction(s): "Drug allergy", notes: known allergies: codeine, ibuprofen, azithromycin; Azithromycin, reaction(s): "Drug allergy", notes: known allergies: codeine, ibuprofen, azithromycin. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Apr2022, 9 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant) with onset 27Apr2022, 9 days after the suspect product(s) administration, outcome "not recovered" and all described as "Started COVID-19 symptoms on 18Apr. Tested positive with rapid (18Apr) and PCR (19Apr) testing.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Positive; (18Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: part of the medication combo was not administered (with no reported adverse event); Initial information received on 21-Apr-2022 regarding an unsolicited valid non-serious case received from Other Health Professional.  This case involves a 2-month-old female patient for whom part of the medication combo was not administered (with no reported adverse event) while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV (MRC5)/HIB (PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine (Rotavirus vaccine), hepatitis B vaccine (Hepatitis B vaccine), and pneumococcal vaccine CONJ13v (CRM197) (Prevnar 13), all for prophylactic vaccination.  On 21-Apr-2022, the patient received the only DTAP/IPV portion of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine with unknown formulation, strength, (dose: 0.25 mL to 2 mL for vaccine) (lot UJ592AA, expiry date: 18-Dec-2022) via unknown route in the right thigh for Immunization.  On 21-Apr-2022, physician gave the Dtap/IPV portion only  of Pentacel to the patient and another part of the medication combo (ACT-HIB) was not administered (with no reported adverse event) (incorrect dose administered) (latency: same day).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.08
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Medication error, No adverse event
Clinical narrative: 4th dose of Ipol by mistake with no reported adverse event; Initial information received on 27-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 1 years old male patient who experienced 4th dose of ipol by mistake with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SODIUM (NA).  On 26-Apr-2022, the patient received a  dose of 0.5 ml suspect IPV (VERO) suspection for injection (strength,administration site : unknown)(lot number: V1A011M ,Expiration date : 10-feb-2022)via intramuscular route in unknown administration site for immunization.  On 26-APR-2022 the patient developed non-serious event 4th dose of ipol by mistake with no reported adverse event (medication error) (latency:1 day) following the administration of IPV (VERO).  Action taken : not applicable.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event 4th dose of ipol by mistake with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine  headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 infection.  I tested positive for COVID-19 on April 27, 2022.  My first symptoms were noticed on April 25th but I tested negative that day.  By the 27th I had more symptoms and tested positive.  Other than that, the only reaction to the vaccine itself seemed to be a sore right arm for a couple of days.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Cognitive disorder, Hemiparesis, Memory impairment
Clinical narrative: Patient suffered a stroke, prior med history is unknown, currently hospitalized, length of time unknown, cognitive, memory, expression, use of right side fully impacted.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Headache, Nausea, Pain in extremity
Clinical narrative: headache, left arm quite sore, nausea on-going.  took 2 tylenol and drinking some sprite
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Laboratory test
Clinical narrative: - Spike in inflammation (Calprotectin)  levels and symptoms related to Crohn's Disease. Calprotectin levels increased from 162 to 1,700 which was more than triple what it has ever reached in the t 7 years since she's been diagnosed.  - Test results showed that her system stopped responding to Vedolizumab in the months following the Covid vaccination. (Test/lab results PRIOR to Covid vaccination showed that her system was responding positively to Vedolizumab and her Calprotectin levels were acceptable).  - At this time she has failed to respond to new treatments.  (New treatments were tried in efforts to bring the inflammation back under control. These included increasing the dosage of Vedolizumab, trying Stelara,  and taking Budesonide. None of these have produced the desired results or brought symptoms undercontrol.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Injection site pain awful for 3 days. Painful Lymph node swelling under left arm pit for 3 days. Nauseous, headaches,  uterine cramping, and vaginal bleeding going on through day 4.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Uterine spasm, Vaginal haemorrhage
