chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site joint movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization; Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization; Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Nov2023. No other vaccine on same date or in four weeks. The following information was reported: DIZZINESS (hospitalization), SYNCOPE (hospitalization), HEAD INJURY (hospitalization) all with onset 31Aug2024 at 11:00, outcome "recovering" and all described as "Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization". The patient was hospitalized for dizziness, syncope, head injury (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of dizziness, syncope, head injury with Iv fluid.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization; Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization; Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization; This is a spontaneous report received from a Consumer or other non HCP.  A 26-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 26 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Nov2023. No other vaccine on same date or in four weeks. The following information was reported: DIZZINESS (hospitalization), SYNCOPE (hospitalization), HEAD INJURY (hospitalization) all with onset 31Aug2024 at 11:00, outcome "recovering" and all described as "Extreme dizziness that lead to fainting and hitting head on floor, required hospitalization". The patient was hospitalized for dizziness, syncope, head injury (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of dizziness, syncope, head injury with Iv fluid.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Headache; Fatigue; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; pains; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Aug2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bipolar" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism resulting in post procedural RAI thyroid ablation to treat Graves' Disease; "Osteoporosis" (unspecified if ongoing); "Graves' Disease" (unspecified if ongoing), notes: Hypothyroidism resulting in post procedural RAI thyroid ablation to treat Graves' Disease; "Allergies:Latex" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Aug2014; SERTRALINE HCL, start date: 01Jun2006; LITHIUM CARBONATE, start date: 01May2017; PROPRANOLOL, start date: 01Aug2017; TRAZODONE, start date: 01Nov2017. The following information was reported: FATIGUE (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered"; HEADACHE (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 29Aug2024 at 14:00, outcome "not recovered" and all described as "Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site"; PAIN (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered", described as "pains". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, vaccination site erythema, vaccination site warmth, headache, fatigue, vaccination site pain, pain.  Additional information: The patient received vaccination in Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the vaccines   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; Headache; Fatigue; Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site; pains; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Aug2024 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Aug2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bipolar" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism resulting in post procedural RAI thyroid ablation to treat Graves' Disease; "Osteoporosis" (unspecified if ongoing); "Graves' Disease" (unspecified if ongoing), notes: Hypothyroidism resulting in post procedural RAI thyroid ablation to treat Graves' Disease; "Allergies:Latex" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Aug2014; SERTRALINE HCL, start date: 01Jun2006; LITHIUM CARBONATE, start date: 01May2017; PROPRANOLOL, start date: 01Aug2017; TRAZODONE, start date: 01Nov2017. The following information was reported: FATIGUE (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered"; HEADACHE (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 29Aug2024 at 14:00, outcome "not recovered" and all described as "Swelling, pain, red puffy patch, hot to the touch at COMIRNITY injection site"; PAIN (non-serious) with onset 29Aug2024 at 14:00, outcome "not recovered", described as "pains". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, vaccination site erythema, vaccination site warmth, headache, fatigue, vaccination site pain, pain.  Additional information: The patient received vaccination in Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the vaccines   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Lethargy, Pruritus, Swelling face
Clinical narrative: swollen face; lethargic; Headache; itching; tired; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 30Aug2024 as dose number unknown, single). The patient's relevant medical history included: "Allergy: latex" (unspecified if ongoing); "Allergy: antibiotic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 31Aug2024 at 03:00, outcome "not recovered"; PRURITUS (non-serious) with onset 31Aug2024 at 03:00, outcome "not recovered", described as "itching"; LETHARGY (non-serious) with onset 31Aug2024 at 03:00, outcome "not recovered", described as "lethargic"; SWELLING FACE (non-serious) with onset 31Aug2024 at 03:00, outcome "not recovered", described as "swollen face"; FATIGUE (non-serious) with onset 31Aug2024 at 03:00, outcome "not recovered", described as "tired". Therapeutic measures were not taken as a result of swelling face, lethargy, headache, pruritus, fatigue. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: slight nausea; definite dizziness; not feeling well; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Aug2024 at 05:00 as dose 1, single (Lot number: LM2216) at the age of 52 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 28Aug2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergy". The following information was reported: DIZZINESS (non-serious) with onset 30Aug2024 at 17:00, outcome "not recovered", described as "definite dizziness"; MALAISE (non-serious) with onset 30Aug2024 at 17:00, outcome "not recovered", described as "not feeling well"; NAUSEA (non-serious) with onset 30Aug2024 at 17:00, outcome "not recovered", described as "slight nausea". Therapeutic measures were not taken as a result of nausea, dizziness, malaise.  Additional information: It was reported that 48 hours after shot experienced slight nausea and definite dizziness, enough to need to sit down. It's been 24 hours so far of not feeling well. She had never had a reaction to a flu shot before, this was a side effect of the Covid shot. No hospitalization Prolonged required. The patient did not received any other vaccines within 4 weeks prior to the vaccine(s) for which they are reporting. The patient was not taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Dizziness, Head discomfort, Headache, Illness
