chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Rash, Urticaria
Clinical narrative: She described the reaction as hives, welts, and rashes; She described the reaction as hives, welts, and rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Jul2022 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation; pneumococcal polysaccharide vaccine, 23-valent (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE 1, SINGLE), for Immunization. The following information was reported: URTICARIA (non-serious), RASH (non-serious), outcome "not recovered" and all described as "She described the reaction as hives, welts, and rashes". The events "she described the reaction as hives, welts, and rashes" required emergency room visit. Additional information included: The patient received the Prevnar 13 injection on 25Jul2022 in left arm. Since the injection she had been having a reaction on the left hand side of her body for more than 3 weeks. She has been to her primary care doctor, endocrinologist, and the ER. She described the reaction as hives, welts, and rashes. She would like to know if there is any information on this type of reaction and also like to report her reaction. She states that she believes she has had the PCV23 vaccine as well. The patient confirmed the hives, welts, and rashes are all ongoing and persisting, no change. The patient was not admitted to the hospital, just went to the emergency room on 07Aug2022. Prevnar 13: Had 1 dose of Prevnar 13 several years prior to caller's 2nd dose of Prevnar 13. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
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 46-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EW0150), in left arm, on 12Apr2021 as dose 2, single (Lot number: FJ8762), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: EN6205) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing). Known allergies: No. Concomitant medication(s) included: LIALDA; LEVOTHYROXINE; TURMERIC [CURCUMA LONGA]; VITAMIN D NOS; FISH OIL. 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 received PAXLOVID for COVID-19 treatment from 03Aug2022 to 07Aug2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (11Aug2022) Positive, notes: Then, at day 9, I rebounded terribly, tested Positive; (Aug2022) Negative, notes: I tested negative after 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 4-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 4 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown), administration date: Jul2022, when the patient was 3 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 12Aug2022, outcome "recovered" (Aug2022), described as "Fever". Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient had no medical history and no known allergies. The patient was not administered any other vaccine in four weeks. The patient did not receive any other medication in two weeks. The patient did not have Covid-19 and was not tested for Covid-19 prior to vaccination. The patient developed fever and was treated with Motrin and Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Jul2021 at 10:30 as dose 2, single (Lot number: EWD153), in left arm, on 31Dec2021 at 10:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 26Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left 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 "recovering" and all described as "Treatment of COVID-19". The patient received PAXLOVID for COVID-19 treatment from 03Aug2022 to 07Aug2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound approximately 5 days after last dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Thyroid disease" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicilin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient has taken Paxlovid for treatment of COVID-19. Treatment start date was16Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: 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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJ1614), as dose 2, single (Lot number: EWO175) and as dose 3 (booster), single (Lot number: EWO169), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; TRINTELLIX; VITAMIN D3 (Other medication in 2weeks). Past drug history included: Tetanus for Immunization, reaction(s): "Known allergies: Tetanus"; Morphine, reaction(s): "Known allergies: Morphine"; Prednisone, reaction(s): "Known allergies: Prednisone". Vaccination history included: Influenza vaccine, for Immunization, reaction(s): "Known allergies: Influenza Vaccine". 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 of Paxlovid started from 06Aug2022 to 12Aug2022
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: el9264), on 23Feb2021 as dose 2, single (Lot number: en6202), on 25Sep2021 as dose 3 (booster), single (Lot number: ff2589) and on 12Apr2022 as dose 4 (booster), single (Lot number: fj9943) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "coronary artery disease" (unspecified if ongoing); "CKD" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11Aug2022) Negative; (13Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was treated with Paxlovid from 04Aug2022 to 08Aug2022. Received 2 negative covid tests 48 hours apart (11Aug2022 and 13Aug2022) after Paxlovid treatment.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FH8027) 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: "type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATORVASTATIN, stop date: 07Aug2022; LISINOPRIL; OMEPRAZOLE; ESCITALOPRAM; JARDIANCE; TRULICITY.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Aug2022) Positive, notes: tested positive still on  day 7 (Aug13). Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Aug2022 to 12Aug2022.  Clinical summery: The patient had no known allergies. Terrible bitter taste in mouth started 2h post Paxlovid first dose from 07Aug2022 and lasted approx. 36h post final dose to 14Aug2022. Rebound symptoms tested positive still on day 07Aug2022(13Aug2022) then mild symptoms reappeared on 17Aug2022 included sore throat, congestion in ears, runny nose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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 71-year-old male patient received BNT162b2 (BNT162B2), on 09Jun2022 at 02:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Other medical history: Obese high blood pressure high colesterol; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Obese high blood pressure high colesterol; "high colesterol" (unspecified if ongoing), notes: Other medical history: Obese high blood pressure high colesterol. There were no concomitant medications. 