chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscular weakness, Myocardial infarction, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pneumonia, Renal impairment, Shock, Weight
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased, Weight increased
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809), in left arm and on 09Sep2021 as dose 2, single (Lot number: FF2588) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 08Aug2022, outcome "unknown" and all described as "Covid-19". The patient was hospitalized for drug ineffective (start date: 08Aug2022); for covid-19 (start date: 08Aug2022, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Low, notes: electrolytes were very low; Oxygen saturation: (unspecified date) Low, notes: oxygen was low; SARS-CoV-2 test: (08Aug2022) Positive; Weight: (unspecified date) 152 lbs, notes: He went from 177lbs to 152lbs.  Clinical course: It was reported by the patients Wife that patient had a reaction to the serum on 25Mar2021. Got another Covid-19 booster. Was on a ventilator for 30 days last Aug2022 after catching Covid-19. Had adverse reactions to the first Covid shot. On 09Sep2021, he got the booster and the same thing happened with the foot. He ended up getting covid anyway and on 08Aug2022, the ambulance had to come get him. He couldn't keep any food down before the ambulance came to get him, not even water or crushed ice. When he got to the hospital, his electrolytes were very low, oxygen was low, kidneys were shutting down. He was lucky to be alive. Got the vaccine in his left arm at a hospital parking lot vaccine drive. Can't remember which arm the Dose was given in.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: His right foot swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EM9809) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "His right foot swelled up".  Additional information: Patient and his wife are on the line together. Wife said he had a reaction to the serum on 25Mar2021. Had adverse reactions to the first COVID shot. His right foot swelled up and he couldn't put pressure on it. Swelling started about a day after. It was not right away. Couldn't put shoes on or anything. After the shots, they did call and tell Pfizer about the feet swelling up and couldn't put shoes on. Need help to pay for some of these bills. Shocking that the vaccine didn't do what it was supposed to do. The patient received Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine was reported as none. The patients Concomitant Drugs, Medical History (including any illness at time of vaccination) and Family Medical History Relevant to Adverse Events (AEs) was reported as not provided. Specific Relevant Test: For Thromboembolic events with Thrombocytopenia and Autopsy information was reported as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: on blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "on blood thinners". Therapeutic measures were taken as a result of thrombosis.  Clinical Course: Stop promoting this damn shot two of patient friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035009 same reporter/drug/event, different patient;US-PFIZER INC-202300035010 same reporter/drug/event, different patient;US-PFIZER INC-202300035011 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: on blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "on blood thinners". Therapeutic measures were taken as a result of thrombosis.  Clinical course: It was reported that Two of my friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035000 same reporter/drug, different patient/event;US-PFIZER INC-202300035010 same reporter/drug/event, different patient;US-PFIZER INC-202300035011 same reporter/drug/event, different patient;US-PFIZER INC-202300035001 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: on blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "on blood thinners". Therapeutic measures were taken as a result of thrombosis.  Clinical Course: Stop promoting this damn shot Two of patient friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035009 same reporter/drug/event, different patient;US-PFIZER INC-202300035000 same reporter/drug, different patient/event;US-PFIZER INC-202300035001 same reporter/drug/event, different patient;US-PFIZER INC-202300035011 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: on blood thinners; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "on blood thinners". Therapeutic measures were taken as a result of thrombosis.  Clinical course: It was reported as Two of my friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035010 same reporter/drug/event, different patient;US-PFIZER INC-202300035009 same reporter/drug/event, different patient;US-PFIZER INC-202300035001 same reporter/drug/event, different patient;US-PFIZER INC-202300035000 same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, single), for Covid-19 immunization; Bnt162b2 (Dose: 2nd, single), for Covid-19 immunization; Bnt162b2 (Dose: 3rd, booster single), for Covid-19 immunization; Bnt162b2 (Dose: 4th, single booster), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: It was reported that all of the patient's shots including the 3 boosters were all Pfizer. The patient had absolutely no complications and only a sore arm after each shot. That made the patient want to always use the same pharma company going forward.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035212 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Investigation
