chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Hypersomnia
Clinical narrative: He took the vaccine and was shaky about 30 minutes following the vaccine, and had coffee in the car but could not hold it to drink it due to the shakes.  They got home, and they ate something and around 2:00 PM his nephrologist called and told him to stop taking the Lasix as there was something wrong with his kidney's.   He went to bed as he was so tired and still shaking.  His wife let him rest that night.  The next morning on 2/12/21 he woke up, checked his sugar and wrote down his #'s, and he did eat something, and went back to sleep, and she woke him up to eat again, and ate something, and went back to sleep.  On Saturday morning 2/13/21 she got him up and he was able to eat something and she gave him something to drink and had him read the cup which said "you are loved".  He then went right back to sleep.  She then woke him up for snacks which was normal and he went back to sleep.  He went back to sleep and looked at him around 7:00 and he was breathing fine and then told him that she was going to get up and make something to eat around 8 and tried to wake him up and realized that he had died as he was cold and did not respond.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Peripheral coldness, Renal disorder, Tremor
Clinical narrative: He took the vaccine and was shaky about 30 minutes following the vaccine, and had coffee in the car but could not hold it to drink it due to the shakes.  They got home, and they ate something and around 2:00 PM his nephrologist called and told him to stop taking the Lasix as there was something wrong with his kidney's.   He went to bed as he was so tired and still shaking.  His wife let him rest that night.  The next morning on 2/12/21 he woke up, checked his sugar and wrote down his #'s, and he did eat something, and went back to sleep, and she woke him up to eat again, and ate something, and went back to sleep.  On Saturday morning 2/13/21 she got him up and he was able to eat something and she gave him something to drink and had him read the cup which said "you are loved".  He then went right back to sleep.  She then woke him up for snacks which was normal and he went back to sleep.  He went back to sleep and looked at him around 7:00 and he was breathing fine and then told him that she was going to get up and make something to eat around 8 and tried to wake him up and realized that he had died as he was cold and did not respond.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: He took the vaccine and was shaky about 30 minutes following the vaccine, and had coffee in the car but could not hold it to drink it due to the shakes.  They got home, and they ate something and around 2:00 PM his nephrologist called and told him to stop taking the Lasix as there was something wrong with his kidney's.   He went to bed as he was so tired and still shaking.  His wife let him rest that night.  The next morning on 2/12/21 he woke up, checked his sugar and wrote down his #'s, and he did eat something, and went back to sleep, and she woke him up to eat again, and ate something, and went back to sleep.  On Saturday morning 2/13/21 she got him up and he was able to eat something and she gave him something to drink and had him read the cup which said "you are loved".  He then went right back to sleep.  She then woke him up for snacks which was normal and he went back to sleep.  He went back to sleep and looked at him around 7:00 and he was breathing fine and then told him that she was going to get up and make something to eat around 8 and tried to wake him up and realized that he had died as he was cold and did not respond.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: had a soreness on the arm; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm (unspecified) on 28Jan2021, as single dose for COVID-19 immunisation. Patient's medical history included Acid reflux, Meniere's disease, arthritis in her neck (neuropathic pain) and nausea on 26Jan2021. Concomitant medications included rivaroxaban (XARELTO) as a  blood thinner. Patient stated that she had first dose of the vaccine last Thursday (28Jan2021) and scheduled to take the second dose of the COVID-19 vaccine on 13Feb2021. She mentioned that she didn't have any problem until (26Jan2021) when she experienced nausea. She mentioned it was not continuous but an "on and off" thing. She wasn't sure if it could be attributed to the COVID-19 vaccine, her acid reflux, her Meniere's disease, or her arthritis in her neck (neuropathic pain). She also mentioned that she was taking Xarelto (blood thinner). Patient clarified that she took a Xarelto before and after her first dose. Patient had a soreness on the arm after the first dose. Reported that hopefully she can take the second dose of the vaccine on 13Feb2021. Patient was questioned that is it ok if continue the Xarelto (blood thinner) on the day of vaccination. Patient asked about the other reactions of the vaccine because she has multiple health issues. Outcome of the event was unknown.     Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a soreness on the arm; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm (unspecified) on 28Jan2021, as single dose for COVID-19 immunisation. Patient's medical history included Acid reflux, Meniere's disease, arthritis in her neck (neuropathic pain) and nausea on 26Jan2021. Concomitant medications included rivaroxaban (XARELTO) as a  blood thinner. Patient stated that she had first dose of the vaccine last Thursday (28Jan2021) and scheduled to take the second dose of the COVID-19 vaccine on 13Feb2021. She mentioned that she didn't have any problem until (26Jan2021) when she experienced nausea. She mentioned it was not continuous but an "on and off" thing. She wasn't sure if it could be attributed to the COVID-19 vaccine, her acid reflux, her Meniere's disease, or her arthritis in her neck (neuropathic pain). She also mentioned that she was taking Xarelto (blood thinner). Patient clarified that she took a Xarelto before and after her first dose. Patient had a soreness on the arm after the first dose. Reported that hopefully she can take the second dose of the vaccine on 13Feb2021. Patient was questioned that is it ok if continue the Xarelto (blood thinner) on the day of vaccination. Patient asked about the other reactions of the vaccine because she has multiple health issues. Outcome of the event was unknown.     Information on the Batch/Lot number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disability, Impaired driving ability, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periarthritis
