chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Eye contusion
Clinical narrative: black eye; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EYE CONTUSION (black eye) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history conditions, allergy, concomitant diseases and risk factor and also unknown if she had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE CONTUSION (black eye). At the time of the report, EYE CONTUSION (black eye) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: How long does a reaction last from a Moderna booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (How long does a reaction last from a Moderna booster) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (How long does a reaction last from a Moderna booster). At the time of the report, IMMUNISATION REACTION (How long does a reaction last from a Moderna booster) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2023: Non-significant follow up received.
Age: 89.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Injection site swelling, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: arm from the area of the shot to her finger tips was swollen so bad; urinary issues; loss of energy; tingling in fingers; still swollen with pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad), URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad), URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain). In 2023, PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad) had resolved. At the time of the report, URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment were not provided.  Patient just received the latest covid shot. She woke up during the night and her arm from the area of the shot to her fingertips was swollen so bad she could go back to sleep, and the next day, still swollen with pain and tingling in fingers, and urinary issues and extreme loss of energy. It's been over a week, and the swelling is gone but still pain and tingling in fingers, and urinary issues and still no energy.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Live fallow-up received with IRD 29-Oct-2023. reference number was updated.
Age: 89.0
Sex: F
Vaccine: UNK
Symptoms: Sleep disorder, Urinary tract disorder
Clinical narrative: arm from the area of the shot to her finger tips was swollen so bad; urinary issues; loss of energy; tingling in fingers; still swollen with pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad), URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad), URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain). In 2023, PERIPHERAL SWELLING (arm from the area of the shot to her finger tips was swollen so bad) had resolved. At the time of the report, URINARY INCONTINENCE (urinary issues), ASTHENIA (loss of energy), PARAESTHESIA (tingling in fingers) and PAIN IN EXTREMITY (still swollen with pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment were not provided.  Patient just received the latest covid shot. She woke up during the night and her arm from the area of the shot to her fingertips was swollen so bad she could go back to sleep, and the next day, still swollen with pain and tingling in fingers, and urinary issues and extreme loss of energy. It's been over a week, and the swelling is gone but still pain and tingling in fingers, and urinary issues and still no energy.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Live fallow-up received with IRD 29-Oct-2023. reference number was updated.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Feeding disorder, Fluid intake reduced, Pain in extremity, Vomiting
Clinical narrative: unable to eat or drink; sore arm; vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat or drink), PAIN IN EXTREMITY (sore arm), VOMITING (vomiting) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Progressive supranuclear palsy (end stages of disease).    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced FEEDING DISORDER (unable to eat or drink), PAIN IN EXTREMITY (sore arm), VOMITING (vomiting) and FATIGUE (fatigue). At the time of the report, FEEDING DISORDER (unable to eat or drink), PAIN IN EXTREMITY (sore arm), VOMITING (vomiting) and FATIGUE (fatigue) had not resolved.            No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment medications were reported.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: body aches; joint pain; headache; tiredness; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) in a 41-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Apr-2023.    On 29-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 30-Oct-2023, the patient experienced ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness). On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported. The patient did not experience any additional symptoms/events. No medicines were taken in response to the event.
Sex: U
Vaccine: UNK
Symptoms: COVID-19, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: covid-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 infection) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (covid-19 infection). At the time of the report, COVID-19 (covid-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, SARS-CoV-2 test: Positive, Positive, Positive and Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient had the moderna booster about a month ago and about a week ago had minor symptoms common with upper respiratory infection and seasonal allergies. patient did a covid test and the results were positive. Redid the test 3 times all with positive result. Were the positive test results caused by patients body creating antibodies from the booster or did have a mild case of covid?. Patient did not have a fever, cough or body aches. Patient was tired and had an off and on again headache for a few days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Significant live-follow-up received on 29-Oct-2023. Reference number added.
