chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; sweating; Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration); Diarrhea at 18 hours after administration; Injection site pain; Muscle aches; fatigue; severe nausea (no vomiting); mental fog (last about 4-6hrs); Within one minute: tachycardia (lasted about 3mins); dizziness (lasted 4-6hrs); weakness (lasted 12hours); This is a spontaneous report from a contactable consumer reported for herself.   A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 17Dec2020 at 19:30 via unspecified route of administration at the right arm in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient haven't known allergies. About 7 years ago the patient had received HPV vaccine on unknown date and she experienced reaction to excipient. Within one minute the patient experienced tachycardia (lasted about 3mins), mental fog (last about 4-6hrs), dizziness (lasted 4-6hrs), and weakness (lasted 12hours). Starting 15mins after vaccine, severe nausea (no vomiting) that last two hours. Muscle aches and fatigue started at two hours after vaccine administration. Injection site pain started 6hrs after administration. On 18Dec2020 chills and sweating. Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration). Due to fever, other symptoms, and recent exposure to COVID at place of employment, COVID nasal swab was done on 19Dec2020 at 1300 to rule out possible active diagnose. Test pending at this time. Tylenol administered to reduce fever and symptoms. Outcome of events at the time of last observation was reported as recovering.  Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tachycardia
Clinical narrative: Chills; sweating; Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration); Diarrhea at 18 hours after administration; Injection site pain; Muscle aches; fatigue; severe nausea (no vomiting); mental fog (last about 4-6hrs); Within one minute: tachycardia (lasted about 3mins); dizziness (lasted 4-6hrs); weakness (lasted 12hours); This is a spontaneous report from a contactable consumer reported for herself.   A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 17Dec2020 at 19:30 via unspecified route of administration at the right arm in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient haven't known allergies. About 7 years ago the patient had received HPV vaccine on unknown date and she experienced reaction to excipient. Within one minute the patient experienced tachycardia (lasted about 3mins), mental fog (last about 4-6hrs), dizziness (lasted 4-6hrs), and weakness (lasted 12hours). Starting 15mins after vaccine, severe nausea (no vomiting) that last two hours. Muscle aches and fatigue started at two hours after vaccine administration. Injection site pain started 6hrs after administration. On 18Dec2020 chills and sweating. Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration). Due to fever, other symptoms, and recent exposure to COVID at place of employment, COVID nasal swab was done on 19Dec2020 at 1300 to rule out possible active diagnose. Test pending at this time. Tylenol administered to reduce fever and symptoms. Outcome of events at the time of last observation was reported as recovering.  Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Laboratory test, Nausea
Clinical narrative: I was given the vaccine at 5: 00 pm, 5-10 min later my throat felt like it was closing; It felt tight and i couldnt swallow or breathe properly; It felt tight and i couldnt swallow or breathe properly; This is a spontaneous report from a contactable consumer.   A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 5730), via an unspecified route of administration in the right arm on 17Dec2020 17:00 at a single dose (1st dose) for COVID-19 immunization. Medical history included bipolar 2 and hypothyroid. Concomitant medication included levothyroxine, lorazepam, oxcarbazepine and quetiapine (QUETIAPINE). The patient previously took morphine and cefalexin and experienced drug allergy. The patient reported that she was given the vaccine at 5:00 pm, and 5-10 min later her throat felt like it was closing. It felt tight and she couldn't swallow or breathe properly. She told the nurses, they observed her and listened to her neck and chest. It was not improving so then she was given 50 mg of benadryl. It immediately opened her throat up. However 3-5 min later her throat started to close again. She went to the ER and was given fluids steroids and antihistamines along with Ativan. The outcome of the events was recovered with sequelae on 17Dec2020.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Throat tightness, Vomiting
Clinical narrative: I was given the vaccine at 5: 00 pm, 5-10 min later my throat felt like it was closing; It felt tight and i couldnt swallow or breathe properly; It felt tight and i couldnt swallow or breathe properly; This is a spontaneous report from a contactable consumer.   A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 5730), via an unspecified route of administration in the right arm on 17Dec2020 17:00 at a single dose (1st dose) for COVID-19 immunization. Medical history included bipolar 2 and hypothyroid. Concomitant medication included levothyroxine, lorazepam, oxcarbazepine and quetiapine (QUETIAPINE). The patient previously took morphine and cefalexin and experienced drug allergy. The patient reported that she was given the vaccine at 5:00 pm, and 5-10 min later her throat felt like it was closing. It felt tight and she couldn't swallow or breathe properly. She told the nurses, they observed her and listened to her neck and chest. It was not improving so then she was given 50 mg of benadryl. It immediately opened her throat up. However 3-5 min later her throat started to close again. She went to the ER and was given fluids steroids and antihistamines along with Ativan. The outcome of the events was recovered with sequelae on 17Dec2020.