chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Lichenoid keratosis
Clinical narrative: extremely itchy lichenoid; got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash". The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "not recovered", described as "extremely itchy lichenoid"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "got worse".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  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, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: extremely itchy lichenoid; got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash". The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "not recovered", described as "extremely itchy lichenoid"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "got worse".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  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: Cardiac disorder, Neoplasm malignant
Clinical narrative: I have cancer; I have a heart problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 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 series complete; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I have cancer"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "I have a heart problem". Additional information: The patient has cancer and also, a heart problem. Patient knew these things lose their effectiveness over time and doesn't want to be in a position where she gets COVID and not protected. She thinks Pfizer needs to address this problem for older people that have immune compromised situation and believes that they need to let them know what to do or at least get give them the information.  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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Cardiac disorder
Clinical narrative: Arteriosclerotic cardiovascular disease; Heart issues; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as DOSE 2, SINGLE (lot number: EW0162) at the age of 63 years old, for COVID-19 immunization. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration, administered in the right arm (lot number: EP7534) as DOSE 1, SINGLE, AE: Bell's palsy 12 hours post vaccination), administration date: Mar2021, when the patient was 63 years old, for COVID-19 Immunization, reaction: "Bells Palsy." Patient did not receive other vaccine in four weeks. Patient was not tested for COVID post vaccination. The following information was reported: CARDIAC DISORDER (death, hospitalization, disability, medically significant) with onset 23Jul2021, outcome "fatal" described as "Heart issues"; ARTERIOSCLEROSIS (death, hospitalization, disability, medically significant) with onset 03Sep2021, outcome "fatal" described as "Arteriosclerotic cardiovascular disease." The patient was hospitalized for cardiac disorder (start date: 2021, discharge date: 2021). The events "heart issues" and "arteriosclerotic cardiovascular disease" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cardiac disorder, arteriosclerosis which included stents to try and save arteries. It was reported that the patient required 2 stents due to "new heart issues." 23Jul2021 required 1 stent due to "new heart issues." 03Sep2021 Death classified as Arteriosclerotic cardiovascular disease. The patient's date of death was 16Nov2021. Reported cause of death: "Arteriosclerotic cardiovascular disease" and "Heart issues." No autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300049978 same patient and product; different dose number and events;; Reported Cause(s) of Death: Arteriosclerotic cardiovascular disease; Heart issues
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Facial pain, Thrombosis
Clinical narrative: Almost completely over stroke /Affecting left side; Blood clot in lower left leg; After shots balance worsened; Pressure on left side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "After shots balance worsened", "Almost completely over stroke", "Pressure on left side of face", "Affecting left side", "Blood clot in lower left leg". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Almost completely over stroke /Affecting left side"; THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot in lower left leg"; BALANCE DISORDER (non-serious), outcome "unknown", described as "After shots balance worsened"; FACIAL PAIN (non-serious), outcome "unknown", described as "Pressure on left side of face".  Clinical course: Having reaction to shots (2 + 1 booster). Almost completely over stroke 10Dec2, affecting left side, & after shots balance worsened (98% now 80%) & now need a cane, blood clot in lower left leg & pressure on left side of face. All of these things occurring after shots. ER many times from COVID shots.   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-202300049896 Same patient/event, same drug in different dose;US-PFIZER INC-PV202300018058 Same patient/event, same drug in different dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: My whole head was aching only my left side and it keeps traveling from one place to another; 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 18Jan2023 as dose 4 (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 (Dose: 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 19Jan2023, outcome "not recovered", described as "My whole head was aching only my left side and it keeps traveling from one place to another".  Additional information: Patient reported that on 18Jan2023 got a Covid shot in left arm fourth shot the next morning. I woke up on my left side. Patient's whole head was aching only left side and it keeps traveling from one place to another. It's now 29Jan2023 and patient still had the same symptoms after going to the doctor patient need help.  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: Blood test normal, Facial pain, Fatigue, Headache, Magnetic resonance imaging head normal
