chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Diarrhea (Patient was having constant diarrhea) and HIV disease (He was also HIV positive as verbalized).    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In October 2024, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient had no previous COVID-19 diagnosis. It was reported that patient had received all his COVID-19 vaccines from Moderna since when the vaccines were first released but before that he had been struggling with constant diarrhea and had some tools to manage it. After he started having his Moderna COVID-19 vaccines, it all went away. However, after receiving his most recent dose, which was at the beginning of October this year, he feels like the diarrhea was coming back. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-776351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776351:Same patient diffrent suspect
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Headache, Lymph node pain
Clinical narrative: mood changes (cranky); diarrhea; very sore lymph nodes under right arm,; headache; extreme fatigue/exhausted; injection site deep pain and swelling; injection site deep pain and swelling; fever; severe body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (severe body aches), MOOD ALTERED (mood changes (cranky)), DIARRHOEA (diarrhea), LYMPH NODE PAIN (very sore lymph nodes under right arm,) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2024.    On 01-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 02-Nov-2024, the patient experienced PAIN (severe body aches), DIARRHOEA (diarrhea), LYMPH NODE PAIN (very sore lymph nodes under right arm,), HEADACHE (headache), FATIGUE (extreme fatigue/exhausted), VACCINATION SITE PAIN (injection site deep pain and swelling), VACCINATION SITE SWELLING (injection site deep pain and swelling) and PYREXIA (fever). On an unknown date, the patient experienced MOOD ALTERED (mood changes (cranky)). At the time of the report, PAIN (severe body aches), DIARRHOEA (diarrhea), LYMPH NODE PAIN (very sore lymph nodes under right arm,), HEADACHE (headache), VACCINATION SITE PAIN (injection site deep pain and swelling), VACCINATION SITE SWELLING (injection site deep pain and swelling) and PYREXIA (fever) was resolving, MOOD ALTERED (mood changes (cranky)) outcome was unknown and FATIGUE (extreme fatigue/exhausted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2024, Body temperature: 100.7.         Concomitant medication was not reported. Patient reported she was still exhausted today. Her reactions were somewhat better. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: mood changes (cranky); diarrhea; very sore lymph nodes under right arm,; headache; extreme fatigue/exhausted; injection site deep pain and swelling; injection site deep pain and swelling; fever; severe body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (severe body aches), MOOD ALTERED (mood changes (cranky)), DIARRHOEA (diarrhea), LYMPH NODE PAIN (very sore lymph nodes under right arm,) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2024.    On 01-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 02-Nov-2024, the patient experienced PAIN (severe body aches), DIARRHOEA (diarrhea), LYMPH NODE PAIN (very sore lymph nodes under right arm,), HEADACHE (headache), FATIGUE (extreme fatigue/exhausted), VACCINATION SITE PAIN (injection site deep pain and swelling), VACCINATION SITE SWELLING (injection site deep pain and swelling) and PYREXIA (fever). On an unknown date, the patient experienced MOOD ALTERED (mood changes (cranky)). At the time of the report, PAIN (severe body aches), DIARRHOEA (diarrhea), LYMPH NODE PAIN (very sore lymph nodes under right arm,), HEADACHE (headache), VACCINATION SITE PAIN (injection site deep pain and swelling), VACCINATION SITE SWELLING (injection site deep pain and swelling) and PYREXIA (fever) was resolving, MOOD ALTERED (mood changes (cranky)) outcome was unknown and FATIGUE (extreme fatigue/exhausted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2024, Body temperature: 100.7.         Concomitant medication was not reported. Patient reported she was still exhausted today. Her reactions were somewhat better. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Purpura
Clinical narrative: Developed ITP 48 hours after receiving Moderna Covid-19 and Flu vaccine; This spontaneous case was reported by a patient and describes the occurrence of PURPURA (Developed ITP 48 hours after receiving Moderna Covid-19 and Flu vaccine) in a 65-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080469) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    Concurrent medical conditions included Hypertension.   On 04-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 06-Oct-2024, the patient experienced PURPURA (Developed ITP 48 hours after receiving Moderna Covid-19 and Flu vaccine). The patient was treated with Tranexamic acid (intravenous use) at a dose of UNK, x2. At the time of the report, PURPURA (Developed ITP 48 hours after receiving Moderna Covid-19 and Flu vaccine) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.  It was unknown if the patient experienced any additional symptoms/events.   