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injury, Product administration error
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: questioning Rheumatoid Arthritis; Pain in feet, ankles, knees, shoulders, neck and wrists; Feels like all of my joints are broken; stiff neck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in the right arm on 20Jan2021 14:30 PM at single dose for covid-19 immunisation. The patient was not pregnant. Medical history included Lupus. No known allergies. Concomitant medication (other medications in two weeks) included melatonin and ibuprofen. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. The patient experienced feels like all of my joints are broken, questioning Rheumatoid Arthritis. Pain in feet, ankles, knees, shoulders, neck and wrists. Stiff neck. All from 23Jan2021 06:00 AM and resulted in Doctor or other healthcare professional office/clinic visit. Treatment epi for events included Medrol steroid shot. The outcome of events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint injury, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: questioning Rheumatoid Arthritis; Pain in feet, ankles, knees, shoulders, neck and wrists; Feels like all of my joints are broken; stiff neck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in the right arm on 20Jan2021 14:30 PM at single dose for covid-19 immunisation. The patient was not pregnant. Medical history included Lupus. No known allergies. Concomitant medication (other medications in two weeks) included melatonin and ibuprofen. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. The patient experienced feels like all of my joints are broken, questioning Rheumatoid Arthritis. Pain in feet, ankles, knees, shoulders, neck and wrists. Stiff neck. All from 23Jan2021 06:00 AM and resulted in Doctor or other healthcare professional office/clinic visit. Treatment epi for events included Medrol steroid shot. The outcome of events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Ear pain, Frequent bowel movements, Myalgia
Clinical narrative: Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Frequent bowel movements, Head discomfort, Muscle spasms
Clinical narrative: Frequent bowel movements 24hrs, ear popping and pain 24 hrs, weird head feeling (not a headache) 48 hrs, leg cramps began maybe a couple of days later and still continue over a month later, high fever lasting 3 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Delirium, Dizziness, Fatigue, Heart rate irregular
Clinical narrative: had some delirium; fever of 100.0; Arm and shoulder pain; Arm and shoulder pain; fatigue; dizziness; nausea; mild diarrhea; achiness; headache; This is a spontaneous report from a Pfizer sponsored program- Company Information via contactable consumer. A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot no. EL9269), via an unspecified route of administration on 12Feb2021 19:30 at single dose, covid-19 immunisation. Anatomical Location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EL8982, Anatomical Location: left arm) on 22Jan2021 08:00 PM. Medical history included allergies (allergies: Some antibiotics), PTSD, anxiety, possible IBS, irregular heartbeat at times. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and  fluoxetine. On 13Feb2021 01:15 AM, patient experience arm and shoulder pain, fatigue, fever of 100.0, dizziness, mild nausea and diarrhea, achiness, headache and had some delirium with fever, patient think it was related to her PTSD as well and not just the fever. Patient not had COVID prior vaccination. Patient was not tested COVID post vaccination. The outcome of the event was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: had some delirium; fever of 100.0; Arm and shoulder pain; Arm and shoulder pain; fatigue; dizziness; nausea; mild diarrhea; achiness; headache; This is a spontaneous report from a Pfizer sponsored program- Company Information via contactable consumer. A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot no. EL9269), via an unspecified route of administration on 12Feb2021 19:30 at single dose, covid-19 immunisation. Anatomical Location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EL8982, Anatomical Location: left arm) on 22Jan2021 08:00 PM. Medical history included allergies (allergies: Some antibiotics), PTSD, anxiety, possible IBS, irregular heartbeat at times. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and  fluoxetine. On 13Feb2021 01:15 AM, patient experience arm and shoulder pain, fatigue, fever of 100.0, dizziness, mild nausea and diarrhea, achiness, headache and had some delirium with fever, patient think it was related to her PTSD as well and not just the fever. Patient not had COVID prior vaccination. Patient was not tested COVID post vaccination. The outcome of the event was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Delirium, Diarrhoea, Dizziness, Fatigue