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: I was given the vaccine at 5: 00 pm, 5-10 min later my throat felt like it was closing; It felt tight and i couldnt swallow or breathe properly; It felt tight and i couldnt swallow or breathe properly; This is a spontaneous report from a contactable consumer.   A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 5730), via an unspecified route of administration in the right arm on 17Dec2020 17:00 at a single dose (1st dose) for COVID-19 immunization. Medical history included bipolar 2 and hypothyroid. Concomitant medication included levothyroxine, lorazepam, oxcarbazepine and quetiapine (QUETIAPINE). The patient previously took morphine and cefalexin and experienced drug allergy. The patient reported that she was given the vaccine at 5:00 pm, and 5-10 min later her throat felt like it was closing. It felt tight and she couldn't swallow or breathe properly. She told the nurses, they observed her and listened to her neck and chest. It was not improving so then she was given 50 mg of benadryl. It immediately opened her throat up. However 3-5 min later her throat started to close again. She went to the ER and was given fluids steroids and antihistamines along with Ativan. The outcome of the events was recovered with sequelae on 17Dec2020.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Comminuted fracture, Epistaxis, Facial bones fracture, Haemorrhage, Loss of consciousness
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subcutaneous haematoma, Tenderness
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Computerised tomogram head, Computerised tomogram neck, Echocardiogram
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Face injury, Facial bones fracture, Fall, Full blood count
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemorrhage, Loss of consciousness, Metabolic function test, Skin laceration, Thyroxine free
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray limb
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial bones fracture, Fall, Inappropriate schedule of product administration, Loss of consciousness, Skin laceration
Clinical narrative: COVID VACCINE GIVEN 12/16/20 at 9:44 AM. REPORTS SUBSEQUENT UNCONSCIOUSNESS /FALL AND ED/HOSPITAL. For LACERATIONS AND FACIAL FRACTURES, 3 day stay. WILL REQUIRE SURGERY FOR FACIAL FRACTURES. TDAP VACCINE GIVEN 12/16/2020 at 5:47 PM.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Ear congestion, Fatigue, Headache, Malaise
Clinical narrative: Near syncopal episode the morning after; Extreme fatigue; generally unwell; body aches; nausea; chills; ear fullness; abdominal pain; This is a spontaneous report from a contactable consumer (patient). This 26-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1686, at single dose on 17Dec2020 08:00 on left arm for COVID-19 immunisation. Medical history included Environmental allergies, childhood asthma. The patient had no covid prior vaccination. The patient did not have covid tested post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included cetirizine hydrochloride (ZYRTEC), birth control, multivitamin. The patient experienced Extreme fatigue, generally unwell, body aches, abdominal pain, nausea, chills, ear fullness. Near syncopal episode the morning after on 18Dec2020. No treatment was received for all events. The outcome of the events was resolving.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Presyncope
Clinical narrative: Near syncopal episode the morning after; Extreme fatigue; generally unwell; body aches; nausea; chills; ear fullness; abdominal pain; This is a spontaneous report from a contactable consumer (patient). This 26-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1686, at single dose on 17Dec2020 08:00 on left arm for COVID-19 immunisation. Medical history included Environmental allergies, childhood asthma. The patient had no covid prior vaccination. The patient did not have covid tested post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included cetirizine hydrochloride (ZYRTEC), birth control, multivitamin. The patient experienced Extreme fatigue, generally unwell, body aches, abdominal pain, nausea, chills, ear fullness. Near syncopal episode the morning after on 18Dec2020. No treatment was received for all events. The outcome of the events was resolving.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Ear discomfort, Fatigue, Malaise
Clinical narrative: Near syncopal episode the morning after; Extreme fatigue; generally unwell; body aches; nausea; chills; ear fullness; abdominal pain; This is a spontaneous report from a contactable consumer (patient). This 26-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1686, at single dose on 17Dec2020 08:00 on left arm for COVID-19 immunisation. Medical history included Environmental allergies, childhood asthma. The patient had no covid prior vaccination. The patient did not have covid tested post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included cetirizine hydrochloride (ZYRTEC), birth control, multivitamin. The patient experienced Extreme fatigue, generally unwell, body aches, abdominal pain, nausea, chills, ear fullness. Near syncopal episode the morning after on 18Dec2020. No treatment was received for all events. The outcome of the events was resolving.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia
Clinical narrative: A few minutes after swelling around  face, lips and tongue. I went to ER I got EpiPen, IV Benadryl for swelling. I was sent home my mouth started swelling again and trouble breathing. I went back again to ER on 12/21 they repeated the same treatments. Then I was sent home followed up with my PCP on 12/21 it was probably allergic reaction and immune response. He gave me steriods RX and taking over counter Pepcid, Benadryl. I dint have to miss any work.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: A few minutes after swelling around  face, lips and tongue. I went to ER I got EpiPen, IV Benadryl for swelling. I was sent home my mouth started swelling again and trouble breathing. I went back again to ER on 12/21 they repeated the same treatments. Then I was sent home followed up with my PCP on 12/21 it was probably allergic reaction and immune response. He gave me steriods RX and taking over counter Pepcid, Benadryl. I dint have to miss any work.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Apparent life threatening event, Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia
Clinical narrative: A few minutes after swelling around  face, lips and tongue. I went to ER I got EpiPen, IV Benadryl for swelling. I was sent home my mouth started swelling again and trouble breathing. I went back again to ER on 12/21 they repeated the same treatments. Then I was sent home followed up with my PCP on 12/21 it was probably allergic reaction and immune response. He gave me steriods RX and taking over counter Pepcid, Benadryl. I dint have to miss any work.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder, Swelling face
Clinical narrative: A few minutes after swelling around  face, lips and tongue. I went to ER I got EpiPen, IV Benadryl for swelling. I was sent home my mouth started swelling again and trouble breathing. I went back again to ER on 12/21 they repeated the same treatments. Then I was sent home followed up with my PCP on 12/21 it was probably allergic reaction and immune response. He gave me steriods RX and taking over counter Pepcid, Benadryl. I dint have to miss any work.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: A few minutes after swelling around  face, lips and tongue. I went to ER I got EpiPen, IV Benadryl for swelling. I was sent home my mouth started swelling again and trouble breathing. I went back again to ER on 12/21 they repeated the same treatments. Then I was sent home followed up with my PCP on 12/21 it was probably allergic reaction and immune response. He gave me steriods RX and taking over counter Pepcid, Benadryl. I dint have to miss any work.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia
Clinical narrative: Lip swelling; This is a spontaneous report from a contactable consumer reporting for herself. This 31-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 at 08:00, at single dose, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included soy allergy and COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 20Dec2020 the patient experienced lip swelling which resulted in Emergency room/department or urgent care. Treatment was given. The event was resolving.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Lip swelling; This is a spontaneous report from a contactable consumer reporting for herself. This 31-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 at 08:00, at single dose, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included soy allergy and COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 20Dec2020 the patient experienced lip swelling which resulted in Emergency room/department or urgent care. Treatment was given. The event was resolving.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Apparent life threatening event, Dyspnoea, Heart rate increased, Lip swelling, Paraesthesia
Clinical narrative: Lip swelling; This is a spontaneous report from a contactable consumer reporting for herself. This 31-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 at 08:00, at single dose, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included soy allergy and COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 20Dec2020 the patient experienced lip swelling which resulted in Emergency room/department or urgent care. Treatment was given. The event was resolving.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder, Swelling face
Clinical narrative: Lip swelling; This is a spontaneous report from a contactable consumer reporting for herself. This 31-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 at 08:00, at single dose, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included soy allergy and COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 20Dec2020 the patient experienced lip swelling which resulted in Emergency room/department or urgent care. Treatment was given. The event was resolving.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling; This is a spontaneous report from a contactable consumer reporting for herself. This 31-year-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 at 08:00, at single dose, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included soy allergy and COVID-19 on an unknown date prior to vaccination. Concomitant medications were not reported. On 20Dec2020 the patient experienced lip swelling which resulted in Emergency room/department or urgent care. Treatment was given. The event was resolving.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling hot, Flushing, Headache
