chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Lip swelling, Urticaria
Clinical narrative: Inflammation and skin welts noted in areas of clothing and watch contact with skin; Inflammation and skin welts noted in areas of clothing and watch contact with skin; acute swelling of lip without trauma; This is a spontaneous report from a contactable physician, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 12Jan2021 at 09:30 (at the age of 43-years-old) as a single dose for Covid-19 immunization. Medical history was reported as none. Prior to the vaccination, that patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received dose 1 of BNT162B2 on 29Dec2020 at 09:30, intramuscular in the right buttocks. On 15Jan2021 at 12:00, the patient experienced inflammation and skin welts in the areas of clothing and watch contact with skin; and developed acute swelling of the lip without trauma. Therapeutic measures were not taken and the events resulted in a physician or other healthcare professional office visit. The clinical outcome of the event skin inflammation, skin welts and lip swelling was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: I started itching all over my body around 9:00 am. Around 6:00 pm my lips started swelling. At 7:00 pm I noticed hives and a rash on my chest, back, stomach, and sides. I took 2 Benadryl and stopped itching. The next day my lips were still swollen, so I took Zyrtec and the swelling went down.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: I started itching all over my body around 9:00 am. Around 6:00 pm my lips started swelling. At 7:00 pm I noticed hives and a rash on my chest, back, stomach, and sides. I took 2 Benadryl and stopped itching. The next day my lips were still swollen, so I took Zyrtec and the swelling went down.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling cold, Hypoaesthesia oral, Paraesthesia, Skin warm
Clinical narrative: pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat.  Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot.  They checked her blood pressure and it was high at that time 153/?  Pt was from out of town so transported to Urgent Care via ambulance.  Her blood pressure was 170/? at this time.  They did an EKG which was normal.  Pt was given Benadryl.  Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg.   Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong.  Pt is waiting for her PCP to do tele visit for a FU.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Electrocardiogram, Heart rate increased, Hypertension, Hypoaesthesia oral
Clinical narrative: pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat.  Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot.  They checked her blood pressure and it was high at that time 153/?  Pt was from out of town so transported to Urgent Care via ambulance.  Her blood pressure was 170/? at this time.  They did an EKG which was normal.  Pt was given Benadryl.  Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg.   Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong.  Pt is waiting for her PCP to do tele visit for a FU.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Panic attack, Paraesthesia, Skin warm
Clinical narrative: pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat.  Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot.  They checked her blood pressure and it was high at that time 153/?  Pt was from out of town so transported to Urgent Care via ambulance.  Her blood pressure was 170/? at this time.  They did an EKG which was normal.  Pt was given Benadryl.  Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg.   Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong.  Pt is waiting for her PCP to do tele visit for a FU.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood test, Dysaesthesia, Electrocardiogram, Feeling cold
Clinical narrative: pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat.  Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot.  They checked her blood pressure and it was high at that time 153/?  Pt was from out of town so transported to Urgent Care via ambulance.  Her blood pressure was 170/? at this time.  They did an EKG which was normal.  Pt was given Benadryl.  Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg.   Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong.  Pt is waiting for her PCP to do tele visit for a FU.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Hypersensitivity, Hypertension, Hypoaesthesia oral
