chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Chills; Nausea; Fatigue; This is a spontaneous report received from a contactable healthcare professional.  A 52-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 included: "Diabetic" (unspecified if ongoing); "Heart conditions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  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-PV202200071855 Same patient and product; different dose and event.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: chills; nausea; fatigue; stated arm where shot was given became sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Optional Information: Diabetic; "Heart conditions" (unspecified if ongoing), notes: Optional Information: Heart conditions. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization, reaction(s): "chills", "fatigue", "nausea". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Sep2022, outcome "unknown", described as "stated arm where shot was given became sore"; CHILLS (non-serious) with onset 24Sep2022, outcome "unknown"; FATIGUE (non-serious) with onset 24Sep2022, outcome "unknown"; NAUSEA (non-serious) with onset 24Sep2022, outcome "unknown".  Additional information: Patient stated arm where shot was given became sore later in the evening same day. By next day patient had similar symptoms when she received last Covid shot - chills, nausea, fatigue.  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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nausea, Vaccination site pain
Clinical narrative: chills; nausea; fatigue; stated arm where shot was given became sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Optional Information: Diabetic; "Heart conditions" (unspecified if ongoing), notes: Optional Information: Heart conditions. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization, reaction(s): "chills", "fatigue", "nausea". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Sep2022, outcome "unknown", described as "stated arm where shot was given became sore"; CHILLS (non-serious) with onset 24Sep2022, outcome "unknown"; FATIGUE (non-serious) with onset 24Sep2022, outcome "unknown"; NAUSEA (non-serious) with onset 24Sep2022, outcome "unknown".  Additional information: Patient stated arm where shot was given became sore later in the evening same day. By next day patient had similar symptoms when she received last Covid shot - chills, nausea, fatigue.  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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2weeks. Patient received paxlovid as COVID-19 treatment from 22Sep2022 via oral route.  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-202201191142 Same reporter/patient, different product/events;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "myogenic ptosis" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: Cat dander" (unspecified if ongoing); "Known allergies: Dog dander" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive, notes: COVID 19 Treatment, diagnosed with covid 19 on 13Sep2022 and took paxlovid 13Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported events Vaccination Failure and Covid-19 cannot be excluded for the suspect drug BNT162b2 .
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDCA22-01987 (Moderna).  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 24Jan2022. The patient was 24 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: LEVOTHYROXINE; DICLECTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive.   Clinical course: She states she is 34 weeks and 3 days into her pregnancy. No allergies, Concomitant product code: Prenatal vitamins 100 U.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia, Vaccination site mass
Clinical narrative: injection site, the area is still swollen; injection site, the area is still swollen and there is a knot around 2-3 inches; chills; fever; sore muscles; lack of energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024493 (Moderna).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Covid 19" (unspecified if ongoing), notes: had prior to getting the 1st dose and stayed at home, mild symptoms. Concomitant medication(s) included: AMLODIPINE taken for coronary artery disease; ATORVASTATIN taken for blood cholesterol; BABY ASPIRIN; MAGNESIUM; ZINC; VIT D [COLECALCIFEROL]. Vaccination history included: moderna (DOSE 1), administration date: 20Feb2021, for COVID-19 Immunization, reaction(s): "chills", "fever", "sore muscle", "lack of energy"; coviD-19 vaccine (DOSE 2), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "chills", "fever", "sore muscle", "lack of energy". The following information was reported: CHILLS (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021); PYREXIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "fever"; ASTHENIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "lack of energy"; MYALGIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "sore muscles"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "injection site, the area is still swollen"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "injection site, the area is still swollen and there is a knot around 2-3 inches". The events "chills", "fever", "sore muscles", "lack of energy", "injection site, the area is still swollen" and "injection site, the area is still swollen and there is a knot around 2-3 inches" required physician office visit.  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: Vaccination site swelling
Clinical narrative: injection site, the area is still swollen; injection site, the area is still swollen and there is a knot around 2-3 inches; chills; fever; sore muscles; lack of energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024493 (Moderna).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Covid 19" (unspecified if ongoing), notes: had prior to getting the 1st dose and stayed at home, mild symptoms. Concomitant medication(s) included: AMLODIPINE taken for coronary artery disease; ATORVASTATIN taken for blood cholesterol; BABY ASPIRIN; MAGNESIUM; ZINC; VIT D [COLECALCIFEROL]. Vaccination history included: moderna (DOSE 1), administration date: 20Feb2021, for COVID-19 Immunization, reaction(s): "chills", "fever", "sore muscle", "lack of energy"; coviD-19 vaccine (DOSE 2), administration date: 20Mar2021, for COVID-19 Immunization, reaction(s): "chills", "fever", "sore muscle", "lack of energy". The following information was reported: CHILLS (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021); PYREXIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "fever"; ASTHENIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "lack of energy"; MYALGIA (non-serious) with onset 02Sep2021, outcome "recovered" (05Sep2021), described as "sore muscles"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "injection site, the area is still swollen"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "injection site, the area is still swollen and there is a knot around 2-3 inches". The events "chills", "fever", "sore muscles", "lack of energy", "injection site, the area is still swollen" and "injection site, the area is still swollen and there is a knot around 2-3 inches" required physician office visit.  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: Ear swelling, Lymphadenopathy, Pain, Sleep disorder, Swelling