Clinical narrative: Patient felt flushed and hot and felt a sudden headache start.  Escorted to a bed to lay down.  Ice packs applied to forehead and neck.  BP 137/87, pulse 92, RR 20, temp 98.2.  Rapid Response team called.  Patient drank apple juice.  When asked about a hx of reactions, patient stated she had a hx of reactions to T-dap, Hepatitis, A, and flu.  She stated her reactions usually occur 2 hours after the vaccines and has a high fever of 103.0F with chills.  She stated she had pre-medicated with 1 gram of Tylenol prior to coming to the COVID vaccination clinic.  Repeat vital signs BP 138/89, pulse 94, RR 22.  No improvement on how she felt and was transported to the ED via wheelchair.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Laboratory test normal
Clinical narrative: Patient felt flushed and hot and felt a sudden headache start.  Escorted to a bed to lay down.  Ice packs applied to forehead and neck.  BP 137/87, pulse 92, RR 20, temp 98.2.  Rapid Response team called.  Patient drank apple juice.  When asked about a hx of reactions, patient stated she had a hx of reactions to T-dap, Hepatitis, A, and flu.  She stated her reactions usually occur 2 hours after the vaccines and has a high fever of 103.0F with chills.  She stated she had pre-medicated with 1 gram of Tylenol prior to coming to the COVID vaccination clinic.  Repeat vital signs BP 138/89, pulse 94, RR 22.  No improvement on how she felt and was transported to the ED via wheelchair.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Headache
Clinical narrative: Patient felt flushed and hot and felt a sudden headache start.  Escorted to a bed to lay down.  Ice packs applied to forehead and neck.  BP 137/87, pulse 92, RR 20, temp 98.2.  Rapid Response team called.  Patient drank apple juice.  When asked about a hx of reactions, patient stated she had a hx of reactions to T-dap, Hepatitis, A, and flu.  She stated her reactions usually occur 2 hours after the vaccines and has a high fever of 103.0F with chills.  She stated she had pre-medicated with 1 gram of Tylenol prior to coming to the COVID vaccination clinic.  Repeat vital signs BP 138/89, pulse 94, RR 22.  No improvement on how she felt and was transported to the ED via wheelchair.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Bradycardia, Cold sweat, Dysphagia, Fatigue
Clinical narrative: Experienced a syncopal episode within 20 minutes of receiving vaccine with reported bradycardia. Patient received IV fluids and was monitored in the emergency department. Patient discharged at 11:40 am after orally hydrating without difficulty, heart rate in the 60's, and being normotensive.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Hyperhidrosis, Loss of consciousness, Metabolic function test normal, Mydriasis
Clinical narrative: Experienced a syncopal episode within 20 minutes of receiving vaccine with reported bradycardia. Patient received IV fluids and was monitored in the emergency department. Patient discharged at 11:40 am after orally hydrating without difficulty, heart rate in the 60's, and being normotensive.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pulse abnormal, Sensation of foreign body, Throat clearing, Tryptase
Clinical narrative: Experienced a syncopal episode within 20 minutes of receiving vaccine with reported bradycardia. Patient received IV fluids and was monitored in the emergency department. Patient discharged at 11:40 am after orally hydrating without difficulty, heart rate in the 60's, and being normotensive.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Syncope
Clinical narrative: Experienced a syncopal episode within 20 minutes of receiving vaccine with reported bradycardia. Patient received IV fluids and was monitored in the emergency department. Patient discharged at 11:40 am after orally hydrating without difficulty, heart rate in the 60's, and being normotensive.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Middle insomnia, Oedema, Swollen tongue, Tongue discomfort
Clinical narrative: Went to sleep at 8am. Woke up at 1am with unilateral angioedema. Presented to ER, given 125 mg  methylprednisolone, 20 mg famotidine, and 25 extra mg of diphenhydramine (in additional to 50 mg I had already taken). Observed in ER. Swelling decreased. I was not admitted because I'm a doctor. Symptoms resolved 10 hours later.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Blood potassium decreased, Full blood count normal, Metabolic function test normal, SARS-CoV-2 test negative
Clinical narrative: Went to sleep at 8am. Woke up at 1am with unilateral angioedema. Presented to ER, given 125 mg  methylprednisolone, 20 mg famotidine, and 25 extra mg of diphenhydramine (in additional to 50 mg I had already taken). Observed in ER. Swelling decreased. I was not admitted because I'm a doctor. Symptoms resolved 10 hours later.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Went to sleep at 8am. Woke up at 1am with unilateral angioedema. Presented to ER, given 125 mg  methylprednisolone, 20 mg famotidine, and 25 extra mg of diphenhydramine (in additional to 50 mg I had already taken). Observed in ER. Swelling decreased. I was not admitted because I'm a doctor. Symptoms resolved 10 hours later.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Disturbance in attention, Dizziness, Headache, Heart rate increased