Clinical narrative: Nine children were evaluated after experiencing an allergic reaction to the first dose; This is a literature report.  An 8-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), 10 min after the suspect product administration, outcome "recovered", described as "Nine children were evaluated after experiencing an allergic reaction to the first dose". The patient underwent the following laboratory tests and procedures: Brighton score: 2. Therapeutic measures were taken as a result of anaphylactic reaction. Additional information: Age: 8; Sex: M; Atopic history: No; Anaphylaxis cause: No; Onset after receipt, min: 10; Signs and symptom: Throat hurt, closing up, dry heaving, gagging, nausea, difficulty breathing; Intervention: Epinephrine, diphenhydramine, famotidine, steroids; Time to symptoms resolution, h: Several; Meet Resource criteria: Yes; Brighton score: 2; Symptoms after second dose: None.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the event anaphylaxis with the suspect product.,Linked Report(s) : US-PFIZER INC-PV202300015137 Same article/ drug and different patient/ event;
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Investigation
Clinical narrative: Nine children were evaluated after experiencing an allergic reaction to the first dose; This is a literature report.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Allergic rhinitis" (unspecified if ongoing), notes: Atopic history. The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant), 120 min after the suspect product administration, outcome "recovered", described as "Nine children were evaluated after experiencing an allergic reaction to the first dose". The patient underwent the following laboratory tests and procedures: Brighton score: INS, notes: insufficient information to meet case definition. Therapeutic measures were taken as a result of hypersensitivity. Additional information: Age: 10; Sex: M; Atopic history: Allergic rhinitis; Anaphylaxis cause: No; Onset after receipt, min: 120; Signs and symptom: Itchy hives; Intervention: Diphenhydramine, steroids; Time to symptoms resolution, h: 6; Meet Resource criteria: INS; Brighton score: INS; Symptoms after second dose: None.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event hypersensitivity and the use of suspect product cannot 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-PV202300015137 Same article/ drug and different patient/ event;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Herpes zoster, Rhinorrhoea, SARS-CoV-2 test, Sensitive skin
Clinical narrative: shingles outbreak; sensitive skin upper body; cough; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 14:15 as dose 3 (booster), single (Lot number: gl0446) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Naproxen/ aleve, reaction(s): "Known allergies: Naproxen/ Aleve", notes: Known allergies: Naproxen/ Aleve. Vaccination history included: BNT162b2 (Dose Number: 2, booster, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 10May2022, when the patient was 65-year-old, for COVID-19 Immunization; Jnj (Dose Number: 1, Batch/Lot No: withheld, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: Jul2021, when the patient was 64 years old, for COVID-19 Immunization; Flu, administration date: Nov2021, when the patient was 64 years old, for Influenza immunization. The following information was reported: COUGH (non-serious) with onset 29Dec2022, outcome "recovered" (03Jan2023); RHINORRHOEA (non-serious) with onset 29Dec2022, outcome "recovered" (03Jan2023), described as "runny nose"; SENSITIVE SKIN (non-serious) with onset 29Dec2022, outcome "recovered", described as "sensitive skin upper body"; HERPES ZOSTER (non-serious) with onset 29Dec2022, outcome "recovered", described as "shingles outbreak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of herpes zoster, sensitive skin, cough, rhinorrhoea.  Additional information: If COVID prior vaccination: No, if COVID tested post vaccination: Yes. Other medications in two weeks: None, Shingles outbreak-sensitive skin upper body. Cough and runny nose for 6 days.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: she had swollen lymph nodes on the left side where she was administered the vaccines; her arm was very painful; She had fatigue with the Bivalent vaccine, and also with the other doses too.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL8982, Expiration Date: May2021) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "She had fatigue with the Bivalent vaccine, and also with the other doses too."; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "her arm was very painful"; VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she had swollen lymph nodes on the left side where she was administered the vaccines". Therapeutic measures were taken as a result of vaccination site lymphadenopathy, vaccination site pain.  