Clinical narrative: pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat.  Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot.  They checked her blood pressure and it was high at that time 153/?  Pt was from out of town so transported to Urgent Care via ambulance.  Her blood pressure was 170/? at this time.  They did an EKG which was normal.  Pt was given Benadryl.  Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg.   Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong.  Pt is waiting for her PCP to do tele visit for a FU.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: pt states that within 10 minutes after vax that she experienced cool tingling sensation down both legs below knees and had a rapid heart beat.  Pt discussed her symptoms w/ medic at facility when she noticed a tingling at the top of her head and her top lip that was numb and hot.  They checked her blood pressure and it was high at that time 153/?  Pt was from out of town so transported to Urgent Care via ambulance.  Her blood pressure was 170/? at this time.  They did an EKG which was normal.  Pt was given Benadryl.  Dr. told her she had a Panic Attack and issued Hydroxyzine 25mg.   Pt. said she has had panic attack before and it wasn't the same but she thinks it may have been from anxiety but is trying to determine what went wrong.  Pt is waiting for her PCP to do tele visit for a FU.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Tremor
Clinical narrative: Patient states feeling nausea vomiting.  BP 206/93 pulse 90 spo2 98% at 4:05 PM repeated BP 209/88 P 94  Sao2 98% Transferred to urgent care via w/c. Warm handoff given to urgent care staff.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Patient states feeling nausea vomiting.  BP 206/93 pulse 90 spo2 98% at 4:05 PM repeated BP 209/88 P 94  Sao2 98% Transferred to urgent care via w/c. Warm handoff given to urgent care staff.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Difficulty breathing/throat constriction/difficulty speaking, high blood pressure, tremors. Paramedics gave .3 epi IM and then IV benadryl. Taken to ED. Released after 1/2 hour observation. Fine until next day at 11:00 or so in the morning. showed similar symptoms and difficulty walking. Gave OTC benadryl; symptoms resolved. Has been fine ever since
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Gait disturbance, Hypertension, Throat tightness
Clinical narrative: Difficulty breathing/throat constriction/difficulty speaking, high blood pressure, tremors. Paramedics gave .3 epi IM and then IV benadryl. Taken to ED. Released after 1/2 hour observation. Fine until next day at 11:00 or so in the morning. showed similar symptoms and difficulty walking. Gave OTC benadryl; symptoms resolved. Has been fine ever since
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Difficulty breathing/throat constriction/difficulty speaking, high blood pressure, tremors. Paramedics gave .3 epi IM and then IV benadryl. Taken to ED. Released after 1/2 hour observation. Fine until next day at 11:00 or so in the morning. showed similar symptoms and difficulty walking. Gave OTC benadryl; symptoms resolved. Has been fine ever since
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Lip swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Flushing, tongue swelling. Epipen used and repeated x 1. IV benadryl.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epinephrine, Flushing, Swollen tongue
Clinical narrative: Flushing, tongue swelling. Epipen used and repeated x 1. IV benadryl.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Dizziness, Feeling hot, Headache
Clinical narrative: Emp. vaccinated at 1004, 1015 developed HA/numb mouth. Developed dizziness with numbness all over body below the neck, eased to floor by staff, taken to ER at 1030. Eyes became edematous, treated with Benadryl per employee in ER for 2 hours and at hoome developed tongue swelling again, took additional Benadryl. Continued experienced furry feeling to tongue for one week and resolved.   Grade 4 allergic reaction/angioedema type presentation within less than 15 minutes.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Swelling face, Swollen tongue
Clinical narrative: Emp. vaccinated at 1004, 1015 developed HA/numb mouth. Developed dizziness with numbness all over body below the neck, eased to floor by staff, taken to ER at 1030. Eyes became edematous, treated with Benadryl per employee in ER for 2 hours and at hoome developed tongue swelling again, took additional Benadryl. Continued experienced furry feeling to tongue for one week and resolved.   Grade 4 allergic reaction/angioedema type presentation within less than 15 minutes.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dizziness, Eye oedema, Headache, Hypersensitivity
Clinical narrative: Emp. vaccinated at 1004, 1015 developed HA/numb mouth. Developed dizziness with numbness all over body below the neck, eased to floor by staff, taken to ER at 1030. Eyes became edematous, treated with Benadryl per employee in ER for 2 hours and at hoome developed tongue swelling again, took additional Benadryl. Continued experienced furry feeling to tongue for one week and resolved.   Grade 4 allergic reaction/angioedema type presentation within less than 15 minutes.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Swollen tongue
