chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Epistaxis, Fatigue
Clinical narrative: very sick; arm swoll up where I got the shot; Where I got the shot, it was sore for weeks; my nose clogged; hard for me to breath; when I blow my nose blood comes out; head hurts; feel dizzy; extremely tired; heart gets a funny feeling; my body will super hot, then sometimes my body will get real cold; I start shivering; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "very sick"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm swoll up where I got the shot"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "Where I got the shot, it was sore for weeks"; NASAL CONGESTION (non-serious) with onset 2021, outcome "not recovered", described as "my nose clogged"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "hard for me to breath"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "when I blow my nose blood comes out"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "head hurts"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "feel dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "extremely tired"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "heart gets a funny feeling"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "my body will super hot, then sometimes my body will get real cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "I start shivering"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweating". Additional information: The day after patient took vaccine he become very very sick. His arm swoll up where he got the shot, it was sore for weeks, nose clogged up and it still is 6 1/2 weeks after he took the vaccine and still counting. Its very hard for him to breath, when he blow nose blood comes out which is still going on head hurts, he feel dizzy, he be extremely tired everyday, heart gets a funny feeling when he breath in out, some times body will super hot to the point he start sweating then some times my body will get real cold and he start shivering. Something needs to be done about this because every since he took Covid-19 vaccine I have been sick. He asked for help because vaccine is slowly killing him.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling of body temperature change, Headache, Hyperhidrosis, Illness
Clinical narrative: very sick; arm swoll up where I got the shot; Where I got the shot, it was sore for weeks; my nose clogged; hard for me to breath; when I blow my nose blood comes out; head hurts; feel dizzy; extremely tired; heart gets a funny feeling; my body will super hot, then sometimes my body will get real cold; I start shivering; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "very sick"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm swoll up where I got the shot"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "Where I got the shot, it was sore for weeks"; NASAL CONGESTION (non-serious) with onset 2021, outcome "not recovered", described as "my nose clogged"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "hard for me to breath"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "when I blow my nose blood comes out"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "head hurts"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "feel dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "extremely tired"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "heart gets a funny feeling"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "my body will super hot, then sometimes my body will get real cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "I start shivering"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweating". Additional information: The day after patient took vaccine he become very very sick. His arm swoll up where he got the shot, it was sore for weeks, nose clogged up and it still is 6 1/2 weeks after he took the vaccine and still counting. Its very hard for him to breath, when he blow nose blood comes out which is still going on head hurts, he feel dizzy, he be extremely tired everyday, heart gets a funny feeling when he breath in out, some times body will super hot to the point he start sweating then some times my body will get real cold and he start shivering. Something needs to be done about this because every since he took Covid-19 vaccine I have been sick. He asked for help because vaccine is slowly killing him.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain, Vaccination site swelling
Clinical narrative: very sick; arm swoll up where I got the shot; Where I got the shot, it was sore for weeks; my nose clogged; hard for me to breath; when I blow my nose blood comes out; head hurts; feel dizzy; extremely tired; heart gets a funny feeling; my body will super hot, then sometimes my body will get real cold; I start shivering; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "very sick"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "arm swoll up where I got the shot"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered", described as "Where I got the shot, it was sore for weeks"; NASAL CONGESTION (non-serious) with onset 2021, outcome "not recovered", described as "my nose clogged"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "hard for me to breath"; EPISTAXIS (non-serious) with onset 2021, outcome "unknown", described as "when I blow my nose blood comes out"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "head hurts"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "feel