chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 08:00 as dose 1, single (Lot number: EN6207), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 03Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 09May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "known allergy to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction: "known allergy"; Cipro, reaction: "known allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered with sequelae" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 3 negative tests; (unspecified date) Negative, notes: 3 negative tests; (unspecified date) Negative, notes: 3 negative tests; (2022) Positive, notes: kept testing positive for a week; (01Aug2022) Positive, notes: after 3 negative tests, she tested positive again. Therapeutic measures were taken as a result of covid-19, which included nirmatrelvir-ritonavir (Paxlovid) full dose tablet combo therapy pack from 08Jul2022 to 13Jul2022. Clinical course: After 3 negative tests, the patient tested positive again on 01Aug2022 and kept testing positive for a week. The nurse (RN) at the doctors office told her to stop testing. Symptoms were not as severe, but came back. The patient had recovered with sequel on 02Oct2022 from the recurrence with no treatment received. The patient received fifth dose of Pfizer / BioNTech (BNT162B2;BNT162B2 OMI BA.4-5) on 30Oct2022 at 01:00 PM (Lot number: GH9697) in the left arm for Covid-19 immunization.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Incorrect dose administered, Interchange of vaccine products, Rash, Rash macular
Clinical narrative: swelling of both ankles,  both knees and right elbow; rash; read blotches on ankles and blister; read blotches on ankles and blister; product=COVID 19, brand=Pfizer; prev dose brand=moderna; Moderna: 02Oct2022; Pfizer Bivalent: 02Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GJ6739) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Oct2022 as dose 4 (booster), single (Lot number: 056M21A), in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 30Sep2022 as unk, single. Vaccination history included: moderna (DOSE 1, SINGLE; Lot No: 025J20-2a; anatomical location: Arm Right, Administration Time: 04:00 PM), administration date: 28Jan2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE;  Lot No: 013a2121A; anatomical location: Arm left, Administration Time: 04:00 PM), administration date: 25Feb2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 3, SINGLE;  Lot No: 066d21a; anatomical location: Arm left, Administration Time: 12:00 PM), administration date: 23Aug2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 02Oct2022, outcome "unknown", described as "Moderna: 02Oct2022; Pfizer Bivalent: 02Oct2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 02Oct2022 at 15:00, outcome "unknown", described as "product=COVID 19, brand=Pfizer; prev dose brand=moderna"; RASH (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered"; RASH MACULAR (non-serious), BLISTER (non-serious) all with onset 03Oct2022 at 08:00, outcome "not recovered" and all described as "read blotches on ankles and blister"; SWELLING (non-serious) with onset 08Oct2022, outcome "not recovered", described as "swelling of both ankles,  both knees and right elbow". The events "read blotches on ankles and blister", "swelling of both ankles,  both knees and right elbow" and "rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, blister, swelling, rash.  Additional information: There were no known allergies. Patient received antibiotics followed by prednisone.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling
Clinical narrative: swelling of both ankles,  both knees and right elbow; rash; read blotches on ankles and blister; read blotches on ankles and blister; product=COVID 19, brand=Pfizer; prev dose brand=moderna; Moderna: 02Oct2022; Pfizer Bivalent: 02Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GJ6739) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Oct2022 as dose 4 (booster), single (Lot number: 056M21A), in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 30Sep2022 as unk, single. Vaccination history included: moderna (DOSE 1, SINGLE; Lot No: 025J20-2a; anatomical location: Arm Right, Administration Time: 04:00 PM), administration date: 28Jan2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 2, SINGLE;  Lot No: 013a2121A; anatomical location: Arm left, Administration Time: 04:00 PM), administration date: 25Feb2021, when the patient was 76-year-old, for Covid-19 Immunization; moderna (DOSE 3, SINGLE;  Lot No: 066d21a; anatomical location: Arm left, Administration Time: 12:00 PM), administration date: 23Aug2021, when the patient was 76-year-old, for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 02Oct2022, outcome "unknown", described as "Moderna: 02Oct2022; Pfizer Bivalent: 02Oct2022"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 02Oct2022 at 15:00, outcome "unknown", described as "product=COVID 19, brand=Pfizer; prev dose brand=moderna"; RASH (non-serious) with onset 03Oct2022 at 08:00, outcome "recovered"; RASH MACULAR (non-serious), BLISTER (non-serious) all with onset 03Oct2022 at 08:00, outcome "not recovered" and all described as "read blotches on ankles and blister"; SWELLING (non-serious) with onset 08Oct2022, outcome "not recovered", described as "swelling of both ankles,  both knees and right elbow". The events "read blotches on ankles and blister", "swelling of both ankles,  both knees and right elbow" and "rash" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, blister, swelling, rash.  Additional information: There were no known allergies. Patient received antibiotics followed by prednisone.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown), in left arm, on 05Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction: "Known allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive; (Nov2022) Negative, notes: testing negative last week. Therapeutic measures were taken as a result of covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: Didn't feel good; Coughing a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient 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: MALAISE (non-serious), outcome "unknown", described as "Didn't feel good"; COUGH (non-serious), outcome "unknown", described as "Coughing a lot".  Additional information: The patient didn't feel good and laid down. She normally doesn't cough.   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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The reporter's parents got Pfizer as well as her brother (patient) and sister got Pfizer and she doesn't want to get COVID. All 15 got COVID and all but 3 had vaccinations and she couldn't imagine what would be like. She had a couple family members get COVID and one got Pneumonia. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: all got covid.  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: Death