Clinical narrative: My whole head was aching only my left side and it keeps traveling from one place to another; 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 18Jan2023 as dose 4 (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 (Dose: 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 19Jan2023, outcome "not recovered", described as "My whole head was aching only my left side and it keeps traveling from one place to another".  Additional information: Patient reported that on 18Jan2023 got a Covid shot in left arm fourth shot the next morning. I woke up on my left side. Patient's whole head was aching only left side and it keeps traveling from one place to another. It's now 29Jan2023 and patient still had the same symptoms after going to the doctor patient need help.  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: Oropharyngeal pain, Somnolence, Tendon disorder
Clinical narrative: My whole head was aching only my left side and it keeps traveling from one place to another; 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 18Jan2023 as dose 4 (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 (Dose: 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 19Jan2023, outcome "not recovered", described as "My whole head was aching only my left side and it keeps traveling from one place to another".  Additional information: Patient reported that on 18Jan2023 got a Covid shot in left arm fourth shot the next morning. I woke up on my left side. Patient's whole head was aching only left side and it keeps traveling from one place to another. It's now 29Jan2023 and patient still had the same symptoms after going to the doctor patient need help.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Fever 102-103; Shortness of breath; Fatigue; Elevated HR; Swollen lymph node under the arm on the side of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jan2023 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: HEART RATE INCREASED (non-serious) with onset 28Jan2023, outcome "unknown", described as "Elevated HR"; FATIGUE (non-serious) with onset 28Jan2023, outcome "unknown"; PYREXIA (non-serious) with onset 28Jan2023, outcome "unknown", described as "Fever 102-103"; DYSPNOEA (non-serious) with onset 28Jan2023, outcome "unknown", described as "Shortness of breath"; LYMPHADENOPATHY (non-serious) with onset 28Jan2023, outcome "unknown", described as "Swollen lymph node under the arm on the side of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  Additional information: Booster on Friday. Saturday: fever 102-103, shortness of breath, fatigue, elevated HR, swollen lymph node under the arm on the side of injection. Sunday: fatigue, taking ibuprofen every 6 hours. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever 102-103; Shortness of breath; Fatigue; Elevated HR; Swollen lymph node under the arm on the side of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jan2023 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: HEART RATE INCREASED (non-serious) with onset 28Jan2023, outcome "unknown", described as "Elevated HR"; FATIGUE (non-serious) with onset 28Jan2023, outcome "unknown"; PYREXIA (non-serious) with onset 28Jan2023, outcome "unknown", described as "Fever 102-103"; DYSPNOEA (non-serious) with onset 28Jan2023, outcome "unknown", described as "Shortness of breath"; LYMPHADENOPATHY (non-serious) with onset 28Jan2023, outcome "unknown", described as "Swollen lymph node under the arm on the side of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  Additional information: Booster on Friday. Saturday: fever 102-103, shortness of breath, fatigue, elevated HR, swollen lymph node under the arm on the side of injection. Sunday: fatigue, taking ibuprofen every 6 hours. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pancreatic disorder
Clinical narrative: pancreatic issues; illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), 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: PANCREATIC DISORDER (hospitalization), outcome "unknown", described as "pancreatic issues"; ILLNESS (non-serious), outcome "unknown".  Clinical information: It was reported that the son has been dealing with pancreatic issues since his covid vaccine. He is only 16 we are currently under the care of (Hospital name withheld). Prior to this (Name withheld) was very healthy. He is trying to finish his junior year of high school. They believed his illness could be related to the vaccine.  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: Gait inability, Musculoskeletal stiffness, Myalgia
Clinical narrative: lost the ability to walk for a few days; muscles were extremely stiff and painfull; muscles were extremely stiff and painfull; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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 (DOSE 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: GAIT INABILITY (non-serious), outcome "recovered", described as "lost the ability to walk for a few days"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), outcome "recovered" and all described as "muscles were extremely stiff and painfull".  Additional information: Reporter type: Consumer. 64 year old female patient. On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 2 for Covid-19 immunisation. Reportedly, the individual experienced a severe reaction to the second dose, lost the ability to walk for a few days, but it came back fully after 6 months, their muscles were extremely stiff and painful. It is currently resolved. Their healthcare provider recommended that they do not get any more Mrna vaccines, so I had J&J as my booster.  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: Death
