chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: Burning and stinging lasting 5 days now. This began 3 days after the injection
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the expiration/beyond-use-date
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Dose error
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Atrial fibrillation, Pain, Pyrexia
Clinical narrative: FEVER, ACHES, AFIB AS MONITORED ON SMART WATCH.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Amniotic fluid volume decreased, Bradycardia foetal, Cytomegalovirus test, Cytomegalovirus test negative, Exposure during pregnancy
Clinical narrative: G1P0 (EDC 3/10/25). Uncomplicated pregnancy with normal detailed anatomic survey with appropriate fetal growth noted 10/24 at 20wks gestation. On 11/4, she underwent uncomplicated flulaval vaccination. On 11/10, pt reported performing ultrasound on herself (she is a sonographer) after feeling decreased fetal movement and noted low fluid and fetal bradycardia. A visit to Labor and Delivery triage noted appropriate fetal monitoring without decelerations. On 11/15, formal ultrasound confirmed 1st centile fetal growth restriction, oligohydramnios, echogenic bowel, thickened abnormal placenta, and left cerebellar echogenic findings concerning for hemorrhage. Collectively, findings indicate significant placental dysfunction with concern for hypoxic/ischemic cerebral injury. This was confirmed on repeat evaluation 11/21 by fetal MRI at outside institution and repeat US with maternal fetal medicine.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Foetal growth restriction, Foetal hypokinesia, Kleihauer-Betke test negative, Magnetic resonance imaging abdominal abnormal, Oligohydramnios
Clinical narrative: G1P0 (EDC 3/10/25). Uncomplicated pregnancy with normal detailed anatomic survey with appropriate fetal growth noted 10/24 at 20wks gestation. On 11/4, she underwent uncomplicated flulaval vaccination. On 11/10, pt reported performing ultrasound on herself (she is a sonographer) after feeling decreased fetal movement and noted low fluid and fetal bradycardia. A visit to Labor and Delivery triage noted appropriate fetal monitoring without decelerations. On 11/15, formal ultrasound confirmed 1st centile fetal growth restriction, oligohydramnios, echogenic bowel, thickened abnormal placenta, and left cerebellar echogenic findings concerning for hemorrhage. Collectively, findings indicate significant placental dysfunction with concern for hypoxic/ischemic cerebral injury. This was confirmed on repeat evaluation 11/21 by fetal MRI at outside institution and repeat US with maternal fetal medicine.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Parvovirus B19 test negative, Placental disorder, Placental hypertrophy, Prenatal screening test, Toxoplasma serology negative
Clinical narrative: G1P0 (EDC 3/10/25). Uncomplicated pregnancy with normal detailed anatomic survey with appropriate fetal growth noted 10/24 at 20wks gestation. On 11/4, she underwent uncomplicated flulaval vaccination. On 11/10, pt reported performing ultrasound on herself (she is a sonographer) after feeling decreased fetal movement and noted low fluid and fetal bradycardia. A visit to Labor and Delivery triage noted appropriate fetal monitoring without decelerations. On 11/15, formal ultrasound confirmed 1st centile fetal growth restriction, oligohydramnios, echogenic bowel, thickened abnormal placenta, and left cerebellar echogenic findings concerning for hemorrhage. Collectively, findings indicate significant placental dysfunction with concern for hypoxic/ischemic cerebral injury. This was confirmed on repeat evaluation 11/21 by fetal MRI at outside institution and repeat US with maternal fetal medicine.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: G1P0 (EDC 3/10/25). Uncomplicated pregnancy with normal detailed anatomic survey with appropriate fetal growth noted 10/24 at 20wks gestation. On 11/4, she underwent uncomplicated flulaval vaccination. On 11/10, pt reported performing ultrasound on herself (she is a sonographer) after feeling decreased fetal movement and noted low fluid and fetal bradycardia. A visit to Labor and Delivery triage noted appropriate fetal monitoring without decelerations. On 11/15, formal ultrasound confirmed 1st centile fetal growth restriction, oligohydramnios, echogenic bowel, thickened abnormal placenta, and left cerebellar echogenic findings concerning for hemorrhage. Collectively, findings indicate significant placental dysfunction with concern for hypoxic/ischemic cerebral injury. This was confirmed on repeat evaluation 11/21 by fetal MRI at outside institution and repeat US with maternal fetal medicine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Limb mass
Clinical narrative: Patient had a bump on arm and bruising after. Patient still has bruising 11/22/2024.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Feeling hot, Headache, Lethargy
