chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Illness, Myalgia
Clinical narrative: fatigue; muscle aches; headaches; chills / teeth chattering; sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced ILLNESS (sick). On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering). In April 2023, ILLNESS (sick) had resolved. At the time of the report, FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had no known allergies and medical history. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. Her first dose ever was Pfizer in 2021, but every dose after that was Moderna. She took them every 6 months because she was old and it was what her physician recommends. She stated that somewhere in the beginning, she snuck in an extra dose because she was so petrified. She stated that she believed it was when there was a 2nd dose, where the first dose was a higher amount and the second dose was less. She had never gotten COVID. She received this dose in September of 2021. She said that was why she had stuck with Moderna and had gotten everything (every vaccine) plus her unauthorized one. In 2023 she received doses in April and September. She did not want to delay this dose too much because it had been a full 6months and COVID was wearing its ugly head. She said she would be waiting 4 weeks until getting her flu shot. Her last dose was in March 2024 and then in September 2024. She received the vaccine this morning (9-Sep-2024) and had the usual side effects that she got with all prior vaccines. She stated that she had the vaccine in the morning and by 3 in the afternoon, she had the fatigue, muscle aches, headaches and chills. She said sometimes she had teeth chattering and was sick the day after the vaccine but by that evening, she was fine. She tried to plan her activities accordingly. Reporter causality was not reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-773529 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773529:Same patient different product (Spikevax 2023-2024 XBB.1.5)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Myalgia
Clinical narrative: sick; fatigue; muscle aches; headaches; chills / teeth chattering; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a 77-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering). At the time of the report, ILLNESS (sick) had resolved and FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient had no known allergies and medical history. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. She stated that she will get the vaccine in the morning and by 3 in the afternoon, she started to get the fatigue, muscle aches, headaches and chills. She said sometimes she gets teeth chattering and was sick the day after the vaccine but by that evening, she was fine. She tries to plan her activities accordingly. No treatment medication was reported.   This case was linked to MOD-2024-773529 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: When I got the Moderna booster, I got chronic hives a week after getting it for like a year and a half and then it kind of sub sided; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (When I got the Moderna booster, I got chronic hives a week after getting it for like a year and a half and then it kind of sub sided) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: SPIKEVAX (Dose 2, two dose series), SPIKEVAX (Dose 1 and two dose series). Past adverse reactions to the above products included No adverse effect with SPIKEVAX and SPIKEVAX.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA CHRONIC (When I got the Moderna booster, I got chronic hives a week after getting it for like a year and a half and then it kind of sub sided). At the time of the report, URTICARIA CHRONIC (When I got the Moderna booster, I got chronic hives a week after getting it for like a year and a half and then it kind of sub sided) was resolving.            No relevant concomitant medications were reported.  When the patient got the Moderna booster dose, the patient got chronic hives a week after getting it for like a year and a half and then it kind of subsided. Hence the patient was thinking of switching over to the Novavax vaccine and asked about what was the likelihood that the patient would get that reaction to the Novavax vaccine as same as that experienced after receiving the Moderna vaccine.  No treatment medication reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Swollen red and inflamed area of my bicep, away from the upper arm area that was injected; Swollen red and inflamed area of my bicep, away from the upper arm area that was injected; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Swollen red and inflamed area of my bicep, away from the upper arm area that was injected) and INFLAMMATION (Swollen red and inflamed area of my bicep, away from the upper arm area that was injected) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Sanofi flu for seniors (Sanofi flu for seniors and Sanofi enhanced flu vaccine) on 01-Sep-2024. Past adverse reactions to the above products included No adverse effect with Sanofi flu for seniors. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 01-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 02-Sep-2024, the patient experienced PERIPHERAL SWELLING (Swollen red and inflamed area of my bicep, away from the upper arm area that was injected) and INFLAMMATION (Swollen red and inflamed area of my bicep, away from the upper arm area that was injected). At the time of the report, PERIPHERAL SWELLING (Swollen red and inflamed area of my bicep, away from the upper arm area that was injected) and INFLAMMATION (Swollen red and inflamed area of my bicep, away from the upper arm area that was injected) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no medical history, concomitant disease or risk factor. The patient reported that swollen red and inflamed area of her bicep, away from the upper arm area that was injected. The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment medications were reported.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Injection site pain, Insomnia, Lethargy
Clinical narrative: slight lethargy; 4 inches long blood clot that came out from the daughter's nose/bleeding; could not sleep well at night; arm pain; light fever; headache; soreness in the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INSOMNIA (could not sleep well at night), PAIN IN EXTREMITY (arm pain), EPISTAXIS (4 inches long blood clot that came out from the daughter's nose/bleeding), LETHARGY (slight lethargy) and PYREXIA (light fever) in a 6-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sore throat (patient had little sore throat last Friday.). Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (Previous covid shot is Pfizer (consumer said it was 2022).) in 2022. Past adverse reactions to the above products included No adverse effect with Pfizer Covid-19 vaccine.   On 07-Sep-2024, the patient received first dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form. On 07-Sep-2024, the patient experienced INSOMNIA (could not sleep well at night), PAIN IN EXTREMITY (arm pain), PYREXIA (light fever), HEADACHE (headache) and INJECTION SITE PAIN (soreness in the injection site). On 08-Sep-2024, the patient experienced EPISTAXIS (4 inches long blood clot that came out from the daughter's nose/bleeding). On an unknown date, the patient experienced LETHARGY (slight lethargy). At the time of the report, INSOMNIA (could not sleep well at night), PAIN IN EXTREMITY (arm pain), EPISTAXIS (4 inches long blood clot that came out from the daughter's nose/bleeding), LETHARGY (slight lethargy) and INJECTION SITE PAIN (soreness in the injection site) was resolving and PYREXIA (light fever) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown) was unknown.   Patient had no allergies. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient had had the Moderna 2024-2205 vaccine last 07-Sep-2024 around 5pm. Suspect vaccine dosage text was reported as first dose.  Patient experienced arm pain, soreness in the injection site, light fever and could not sleep well at night. On the next day morning, patient had bleeding (which was severe) and had a 4 inches long blood clot that came out from the daughter's nose. After that patient was fine but still had fever and headache. At the time of reporting, she seems to be okay. Patient had slight lethargy but is comfortable going to school.  Treatment information was not provided.  Reporter causality was not reported.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: slight lethargy; 4 inches long blood clot that came out from the daughter's nose/bleeding; could not sleep well at night; arm pain; light fever; headache; soreness in the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INSOMNIA (could not sleep well at night), PAIN IN EXTREMITY (arm pain), EPISTAXIS (4 inches long blood clot that came out from the daughter's nose/bleeding), LETHARGY (slight lethargy) and PYREXIA (light fever) in a 6-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sore throat (patient had little sore throat last Friday.). Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (Previous covid shot is Pfizer (consumer said it was 2022).) in 2022. Past adverse reactions to the above products included No adverse effect with Pfizer Covid-19 vaccine.   On 07-Sep-2024, the patient received first dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form. On 07-Sep-2024, the patient experienced INSOMNIA (could not sleep well at night), PAIN IN EXTREMITY (arm pain), PYREXIA (light fever), HEADACHE (headache) and INJECTION SITE PAIN (soreness in the injection site). On 08-Sep-2024, the patient experienced EPISTAXIS (4 inches long blood clot that came out from the daughter's nose/bleeding). On an unknown date, the patient experienced LETHARGY (slight lethargy). At the time of the report, INSOMNIA (could not sleep well at night), PAIN IN EXTREMITY (arm pain), EPISTAXIS (4 inches long blood clot that came out from the daughter's nose/bleeding), LETHARGY (slight lethargy) and INJECTION SITE PAIN (soreness in the injection site) was resolving and PYREXIA (light fever) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown) was unknown.   