Clinical narrative: The swelling moved to under right jaw, then in front of right ear; The swelling moved to under right jaw, then in front of right ear. It stayed in front of right ear for about 3 days; so swollen that it was painful and woke patient up at night; woke patient up at night; swollen lymph nodes on the right side of neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 70-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose: 4, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Sep2022, outcome "recovering", described as "swollen lymph nodes on the right side of neck"; SWELLING (non-serious), outcome "recovering", described as "The swelling moved to under right jaw, then in front of right ear"; EAR SWELLING (non-serious), outcome "recovering", described as "The swelling moved to under right jaw, then in front of right ear. It stayed in front of right ear for about 3 days"; PAIN (non-serious), outcome "recovering", described as "so swollen that it was painful and woke patient up at night"; SLEEP DISORDER (non-serious), outcome "recovering", described as "woke patient up at night". Therapeutic measures were taken as a result of lymphadenopathy, swelling, ear swelling, pain, sleep disorder.  Additional information: On 25Sep2022, patient developed swollen lymph nodes on the right side of neck. The swelling moved to under right jaw, then in front of right ear. It stayed in front of right ear for about 3 days, so swollen that it was painful and woke patient up at night. Patient took ibuprofen around the clock. It is finally diminishing a week later. Patient had no reactions with the first four vaccines.  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: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: patient had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003488 (Novavax).  A 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: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "patient had an allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: Nausea; Fatigue; Arm soreness; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 43-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Sep2022, outcome "unknown", described as "Arm soreness"; FATIGUE (non-serious) with onset 25Sep2022, outcome "unknown"; NAUSEA (non-serious) with onset 25Sep2022, outcome "unknown".  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I came home with COVID; I came home with COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2022 as dose number unknown (booster), single (Lot number: FK9894) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "not recovered" and all described as "I came home with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2022) Positive. The patient is a teacher. The patient received the Omicron booster on 07Sep2022. Students returned and on 19Sep2022, the patient came home with COVID. The patient had been wearing a mask at school and at stores. The patient's symptoms were extensive. The patient is still testing a strong positive on Saturday 24Sep2022 and experiencing symptoms. The booster before the Omicron was (Pfizer FK9894) on 14Apr2022. The patient has hypertension so he/she have always looked to avoid COVID.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: temperature is now 103 to 104; got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 24Sep2022 at 03:00, outcome "unknown", described as "got sick"; PYREXIA (non-serious) with onset 26Sep2022, outcome "not recovered", described as "temperature is now 103 to 104". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was having a flare up of all the other side effects again and  just trying to figure out is this normal or adverse.   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: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pericarditis, Pleural effusion
Clinical narrative: rapid atrial fibrillation; pericarditis; plueral effusions; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient in her 60's received BNT162b2 (COMIRNATY), 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: ATRIAL FIBRILLATION (medically significant), outcome "recovered", described as "rapid atrial fibrillation"; PERICARDITIS (medically significant), outcome "recovered"; PLEURAL EFFUSION (non-serious), outcome "recovered", described as "plueral effusions". Therapeutic measures were taken as a result of pericarditis. Clinical course: patient suffered rapid atrial fibrillation, pericarditis and plueral effusions after receiving vaccination with Comirnaty. She was placed on colchicine which she could not tolerate and switched to steroids to treat the pericarditis. The situation resolved after several months and the woman is currently doing well. Patient has not prior of adverse vaccine reactions or known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Atrial fibrillation, Pericarditis and Pleural effusion and the suspect drug BNT162b2 (COMIRNATY) cannot be excluded. The case will be reassessed once new information is available.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness on forehead and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchiness on forehead and feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Pain in extremity
Clinical narrative: Sore arm in male diabetic; Sore arm in male diabetic; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Sore arm in male diabetic".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity
Clinical narrative: following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 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: PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "following her Covid injections (all three Pfizer) her arm and armpit lymphs were sore".  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: Drug ineffective, Suspected COVID-19
Clinical narrative: Ironically I just got COVID for the second time [after receiving the Pfizer/BioNTech vaccine]; Ironically I just got COVID for the second time [after receiving the Pfizer/BioNTech vaccine]; 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 (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 "Ironically I just got COVID for the second time [after receiving the Pfizer/BioNTech vaccine]".  Clinical course: The patients age was provided as 50 (no units provided).  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: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003483.  A female patient received BNT162b2 (BNT162B2), in Dec2020 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown". She did not complete her series.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported anaphylactic reaction was likely related to BNT162b2 due to temporal relationship and known safety profile of this product.