Additional Information: Reporter reported that After the 1st vaccine her arm was very painful, she took Advil but it didn't improve the pain so she used ice, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine, she would like to add that with the three previous vaccines (the first two and a booster) She had the nodules inflamed but on the left side, where they gave her the vaccine. There is a product complaint to report, The sample of the product not available to be returned; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036537 same patient, different vaccine dose number, different event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: She had swollen lymph nodes on the left side where she was administered the vaccines/I have had the nodules inflamed but on the left side, where they gave me the vaccine; She had normal pain; She had fatigue with the Bivalent vaccine, and also with the other doses too.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EN6204, Expiration Date: Jun2021) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL8982, Expiry: May2021), administration date: 01Mar2021, when the patient was 61-year-old, for COVID-19 immunization, reaction(s): "After the 1st vaccine her arm was very painful", "She had swollen lymph nodes on the left side where she was administered the vaccines/She had swollen lymph nodes on her left arm after the first 3 vaccines", "Fatigue". The following information was reported: VACCINATION SITE LYMPHADENOPATHY (non-serious), outcome "unknown", described as "She had swollen lymph nodes on the left side where she was administered the vaccines/I have had the nodules inflamed but on the left side, where they gave me the vaccine"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "She had normal pain"; FATIGUE (non-serious), outcome "unknown", described as "She had fatigue with the Bivalent vaccine, and also with the other doses too.". Therapeutic measures were taken as a result of vaccination site lymphadenopathy, vaccination site pain.  Additional information: She had swollen lymph nodes on her left arm after the first 3 vaccines, where she was administered the vaccines. After the 1st vaccine her arm was very painful, and after the 2nd and 3rd vaccine she had normal pain. If she needed to, she took Advil but it didn't improve the pain so she used ice. She did the same with the other doses, just used ice. She does not have the Advil to provide the Lot/Expiry numbers. She had fatigue with the Bivalent vaccine, and also with the other doses too. Patient did not received any any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. I have had the nodules inflamed but on the left side, where they gave me the vaccine. There were no Investigations reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036537 same patient, different vaccine dose number, different event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenitis, Streptococcal infection, Vaccination site pain, Vaccination site swelling
Clinical narrative: she had swollen lymph nodes on the left side where she was administered the vaccines; she had normal pain vaccine arm; nodules inflamed but on the left side; She had fatigue with the Bivalent vaccine, and also with the other doses too; she just had strep 2 times, in Nov2022 and beginning of Jan2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EL8982, Expiry: May2021, 1st 2 doses were from Withheld), administration date: 01Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "arm was very painful", "she had swollen lymph nodes on the left side where she was administered the vaccines", "nodules inflamed but on the left side"; BNT162b2 (Dose: 02, Lot: EN6204, Expiry: Jun2021, 1st 2 doses were from Withheld), administration date: 23Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "nodules inflamed but on the left side", "She had normal pain", "she had swollen lymph nodes on the left side where she was administered the vaccines". The following information was reported: STREPTOCOCCAL INFECTION (non-serious) with onset Nov2022, outcome "unknown", described as "she just had strep 2 times, in Nov2022 and beginning of Jan2023"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "she had swollen lymph nodes on the left side where she was administered the vaccines"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she had normal pain vaccine arm"; LYMPHADENITIS (non-serious), outcome "unknown", described as "nodules inflamed but on the left side"; FATIGUE (non-serious), outcome "unknown", described as "She had fatigue with the Bivalent vaccine, and also with the other doses too". Therapeutic measures were taken as a result of vaccination site pain, streptococcal infection.  Additional information: With the 3 prior vaccines she had swollen lymph nodes on the left side where she was administered the vaccines. She had swollen lymph nodes on her left arm after the first 3 vaccines. After the 1st vaccine her arm was very painful, and after the 2nd and 3rd vaccine she had normal pain. If she needed to, she took Advil but it didnt improve the pain so she used ice. She did the same with the other doses, just used ice. She does not have the Advil to provide the Lot/Expiry numbers. She had fatigue with the Bivalent vaccine, and also with the other doses too.