Sex: U
Vaccine: UNK
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: aches and pains; low grade fever; chills; nausea from my headache; nausea from my headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains), PYREXIA (low grade fever), CHILLS (chills), NAUSEA (nausea from my headache) and HEADACHE (nausea from my headache) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2023 at 10:00 AM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pains), PYREXIA (low grade fever), CHILLS (chills), NAUSEA (nausea from my headache) and HEADACHE (nausea from my headache). At the time of the report, PAIN (aches and pains), PYREXIA (low grade fever), CHILLS (chills), NAUSEA (nausea from my headache) and HEADACHE (nausea from my headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Low grade fever.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patent received vaccine on 10 a m on Saturday. Thought patient was doing fine but have since had chills low grade fever aches and pains and nausea from headache.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Live follow-up received on 29-Oct-23 with no new information.
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: extremely tired; Arm pain (injection arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain (injection arm)) and FATIGUE (extremely tired) in a 7-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 25-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (Arm pain (injection arm)). On an unknown date, the patient experienced FATIGUE (extremely tired). On 27-Oct-2023, VACCINATION SITE PAIN (Arm pain (injection arm)) had resolved. At the time of the report, FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Patient had arm pain (injection arm) and was extremely tired. The patient did not experience any additional symptoms/events.  No medicines were given to patient. The patient had no medical history, concomitant disease or risk factor. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: arm pain at injection site; Extremely tired; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), VACCINATION SITE PAIN (arm pain at injection site) and FATIGUE (Extremely tired) in a 42-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     null Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 01-Apr-2023.    On 29-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PAIN (achy) and FATIGUE (Extremely tired). On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (arm pain at injection site). At the time of the report, PAIN (achy), VACCINATION SITE PAIN (arm pain at injection site) and FATIGUE (Extremely tired) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: UNK
Symptoms: Vaccination site swelling
Clinical narrative: right arm vaccination site is swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (right arm vaccination site is swollen) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE SWELLING (right arm vaccination site is swollen). At the time of the report, VACCINATION SITE SWELLING (right arm vaccination site is swollen) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that arm was swollen the size of a Ping-Pong ball. No treatment information was provided.
Sex: U
Vaccine: RSV
Symptoms: Needle issue
Clinical narrative: went to put needle on and it snapped at the neck; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5021, Expiration Date: Feb2025) for immunisation; for immunisation, Device Lot Number: HA3217, Device Expiration Date: Mar2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "went to put needle on and it snapped at the neck".  Additional information: Pharmacist calling about Abrysvo vaccine. Abrysvo Vial Adapter: packaging was discarded and does not see details on the adapter. Abrysvo Antigen Vial (Lot number: HF5021, Expiration Date: Feb2025, NDC: 00069020701). Abrysvo Diluent Syringe (Lot number: HA3217, Expiration Date: Mar2025, NDC: 00069025001). When she went to put needle on vaccine, it snapped right at the neck. States she had mixed it, drew it up, and then went to put the needle on and it snapped at the neck. Confirms no patient involvement. Abrysvo carton was discarded. The sample of the product is available to be returned. Informed of prepaid (courier site name) that may arrive to retrieve sample. The packaging was sealed and intact.   The reporter considered "went to put needle on and it snapped at the neck" not related to rsv vaccine prot.subunit pref 2v. Causality for "went to put needle on and it snapped at the neck" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site extravasation
Clinical narrative: but most of the vaccine leaked out of her arm; but most of the vaccine leaked out of her arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE EXTRAVASATION (non-serious), UNDERDOSE (non-serious) all with onset 2023, outcome "unknown" and all described as "but most of the vaccine leaked out of her arm".  Additional information: A pharmacist informed that a patient was vaccinated but most of the vaccine leaked out of her arm. They need guidance if they have to re-vaccinate the patient. Stated that a dose of COMIRNATY 2023-2024 formula Prefilled syringe was administered. Upon clarifying, it was mentioned that the immunizing pharmacist was able to administer the full dose.   The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.  Follow-up (18Oct2023): This is a spontaneous follow-up report received from a contactable reporter(s) (Pharmacist), Program ID.  Updated information includes: Reporter information and patient initials. Previously reported information was amended: vaccine underdose was added as an event.