Medication details and reason for taking the medicine was IV steroids weaned to oral steroids, IVIG via IV, vincristine x1 IV, 4 units of platelets.   It is unknown if the patient had any additional medical history, concomitant disease or risk factor.  Lab data/results of CBC, CMP. It was unknown if there were additional lab data/results available.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: excrutiating pain in the arm and shoulder after administration; had loss of upper body strength; excrutiating pain in the arm and shoulder after administration; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (excrutiating pain in the arm and shoulder after administration), ASTHENIA (had loss of upper body strength) and ARTHRALGIA (excrutiating pain in the arm and shoulder after administration) in a 63-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Basal ganglia infarction in 2016. Concurrent medical conditions included Autoimmune disorder NOS (autoimmune disease), Arthritis, Dermatitis and Vascular parkinsonism.    In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PAIN IN EXTREMITY (excrutiating pain in the arm and shoulder after administration), ASTHENIA (had loss of upper body strength) and ARTHRALGIA (excrutiating pain in the arm and shoulder after administration). At the time of the report, PAIN IN EXTREMITY (excrutiating pain in the arm and shoulder after administration) was resolving and ASTHENIA (had loss of upper body strength) and ARTHRALGIA (excrutiating pain in the arm and shoulder after administration) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He received Spikevax recently and then complained of excruciating pain in the arm and shoulder after administration. About 7 to 10 days later he had loss of upper body strength. The patient did not experience any additional symptoms/events. There were no lab data/results available.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: He had a pericarditis; This serious initial Spontaneous safety report was received by Novavax on 23-Sep-2024 from a Consumer or other non health professional.  A Male of unspecified age was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was not provided in the report) on an unspecified date.  The following medical history was reported: HEART TRANSPLANT.   No concomitant medications were reported.  On an unspecified date after vaccination, the patient experienced He had a pericarditis(Pericarditis)(Serious: Other Medically Important Condition).  At the time of reporting, the event outcome of Pericarditis was Unknown.; Sender's Comments: This Male of an unspecified age experienced Pericarditis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Pericarditis was assessed as serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pericarditis is considered Possible.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: sore arm; patient is a 10-year-old male/ he received the Comirnaty for 12 years and up; patient is a 10-year-old male/ he received the Comirnaty for 12 years and up; This is a spontaneous report received from a Pharmacist from medical information team, Program ID.  A 10-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 31Oct2024 as dose 1, single (Lot number: LM2219, Expiration Date: 29Mar2025) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 31Oct2024, outcome "unknown" and all described as "patient is a 10-year-old male/ he received the Comirnaty for 12 years and up"; PAIN IN EXTREMITY (non-serious) with onset 31Oct2024, outcome "not recovered", described as "sore arm". Additional information:  A 10 year old male, was supposed to get the Pfizer Covid Vaccine for 5-11 year old,  but received a full dose of the Comirnaty 12 up instead. This happened last night (31Oct2024). They checked with the patient and made a visit with them and talked with him. There were no issues reported regarding receiving this dose except a sore arm. They reported there was nothing that occurred out of the ordinary in comparison to the last Pfizer Shots.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electric shock sensation, Insomnia, Weight, X-ray
Clinical narrative: He described the feeling as kind of static electricity and his muscles are affected; could not sleep last night; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2021 as dose 2, single (Lot number: EW0182) at the age of 70 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single; Lot number: ER8736; administered to the top right shoulder on his right arm), administration date: 12May2021, for COVID-19 immunisation. The following information was reported: ELECTRIC SHOCK SENSATION (non-serious) with onset Jun2024, outcome "not recovered", described as "He described the feeling as kind of static electricity and his muscles are affected"; INSOMNIA (non-serious) with onset 2024, outcome "unknown", described as "could not sleep last night". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: 01Nov2024: both doses were administered to the top right shoulder on his right arm. Reporter advised he experienced the unnatural feeling of electricity fritting to the body after getting the Pfizer covid vaccine. He described the feeling as kind of static electricity and his muscles were affected. Within the last 6 months of this year (2024) around June, July, August, September, October and in November, he was getting weird symptoms like electricity flittering through his body and he rubs his arm, leg, face and it feels staticky and is weird and unnatural and he does not know how to describe it. Clarified the feeling like electricity flittering through his body began around Jun2024 and it came on lightly at first and then would come and go and some days come on and some days would not. He was reporting because he was starting to panic as it hit him hard this morning.  In the last week, it comes and goes and this morning the attack hit heavy this morning to the point where he could not sleep last night because of it and this morning the symptoms were strong. He thought all his muscles would lock up on him and if he was not feeling this way for this feeling, he would have driven to the emergency room but the emergency room is 30 miles from his house and he was scared of driving on the highway because of the way he is feeling and did not think it was proper to drive. He stated he can't remember and might have been taking some sleep aids. No treatment required for the reported event and states he did not know what it was and did not really go to the ER or complain to the doctor about it and was just taking each day at a time to see how it was going and this morning really scared him because it was really intense for that feeling. He wanted to ask if there were any similar complaints like his.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immune-mediated adverse reaction
Clinical narrative: both injections had horrible immune response reaction; This is a spontaneous report received from a Nurse.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 07Jan2021 as dose 2, single (Lot number: EK9231) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccination time: 15:00, Batch/Lot number: EH9899, Anatomical location: Arm Right), administration date: 18Dec2020, when the patient was 50-year-old, for COVID-19 immunisation, reaction(s): "had horrible immune response reaction/ severe immunoreactive response to the vaccine", "Severe headache", "Photophobia", "eye pain", "myalgia", "diarrhea", "skin sensitivity", "lesions and blisters around mouth and lips, oral lesions", "lesions and blisters around mouth and lips, oral lesions/intra-oral lesions/Buccal lesion", "lesions and blisters around mouth and lips, oral lesions", "lesions and blisters around mouth and lips, oral lesions", "inflammation", "pharyngitis", "lymph node inflammation in neck", "BL earache", "Nausea", "Diaphoresis", "fatigue". The following information was reported: IMMUNE-MEDIATED ADVERSE REACTION (medically significant) with onset Jan2021, outcome "unknown", described as "both injections had horrible immune response reaction". Clinical course: Patient got the COVID vaccine on 18Dec2020 and 07Jan2021, with both injections had horrible immune response reaction. Patient filed initial report around 10Jan2021, a few days after 2nd dose after having same issues from 1st dose.; Sender's Comments: Based on the temporal relationship, the association between the events "horrible immune reaction" with BNT162b2 can not be fully 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.,Linked Report(s) : US-PFIZER INC-2020509101 same patient/product, different dose/events;
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting on day 2 after vaccination; Nausea and vomiting on day 2 after vaccination; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 as dose 1, single (Lot number: 00069243210) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Hypersensitivity". The patient did not receive any other vaccines on the same date as the vaccine(s). It was unknown if the patient receive any other vaccines within 4 weeks prior to the vaccine(s). It was unknown if the patient was taking any medications within 2 weeks of the event starting. The following information was reported: NAUSEA (non-serious), VOMITING (non-serious) all with onset 03Nov2024 at 13:30, outcome "recovering" and all described as "Nausea and vomiting on day 2 after vaccination". Therapeutic measures were not taken as a result of nausea, vomiting.  No follow-up attempts are possible.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Vaccination site pain, Weight
Clinical narrative: real chilling like cold/got cold a lot, my body; Chills; Sore at the injection; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 2024, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "unknown", described as "Sore at the injection"; FEELING COLD (non-serious) with onset 2024, outcome "unknown", described as "real chilling like cold/got cold a lot, my body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling cold, chills, vaccination site pain.  Additional information: The patient reported that she took the COVID shot and the only side effects she experienced were real chilling like cold on her body and went sore at the injection. The patient took Alka-Seltzer (Cold & Flu). The patient did not receive any vaccines on same date with the vaccine. The patient had no other vaccination within four weeks prior to the first administration date of the vaccine. The patient had previously received a COVID shot.