Patient had no allergies. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient had had the Moderna 2024-2205 vaccine last 07-Sep-2024 around 5pm. Suspect vaccine dosage text was reported as first dose.  Patient experienced arm pain, soreness in the injection site, light fever and could not sleep well at night. On the next day morning, patient had bleeding (which was severe) and had a 4 inches long blood clot that came out from the daughter's nose. After that patient was fine but still had fever and headache. At the time of reporting, she seems to be okay. Patient had slight lethargy but is comfortable going to school.  Treatment information was not provided.  Reporter causality was not reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling of despair, Gait disturbance, Headache
Clinical narrative: difficulty walking; Despair of exhaustion; severe tiredness/exhaustion/completely exhausted; headaches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (difficulty walking), FEELING OF DESPAIR (Despair of exhaustion), FATIGUE (severe tiredness/exhaustion/completely exhausted) and HEADACHE (headaches) in a 32-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking), FEELING OF DESPAIR (Despair of exhaustion), FATIGUE (severe tiredness/exhaustion/completely exhausted) and HEADACHE (headaches). At the time of the report, GAIT DISTURBANCE (difficulty walking) outcome was unknown and FEELING OF DESPAIR (Despair of exhaustion), FATIGUE (severe tiredness/exhaustion/completely exhausted) and HEADACHE (headaches) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had severe problems with his health. Patient was completely exhausted and unable to work or function. Reporter stated that it had been 2 years since his Moderna vaccine. The reporter stated that the patient had seen several doctors without finding relief and nobody was able to help him. No treatment medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2024: Live significant follow-up received: Added new event of feeling of despair, updated narrative.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness
Clinical narrative: Significant exacerbation of chronic low back pain with tightness and pain extending through buttocks to hips; Significant exacerbation of chronic low back pain with tightness and pain extending through buttocks to hips; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Aug2024 as dose 1, single (Lot number: LM2216) at the age of 64 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing). Concomitant medication(s) included: SELEGILINE, start date: Jun2013. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: MUSCLE TIGHTNESS (non-serious), BACK PAIN (non-serious) all with onset 29Aug2024 at 06:00, outcome "not recovered" and all described as "Significant exacerbation of chronic low back pain with tightness and pain extending through buttocks to hips". Therapeutic measures were taken as a result of muscle tightness, back pain.  Additional information: the patient did not receive any other vaccines on the same date as the vaccine or any other vaccines within 4 weeks prior to the vaccine. Treatment received for the adverse event included Aleve, Voltaren, heat.
Age: 47.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Pain during injection and soreness in right arm for more than 24 hours; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Aug2024 as dose number unknown, single) intramuscular, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; SERTRALINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered", described as "Pain during injection and soreness in right arm for more than 24 hours". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient was taking other medications within 2 weeks of the event starting. Pain during injection and soreness in right arm for more than 24 hours. No pain or soreness in left arm, which received the flu shot. Event did not caused Hospitalization. Reason for batch/lot was unknown was Misplaced/discarded.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Nausea
Clinical narrative: muscle weakness; chills; headache; extreme nausea; fatigue; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 67-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Sep2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "hyperthyroid" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing), notes: Drug name: Unknown. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 03Sep2024 at 18:00, outcome "recovering"; NAUSEA (non-serious) with onset 03Sep2024 at 18:00, outcome "recovering", described as "extreme nausea"; FATIGUE (non-serious) with onset 03Sep2024 at 18:00, outcome "recovering"; HEADACHE (non-serious) with onset 03Sep2024 at 18:00, outcome "recovering"; MUSCULAR WEAKNESS (non-serious) with onset 03Sep2024 at 18:00, outcome "recovering", described as "muscle weakness". Therapeutic measures were not taken as a result of muscular weakness, chills, headache, nausea, fatigue.  Additional information: Patient did not receive any other vaccines on the same date as the reported vaccine. Patient did not receive any other vaccines within 4 weeks prior to the vaccine. It was unknown if patient taking any other medications within 2 weeks of the event starting. It was reported the effects patient felt from the vaccine were chills/headache/extreme nausea/muscle weakness/fatigue. Anatomical site of vaccine administration was deltoid. Batch/lot was not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Sensitive skin