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previous information: updated events 'Accidental exposure to product'+ 'Exposure via skin contact' to 'Vaccination site extravasation'.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: flush; dizzy; After receiving the vaccine the blood pressure was 130/78; nauseous; was not able to stand; not feeling well; does not feel right; had a little panic attack; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 43-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, 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. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 24Oct2023, outcome "recovered", described as "After receiving the vaccine the blood pressure was 130/78"; DIZZINESS (non-serious) with onset 24Oct2023, outcome "recovering", described as "dizzy"; FEELING ABNORMAL (non-serious) with onset 24Oct2023, outcome "recovering", described as "does not feel right"; FLUSHING (non-serious) with onset 24Oct2023, outcome "recovering", described as "flush"; PANIC ATTACK (non-serious) with onset 24Oct2023, outcome "recovering", described as "had a little panic attack"; NAUSEA (non-serious) with onset 24Oct2023, outcome "recovering", described as "nauseous"; MALAISE (non-serious) with onset 24Oct2023, outcome "recovering", described as "not feeling well"; DYSSTASIA (non-serious) with onset 24Oct2023, outcome "recovering", described as "was not able to stand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional information: Nurse Practitioner called regarding a patient in her office that received the Pfizer Covid vaccine, Comirnaty today. reporter stated the patient became flush and dizzy immediately after receiving the vaccine. reporter stated the patient came in with her blood pressure at 109/60, then it went up slightly to 130/78 after the vaccine, and them came down to 100/60 back to her baseline within. Reporter stated the patient was not feeling well and did not feel right and was not able to stand even though the patient was no longer dizzy. Reporter stated that the patient felt like she was unable to stand without falling. Reporter stated she gave the patient Zofran since she was nauseous. Reporter stated she believed the blood pressure was a reaction to the reaction, since she was not feeling well and had a little panic attack. Reporter stated the patient walked out feeling better after 1 hour of receiving the vaccine, her blood pressure was normal. Reporter stated the patient was a 43 year old female.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Malaise, Nausea, Panic attack
Clinical narrative: flush; dizzy; After receiving the vaccine the blood pressure was 130/78; nauseous; was not able to stand; not feeling well; does not feel right; had a little panic attack; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 43-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, 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. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 24Oct2023, outcome "recovered", described as "After receiving the vaccine the blood pressure was 130/78"; DIZZINESS (non-serious) with onset 24Oct2023, outcome "recovering", described as "dizzy"; FEELING ABNORMAL (non-serious) with onset 24Oct2023, outcome "recovering", described as "does not feel right"; FLUSHING (non-serious) with onset 24Oct2023, outcome "recovering", described as "flush"; PANIC ATTACK (non-serious) with onset 24Oct2023, outcome "recovering", described as "had a little panic attack"; NAUSEA (non-serious) with onset 24Oct2023, outcome "recovering", described as "nauseous"; MALAISE (non-serious) with onset 24Oct2023, outcome "recovering", described as "not feeling well"; DYSSTASIA (non-serious) with onset 24Oct2023, outcome "recovering", described as "was not able to stand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional information: Nurse Practitioner called regarding a patient in her office that received the Pfizer Covid vaccine, Comirnaty today. reporter stated the patient became flush and dizzy immediately after receiving the vaccine. reporter stated the patient came in with her blood pressure at 109/60, then it went up slightly to 130/78 after the vaccine, and them came down to 100/60 back to her baseline within. Reporter stated the patient was not feeling well and did not feel right and was not able to stand even though the patient was no longer dizzy. Reporter stated that the patient felt like she was unable to stand without falling. Reporter stated she gave the patient Zofran since she was nauseous. Reporter stated she believed the blood pressure was a reaction to the reaction, since she was not feeling well and had a little panic attack. Reporter stated the patient walked out feeling better after 1 hour of receiving the vaccine, her blood pressure was normal. Reporter stated the patient was a 43 year old female.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site discomfort, Vaccination site pain