Clinical narrative: had some delirium; fever of 100.0; Arm and shoulder pain; Arm and shoulder pain; fatigue; dizziness; nausea; mild diarrhea; achiness; headache; This is a spontaneous report from a Pfizer sponsored program- Company Information via contactable consumer. A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot no. EL9269), via an unspecified route of administration on 12Feb2021 19:30 at single dose, covid-19 immunisation. Anatomical Location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EL8982, Anatomical Location: left arm) on 22Jan2021 08:00 PM. Medical history included allergies (allergies: Some antibiotics), PTSD, anxiety, possible IBS, irregular heartbeat at times. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and  fluoxetine. On 13Feb2021 01:15 AM, patient experience arm and shoulder pain, fatigue, fever of 100.0, dizziness, mild nausea and diarrhea, achiness, headache and had some delirium with fever, patient think it was related to her PTSD as well and not just the fever. Patient not had COVID prior vaccination. Patient was not tested COVID post vaccination. The outcome of the event was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: had some delirium; fever of 100.0; Arm and shoulder pain; Arm and shoulder pain; fatigue; dizziness; nausea; mild diarrhea; achiness; headache; This is a spontaneous report from a Pfizer sponsored program- Company Information via contactable consumer. A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot no. EL9269), via an unspecified route of administration on 12Feb2021 19:30 at single dose, covid-19 immunisation. Anatomical Location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EL8982, Anatomical Location: left arm) on 22Jan2021 08:00 PM. Medical history included allergies (allergies: Some antibiotics), PTSD, anxiety, possible IBS, irregular heartbeat at times. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) and  fluoxetine. On 13Feb2021 01:15 AM, patient experience arm and shoulder pain, fatigue, fever of 100.0, dizziness, mild nausea and diarrhea, achiness, headache and had some delirium with fever, patient think it was related to her PTSD as well and not just the fever. Patient not had COVID prior vaccination. Patient was not tested COVID post vaccination. The outcome of the event was recovering.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Pain, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: patient reported developing shingles 3 days after receiving shot
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: patient reported developing shingles 3 days after receiving shot
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, Cardiac flutter, Syncope
Clinical narrative: fell faint(fainted); heart flutters; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, intramuscular on 29Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included MVA (motor vehicle accident), TBI (traumatic brain injury) in 2007, vagovasal and Hypotension post TBI (traumatic brain injury), Celiac Disease. The patient had known allergies: ibuprofen and milk products. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), folic acid, ibuprofen and progesterone. On 29Jan2021 14:15, the patient experienced heart flutters and "fell faint" (fainted) and assisted safely to the ground. Patient was monitored and released. No treatment given. The patient had no other vaccines in the last four weeks. The patient has not tested positive for COVID post vaccination. The outcome of the events was recovered on Jan2021. The events were assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded.This case will be re-evaluated upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac flutter, Syncope
Clinical narrative: fell faint(fainted); heart flutters; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, intramuscular on 29Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included MVA (motor vehicle accident), TBI (traumatic brain injury) in 2007, vagovasal and Hypotension post TBI (traumatic brain injury), Celiac Disease. The patient had known allergies: ibuprofen and milk products. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), folic acid, ibuprofen and progesterone. On 29Jan2021 14:15, the patient experienced heart flutters and "fell faint" (fainted) and assisted safely to the ground. Patient was monitored and released. No treatment given. The patient had no other vaccines in the last four weeks. The patient has not tested positive for COVID post vaccination. The outcome of the events was recovered on Jan2021. The events were assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded.This case will be re-evaluated upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Pruritus, Syncope
Clinical narrative: fell faint(fainted); heart flutters; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number: EL3246, intramuscular on 29Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included MVA (motor vehicle accident), TBI (traumatic brain injury) in 2007, vagovasal and Hypotension post TBI (traumatic brain injury), Celiac Disease. The patient had known allergies: ibuprofen and milk products. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), folic acid, ibuprofen and progesterone. On 29Jan2021 14:15, the patient experienced heart flutters and "fell faint" (fainted) and assisted safely to the ground. Patient was monitored and released. No treatment given. The patient had no other vaccines in the last four weeks. The patient has not tested positive for COVID post vaccination. The outcome of the events was recovered on Jan2021. The events were assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded.This case will be re-evaluated upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling in lips and tongue; This is a spontaneous report from a contactable consumer reported that a 69-year-old female non-pregnant patient (consumer) received first dose of BNT162B2 (COVID 19, brand: Pfizer, lot number: EN6198, Solution for injection) via an unspecified route of administration on 24Feb2021 at 15:45 on Right arm for COVID-19 immunization. Patient medical history included Sjogrens Syndrome, known allergies: Penicillin. Concomitant medications included gabapentin at 600 mg and betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) (received both within 2 weeks of vaccination). The most recent COVID-19 vaccine was administered on Public Health Clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 at 03:45 AM, patient had tingling in lips and tongue. Treatment received for the adverse event was Benadryl. No seriousness criteria was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date in Feb2021.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia, Throat irritation, Throat tightness