Clinical narrative: BEGINNING EVENING OF 11/21/24, PT REPORTS EXPERIENCING HEADACHE AND LETHARGY. TREATED AS DEHYDRATION, LATER DEVELOPED WATERY NASAL DISCHARGE, SORE THROAT WITH SWOLLEN LYMPH NODES. ALTERNATING CHILLS AND OVERHEATED.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: BEGINNING EVENING OF 11/21/24, PT REPORTS EXPERIENCING HEADACHE AND LETHARGY. TREATED AS DEHYDRATION, LATER DEVELOPED WATERY NASAL DISCHARGE, SORE THROAT WITH SWOLLEN LYMPH NODES. ALTERNATING CHILLS AND OVERHEATED.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Patient  experienced a vaso vagal response within 10 minutes of administration of comirnaty covid-19 vaccine
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Erythema, Feeling hot, Skin irritation
Clinical narrative: patient came back after leaving the clinic with redness/skin irritation  on left collarbone and just below the left shoulder blade.  Later she said she felt like her stomach hurt and that she was hot.  Recommended patient stay in clinic area for awhile longer for observation, offered her a drink.  School nurse, recommended she take some Benadryl tonight.  Told them if they were feeling concerned to seek care at the Urgent Care.  Mom felt comfortable going home and doing Benadryl.  I discussed that we would be completing a VAERS.  Also said they might want to follow up with provider.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: feeling dizzy and black out. but still conscious
Age: 59.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reports that she experienced numbness, tingling and burning all the way down arm into fingertips. This started within about an hour of vaccination (11/18/24) and and persisted through the next day. Patient called at 5pm 11/19/24 to report this, and by this point she said her arm was feeling normal
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia
Clinical narrative: Patient experienced the numbness on the arm side from the Imovax shot, the first initial dose.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Migraine, Pyrexia
Clinical narrative: Migraines for 3 days after every COVID 19 vaccination. Migraines alleviated by Sumatriptan succinate 100 mg. Migraines only somewhat alleviated for about an hour, then came back in full force. Same thing happened with COVID itself. Lasted about a week with additional cough and fever.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood test, Magnetic resonance imaging head normal, Transient global amnesia
Clinical narrative: 11/18/24 have no memory of driving to work, urgent care,  ambulance ride to ER, and multiple hours in ER. After 6 hours of being awake, my brain became alert and aware of my surroundings. ER Md diagnosed Transient Global Amnesia after a clear and healthy MRI was done. ALL bloodwork done was within normal limits..no stroke and no tumors diagnosed.  COMIRNATY vaccine was given 17 days before the TGA dignosis.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Exposure during pregnancy, Foetal growth restriction, Muscle spasms, Thrombosis, Ultrasound scan vagina
Clinical narrative: I was 7 weeks 2 days pregnant on 11/12/24 based on my LMP of 9/22/24 (estimated due date was 7/4/25) and had my first prenatal appointment and an ultrasound on 11/12/24 where the embryo?s heartbeat was 120 bpm. They measured me at 6 weeks 4 days gestation instead of 7 weeks 2 days but said the difference of 5 days wasn?t a big deal as I could have ovulated later than I thought. I asked my provider during that appointment if I could have the Covid 19 vaccine and flu shot while being pregnant. She said yes so after my prenatal appointment I went to pharmacy and got both. Four days later, on  Saturday, 11/16/24, after having no pregnancy complications up until that point, I started spotting. The spotting progressed to heavy bleeding with cramps and passage of clots. On Monday, 11/18/24 I went in for an emergency ultrasound and they confirmed there was no longer a heartbeat and that the embryo stopped growing on 11/14/24, two days after I received the Covid and flu shots. I elected to pursue a D&C with genetic testing as this was a total shock, we had seen a strong heartbeat less than a week prior. They scheduled me for the procedure on Wednesday, 11/20/24 but I ended up passing the pregnancy tissue naturally at home on Tuesday night, 11/19/24. The following morning, 11/20/24 I went to the OBGYN again and got a 3rd ultrasound that confirmed I had passed all products of conception and my uterus was empty. I continue to bleed/spot at the time of this writing, 11/22/24.