chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Headache and no interference with activity; Moderate muscle pain with some interference with activity; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), HEADACHE (Headache and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and VACCINATION SITE SWELLING (Mild injection site swelling) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), HEADACHE (Headache and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling) and FATIGUE (Mild fatigue and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), HEADACHE (Headache and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.            No concomitant medications were reported.  It was reported that worst pain (Injection site pain), worst tenderness (Injection site tenderness), worst swelling (Injection site swelling), worst intensity of fatigue, worst intensity of feeling unwell, worst intensity of pain (Muscle pain) and maximum headache severity experienced anytime during the 2 days after the COVID-19 vaccination, which occurred Friday, 2- Feb-2024 and Saturday, 3-Feb-2024 was recorded.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Joint pain and no interference with activity; Moderate muscle pain with some interference with activity; Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fatigue and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity). At the time of the report, ARTHRALGIA (Joint pain and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.            No concomitant medications were reported.  It was reported that worst pain (Injection site pain), worst tenderness (Injection site tenderness), worst redness (Injection site redness), worst intensity of fatigue, worst intensity of pain (Muscle pain) and worst intensity of joint pain experienced anytime during the 2 days after the COVID-19 vaccination, which occurred Saturday, 3-Feb-2024 and Sunday, 4-Feb-2024 was recorded.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Moderate muscle pain with some interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and MYALGIA (Moderate muscle pain with some interference with activity). At the time of the report, VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.            Subject ID was reported and auto-curettement Subject ID was reported.  Concomitant medication was not reported.  It was reported that the symptom of vaccination site pain, vaccination site erythema, Vaccination site swelling, and myalgia was experienced anytime during the 2 days after vaccination on either occurred on 03-Feb-2024 and 04-Feb-2024.  No treatment medications provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Ear infection, SARS-CoV-2 test, Sinusitis
Clinical narrative: Also got an upper sinus infection and an infection in my left ear.; Also got an upper sinus infection and an infection in my left ear.; Patient tested positive for COVID-19 on January 19, 2024; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Also got an upper sinus infection and an infection in my left ear.), EAR INFECTION (Also got an upper sinus infection and an infection in my left ear.) and COVID-19 (Patient tested positive for COVID-19 on January 19, 2024) in a 62-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205F232A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu on 23-Sep-2023 and RSV on 23-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu and RSV.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 19-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Patient tested positive for COVID-19 on January 19, 2024). On an unknown date, the patient experienced SINUSITIS (Also got an upper sinus infection and an infection in my left ear.) and EAR INFECTION (Also got an upper sinus infection and an infection in my left ear.). At the time of the report, SINUSITIS (Also got an upper sinus infection and an infection in my left ear.) and EAR INFECTION (Also got an upper sinus infection and an infection in my left ear.) had not resolved and COVID-19 (Patient tested positive for COVID-19 on January 19, 2024) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Skin swelling
Clinical narrative: The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced the skin just "puffed up"; The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced itching skin at the injection site; This spontaneous case was reported by a patient and describes the occurrence of SKIN SWELLING (The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced the skin just "puffed up") and INJECTION SITE PRURITUS (The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced itching skin at the injection site) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Jan-2024, the patient experienced SKIN SWELLING (The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced the skin just "puffed up") and INJECTION SITE PRURITUS (The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced itching skin at the injection site). At the time of the report, SKIN SWELLING (The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced the skin just "puffed up") and INJECTION SITE PRURITUS (The reporter states that she received her dose of Moderna Spikevax COVID-19 vaccine on 11JAN2024 and on the 29JAN2024 she experienced itching skin at the injection site) had not resolved.