Clinical narrative: father died/Her parents got Pfizer as well as her brother and sister got Pfizer; This is a spontaneous report received from contactable reporter (consumer or other non-HCP).  A male patient received BNT162b2 (BNT162B2), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal" described as "father died/Her parents got Pfizer as well as her brother and sister got Pfizer." The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: The reporter received the shot as her and her sister take turns staying with mom after her father died. Her parents got Pfizer as well as her brother and sister got Pfizer and she doesn't want to get COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: father died/Her parents got Pfizer as well as her brother and sister got Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The reporter's mother and sister (patient) got the shot (Pfizer) a week and half before reporter. /15 family members went to a graduation party and wedding and all 15 got COVID and all but 3 had vaccinations and she couldn't imagine what would be like. A couple family members got COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Nasopharyngeal swab, Pain
Clinical narrative: All over muscle twitching; Headache; generalized body aches/pain; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2021 as dose 1, single (Lot number: FA7485) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "COVID-19", start date: 09Oct2020 (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SLYND; XYZAL. Past drug history included: Sulfa, percocet, reaction(s): "Drug Allergy". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 11Aug2021, outcome "not recovered", described as "All over muscle twitching"; HEADACHE (non-serious) with onset 11Aug2021, outcome "not recovered"; PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "generalized body aches/pain". The events "all over muscle twitching", "headache" and "generalized body aches/pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle twitching, headache, pain.  Additional information: It was also reported that there was no other vaccine in four weeks. Patient had all over muscle twitching. Headache for 3 months, generalized body aches/pain on 11Aug2021 at 12:00 am. Patient had taken every medicine possible. Patient had Covid prior to vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab positive/Covid treatment; Nasal Swab positive/Covid treatment; This is a spontaneous report received from contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2021 as dose 1, single (Lot number: FA7485), in left arm and on 02Sep2021 as dose 2, single (Lot number: Fc3182) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Covid", start date: 09Oct2020 (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SLYND; XYZAL. Past drug history included: Percocet, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "not recovered" and all described as "Nasal Swab positive/Covid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2020) Positive, notes: Nasal Swab; (01Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure.; Sender's Comments: Based on the available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and both events VACCINATION FAILURE and COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "she had a tiny bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: The patient already took the primary series and two booster shots from Pfizer and scheduled for the fifth shot. The patient been hearing reports that Pfizer and Moderna are planning on working with boosters that contain flu shots as well. The patient is suggesting that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that.  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-PV202200098882 same patient and event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "she had a tiny bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: She was suggesting that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that. Caller mentioned she already took the primary series and two booster shots from Pfizer and scheduled for the fifth shot. The patient had a tiny bit of sore arm after that four shots from Pfizer other than that she had no problem with the vaccines.   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: Pain in extremity
Clinical narrative: she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, she had a tiny bit of sore arm after that four shots from Pfizer), for COVID-19 Immunization, reaction(s): "she had a tiny bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: Patient was suggested that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 09:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM 2- HTN" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Shrimp; "DM 2- HTN" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective / COVID-19 cannot be ruled out
Sex: M
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 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single, in Jul2021 as dose 2, single and in Feb2022 as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19 "; COVID-19 (medically significant), outcome "unknown". 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. Anti-viral COVID 19 Treatment from 28Oct2022 to 01Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-month-old patient received BNT162b2 (BNT162B2), as dose 1, 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: PYREXIA (non-serious), outcome "unknown", described as "mild fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: children, vaccinated at 6 and 7 months, also Pfizer, had the kind of mild fever "that a single paracetamol solved". It was unknown if patient received other vaccine in four weeks. It was unknown if patient had COVID prior vaccination. It was unknown if patient tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, 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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 12:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 at 12:30 as dose 1, single (Lot number: EN6204), in left arm, on 03Apr2021 at 12:30 as dose 2, single (Lot number: EP6955), in left arm, on 19Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 at 14:45 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderately Obese BMI: 32.6" (unspecified if ongoing); "Environmental Allergies" (unspecified if ongoing); "Elevated Blood Pressure Readings at Doctor's office without diagnosis of hypertension" (unspecified if ongoing); "Vitamin D and B-12 Deficiencies" (unspecified if ongoing); "Vitamin D and B-12 Deficiencies" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cefprozil, reaction(s): "Known allergies: Cefprozil"; Augmentin, reaction(s): "Known allergies: Augmentin"; Celebrex, reaction(s): "Known allergies: Celebrex".