chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: when she did it this time, there were issues with the pressure and the two pieces split apart and one piece went flying. She wasn't able to use the product; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (10Nov2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5023, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE CONNECTION ISSUE (non-serious), outcome "unknown", described as "when she did it this time, there were issues with the pressure and the two pieces split apart and one piece went flying. She wasn't able to use the product".  Causality for "when she did it this time, there were issues with the pressure and the two pieces split apart and one piece went flying. she wasn't able to use the product" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: NDC number was 00069-0207-01. Clarified the reporter connected it all together. She pushed the liquid into the vial. The syringe filled up with liquid. Then the syringe popped up and landed on the ground in the dust. Pharmacist states this is her 10th time using this vaccine, but when she put the vial and adaptor and screwed on syringe, something with the pressure, it turned around and the liquid started coming back into the syringe. Then, the two pieces split apart and the adaptor came off of the syringe, and syringe part with some liquid but wasn't fully mixed ended up on the floor. Product was unable to be administered. If it were to recur, it could likely cause or contribute to death or serious injury.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Muscle swelling, Pallor, Peripheral swelling, Skin induration
Clinical narrative: 24 hours after, noticed swelling over the entire right tricep that progressed to 48 hours after.  Skin was red, blanching, indurated.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: DEVELOPED A LARGE RASH ON MOST OF ARM THAT PERSISTED THROUGH DEC 1, 2023. PATIENT USED HYDROCORTISONE 1PERCENT CREAM ON RASH AT ONSET OF RASH BUT NOTHING BY MOUTH UNTIL  SHE TOOK ALLERGRA 180MG TABS APPOXIMATELY 4 WEEKS AFTER RASH BEGAN AND IT LESSENED.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Anxiety, Dyspnoea, Heart rate increased, Hot flush
Clinical narrative: Roughly 15 minutes after vaccine administration, patient experienced stomach pain, nausea, hot flashes, high heart rate, and shortness of breath. I began immediately monitoring the patient and called EMS upon learning of the symptoms. He was very anxious during the course of the events. I administered one dose of epinephrine 0.3mg intramuscularly after determining the symptoms were not subsiding. EMS arrived shortly after and determined the patient was stable and transported to the hospital. Later that evening, I contacted the emergency department and determined the patient was discharged with prescriptions for ondansetron odt 4mg every 8 hours as needed and diazepam 5mg every 12 hours as needed.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea
Clinical narrative: Roughly 15 minutes after vaccine administration, patient experienced stomach pain, nausea, hot flashes, high heart rate, and shortness of breath. I began immediately monitoring the patient and called EMS upon learning of the symptoms. He was very anxious during the course of the events. I administered one dose of epinephrine 0.3mg intramuscularly after determining the symptoms were not subsiding. EMS arrived shortly after and determined the patient was stable and transported to the hospital. Later that evening, I contacted the emergency department and determined the patient was discharged with prescriptions for ondansetron odt 4mg every 8 hours as needed and diazepam 5mg every 12 hours as needed.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Fall, Loss of consciousness, Seizure
Clinical narrative: Patient was administered RSV vaccine Arexvy. Patient stated he had a reaction to shingles vaccine in the past (seizures). Patient received vaccine and walked to bench to sit down. Within 1 minute, patient appeared to slump down and lose consciousness. Pharmacy staff called 911. He started to have a seizure, and his friend, had his epipen and administered the epipen. He was sliding off the bench so friend and I moved him to the floor. The patient had 4 seizures before the EMS arrived. I did not leave his side. He always maintained a pulse and was breathing. EMS took him to hospital.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: RED AND WATM TO TOUCH
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Mobility decreased, Pain in extremity, Therapy change
Clinical narrative: pt states on Monday after getting spikevax her heart rate rose to 160, and her right arm not the site that was injected started hurting and she could not lift it.  Her  Dr advised to increase bystolic since pt on low dose. As of 12/1/23 patient is feeling better.