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The reporter stated that she received her dose of Moderna Spikevax COVID-19 vaccine on 11-JAN-2024 and on the 29-JAN-2024 she experienced itching skin at the injection site and the skin just "puffed up". It lasted 30-45 minutes to an hour and the skin went back to normal. Reporter stated that it happened again on 31-JAN-2024 and again yesterday, 08-FEB-2024. Reporter stated there was no action that brings it on, as yesterday it occurred in the morning while lying in bed. Reporter stated that she had at least 4-5 doses of Moderna with no previous side effects or issues.  Patient's lab test infomation was reported as unknown. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: I woke up around 4 or 5AM with headache and queasiness; I woke up around 4 or 5AM with headache and queasiness; Arm got very sore by 10 or 11 that night; Headache and fatigue were severe enough that I really couldn't get out of bed all day to do much more than go to the bathroom and drink water.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm got very sore by 10 or 11 that night), HEADACHE (I woke up around 4 or 5AM with headache and queasiness), FATIGUE (Headache and fatigue were severe enough that I really couldn't get out of bed all day to do much more than go to the bathroom and drink water.) and NAUSEA (I woke up around 4 or 5AM with headache and queasiness) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032089) for Headache and Tenderness NOS.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19) on 09-Sep-2023.    On 07-Feb-2024 at 12:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 07-Feb-2024, the patient experienced PAIN IN EXTREMITY (Arm got very sore by 10 or 11 that night) and FATIGUE (Headache and fatigue were severe enough that I really couldn't get out of bed all day to do much more than go to the bathroom and drink water.). On 08-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (I woke up around 4 or 5AM with headache and queasiness) and NAUSEA (I woke up around 4 or 5AM with headache and queasiness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm and Headache, at a dose of 2 dosage form, 2 tablets at a time, only two or three times. On 09-Feb-2024, PAIN IN EXTREMITY (Arm got very sore by 10 or 11 that night), HEADACHE (I woke up around 4 or 5AM with headache and queasiness), FATIGUE (Headache and fatigue were severe enough that I really couldn't get out of bed all day to do much more than go to the bathroom and drink water.) and NAUSEA (I woke up around 4 or 5AM with headache and queasiness) had resolved.            Concomitant medication was not provided. Patient had headache and fatigue severe enough that he really couldn't get out of bed all day to do much more than go to the bathroom and drink water. Patient got reminded of descriptions of a migraine, where the headache was bad enough to be nauseating in itself and don't want to open eyes, reading or looking closely at something could make it worse or be nauseating. By 8PM or 9PM patient felt like it seemed to be tapering off, and by the next morning, it seemed to have cleared up, although still feeling worn down.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dizziness, Heart rate, Heart rate decreased, Oxygen consumption
Clinical narrative: Cardiac discomfort; Pulse rate dropped; 30% decline in VO2 Max (persistent); light headed; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISCOMFORT (Cardiac discomfort), HEART RATE DECREASED (Pulse rate dropped), OXYGEN CONSUMPTION DECREASED (30% decline in VO2 Max (persistent)) and DIZZINESS (light headed) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 08-Dec-2023; for Drug use for unknown indication: Metoprolol (Patient discontinued Metoprolol at the advice of cardiologist). Past adverse reactions to the above products included No adverse event with Flu shot and Metoprolol.    On 08-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Dec-2023, the patient experienced CARDIAC DISCOMFORT (Cardiac discomfort), HEART RATE DECREASED (Pulse rate dropped), OXYGEN CONSUMPTION DECREASED (30% decline in VO2 Max (persistent)) and DIZZINESS (light headed). At the time of the report, CARDIAC DISCOMFORT (Cardiac discomfort), HEART RATE DECREASED (Pulse rate dropped), OXYGEN CONSUMPTION DECREASED (30% decline in VO2 Max (persistent)) and DIZZINESS (light headed) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2023, Heart rate: dropped. On 10-Dec-2023, Oxygen consumption: 30% decline in VO2 Max (persistent).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported.  Reportedly, patient had 30 percent decline in VO2 Max (persistent), cardiac discomfort, lightheaded, pulse rate dropped.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen consumption decreased
Clinical narrative: Cardiac discomfort; Pulse rate dropped; 30% decline in VO2 Max (persistent); light headed; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISCOMFORT (Cardiac discomfort), HEART RATE DECREASED (Pulse rate dropped), OXYGEN CONSUMPTION DECREASED (30% decline in VO2 Max (persistent)) and DIZZINESS (light headed) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) on 08-Dec-2023; for Drug use for unknown indication: Metoprolol (Patient discontinued Metoprolol at the advice of cardiologist). Past adverse reactions to the above products included No adverse event with Flu shot and Metoprolol.    On 08-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Dec-2023, the patient experienced CARDIAC DISCOMFORT (Cardiac discomfort), HEART RATE DECREASED (Pulse rate dropped), OXYGEN CONSUMPTION DECREASED (30% decline in VO2 Max (persistent)) and DIZZINESS (light headed). At the time of the report, CARDIAC DISCOMFORT (Cardiac discomfort), HEART RATE DECREASED (Pulse rate dropped), OXYGEN CONSUMPTION DECREASED (30% decline in VO2 Max (persistent)) and DIZZINESS (light headed) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2023, Heart rate: dropped. On 10-Dec-2023, Oxygen consumption: 30% decline in VO2 Max (persistent).