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: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medication in 2 weeks. No treatment AE. No known allergies.   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 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 18Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 08Apr2021 as dose 2, single (Lot number: EW0162), in right arm and on 06Dec2021 at 16:15 as dose 3 (booster), single (Lot number: FJ8757) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID, start date: 19Apr2022. Past drug history included: Toradol, reaction(s): "known allergies: Toradol", notes: known allergies: Toradol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 2 days 23 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received treatment with anti viral drug Paxlovid (lot: 607764) from 12Aug2022 to 15Aug2022. other medication in 2weeks product: NP Thyroid 90 mcg (brand: ACELLA).  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19 07Aug2022; Pfizer / BioNTech / Treatment of COVID-19 07Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: ff2589), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 67 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: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; LISINOPRIL; ROSUVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 07Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive 10 days after testing negative day 5 and day 7; (11Aug2022) Negative, notes: Tested positive 10 days after testing negative day 5 and day 7; (13Aug2022) Negative, notes: Tested positive 10 days after testing negative day 5 and day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date was 7Aug2022 and stop date was 11Aug2022.  Clinical Information:Patient received vaccine received and other medication in 2weeks.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 13Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar disorder" (unspecified if ongoing), notes: Other medical history: Bipolar disorder. The patient's concomitant medications were not reported. Past drug history included: Gabapentin, reaction(s): "Known allergies: gabapentin"; Cyclobenzaprine, reaction(s): "Known allergies: cyclobenzaprine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Paxlovid rebound; (14Aug2022) Positive, notes: positive COVID test on 14Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on 30Jul2022 to 03Aug2022 administered orally. Paxlovid rebound, developed URI (Upper respiratory infection) symptoms and positive COVID test on 14Aug2022.  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 information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right 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), outcome "unknown" and all described as "COVID 19 Treatment". 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. Clinical course: Patient received vaccine. It was unknown if patient had taken other medications in two weeks. Anti-viral details provided as, Paxlovid used for covid 19 treatment, start date 06Aug2022 and treatment stop date given as 11Aug2022. Indication was reported as treatment of COVID 19. Event Rebound start date was 15Aug2021 and start time was 12:00 PM. It was unknown if patient recovered. No treatment for AE.  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: Blood pressure measurement, 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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: Ew0196), in left arm and on 01Apr2022 at 15:00 as dose 4 (booster), single (Lot number: Fk9893) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Breast cancer recovery in year 4" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: IRBESARTAN; LEVOTHYROXIN; LEVOFLOXACIN; METFORMIN; ACICLOVIR; ZYDUS received in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive, notes: Also COVID test was much more immediate in giving positive very dark lines. The 2 previous COVID test were very light lines; (15Aug2022) Positive, notes: Experienced rebound 4 days final paxlovid dose. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details for COVID 19 treatment included Paxlovid, Treatment start date 06Aug2022, Treatment stop date 11Aug2022, Lot number 00069-1085-30.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech/ Treatment of COVID-19 start: 12Aug2022; Pfizer / BioNTech/ Treatment of COVID-19 start: 12Aug2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recent Breast Cancer Diagnosis" (ongoing). 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 "Pfizer / BioNTech/ Treatment of COVID-19 start: 12Aug2022". 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.  Clinical course: Other medication in 2 weeks: No. Patient was received Anti viral treatment as Paxlovid, started on 12Aug2022 and stopped on 17Aug2022 for Covid 19 treatment. Patient has, Head cold symptoms including sneezing, runny nose, stuffy nose. She was mostly asymptomatic prior to Paxlovid except for achy neck and back and fatigue. She took Paxlovid because of a cancer diagnosis. If patient recovered: Recovering and no any treatment for event. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Off-Label use; Interchange of vaccine products; Booster; a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid; a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 40-year-old female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jan2022 as dose 1, single (Batch/Lot number: unknown), on 15Feb2022 as dose 2, single (Batch/Lot number: unknown) and on 03Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "not recovered" and all described as "a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid"; OFF LABEL USE (medically significant), outcome "not recovered", described as "Off-Label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered"; IMMUNISATION (medically significant), outcome "not recovered", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive, notes: She tested positive for Covid today. Clinical course: The reporter stated that patient who got a booster dose of Comirnaty 30 days ago, and now positive for Covid. They were wondering if she can take Paxlovid that close to the booster dose. The reporter was originally asking about the interval from getting the booster dose and taking Paxlovid, was asking if it is ok to take or too soon.