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036537 same patient, different vaccine dose number, different event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Chest X-ray, Echocardiogram, Investigation, Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose number unknown (booster), single (Lot number: EW0186) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "chest pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Janssen covid-19 vaccine (she got the J and J and had a good night's sleep and was fine), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (life threatening) with onset 25Nov2021, outcome "recovered" (Jan2022). It was reported that the patient suffered from myocarditis 5 days after Pfizer booster vaccine. Had some chest pain. The event "myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Cardiac stress test: Unknown results; Chest X-ray: Unknown results; Echocardiogram: Unknown results; number of tests: Unknown results, notes: Went to the doctor, had a number of tests then went to the cardiologist and had a number of tests. Therapeutic measures were not taken as a result of myocarditis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036624 same reporter, product and patient, different event.;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 20Nov2021 as dose number unknown (booster), single (Lot number: EW0186) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "chest pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Janssen covid-19 vaccine (she got the J and J and had a good night's sleep and was fine), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: MYOCARDITIS (life threatening) with onset 25Nov2021, outcome "recovered" (Jan2022). It was reported that the patient suffered from myocarditis 5 days after Pfizer booster vaccine. Had some chest pain. The event "myocarditis" required physician office visit. The patient underwent the following laboratory tests and procedures: Cardiac stress test: Unknown results; Chest X-ray: Unknown results; Echocardiogram: Unknown results; number of tests: Unknown results, notes: Went to the doctor, had a number of tests then went to the cardiologist and had a number of tests. Therapeutic measures were not taken as a result of myocarditis.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300036624 same reporter, product and patient, different event.;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Hypoaesthesia
Clinical narrative: Numbness on the right side of body/Numbness remains in right side foot in her toes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 2, single (Lot number: EN6204) at the age of 77 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EM9809, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 06Feb2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 05Jul2021, outcome "recovered with sequelae", described as "Numbness on the right side of body/Numbness remains in right side foot in her toes". The event "numbness on the right side of body/numbness remains in right side foot in her toes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: After the dose received on 07Mar2021, Name (withheld) experienced numbness on the right side of body (around Jul2021). PCP did workup for stroke (brain CT) and no signs of stroke. Numbness remains in right side foot in her toes. With recent (withheld) reporting of potential stroke in 65+ Name (withheld) wanted to report to Pfizer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Haemodynamic test, Investigation, Metabolic function test
Clinical narrative: Asymmetric morbilliform eruption; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RASH MORBILLIFORM (hospitalization), 2 days after the suspect product(s) administration, outcome "unknown", described as "Asymmetric morbilliform eruption". The patient underwent the following laboratory tests and procedures: C-reactive protein: unremarkable; Full blood count: unremarkable; Haemodynamic test: stable; febrile: afebrile; negative; Metabolic function test: unremarkable; Physical exam: demonstrated morbilliform papules, notes: that coalesced into an erythematous plaque with sharp demarcation on his left proximal arm and trunk with fine overlying desquamation and relative sparing of the axillary vault. there was no mucosal, facial, or acral involvement; Red blood cell sedimentation rate: unremarkable.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events morbiliform rash and the use of suspect product cannot 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: M
Vaccine: COVID19
Symptoms: Physical examination, Rash morbilliform, Red blood cell sedimentation rate