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: I was 7 weeks 2 days pregnant on 11/12/24 based on my LMP of 9/22/24 (estimated due date was 7/4/25) and had my first prenatal appointment and an ultrasound on 11/12/24 where the embryo?s heartbeat was 120 bpm. They measured me at 6 weeks 4 days gestation instead of 7 weeks 2 days but said the difference of 5 days wasn?t a big deal as I could have ovulated later than I thought. I asked my provider during that appointment if I could have the Covid 19 vaccine and flu shot while being pregnant. She said yes so after my prenatal appointment I went to pharmacy and got both. Four days later, on  Saturday, 11/16/24, after having no pregnancy complications up until that point, I started spotting. The spotting progressed to heavy bleeding with cramps and passage of clots. On Monday, 11/18/24 I went in for an emergency ultrasound and they confirmed there was no longer a heartbeat and that the embryo stopped growing on 11/14/24, two days after I received the Covid and flu shots. I elected to pursue a D&C with genetic testing as this was a total shock, we had seen a strong heartbeat less than a week prior. They scheduled me for the procedure on Wednesday, 11/20/24 but I ended up passing the pregnancy tissue naturally at home on Tuesday night, 11/19/24. The following morning, 11/20/24 I went to the OBGYN again and got a 3rd ultrasound that confirmed I had passed all products of conception and my uterus was empty. I continue to bleed/spot at the time of this writing, 11/22/24.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event, administered after 10 week refrigeration expiry by 5 days.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event, dose was administered 5 days post thaw expiry and will need to be repeated.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event, vaccine was administered 5 days post that refrigeration expiry. Will require additional dose.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event, patient was given dose that was 5 days post refrigerator storage expiry. Patient will need revaccination.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient came into the pharmacy for a flu vaccine. Prior to administering the vaccine he told me that he didn't like shots. Patient was then given the flu vaccine. I asked him how he was doing as I applied a Bandaid to the injection site. He said that he was doing fine. He then stood up and tried to walk and fainted. I caught him before he hit the floor. He came to about 5 seconds later and asked where he was. I asked him if I could lift him into a chair and he said yes. He then fainted two more times in the chair about 30 seconds apart while we were giving first aid. He said that he hadn't really had much to eat or drink today only a protein bar. We gave him some water and skittles and he remained in the pharmacy lobby for about another 30 minutes. His color came back and two of his friends showed up to drive him home. He was offered EMS, but said that he was fine.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash, Pyrexia, Rash pruritic
Clinical narrative: PATIENT HAS ITCHY SKIN RASH LOCATED NEXT TO INJECTION SITE AND FEVER
Age: 55.0
Sex: M
Vaccine: COVID19, FLU3, HEP, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient notified by provider. Can come back 11/22/2024 for second dose. Pt unable to come was told to come back after 1 month to get actual dose pt agreed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling  / redness to vaccine site.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states she had severe right arm pain and when she lifts her (R) arm she can not lift all the way up.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: Her body is achy; Is having really mild symptonms; he inadvertently administered VARIVAX to a 58-year female patient instead of a shingles vaccine.  No symptoms reported.  HCP has not yet administered the shingles vaccine to the patient; This spontaneous report as received from a nurse practitioner refers to a 58 year old female patient. On 14-NOV-2024, the patient was mistakenly vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as 4006582 exp date 26-MAR-2026) instead of Zoster Vaccine Live (manufacturer unknown). The patient was also vaccinated with a dose of covid-19 vaccine (dose, route and lot # not reported) and a dose of influenza vaccine (dose, route and lot # not reported).      On 15-NOV-2024, the patient reported she felt okay, but was having really mild symptoms and her body was achy. At the time of the report, the patient had not recovered.  The causality between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Lot number 4006582 is an invalid lot number for varicella virus vaccine live (oka/merck).
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Her body is achy; Is having really mild symptonms; he inadvertently administered VARIVAX to a 58-year female patient instead of a shingles vaccine.  No symptoms reported.  HCP has not yet administered the shingles vaccine to the patient; This spontaneous report as received from a nurse practitioner refers to a 58 year old female patient. On 14-NOV-2024, the patient was mistakenly vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as 4006582 exp date 26-MAR-2026) instead of Zoster Vaccine Live (manufacturer unknown). The patient was also vaccinated with a dose of covid-19 vaccine (dose, route and lot # not reported) and a dose of influenza vaccine (dose, route and lot # not reported).      On 15-NOV-2024, the patient reported she felt okay, but was having really mild symptoms and her body was achy. At the time of the report, the patient had not recovered.  The causality between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Lot number 4006582 is an invalid lot number for varicella virus vaccine live (oka/merck).