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported.  Reportedly, patient had 30 percent decline in VO2 Max (persistent), cardiac discomfort, lightheaded, pulse rate dropped.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Age: 1.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse. A 14-month-old male patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 03Nov2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 months, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALSARTAN; LEVOTHYROXINE SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19- treatment with Paxlovid from 20Dec2023 to 24Dec2023. The patient had no known allergies. Vaccine lot number was unknown since misplaced/discarded.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted historical vaccines; suspect product details (updated previous Paxlovid to BNT162b2 omi xbb.1.5, then added COVID-19 VACCINE as co-suspect and their therapy details); event details (updated previous events COVID-19 recurrent and Disease recurrence to Drug ineffective and COVID-19 respectively, then deleted Off label use and Drug use in unapproved population as events, case has been upgraded to serious).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA) can not be fully excluded.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came said that her right arm is still hurting. It started with sore and pain. Just been taking Ibuprofen to relieve the pain. The pain felt like "someone is grabbing her hard," sharp pain. She said she can't lift her arm higher than 40 to 45 degrees.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Within 1.5 hours of vaccination experienced weakness, cld shivers, fever
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received x2 non diluted doses.  Patient left clinic in stable condition. Will follow up in person tomorrow 2/14/23 @ 1335. After care instructions discussed with mother. Mother verbalized understanding.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Cellulitis, Dizziness, Erythema, Herpes zoster, Immediate post-injection reaction
Clinical narrative: Patient felt like she was going to pass out, had severe pain in right arm immediately after receiving the vaccine. Five days later the patient was having redness and irritation in the arm still in addition to the pain and went into the urgent care. Pt reports now having a staph infection, cellulitis, and now has an active shingles outbreak.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Pain in extremity, Skin irritation, Staphylococcal infection
Clinical narrative: Patient felt like she was going to pass out, had severe pain in right arm immediately after receiving the vaccine. Five days later the patient was having redness and irritation in the arm still in addition to the pain and went into the urgent care. Pt reports now having a staph infection, cellulitis, and now has an active shingles outbreak.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: just a little sore, no problem after this dose; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 89-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: 1233) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "just a little sore, no problem after this dose".
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included taking Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocardial infarction, Neck surgery, Pain, Weight
Clinical narrative: painful and the worse pain he went through in life; neck surgery; heart attack; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 1, single (Lot number: FF2587), in right arm and on 30Sep2021 as dose 2, single (Lot number: 301458A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (hospitalization) with onset 10Oct2021, outcome "unknown", described as "heart attack"; NECK SURGERY (hospitalization) with onset 01Feb2024, outcome "unknown"; PAIN (hospitalization), outcome "unknown", described as "painful and the worse pain he went through in life". The patient underwent the following laboratory tests and procedures: Electrocardiogram: Unknown results, notes: Had 10 EKGs; Weight: 200 pounds or little less. Therapeutic measures were taken as a result of neck surgery.  Additional information: Caller states 'your vaccine almost killing me'. He was forced to get 2 shots of the Pfizer Covid 19 Vaccine and had a heart attack. He mentioned he has had neck surgery as well. Initially confirmed he was admitted to the hospital, but then clarified he was only there for less than an hour. They did not know what to do. He was just lying there in pain, and sent back. Had work, was getting ready to go to it. It was close 16:00 in the afternoon. Later clarified it was between 3:00-4:00 in the afternoon. He could not go to work. He was taken hospital the ER Neck Surgery