Age: 67.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Acute myocardial infarction, Death
Clinical narrative: Pt had vaccine on 11/26/23 approx 12 noon  expired 10/27/23 presumed AMI
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Chest X-ray, Chest discomfort, Decreased appetite
Clinical narrative: I received the Shingrix shot at about 10:15am in a nurse's clinic, with zero apparent side-effects right away. Approximately 12 hours later (around 10:15pm), I laid down to go to sleep, and suddenly went into a "convulsive" state. I couldn't breathe, and shook so hard I could barely stand up, walk, speak, or even call for help. Desperate to stop shaking, I flopped into my jacuzzi to see if the warm water might calm me down. Within about 10 minutes, that did relax me a little, and the violent shaking subsided enough to stumble back into my house, but the breathing difficulty seemed to worsen. I felt like I had been run over by a truck. It was such an unfamiliar sensation, I didn't know what to do. I tried to lay back down, with the idea I would call the nurse clinic in the morning. I was in no shape to drive, or even ask for help. I was scared. Laying down again, I struggled to breathe properly all night long - barely resting. By morning I was so exhausted, I had no strength (or even the will) to contact facility for help. Instead I stayed in bed sleeping all day. I remained there all through Saturday night, and into the next day - which was a Sunday. I think Saturday night I took an ibuprofin because my legs had become painful too. All this time I continued having chest tightness and labored breathing. By that evening, I finally felt some relief, and although talking was still difficult, I was able to write an email to the nurse's line at facility about my situation. Sunday night I finally got up and ate some chicken soup and toast, as I had not eaten much since dinner Friday evening. Monday morning, I started to feel a bit better, and by Tuesday morning I felt well enough to resume strenuous exercise - which I did without chest pain or further trauma. It was all so very strange and frightening. With no history of allergic reactions to anything, my delayed Shingrix reaction seemed extremely unusual and my symptoms seemed "over the top". It wasn't just muscle soreness, nausea, or fatigue, it was traumatic.  I feared I was having a heart attack, although I've never had one; so I didn't really know what was going on. Being unable to breathe is not normal for me. Ever. And the shaking wasn't from chills. I was not cold. But I shook violently all over. Legs, arms, hands, fingers, even my internal organs felt like they were shaking uncontrollably. My chest felt like it was getting squeezed by a mammogram machine. Only analogy I can make. During this episode, I do not believe I ever ran a fever, although I took my temperature only once. (although it was over a month between these other vaccines, I have noted that I had had a fairly recent COVID shot, and a high dose flu shot within about 6 weeks of getting this Shingrix shot)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Dysstasia, Electrocardiogram, Exercise tolerance decreased, Fatigue
Clinical narrative: I received the Shingrix shot at about 10:15am in a nurse's clinic, with zero apparent side-effects right away. Approximately 12 hours later (around 10:15pm), I laid down to go to sleep, and suddenly went into a "convulsive" state. I couldn't breathe, and shook so hard I could barely stand up, walk, speak, or even call for help. Desperate to stop shaking, I flopped into my jacuzzi to see if the warm water might calm me down. Within about 10 minutes, that did relax me a little, and the violent shaking subsided enough to stumble back into my house, but the breathing difficulty seemed to worsen. I felt like I had been run over by a truck. It was such an unfamiliar sensation, I didn't know what to do. I tried to lay back down, with the idea I would call the nurse clinic in the morning. I was in no shape to drive, or even ask for help. I was scared. Laying down again, I struggled to breathe properly all night long - barely resting. By morning I was so exhausted, I had no strength (or even the will) to contact facility for help. Instead I stayed in bed sleeping all day. I remained there all through Saturday night, and into the next day - which was a Sunday. I think Saturday night I took an ibuprofin because my legs had become painful too. All this time I continued having chest tightness and labored breathing. By that evening, I finally felt some relief, and although talking was still difficult, I was able to write an email to the nurse's line at facility about my situation. Sunday night I finally got up and ate some chicken soup and toast, as I had not eaten much since dinner Friday evening. Monday morning, I started to feel a bit better, and by Tuesday morning I felt well enough to resume strenuous exercise - which I did without chest pain or further trauma. It was all so very strange and frightening. With no history of allergic reactions to anything, my delayed Shingrix reaction seemed extremely unusual and my symptoms seemed "over the top". It wasn't just muscle soreness, nausea, or fatigue, it was traumatic.  