Clinical narrative: describes increased heart rate and being able to feel heart beating.  Weakness described as woozy feeling.  Treated in the Emergency Department.  Pulse 116, BP 163/101
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal
Clinical narrative: describes increased heart rate and being able to feel heart beating.  Weakness described as woozy feeling.  Treated in the Emergency Department.  Pulse 116, BP 163/101
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased, Palpitations
Clinical narrative: describes increased heart rate and being able to feel heart beating.  Weakness described as woozy feeling.  Treated in the Emergency Department.  Pulse 116, BP 163/101
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin increased, Blood osmolarity increased, Blood urea increased, Contusion, Haemorrhage
Clinical narrative: got shot Friday developed platelet count of 0 3 days later! had cbc normal 6 months prior
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia, Monocyte percentage increased, Platelet count decreased, Platelet transfusion, Thrombocytopenia
Clinical narrative: got shot Friday developed platelet count of 0 3 days later! had cbc normal 6 months prior
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count abnormal, Platelet count decreased
Clinical narrative: got shot Friday developed platelet count of 0 3 days later! had cbc normal 6 months prior
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: became sob coughing swelling throat in 10 minutes  used my eppy pen was sent to the ER RECEIVED BENADRYL 50 MG IV PEPCID 40 MG IV AND SOLUMEDDROL IV RECIEVED 2 RACEMI EPPY BREATHING TREATMENTS
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Pharyngeal swelling
Clinical narrative: became sob coughing swelling throat in 10 minutes  used my eppy pen was sent to the ER RECEIVED BENADRYL 50 MG IV PEPCID 40 MG IV AND SOLUMEDDROL IV RECIEVED 2 RACEMI EPPY BREATHING TREATMENTS
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Cough, Hyperhidrosis, Nausea, Palpitations
Clinical narrative: initially developed nausea, dizziness, hypertension within minutes, then after 10-20 minutes she developed cough and severe shortness of breath. Seen in ED received epi pen, IV benadryl, IV solumedrol, and IV famotidine multiple albuterol nebulizers and duo neb was discharged 8 hours later.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: initially developed nausea, dizziness, hypertension within minutes, then after 10-20 minutes she developed cough and severe shortness of breath. Seen in ED received epi pen, IV benadryl, IV solumedrol, and IV famotidine multiple albuterol nebulizers and duo neb was discharged 8 hours later.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Hypertension, Nausea
Clinical narrative: initially developed nausea, dizziness, hypertension within minutes, then after 10-20 minutes she developed cough and severe shortness of breath. Seen in ED received epi pen, IV benadryl, IV solumedrol, and IV famotidine multiple albuterol nebulizers and duo neb was discharged 8 hours later.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Muscular weakness, Paraesthesia
Clinical narrative: Received Covid 19 vaccine on left deltoid via IM. I felt warm in my left deltoid immediately after the injection. While I was sitting in the recovery area I started feeling palpitations and Shortness of breath. I actually felt I was going into cardiac arrest. Personnel started assessing me and upon checking my vital signs my  SBP was in 150?s-160?s and DBP was in 100?s range. Normally my BP ranges in 110?s. I also started feeling numbness on my left arm. My bilateral lower extremities were also numb, tingling, burning and very weak. I was not able to stand up and bear weight. I then was taken to the ED where blood work was done and ATIVAN Po was given. I was then discharged at 2325. The next morning, I felt my legs are still heavy and sore. They are still very heavy and sore while I am writing this and I feel like they will buckle when I walk.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Coagulation test, Dyspnoea, Dysstasia
Clinical narrative: Received Covid 19 vaccine on left deltoid via IM. I felt warm in my left deltoid immediately after the injection. While I was sitting in the recovery area I started feeling palpitations and Shortness of breath. I actually felt I was going into cardiac arrest. Personnel started assessing me and upon checking my vital signs my  SBP was in 150?s-160?s and DBP was in 100?s range. Normally my BP ranges in 110?s. I also started feeling numbness on my left arm. My bilateral lower extremities were also numb, tingling, burning and very weak. I was not able to stand up and bear weight. I then was taken to the ED where blood work was done and ATIVAN Po was given. I was then discharged at 2325. The next morning, I felt my legs are still heavy and sore. They are still very heavy and sore while I am writing this and I feel like they will buckle when I walk.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Full blood count, Hypoaesthesia, Immediate post-injection reaction, Limb discomfort