Age: 19.0
Sex: F
Vaccine: COVID19, HPVX
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness; Shortness of breath; This is a spontaneous report received from a Consumer or other non HCP.  A 19-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Nov2024 at 10:00 as dose 1 single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 04Nov2024 as dose 2, single) for immunisation. No other vaccines were administered in the previous four weeks. The patient's relevant medical history included: "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (hospitalization) with onset 04Nov2024 at 22:00, outcome "unknown", described as "Chest tightness"; DYSPNOEA (hospitalization) with onset 04Nov2024 at 22:00, outcome "unknown", described as "Shortness of breath". Therapeutic measures were taken as a result of chest discomfort, dyspnoea. Treatment: albuterol, prednisone.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA277596 (SANOFI).  Initial information received on 10Sep2024 regarding an unsolicited valid non-serious case received from a patient. This case involves a 84 years old female patient who experienced a bad headache while being treated with SARILUMAB [KEVZARA] delivered via sarilumab autoinjector and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. In Mar2024, the patient started taking KEVZARA (SARILUMAB) Solution for injection 200 mg QOW (strength: 200mg/1.14ml) subcutaneous for rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement. On 09Sep2024, the patient started taking COVID-19 VACCINE (with unknown dose, formulation, strength, route, frequency) for Prophylactic vaccination. On 09Sep2024 the patient developed a non-serious event "bad headache" (headache) (latency: approximately 6 months) following the first dose intake (unknown batch number and expiry date) of SARILUMAB and COVID-19 VACCINE. It was reported "patient was having a bad headache last night, however patient also had 2 steroid shots and covid booster shot yesterday. Information regarding batch number and expiration date corresponding to the one at time of event occurrence were requested.  Action taken with SARILUMAB was no action taken and was unknown for COVID-19 VACCINE for the event It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: COVID19
Symptoms: Bradycardia
Clinical narrative: Bradycardia, a condition where the heart rate is slower than normal; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): MOD-2024-776108 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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: BRADYCARDIA (medically significant), outcome "unknown", described as "Bradycardia, a condition where the heart rate is slower than normal". Clinical course: The patient called in stating the previous vaccine received was Pfizer and had reaction with that vaccine which was bradycardia, a condition where the heart rate is slower than normal. The event was reported as serious (Other medically important condition).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: issues with her eyes; This is a spontaneous report received from a nurse. A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 30Dec2021 at 10:15 as dose 3 (booster), single (lot number: FJ1620) at the age of 52 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "vitamin D deficiency" (unspecified if ongoing). Concomitant medication included: VIT D, taken for vitamin d deficiency. Vaccination history included: BNT162b2 (dose 1, deltoid (don't remember which arm), lot EL9216), administration date: 16Jan2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (dose 2, deltoid, lot EN6204), administration date: 09Mar2021, when the patient was 52-year-old, for COVID-19 immunization. There were no adverse events following the reported vaccination histories. The following information was reported: EYE DISORDER (medically significant) with onset 19Jan2022, outcome "not recovered", described as "issues with her eyes". The patient had some issues with her eyes from approximately 19Jan2022 which required a visit to the Physician's Office. The patient went to the eye doctor for several visits (4 times) with no resolve. The event did not require a visit to the Emergency Room. However, ongoing treatment (therapeutic measures taken) included Ocrevus infusion every 6 months. The patient did not receive any other vaccines on the same date as the Pfizer suspect vaccine. Location of injection/shot: deltoid.; Sender's Comments: Based on the temporal relationship, the association between the event "issues with her eye" with BNT162b2 can not be fully 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.