I feared I was having a heart attack, although I've never had one; so I didn't really know what was going on. Being unable to breathe is not normal for me. Ever. And the shaking wasn't from chills. I was not cold. But I shook violently all over. Legs, arms, hands, fingers, even my internal organs felt like they were shaking uncontrollably. My chest felt like it was getting squeezed by a mammogram machine. Only analogy I can make. During this episode, I do not believe I ever ran a fever, although I took my temperature only once. (although it was over a month between these other vaccines, I have noted that I had had a fairly recent COVID shot, and a high dose flu shot within about 6 weeks of getting this Shingrix shot)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Feeling abnormal, Gait disturbance, Hypersomnia, Impaired driving ability
Clinical narrative: I received the Shingrix shot at about 10:15am in a nurse's clinic, with zero apparent side-effects right away. Approximately 12 hours later (around 10:15pm), I laid down to go to sleep, and suddenly went into a "convulsive" state. I couldn't breathe, and shook so hard I could barely stand up, walk, speak, or even call for help. Desperate to stop shaking, I flopped into my jacuzzi to see if the warm water might calm me down. Within about 10 minutes, that did relax me a little, and the violent shaking subsided enough to stumble back into my house, but the breathing difficulty seemed to worsen. I felt like I had been run over by a truck. It was such an unfamiliar sensation, I didn't know what to do. I tried to lay back down, with the idea I would call the nurse clinic in the morning. I was in no shape to drive, or even ask for help. I was scared. Laying down again, I struggled to breathe properly all night long - barely resting. By morning I was so exhausted, I had no strength (or even the will) to contact facility for help. Instead I stayed in bed sleeping all day. I remained there all through Saturday night, and into the next day - which was a Sunday. I think Saturday night I took an ibuprofin because my legs had become painful too. All this time I continued having chest tightness and labored breathing. By that evening, I finally felt some relief, and although talking was still difficult, I was able to write an email to the nurse's line at facility about my situation. Sunday night I finally got up and ate some chicken soup and toast, as I had not eaten much since dinner Friday evening. Monday morning, I started to feel a bit better, and by Tuesday morning I felt well enough to resume strenuous exercise - which I did without chest pain or further trauma. It was all so very strange and frightening. With no history of allergic reactions to anything, my delayed Shingrix reaction seemed extremely unusual and my symptoms seemed "over the top". It wasn't just muscle soreness, nausea, or fatigue, it was traumatic.  I feared I was having a heart attack, although I've never had one; so I didn't really know what was going on. Being unable to breathe is not normal for me. Ever. And the shaking wasn't from chills. I was not cold. But I shook violently all over. Legs, arms, hands, fingers, even my internal organs felt like they were shaking uncontrollably. My chest felt like it was getting squeezed by a mammogram machine. Only analogy I can make. During this episode, I do not believe I ever ran a fever, although I took my temperature only once. (although it was over a month between these other vaccines, I have noted that I had had a fairly recent COVID shot, and a high dose flu shot within about 6 weeks of getting this Shingrix shot)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Myalgia, Nausea, Seizure, Tremor
Clinical narrative: I received the Shingrix shot at about 10:15am in a nurse's clinic, with zero apparent side-effects right away. Approximately 12 hours later (around 10:15pm), I laid down to go to sleep, and suddenly went into a "convulsive" state. I couldn't breathe, and shook so hard I could barely stand up, walk, speak, or even call for help. Desperate to stop shaking, I flopped into my jacuzzi to see if the warm water might calm me down. Within about 10 minutes, that did relax me a little, and the violent shaking subsided enough to stumble back into my house, but the breathing difficulty seemed to worsen. I felt like I had been run over by a truck. It was such an unfamiliar sensation, I didn't know what to do. I tried to lay back down, with the idea I would call the nurse clinic in the morning. I was in no shape to drive, or even ask for help. I was scared. Laying down again, I struggled to breathe properly all night long - barely resting. By morning I was so exhausted, I had no strength (or even the will) to contact facility for help. Instead I stayed in bed sleeping all day. I remained there all through Saturday night, and into the next day - which was a Sunday. I think Saturday night I took an ibuprofin because my legs had become painful too. All this time I continued having chest tightness and labored breathing. By that evening, I finally felt some relief, and although talking was still difficult, I was able to write an email to the nurse's line at facility about my situation. Sunday night I finally got up and ate some chicken soup and toast, as I had not eaten much since dinner Friday evening. Monday morning, I started to feel a bit better, and by Tuesday morning I felt well enough to resume strenuous exercise - which I did without chest pain or further trauma. It was all so very strange and frightening. With no history of allergic reactions to anything, my delayed Shingrix reaction seemed extremely unusual and my symptoms seemed "over the top". It wasn't just muscle soreness, nausea, or fatigue, it was traumatic.  