Clinical narrative: Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV.  She then refused transport again and departed.  10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Pruritus, Throat tightness
Clinical narrative: Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV.  She then refused transport again and departed.  10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Pruritus, Throat tightness
Clinical narrative: Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV.  She then refused transport again and departed.  10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Appendicitis, Computerised tomogram abnormal, Culture wound, Full blood count
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metabolic function test
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Computerised tomogram, Culture
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count, Human chorionic gonadotropin, Incisional drainage, Metabolic function test, Urine analysis
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Wound infection
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Appendicitis, SARS-CoV-2 test negative
Clinical narrative: Please link to patient's VAERS report:1057000 dated 2/26/2021  Acute appendicitis, s/p appendectomy. Superficial wound infection requiring I&D. Persistent RLQ pain
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Ocular hyperaemia, Pruritus
Clinical narrative: 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; increase SOB; tightness chest; facial swelling; eye redness; flushing; This is a spontaneous report from a contactable Pharmacist. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EN6198,) via intramuscular route of administration on 29Jan2021 at 24:00 SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's family medical history included sports induced asthma and gallstones from an unknown date and unknown if ongoing. The patient experienced 15:30 approximately 10 minutes after receiving vaccine patient reported and had notable facial swelling, eye redness and flushing on 19Feb2021 at 15:15. The patient underwent lab tests and procedures which included blood pressure measurement: 118/86, heart rate: 100, Respiratory rate: 18, oxygen saturation: 96 % and blood pressure measurement: 112/82, heart rate: 123, Respiratory rate: 18, oxygen saturation: 98 % an unspecified date. The events were assessed as non-serious by the reporter. The patient received treatment with 0.15 Epinephrine IM via home Epi- Pen self-delivered by patient's mother. The outcome of the events as unknown.  No further follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relationship, the association between the onset of throat irritation, pruritus, dyspnea, chest discomfort, swelling face, ocular hyperemia and flushing and administration of vaccine cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat irritation
Clinical narrative: 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; increase SOB; tightness chest; facial swelling; eye redness; flushing; This is a spontaneous report from a contactable Pharmacist. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EN6198,) via intramuscular route of administration on 29Jan2021 at 24:00 SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's family medical history included sports induced asthma and gallstones from an unknown date and unknown if ongoing. The patient experienced 15:30 approximately 10 minutes after receiving vaccine patient reported and had notable facial swelling, eye redness and flushing on 19Feb2021 at 15:15. The patient underwent lab tests and procedures which included blood pressure measurement: 118/86, heart rate: 100, Respiratory rate: 18, oxygen saturation: 96 % and blood pressure measurement: 112/82, heart rate: 123, Respiratory rate: 18, oxygen saturation: 98 % an unspecified date. The events were assessed as non-serious by the reporter. The patient received treatment with 0.15 Epinephrine IM via home Epi- Pen self-delivered by patient's mother. The outcome of the events as unknown.  No further follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relationship, the association between the onset of throat irritation, pruritus, dyspnea, chest discomfort, swelling face, ocular hyperemia and flushing and administration of vaccine cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Dyspnoea, Flushing, Heart rate
Clinical narrative: 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; increase SOB; tightness chest; facial swelling; eye redness; flushing; This is a spontaneous report from a contactable Pharmacist. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EN6198,) via intramuscular route of administration on 29Jan2021 at 24:00 SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's family medical history included sports induced asthma and gallstones from an unknown date and unknown if ongoing. The patient experienced 15:30 approximately 10 minutes after receiving vaccine patient reported and had notable facial swelling, eye redness and flushing on 19Feb2021 at 15:15. The patient underwent lab tests and procedures which included blood pressure measurement: 118/86, heart rate: 100, Respiratory rate: 18, oxygen saturation: 96 % and blood pressure measurement: 112/82, heart rate: 123, Respiratory rate: 18, oxygen saturation: 98 % an unspecified date. The events were assessed as non-serious by the reporter. The patient received treatment with 0.15 Epinephrine IM via home Epi- Pen self-delivered by patient's mother. The outcome of the events as unknown.  No further follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relationship, the association between the onset of throat irritation, pruritus, dyspnea, chest discomfort, swelling face, ocular hyperemia and flushing and administration of vaccine cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ocular hyperaemia, Oxygen saturation, Pruritus, Respiratory rate, Swelling face