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 32.6. Therapeutic measures were taken as a result of vaccination failure, covid-19 and the treatment was Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: en6202), in left arm, on 20Mar2021 as dose 2, single (Lot number: en6202), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: en01179), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FX9894) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Tested positive for Covid after taking. The patient received COVID 19 Treatment Paxlovid from 28Oct2022 to 02Nov2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She just had a little bit of a sore arm, very slightly; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "drug allergy issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vaccine for immunisation, reaction(s): "seizures"; Vaccine for immunisation, reaction(s): "loss of muscle control". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She just had a little bit of a sore arm, very slightly".  Additional information: the reporter assessed the event as non-serious. It was reported as she had seizures with vaccines as a child and was hospitalized and had loss of muscle control so she never gets pneumonia vaccines and flu vaccines. They were not aware what shots she was given that caused such a severe reaction but just know that it was vaccines. When this one came out she was really afraid to get it. They had a doctor and ER tech to wait with her because they knew she could have complications, but she never did. They said that the original (Covid vaccine) was just as good as the new one at fighting. The patient had a lot of drug allergy issues to anything. They were cautious with whatever they gave her. There was only one antibiotic she could take. It was reported as her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. She declined providing their information.  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-202201287002 same reporter/product/AE, different patient;US-PFIZER INC-202201287001 same reporter/product/AE, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She just had a little bit of a sore arm; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "seizures" (unspecified if ongoing), notes: she had seizures; "drug allergy" (unspecified if ongoing), notes: She has a lot of drug allergy issues to anything. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "She just had a little bit of a sore arm"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "She just had a little bit of a sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She just had a little bit of a sore arm".  Additional information: The patient stated her doctor was worried about her getting the Covid vaccine because she had seizures with vaccines as a child and was hospitalized and had loss of muscle control so she never gets pneumonia vaccines and flu vaccines. They don't know what shots she was given that caused such a severe reaction but just know that it was vaccines. When this one came out she was really afraid to get it. They had a doctor and ER tech to wait with her because they knew she could have complications, but she never did. She just had a little bit of a sore arm, very slightly. She had 3 of the original Pfizer covid shots, two primary and a booster. Her last booster dose was in Jan. They say that the original (Covid vaccine) is just as good as the new one at fighting. She had a lot of drug allergy issues to anything. They have to be cautious with whatever they give her. There was only one antibiotic she could take. Everyone she knows that had taken the Moderna (covid vaccine) has had issues but no one with Pfizer has. Her family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. She declined providing their information. The patient stated there are still conspiracy theories people saying don't get the shots they are killing us. The patient stated she does not want to report this because it was minor and hardly anything, it was just like wow did I just have a shot.  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-202201286932 similar report from same reporter;
Age: 72.0
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). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH9702) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EJ1686), in right arm, on 11Feb2021 as dose 2, single (Lot number: EJ1684), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: BvFK9729), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arrhythmia" (unspecified if ongoing); "Cardiomegaly" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS-C" (unspecified if ongoing); "hx C Diff" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: narcotics" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2021; ZOLPIDEM, start date: 01Jul2020, stop date: 26Oct2022; PANTOPRAZOLE; LINZESS, start date: 05Apr2021; PRAVASTATIN NA, start date: 10Oct2021, stop date: 29Oct2022; MONTELUKAST, start date: 01Jan2017; METOPROLOL, start date: 02Sep2014; SLOW-MAG, start date: 18Oct2021; FEXOFENADINE HYDROCHLORIDE, start date: 01Jan2010; D3, start date: 02Mar2011; ASPIRIN [ACETYLSALICYLIC ACID], start date: 15Sep2015; CALCIUM CITRATE, start date: 11Oct2021; HFA DOBIPRO, start date: 01Jul2020; FLOVENT; IPRATROPIUM BROMIDE, start date: 01Nov2019; NASACORT, start date: 01Mar2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Reclast metoclopramide, reaction(s): "Known allergies: Reclast Metoclopramide"; Trazadone, reaction(s): "Known allergies: Trazadone"; Aleve, reaction(s): "Known allergies: Aleve"; Clindamycin, reaction(s): "Known allergies: Clindamycin"; Iv vancomycin, reaction(s): "Known allergies: IV vancomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2022) Positive, notes: Diagnosed with Covid using home antigen test 29Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Diagnosed with Covid using home antigen test 29Oct2022. Started Paxlovid around noon.