Clinical narrative: experienced arm pain at the injection site; discomfort at the injection site/discomfort she thinks at the site; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 89-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 89 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: diagnosed many years ago; "Hypertension" (ongoing), notes: diagnosed many years ago. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/ lot number: EN6203), administration date: 07Mar2021, for COVID-19 Immunization, reaction(s): "experienced pain/arm pain at the injection site"; bnt162b2 (DOSE 2, SINGLE, Batch/ lot number: EL926), administration date: 28Mar2021, for COVID-19 Immunization, reaction(s): "experienced pain/arm pain at the injection site"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/ lot number: 30145BA), administration date: 30Sep2021, for COVID-19 Immunization, reaction(s): "experienced pain/arm pain at the injection site". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset Oct2023, outcome "unknown", described as "discomfort at the injection site/discomfort she thinks at the site "; VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "experienced arm pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain.  Additional information: This report was for the reporter's mother. The reporter's mother experienced arm pain at the injection site after the Pfizer covid vaccines and the patient did not seek medical help and only took Tylenol. The reporter had the patient's shot information from 2021. The caller had three covid vaccines and the booster. Both the reporter's mother and she both had the same shot on same day but the reporter's mother was ok except for arm and body discomfort at the injection site and the reporter was not concerned about that. For the injection site pain, reporter stated it was unknown for the dosages for those vaccines as the dose is not written down and it was probably 0.1 but she would have to find out. Due to the reporter stated the patient experienced the arm pain at the injection site for all of her Pfizer Covid vaccines, the patient's first dose was populated into the formal suspect product field. The patient had been covid negative and had been fine except for that discomfort she thinks at the site and they had been pretty lucky.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347227 same reporter, vaccine, different patient and event;US-PFIZER INC-202300347233 same reporter, vaccine, different patient and event;
Sex: U
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: Psychiatric adverse reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "Psychiatric adverse reaction".  Additional information: Patient Age Not Provided. Patient Gender: Non-phone report; not provided in correspondence/communication. Psychiatric adverse reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Dizziness, Swelling
Clinical narrative: swelling under my right rib; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 19:15 as dose 1, single (Lot number: HG4680) at the age of 57 years, in left arm for covid-19 immunisation; influenza vaccine rha 4v (baculovirus) (FLUBLOK QUADRIVALENT), on 04Oct2023 as dose 1, single (Lot number: U8058AA), in left arm for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing); "NASH" (unspecified if ongoing); "TBI" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN; ZOLOFT; VYVANSE; PANTOPRAZOLE. Past drug history included: Gabapentin, reaction(s): "known allergies: Gabapentin", notes: known allergies: Sulfa, Gabapentin and immitrex; Imitrex, reaction(s): "known allergies: Imitrex", notes: known allergies: Sulfa, Gabapentin and immitrex. Vaccination history included: Covid-19 vaccine (DOSE NUMBER 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 2, SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 1, SINGLE, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 06Oct2023, outcome "not recovered"; SWELLING (non-serious) with onset 06Oct2023, outcome "not recovered", described as "swelling under my right rib". The events "swelling under my right rib" and "dizziness" required physician office visit.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Reaction to excipient
Clinical narrative: Caller stated she looked up information online if Comirnaty contains PEG and found out that it did. Caller said she might have had a reaction with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single; ABRYSVO. The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "Caller stated she looked up information online if Comirnaty contains PEG and found out that it did. Caller said she might have had a reaction with it".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site; Low grade fever; redness and swelling at injection site; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A 65-year-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in arm. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 20Oct2023, outcome "recovered" (Oct2023), described as "Low grade fever"; INJECTION SITE SWELLING (non-serious), INJECTION SITE ERYTHEMA (non-serious) all with onset 20Oct2023, outcome "recovered" (Oct2023) and all described as "redness and swelling at injection site". Therapeutic measures were not taken as a result of injection site swelling, pyrexia, injection site erythema.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort
Clinical narrative: Burning sensation along entire spinal column. Was very uncomfortable; Burning sensation along entire spinal column. Was very uncomfortable; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 15:00 as dose 1, single (Lot number: HG2649) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation, on 05Oct2023 as dose number unknown, single; RESTASIS; ROSUVASTATIN; UBRELVY; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: BURNING SENSATION (non-serious), DISCOMFORT (non-serious) all with onset 24Oct2023 at 13:00, outcome "recovered" (Oct2023) and all described as "Burning sensation along entire spinal column. Was very uncomfortable". Therapeutic measures were not taken as a result of burning sensation, discomfort.  Additional information: Facility type vaccine: PRIVACY. Patient did not had COVID prior vaccination. Patient did not tested COVID post vaccination. Burning sensation along entire spinal column. Was very uncomfortable and lasted about two hours.