Clinical narrative: 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; increase SOB; tightness chest; facial swelling; eye redness; flushing; This is a spontaneous report from a contactable Pharmacist. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EN6198,) via intramuscular route of administration on 29Jan2021 at 24:00 SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's family medical history included sports induced asthma and gallstones from an unknown date and unknown if ongoing. The patient experienced 15:30 approximately 10 minutes after receiving vaccine patient reported and had notable facial swelling, eye redness and flushing on 19Feb2021 at 15:15. The patient underwent lab tests and procedures which included blood pressure measurement: 118/86, heart rate: 100, Respiratory rate: 18, oxygen saturation: 96 % and blood pressure measurement: 112/82, heart rate: 123, Respiratory rate: 18, oxygen saturation: 98 % an unspecified date. The events were assessed as non-serious by the reporter. The patient received treatment with 0.15 Epinephrine IM via home Epi- Pen self-delivered by patient's mother. The outcome of the events as unknown.  No further follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relationship, the association between the onset of throat irritation, pruritus, dyspnea, chest discomfort, swelling face, ocular hyperemia and flushing and administration of vaccine cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; 1530: Approximately 10 minutes after receiving vaccine patient reported having itching to throat, and hands; increase SOB; tightness chest; facial swelling; eye redness; flushing; This is a spontaneous report from a contactable Pharmacist. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EN6198,) via intramuscular route of administration on 29Jan2021 at 24:00 SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's family medical history included sports induced asthma and gallstones from an unknown date and unknown if ongoing. The patient experienced 15:30 approximately 10 minutes after receiving vaccine patient reported and had notable facial swelling, eye redness and flushing on 19Feb2021 at 15:15. The patient underwent lab tests and procedures which included blood pressure measurement: 118/86, heart rate: 100, Respiratory rate: 18, oxygen saturation: 96 % and blood pressure measurement: 112/82, heart rate: 123, Respiratory rate: 18, oxygen saturation: 98 % an unspecified date. The events were assessed as non-serious by the reporter. The patient received treatment with 0.15 Epinephrine IM via home Epi- Pen self-delivered by patient's mother. The outcome of the events as unknown.  No further follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relationship, the association between the onset of throat irritation, pruritus, dyspnea, chest discomfort, swelling face, ocular hyperemia and flushing and administration of vaccine cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Dysphagia, Fatigue, Heart rate increased
Clinical narrative: I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pain, Panic attack, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sleep disorder, Speech disorder, Swollen tongue, Tongue discomfort
Clinical narrative: I had an allergic reaction; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; I experienced a tingling feeling in my lips, which then spread to my mouth, throat and tongue.; lightheaded; elevated heart rate; tongue was swollen; my tongue felt like it was numb/burnt by drinking a hot liquid; my tongue felt like it was numb/burnt by drinking a hot liquid; woke up in the middle of the night; trouble sleeping; This is a spontaneous report from contactable consumers (one is the patient). A 28-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6203), via an unspecified route of administration in the left arm on 25Feb2021 15:30 at a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, migraines, asthma, hay fever, acid reflux, hives when exercising outdoors in the cold, and allergies: latex, cats, dustmites, gluten and dairy intolerance; all from unknown dates. Concomitant medications included sumatriptan, bupropion, pepsin, calcium carbonate and unspecified herbs. The patient did not received other vaccine in four weeks. The patient previously took fluconazole (DIFLUCAN) and experienced allergies. A few minutes after taking the vaccine, the patient experienced a tingling feeling in lips, which then spread to mouth, throat and tongue. The patient told a nurse and she said that she looked fine. The patient asked if lips were swollen but they weren't. Then a few minutes later she felt very lightheaded and had an elevated heart rate. Then around this time, she saw her tongue was swollen to about double the size. The nurse said she looked fine, and monitored her for 30 minutes then let her go. This swollen tongue lasted for about 2.5 - 3 hours. After the swelling subsided, tongue felt like it was numb/burnt by drinking a hot liquid. 12 hours later, she woke up in the middle of the night with an elevated heart rate and had trouble sleeping. The patient spoke to her doctor and it sounds like she had an allergic reaction, even though she have no history of allergies for any of the vaccine ingredients. Onset date of all events were reported as 25Feb2021 15:30. Outcome of all events reported as recovered on an unspecified date. No treatment was given for all events. The patient was not diagnosed of covid prior vaccination and has not tested for covid post vaccination.