I feared I was having a heart attack, although I've never had one; so I didn't really know what was going on. Being unable to breathe is not normal for me. Ever. And the shaking wasn't from chills. I was not cold. But I shook violently all over. Legs, arms, hands, fingers, even my internal organs felt like they were shaking uncontrollably. My chest felt like it was getting squeezed by a mammogram machine. Only analogy I can make. During this episode, I do not believe I ever ran a fever, although I took my temperature only once. (although it was over a month between these other vaccines, I have noted that I had had a fairly recent COVID shot, and a high dose flu shot within about 6 weeks of getting this Shingrix shot)
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose, Syncope
Clinical narrative: Pt fainted just prior to exiting the store.  Fortunately mom was present with him and caught him on the way down.  EMS  was called.  Pt. remained on floor but was alert and conversing while waiting for EMS.  Pt stated he had been dizzy all day.  Mom stated pt. has passed out before while giving blood.   EMS spent about 20 minutes with pt.  Mom and pt. refused ambulance service to hospital and any further treatment.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site movement impairment, Peripheral swelling
Clinical narrative: Per patient's mother, arm because so swollen after vaccination that he could not lift his arm. He had to be evaluated by his pediatrician. As of 12/1/23 mom said reaction has improved.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: muscle weakness; fever; leg pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Nov2023 as dose number unknown, single (Lot number: HM1067) at the age of 67 years, in left arm for immunisation; for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALPRAZOLAM; BUPROPION; TADALAFIL. The following information was reported: PYREXIA (non-serious) with onset 19Nov2023, outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2023, outcome "unknown", described as "leg pain"; MUSCULAR WEAKNESS (non-serious) with onset 20Nov2023, outcome "unknown", described as "muscle weakness".  Additional information: The patient was healthy, he is very healthy otherwise does not put that back in there.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 14:30 as dose 1, single (Lot number: HG4628) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Vaccine administration time: 10:45 AM, Vaccine dose number: 1, Vaccine location: Left arm), administration date: 04Apr2023, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative multiple times; Positive, notes: testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID from 12Nov2023 to 16Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphlaxic after first 2 Pfizer vax; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "EDS" (unspecified if ongoing); "Mast cell activation positive biopsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "Allergy"; Benadryl, reaction(s): "Allergy". Vaccination history included: Hpv vaccines, reaction(s): "Allergy". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphlaxic after first 2 Pfizer vax". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 13:15 as dose 1, single (Lot number: HG4628) at the age of 77 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Stage 4 metastatic lung cancer- 2017", start date: 2017 (unspecified if ongoing); "penicillan allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin"; Iodine, reaction(s): "Allergy: iodine"; Aspirin, reaction(s): "Allergy: aspirin"; Tylenol, reaction(s): "Allergy: tylenol". Vaccination history included: Covid-19 vaccine (DOSE 5(BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4(BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3(BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included paxlovid from 15Nov2023 to 20Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug Allergy: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Dose 1-4: Moderna COVID-19 Vaccine, Dose 6: Comirnaty (2023-2024 Formula); Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HG4677) at the age of 59 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose 5 (booster), single, lot number: GJ3277, in the right arm), administration date: 08Oct2022, when the patient was 58-year-old, for COVID-19 Immunization; moderna (Dose 4 (single), single, lot number: 038A22A, in the right arm), administration date: 17May2022, when the patient was 58-year-old, for COVID-19 Immunization; moderna (Dose 3 (booster), single, lot number: 050C21A, in the right arm), administration date: 14Nov2021, when the patient was 57-year-old, for COVID-19 Immunization; moderna (Dose 2, single, lot number: 016C21A, in the right arm), administration date: 04May2021, when the patient was 57-year-old, for COVID-19 Immunization; moderna (Dose 1, single, lot number: 031B21A, in the right arm), administration date: 06Apr2021, when the patient was 56-year-old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1-4: Moderna COVID-19 Vaccine, Dose 6: Comirnaty (2023-2024 Formula)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid positive two days after negative test; Negative, notes: Covid positive two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: i did catch Covid last week; i did catch Covid last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Nov2023, outcome "recovered" and all described as "i did catch Covid last week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2023) Positive, notes: Flowflex. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient's reaction to the vaccine was normal. However he did catch Covid last week. Patient tested positive Tuesday 11Nov. Patient had no covid prior vaccination. He denied for any other medical history.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Known allergies were reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema infected, Gait disturbance
Clinical narrative: barely walk after she got vaccinated with Pfizer booster; severe eczema on the top of my hands, there was pus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 08Jan2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "the hips on down, my joints were sore and stiff", "the hips on down, my joints were sore and stiff". The following information was reported: GAIT DISTURBANCE (medically significant), outcome "unknown", described as "barely walk after she got vaccinated with Pfizer booster"; ECZEMA INFECTED (medically significant), outcome "unknown", described as "severe eczema on the top of my hands, there was pus". The event "severe eczema on the top of my hands, there was pus" required physician office visit. Clinical course: Caller, a consumer can barely walk after she got vaccinated with Pfizer booster. She wanted to know if there is a way or we have developed something to take the booster out from her body. Caller stated "I got the first COVID vaccine, no problem. I got the 2nd COVID vaccine and from the hips on down, my joints were sore and stiff, but overnight, it went away. I got the booster on 08Jan2021, by 01May had to go see a dermatologist because I had severe eczema on the top of my hands, there was pus".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose fluctuation, Burning sensation, Drug ineffective
Clinical narrative: Reynaud's; Fluctuating sugar; Awful leg pain; Joint pain; Burning of hands and feet; Ringing in ears; Pain on top of head; Got covid; Got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Jan2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "Got covid"; RAYNAUD'S PHENOMENON (non-serious), outcome "not recovered", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "not recovered", described as "Fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Awful leg pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning of hands and feet"; TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears"; HEADACHE (non-serious), outcome "not recovered", described as "Pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: Fluctuating. Clinical course: Patient had awful side effects from Pfizer Covid vaccine that she took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So she did not get the Covid vaccine boosters because she still had problems from side effects. She just got covid for the first time on 23Nov2023 and she did not know if it was ok for her to take Paxlovid or if she should take it to stop the viral load and spike proteins that harm her. She would like to know if it was ok for her to start taking Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Raynaud's phenomenon, Suspected COVID-19, Tinnitus
Clinical narrative: Reynaud's; Fluctuating sugar; Awful leg pain; Joint pain; Burning of hands and feet; Ringing in ears; Pain on top of head; Got covid; Got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Jan2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "Got covid"; RAYNAUD'S PHENOMENON (non-serious), outcome "not recovered", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "not recovered", described as "Fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Awful leg pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning of hands and feet"; TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears"; HEADACHE (non-serious), outcome "not recovered", described as "Pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: Fluctuating. Clinical course: Patient had awful side effects from Pfizer Covid vaccine that she took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So she did not get the Covid vaccine boosters because she still had problems from side effects. She just got covid for the first time on 23Nov2023 and she did not know if it was ok for her to take Paxlovid or if she should take it to stop the viral load and spike proteins that harm her. She would like to know if it was ok for her to start taking Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose fluctuation, Burning sensation, COVID-19