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Lymphoma
Clinical narrative: recurrence/worsening of lymphoma; recurrence/worsening of lymphoma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 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: LYMPHOMA (medically significant), outcome "unknown", described as "recurrence/worsening of lymphoma". Clinical courses is as follows: The reporter heard a story anecdotally from brother who is a physician. He said a colleague was also suspicious of a link between recurrence/worsening of lymphoma (in himself) after mRNA vaccination. That was in spring of 2021 when were getting vaccinated. 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: Balance disorder, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: tachycardia; shortness of breath; Chest pressure/tightness; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; She can't work at all.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart issue" (unspecified if ongoing), notes: Exclusive- Women injured by Pfizer shot forced to get vaccine despite pre-existing heart issue. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "balance issues", "chest pressure", "chest pressure/tightness", "Cough", "dizziness/balance issues", "Shortness of breath", "fatigue", "severe headache[s]", "muscle aches", "nausea", "Heart racing", "Tachycardia". The following information was reported: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest pressure/tightness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "She can't work at all.".  Additional Information: It was reported that the patient, 45 couldn't get a medical exemption from her employer's COVID-19 vaccine mandate despite a pre-existing heart condition-now she can't work at all. The patient received her second Pfizer shot on 03Oct2021 and experienced the same severe reactions as with first dose. The symptoms included severe headache[s], severe muscle aches, racing heartbeat, nausea, severe fatigue and dizziness/balance issues, chest pressure/tightness, shortness of breath and a severe cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Impaired work ability, Myalgia
Clinical narrative: tachycardia; shortness of breath; Chest pressure/tightness; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; She can't work at all.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart issue" (unspecified if ongoing), notes: Exclusive- Women injured by Pfizer shot forced to get vaccine despite pre-existing heart issue. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "balance issues", "chest pressure", "chest pressure/tightness", "Cough", "dizziness/balance issues", "Shortness of breath", "fatigue", "severe headache[s]", "muscle aches", "nausea", "Heart racing", "Tachycardia". The following information was reported: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest pressure/tightness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "She can't work at all.".  Additional Information: It was reported that the patient, 45 couldn't get a medical exemption from her employer's COVID-19 vaccine mandate despite a pre-existing heart condition-now she can't work at all. The patient received her second Pfizer shot on 03Oct2021 and experienced the same severe reactions as with first dose. The symptoms included severe headache[s], severe muscle aches, racing heartbeat, nausea, severe fatigue and dizziness/balance issues, chest pressure/tightness, shortness of breath and a severe cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia
Clinical narrative: tachycardia; shortness of breath; Chest pressure/tightness; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; She can't work at all.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart issue" (unspecified if ongoing), notes: Exclusive- Women injured by Pfizer shot forced to get vaccine despite pre-existing heart issue. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "balance issues", "chest pressure", "chest pressure/tightness", "Cough", "dizziness/balance issues", "Shortness of breath", "fatigue", "severe headache[s]", "muscle aches", "nausea", "Heart racing", "Tachycardia". The following information was reported: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest pressure/tightness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "She can't work at all.".  Additional Information: It was reported that the patient, 45 couldn't get a medical exemption from her employer's COVID-19 vaccine mandate despite a pre-existing heart condition-now she can't work at all. The patient received her second Pfizer shot on 03Oct2021 and experienced the same severe reactions as with first dose. The symptoms included severe headache[s], severe muscle aches, racing heartbeat, nausea, severe fatigue and dizziness/balance issues, chest pressure/tightness, shortness of breath and a severe cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL was given to a 7 year-old. However, it is only indicated for 4-6 year old patients with no reported AE; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient who was given DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]. however, it was only indicated for 4-6 year old patients with no reported ae(adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  On 30-Aug-2022, the patient received a 0.5ml once dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation was unknown, lot C6002BA and expiry date: 18-May-2024) via intramuscular route in the left lower thigh for Immunization.  On 30-Aug-2022 the patient developed a non-serious event of quadracel was given to a 7 year-old. however, it is only indicated for 4-6-year-old patients with no reported ae (product administered to patient of inappropriate age) (Latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  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 guidelines. 