Clinical narrative: feeling sick/sick; Heaviness/headache and just like heavy; Headache; Dizzy/feel dizzy; 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 28Aug2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID). The patient's relevant medical history included: "operation", start date: 2024 (unspecified if ongoing), notes: two months ago. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 2024, outcome "not recovered", described as "Dizzy/feel dizzy"; HEADACHE (non-serious) with onset 2024, outcome "not recovered"; HEAD DISCOMFORT (non-serious) with onset 2024, outcome "not recovered", described as "Heaviness/headache and just like heavy"; ILLNESS (non-serious) with onset 2024, outcome "not recovered", described as "feeling sick/sick". The action taken for levothyroxine sodium was unknown.  Additional information: The reporter considered other medications as co-suspects, the patient received unspecified medications for an unknown indication. Consumer stated, "I had a shot on Wednesday, and I got through Wednesday all okay. On Thursday, I started feeling sick, and then on Friday and Saturday, I had been very, very sick. I wondered how long it would last because I had called my family doctor, and they had said it should be over any side effects, but I still had them. I had all the medications I took, so that could have been it too, but it was like a heaviness, a headache, and just feeling heavy and dizzy. I did not know what was going on. I wondered how long they lasted with the COVID-19 shot I had taken." Consumer stated, "Comirnaty. The latest COVID-19 shot." Consumer stated, "I did not even know if that was the side effect from the shot or not." When clarified if taking the other medications, the consumer stated, "Right. I had called some doctors at work, you know, concerned about this, and they had told me what to do. So, I was trying to figure out if the side effects were from the COVID shot or not, combined with these other medications. I asked if there was a problem with Synthroid and this drug or not." Consumer stated, "No. I just wanted to talk to this department that knew. I just wanted to talk to some medical people who understood the situation. I felt heavy and dizzy, and I had an operation that was two months ago; it was all interconnected. So, I just wanted to know what your end of it was as far as side effects were concerned."  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dysacusis
Clinical narrative: hearing echo; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 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: DYSACUSIS (non-serious) with onset 2024, outcome "unknown", described as "hearing echo".  Additional information: The patient stated that he got the Comirnaty vaccine on 30Aug2024. He had developed a hearing echo when other ppl talk and when he spoke. He did not had any issues prior to receive the vaccine. He was called to saw who would pay for his follow up medical visit and care due to this side effect.  Batch/lot number is not provided, and it cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: her chest was hurting her as well; vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her; vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her; vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her; vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her; vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 29-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "GI problems" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "her chest was hurting her as well"; VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Sep2024, outcome "unknown" and all described as "vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her".  Additional information: Caller, 29-year-old female, stated that she received the 2024/2025 Comirnaty vaccine yesterday afternoon at the pharmacy. Caller stated the vaccine was administered in her right arm in which she now has a bump, it was swollen, big, red, itching, and was hurting her. Caller stated that she has chronic health conditions such as GI problems and asthma. Caller stated that her chest was hurting her as well. Caller stated that she contacted her PCP, however they are not able to get her in to be seen. Caller was asking if these are normal side effects and asked what she should do about them? Caller provided that she was going to go to the ER for further assessment. Caller was a consumer calling about the new Comirnaty vaccine and said that she just wanted to know, she got the new vaccine yesterday and got it in the right arm. Her right arm has a bump that was swollen, red, it was hurting her, and was itchy. She was not sure if that was a normal reaction. She got the injection on her right side and had the reaction, said that it was painful, swollen, with redness, and was itching. Can she go to the urgent care or ER? She was just curious if this was a normal reaction?  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: she started feeling a burning sensation on the top of the feet/ It is more at the top where the toes are; This is a spontaneous report received from a Nurse from medical information team.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 04Sep2024, outcome "not recovered", described as "she started feeling a burning sensation on the top of the feet/ It is more at the top where the toes are". Therapeutic measures were taken as a result of burning sensation.  