Clinical narrative: Emp. vaccinated at 1004, 1015 developed HA/numb mouth. Developed dizziness with numbness all over body below the neck, eased to floor by staff, taken to ER at 1030. Eyes became edematous, treated with Benadryl per employee in ER for 2 hours and at hoome developed tongue swelling again, took additional Benadryl. Continued experienced furry feeling to tongue for one week and resolved.   Grade 4 allergic reaction/angioedema type presentation within less than 15 minutes.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right side facial numbness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL1284, expiration date unknown), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and coronary artery disease. Concomitant medication included atorvastatin (LIPITOR), levothyroxine sodium (SYNTHROID), famotidine (PEPCID), and acetylsalicylic acid (BABY ASPIRIN). The reporter was reporting a side for "COVID-19 the Pfizer shot" which she received on 13Jan2021. On an unspecified date, she experienced facial numbness, right side facial numbness. She went to the emergency care on 15Jan2021, no treatment received. The outcome of the event was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Death, Dizziness, Fall, Feeling abnormal
Clinical narrative: Patient's daughter called on 1/28/21 reported mother had adverse reaction on 1/20/21 she was sick was hospitalized on 1/24/21 and eventually died on 1/25/21
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Memory impairment, Oxygen saturation decreased, SARS-CoV-2 test negative, X-ray of pelvis and hip normal
Clinical narrative: Patient's daughter called on 1/28/21 reported mother had adverse reaction on 1/20/21 she was sick was hospitalized on 1/24/21 and eventually died on 1/25/21
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: Patient's daughter called on 1/28/21 reported mother had adverse reaction on 1/20/21 she was sick was hospitalized on 1/24/21 and eventually died on 1/25/21
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Injection was inproperly given in the back of my upper arm in the fleshy area. Unknown if it reached muscle or only subQ tissue.  Significant Unilateral swelling and decreased sensation noted to left side of face 2 days after receiving vaccine.  Resolved on its own in 2 days.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Sensory loss, Swelling face
Clinical narrative: Injection was inproperly given in the back of my upper arm in the fleshy area. Unknown if it reached muscle or only subQ tissue.  Significant Unilateral swelling and decreased sensation noted to left side of face 2 days after receiving vaccine.  Resolved on its own in 2 days.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Lymphadenopathy, Neuropathy peripheral, Office visit, Throat tightness
Clinical narrative: Within 5 minutes of administration.  Tunnel vision, lightheaded, feeling of doom, elevated HR & BP, tingling, then numbness, then feeling of swelling of lips, left tongue, left throat, left arm.  Benadryl administered.  Around the clock benadryl, initially 25mg Q6.  ED visit on 1/15 with all the above symptoms plus inability to control swallow, feeling of swelling in R throat, resulting in ED visit.  Started on prednisone burst (40mg day x5 days).  Symptoms more controlled on steroids plus benadryl, but breakthrough exacerbations at times of meds wearing off.  Feelings of skin burning, described as on fire, intermittent lace rash on R inner arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Within 5 minutes of administration.  Tunnel vision, lightheaded, feeling of doom, elevated HR & BP, tingling, then numbness, then feeling of swelling of lips, left tongue, left throat, left arm.  Benadryl administered.  Around the clock benadryl, initially 25mg Q6.  ED visit on 1/15 with all the above symptoms plus inability to control swallow, feeling of swelling in R throat, resulting in ED visit.  Started on prednisone burst (40mg day x5 days).  Symptoms more controlled on steroids plus benadryl, but breakthrough exacerbations at times of meds wearing off.  Feelings of skin burning, described as on fire, intermittent lace rash on R inner arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness, Heart rate increased, Hypoaesthesia
Clinical narrative: Within 5 minutes of administration.  Tunnel vision, lightheaded, feeling of doom, elevated HR & BP, tingling, then numbness, then feeling of swelling of lips, left tongue, left throat, left arm.  Benadryl administered.  Around the clock benadryl, initially 25mg Q6.  ED visit on 1/15 with all the above symptoms plus inability to control swallow, feeling of swelling in R throat, resulting in ED visit.  Started on prednisone burst (40mg day x5 days).  Symptoms more controlled on steroids plus benadryl, but breakthrough exacerbations at times of meds wearing off.  Feelings of skin burning, described as on fire, intermittent lace rash on R inner arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia, Peripheral swelling, Pharyngeal swelling, Rash
Clinical narrative: Within 5 minutes of administration.  Tunnel vision, lightheaded, feeling of doom, elevated HR & BP, tingling, then numbness, then feeling of swelling of lips, left tongue, left throat, left arm.  Benadryl administered.  Around the clock benadryl, initially 25mg Q6.  ED visit on 1/15 with all the above symptoms plus inability to control swallow, feeling of swelling in R throat, resulting in ED visit.  Started on prednisone burst (40mg day x5 days).  Symptoms more controlled on steroids plus benadryl, but breakthrough exacerbations at times of meds wearing off.  Feelings of skin burning, described as on fire, intermittent lace rash on R inner arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin burning sensation, Swollen tongue, Tunnel vision