Clinical narrative: Injection site pain awful for 3 days. Painful Lymph node swelling under left arm pit for 3 days. Nauseous, headaches,  uterine cramping, and vaginal bleeding going on through day 4.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymph node pain, Nausea, SARS-CoV-2 test, Uterine spasm
Clinical narrative: Injection site pain awful for 3 days. Painful Lymph node swelling under left arm pit for 3 days. Nauseous, headaches,  uterine cramping, and vaginal bleeding going on through day 4.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaginal haemorrhage
Clinical narrative: Injection site pain awful for 3 days. Painful Lymph node swelling under left arm pit for 3 days. Nauseous, headaches,  uterine cramping, and vaginal bleeding going on through day 4.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Periarthritis
Clinical narrative: Frozen shoulder, extreme pain, limited mobility
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood test, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: 30 minutes after I woke up on 1/13/2022, the day after the vaccination, I started experiencing severe vertigo. I could not stand or walk by myself. I could I sit upright. These symptoms lasted for 24 hours. I woke up on 1/14/2022 and the vertigo was gone. For the first couple of days after this incident I was exhausted and feeling very out of it. I thought this would pass given what just happened.  Feb I went to the Dr. because my heart was racing and I felt off. I also developed my first UTI. I am still experiencing several of the symptoms described above 4 months later.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Memory impairment, Mobility decreased, Palpitations
Clinical narrative: 30 minutes after I woke up on 1/13/2022, the day after the vaccination, I started experiencing severe vertigo. I could not stand or walk by myself. I could I sit upright. These symptoms lasted for 24 hours. I woke up on 1/14/2022 and the vertigo was gone. For the first couple of days after this incident I was exhausted and feeling very out of it. I thought this would pass given what just happened.  Feb I went to the Dr. because my heart was racing and I felt off. I also developed my first UTI. I am still experiencing several of the symptoms described above 4 months later.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vertigo
Clinical narrative: 30 minutes after I woke up on 1/13/2022, the day after the vaccination, I started experiencing severe vertigo. I could not stand or walk by myself. I could I sit upright. These symptoms lasted for 24 hours. I woke up on 1/14/2022 and the vertigo was gone. For the first couple of days after this incident I was exhausted and feeling very out of it. I thought this would pass given what just happened.  Feb I went to the Dr. because my heart was racing and I felt off. I also developed my first UTI. I am still experiencing several of the symptoms described above 4 months later.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dysstasia, Fall
Clinical narrative: My arm where he injected the vaccine started to feel sore. I began to feel body aches, fatigue, and an overwhelming feeling of just not feeling well. This happened the day after I got the shot in the evening.  I took Tylenol PM @ 6PM for the pain and went and laid down.  I had chills and shaking and my body ached.  Around 9 PM, I went to the bathroom and felt dizzy.  I fell and hit my knee on the floor.  I was dizzy and unable to get up off of the floor for about 15 minutes because I felt extremely weak.   Today, I just feel weak, cold, and a little achy.  I have not had to take any medication.  I don't feel dizzy anymore.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Injection site pain, Joint injury, Malaise
Clinical narrative: My arm where he injected the vaccine started to feel sore. I began to feel body aches, fatigue, and an overwhelming feeling of just not feeling well. This happened the day after I got the shot in the evening.  I took Tylenol PM @ 6PM for the pain and went and laid down.  I had chills and shaking and my body ached.  Around 9 PM, I went to the bathroom and felt dizzy.  I fell and hit my knee on the floor.  I was dizzy and unable to get up off of the floor for about 15 minutes because I felt extremely weak.   Today, I just feel weak, cold, and a little achy.  I have not had to take any medication.  I don't feel dizzy anymore.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: My arm where he injected the vaccine started to feel sore. I began to feel body aches, fatigue, and an overwhelming feeling of just not feeling well. This happened the day after I got the shot in the evening.  I took Tylenol PM @ 6PM for the pain and went and laid down.  I had chills and shaking and my body ached.  Around 9 PM, I went to the bathroom and felt dizzy.  I fell and hit my knee on the floor.  I was dizzy and unable to get up off of the floor for about 15 minutes because I felt extremely weak.   Today, I just feel weak, cold, and a little achy.  I have not had to take any medication.  I don't feel dizzy anymore.