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, VARCEL, COVID19, FLU3, VARCEL, COVID19, FLUX, VARCEL
Symptoms: Ill-defined disorder, Pain, Wrong product administered
Clinical narrative: Her body is achy; Is having really mild symptonms; he inadvertently administered VARIVAX to a 58-year female patient instead of a shingles vaccine.  No symptoms reported.  HCP has not yet administered the shingles vaccine to the patient; This spontaneous report as received from a nurse practitioner refers to a 58 year old female patient. On 14-NOV-2024, the patient was mistakenly vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as 4006582 exp date 26-MAR-2026) instead of Zoster Vaccine Live (manufacturer unknown). The patient was also vaccinated with a dose of covid-19 vaccine (dose, route and lot # not reported) and a dose of influenza vaccine (dose, route and lot # not reported).      On 15-NOV-2024, the patient reported she felt okay, but was having really mild symptoms and her body was achy. At the time of the report, the patient had not recovered.  The causality between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.  Lot number 4006582 is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body height, Bone pain, Hypoaesthesia, Lethargy
Clinical narrative: make her arm feel better/ arm swelling after vaccination; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "make her arm feel better/ arm swelling after vaccination".  Additional information: The patient wanted to know what she needs to do following after COMIRNATY administration to make her arm feel better. The patient experienced arm swelling after vaccination of COMIRNATY 12 plus.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: make her arm feel better/ arm swelling after vaccination; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "make her arm feel better/ arm swelling after vaccination".  Additional information: The patient wanted to know what she needs to do following after COMIRNATY administration to make her arm feel better. The patient experienced arm swelling after vaccination of COMIRNATY 12 plus.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: make her arm feel better/ arm swelling after vaccination; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "make her arm feel better/ arm swelling after vaccination".  Additional information: The patient wanted to know what she needs to do following after COMIRNATY administration to make her arm feel better. The patient experienced arm swelling after vaccination of COMIRNATY 12 plus.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 40.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; PROQUAD was administered to a 40 year old patient instead of MMR II.; This spontaneous report was received from Other Health Professional (medical assistant) and refers to a 40-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-OCT-2024, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, route, anatomical location, lot#, and expiration date were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, and dose were not provided) (Wrong product administered). No additional adverse event (AE) reported (No adverse event).  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: got heart conditions; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "got heart conditions".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400303130 Same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia, Pain in extremity
Clinical narrative: Left arm pain and minor left pectoral muscle pain with minor twinge of left axillary pain; Left arm pain and minor left pectoral muscle pain with minor twinge of left axillary pain; Left arm pain and minor left pectoral muscle pain with minor twinge of left axillary pain; This is a spontaneous report received from an Other HCP from a sales representative.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Nov2024 at 15:30 as dose 1,single (Lot number: LP1780), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious), AXILLARY PAIN (non-serious) all with onset 17Nov2024 at 04:00, outcome "recovering" and all described as "Left arm pain and minor left pectoral muscle pain with minor twinge of left axillary pain". Therapeutic measures were not taken as a result of pain in extremity, myalgia, axillary pain.  Additional Information: Patient did not receive any other vaccines on the same date as the vaccine. Patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was taking other medications within 2 weeks of the event starting. Left arm pain and minor left pectoral muscle pain with minor twinge of left axillary pain  No follow-up attempts are possible.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: lost about 35 pounds; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost about 35 pounds". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Blood test, Chills, Fatigue
Clinical narrative: I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2022 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: POST-ACUTE COVID-19 SYNDROME (disability, medically significant) with onset 23Dec2022, outcome "recovering", DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant), outcome "unknown" and all described as "I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine". The event "i have had long covid symptoms since 23dec2022 - shortly after i received the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Never tested positive. Therapeutic measures were taken as a result of post-acute covid-19 syndrome. Clinical course: Patient did not receive other vaccine same date. Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks (spironolactone). After Emergency room visit in Jul2023 patient started medications. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400305819 same reporter/patient/drug, different events;
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Heart rate, Heart rate increased, Hyperhidrosis, Inappropriate sinus tachycardia