Clinical narrative: Within 5 minutes of administration.  Tunnel vision, lightheaded, feeling of doom, elevated HR & BP, tingling, then numbness, then feeling of swelling of lips, left tongue, left throat, left arm.  Benadryl administered.  Around the clock benadryl, initially 25mg Q6.  ED visit on 1/15 with all the above symptoms plus inability to control swallow, feeling of swelling in R throat, resulting in ED visit.  Started on prednisone burst (40mg day x5 days).  Symptoms more controlled on steroids plus benadryl, but breakthrough exacerbations at times of meds wearing off.  Feelings of skin burning, described as on fire, intermittent lace rash on R inner arm.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Feeling hot, Headache, Insomnia, Nausea
Clinical narrative: Symptoms emerged around 7pm(1/27): body stiffness/aches, headache, warmness in body. Gradually throughout night, I was feeling worse body warmness, mild nausea, worst bodystiffness/aches. I checked my temperature at 1200am 1/28 and it was 101.5 and my pulse was elevated and I felt a sense of warmness/flush feeling in my body and had tachycardia-palpitations and pounding headache/body aches and nausea sensation. At that point, I decided to go the ER. I contacted my work. I work at  Center and contacted a nurse on call who emailed my supervisor. I went to Hospital  around 1245 AM and was seen by an ER Doc around 1am. In triage in the ER area, I had an elevated blood pressure(151/92) and pulse(158), my body temperature was 99.5. The ER doc said the vaccine itself caused the issues I was experiencing and he said he had similiar issues. He ordered IV of medications Zofran and Toradol to address the mild nausea and fever and pain I was experiencing . I was given an IV of sodium chloride as well.  By 3am, I felt some slight improvement from the time I arrived at the ER department
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Tachycardia
Clinical narrative: Symptoms emerged around 7pm(1/27): body stiffness/aches, headache, warmness in body. Gradually throughout night, I was feeling worse body warmness, mild nausea, worst bodystiffness/aches. I checked my temperature at 1200am 1/28 and it was 101.5 and my pulse was elevated and I felt a sense of warmness/flush feeling in my body and had tachycardia-palpitations and pounding headache/body aches and nausea sensation. At that point, I decided to go the ER. I contacted my work. I work at  Center and contacted a nurse on call who emailed my supervisor. I went to Hospital  around 1245 AM and was seen by an ER Doc around 1am. In triage in the ER area, I had an elevated blood pressure(151/92) and pulse(158), my body temperature was 99.5. The ER doc said the vaccine itself caused the issues I was experiencing and he said he had similiar issues. He ordered IV of medications Zofran and Toradol to address the mild nausea and fever and pain I was experiencing . I was given an IV of sodium chloride as well.  By 3am, I felt some slight improvement from the time I arrived at the ER department
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Body temperature increased, Electrocardiogram, Feeling hot
Clinical narrative: Symptoms emerged around 7pm(1/27): body stiffness/aches, headache, warmness in body. Gradually throughout night, I was feeling worse body warmness, mild nausea, worst bodystiffness/aches. I checked my temperature at 1200am 1/28 and it was 101.5 and my pulse was elevated and I felt a sense of warmness/flush feeling in my body and had tachycardia-palpitations and pounding headache/body aches and nausea sensation. At that point, I decided to go the ER. I contacted my work. I work at  Center and contacted a nurse on call who emailed my supervisor. I went to Hospital  around 1245 AM and was seen by an ER Doc around 1am. In triage in the ER area, I had an elevated blood pressure(151/92) and pulse(158), my body temperature was 99.5. The ER doc said the vaccine itself caused the issues I was experiencing and he said he had similiar issues. He ordered IV of medications Zofran and Toradol to address the mild nausea and fever and pain I was experiencing . I was given an IV of sodium chloride as well.  By 3am, I felt some slight improvement from the time I arrived at the ER department
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Heart rate increased, Musculoskeletal stiffness, Nausea
Clinical narrative: Symptoms emerged around 7pm(1/27): body stiffness/aches, headache, warmness in body. Gradually throughout night, I was feeling worse body warmness, mild nausea, worst bodystiffness/aches. I checked my temperature at 1200am 1/28 and it was 101.5 and my pulse was elevated and I felt a sense of warmness/flush feeling in my body and had tachycardia-palpitations and pounding headache/body aches and nausea sensation. At that point, I decided to go the ER. I contacted my work. I work at  Center and contacted a nurse on call who emailed my supervisor. I went to Hospital  around 1245 AM and was seen by an ER Doc around 1am. In triage in the ER area, I had an elevated blood pressure(151/92) and pulse(158), my body temperature was 99.5. The ER doc said the vaccine itself caused the issues I was experiencing and he said he had similiar issues. He ordered IV of medications Zofran and Toradol to address the mild nausea and fever and pain I was experiencing . I was given an IV of sodium chloride as well.  By 3am, I felt some slight improvement from the time I arrived at the ER department