Clinical narrative: skin sensitivity on both arms; Fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Sep2024 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 03Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "drug allergy" (unspecified if ongoing), notes: Name of Drug as Reported as no. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 04Sep2024, outcome "recovering"; HEADACHE (non-serious) with onset 04Sep2024, outcome "recovering"; SENSITIVE SKIN (non-serious) with onset 04Sep2024, outcome "recovering", described as "skin sensitivity on both arms". Therapeutic measures were not taken as a result of sensitive skin, fatigue, headache.  Additional information: the right bicep, the patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which it was are reporting. The patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: very bad chills; Fever; today again he has 101; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 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: PYREXIA (non-serious) with onset 03Sep2024, outcome "not recovered", described as "Fever; today again he has 101"; CHILLS (non-serious) with onset 03Sep2024, outcome "not recovered", described as "very bad chills". Relevant laboratory tests and procedures are available in the appropriate section.  Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: aches; Fatigue; chills; fever; vomiting; headache; sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Sep2024 at 22:00 as dose 1, single (Lot number: Lm2215) at the age of 73 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 01Sep2024 as dose number unknown, single (Lot number: UT8437AA), in left arm for immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing), notes: Name of Drug as Reported as No. Concomitant medication(s) included: METOPROLOL; ATORVASTATIN; SUPER OMEGA 3 [FISH OIL]; CALCIUM CITRATE; SUPER B COMPLEX WITH C; TURMERIC [CURCUMA LONGA]; CO Q10; D3. The patient also took other concomitant therapy. Past drug history included: Steroid injections, notes: Patient receive steroid injections in her SI joints. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2021, for Covid-19 Immunization, reaction(s): "chills", "aches", "sore arm", "fever". The following information was reported: FATIGUE (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); PAIN (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024), described as "aches"; CHILLS (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); PYREXIA (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024), described as "fever"; HEADACHE (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); VOMITING (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); PAIN IN EXTREMITY (non-serious), outcome "recovered" (Sep2024), described as "sore arm". Therapeutic measures were not taken as a result of pain, fatigue, chills, pyrexia, vomiting, headache.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. Patient taking any other medications within 2 weeks of the event starting was reported as 'Yes'. Patient had fatigue, aches, chills, fever, vomiting and headache which had lasted 3 days so far. That was her first time using Pfizer vaccine. Patient had only had Moderna so far since 2021 and experienced aches, chills and fever for 18-24 hours. Also experienced a sore arm for 3 days with both vaccines. For events (fatigue, aches, chills, fever vomiting and headache) hospitalization and prolongation of hospitalization was reported as No.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: aches; Fatigue; chills; fever; vomiting; headache; sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Sep2024 at 22:00 as dose 1, single (Lot number: Lm2215) at the age of 73 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 01Sep2024 as dose number unknown, single (Lot number: UT8437AA), in left arm for immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing), notes: Name of Drug as Reported as No. Concomitant medication(s) included: METOPROLOL; ATORVASTATIN; SUPER OMEGA 3 [FISH OIL]; CALCIUM CITRATE; SUPER B COMPLEX WITH C; TURMERIC [CURCUMA LONGA]; CO Q10; D3. The patient also took other concomitant therapy. Past drug history included: Steroid injections, notes: Patient receive steroid injections in her SI joints. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2021, for Covid-19 Immunization, reaction(s): "chills", "aches", "sore arm", "fever". The following information was reported: FATIGUE (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); PAIN (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024), described as "aches"; CHILLS (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); PYREXIA (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024), described as "fever"; HEADACHE (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); VOMITING (non-serious) with onset 03Sep2024, outcome "recovered" (Sep2024); PAIN IN EXTREMITY (non-serious), outcome "recovered" (Sep2024), described as "sore arm". Therapeutic measures were not taken as a result of pain, fatigue, chills, pyrexia, vomiting, headache.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. Patient taking any other medications within 2 weeks of the event starting was reported as 'Yes'. Patient had fatigue, aches, chills, fever, vomiting and headache which had lasted 3 days so far. That was her first time using Pfizer vaccine. Patient had only had Moderna so far since 2021 and experienced aches, chills and fever for 18-24 hours. Also experienced a sore arm for 3 days with both vaccines. For events (fatigue, aches, chills, fever vomiting and headache) hospitalization and prolongation of hospitalization was reported as No.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: feel 'flu-like' for a day; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feel 'flu-like' for a day".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400253223 Same patient/vaccine, different dose/event;US-PFIZER INC-202400253224 Same patient/vaccine, different dose/event;
Age: 68.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Back pain, Oral mucosal erythema, Tongue ulceration
Clinical narrative: Severe-Tongue Ulcers causing pain in eating; Redness all in mouth; Mild-Back pain; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Sep2024 at 15:45 as dose 1, single (Lot number: 00069-2432-10) at the age of 68 years for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 08Sep2024 as dose 5, single (Lot number: 49281-0124-65), in left arm for immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization; Fluzone high dose (DOSE 1, SINGLE), for Immunization; Fluzone high dose (DOSE 2, SINGLE), for Immunization; Fluzone high dose (DOSE 3, SINGLE), for Immunization; Fluzone high dose (DOSE 4, SINGLE), for Immunization. The following information was reported: BACK PAIN (non-serious) with onset 08Sep2024 at 17:00, outcome "not recovered", described as "Mild-Back pain"; ORAL MUCOSAL ERYTHEMA (non-serious) with onset 08Sep2024 at 17:00, outcome "not recovered", described as "Redness all in mouth"; TONGUE ULCERATION (non-serious) with onset 08Sep2024 at 17:00, outcome "not recovered", described as "Severe-Tongue Ulcers causing pain in eating". Therapeutic measures were not taken as a result of tongue ulceration, oral mucosal erythema, back pain.  Additional information: Severe tongue ulcers causing pain in eating. Redness all in mouth. Mild back pain. Vaccine was administered at pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which they were reporting. Patient received COMIRNATY 2024-2025 FORMULA at left shoulder. No hospitalization prolonged reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Heart rate increased, Rash
Clinical narrative: Weakness; can't walk very far now and wears out; rash and itched for about 3-4 days/ a bad a rash all over his body that was mostly on his back; rash and itched for about 3-4 days/ a bad a rash all over his body that was mostly on his back; Shortness of breath; rapid heartbeat; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2024 as dose number unknown, 0.3ml single (Lot number: GL2042) at the age of 83 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: DYSPNOEA (non-serious) with onset 07Sep2024, outcome "not recovered", described as "Shortness of breath"; HEART RATE INCREASED (non-serious) with onset 07Sep2024, outcome "not recovered", described as "rapid heartbeat"; RASH PRURITIC (non-serious), RASH (non-serious) all with onset 07Sep2024, outcome "recovering" and all described as "rash and itched for about 3-4 days/ a bad a rash all over his body that was mostly on his back"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "can't walk very far now and wears out". Additional information: Caller is a consumer that reported that he got the shot for the Covid and he broke out in a rash and itched for about 3-4 days. He had a rash on his body, shortness of breath, and kind of a rapid heartbeat. He had exactly what was on the form that they give you after getting the shot. Caller clarified the product to be the Covid-19 vaccine. The form says that you can have allergies and difficulty breathing, which he did not have, but he had a fast heart beat and a bad a rash all over his body that was mostly on his back, weakness, and shortness of breath. He got the vaccination on the Thursday 05Sep2024. He can't walk very far and has to stop to get his breath. He can't walk very far now and wears out. He did not used to be like that. He just doesn't want to have to run out of breath for the rest of his life and wants to enjoy things. He used to do a lot of walking and he can not walk very far now. He is curious if that will go away.