Sex: U
Vaccine: PPV
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Red rash at injection site; Red rash at injection site; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Red rash at injection site". Additional information: Red rash at injection site similar to that caused by the pneumonia vaccination. Event took place after use of product.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), on 15Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bone marrow transplant recipient" (unspecified if ongoing), notes: Bone marrow transplant recipient. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Very faint positive test line on at-home rapid tests about 4 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as COVID 19 Treatment from 29Oct2022 to 03Nov2022.  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: Thyroxine free
Clinical narrative: Graves' disease; Autoimmune Inflammatory Syndrome Induced by Unknown; This is a literature report for the following literature source(s): "Case Series Of New Onset Graves' Hyperthyroidism After Administration Of Sars-Cov. A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: BASEDOW'S DISEASE (medically significant), 1 month after the suspect product(s) administration, outcome "recovering", described as "Graves' disease"; ASIA SYNDROME (medically significant), outcome "recovering", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: below 0.003, notes: 4 months later; Thyroid stimulating immunoglobulin: 3.99, notes: 4 months later; Thyroxine free: 4.1 ng/dL, notes: 4 months later; Autoantibody test: positive. Therapeutic measures were taken as a result of basedow's disease, asia syndrome. Additional information: The patient developed hyperthyroid symptoms one month following the first dose of the Pfizer vaccination. She responded well to methimazole 10 mg daily.  The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event Graves' disease, Autoimmune/inflammatory syndrome induced by adjuvants and the suspect drug   BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;
Sex: F
Vaccine: COVID19
Symptoms: ASIA syndrome, Autoantibody test, Basedow's disease, Blood thyroid stimulating hormone, Thyroid stimulating immunoglobulin
Clinical narrative: Graves' disease (GD); Autoimmune Inflammatory Syndrome Induced by Adjuvants; This is a literature report.  A 27-year-old female patient 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: BASEDOW'S DISEASE (medically significant), 14 days after the suspect product(s) administration, outcome "recovering", described as "Graves' disease (GD)"; ASIA SYNDROME (medically significant), outcome "recovering", described as "Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA)". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 0.01 uiU/mL; Thyroid stimulating immunoglobulin: 4.5; Thyroxine free: 3.3 ng/dL; Autoantibody test: positive. Therapeutic measures were taken as a result of basedow's disease, ASIA syndrome. Additional information: The patient developed tachycardia 14 days after the Pfizer vaccination. She responded well to methimazole 20 mg daily. The patient didn't had a personal or family history of thyroid disease. Our case series adds to the growing evidence for SARS-CoV-2 vaccine-induced Graves' disease (GD), suggesting the incidence may be higher than initially thought and may occur after the 1st, 2nd or booster doses. One potential mechanism is the Autoimmune Inflammatory Syndrome Induced by Adjuvants (ASIA), which is likely triggered by the mRNA lipid nanoparticles present in the SARS-CoV-2 vaccine. Our patients all met criteria for ASIA with exposure to adjuvants, manifestations of autoimmune endocrine disorders, and positive autoantibodies. In our case series, patients had symptoms for weeks to months before their diagnosis of GD highlighting the importance of patient education regarding possible thyroid complications following vaccination to ensure prompt diagnosis and treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event Graves' disease, Autoimmune/inflammatory syndrome induced by adjuvants and the suspect drug   BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-PV202200099853 Same article and different patient /drug.;