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Tachycardia
Clinical narrative: Symptoms emerged around 7pm(1/27): body stiffness/aches, headache, warmness in body. Gradually throughout night, I was feeling worse body warmness, mild nausea, worst bodystiffness/aches. I checked my temperature at 1200am 1/28 and it was 101.5 and my pulse was elevated and I felt a sense of warmness/flush feeling in my body and had tachycardia-palpitations and pounding headache/body aches and nausea sensation. At that point, I decided to go the ER. I contacted my work. I work at  Center and contacted a nurse on call who emailed my supervisor. I went to Hospital  around 1245 AM and was seen by an ER Doc around 1am. In triage in the ER area, I had an elevated blood pressure(151/92) and pulse(158), my body temperature was 99.5. The ER doc said the vaccine itself caused the issues I was experiencing and he said he had similiar issues. He ordered IV of medications Zofran and Toradol to address the mild nausea and fever and pain I was experiencing . I was given an IV of sodium chloride as well.  By 3am, I felt some slight improvement from the time I arrived at the ER department
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Flu symptoms: headache, body aches, fever, chills, rash
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Influenza, Pain, Pyrexia
Clinical narrative: Flu symptoms: headache, body aches, fever, chills, rash
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: pt. describes swollen lymph gland located in left arm pit starting day after vaccination
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: pt. describes swollen lymph gland located in left arm pit starting day after vaccination
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Chest pain, Computerised tomogram abdomen abnormal, Delirium
Clinical narrative: Delirium; Shortness of Breath; Nausea; Weakness; Loss of Appetite; This is a spontaneous report from a contactable consumer.  A 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 12Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Relevant medical history included mild CHF, osteoporosis, osteoarthritis and had Covid prior vaccination. Patient has known allergies to medications, food, or other products. The vaccine was given on 12Jan2021 in Independent living facility and no other vaccine was received in four weeks. There were other medications received in two weeks but were not reported.  On 13Jan2021 10:00, patient experienced delirium, nausea, weakness, loss of appetite, shortness of breath. Patient did not receive any treatment for all of events and outcome was recovering. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Gastrointestinal inflammation, Hypotension, Lethargy, Muscle spasms
Clinical narrative: Delirium; Shortness of Breath; Nausea; Weakness; Loss of Appetite; This is a spontaneous report from a contactable consumer.  A 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 12Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Relevant medical history included mild CHF, osteoporosis, osteoarthritis and had Covid prior vaccination. Patient has known allergies to medications, food, or other products. The vaccine was given on 12Jan2021 in Independent living facility and no other vaccine was received in four weeks. There were other medications received in two weeks but were not reported.  On 13Jan2021 10:00, patient experienced delirium, nausea, weakness, loss of appetite, shortness of breath. Patient did not receive any treatment for all of events and outcome was recovering. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting, Withdrawal syndrome
Clinical narrative: Delirium; Shortness of Breath; Nausea; Weakness; Loss of Appetite; This is a spontaneous report from a contactable consumer.  A 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 12Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Relevant medical history included mild CHF, osteoporosis, osteoarthritis and had Covid prior vaccination. Patient has known allergies to medications, food, or other products. The vaccine was given on 12Jan2021 in Independent living facility and no other vaccine was received in four weeks. There were other medications received in two weeks but were not reported.  On 13Jan2021 10:00, patient experienced delirium, nausea, weakness, loss of appetite, shortness of breath. Patient did not receive any treatment for all of events and outcome was recovering. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Delirium, Dyspnoea, Nausea