Clinical narrative: Reynaud's; Fluctuating sugar; Awful leg pain; Joint pain; Burning of hands and feet; Ringing in ears; Pain on top of head; Got covid; Got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Jan2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "Got covid"; RAYNAUD'S PHENOMENON (non-serious), outcome "not recovered", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "not recovered", described as "Fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Awful leg pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning of hands and feet"; TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears"; HEADACHE (non-serious), outcome "not recovered", described as "Pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: Fluctuating. Clinical course: Patient had awful side effects from Pfizer Covid vaccine that she took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So she did not get the Covid vaccine boosters because she still had problems from side effects. She just got covid for the first time on 23Nov2023 and she did not know if it was ok for her to take Paxlovid or if she should take it to stop the viral load and spike proteins that harm her. She would like to know if it was ok for her to start taking Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Headache, Pain in extremity, Reynold's syndrome, Tinnitus
Clinical narrative: Reynaud's; Fluctuating sugar; Awful leg pain; Joint pain; Burning of hands and feet; Ringing in ears; Pain on top of head; Got covid; Got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Jan2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Nov2023, outcome "unknown" and all described as "Got covid"; RAYNAUD'S PHENOMENON (non-serious), outcome "not recovered", described as "Reynaud's"; BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "not recovered", described as "Fluctuating sugar"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Awful leg pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning of hands and feet"; TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears"; HEADACHE (non-serious), outcome "not recovered", described as "Pain on top of head". The patient underwent the following laboratory tests and procedures: Blood glucose: Fluctuating. Clinical course: Patient had awful side effects from Pfizer Covid vaccine that she took in Jan2021 - fluctuating sugar, awful leg pain, joint pain, Reynaud's, burning of hands and feet, ringing in ears, pain on top of head, etc. So she did not get the Covid vaccine boosters because she still had problems from side effects. She just got covid for the first time on 23Nov2023 and she did not know if it was ok for her to take Paxlovid or if she should take it to stop the viral load and spike proteins that harm her. She would like to know if it was ok for her to start taking Paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Bell's palsy
Clinical narrative: 10Nov I was diagnosed with Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Lot number: HG4633) at the age of 63 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), Single, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, Single, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, Single, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 09Nov2023 at 18:00, outcome "not recovered", described as "10Nov I was diagnosed with Bells Palsy". The event "10nov i was diagnosed with bells palsy" required emergency room visit. Therapeutic measures were taken as a result of bell's palsy.  Clinical course: Other vaccine 4 weeks details: other vaccine 4 weeks product: Flu shot. 10Nov2023 patient was diagnosed with Bells Palsy and treatment was provided with Prednisone. Patient had covid prior vaccination, had not covid tested post vaccination. No known allergies, no other medical history.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Discomfort, Myalgia
Clinical narrative: severe muscle pain/worse than what she had when she was diagnosed with it/still wake up and achy and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 80-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Nov2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "Polymyalgia" (ongoing), notes: My question to your company would your vaccine cause a flare up of my Polymyalgia or it the muscle pain cause just taking your meds. Concomitant medication(s) included: PREDNISONE taken for myalgia. Vaccination history included: Influenza (influenza and Covid vaccines two weeks before Abrysvo), administration date: Oct2023, for Immunization; Covid vaccine (influenza and Covid vaccines two weeks before Abrysvo), administration date: Oct2023, for Covid-19 Immunization.The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "severe muscle pain/worse than what she had when she was diagnosed with it/still wake up and achy and uncomfortable". Additional information:She is waiting to hear from her doctor and they did increase the prednisone to 15mg due to a possible reaction to the vaccine. Patient was better but this is worse than what she had when she was diagnosed with it.  Patient still wake up and achy and uncomfortable The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer Survivor" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Nov2023 to 18Nov2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300410642 same patient, different drug and different AE.;