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Weakness; can't walk very far now and wears out; rash and itched for about 3-4 days/ a bad a rash all over his body that was mostly on his back; rash and itched for about 3-4 days/ a bad a rash all over his body that was mostly on his back; Shortness of breath; rapid heartbeat; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Sep2024 as dose number unknown, 0.3ml single (Lot number: GL2042) at the age of 83 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: DYSPNOEA (non-serious) with onset 07Sep2024, outcome "not recovered", described as "Shortness of breath"; HEART RATE INCREASED (non-serious) with onset 07Sep2024, outcome "not recovered", described as "rapid heartbeat"; RASH PRURITIC (non-serious), RASH (non-serious) all with onset 07Sep2024, outcome "recovering" and all described as "rash and itched for about 3-4 days/ a bad a rash all over his body that was mostly on his back"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "can't walk very far now and wears out". Additional information: Caller is a consumer that reported that he got the shot for the Covid and he broke out in a rash and itched for about 3-4 days. He had a rash on his body, shortness of breath, and kind of a rapid heartbeat. He had exactly what was on the form that they give you after getting the shot. Caller clarified the product to be the Covid-19 vaccine. The form says that you can have allergies and difficulty breathing, which he did not have, but he had a fast heart beat and a bad a rash all over his body that was mostly on his back, weakness, and shortness of breath. He got the vaccination on the Thursday 05Sep2024. He can't walk very far and has to stop to get his breath. He can't walk very far now and wears out. He did not used to be like that. He just doesn't want to have to run out of breath for the rest of his life and wants to enjoy things. He used to do a lot of walking and he can not walk very far now. He is curious if that will go away.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: getting COVID four different times; getting COVID four different times; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00176 (Novavax).  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: getting COVID four different times. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID four different times". Clinical course: Consumer stated that her Health Care provider does not believe in any of this and he ended up getting COVID four different times, and he was vaccinated. She does not know what he was vaccinated with.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400118363 Same reporter, different patient and AE;
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Suffered a fall day after, Couldn't get off floor for 30-40 minutes; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 72-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FALL (medically significant) with onset 2021, outcome "unknown", described as "Suffered a fall day after, Couldn't get off floor for 30-40 minutes". Clinical course: Took first Covid vaccination in 2021. Suffered a fall day after. Couldn't get off floor for 30-40 minutes.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400117658 Same patient, different dose/events;US-PFIZER INC-2021288710 Same patient, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID; Tested Positive for COVID; This is a spontaneous report received from a Nurse, Program ID.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm and as dose 2, single (Batch/Lot number: unknown), in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Pernicious anemia" (unspecified if ongoing); "Major back surgery lumbar area, 4th plexus surgery", start date: Jun2024 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Sep2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She only took one or two (Pfizer Covid-19 Vaccine); Tested Positive for COVID. The patient's mother stated she was in the car with her daughter recently and her daughter just tested positive for COVID, she said she had every COVID Vaccine, she now has a fungal infection from her mold infected house. She said she is immunocompromised and her weight went down to 111 Pounds. As for treatment, registered nurse (RN) stated that they gave her a shot of Dexamethasone. As for prior vaccination details, RN stated that she had, would have to guess it and say it was, just guessing, was going to say it was 2021. She's had Covid 4-5 times, she has had Covid at least 4 times. She said the Pfizer Covid-19 Vaccine did not help.  The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Based on the known drug safety profile, the reported events Drug ineffective, Covid-19 are assessed as related to suspect drug .