Clinical narrative: Delirium; Shortness of Breath; Nausea; Weakness; Loss of Appetite; This is a spontaneous report from a contactable consumer.  A 97-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 12Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Relevant medical history included mild CHF, osteoporosis, osteoarthritis and had Covid prior vaccination. Patient has known allergies to medications, food, or other products. The vaccine was given on 12Jan2021 in Independent living facility and no other vaccine was received in four weeks. There were other medications received in two weeks but were not reported.  On 13Jan2021 10:00, patient experienced delirium, nausea, weakness, loss of appetite, shortness of breath. Patient did not receive any treatment for all of events and outcome was recovering. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: HPV4, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no additional AE reported; Caller reports receiving a dose of GARDASIL 9 on an unspecified date last week and his physician is advising that he restart the vaccination schedule; This spontaneous report was received from an adult patient of unknown age and gender who referred to herself/himself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2016, the 23-year-old patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient was unsure which Merck hpv vaccine was administered. The patient reported never receiving the remaining doses.  On an unspecified date in January 2021 (reported as an unspecified date last week), the patient was vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) and the physician was advising that he restart the vaccination schedule. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No complaints, signs, symptoms, further AE/PQC.; a patient received expired VAQTA.; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-JAN-2021, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T008149 (lot number T008149 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) formulation vial), expiration date: 06-JAN-2021 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis.  No complains, signs, symptoms and adverse event was reported.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: no adverse event; patient received the PROQUAD injection last year on 8/25/2020. The patient is 26 years old; This spontaneous report has been received from a pharmacist referring to a 26-year-old patient of unspecified gender. There was no information about patient's concomitant medications, concurrent conditions, drug allergy and pertinent medical history.  On 25-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route of administration, lot # and expiration date were provided) for prophylaxis.         No other AE reported.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Vertigo, Vestibular neuronitis
Clinical narrative: vestibular neuronitis; sudden sensorineural hearing loss; vertigo; hearing loss in the left ear / asymmetrical hearing loss; Information has been received from a lawyer regarding a case in litigation, and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported. Approximately on 24-JAN-2017 (reported as: in or around), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and dosage information were unknown) for routine health maintenance and prevention of shingles (herpes zoster).  On an unknown date the patient experienced vertigo, recurrent vestibular neuronitis, sudden sensorineural hearing and asymmetrical hearing loss (hearing loss in the left ear).  The adverse events were considered to be serious, progressive, permanent and incurable (disabling).  It was also mentioned that the patient suffered from physical limitations, mental and emotional distress, mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury as result of the adverse events.  The causality between vertigo, recurrent vestibular neuronitis, sudden sensorineural hearing and asymmetrical hearing loss and zoster vaccine live (ZOSTAVAX) was considered to be related by the lawyer.  Upon internal review, deafness unilateral and deafness neurosensory were considered to be medically significant events.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: vision loss; Shingles; other zoster-related conditions.; This spontaneous report as received from a lawyer and the patient (pt) regarding a case in litigation, refers to a pt of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. In 2015, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) for the longterm prevention of shingles and zoster-related conditions. Subsequent to pt's vaccination, the pt was treated by healthcare providers for shingles, vision loss and other zoster-related conditions. As a direct and proximate result of the use of zoster vaccine live(ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review vision loss was considered as medically significant.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: no adverse reactions or side effects experienced; pt received hepatitis B vaccine on 05-MAR-2010, 09-APR-2010 and on 27-OCT-2010; This spontaneous report as received from a lawyer refers to a 56-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were captured in case MARRS # 2008USA003864.  The patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) on 05-MAR-2010, on 09-APR-2010 and on 27-OCT-2010. She experienced no adverse reactions or side effects.  This is one of 2 reports concerning the same patient.; Sender's Comments:  US-009507513-2008USA003864:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles twice; rash on an arm; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced rash on an arm that had Shingles twice on it. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac flutter