dizzy"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "extremely tired"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "heart gets a funny feeling"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2021, outcome "unknown", described as "my body will super hot, then sometimes my body will get real cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "I start shivering"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "unknown", described as "sweating". Additional information: The day after patient took vaccine he become very very sick. His arm swoll up where he got the shot, it was sore for weeks, nose clogged up and it still is 6 1/2 weeks after he took the vaccine and still counting. Its very hard for him to breath, when he blow nose blood comes out which is still going on head hurts, he feel dizzy, he be extremely tired everyday, heart gets a funny feeling when he breath in out, some times body will super hot to the point he start sweating then some times my body will get real cold and he start shivering. Something needs to be done about this because every since he took Covid-19 vaccine I have been sick. He asked for help because vaccine is slowly killing him.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin increased, Blood urine present, Computerised tomogram, Cystitis
Clinical narrative: bladder infection; blood in urine; high bilirubin count; had period from 29Apr2021 to 21May2021 and it stopped only for a few days and started again from  24May2021 to 08Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Mar2021 09:30 (Lot number: EN6202) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "gastric bypass", start date: Oct2000, stop date: Oct2000. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; CRANBERRY; PROBIOTIC [BIFIDOBACTERIUM LACTIS], and unspecified multivitamins. Past drug history included: Codeine, reaction(s): "drug allergy", notes: Possible. Vaccination history included: BNT162B2 (1st dose; Lot number: EN6201 at 09:30 in the left arm), administration date: 15Feb2021, when the patient was 48 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: CYSTITIS (hospitalization) with onset Mar2021, outcome "unknown", described as "bladder infection"; BLOOD URINE PRESENT (hospitalization) with onset Mar2021, outcome "unknown", described as "blood in urine"; BLOOD BILIRUBIN INCREASED (hospitalization) with onset Mar2021, outcome "unknown", described as "high bilirubin count"; OLIGOMENORRHOEA (non-serious) with onset 29Apr2021, outcome "unknown", described as "had period from 29Apr2021 to 21May2021 and it stopped only for a few days and started again from  24May2021 to 08Jun2021". The clinical course was reported as follows: The patient got her period from 29Apr2021 until 21May2021 and it stopped only for a few days and started again from 24May2021 until 08Jun2021. She also ended up with a bladder infection at the beginning of Jun2021 in which she ended up in the hospital for. She felt my symptoms back in Mar2021 after the 2nd vaccination, but doctor did not find any signs of bacteria then. She did have blood in the urine and a high bilirubin count. Urologist exams, computerised tomogram (CT) scan, and unspecified antibiotics were given for treatment. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; sars-cov-2 test: (18Mar2021) negative; urological examination: (unspecified date) unknown results; blood bilirubin: (Mar2021) high.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, SARS-CoV-2 test, Urological examination
Clinical narrative: bladder infection; blood in urine; high bilirubin count; had period from 29Apr2021 to 21May2021 and it stopped only for a few days and started again from  24May2021 to 08Jun2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Mar2021 09:30 (Lot number: EN6202) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "gastric bypass", start date: Oct2000, stop date: Oct2000. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; CRANBERRY; PROBIOTIC [BIFIDOBACTERIUM LACTIS], and unspecified multivitamins. Past drug history included: Codeine, reaction(s): "drug allergy", notes: Possible. Vaccination history included: BNT162B2 (1st dose; Lot number: EN6201 at 09:30 in the left arm), administration date: 15Feb2021, when the patient was 48 years old, for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following information was reported: CYSTITIS (hospitalization) with onset Mar2021, outcome "unknown", described as "bladder infection"; BLOOD URINE PRESENT (hospitalization) with onset Mar2021, outcome "unknown", described as "blood in urine"; BLOOD BILIRUBIN INCREASED (hospitalization) with onset Mar2021, outcome "unknown", described as "high bilirubin count"; OLIGOMENORRHOEA (non-serious) with onset 29Apr2021, outcome "unknown", described as "had period from 29Apr2021 to 21May2021 and it stopped only for a few days and started again from  24May2021 to 08Jun2021". The clinical course was reported as follows: The patient got her period from 29Apr2021 until 21May2021 and it stopped only for a few days and started again from 24May2021 until 08Jun2021. She also ended up with a bladder infection at the beginning of Jun2021 in which she ended up in the hospital for. She felt my symptoms back in Mar2021 after the 2nd vaccination, but doctor did not find any signs of bacteria then. She did have blood in the urine and a high bilirubin count. Urologist exams, computerised tomogram (CT) scan, and unspecified antibiotics were given for treatment. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; sars-cov-2 test: (18Mar2021) negative; urological examination: (unspecified date) unknown results; blood bilirubin: (Mar2021) high.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pulmonary embolism