Clinical narrative: I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2022 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: POST-ACUTE COVID-19 SYNDROME (disability, medically significant) with onset 23Dec2022, outcome "recovering", DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant), outcome "unknown" and all described as "I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine". The event "i have had long covid symptoms since 23dec2022 - shortly after i received the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Never tested positive. Therapeutic measures were taken as a result of post-acute covid-19 syndrome. Clinical course: Patient did not receive other vaccine same date. Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks (spironolactone). After Emergency room visit in Jul2023 patient started medications. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400305819 same reporter/patient/drug, different events;
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Pyrexia
Clinical narrative: I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2022 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: POST-ACUTE COVID-19 SYNDROME (disability, medically significant) with onset 23Dec2022, outcome "recovering", DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant), outcome "unknown" and all described as "I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine". The event "i have had long covid symptoms since 23dec2022 - shortly after i received the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Never tested positive. Therapeutic measures were taken as a result of post-acute covid-19 syndrome. Clinical course: Patient did not receive other vaccine same date. Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks (spironolactone). After Emergency room visit in Jul2023 patient started medications. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400305819 same reporter/patient/drug, different events;
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2022 at 13:30 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: POST-ACUTE COVID-19 SYNDROME (disability, medically significant) with onset 23Dec2022, outcome "recovering", DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant), outcome "unknown" and all described as "I have had long covid symptoms since 23Dec2022 - shortly after I received the vaccine". The event "i have had long covid symptoms since 23dec2022 - shortly after i received the vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Never tested positive. Therapeutic measures were taken as a result of post-acute covid-19 syndrome. Clinical course: Patient did not receive other vaccine same date. Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks (spironolactone). After Emergency room visit in Jul2023 patient started medications. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400305819 same reporter/patient/drug, different events;
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Neck pain
Clinical narrative: Very tired for 10 days and a sore neck.; Very tired for 10 days and a sore neck.; This is a spontaneous report received from a Consumer or other non HCP.  A 90-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Nov2024 as dose 1, single (Lot number: LM2216) at the age of 90 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "white pepper allergy" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN; TAMSULOSIN HCL; FINASTERIDE; ATORVASTATIN; METOPROLOL. The following information was reported: NECK PAIN (non-serious) with onset 09Nov2024 at 13:15, outcome "not recovered", FATIGUE (non-serious) with onset 09Nov2024 at 13:15, outcome "recovered" and all described as "Very tired for 10 days and a sore neck.". Therapeutic measures were not taken as a result of neck pain, fatigue. Additional information: The patient did  not receive any other vaccines on the same date as the suspect vaccine nor any other vaccines within 4 weeks prior to the vaccine.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Malaise, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Extremely tired; Very red and swollen arm; swollen arm; Stiff and "score" neck; general feeling of malaise; This is a spontaneous report received from a Consumer or other non HCP.  An 89-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Nov2024 at 01:00 as dose 1, 30 ug single (Lot number: LM2216) at the age of 89 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart attack", start date: 1999 (not ongoing); "stent", start date: 1999 (unspecified if ongoing); "Sulfur allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 09Nov2024 at 13:15, outcome "not recovered", described as "Extremely tired"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 09Nov2024 at 13:15, outcome "not recovered", described as "Stiff and "score" neck"; ERYTHEMA (non-serious) with onset 09Nov2024 at 13:15, outcome "not recovered", described as "Very red and swollen arm"; MALAISE (non-serious) with onset 09Nov2024 at 13:15, outcome "not recovered", described as "general feeling of malaise"; PERIPHERAL SWELLING (non-serious) with onset 09Nov2024 at 13:15, outcome "not recovered", described as "swollen arm". Therapeutic measures were not taken as a result of fatigue, peripheral swelling, musculoskeletal stiffness, malaise.  Additional Information: It was reported that the patient was extremely tired for now 10 days. The patient did not receive any other vaccines on the same date or within 4 weeks prior as the suspect vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Mobility decreased
Clinical narrative: Just like getting flu. Chills, tired, can barely get out of bed, not very hungry. I think it was for only one long day.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Headache, fatigue, stomach upset
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: About 4 hours after I rec'd, I felt itchiness under the injection site.  When I looked at it there was one large red, raised welt a couple of inches below the injection site.   I took Tylenol and loratidine.  By morning it was visible but toned down with soreness instead of itch.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Nodule
Clinical narrative: Starting ~ 6 hrs post injection: fever (101 -102 degrees),  headache, extreme fatigue; significant bone pain (esp forearm and below knee), joint pain, arthrus reaction (hard, painful nodule); urinary incontinence.