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 21Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in left leg for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2022 as dose 3 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid taken from 24Jan2024 to 29Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: still got COVID; still got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250.  A 64-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID".  Additional information: Patient got two doses on the left arm and two on the right. Body height: 4'11 something.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2023 as dose number unknown (booster), single (Lot number: 8057965), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid for COVID-19 treatment from 30Jan2024 to 03Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: took the pfjzer Covid vaccines and now has Covid; took the pfjzer Covid vaccines and now has Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 80-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took the pfjzer Covid vaccines and now has Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient stated they took the Pfizer Covid Vaccine and now has covid. He stated he is very sick.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Feb2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: En6204), in left arm, on 26May2021 as dose 2, single (Lot number: Ew0176), in left arm, on 24Nov2021 as dose 3 (booster), single (Lot number: Ff2593), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: Fj9943) at the age of 59 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 24Jan2024 to 29Jan2024 as treatment for COVID-19.   No follow-up attempts are possible.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was given Paxlovid on 29Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 06Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single), as dose 5 (booster), single) and as dose 6 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic type 2" (unspecified if ongoing); "BPH" (unspecified if ongoing); "High BP" (unspecified if ongoing); "Lipids" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 24Jan2024 to 28Jan2024.   Additional information: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 09:00 as dose 1, single (Lot number: HG2649) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing); "CKD3 (Chronic kidney disease)" (unspecified if ongoing); "Spondylarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (Dose Number: 5, Batch/Lot No: AS7185B, Location of injection: Arm Left), administration date: 17May2023, when the patient was 43-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose Number: 4, Batch/Lot No: 030G22B, Location of injection: Arm Right), administration date: 03Oct2022, when the patient was 42-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose Number: 3, Batch/Lot No: 084J21A, Location of injection: Arm Right), administration date: 13Apr2022, when the patient was 42-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (Dose Number: 2, Batch/Lot No: 011F21A), administration date: 19Oct2021, when the patient was 41-year-old, for COVID-19 Immunization; janssen COVID-19 vaccine (Dose Number: 1, Batch/Lot No: 1805029), administration date: 11Mar2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2024) Positive, notes: I got sick with COVID-19; (07Feb2024) Positive, notes: On 07Feb I tested (still or again) positive for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Dec2023 at 10:00 as dose 1 (toppac), single (Lot number: HG9498) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid from  23Jan2024 to 28Jan2024.
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild HLD" (unspecified if ongoing), notes: mild HLD; "GERD" (unspecified if ongoing); "vasomotor rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 26.3; SARS-CoV-2 test: (02Feb2024) Negative; (04Feb2024) Negative; (Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID-19 treatment from 29Jan2024 to 03Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the known information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 1st and 2nd dose are Moderna, 3rd dose is Pfizer; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: 7L3198) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2021 as dose 1, single (Lot number: 039A21A), in left arm and on 29Apr2021 as dose 2, single (Lot number: 045B21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Jan2022, outcome "unknown", described as "1st and 2nd dose are Moderna, 3rd dose is Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive, notes: Positive COVID test 6 days after completing treatment; (2024) Negative, notes: Had previously tested negative twice following treatment; (2024) Negative, notes: Had previously tested negative twice following     treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech: Dose Number: 4; Moderna: Dose Number: 1, 2, 3; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 at 17:00 as dose 4 (booster, initial Pfizer dose), single (Lot number: GJ3274) at the age of 55 years, in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2021 as dose 1, single (Lot number: 019B21A), in left arm, on 30Apr2021 as dose 2, single (Lot number: 001C21OA), in left arm and on 21Dec2021 at 14:00 as dose 3 (booster), single (Lot number: 078J21A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Dec2022 at 17:00, outcome "recovered", described as "Pfizer/BioNTech: Dose Number: 4; Moderna: Dose Number: 1, 2, 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: COVID-19 symptoms were gone after taking Paxlovid for a few days.  No follow-up attempts are possible.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: hh7595) at the age of 31 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (23Dec2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2023) Negative; (24Dec2023) Negative; (25Dec2023) Negative; (26Dec2023) Negative; (27Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included taking PAXLOVID from 18Dec2023 to 24Dec2023. The patient tested negative for Covid with no symptoms from 23Dec2023 to 27Dec2023.