Clinical narrative: Booster; got a PE; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "got a PE". Clinical course: the patient got a pulmonary embolism (PE) after receiving his third Pfizer vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Limited information precludes a comprehensive causality assessment of events with BNT162B2 Vaccine ,however causal role cannot be excluded due to possible temporal association..Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Feeling abnormal, Immunisation, Paraesthesia
Clinical narrative: booster; She was kind of feeling bad; Shoulder was sore; Had a little tingling in her fingers; Breathing was kind of off a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization, reaction(s): "got the first two shots and there was no problem"; Bnt162b2 (DOSE: 2), for COVID-19 immunization, reaction(s): "got the first two shots and there was no problem". The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021, outcome "unknown", described as "booster"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "She was kind of feeling bad"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "Shoulder was sore"; PARAESTHESIA (non-serious) with onset Nov2021, outcome "unknown", described as "Had a little tingling in her fingers"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "Breathing was kind of off a little bit".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Pain in extremity
Clinical narrative: booster; I am just a little sore in my arm; My shoulder was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer- Unknown, I was saying that we both got the first two shots and there was no problem but then she thinks, what she did was in her mind (voice not clear).), for COVID-19 Immunization, reaction(s): "there was no problem"; Covid-19 vaccine (Dose:2, Manufacturer- Unknown, I was saying that we both got the first two shots and there was no problem but then she thinks, what she did was in her mind (voice not clear).), for COVID-19 Immunization, reaction(s): "there was no problem". The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "I am just a little sore in my arm"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "My shoulder was sore".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Migraine
Clinical narrative: she would have imbalances out of the blue; Migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient received palbociclib (IBRANCE) (ongoing) (Batch/Lot number: unknown) at 100 mg; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "Migraine"; BALANCE DISORDER (non-serious), outcome "unknown", described as "she would have imbalances out of the blue". The action taken for palbociclib was unknown. Therapeutic measures were taken as a result of balance disorder. Additional information: Patient, reporting on Ibrance and who explains she was taking the product when she took at the second of the Covid shots and the second shot caused huge numbers. Patient clarifies that this means that the first 3 weeks after the Covid second shot did not ring well with the Ibrance and caused her to have multiple migraines. She was having a minimum of 3 each day and that went on for 6 weeks. It has slowly gone back to one a day at this point. The patient stated she wants to report his and is calling to renew her Ibrance refill. The patient explains she tore off the information she needed from the package and threw the box away. She confirms that the migraines started immediately after the second dose. Also, she got the second shot on the same day she started the Ibrance cycle. The patient does not know the exact date but this was several months ago. Patient doesn't have her vaccine card available and has no date, NDC, Lot, or Expiry to provide. It was confirmed the product was the Pfizer Covid vaccine. It was explained that they were continuing, the migraines. She doesn't have a problem with the migraine and the Ibrance normally but with the second shot she had the problem. The patient described them as electronic instead pain and they were also throwing her balance off; she would have imbalances out of the blue. She went to the neurologist and has recently started on a new medication for people that have a brain dysfunction as treatment for this, maybe that is helping. She has to build up with the product but it is scary to be on this type of medication. The product name is (name withheld), captured as spelled by the patient, 25mg tablets twice a day and that dose will increase next week. No NDC, Lot, or Expiry given by the patient when probed. When asking product information: The patient explains she tore off the information she needed from the package and threw the box away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Haemorrhoids thrombosed