Clinical narrative: died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  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-202300047644 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047643 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047642 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047646 as same reporter/drug, different patient/event;;US-PFIZER INC-202300047640 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047645 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047636 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047639 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047641 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047638 as same reporter/drug/event, different patient.;US-PFIZER INC-202300047637 as same reporter/drug/event, different patient.;; Reported Cause(s) of Death: died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Acne outbreak requiring medication following Comirnaty booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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; unknown manufacturer), for COVID-19 immunization. The following information was reported: ACNE (non-serious), outcome "unknown", described as "Acne outbreak requiring medication following Comirnaty booster".  Additional information: Patient reported acne outbreak requiring medication following Comirnaty booster. Event took place after use of product.  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: Dizziness, Illness
Clinical narrative: dizzy; I'm tired of being sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "I'm tired of being sick"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizzy". The events "dizzy" and "i'm tired of being sick" required physician office visit. Additional information: the patient received the vaccine 23 months ago and was dizzy every day, so had been to to 9 doctors they all said they didn't know.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pulmonary hypertension
Clinical narrative: CTEPH; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A male patient 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: PULMONARY HYPERTENSION (medically significant), outcome "unknown", described as "CTEPH". The patient underwent the following laboratory tests and procedures: scans/tests: CTEPH, notes: diagnosed with CTEPH after many scans and tests.  Clinical course: Reporter stated that she believed her husband reacted to the Pfizer vaccine they received in Jan/Feb2021. He had now been diagnosed with CTEPH after many scans and tests that started with breathing problems the week after receiving the vaccine. She believed his case needs to be documented, because up until he received the vaccine, none of these problems were on the radar.  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: Lichenoid keratosis
Clinical narrative: extremely itchy lichenoid rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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: LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "extremely itchy lichenoid rash".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.   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: Rash
Clinical narrative: She got a rash all over her body; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  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: RASH (hospitalization), outcome "recovered", described as "She got a rash all over her body". Therapeutic measures were taken as a result of rash.  Clinical information: On 13Jan2023, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech Covid-19 vaccine for an unspecified indication. The patient reported, their wife had one dose of the Pfizer vaccine and had a reaction. She got a rash all over her body and went to the hospital, they gave her steroids and she recovered, but she never got the second dose. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: intentional administration of FLUZONE HIGH DOSE QUADRIVALENT to a 64-year-old, high risk patient, with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 64-year-old, high risk patient of unknown gender who had intentional administration of influenza quadrival A-B high dose HV vaccine [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (lot number, expiry date: not reported) via unknown route in unknown administration site for Immunization.  On an unknown date there was intentional administration of fluzone high dose quadrivalent to a 64-year-old, high risk patient, with no reported adverse event (off label use, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: pentacel was administered to a patient after the expiration date, with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient and it was reported that Diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine [Pentacel] (VERO) was administered to a patient after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 01-Feb-2023, the patient received an unknown dose of suspect Diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (lot UJ640AAA, Expiry date: 28-Jan-2023) (with unknown formulation, strength, route and at unknown administration site) for immunization.  On 01-Feb-2023, reporter reported that pentacel was administered to a patient after the expiration date, with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  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 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: 0.42