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Body ache; Severe body pain; Chills; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years intramuscular, in right arm for immunisation; for immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes. Concomitant medication(s) included: TRESIBA taken for diabetes mellitus; NOVOLOG taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), administration date: Oct2023, for COVID-19 IMMUNISATION; Influenza vaccine, administration date: 2023, for IMMUNISATION. The following information was reported: PAIN (non-serious) with onset 23Oct2023, outcome "unknown", described as "Body ache; Severe body pain"; CHILLS (non-serious) with onset 23Oct2023, outcome "unknown"; MYALGIA (non-serious) with onset 23Oct2023, outcome "recovered" (Oct2023), described as "Muscle pain". Therapeutic measures were taken as a result of pain, chills, myalgia.  Additional information: on 23Oct2023 the patient did not feel any side effects what so ever Friday, Saturday, Sunday and then Monday, patient started getting chills, body aches and muscle pain and that was the 23Oct2023. Then it went away after he took 3 Ibuprofen. Then Tuesday night, not until 2 AM in the morning he was getting the same thing, the severe body pain, the muscle pain, the chills and then again he took the 3 Ibuprofen and then within an hour that muscle pain was gone and then this morning, patient had to get blood drawn because he is a diabetic and they need to read his blood and then he was going to go MD now, a new Urgent Care to find out about this (Intent : Medical Query) but then he decided just to contact Pfizer first instead. The patient got the COVID (Pfizer COVID-19 Vaccine), two weeks ago. He got the Influenza (Unspecified Influenza Vaccine) a couple of weeks ago and then he just got the RSV the third one. The patient had treatment for just only the RSV that he took the Ibuprofen but the others he did not have any side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Lot number: HF9275) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "C4 spinal cord injury with brown-sequard syndrome" (unspecified if ongoing); "C4 spinal cord injury with brown-sequard syndrome" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 15Oct2023 to 19Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348168 same patient, different drug and different AE.;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: blisters at the injection site; itching at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: moderna covid-19 vaccine (DOSE 1, SINGLE), administration date: 06Feb2021, when the patient was 74-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 2, SINGLE), administration date: 06Mar2021, when the patient was 74-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 3, (BOOSTER) SINGLE), administration date: 27Oct2021, when the patient was 75-year-old, for COVID-19 immunization; moderna covid-19 vaccine (DOSE 4, (BOOSTER) SINGLE), administration date: 12Apr2022, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 24Oct2023, outcome "unknown", described as "itching at the injection site"; VACCINATION SITE VESICLES (non-serious) with onset 25Oct2023, outcome "unknown", described as "blisters at the injection site". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site vesicles.  Additional information: The caller (patient's wife) wanted to know if itching and blisters at the injection site is normal or have been reported after receiving the Pfizer COVID vaccine. Her husband went on Tuesday to (institution name withheld) to get the COVID-19 shot and he got Pfizer.  The next morning when he woke up he had a blister. When he went to take bandage off, the blister popped, it was a clear fluid and that was Wednesday. The injection site itched all night long and when he woke up on 25Oct2023 to take the band-aid off, the blister popped. Her husband also had blisters at the injection site today, 26Oct2023, but caller didn't look because she didn't want to have to pop it again.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 23-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: 1231) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of rash.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: A large red spot on her arm at the injection site; 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 73-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 18Oct2023, outcome "unknown", described as "A large red spot on her arm at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pollen allergy" (unspecified if ongoing). Concomitant medication(s) included: BENICAR; VIMPAT; CHLORTHALIDONE; AMLODIPINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 18Oct2023, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 18Oct2023, outcome "recovering". The events "aches" and "fatigue" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue. Additional information: No COVID prior vaccination. No other vaccine in four weeks. The patient had experienced aches and fatigue. Now into the 8th day. Only usually 3 days.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 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 NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Oct2023, outcome "unknown" and all described as "COVID 19". Event details: the patient and her husband have taken all of the COVID 19 vaccines produced by Pfizer. They took the most current vaccine two weeks ago. Two days ago they contracted COVID 19. They were surprised to have contracted the virus with the current vaccine.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300349430 same reporter/vaccine/event, different patient;