Additional information: A Nurse called as a consumer called for information about if a feeling on the skin, like walking on a hot pepper patch, specifically on the top of the feet, not the bottom had been reported after the administration of the Comirnaty vaccine. The Consumer reported that she was administered with the Comirnaty vaccine the previous day, and that day she was outside on the grass and maybe something was on the socks, because she started feeling a burning sensation on the top of the feet, she removed her socks and washed her feet without feeling relief, then she applied hydrocortisone cream and her feel still feel like burning. Reporter called about the covid shot the previous day, it was about 24 hours ago. It's the one manufactured by she wanted to know if any one had reported side effect as like skin felt like as clarified and confirmed, walking in a hot pepper patch. She stated it felt like that on the top of her feet at the toes. It was more at the top where the toes were. Top of foot at the toes. At first she thought she came in contact with something. She took her socks off, washed feet with soap and water, soaked them in cold water, put Hydrocortisone cream on it, but it's still burning.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat topping at 102 beats per minute; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Sep2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL XL, start date: 02Nov2022. The following information was reported: HEART RATE INCREASED (non-serious) with onset 03Sep2024 at 13:00, outcome "not recovered", described as "Rapid heartbeat topping at 102 beats per minute". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased.  Additional information: Patient did not receive any other vaccines on the same date or within 4 weeks prior of Pfizer-BioNTech COVID Vaccine. Patient was not hospitalized due to the event. The patient had allergy (Drug name not reported) and other relevant medical history reported as none.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 52.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Chills; sweating; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old male patient 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 52 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Sep2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: Drug name: No (drug name unknown). Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2024. The following information was reported: CHILLS (non-serious) with onset 04Sep2024 at 06:00, outcome "recovered" (04Sep2024); HYPERHIDROSIS (non-serious) with onset 04Sep2024 at 06:00, outcome "recovered" (04Sep2024), described as "sweating". Therapeutic measures were not taken as a result of chills, hyperhidrosis.  Additional information: Did the patient receive any other vaccines within 4 weeks Prior to the vaccine(s) for which you are reporting?: No. Were you/Was the patient taking any other medications within 2 weeks of the event starting: Yes. Comirnaty vaccine on Left Shoulder.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Overdose, Product administered to patient of inappropriate age
Clinical narrative: She is due to go into heart surgery; Comirnaty for 12 and older inadvertently administered to 7 years, 8 months old patient; Comirnaty for 12 and older inadvertently administered to 7 years, 8 months old patient; This is a spontaneous report received from a Nurse from medical information team.  A 7-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "She is due to go into heart surgery"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "Comirnaty for 12 and older inadvertently administered to 7 years, 8 months old patient". Additional information: Nurse in doctor's office is calling and states that a patient called in about her daughter with special medical needs she was given an adult dose. She was given Comirnaty 12+ years. She is due to go into heart surgery. She received 3 times the dose than she should have received. The patient is waiting for medical information for what to look for short and long acting.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event heart disorder was related to the suspect product event most likely due to patient underlying contributory factors.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: malaise; Headache; ongoing intermittent low grade fevers; arm soreness; This is a spontaneous report received from a Physician from a sales representative.  A 54-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 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: HEADACHE (non-serious) with onset Sep2024, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Sep2024, outcome "unknown", described as "arm soreness"; MALAISE (non-serious) with onset Sep2024, outcome "unknown"; PYREXIA (non-serious) with onset Sep2024, outcome "not recovered", described as "ongoing intermittent low grade fevers".  Additional Information: Patient did not receive any other vaccines on the same date as the suspect vaccine. Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Mild-to-moderate fatigue; Mild-to-moderate arm pain; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Sep2024 at 16:30 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 07Sep2024, in right arm. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Sep2024, outcome "not recovered", described as "Mild-to-moderate arm pain"; FATIGUE (non-serious) with onset 08Sep2024, outcome "not recovered", described as "Mild-to-moderate fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information included: Mild-to-moderate arm pain (began 3-4 hours post injection). Mild-to-moderate fatigue (began about 17 hours post injection). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: A day after the booster and vaccine, my top of my feet was painful and swollen; A day after the booster and vaccine, my top of my feet was painful and swollen; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), on 05Sep2024 as dose 1, single), in right arm for immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "Allergy" (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. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 06Sep2024 at 16:00, outcome "not recovered" and all described as "A day after the booster and vaccine, my top of my feet was painful and swollen". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: floaters in left eye; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2024 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Sumycin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 06Sep2024 at 12:15, outcome "not recovered", described as "floaters in left eye". Therapeutic measures were not taken as a result of vitreous floaters.  