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Off-Label use; Interchange of vaccine products; Booster; a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid; a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 40-year-old female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jan2022 as dose 1, single (Batch/Lot number: unknown), on 15Feb2022 as dose 2, single (Batch/Lot number: unknown) and on 03Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "not recovered" and all described as "a 40 year old female patient who got a booster dose of Comirnaty 30 days ago, and is now positive for Covid"; OFF LABEL USE (medically significant), outcome "not recovered", described as "Off-Label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered"; IMMUNISATION (medically significant), outcome "not recovered", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive, notes: She tested positive for Covid today. Clinical course: The reporter stated that patient who got a booster dose of Comirnaty 30 days ago, and now positive for Covid. They were wondering if she can take Paxlovid that close to the booster dose. The reporter was originally asking about the interval from getting the booster dose and taking Paxlovid, was asking if it is ok to take or too soon.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product cannot be fully excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: 3 days after 2nd dose: Hives on neck and chest; Dose 1: 21May2021; Dose 2: 6Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jun2021 at 15:00 as dose 2, single (Lot number: EW0172) at the age of 19 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Exercise induced anaphylaxis" (unspecified if ongoing); "Known allergies: fruits" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0712; Anatomical location: Right Arm; Vaccine Administration Time: 15:00), administration date: 21May2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Jun2021 at 15:00, outcome "unknown", described as "Dose 1: 21May2021; Dose 2: 6Jun2021"; URTICARIA (non-serious) with onset 09Jun2021 at 15:00, outcome "unknown", described as "3 days after 2nd dose: Hives on neck and chest".  Additional Information: Patient did not take other vaccine in four weeks and also did not take other medications in two weeks. Patient did not have COVID prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201067878 same patient, different dose/events;
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Histamine level, Histamine level increased
Clinical narrative: Anaphylactic reactions happening every time she exercise/sweat.; high histamine levels; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 at 15:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 20 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Exercise induced anaphylaxis" (unspecified if ongoing); "known allergies: fruits" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccines within four weeks or other medications within two weeks of the vaccination. Vaccination history included: BNT162b2 (dose 1; lot number: EW0172), administration date: 21May2021, when the patient was 19-years-old, for COVID-19 immunization; BNT162b2 (dose 2; lot number: EW0172), administration date: 06Jun2021, when the patient was 19-years-old, for COVID-19 immunization, reaction(s): "Hives on neck and chest". The following information was reported: On 27Jan2022 at 20:15, after the third dose, the patient had anaphylactic reactions happening every time she exercised or sweat. She had hives on neck and chest. She was diagnosed with high histamine levels and exercise induced allergy. She had uncontrollable anaphylactic reactions happening about once a month and continuing. The symptoms included itching all over her body, swollen face/feet, hives and redness all over the face, no airway through nostrils, coughing, wheezing, and trouble breathing. The events required an emergency room visit and were reported as life-threatening. The patient received treatment with an unspecified steroid. The clinical outcomes of the anaphylactic reactions and high histamine levels were recovered with sequelae on unknown dates in 2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201067858 same patient, different dose, different AE;
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Anaphylactic reactions happening every time she exercise/sweat.; high histamine levels; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 at 15:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 20 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Exercise induced anaphylaxis" (unspecified if ongoing); "known allergies: fruits" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccines within four weeks or other medications within two weeks of the vaccination. Vaccination history included: BNT162b2 (dose 1; lot number: EW0172), administration date: 21May2021, when the patient was 19-years-old, for COVID-19 immunization; BNT162b2 (dose 2; lot number: EW0172), administration date: 06Jun2021, when the patient was 19-years-old, for COVID-19 immunization, reaction(s): "Hives on neck and chest". The following information was reported: On 27Jan2022 at 20:15, after the third dose, the patient had anaphylactic reactions happening every time she exercised or sweat. She had hives on neck and chest. She was diagnosed with high histamine levels and exercise induced allergy. She had uncontrollable anaphylactic reactions happening about once a month and continuing. The symptoms included itching all over her body, swollen face/feet, hives and redness all over the face, no airway through nostrils, coughing, wheezing, and trouble breathing. The events required an emergency room visit and were reported as life-threatening. The patient received treatment with an unspecified steroid. The clinical outcomes of the anaphylactic reactions and high histamine levels were recovered with sequelae on unknown dates in 2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201067858 same patient, different dose, different AE;
Sex: F
Vaccine: PNC20
Symptoms: Anosmia, Malaise, Nasal discomfort, Sneezing