Age: 60.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Type III immune complex mediated reaction, Urinary incontinence
Clinical narrative: Starting ~ 6 hrs post injection: fever (101 -102 degrees),  headache, extreme fatigue; significant bone pain (esp forearm and below knee), joint pain, arthrus reaction (hard, painful nodule); urinary incontinence.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: She has had constant lung infections since the shot . She can't breathe . She has to get hospitalized and constant medications . It's not ok
Age: 53.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Herpes zoster, Rash, Rash pruritic, Urticaria
Clinical narrative: Four days after receiving three vaccines, I felt itchy on my waist and left arm.  There was no rash. The next day I had small bumbs on my waist, and my dermatologist saw it and prescribed  steroid cream.  Derm thought it was just a rash from a change in the weather. I applied the steroid cream to my waist but not my arm. The rash got a lot worse -very itchy, painful, and red  welts on my waist. No blisters. Saw a telesod who said it was shingles. Started Valtrex for seven days.  Currently it?s been 11 days since the itching starting and 1 day after finishing valtrex. No blisters but still have the rash and intense itching on waist, right arm, and a little on the left arm.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Syncope
Clinical narrative: Four hours after getting her 5th  Pfizer COVID vaccine in 5 years, our daughter collapses and nearly died after getting her shot at our local pharmacy. She had to spend 6 hours at the ER at Hospital before recovering enough to come home.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Seizure
Clinical narrative: Four hours after getting her 5th  Pfizer COVID vaccine in 5 years, our daughter collapses and nearly died after getting her shot at our local pharmacy. She had to spend 6 hours at the ER at Hospital before recovering enough to come home.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Vitreous floaters
Clinical narrative: Eye floaters in left eye as of 11/16 around 2:00 PM. Light headed since 11/19 AM
Age: 65.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: COVID-19, Cough, Influenza A virus test negative, Influenza B virus test positive, Influenza like illness
Clinical narrative: Flu like symptoms. Cough, nasal drip, fever
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: Flu like symptoms. Cough, nasal drip, fever
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Rash, Sinus congestion
Clinical narrative: Rash, itch, sore arm, ringing ears, stuffed head, tiredness, rash spread slightly from day 2 to 3.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Rash, itch, sore arm, ringing ears, stuffed head, tiredness, rash spread slightly from day 2 to 3.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3, HEP, TDAP
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: administered 4 vaccines to patient, she was alert and fine during administration. Shortly after the last vaccine was given she stopped responding and slouched over, it is unclear if it was a seizure or fainting. I got her to the ground and instructed my tech to call EMS. She became alert within a few seconds. We gave her ice packs and something to drink. She asked me to call her mom who instructed me to cancel the ambulance and that she would pick her up. I verified with the patient if she wanted me to cancel the ambulance and she confirmed.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: Extreme pain during menstruation
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a Fluad vaccine on 8/1/2024 and came in again on 11/20 for another fluad vaccine. Once the duplication was identified, we called the patient and he did not remember getting  the vaccine in August  but has experienced no adverse effects at all.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever and chills, muscle and joint aches and severe headache.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Pain in extremity
Clinical narrative: Pain and joint swelling the left hand.  (Same arm as vaccination.)  First noticed immediately upon waking the morning following the vaccination the evening before.  Pain/swelling severe enough to prevent use of hand.  Pain focused in the metacarpophalangeal joint of the middle finger.  The joint pain/swelling continued on the second day following vaccination, a perhaps a more severe level than the first day.  Ibuprofen treatment was initiated on this second morning.  (Time of writing is middle of this second day.)