Clinical narrative: a significant thrombosed external hemorrhoid; Chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 03:30 (Lot number: 8W 0158) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme's disease" (unspecified if ongoing); "myocarditis" (unspecified if ongoing), notes: mirroring a severe case of myocarditis suffered 20 years ago. The patient's concomitant medications were not reported. The following information was reported: HAEMORRHOIDS THROMBOSED (non-serious) with onset 10Apr2021 12:00, outcome "recovered with sequelae", described as "a significant thrombosed external hemorrhoid"; CHEST PAIN (non-serious) with onset 10Apr2021 12:00, outcome "recovered with sequelae", described as "Chest pains". Therapeutic measures were not taken as a result of haemorrhoids thrombosed, chest pain.  Clinical course: Chest pains...mirroring a severe case of myocarditis suffered 20 years ago. Chest pains started 2 days after vaccine date and persisted for 2 weeks. Also, a significant thrombosed external hemorrhoid appeared 3 days after vaccine date.  Follow-Up (01Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dark circles under eyes, Lacrimation increased, Rhinorrhoea
Clinical narrative: runny nose; watery eyes/dark bags under his eyes; watery eyes/dark bags under his eyes; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 14:30 (Lot number: FK5618) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 20Nov2021 (Batch/Lot number: unknown). Relevant medical history included: "Asthma" (unspecified if ongoing); "Just seasonal allergies" (unspecified if ongoing), notes: known allergies: No - just seasonal allergies. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLUTICASONE. The following information was reported: COUGH (medically significant) with onset 26Nov2021, outcome "not recovered", described as "cough"; RHINORRHOEA (medically significant) with onset 26Nov2021 19:00, outcome "not recovered", described as "runny nose"; LACRIMATION INCREASED (medically significant), DARK CIRCLES UNDER EYES (medically significant) all with onset 26Nov2021 19:00, outcome "not recovered" and all described as "watery eyes/dark bags under his eyes". The events "cough", "runny nose", "watery eyes/dark bags under his eyes" and "watery eyes/dark bags under his eyes" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of cough, rhinorrhoea, lacrimation increased, dark circles under eyes.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-167099 (Moderna).  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number, expiry date were not reported), administration date: 10Mar2021, for Covid-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Immunisation, Rash, Rash pruritic
Clinical narrative: rash that has become increasingly worse, spreading all over her body/rash feels like poison ivy and looks very prickly and itchy; rash feels like poison ivy and looks very prickly and itchy; rash is like poison ivy all over her body and it is very uncomfortable; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101689900 (Pfizer).  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: EW0196) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, LOT: EN6203, Route, Anatomical Location: left arm), administration date: 02Mar2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, LOT: EP6955, around 3:00pm, Route, Anatomical Location: left arm), administration date: 27Mar2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash that has become increasingly worse, spreading all over her body/rash feels like poison ivy and looks very prickly and itchy"; RASH PRURITIC (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash feels like poison ivy and looks very prickly and itchy"; DISCOMFORT (non-serious) with onset 19Nov2021, outcome "not recovered", described as "rash is like poison ivy all over her body and it is very uncomfortable"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of rash, rash pruritic, discomfort.  Additional information: The caller stated that the rash had gotten worse with a mighty force and states that it feels like poison ivy and looks very prickly and itchy. It started on the inside of the right arm, which was the opposite of the left arm, which she got the shot it. The rash started on the left arm and was spreading everywhere, all over her body, with a vengeance. It was like poison ivy all over her body and it was very uncomfortable. She has tried Cortisone cream and tried taking Benadryl. Because Benadryl was an antihistamine, she thought it should calm things down. It did for a little bit but, not enough to stop it. She was having to take it every 3 or 4 hours.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Headache, Magnetic resonance imaging, Magnetic resonance imaging head, Neck pain
Clinical narrative: has been experiencing lost vision on one eye; ringing of his left ear; major pain on the top of his head and back of the neck; blurring of vision all the time; major pain on the top of his head and back of the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant) with onset 2021, outcome "not recovered", described as "has been experiencing lost vision on one eye"; TINNITUS (medically significant) with onset 2021, outcome "not recovered", described as "ringing of his left ear"; HEADACHE (medically significant), NECK PAIN (medically significant) all with onset 2021, outcome "not recovered" and all described as "major pain on the top of his head and back of the neck"; VISION BLURRED (medically significant) with onset 2021, outcome "not recovered", described as "blurring of vision all the time". The events "has been experiencing lost vision on one eye", "ringing of his left ear", "major pain on the top of his head and back of the neck", "blurring of vision all the time" and "major pain on the top of his head and back of the neck" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (2021) unknown results, notes: undergone an MRI for his eye and brain; magnetic resonance imaging head: (2021) unknown results, notes: undergone an MRI for his eye and brain. Therapeutic measures were taken as a result of blindness, tinnitus, headache, vision blurred, neck pain.  