Clinical narrative: sneezing; general malaise; cannot smell; cannot get rid of her nasal problems; 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.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Jul2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (flu vaccine for over 65-years-old; had a reaction); Pneumonia shots (not Prevnar; never had a problem). The following information was reported: NASAL DISCOMFORT (non-serious) with onset Jul2022, outcome "unknown", described as "cannot get rid of her nasal problems"; ANOSMIA (non-serious) with onset Jul2022, outcome "unknown", described as "cannot smell"; MALAISE (non-serious) with onset Jul2022, outcome "unknown", described as "general malaise"; SNEEZING (non-serious) with onset Jul2022, outcome "unknown".  Additional information: patient was over 65-years of age. She reported that when she came home from the shot, she immediately started sneezing then went on for 3 days in a row. She added she had general malaise, cannot smell, and cannot get rid of her nasal problems. She never had a problem with her previous pneumonia shots (not Prevnar) but had a reaction years ago to the flu vaccine for over 65-years-old. She wanted to know how long it will last and what is in the vaccine that caused it.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Neuropathy peripheral
Clinical narrative: neuropathy; muscle weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness".  Clinical course: Patient had enquiry that patient wanted to know what to do about the neuropathy and muscle weakness as well as other complications that patient had from COVID vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Warm autoimmune haemolytic anaemia
Clinical narrative: Warm Autoimmune Hemolytic Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158), administration date: 09Apr2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 05May2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: WARM AUTOIMMUNE HAEMOLYTIC ANAEMIA (hospitalization, medically significant, life threatening) with onset 25Nov2021, outcome "not recovered", described as "Warm Autoimmune Hemolytic Anemia". The patient was hospitalized for warm autoimmune haemolytic anaemia (hospitalization duration: 5 day(s)). The event "warm autoimmune hemolytic anemia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of warm autoimmune haemolytic anaemia with blood transfusion and medications. The patient did not have covid prior to vaccination and tested positive post vaccination. The patient had no known allergies.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Warm Autoimmune Hemolytic Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158), administration date: 09Apr2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 05May2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: WARM AUTOIMMUNE HAEMOLYTIC ANAEMIA (hospitalization, medically significant, life threatening) with onset 25Nov2021, outcome "not recovered", described as "Warm Autoimmune Hemolytic Anemia". The patient was hospitalized for warm autoimmune haemolytic anaemia (hospitalization duration: 5 day(s)). The event "warm autoimmune hemolytic anemia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of warm autoimmune haemolytic anaemia with blood transfusion and medications. The patient did not have covid prior to vaccination and tested positive post vaccination. The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Polymerase chain reaction
Clinical narrative: About 1 week after dose 1 I experienced pain in the right shoulder joint and surrounding muscle; About 1 week after dose 1 I experienced pain in the right shoulder joint and surrounding muscle; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "About 1 week after dose 1 I experienced pain in the right shoulder joint and surrounding muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional information: No other vaccine in four weeks, other medications in two weeks: Multivitamins. All 3 injections were administered in the right arm at each visit. About 1 week after dose #1 I experienced pain in the right shoulder joint and surrounding muscle. A few days after dose #2 I experienced increased pain in the right shoulder joint adverse event increased pain in the right shoulder joint and surrounding muscle. The symptoms reduced slightly but after dose #3 I again experienced increased pain in the right shoulder joint and surrounding muscle. These symptoms still continue. There is also pain when raising the arm overhead, lifting items overhead and performing any activity requiring rotation of the right shoulder. The left (did not have any injections) remains without any similar symptoms. Adverse event treatment includes that heating pad & used analgesics. No covid prior vaccination, covid tested post vaccination. Known allergies includes that NKDA. Other medical history none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE; FLUTICASONE; FISH OIL; TURMERIC [CURCUMA LONGA ROOT]; CHOLECALCIFEROL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, 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, notes: Product: COVID 19 Treatment; (Aug2022) Positive, notes: Rebound symptoms of COVID which occurred 3-4 days after finishing paxlovid; (Aug2022) Negative, notes: Tested positive again after having tested negative; (Aug2022) Positive, notes: Tested positive again after having tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 treatment start date was 08Aug2022 and stop on 12Aug2022. Rebound symptoms of COVID which occurred 3-4 days after finishing paxlovid, including cough, sore throat, congestion, fatigue. Tested positive again after having tested negative.  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 Reported events VACCINATION FAILURE & COVID-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: We all got COVID; We all got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: "Heart condition" (unspecified if ongoing), notes: My husband has a heart condition so we knew it was very important to get the vaccine. 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 "We all got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown, notes: 'We all got COVID'.  Clinical course reported that My whole family got the 1st and 2nd dose as soon as it became available. My husband has a heart condition so we knew it was very important to get the vaccine. We did not get COVID so we thought we were all good, but we still got the booster as soon as we could. We thought we were definitely good then, but then we all got COVID. The commercial emphasizes the fact that you can never be too careful and it is our responsibility to ourselves and our community to take action and get the shot. We were all very surprised when we got the test done (we thought we had a common cold). Fortunately the symptoms were fairly minor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200045403 Same reporter/drug/event, different patient;