Clinical narrative: Asymmetric morbilliform eruption; This is a literature report for the following literature source(s):   A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RASH MORBILLIFORM (hospitalization), 2 days after the suspect product(s) administration, outcome "unknown", described as "Asymmetric morbilliform eruption". The patient underwent the following laboratory tests and procedures: C-reactive protein: unremarkable; Full blood count: unremarkable; Haemodynamic test: stable; febrile: afebrile; negative; Metabolic function test: unremarkable; Physical exam: demonstrated morbilliform papules, notes: that coalesced into an erythematous plaque with sharp demarcation on his left proximal arm and trunk with fine overlying desquamation and relative sparing of the axillary vault. there was no mucosal, facial, or acral involvement; Red blood cell sedimentation rate: unremarkable.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events morbiliform rash and the use of suspect product cannot 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
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Sleep disorder
Clinical narrative: Approximately 14 hours after this booster injection, I was awaken at 1 AM by an extremely strong pain in my lower back that was exactly like the pain of the kidney stone I had experienced in 1996.  I was so certain that it was another kidney stone that I got dressed and packed a backpack with essential items.  However, I decided to wait for a while. This pain lasted for approximately 1.5 hours and then fairly quickly faded afterwards.  FYI, this was my first Moderna injection.  All previous ones were Pfizer.  Please note that this side effect is not officially listed by the CDC, yet when I did an internet search, I found that many people had experienced back pain after a COVID shot or booster.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Arrhythmia
Clinical narrative: Patient came in on 1-26-23 and states she has had a heart arrhythmia and has since started the Metoprolol Tartrate 25mg twice daily written by Dr. I am not positive what tests the MD did but they told her it was likely due to the Flu shot.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: none, vaccine given with BUD date of 1/20/23.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient was given HPV first dose along with MCV and Fluarix. Patient was asked to wait in the waiting area for 15 min to take blood pressure, minutes  after that patient  had a convulsive syncope Dr. and nurse came to patients aide as patient regained conscious, patient was observed for an approximate 45-min to an hour until vitals where stable.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/Administered after best used date
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: No treatment necessary  I called pt and advised that they got an extra dose of the flu vaccine and to call us if they have any concerns or side affects
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient given Moderna Bivalent Booster at 11:00am on 1/23/23 during Nurse Visit.  However, it was discovered after the patient left the clinic that the vaccine expired on 1/20/23, 3 days prior.   Our MGR contacted MODERNA directly and heard back on 1/26/23 that "the lot was tested and maintained the activity necessary to protect against SARS-CoV-2 (COVID-19) virus at the time of administration. "   Patient was contacted by MGR today, 1/26/23.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adulterated product, No adverse event, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Anticoagulant therapy, Cerebellar artery thrombosis, Cerebrovascular accident, Computerised tomogram
Clinical narrative: On October 15th, I developed sustained dizziness, vertigo, nausea and vomiting that did not respond to Zofran and Meclazine.  ED assessment by CT, CTA and MRI diagnosed PICA Stroke.  Hospitalized for 24 hours.  Started on Lipitor 80mg and ASA 81mg.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Full blood count, Magnetic resonance imaging, Metabolic function test, Nausea
Clinical narrative: On October 15th, I developed sustained dizziness, vertigo, nausea and vomiting that did not respond to Zofran and Meclazine.  ED assessment by CT, CTA and MRI diagnosed PICA Stroke.  Hospitalized for 24 hours.  Started on Lipitor 80mg and ASA 81mg.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: On October 15th, I developed sustained dizziness, vertigo, nausea and vomiting that did not respond to Zofran and Meclazine.  ED assessment by CT, CTA and MRI diagnosed PICA Stroke.  Hospitalized for 24 hours.  Started on Lipitor 80mg and ASA 81mg.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/Administered after best used date
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Deep vein thrombosis, Pain, Pulmonary embolism
Clinical narrative: Fever, body ache, chills, pulmonary embolism, dvt , cough, ? this continued until mid July. I have continued to have a fever in the evening currently
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, body ache, chills, pulmonary embolism, dvt , cough, ? this continued until mid July. I have continued to have a fever in the evening currently
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction/Administered after best used date
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate irregular
Clinical narrative: Pronounced irregular heartbeat, which has continued but is less frequent/severe now than right after I got the booster. I do not have health insurance so have not gone to a doctor. I made sure my affairs are in order for my kids (eg, filed a transfer on death for house and car).