Clinical narrative: Received Covid 19 vaccine on left deltoid via IM. I felt warm in my left deltoid immediately after the injection. While I was sitting in the recovery area I started feeling palpitations and Shortness of breath. I actually felt I was going into cardiac arrest. Personnel started assessing me and upon checking my vital signs my  SBP was in 150?s-160?s and DBP was in 100?s range. Normally my BP ranges in 110?s. I also started feeling numbness on my left arm. My bilateral lower extremities were also numb, tingling, burning and very weak. I was not able to stand up and bear weight. I then was taken to the ED where blood work was done and ATIVAN Po was given. I was then discharged at 2325. The next morning, I felt my legs are still heavy and sore. They are still very heavy and sore while I am writing this and I feel like they will buckle when I walk.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Received Covid 19 vaccine on left deltoid via IM. I felt warm in my left deltoid immediately after the injection. While I was sitting in the recovery area I started feeling palpitations and Shortness of breath. I actually felt I was going into cardiac arrest. Personnel started assessing me and upon checking my vital signs my  SBP was in 150?s-160?s and DBP was in 100?s range. Normally my BP ranges in 110?s. I also started feeling numbness on my left arm. My bilateral lower extremities were also numb, tingling, burning and very weak. I was not able to stand up and bear weight. I then was taken to the ED where blood work was done and ATIVAN Po was given. I was then discharged at 2325. The next morning, I felt my legs are still heavy and sore. They are still very heavy and sore while I am writing this and I feel like they will buckle when I walk.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Received Covid 19 vaccine on left deltoid via IM. I felt warm in my left deltoid immediately after the injection. While I was sitting in the recovery area I started feeling palpitations and Shortness of breath. I actually felt I was going into cardiac arrest. Personnel started assessing me and upon checking my vital signs my  SBP was in 150?s-160?s and DBP was in 100?s range. Normally my BP ranges in 110?s. I also started feeling numbness on my left arm. My bilateral lower extremities were also numb, tingling, burning and very weak. I was not able to stand up and bear weight. I then was taken to the ED where blood work was done and ATIVAN Po was given. I was then discharged at 2325. The next morning, I felt my legs are still heavy and sore. They are still very heavy and sore while I am writing this and I feel like they will buckle when I walk.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Gait disturbance, Muscular weakness
Clinical narrative: Patient awoke at 2 am and felt like she could not breathe.  felt hot, tight, and severely weak.  Had chills and shaking.  No fever.  Patient was transported by ambulance, observed in the Emergency department until 5 am and discharged home.  Patient received oral acetaminophen in the ED.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oesophageal discomfort, Tremor
Clinical narrative: Patient awoke at 2 am and felt like she could not breathe.  felt hot, tight, and severely weak.  Had chills and shaking.  No fever.  Patient was transported by ambulance, observed in the Emergency department until 5 am and discharged home.  Patient received oral acetaminophen in the ED.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: Patient awoke at 2 am and felt like she could not breathe.  felt hot, tight, and severely weak.  Had chills and shaking.  No fever.  Patient was transported by ambulance, observed in the Emergency department until 5 am and discharged home.  Patient received oral acetaminophen in the ED.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Patient awoke at 2 am and felt like she could not breathe.  felt hot, tight, and severely weak.  Had chills and shaking.  No fever.  Patient was transported by ambulance, observed in the Emergency department until 5 am and discharged home.  Patient received oral acetaminophen in the ED.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Palpitations, SARS-CoV-2 test negative
Clinical narrative: 1-2 minutes after injection a whole body flush developed along with heart palpitations, tingly throat and tongue, and a rash across the chest and neck.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Palpitations, Paraesthesia oral, Pharyngeal paraesthesia, Rash
Clinical narrative: 1-2 minutes after injection a whole body flush developed along with heart palpitations, tingly throat and tongue, and a rash across the chest and neck.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: 1-2 minutes after injection a whole body flush developed along with heart palpitations, tingly throat and tongue, and a rash across the chest and neck.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Approximately 20-25 minutes after the vaccine my lips and tip of my tongue started tingling, then approximately 20 minutes after that my nose and forehead started to feel numb. I was instructed to take Benadryl and come into be observed. The tingling sensation decreased a little after a few hours but continued throughout the night. The numbness of nose and forehead went away later that evening around 9. When I woke up the next morning the tingling sensation of my lips was gone but then returned later in the morning around 11. Breathing and airway were not impaired.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Approximately 20-25 minutes after the vaccine my lips and tip of my tongue started tingling, then approximately 20 minutes after that my nose and forehead started to feel numb. I was instructed to take Benadryl and come into be observed. The tingling sensation decreased a little after a few hours but continued throughout the night. The numbness of nose and forehead went away later that evening around 9. When I woke up the next morning the tingling sensation of my lips was gone but then returned later in the morning around 11. Breathing and airway were not impaired.