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Weight went down; This is a spontaneous report received from a Nurse, Program ID.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Gastro Intestinal Disease" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "he said my bones were kind of soft" (unspecified if ongoing); "fungal infection called Curvularia" (unspecified if ongoing), notes: I have a fungal infection called Curvularia, it is from a black mold. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2020, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: 2020, for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset Jul2022, outcome "unknown", described as "Weight went down". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was clarified that the patient received the Pfizer COVID-19 vaccine. When further clarified if the patient had experienced (weight went down) after taking COVID-19 vaccine, the patient stated, "I think, I had still got one more after that, I think it was the fall of 22, I got the 4th and final Vaccine." The patient stated, "I think the first series were in 2020 and I think I had the last one in 2022, I think 22 but I am not sure of it. I assume that were available back then."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Sore throat; Cough; Tiredness/fatigue; Chills; Injections site hurt; Body aches; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 as dose 1, 0.3 ml single (Lot number: LM2222, Expiration Date: 24Mar2025) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 1994 (ongoing), notes: Diagnosed about 30 years ago. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 30Aug2024, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset 30Aug2024, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 30Aug2024, outcome "recovered" (04Sep2024), described as "Injections site hurt"; FATIGUE (non-serious) with onset 31Aug2024, outcome "not recovered", described as "Tiredness/fatigue"; COUGH (non-serious) with onset Sep2024, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2024, outcome "not recovered", described as "Sore throat". Therapeutic measures were taken as a result of pain, oropharyngeal pain, cough, vaccination site pain, fatigue, chills.  Additional information: The patient wife stated that the patient received vaccine on 30Aug2024. About an hour after patient went to the home the injection site was normal to hurt, but after that patient had chills and body aches, and a sore throat. The patient was sick and in bed. The patient had been sick since receiving the vaccine. The patient had all the shots and boosters. The injection site pain went away like 5 days later. The patient started experiencing chills about 2 hours after receiving the injection. The patient was experiencing chills on and off and are about the same. The patient started experiencing body aches on the night of 30Aug2024. The sore throat came a couple of days later. The patient still had a horrible cough. The doctor told to take Tylenol for patient symptoms and rest and drink lots of fluids. The patient had tiredness and fatigue, which was noticed on the next day on 31Aug2024. The patient developed the cough a couple days after receiving the vaccine, cough was worse.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore throat; Cough; Tiredness/fatigue; Chills; Injections site hurt; Body aches; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 as dose 1, 0.3 ml single (Lot number: LM2222, Expiration Date: 24Mar2025) at the age of 61 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 1994 (ongoing), notes: Diagnosed about 30 years ago. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 30Aug2024, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset 30Aug2024, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 30Aug2024, outcome "recovered" (04Sep2024), described as "Injections site hurt"; FATIGUE (non-serious) with onset 31Aug2024, outcome "not recovered", described as "Tiredness/fatigue"; COUGH (non-serious) with onset Sep2024, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset Sep2024, outcome "not recovered", described as "Sore throat". Therapeutic measures were taken as a result of pain, oropharyngeal pain, cough, vaccination site pain, fatigue, chills.  Additional information: The patient wife stated that the patient received vaccine on 30Aug2024. About an hour after patient went to the home the injection site was normal to hurt, but after that patient had chills and body aches, and a sore throat. The patient was sick and in bed. The patient had been sick since receiving the vaccine. The patient had all the shots and boosters. The injection site pain went away like 5 days later. The patient started experiencing chills about 2 hours after receiving the injection. The patient was experiencing chills on and off and are about the same. The patient started experiencing body aches on the night of 30Aug2024. The sore throat came a couple of days later. The patient still had a horrible cough. The doctor told to take Tylenol for patient symptoms and rest and drink lots of fluids. The patient had tiredness and fatigue, which was noticed on the next day on 31Aug2024. The patient developed the cough a couple days after receiving the vaccine, cough was worse.