Sex: F
Vaccine: COVID19, COVID19, FLU3
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pretty sure it was COVID-19; Pretty sure it was COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), in Mar2020 as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 10Oct2024, outcome "unknown" and all described as "Pretty sure it was COVID-19". The patient's husband and her got the new Pfizer Covid-19 vaccination on 04Sep2024. By around 10Oct2024, they both got sick. Her husband got sick first. They were pretty sure it was COVID-19 because she got sick within 5 days.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400143605 same reporter/product/event, different patient.;
Sex: F
Vaccine: COVID19, COVID19, FLU3
Symptoms: Pain
Clinical narrative: Pretty sure it was COVID-19; Pretty sure it was COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), in Mar2020 as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 10Oct2024, outcome "unknown" and all described as "Pretty sure it was COVID-19". The patient's husband and her got the new Pfizer Covid-19 vaccination on 04Sep2024. By around 10Oct2024, they both got sick. Her husband got sick first. They were pretty sure it was COVID-19 because she got sick within 5 days.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400143605 same reporter/product/event, different patient.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: pretty sure it was Covid-19 because I got sick within 5 days; pretty sure it was Covid-19 because I got sick within 5 days; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), in Mar2020 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 10Oct2024, outcome "unknown" and all described as "pretty sure it was Covid-19 because I got sick within 5 days". Additional information: The patient's wife stated, "I have a comment. My husband and I got the new Pfizer Covid-19 vaccination on 04Sep2024. We got the 2024-2025 COVID vaccine that protects you from the JN.1 lineage of the Omicron variant. My husband and I have gotten the Covid-19 vaccine since around Mar2020 and every 6 months since then. We got the Covid-19 vaccine on 04Sep2024 and by around 10Oct2024, we both got sick. My husband got sick first. We are pretty sure it was Covid-19 because I got sick within 5 days."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400143600 same reporter/product/event, different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Post vaccination syndrome
Clinical narrative: Post-acute COVID-19 vaccination syndrome (PACVS); debilitated; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. Vaccination history included: Moderna (Dose number unknown, single), for COVID-19 immunisation, reaction(s): "poor response"; Pfizer covid vaccines (Dose number unknown, single), for COVID-19 immunisation. The following information was reported: POST VACCINATION SYNDROME (non-serious), outcome "unknown", described as "Post-acute COVID-19 vaccination syndrome (PACVS)"; ASTHENIA (non-serious), outcome "unknown", described as "debilitated". Additional information: Patient was interested to see what Pfizer was doing or supporting around those who may develop post covid vaccine syndrome. Patient successfully had at least 2 Pfizer COVID vaccines, (initial vaccine was Moderna and had a poor response). With the current Pfizer COVID vaccine, patient was now debilitated and met the criteria for PACVS. Patient's MD knew nothing about this.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 25.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was warm; Injection site was red; Injection site was slightly swollen; This spontaneous case, initially received on 10-Oct-2024 (including additional information received on 17-Oct-2024), was reported by a health professional and concerns an adult male patient.  Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) for indication not reported. Route of administration: Intramuscular, Anatomical Location: Left Arm. Lot number: AW3225B.(batch number unable to be matched).  No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Injection site was warm (outcome: Unknown), Injection site was red (outcome: Not Reported), Injection site was slightly swollen (outcome: Unknown).  Patient advised he woke up on 18-Sep-2024 and noticed injection site was red, warm and slightly swollen. Said it was not painful and he has not experienced any other symptoms.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter did not provide seriousness and causality for the events.; Reporter's Comments: All the events are related to Flucelvax TIV
Sex: F
Vaccine: UNK
Symptoms: Feeling jittery, Injection site pain, Tremor
Clinical narrative: Injection site pain; Little shaky; Jittery; This spontaneous case initially received on 22-Oct-2024, was reported by a non health professional and concerns an elderly female patient.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad (TIV) for an Indication not reported, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported. Lot number: No batch number available reported and would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, 1 day after the vaccination, the patient experienced Injection site pain (outcome: Not Reported), Little shaky (outcome: Not Reported), Jittery (outcome: Not Reported).  Reporter asked if there was mercury or thimerosal included in the vaccine. Informed that the day after she took the vaccine she felt, besides the injection site pain, a little shaky, she didn't know, jittery. Asked how long did it take for these side-effects to disappear.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: The events are related to Fluad TIV
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient was given 12 + vaccine versus 6 mon - age 11. parent informed incorrect vaccine was given. MD notified as well.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone decreased, Tri-iodothyronine free decreased
Clinical narrative: Had Covid shot with zero side effects physically felt. Went for pre physical bloodwork and  my TSH and free T3 were very low. TSH only 0.2.dr says Covid Vaccine can cause this.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysgeusia
Clinical narrative: Client and her mother called to report at 4pm that client was experiencing a metallic taste in her mouth that started shortly after she got her Novavax vaccination.  She also stated she is experiencing a slight tightening in her chest.  She reported she has felt this before other times but stated she thinks it is different this time.  Encourage them to contact her primary care physician if they are further concerned or seek medical attention if they are not available.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema
Clinical narrative: Patient called to say she may be having a reaction to the COMIRNATY 12+ PFS 24-25 INJ she received 11/05/2024. She had no reaction on that day, but the next day, Wednesday 11/06/24, she said she had red spots in hairline (2 spots), and on forehead (4 or 5 spots), and they were still there today (Thursday 11/07/24). She stated they did not itch, and that she had no other spots anywhere else, although her arm where she received the immunization was a little red and maybe swollen.  Patient's primary care physician's office, Dr., was contacted via telephone to relay message about patient's statement, but pharmacy was unable to speak with Dr or nurse, had to leave a message requesting a call back, which was not received before the  doctor's office closed.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 9.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, IPV, TDAP, VARCEL
Symptoms: Cold sweat, Loss of consciousness, Pallor
Clinical narrative: Client received vaccine and was sitting down waiting for vaccine records in the clinic area when she suddenly passed out for a few seconds. Both parents were standing nearby and was able to hold child. Client appeared pale and clammy. A cold rag was applied to her forehead and was fanned. Client's father carried child to the examination bed and her feet was elevated. She was offered crackers and water. Client recovered and verbalized that she was feeling better after the event.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site pain
Clinical narrative: No adverse outcome, other than two day site soreness
Age: 28.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Dizziness, Pallor, Peripheral coldness, Syncope
Clinical narrative: Patient came in for three vaccines. He was alright and having a conversation with me after the first vaccine at 11:59am. Upon administration of the second vaccine at 12:02pm (Heplisav-B), patient began to feel faint. He mentioned being fearful of needles, and asked me to give him a minute before the next vaccine. At that moment he fainted in his chair, became pale, and hands were cold. The pharmacy immediately called store assistance and EMS. With the help of another employee, we lay him vertical on the ground. He immediately came back to consciousness. Paramedics arrived at 12:10pm, monitored, tested and he was clear to go home.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual was given child's dose of vaccine
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Patient was given the pediatric dose instead of the adult dose
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Discomfort, Immediate post-injection reaction, Mobility decreased, Sleep disorder
Clinical narrative: Immediately increased discomfort compared to prior vaccine administrations during the time of administration. This resolved, but subsequently, the night following vaccine administration, I developed severe pain in my left shoulder.  Over the next few days, the pain waxed and waned, present during the day with range of motion and at night when laying on my left arm.  These symptoms have gradually become more intense over the last few weeks despite avoidance of any strenuous activity. I now have significant anterolateral shoulder pain worse with overhead motion and certain rotational motions that wakes me up from sleep nearly every night and makes driving difficult. I have never had shoulder pain prior to this event and have not participated in any vigorous activities prior to or since administration.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual given child's dose
Age: 81.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Infection
Clinical narrative: Patient's wife reported today that he had a reaction and infection due to the vaccine.  She states it started a few days after receiving the vaccines.   She also thinks it was given in the wrong area, too high and too far back in the arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual received child's dose
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual received child's dose
Age: 8.0
Sex: F
Vaccine: COVID19, FLUN3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FluMist administered inadvertently.  Pt has precaution of history of seizures and was determined that they should receive a flu injectable vaccine (IIV).  However, nurse did not review the form to see this indicated and administered FluMist.  This occurred at a mass vaccination clinic where students were receiving FluMist or flu shots.  No adverse reaction occurred at time of vaccination.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual received child's dose of vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual received child's dose of vaccine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual received child's dose of vaccine
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Individual received child's dose of vaccine
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: She said her arm turns redness at injection site. She takes Tylenol to control the pain.
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Wrong product administered
Clinical narrative: Patient did not request prevnar vaccine and reported this to pharmacy on 11/7/24. Patient had soreness at injection site. Patient had requested flu vaccination and we processed and administered the incorrect vaccine. I apologized and offered to give the flu vaccination but she declined at this time.