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: TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: ADACEL was inadvertently administered to a consumer who had a previous dose in 2020 with no adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom experienced diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was inadvertently administered who had a previous dose in 2020 with no adverse event.  The patient's past vaccination(s) included ADACEL in 2020. The patient's past medical history, medical treatment(s) and family history were not provided.   On Unknown date in Sep-2022, the patient received 0.5 ml  dose once (1X) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (strength,lot number and expiry date not reported) via unknown route in unknown administration site for immunization who had a previous dose in 2020 with no adverse event (inappropriate schedule of product administration) (latency: on same day).  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 guidelines. 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: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of expired DAPTACEL to a patient with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Healthcare professional).  This case is linked to case 2022SA391373.  This case involves a 2 years old male patient who experienced administration of expired daptacel to a patient with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation.  On 20-Sep-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5774BA) (dose, formulation, strength, and expiry date: unknown)via intramuscular route in the right deltoid for prophylaxis vaccination.  On 20-SEP-2022 the patient developed a non-serious administration of expired daptacel to a patient with no reported adverse event (expired product administered) (latency one day) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: child received expired ACT-HIB/ liquid component of the ACT-HIB expired on 20Sep2022 with no reported AE; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced child received expired act-hib/ liquid component of the act-hib expired on 20sep2022 with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 21-Sep-2022, the patient received a  0.5ml dose of suspect HIB (PRP/T) VACCINE once ( lot UJ575AAB; expiry date; 20-SEP-2022) via intramuscular route in leg for immunization.  On 21-SEP-2022 the patient developed a non-serious event child received expired act-hib/ liquid component of the act-hib expired on 20-Sep-2022 with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 2.0
Sex: M
Vaccine: MNQ, PNC13
Symptoms: Wrong product administered
Clinical narrative: 2 year old patient mistakenly received a MENQUADFI vaccine instead of the intended PREVNAR 13 vaccine with no reported adverse event; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who had mistakenly received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccine instead of the intended PREVNAR 13 vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  On 22-Sep-2022 the patient developed a non-serious event of 2 year old patient had mistakenly received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccine (dose: 0.5ml, batch number: U7294AC and expiry date: 24-May-2023, route, administration site was unknown for Immunization ) instead of the intended PREVNAR 13 vaccine with no reported adverse event (wrong product administered) (Latency: same day). Nurse asked if a follow up dose at age 11 or 12 of MENQUADFI was recommended.  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 guidelines. 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: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Anaphylactic reaction, Hypersensitivity, Oropharyngeal discomfort, Swollen tongue
Clinical narrative: Allergic reaction vs anaphylaxis with tongue swelling and throat discomfort developing soon after admin, resolving w/o treatment w/in approx 3 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Eye swelling, Hypoaesthesia, Mouth swelling, Musculoskeletal discomfort, Paraesthesia oral
Clinical narrative: Allergic reaction vs anaphylaxis with tongue swelling and throat discomfort developing soon after admin, resolving w/o treatment w/in approx 3 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Allergic reaction vs anaphylaxis with tongue swelling and throat discomfort developing soon after admin, resolving w/o treatment w/in approx 3 hours.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dry throat, Injection site pain, Pain, Throat irritation
Clinical narrative: Dry, scratchy sore throat, sore injection site, aches
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Fatigue, Injection site pain, Insomnia, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Eye swelling, Hypersensitivity, Lip swelling, Mouth swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient received Flulaval and waited while her mother also recieved the vaccine.  Then patient said that she needed to sit that she was getting light headed. She had some water and rested, mother said patient's lip started to swell and we gave 50mg of diphenhydramine. Mother decided to take patient home shortly after giving diphenhydramine. We will followup with patient in an hour.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient received Flulaval and waited while her mother also recieved the vaccine.  Then patient said that she needed to sit that she was getting light headed. She had some water and rested, mother said patient's lip started to swell and we gave 50mg of diphenhydramine. Mother decided to take patient home shortly after giving diphenhydramine. We will followup with patient in an hour.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild