chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Palpitations, Peripheral swelling
Clinical narrative: allergic reaction; arm very swollen and red; arm very swollen and red; heart palpitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neosporin [gramicidin;neomycin sulfate;polymyxin b sulfate], reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2 manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 5 manufacturer unknown), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 07Nov2023, outcome "unknown", described as "allergic reaction"; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 07Nov2023, outcome "unknown" and all described as "arm very swollen and red"; PALPITATIONS (non-serious) with onset Nov2023, outcome "unknown", described as "heart palpitation". The events "allergic reaction", "arm very swollen and red" and "heart palpitation" required physician office visit. Therapeutic measures were not taken as a result of hypersensitivity, peripheral swelling, erythema, palpitations.  Additional information: the patient had vaccine on 7Nov2023, within a couple hours, arm got very swollen and red. She didn't take anything, was worried she was having allergic reaction. She was at another doctor's office, they said to go to at the Medical Center, where she had it. Went back there, spoke to the nurse, didn't seem like she really knew. Was getting the feeling she wasn't taking down the information but, she looked at it. Trying to figure out if she had allergic reaction to this or not. Had 5 of these before, never had reaction. Wondering what they put in the formula this year that could be different. Is kind of in her mind a lot. Was not Covid arm, which comes days after, this was pretty immediate, unless, you can get Covid arm right away. Noticed it getting red, by the time get home to take shower, it was all red. Happened so fast. Didn't have any breathing things she could think of. Last night, felt a little heart palpitation. She is allergic to something in Neosporin, wondering if they put Neosporin in it.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: my arm started to itch around site/Have continued itching mildly all day and mild pain; y arm started to itch around site/Have continued itching mildly all day and mild pain; Injection sight started to swell approximately 2 inches around site; Site felt warm and was moderately pink; Site felt warm and was moderately pink; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, single (Lot number: HG6396), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Shoulder replacement", start date: 24Aug2023 (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 01Nov2023; TYLENOL; IBUPROFEN; ELIQUIS. Vaccination history included: Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 17Nov2023 at 22:45, outcome "not recovered", described as "Injection sight started to swell approximately 2 inches around site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 17Nov2023 at 22:45, outcome "not recovered" and all described as "Site felt warm and was moderately pink"; VACCINATION SITE PRURITUS (non-serious) with onset 17Nov2023 at 22:45, outcome "not recovered", described as "my arm started to itch around site/Have continued itching mildly all day and mild pain"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2023 at 22:45, outcome "not recovered", described as "y arm started to itch around site/Have continued itching mildly all day and mild pain". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site pain, vaccination site swelling, vaccination site warmth, vaccination site erythema. Additional information: other concomitant medication (BP meds).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: headache; Body aches; sore arm; nausea; slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 20Jan2021 at 13:00 as dose 2, single (Lot number: EL8982) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELINEST taken for contraception. Vaccination history included: bnt162b2 (1st dose, Lot EK9231, Vaccination site: left arm upper, Time: 13:00), administration date: 30Dec2020, when the patient was 35-year-old, for COVID-19 immunisation, reaction(s): "headache", "sore arm". The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NAUSEA (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "slight fever". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152033 same patient and reporter, different dose and event;
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; Body aches; sore arm; nausea; slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 20Jan2021 at 13:00 as dose 2, single (Lot number: EL8982) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELINEST taken for contraception. Vaccination history included: bnt162b2 (1st dose, Lot EK9231, Vaccination site: left arm upper, Time: 13:00), administration date: 30Dec2020, when the patient was 35-year-old, for COVID-19 immunisation, reaction(s): "headache", "sore arm". The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NAUSEA (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "slight fever". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152033 same patient and reporter, different dose and event;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Nausea