Additional information: Patient reported that she did not receive any other vaccines on the same date as the vaccine(s) and any other vaccines within 4 weeks PRIOR to the vaccine(s) for which she was reporting. She was not taking any other medications within 2 weeks of the event starting. Patient reported that approx 1 hour after shot, she had floaters in left eye. She had never had floaters. She had every Covid vax and booster available (was in Covid trial in 2020) and never experienced eye floaters as a side effect before.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Left supraclavicular lymph node painful and swollen; Left supraclavicular lymph node painful and swollen; This is a spontaneous report received from a Nurse.  A 61-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in right deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Sep2024), in left arm. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "latex allergy" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN (E.C.), start date: 20May2021. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 06Sep2024 at 15:30, outcome "recovering" and all described as "Left supraclavicular lymph node painful and swollen". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: Facility where vaccine was administered: Pharmacy or Drug Store. The 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.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 90.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Rash macular
Clinical narrative: Bright red, splotchy rash predominately on buttocks and hips. Small amount on left shoulder near injection site.; 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 07Sep2024 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 90 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 07Sep2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious) with onset 07Sep2024 at 18:00, outcome "not recovered", described as "Bright red, splotchy rash predominately on buttocks and hips. Small amount on left shoulder near injection site.". Therapeutic measures were not taken as a result of rash macular.  Additional information: Patient has no allergy. The patient did not received any other vaccines within 4 weeks prior to the vaccine(s) for which they are reporting. The patient was not taking any other medications within 2 weeks of the event starting. Bright red, splotchy rash predominately on buttocks and hips. Small amount on left shoulder near injection site.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Rash, Rash erythematous, Skin irritation
Clinical narrative: he had a really bad rash on his body and on the trunk of his body/the rash on the tops of his thighs; on the top of his legs and back and is very irritating/it is very very irritating and it is burning not itching; he broke out in a fire engine red rash on the trunk of his body; at the base of his back there is some discomfort and burning; at the base of his back there is some discomfort and burning; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccines (All previous vaccines have been Moderna vaccines), for COVID-19 immunisation. The following information was reported: RASH (non-serious), outcome "unknown", described as "he had a really bad rash on his body and on the trunk of his body/the rash on the tops of his thighs"; SKIN IRRITATION (non-serious), outcome "unknown", described as "on the top of his legs and back and is very irritating/it is very very irritating and it is burning not itching"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "he broke out in a fire engine red rash on the trunk of his body"; DISCOMFORT (non-serious), BURNING SENSATION (non-serious), outcome "unknown" and all described as "at the base of his back there is some discomfort and burning". Therapeutic measures were taken as a result of rash, skin irritation, rash erythematous, discomfort, burning sensation. Additional information included: the patient took the Pfizer covid 19 vaccine, and after getting it, he had a really bad rash on his body and on the trunk of his body and also on the top of his legs and back and is very irritating. An hour after vaccine, he broke out in a fire engine red rash on the trunk of his body and it is still there. He said at the base of his back there is some discomfort and burning and she notices the rash on the tops of his thighs. It does not seem to be getting worse. She (patient's wife) have him a teaspoon of Benadryl last night. He has a very bad rash on his body, the trunk of his body and his buttocks and the tops of his legs. On his back, it is very very irritating and it is burning not itching, burning. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: 3 months after the administration of the vaccine he lost all of his hair; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty vaccine (Dose 1), for COVID-19 immunization; Comirnaty vaccine (Dose 2), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset Dec2023, outcome "recovered" (Feb2024), described as "3 months after the administration of the vaccine he lost all of his hair". Additional information: The consumer reported that he has been administered with 3 doses of the Comirnaty vaccine and after the last dose of the vaccine in September 2023, 3 moths after the administration of the vaccine he lost all of his hair. All his hair fell out including the hair on the top of his head. The consumer could not confirm if the hair loss was related with the administration of the vaccine 3 months before. He also reported that his hair regrew back fully in February of 2024. In any event, starting in January, February of the following year his hair on top of his head came back better than it was ever before. He meant that he used to have kind of a bald spot around but now it came back better and thicker, the rest of his body still stays the same. He was scheduled to be administered with a new dose of the Comirnaty vaccine 2024 - 2025 formulation on Thursday. During the call, the consumer also stated that the agent was talking a little too fast for him and he requested to slow down a litter because he was a little hard of hearing.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pyrexia