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Raynaud's phenomenon
Clinical narrative: Arthralgia and Raynauds
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: redness, itching, induration, 8x10cm R lateral deltoid
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Death, General physical health deterioration
Clinical narrative: Resident declined from baseline quickly after receiving vaccine and passed one week after receiving vaccine.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cough, Oxygen saturation decreased, Throat irritation
Clinical narrative: Patient presented this evening accompanied by her parents to Health Center for COVID and flu vaccination. This was Patient's 5th dose of COVID vaccine and she has received yearly flu vaccines for multiple years.  Pt has NKMA; seasonal allergies noted in chart. After screening questions were completed, vaccine was given in her left deltoid at 1826, and pt and family were referred to wait in the clinic for the customary 15 minute observation period. At 1845, Pt's mother approached this nurse to state that Pt was experiencing some "throat tickling". Her mom stated that in response, they had given her some sips of water to drink and that she was able to swallow without difficulty. Mom also reports that Patient has had a dry cough for the last 5 days, but no fever, no productive cough. SaO2 was taken and was 94% on room air with a pulse of 118 at 1852. Pt in no apparent respiratory distress, gums pink, skin color WNL. Advised further observation, during which an occasional dry cough was noted. Pulse ox retaken at 1857: 94% with pulse at 116. Pt continues in NAD, lips pink, color WNL and pt playing on her phone. She states that the tickle is now gone. Dr paged at 1908 to discuss plan of care; immediate return call received. MD provided with above details. Per Dr., pt should be seen in urgent care this evening to further investigate low SaO2/ rule out penumonia. This information communicated to parents who were agreeable to plan. Patient and parents out of clinic at 1920 and call made to Urgent Care with report given on patient.
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain, Product administered to patient of inappropriate age
Clinical narrative: The adverse event was giving a high dose influenza vaccine to a 59 year old.  Upon letting client know that he received a high dose  erroniously, he reported he was achy for 2 days, did not have a fever and stated it did not keep him down, he was able to go about his business.  These symptoms are within the normal signs and symptoms for covid and influenza even with a regular dose.  There was no treatment needed or received.
Age: 17.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Blister, Injection site reaction, Musculoskeletal stiffness, Periorbital oedema, Pruritus
Clinical narrative: 8/21/24 had hepatitis B and meningitis vaccine. Experienced fever, hives (itchy), slight periorbital edema, vomiting, and arm stiffness on L injection site the following day. The 3rd day is when she started getting blisters. She took Benadryl which helped.
Age: 17.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: 8/21/24 had hepatitis B and meningitis vaccine. Experienced fever, hives (itchy), slight periorbital edema, vomiting, and arm stiffness on L injection site the following day. The 3rd day is when she started getting blisters. She took Benadryl which helped.
Age: 16.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient passed out shortly after administration of vaccines.  Appeared to have a mild seizure, but was actually a vaso-vagal response.  Patient was placed on the floor and eventually taken to ER for observation.  Patient regained consciousness within approximately 20 - 30 seconds.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Dyspnoea, Exercise tolerance decreased, Fatigue
Clinical narrative: About 2 weeks after receiving vaccine, patient reports "exercise" fatigue, including walking up stairs. She is short of breath and tired.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: PATIENT REQUESTED AND RECIEVED A SECOND 2024/2025  FLUCELVAX ON 10/23/24 AFTER RECEVING THE FIRST ON 08/03/2024. THE PATIENT REPORTS SHE HAD NO ADVERSE REACTIONS OR ISSUES WITH EITHER IMMUNIZATION.
Age: 19.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Pain, Syncope
Clinical narrative: Patient was given flublok first in left arm, then moved to the right arm and gave comirnity, patient fell forward after getting comirnity vaccine, discolored and came to a few seconds later.  Was very pale, but coherent and aware of fainting.  Got her some water and checked on her over the next 15 minutes.  Patient began feeling better quickly and color was nearly normal after 15 minutes.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: 11/07 RECEIVED PHONE CALL FROM DON AT THE FACILITY REHAB WE HAD DONE A CLINIC THERE ON 10/31/2024 FOR COVID VACCINES FOR THEIR RESIDENTS.  SHE REPORTED THAT HE HAD GOTTTEN CELLULITIS AFTER HIS SHOT AND WAS BEING TREATED WITH CEPHALEXIN CURRENTLY
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Primary stabbing headache
Clinical narrative: Ice pick piercing pain in left temple. Intense intermittent jabs.  Lasted 11 pm 10/21/2024 into following day. Stopped late afternoon. Occasional jabs of lesser intensity continued for approximately 2 weeks and slight numbness remains.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Feeling hot
Clinical narrative: Moderate joint pain in leg/ knee and feeling hot