Clinical narrative: headache; body aches; nausea; shooting pain through back; 101.1 fever; chills; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELINEST taken for contraception (ongoing). Vaccination history included: bnt162b2 (Dose 1, Lot number: EK9231, Time: 13:00, Vaccination site: left arm upper), administration date: 30Dec2020, when the patient was 35-year-old, for COVID-19 immunisation, reaction(s): "headache", "Sore arm"; bnt162b2 (Dose 2, Lot number: EL8982, Time: 13:00, Vaccination site: left arm upper), administration date: 20Jan2021, when the patient was 35-year-old, for COVID-19 immunisation, reaction(s): "Headache", "Body aches", "Sore arm", "nause", "Slight fever". The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "shooting pain through back"; PYREXIA (non-serious), outcome "unknown", described as "101.1 fever"; CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152033 same patient and reporter, different dose and event;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: headache; body aches; nausea; shooting pain through back; 101.1 fever; chills; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELINEST taken for contraception (ongoing). Vaccination history included: bnt162b2 (Dose 1, Lot number: EK9231, Time: 13:00, Vaccination site: left arm upper), administration date: 30Dec2020, when the patient was 35-year-old, for COVID-19 immunisation, reaction(s): "headache", "Sore arm"; bnt162b2 (Dose 2, Lot number: EL8982, Time: 13:00, Vaccination site: left arm upper), administration date: 20Jan2021, when the patient was 35-year-old, for COVID-19 immunisation, reaction(s): "Headache", "Body aches", "Sore arm", "nause", "Slight fever". The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "shooting pain through back"; PYREXIA (non-serious), outcome "unknown", described as "101.1 fever"; CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152033 same patient and reporter, different dose and event;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: rash/red spots; 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 received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: GG7401, Expiration Date: Jun2025) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE taken for breast cancer, start date: 10Sep2023 (ongoing); LETROZOLE, start date: 27Aug2023 (ongoing); ELIQUIS, start date: 2019 (ongoing); ATORVASTATIN, start date: 2019 (ongoing); LOSARTAN POTASSIUM, start date: 2021 (ongoing); FUROSEMIDE, start date: 2019 (ongoing); SPIRONOLACTONE, start date: 2019 (ongoing). The following information was reported: RASH MACULAR (non-serious), outcome "recovered", described as "rash/red spots".
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Headache, Neck pain, Pain
Clinical narrative: joint pain; joint pain,  "especially in my shoulders, neck and hip"; hurting; a little stronger than it is normally; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US136212_NS (Novartis).  An 84-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol lowering treatments" (unspecified if ongoing); "joint pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NECK PAIN (non-serious), outcome "unknown", described as "joint pain,  "especially in my shoulders, neck and hip""; PAIN (non-serious), outcome "unknown", described as "hurting"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "a little stronger than it is normally"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Clinical course: Patient reported she has had two treatments thus far and she still has trouble with "hurting" and having "joint pain". Patient stated she usually has joint pain with all Cholesterol lowering treatments and with this treatment, she has joint pain, "especially in my shoulders, neck and hip". Patient initially stated, "I don't know that it's increased", then stated she feels like it's "a little stronger than it is normally" right after she gets the shot. Patient stated she also has headaches but believes this is from the Covid shot as she states these began for her after taking the Covid shot and she does not know if it's been impacted by this treatment but will take notice of this after the next treatment. Patient has not yet had lab work, but it will be in the next month or so. Patient will also have 6 months checkup around the same time as her next treatment. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: back muscle pain one week later/pain down patient's left arm; back muscle pain one week later/pain down patient's left arm; This is a spontaneous report received from contactable reporter(s) (Consumer (patient's husband)).  An 88-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Lot number: HG4633) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Oct2023, outcome "unknown" and all described as "back muscle pain one week later/pain down patient's left arm". Therapeutic measures were not taken as a result of back pain, pain in extremity.  Additional information: Patient's doctor said that he had patients with similar problems of pain after COVID Pfizer shot. Patient have had multiple Pfizer shots (COVID) with no aftereffects.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: congestive heart failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "congestive heart failure". Clinical course: Reporter mentioned that she believes the Pfizer covid shots her parents got, caused her mother to get congestive heart failure.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin increased, Blood chloride, Blood chloride increased, Blood cholesterol
Clinical narrative: Chloride level 110 mmol/L; Bili total 1.1 mg/dl; Cholesterol 212 mg/dl; Respiratory rate (12 br/min); sick with respiratory virus; 142 mmHG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma", start date: 2016 (ongoing); "overweight" (unspecified if ongoing); "Allergies", start date: 2016 (ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for asthma, hypersensitivity, start date: 2016 (ongoing). Vaccination history included: bnt162b2 (Dose 1, Single, Intramuscular, Arm), administration date: 01Jan2021, for COVID-19 Immunisation; bnt162b2 (Dose 2, Single, Intramuscular, Arm), administration date: 02Feb2021, for COVID-19 Immunisation; bnt162b2 (Dose 3 (Booster), Single, Intramuscular, Arm), administration date: 09Sep2021, for COVID-19 Immunisation; bnt162b2 (Dose 4 (Booster), Single, Intramuscular, Arm, Time: 18:15), administration date: 03Mar2022, for COVID-19 Immunisation. The following information was reported: BLOOD PRESSURE SYSTOLIC INCREASED (non-serious) with onset 25Apr2023, outcome "unknown", described as "142 mmHG"; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 25Apr2023, outcome "unknown", described as "sick with respiratory virus"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Sep2023, outcome "unknown", described as "Respiratory rate (12 br/min)"; BLOOD BILIRUBIN INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Bili total 1.1 mg/dl"; BLOOD CHLORIDE INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Chloride level 110 mmol/L"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Cholesterol 212 mg/dl". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Mother and sisters all took BP meds.  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: Linked Report(s) : US-PFIZER INC-202300335763 Same patient/ product, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood pressure systolic, Blood pressure systolic increased, Influenza A virus test, Influenza B virus test
Clinical narrative: Chloride level 110 mmol/L; Bili total 1.1 mg/dl; Cholesterol 212 mg/dl; Respiratory rate (12 br/min); sick with respiratory virus; 142 mmHG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma", start date: 2016 (ongoing); "overweight" (unspecified if ongoing); "Allergies", start date: 2016 (ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for asthma, hypersensitivity, start date: 2016 (ongoing). Vaccination history included: bnt162b2 (Dose 1, Single, Intramuscular, Arm), administration date: 01Jan2021, for COVID-19 Immunisation; bnt162b2 (Dose 2, Single, Intramuscular, Arm), administration date: 02Feb2021, for COVID-19 Immunisation; bnt162b2 (Dose 3 (Booster), Single, Intramuscular, Arm), administration date: 09Sep2021, for COVID-19 Immunisation; bnt162b2 (Dose 4 (Booster), Single, Intramuscular, Arm, Time: 18:15), administration date: 03Mar2022, for COVID-19 Immunisation. The following information was reported: BLOOD PRESSURE SYSTOLIC INCREASED (non-serious) with onset 25Apr2023, outcome "unknown", described as "142 mmHG"; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 25Apr2023, outcome "unknown", described as "sick with respiratory virus"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Sep2023, outcome "unknown", described as "Respiratory rate (12 br/min)"; BLOOD BILIRUBIN INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Bili total 1.1 mg/dl"; BLOOD CHLORIDE INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Chloride level 110 mmol/L"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Cholesterol 212 mg/dl". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Mother and sisters all took BP meds.  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: Linked Report(s) : US-PFIZER INC-202300335763 Same patient/ product, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Respiratory rate, Respiratory rate decreased, Respiratory syncytial virus test, Respiratory tract infection viral, SARS-CoV-2 test
Clinical narrative: Chloride level 110 mmol/L; Bili total 1.1 mg/dl; Cholesterol 212 mg/dl; Respiratory rate (12 br/min); sick with respiratory virus; 142 mmHG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild asthma", start date: 2016 (ongoing); "overweight" (unspecified if ongoing); "Allergies", start date: 2016 (ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for asthma, hypersensitivity, start date: 2016 (ongoing). Vaccination history included: bnt162b2 (Dose 1, Single, Intramuscular, Arm), administration date: 01Jan2021, for COVID-19 Immunisation; bnt162b2 (Dose 2, Single, Intramuscular, Arm), administration date: 02Feb2021, for COVID-19 Immunisation; bnt162b2 (Dose 3 (Booster), Single, Intramuscular, Arm), administration date: 09Sep2021, for COVID-19 Immunisation; bnt162b2 (Dose 4 (Booster), Single, Intramuscular, Arm, Time: 18:15), administration date: 03Mar2022, for COVID-19 Immunisation. The following information was reported: BLOOD PRESSURE SYSTOLIC INCREASED (non-serious) with onset 25Apr2023, outcome "unknown", described as "142 mmHG"; RESPIRATORY TRACT INFECTION VIRAL (non-serious) with onset 25Apr2023, outcome "unknown", described as "sick with respiratory virus"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Sep2023, outcome "unknown", described as "Respiratory rate (12 br/min)"; BLOOD BILIRUBIN INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Bili total 1.1 mg/dl"; BLOOD CHLORIDE INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Chloride level 110 mmol/L"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 26Sep2023, outcome "unknown", described as "Cholesterol 212 mg/dl". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Mother and sisters all took BP meds.  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: Linked Report(s) : US-PFIZER INC-202300335763 Same patient/ product, different dose/event;
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: gets flu shot every year & usually gets the flu; it didn't work because it was a different strain than they thought; Initial information received on 11-Nov-2023 regarding an unsolicited valid Social Media serious case received via consumer.  This case involves an unknown age female patient and the reporter stated gets flu shot every year & usually gets the flu and it didn't work because it was a different strain than they thought after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, expiry date, form, lot number: unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization). Information on batch number was requested.  On an unknown date the patient had events of gets flu shot every year & usually gets the flu (influenza) and it didn't work because it was a different strain than they thought (vaccination failure) (unknown latency) following the administration of influenza vaccine.  Reportedly, Patient gets flu shot every year & usually gets the flu. Shes been told that it didn't work because it was a different strain than they thought. The whole thing seems to be a krap shoot, for her anyway  It was unknown if any lab data/test results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the events.  Seriousness criteria: event of  it didn't work because it was a different strain than they thought was assessed as medically significant; Sender's Comments: Sanofi company comment dated 20-Nov-2023: This case involves an unknown age female patient and the reporter stated gets flu shot every year & usually gets the flu and it didn't work because it was a different strain than they thought after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 83.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the product; Initial information received on 09-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient. This is a courtesy case from agency.  This case involves a 83 years old female patient who was allergic to the tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date and month in 1962, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer site (lot number, route, administration , dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient was allergic to the product (allergy to vaccine) (unknown latency) following the administration of tetanus toxoid.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 2.0
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 2-year-old who accidently received quadracel and they were supposed to receive daptacel with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves 2-year-old male patient who accidently received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [quadracel (VERO)] and they were supposed to receive diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 ml total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine, Solution for injection (strength, expiry date: unknown) (lot: U78388A) via intramuscular route in the left vastus lateralis for Immunization and 2-year-old who accidently received quadracel and they were supposed to receive daptacel with no reported adverse event (wrong product administered) (latency: same day)   Reportedly, medical assistant calling on behalf of a 2-year-old who accidently received Quadracel and they were supposed to receive Daptacel. She would like to know if it counted for the patient's DTaP. She would also like to know what they should look out for in terms of potential side effects. She states that the patient previously received two Pentacel injections and one Vaxelis injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: medication error due to possible administration of TENIVAC after its expiration date with no reported adverse event; Initial information received on 09-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had medication error due to possible administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adults [TENIVAC] after its expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adults Suspension for injection (lot U7183AA, expiry date: 24-Sep-2023 with unknown dose, strength) via unknown route in unknown administration site as Immunization which was a medication error due to possible administration of tenivac after its expiration date with no reported adverse event (expired product administered) (latency: same day).  It was reported "a nursing supervisor reports that they had vials of TENIVAC which had the expiration dates printed on them as 24SEP23 and 24JUN23; reports that they found this dating method confusing and it caused 3 doses from LOT U7183AA, EXP 24SEP23 and 5 doses from LOT U7092AA, EXP 24JUN23 to possibly be administered to patients after the expiration. She states that this is the only medication that they have which shows the expiration date in that format. The nursing supervisor is unable to provide any additional AE information; she states that they will need to run an internal report to confirm how many doses of expired TENIVAC were actually administered and to which patients. The nursing supervisor reports that the way that the expiration date is printed on the tenivac vials is confusing and easily misinterpreted. she reports that it was confusing to them whether they should read the expiration date printed on the vial, 24sep23, as september 24th, 2023 or september 23rd, 2023. the same issue occurred with the second vial of tenivac with expiration dated as 24jun23. the way that the expiration date was printed may have caused them to use the product after its expiration"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired Fluzone qiv pfs (expired on 30-Jun-2023) with no reported adverse event; Initial information was received on10-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered influenza quadrival a-b vaccine [Fluzone Quadrivalent] (expired on 30-jun-2023) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Nov-2023, the patient received a dose of 0.5 ml of suspect Influenza Quadrival A-B Vaccine (lot number: UT7716MA and Expiry date:30-Jun-2023)(Unknown Formulation and strength) via intramuscular route in in the right arm for immunization.   On 09-Nov-2023 the patient was administered an expired influenza quadrival a-b vaccine (expired on 30-jun-2023) with no reported adverse event (expired product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 12 patients received fluzone hd qiv that was expired at the time of administration with no reported adverse event; Initial information received on 10-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-Dose Quadrivalent] that was expired at the time of administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an expired 0.7 ml dose of suspect Influenza Quadrival A-B High dose HV Vaccine (lot UT7715BA, Expiry date: 30-Jun-2023 with unknown strength and form) via unknown route in unknown administration site as Immunization with no reported adverse event (expired product administered) (latency: same day).  It was reported 'caller stated that 12 patients received Fluzone HD QIV that was expired at the time of administration. What are the next steps? Should we give the high dose again, or a non-high dose? What is non-live? How long should we wait before repeating the dose?"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: once of their office has administered an expired dose of ACTHIB with no reported adverse event; Initial information received on 10-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 months and 14 days old female patient to whom once of their office has administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2023, the patient once of their office has administered an expired dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ837AA; Expiry date: 30-Oct-2023) via intramuscular route in the Left anterior lateral thigh (left thigh) for Immunization with no reported adverse event (expired product administered) (latency: on same day). This dose was administered as a part of a 15-month wellness visit. Reporter stated that the Biohazard team did a pickup.  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient received an expired ACT-HIB (wtih no reported adverse event); Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who received an expired Haemophilus Type B (Hib) Vaccine (Act-Hib) wtih no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine inact (vaqta) for prophylactic vaccination; and pneumococcal vaccine conj 7v (crm197) (prevnar) for prophylactic vaccination.  On 10-Nov-2023, the patient received 0.5 ml of suspect Haemophilus Type B (Hib) Vaccine (Act-Hib) Powder and solvent for solution for injection (lot number: UJ756AA, Expiry date: 12-Aug-2023) (Diluent, Lot number: unknown, expiry date: 07-Oct-2023) (Strength: Standard) (Frequency: once) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation).   On 10-Nov-2023, the patient received an expired Haemophilus Type B (Hib) Vaccine (wtih no reported adverse event) (expired product administered) (latency: same day).  It was reported, A medical assistant transferred from Customer Service stated that a patient received an expired ACT-HIB. Caller is asking if they should revaccinate.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TYP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient that received 2 vaccines about a month a part from each other with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves adult male patient of an unknown age who received 2 Typhoid Vi Polysaccharide Vaccine [Typhim Vi] about a month a part from each other with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Nov-2023, the patient received 0.5 ml once daily (QD) of suspect Typhoid Vi Polysaccharide Vaccine Solution for injection (with an unknown route, administration site , formulation, strength, expiry date and lot number) for immunization.  On 13-Nov-2023, the patient received 2 Typhoid Vi Polysaccharide Vaccine [Typhim Vi] about a month a part from each other with no reported adverse event (extra dose administered) (latency same day).  It was reported, Caller stated that she has a patient that received 2 vaccines about a month a part from each other. Caller stated that the patient is fine and would like to know if there is anything else that she needs to do. The caller did not have any patient details, only that it was a male, 18-40 yrs old. What is docu wented to the only info available at this time. The caller did not have the lot# and exp date for the first product that was administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: dosing done with the fluzone quadrivalent prefilled syringe for a 14-month-old patient, he states that two dosages were administered but not in the appropriate time frame with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 months old and unknown gender patient for whom dosing done with the Influenza Quadrival A-B Vaccine [Fluzone QIV] prefilled syringe but not in the appropriate time frame with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct and 27-Oct both in unknown year, the patient received a dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (lot U8192AA for date 11-Oct and for 27-Oct the lot is U8192BA with unknown strength, dose, expiry date) via unknown route in unknown administration site as immunization not in the appropriate time frame with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  It was reported "the first dose was given on 11OctxxXX and the second dose was given 27OctxxXX so the dose was administered two weeks before it should have been administered and he is looking for some clinical guidance on how to proceed with the patient."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: reporting a pregnant patient inadvertently received 2 doses of adacel with no reported adverse event; pregnant patient received adacel with no reported adverse event; Initial information received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 16 years old female pregnant patient where patient inadvertently received 2 doses of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported reporting a pregnant patient inadvertently received 2 doses of adacel with no reported adverse event occurred at 34 weeks of pregnancy and pregnant patient received adacel with no reported adverse event occurred at 34 weeks of pregnancy and the patient was exposed to vaccine at 29 weeks of pregnancy, during third pregnancy trimester for diphtheria-2/tetanus/5 ac pertussis vaccine.  The date of last menstrual period was reported as 23-Feb-2023. The estimated due date is 30-Nov-2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot U7869AA and expiration date- 18-Aug-2025) via intramuscular route in the right deltoid. On 17-Oct-2023 she also received a dose of the same vaccine lot U7869AA via intramuscular route in the right deltoid (dose, formulation, strength: not provided) for Immunisation (inappropriate schedule of product administration) and (exposure during pregnancy) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event and Additionally, at time of reporting, the pregnancy is still ongoing.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.