Additional information: Treatment received with prednisone, benadryl, codeine and morphine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: has been experiencing lost vision on one eye; ringing of his left ear; major pain on the top of his head and back of the neck; blurring of vision all the time; major pain on the top of his head and back of the neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant) with onset 2021, outcome "not recovered", described as "has been experiencing lost vision on one eye"; TINNITUS (medically significant) with onset 2021, outcome "not recovered", described as "ringing of his left ear"; HEADACHE (medically significant), NECK PAIN (medically significant) all with onset 2021, outcome "not recovered" and all described as "major pain on the top of his head and back of the neck"; VISION BLURRED (medically significant) with onset 2021, outcome "not recovered", described as "blurring of vision all the time". The events "has been experiencing lost vision on one eye", "ringing of his left ear", "major pain on the top of his head and back of the neck", "blurring of vision all the time" and "major pain on the top of his head and back of the neck" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (2021) unknown results, notes: undergone an MRI for his eye and brain; magnetic resonance imaging head: (2021) unknown results, notes: undergone an MRI for his eye and brain. Therapeutic measures were taken as a result of blindness, tinnitus, headache, vision blurred, neck pain.  Additional information: Treatment received with prednisone, benadryl, codeine and morphine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Dyspnoea, Influenza like illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: virus symptoms returned; Difficulty Breathing; A temperature above 99 F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Mar2021 17:15 (Lot number: ER8733) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 06Jan2021, stop date: 26Jan2021, notes: Thought I had a flu; "CLL", start date: 2018 (ongoing), notes: Not taking medications., Green tea only; "Severe Headache" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for headache, start date: 11Aug2021, stop date: 11Nov2021. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 08Mar2021, Time: 14:00, Anatomical Site of injection: left arm, Route of administration: Intramuscular, Batch/Lot number: EN6198, Expiration Date: 30Jun2021), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "virus symptoms returned", "Mind fog", "Headache", "Body ache", "night sweating", "inability to concentrate", "sense of balance", "loss of appetite", "general feeling of exhaustion". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 30Mar2021 04:00, outcome "recovered" (03Apr2021), described as "virus symptoms returned"; DYSPNOEA (non-serious) with onset 30Mar2021 04:00, outcome "recovered" (03Apr2021), described as "Difficulty Breathing"; PYREXIA (non-serious) with onset 30Mar2021 04:00, outcome "recovered" (03Apr2021), described as "A temperature above 99 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness, dyspnoea, pyrexia.  Additional information: Prior Vaccinations (within 4 weeks) was reported as none. It was reported that after each vaccination, virus symptoms returned at no time did the patient have Difficulty breathing or a temperature above 99 F.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Nausea, Pain, Vaccination site pain
Clinical narrative: Body aches; Significant injection site pain; Overall ill feeling; N/V; N/V; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 14:00 (Lot number: FF2590) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Structured information(Patient episode name): Rheumatoid arthritis. Concomitant medication(s) included: METHOTREXATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EP6955), administration date: 24Mar2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EL3248), administration date: 04Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 14:00, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Significant injection site pain"; MALAISE (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Overall ill feeling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 29Nov2021 23:30, outcome "not recovered" and all described as "N/V". Therapeutic measures were not taken as a result of pain, vaccination site pain, malaise, nausea, vomiting.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications that the patient received within 2 weeks of vaccination was Methotrexate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. known allergies was KNDA. Device Date: 29Nov2021  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Body aches; Significant injection site pain; Overall ill feeling; N/V; N/V; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 14:00 (Lot number: FF2590) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Structured information(Patient episode name): Rheumatoid arthritis. Concomitant medication(s) included: METHOTREXATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EP6955), administration date: 24Mar2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EL3248), administration date: 04Mar2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 14:00, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Significant injection site pain"; MALAISE (non-serious) with onset 29Nov2021 23:30, outcome "not recovered", described as "Overall ill feeling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 29Nov2021 23:30, outcome "not recovered" and all described as "N/V". Therapeutic measures were not taken as a result of pain, vaccination site pain, malaise, nausea, vomiting.