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: information on high and low temperature excursions. Products were exposed to a high of 47.4 and a low of 31.4 with no reported adverse event; an ACTHB vaccine was administered to a 5 month-old female, this was after cold excursion of 31.4F with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 month old female patient who had taken HIB (PRP/T) VACCINE [ACT-HIB], this was after cold excursion of 31.4f with no reported adverse event and information on high and low temperature excursions. products were exposed to a high of 47.4 and a low of 31.4 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jan-2023, the patient received a 0.5 mL (milliliter) dose of suspect HIB (PRP/T) VACCINE (Frequency: once, lot: UJ653AAA, expiry date: 30-Mar-2023) (Strength: not reported) via intramuscular route in unknown administration site for immunization.  On 31-Jan-2023, (Latency: same day) the patient developed a non-serious an acthb vaccine was administered to a 5 month old female, this was after cold excursion of 31.4f with no reported adverse event (poor quality product administered) following the administration of HIB (PRP/T) VACCINE. On an unknown date, the HIB (PRP/T) VACCINE information on high and low temperature excursions. products were exposed to a high of 47.4 and a low of 31.4 with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  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: 66.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of Tenivac with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 66 years old male patient who administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Feb-2023, the patient received 0.50 mL of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Strength: standard) (Frequency: once) (lot U6922AA and expiry date: 22-Jan-2023) via intramuscular route in the right arm for Immunization.  On 01-Feb-2023, the patient was administered an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult  with no reported adverse event (expired product administered).  It was reported that "The clinic is wanting to know do they need to repeat the dose."  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 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Injection site pain, Ischaemic stroke, Laboratory test
Clinical narrative: Pain in chest, blurred vision and speech, rapid heartbeat, weakness, pain in left shoulder.  Went to ER and subsequently had an Overnight stay in hospital diagnosed as "Hospitalized with an Ischemic Stroke"
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Vision blurred
Clinical narrative: Pain in chest, blurred vision and speech, rapid heartbeat, weakness, pain in left shoulder.  Went to ER and subsequently had an Overnight stay in hospital diagnosed as "Hospitalized with an Ischemic Stroke"
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Nausea
Clinical narrative: severe chest pain, nausea, diarrhea
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dermatitis, Pruritus
Clinical narrative: A few weeks after the shot I broke out in terrible dermatitis which I'm still suffering months later. I have granuloma annulary which I've had for over a decade and it does not itch. This dermatitis is chronic and I am taking multiple medications to try to control it. There has been no relief since it began.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Chest X-ray, Computerised tomogram abdomen, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: tachycardia, high blood pressure
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fibrin D dimer, Hypertension, Tachycardia
Clinical narrative: tachycardia, high blood pressure
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Muscle spasms, Muscular weakness, Pain
Clinical narrative: Throbbing ache in upper arm began within a few hours, and gradually went away over the next couple days.  By the morning after vaccination, ache in right shoulder and weakness in right arm. Weakness and increasing pain with motion at the right shoulder. Shoulder pain and weakness lasted for about a month. Aching returns intermittently in the 8 months since. Joint pain--particularly in the right hand but systemically as well--starting within a week of vaccination. Occurs at least once a day for the 8 month since. Hand cramps at joints. Pain is sometimes sharp, sometimes dull during occurrences. General fatigue and rapid onset of fatigue from exertion. Began about 2 weeks after vaccination. Not a constant state of fatigue, but a general decrease in ability to sustain exertion, increase in recovery time (both immediately following activity and time to total recovery). Fainting. Once on June 20th, 2022 (about 2 weeks after vaccination). Twice in rapid succession on January 3, 2023. May or may not be related to vaccine. These are the only fainting episodes I've ever had though, and the first time was not long after vaccination.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope
Clinical narrative: Throbbing ache in upper arm began within a few hours, and gradually went away over the next couple days.  By the morning after vaccination, ache in right shoulder and weakness in right arm. Weakness and increasing pain with motion at the right shoulder. Shoulder pain and weakness lasted for about a month. Aching returns intermittently in the 8 months since. Joint pain--particularly in the right hand but systemically as well--starting within a week of vaccination. Occurs at least once a day for the 8 month since. Hand cramps at joints. Pain is sometimes sharp, sometimes dull during occurrences. General fatigue and rapid onset of fatigue from exertion. Began about 2 weeks after vaccination. Not a constant state of fatigue, but a general decrease in ability to sustain exertion, increase in recovery time (both immediately following activity and time to total recovery). Fainting. Once on June 20th, 2022 (about 2 weeks after vaccination). Twice in rapid succession on January 3, 2023. May or may not be related to vaccine. These are the only fainting episodes I've ever had though, and the first time was not long after vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: patient called 2.5 hours after immunization and stated that she was having a shooting pain down her arm into her thumb. she also was having pain at the point of injection. she stated that it started almost immediately after the immunization was given (i was not told at time of imz). advised patient to take over the counter nsaid (she stated she had taken an aleve) and to apply cold compress to point of injection.  followed up next day nerve pain down arm better but still tingly in wrist and inside elbow (crease) and down thumb joint. symptoms have not got worse but still feeling these reactions.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia
Clinical narrative: Fatigue. All the time. Sleeplessness. Headaches.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: N/A.  No adverse reaction
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: N/A. No adverse reaction
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Intensive care, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: stoke in left eye, Central retina artery occlusion
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal artery occlusion
Clinical narrative: stoke in left eye, Central retina artery occlusion
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Injection site irritation, Vertigo
Clinical narrative: I had some irritation at the injection site but I did with all previous and if went away... I started having dizzy spells about 8 days later. This progressed to severe dizziness, vertigo after 10 days to now (Feb 4). I went to Urgent Care on Feb 2 and received Meclizine, Cetirizine, and Fluticasone Propionate nasal spray scripts and started using late that afternoon?I feel somewhat better today but still persistent dizziness?  I did have covid in Sept of 2022 and was prescribed Paxlovid as a precaution. My symptoms were mild and recovered fully with no lingering symptoms.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Pulmonary sarcoidosis, Upper respiratory tract infection
Clinical narrative: URI, exacerbated sarcoidosis lung,
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reported a sore arm for the entire time since vaccine, over 5 months.
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Feeling hot
Clinical narrative: BURNING SENSATION/HOT FEELING ON FACE, RADIATING SLIGHTLY TO NECK
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored in the refrigerator for longer than the 10 week limit
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test normal, Myalgia, X-ray normal
Clinical narrative: Developed  significant widespread myalgias within several days of vaccine - and ongoing  myalgias in both hips and  right thigh
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sever joint pain within days
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscular weakness
Clinical narrative: Mild headache, muscle weakness, fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial spasm, Head discomfort, Hypoaesthesia, Magnetic resonance imaging head abnormal, Muscle twitching
Clinical narrative: Facial twitching and numbess. Head discomfort, facial pulses.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The pharmacist on duty administering the vaccine did not mix with the diluent. The pharmacist administered the full 0.2 ml.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain, Pain
Clinical narrative: Reported by caregiver.  Patient had pain on injection in the arm which continues.  He is able to raise and lower the arm.  He does not have pain to the touch, but has a constant thumping/pain.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling face, Wrong product administered
Clinical narrative: Member was given tetanus vaccine instead of typhoid on 30 jan 23 then given was given thphoid on 31 jan 23. woke up with swelling face on 1 Feb. and again on 2 Feb. member refused treatment. swelling dissipated on its own within 1-2hrs.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event patient was given a second dose of Pfizer Bivalent.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia, Joint swelling, Orthosis user, Pain
Clinical narrative: Mat 14,2021 Right hand lost feeling, watering hose fell from hand, fingers and wrist swollen. Extreme pain in right thumb. would scream if it had any movement Immediately went to local urgent care facility
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Screaming, X-ray limb
Clinical narrative: Mat 14,2021 Right hand lost feeling, watering hose fell from hand, fingers and wrist swollen. Extreme pain in right thumb. would scream if it had any movement Immediately went to local urgent care facility
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Patient told pharmacist that she has fainted from vaccines before, so pharmacist had her sit in the room after the vaccine was administered. About 5 minutes after administration, patient said she was starting to get sweaty and opted to lie down on the floor. We gave her a bottle of water. She then stated she was experiencing nausea and grabbed trash can and vomited. Pharmacist had patient remain in room for an additional 30 minutes with pharmacist, in which she said she was feeling more normal as the time passed. She said she had never actually vomited after a vaccine before, but has felt nauseas after before fainting. No additional treatment was administered.
Age: 3.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Diarrhoea, Lethargy, Pyrexia
Clinical narrative: Fever, lethargy, diarrhea
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The vaccine was stored for longer than the 10 week limit