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Dysphonia, SARS-CoV-2 test positive, Sneezing, Throat irritation
Clinical narrative: I had my vaccination on 10/26/2022. I started to have a scratchy throat and sneezing on 01/08/2023. I tested on 01/10/2023 COVID-19 positive. I did have a raspy throat and it was gone within 24 hours.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster, Oral herpes, Pain, Paraesthesia
Clinical narrative: Chronic frequent Cold sores started a month after my first Pfizer Covid 19 vaccine dose, and increasing in both frequency and severity following each of a total of three doses.  It was more than 8 years since my last cold aore outbreak before receiving the 1st Pfizer Covid19 vaccine dose.  Now they occur monthly without medication regardless of diet and other preventive measures.  More recently, I have been having Shingles symptoms that the  Valacyclovir has subdued.  I had a very mild occurrence of Shingles 6+ years ago so I know the symptoms. But never had it again until now.  And the tingling itchy pain continues to return monthly as does the outbreak of oral herpes cold sores on my lips.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Chronic frequent Cold sores started a month after my first Pfizer Covid 19 vaccine dose, and increasing in both frequency and severity following each of a total of three doses.  It was more than 8 years since my last cold aore outbreak before receiving the 1st Pfizer Covid19 vaccine dose.  Now they occur monthly without medication regardless of diet and other preventive measures.  More recently, I have been having Shingles symptoms that the  Valacyclovir has subdued.  I had a very mild occurrence of Shingles 6+ years ago so I know the symptoms. But never had it again until now.  And the tingling itchy pain continues to return monthly as does the outbreak of oral herpes cold sores on my lips.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion.  No adverse events experienced/reported by patient.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vaccine adulterated due to temperature excursion. No adverse events experienced/reported by patient.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal discomfort, Abnormal dreams, Asthenopia, Blood test, Computerised tomogram
Clinical narrative: Vertigo, severe headaches, eye aches, blurry vision, extreme sensitivity to light, tingling on bottom of feet, flu-like aches, especially in shoulders and neck, dizziness, upset stomach (belch, gas, diarrhea), pixelated vision at 6-8 ft from object, vivid dreams/nightmares, extremely tired, sleeping  10-12 hours/night and napping during the day, inability to function in daily life. Cancelled trip in December. Unable to attend meeting. Convention as a participant. Unable to Chair mtg of  Action Committee.  Not able to drive, attend church, celebrate holidays w family, socialize, be a normal humam.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Diarrhoea, Dizziness, Electrocardiogram, Eructation, Eye pain
Clinical narrative: Vertigo, severe headaches, eye aches, blurry vision, extreme sensitivity to light, tingling on bottom of feet, flu-like aches, especially in shoulders and neck, dizziness, upset stomach (belch, gas, diarrhea), pixelated vision at 6-8 ft from object, vivid dreams/nightmares, extremely tired, sleeping  10-12 hours/night and napping during the day, inability to function in daily life. Cancelled trip in December. Unable to attend meeting. Convention as a participant. Unable to Chair mtg of  Action Committee.  Not able to drive, attend church, celebrate holidays w family, socialize, be a normal humam.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Flatulence, Headache, Hypersomnia, Impaired driving ability
Clinical narrative: Vertigo, severe headaches, eye aches, blurry vision, extreme sensitivity to light, tingling on bottom of feet, flu-like aches, especially in shoulders and neck, dizziness, upset stomach (belch, gas, diarrhea), pixelated vision at 6-8 ft from object, vivid dreams/nightmares, extremely tired, sleeping  10-12 hours/night and napping during the day, inability to function in daily life. Cancelled trip in December. Unable to attend meeting. Convention as a participant. Unable to Chair mtg of  Action Committee.  Not able to drive, attend church, celebrate holidays w family, socialize, be a normal humam.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Magnetic resonance imaging, Nightmare, Paraesthesia
Clinical narrative: Vertigo, severe headaches, eye aches, blurry vision, extreme sensitivity to light, tingling on bottom of feet, flu-like aches, especially in shoulders and neck, dizziness, upset stomach (belch, gas, diarrhea), pixelated vision at 6-8 ft from object, vivid dreams/nightmares, extremely tired, sleeping  10-12 hours/night and napping during the day, inability to function in daily life. Cancelled trip in December. Unable to attend meeting. Convention as a participant. Unable to Chair mtg of  Action Committee.  Not able to drive, attend church, celebrate holidays w family, socialize, be a normal humam.