Clinical narrative: heart flutters; This case was reported by a consumer via media and described the occurrence of heart fluttering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced heart fluttering (serious criteria GSK medically significant). On an unknown date, the outcome of the heart fluttering was unknown.   It was unknown if the reporter considered the heart fluttering to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case or himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced some heart flutters since the day. The reporter asked if Shingrix could cause heart flutters or not. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: already had the shingles shot and it didn't work/ Suspected vaccination failure; worst case of shingles and it was ruining her eyesight; vision problems; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and abnormal vision. On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown and the outcome of the abnormal vision was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and abnormal vision to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's niece. The age at vaccination was not reported. The patient experienced worst case of shingles and it was ruining her eyesight, she already had the shingles shot and it did not work, it made her shingles a lot worse and was still having vision problems at the time of reporting. This case was considered as suspected vaccination failure, as information about Shingles vaccine dose number, laboratory test confirmation for shingles infection and time to event onset was unknown. The consent to follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder, Viral titre
Clinical narrative: Out of range labs; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. A nurse reported that they were vaccinating 17 plus years patients with the adult booster dose of Engerix-B and this was due to low or negative titers, which led to therapy non-responder. The nurse did not have specific details at the time of the call. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Migraine, Pyrexia
Clinical narrative: felt very ill; fever; migraine; This case was reported by a consumer  and described the occurrence of feeling unwell in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, fibromyalgia, ehlers-danlos syndrome and crohn's disease.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell, fever and migraine. On an unknown date, the outcome of the feeling unwell, fever and migraine were recovered/resolved.   The reporter considered the feeling unwell, fever and migraine to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 1st dose of Shingrix, the patient felt very ill and had a fever and migraine, which were recovered. The reporter did not consent to follow up. This case was linked with case US2020AMR240559, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR240559:same patient, 2nd dose
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received Shingrix. On 4th January 2021, 4 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination the patient had muscle aches. The reporter did not consent to follow up.
Age: 76.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: fist dose - November 6 2020 / second dose - November 9 2020; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 9th November 2020, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that a male patient received a 2nd dose of Bexsero outside recommended schedule which led to drug dose administration interval too short. No know side effect was reported. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Adverse event following immunisation, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site; Redness at injection site; Swelling at injection site; Warmth at injection site; Continued pain at injection site described as adhesion muscle pain; Continued pain at injection site since vaccination; A 52 year old female patient received MassBiologic's Td Vaccine (Lot # A112A) via IM in her deltoid muscle on 11/07/2019 at Care Center. The patient indicated she immediately experienced pain, redness, swelling, and warmth at the injection site after receiving the Td product and experienced worsening pain  in her muscle at the injection site. The patient initially went to her primary care physician (PCP) for treatment, however the PCP was unable to provide satisfactory treatment for the worsening pain, so the patient sought treatment from her husband since he is a chiropractor. The patient indicated that all adverse events had resolved shortly after the vaccination (date not provided) except for the continued deep muscle pain that she described as "adhesive muscle pain."    During the follow up on, 10/05/2020, the patient confirmed that she is still experiencing the muscle pain and continues to be treated by her chiropractor husband.; Sender's Comments: MassBiologics medical reviewer assessed all adverse events as labelled and non-serious.  All reactions have resolved except for chronic pain and muscle pain at injection site.