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Approximately 20-25 minutes after the vaccine my lips and tip of my tongue started tingling, then approximately 20 minutes after that my nose and forehead started to feel numb. I was instructed to take Benadryl and come into be observed. The tingling sensation decreased a little after a few hours but continued throughout the night. The numbness of nose and forehead went away later that evening around 9. When I woke up the next morning the tingling sensation of my lips was gone but then returned later in the morning around 11. Breathing and airway were not impaired.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest discomfort, Dizziness, Troponin increased
Clinical narrative: difficult breathing and four extremities weakness
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood pressure increased, Chest pain, Muscular weakness
Clinical narrative: difficult breathing and four extremities weakness
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Computerised tomogram, Dyspnoea, Electrocardiogram, Muscular weakness
Clinical narrative: difficult breathing and four extremities weakness
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oral pruritus, Oropharyngeal discomfort, Pruritus, Sensation of foreign body
Clinical narrative: pt had mouth, throat swelling, difficulty swallowing was transferred to ED
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Wheezing
Clinical narrative: pt had mouth, throat swelling, difficulty swallowing was transferred to ED
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Mouth swelling, Pharyngeal swelling
Clinical narrative: pt had mouth, throat swelling, difficulty swallowing was transferred to ED
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Hearing Loss; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions at a medical office. Subsequent to the inoculation (date not reported), the patient was treated by a physician for hearing loss and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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. The outcome of the event hearing loss and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. In or around 2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a painful and burning rash across her body. The patient was diagnosed with shingles as a result of receiving zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered.    The lawyer considered the events shingles to be disability.
Age: 19.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose of Vivotif two days after taking first dose and took subsequent doses correctly; Spontaneous report received on 02NOV2020.  A healthcare professional reported that a male consumer "took second dose of Vivotif two days after taking first dose and took subsequent doses correctly" (PT: Inappropriate schedule of product administration). He was receiving Vivotif for immunisation. On 28OCT2020, Vivotif was dispensed to consumer and he took the first dose of Vivotif on same day. The consumer took his second dose incorrectly after a gap of two days (on 31OCT2020) instead of every other day as recommended. He took his subsequent dose correctly. He had not taken all four doses of Vivotif yet. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took second dose of Vivotif two days after taking first dose, and took subsequent doses correctly (inappropriate schedule of product administration). Vivotif doses should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took second dose of Vivotif two days after taking first dose, and took subsequent doses correctly (inappropriate schedule of product administration). Vivotif doses should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Eczema, Pruritus, Rash, Rash pruritic
Clinical narrative: eczema; Pruritic rash; Mild redness; Generalize rash, worsening rash; itching all over body; This case was reported by a lawyer and described the occurrence of eczema in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for product used for unknown indication.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, an unknown time after receiving Shingrix, the patient experienced eczema and itchy rash. On an unknown date, the outcome of the eczema and itchy rash were unknown.   It was unknown if the reporter considered the eczema and itchy rash to be related to Shingrix.  The initial information was received on 10 December 2020 via medical record. (Case medically confirmed). On 18 September 2020 the patient received recombinant Zoster(Shingles) vaccine 0.5ml in right deltoid. As per report dated on 08 October 2020 The patient had itching all over the body, in the morning he had rashes was given prednisone. The patient rash was worsening to legs and arms causing him to became very itchy. As per emergency department note dated on 14 October 2020, 76 year old male with multiple medical problems presents with pruritic rash that was diffuse and mostly noted on the extensor surface of his body as well as the intercrural region of his groin. The patient has been doing with this on and off for several weeks now since getting immunization of shingles, Tetanus, pneumonia. The patient had some Eczematous rash on extensor surfaces of leg, arms and intercrural region of his groin with some lichenification. The patient had mild redness. The patient had generalized rash and pain.