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, Mammogram, Muscle tightness, Muscular weakness
Clinical narrative: I received the Covid and flu vaccines in my right arm so my arm was a little sore and tender the day of the shot but I kept moving it to help reduce the soreness. By the next day, my arm and armpit were swollen which I had expected based on my previous Covid vaccines but at some point in the night or morning my right wrist, hand and ring  and  pinky fingers were tight, weak, and hand a stinging/ burning pain. The pain woke me up and made it difficult to sleep. Based on internet, it seemed like I had sudden onset inflammatory arthritis. I used ice a few times and tried stretching and massaging the painful areas but the pain and weakness persisted. I could barely use my hand and had trouble sleeping again. The next day, I had the same  pain and weakness and it spread to my middle finger. One of my right toes also started feeling mildly tight. I had pre scheduled lab work that morning and had them draw blood from my left arm to ensure it wouldn?t make my right arm worse. When I signed on to work, my right hand, wrist, and fingers hurt so bad I had to use my left hand to type and move my laptop mouse for work. I started using a wrist brace and called my chiropractor.  He saw me around  10 am and although it still hurt, the pain started to subside. I continued wearing the brace off and on that afternoon and continued to feel improvement. By the next day (11/13), the swelling in my arm had gone down and my hand, wrist, fingers and toe were back to normal.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Oedema peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: I received the Covid and flu vaccines in my right arm so my arm was a little sore and tender the day of the shot but I kept moving it to help reduce the soreness. By the next day, my arm and armpit were swollen which I had expected based on my previous Covid vaccines but at some point in the night or morning my right wrist, hand and ring  and  pinky fingers were tight, weak, and hand a stinging/ burning pain. The pain woke me up and made it difficult to sleep. Based on internet, it seemed like I had sudden onset inflammatory arthritis. I used ice a few times and tried stretching and massaging the painful areas but the pain and weakness persisted. I could barely use my hand and had trouble sleeping again. The next day, I had the same  pain and weakness and it spread to my middle finger. One of my right toes also started feeling mildly tight. I had pre scheduled lab work that morning and had them draw blood from my left arm to ensure it wouldn?t make my right arm worse. When I signed on to work, my right hand, wrist, and fingers hurt so bad I had to use my left hand to type and move my laptop mouse for work. I started using a wrist brace and called my chiropractor.  He saw me around  10 am and although it still hurt, the pain started to subside. I continued wearing the brace off and on that afternoon and continued to feel improvement. By the next day (11/13), the swelling in my arm had gone down and my hand, wrist, fingers and toe were back to normal.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Tenderness
Clinical narrative: I received the Covid and flu vaccines in my right arm so my arm was a little sore and tender the day of the shot but I kept moving it to help reduce the soreness. By the next day, my arm and armpit were swollen which I had expected based on my previous Covid vaccines but at some point in the night or morning my right wrist, hand and ring  and  pinky fingers were tight, weak, and hand a stinging/ burning pain. The pain woke me up and made it difficult to sleep. Based on internet, it seemed like I had sudden onset inflammatory arthritis. I used ice a few times and tried stretching and massaging the painful areas but the pain and weakness persisted. I could barely use my hand and had trouble sleeping again. The next day, I had the same  pain and weakness and it spread to my middle finger. One of my right toes also started feeling mildly tight. I had pre scheduled lab work that morning and had them draw blood from my left arm to ensure it wouldn?t make my right arm worse. When I signed on to work, my right hand, wrist, and fingers hurt so bad I had to use my left hand to type and move my laptop mouse for work. I started using a wrist brace and called my chiropractor.  He saw me around  10 am and although it still hurt, the pain started to subside. I continued wearing the brace off and on that afternoon and continued to feel improvement. By the next day (11/13), the swelling in my arm had gone down and my hand, wrist, fingers and toe were back to normal.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Rash began to develop on day 7 after vaccines.  Initially thought possible reaction to amoxicillin;  stopped amoxicillin and went to pediatrician; she determined the rash appeared more like a ?measles-like? rash from the MMR vaccine and not an amoxicillin reaction. Rash has continued to worsen, currently on day 6 of rash (day 12 post vaccines).  Rash is red, raised, papular on all parts of body.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gingivitis, Mouth haemorrhage, Pain in extremity
Clinical narrative: Painful, swollen left arm, fatigue, tired  on 11/19/24.  Diarrhea on 11/20/24, mouth bleeding morning of 11/21/24 and 11/23/24.  Bleeding didn?t stop after 4hrs on 11/23/24. Went to urgent care. Diagnosed with gingivitis.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Painful, swollen left arm, fatigue, tired  on 11/19/24.  Diarrhea on 11/20/24, mouth bleeding morning of 11/21/24 and 11/23/24.  Bleeding didn?t stop after 4hrs on 11/23/24. Went to urgent care. Diagnosed with gingivitis.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted and passed out few minutes after receiving the 2 shots while waiting in the IMZ waiting area in what looks like syncope resulting from phobias to needle. She was quickly help by the pharmacy team, her BP was reading 96/68, she was giving some water and  and made to laid down with elevated legs, and the rescues team took over upon arrival. Patient was subsequently fine and left by herself.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fall, Nausea
Clinical narrative: nausea, diarhea, dizziness, causing 3 falls
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given both flu and covid vaccine 6 weeks ago. Patient currently feeling fine and no issues. Realized multiple hours after administration