Clinical narrative: dizziness; low grad fever; malaise; This is a spontaneous report received from a Nurse from a sales representative.  An adult female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy to unknown drug" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, on 26Aug2024. The following information was reported: DIZZINESS (non-serious) with onset Sep2024, outcome "recovered" (Sep2024); PYREXIA (non-serious) with onset Sep2024, outcome "recovered" (Sep2024), described as "low grad fever"; MALAISE (non-serious) with onset Sep2024, outcome "recovered" (Sep2024). Therapeutic measures were not taken as a result of dizziness, pyrexia, malaise.  Additional information: Initially experienced dizziness and within another day, low grad fever and malaise. Resolved within 3 days. The patient didn't receive any other vaccines on the same date as the suspected vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe joint pain in my hands, wrists and foot; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 at 15:00 as dose 1, single (Lot number: Lm2216) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 02Sep2024, outcome "recovered" (04Sep2024), described as "severe joint pain in my hands, wrists and foot". Therapeutic measures were taken as a result of arthralgia.  Additional information: Patient reported that shortly after receiving the updated vaccine for this autumn season she experienced severe joint pain in her hands, wrists and foot. This lasted for about 24 hours. She took Aleve which helped a little but it was very uncomfortable. she do have psoriatic arthritis but was not currently experiencing symptoms. she had never experienced with any of the previous vaccines, and it came on very suddenly. the patient did not received any other vaccines on the same date as the vaccine, patient did not received any other vaccines within 4 weeks Prior to the vaccine, patient was not taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Headache; Muscle pain; Fever; Chills; Joint pain; Feeling unwell; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Sep2024 at 11:00 as dose 1, single (Lot number: 00069-2432-10) at the age of 67 years for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 08Sep2024 as dose number unknown, single (Lot number: 49281-0124-65), in left arm for immunisation. The patient's relevant medical history included: "HIGH BLOOD PRESSURE" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered"; MALAISE (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Feeling unwell"; PYREXIA (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Muscle pain". Therapeutic measures were not taken as a result of headache, myalgia, pyrexia, chills, arthralgia, malaise.  Additional information: The patient had no known allergies. The vaccine facility reported as Pharmacy or Drug Store.   No follow-up attempts are possible.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: Headache; Muscle pain; Fever; Chills; Joint pain; Feeling unwell; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Sep2024 at 11:00 as dose 1, single (Lot number: 00069-2432-10) at the age of 67 years for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 08Sep2024 as dose number unknown, single (Lot number: 49281-0124-65), in left arm for immunisation. The patient's relevant medical history included: "HIGH BLOOD PRESSURE" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered"; MALAISE (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Feeling unwell"; PYREXIA (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered"; ARTHRALGIA (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Joint pain"; MYALGIA (non-serious) with onset 08Sep2024 at 22:00, outcome "not recovered", described as "Muscle pain". Therapeutic measures were not taken as a result of headache, myalgia, pyrexia, chills, arthralgia, malaise.  Additional information: The patient had no known allergies. The vaccine facility reported as Pharmacy or Drug Store.   No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Gait disturbance
Clinical narrative: Suffered a fall day after; chills; wobbly; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 2, single), administration date: 12Mar2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "Lost of bowl control, Urinated and defecated", "Lost of bowl control, Urinated and defecated", "Chills", "Weakness", "Dizzy", "Fell to floor couldn't get off floor"; Bnt162b2 (dose 1, single), administration date: 2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "fall"; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, unknown manufacturer), administration date: 2022, for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, unknown manufacturer), administration date: 2023, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Sep2024, outcome "unknown"; GAIT DISTURBANCE (non-serious) with onset 04Sep2024, outcome "unknown", described as "wobbly"; FALL (non-serious) with onset 05Sep2024, outcome "unknown", described as "Suffered a fall day after".  Additional information: Patient took first Covid vaccination in 2021. Suffered a fall day after. Could not get off floor for 30-40 minutes. Received booster shots in 2022 and 2023. No problem. 04Sep took new vaccine. Had chills and was wobbly that day. Suffered a fall day after. On floor for 40-50 minutes unable to get up. Was wondering why initial vaccination caused this where boosters were okay.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Urinary tract infection
Clinical narrative: UTI; infection was back and spreading; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "UTI", start date: Aug2024 (unspecified if ongoing), notes: cleared up using antibiotics. The patient's concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 30Aug2024, outcome "not recovered", described as "UTI"; DISEASE RECURRENCE (non-serious) with onset 30Aug2024, outcome "not recovered", described as "infection was back and spreading". The events "uti" and "infection was back and spreading" required emergency room visit.  Additional information: Patient stated my partner received the 2024-2025 COVID vaccine last Friday. By evening he wasn't feeling well. This continued through Monday. On Tuesday he was so sick I took him to the ER. Two weeks prior he had a UTI which had cleared up using antibiotics. The ER determined that his infection was back and spreading. I think fighting any remaining bacteria from the UTI + creating COVID antibodies, caused the flare up. He may lose an eye. I'd like to look into this. Something to analyze and warn about?  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.