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications that the patient received within 2 weeks of vaccination was Methotrexate. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. known allergies was KNDA. Device Date: 29Nov2021  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Arthralgia, Blood test, Lymphadenopathy, Neck pain
Clinical narrative: Swollen lymphnode under my left arm pit; A very sore neck and shoulders; A very sore neck and shoulders; I began getting random and severe hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Jun2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Broccoli" (unspecified if ongoing); "known allergies: chocolate" (unspecified if ongoing); "known allergies: plumbs" (unspecified if ongoing); "known allergies: wheat" (unspecified if ongoing); "known allergies: bakers yeast" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: May2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "a very sore neck and shoulders", "swollen lymphnode under my left arm pit", "a very sore neck and shoulders". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jun2021, outcome "not recovered", described as "Swollen lymphnode under my left arm pit"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Jun2021, outcome "not recovered" and all described as "A very sore neck and shoulders"; URTICARIA (non-serious) with onset Jun2021, outcome "not recovered", described as "I began getting random and severe hives". The events "swollen lymphnode under my left arm pit", "a very sore neck and shoulders", "a very sore neck and shoulders" and "i began getting random and severe hives" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, neck pain, arthralgia, urticaria. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. covid test type post vaccination=Nasal Swab (covid test date=Jul2021) covid test result=Negative, covid test type post vaccination=Nasal Swab (covid test date=Jun2021) covid test result=Negative, covid test type post vaccination=Nasal Swab (covid test date=Aug2021) covid test result=Negative.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Swollen lymphnode under my left arm pit; A very sore neck and shoulders; A very sore neck and shoulders; I began getting random and severe hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Jun2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Broccoli" (unspecified if ongoing); "known allergies: chocolate" (unspecified if ongoing); "known allergies: plumbs" (unspecified if ongoing); "known allergies: wheat" (unspecified if ongoing); "known allergies: bakers yeast" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: May2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "a very sore neck and shoulders", "swollen lymphnode under my left arm pit", "a very sore neck and shoulders". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jun2021, outcome "not recovered", described as "Swollen lymphnode under my left arm pit"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Jun2021, outcome "not recovered" and all described as "A very sore neck and shoulders"; URTICARIA (non-serious) with onset Jun2021, outcome "not recovered", described as "I began getting random and severe hives". The events "swollen lymphnode under my left arm pit", "a very sore neck and shoulders", "a very sore neck and shoulders" and "i began getting random and severe hives" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, neck pain, arthralgia, urticaria. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. covid test type post vaccination=Nasal Swab (covid test date=Jul2021) covid test result=Negative, covid test type post vaccination=Nasal Swab (covid test date=Jun2021) covid test result=Negative, covid test type post vaccination=Nasal Swab (covid test date=Aug2021) covid test result=Negative.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on hands after injection, and hives in random places every other day since injection; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.   A 32-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 04Nov2021 at 15:45 (Batch/Lot number: UNKNOWN) at the age of 32 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism"; "Herpes simplex type II", notes: (hsv2); "Fruit allergy", notes: Known allergies: Bananas; "Milk allergy", notes: Known allergies: Milk; "Egg allergy", notes: Known allergies: Eggs and "Allergy to plants", notes: Known allergies: Cilantro, lemongrass (unspecified if ongoing). Concomitant medications included: LEVOTHYROXINE; WEGOVY and OMEPRAZOLE. Past drug history included: Codeine, reaction: "Drug allergy", notes: Known allergies: Codeine. The following information was reported: URTICARIA (non-serious) with onset 04Nov2021 at 18:00, outcome "unknown", described as "hives on hands after injection, and hives in random places every other day since injection". Therapeutic measures were not taken as a result of urticaria.   Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.