chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Arthralgia, Asthenia, Burning sensation, Chest X-ray
Clinical narrative: ALLERGIC REACTION TO VACCINE; COLLAPSED LUNG; HURT TO BREATHE; BURNING SENSATION ON RIB CAGE GOING TO BACK; NOT FEELING GOOD; WEAKNESS; SEVERE HEADACHE; KNEES BREAKING; TEETH SHATTERING; VERY COLD; HURT TO WALK; BLURRED VISION; SHAKY; DIZZINESS; HURT TO TALK; HURT TO DRIVE; PAIN; This spontaneous report received from a patient via email concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry : unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Apr-2021, the patient experienced hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain. On 08-APR-2021, the patient experienced very cold, knees breaking, teeth shattering, severe headache. On 09-APR-2021, the patient experienced not feeling good, weakness. On 15-APR-2021, the patient experienced hurt to breathe, burning sensation on rib cage going to back. On 17-APR-2021, the patient experienced collapsed lung on same day the patient visited emergency room and the doctor gave something for pain via intravenous. The doctor has said to take deep breaths every hour on the hour and to drink lots of water. Laboratory data included: CT scan (NR: not provided) NOT REPORTED, Chest X-ray (NR: not provided) NOT REPORTED, EKG (NR: not provided) NOT REPORTED, and Laboratory test (NR: not provided) NOT REPORTED. On 22-APR-2021, the patient experienced allergic reaction to vaccine. The patient has visited the family doctor on 22-Apr-2021 and doctor gave Gabapentin 100mg 3 times a day and Tramadol every 6 hours for pain. The patient called the doctor as the patient was having pain and is taking 300 mg of gabapentin twice a day and it was still not working. The patient was having an appointment with Dr. again on 30-Apr-2021. Treatment medications (dates unspecified) included: tramadol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, hurt to breathe, burning sensation on rib cage going to back, hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain, and the outcome of very cold, teeth shattering, severe headache, knees breaking, not feeling good, collapsed lung and allergic reaction to vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210456498-COVID-19 VACCINE AD26.COV2.S-collapsed lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Dizziness, Electrocardiogram, Gait disturbance
Clinical narrative: ALLERGIC REACTION TO VACCINE; COLLAPSED LUNG; HURT TO BREATHE; BURNING SENSATION ON RIB CAGE GOING TO BACK; NOT FEELING GOOD; WEAKNESS; SEVERE HEADACHE; KNEES BREAKING; TEETH SHATTERING; VERY COLD; HURT TO WALK; BLURRED VISION; SHAKY; DIZZINESS; HURT TO TALK; HURT TO DRIVE; PAIN; This spontaneous report received from a patient via email concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry : unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Apr-2021, the patient experienced hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain. On 08-APR-2021, the patient experienced very cold, knees breaking, teeth shattering, severe headache. On 09-APR-2021, the patient experienced not feeling good, weakness. On 15-APR-2021, the patient experienced hurt to breathe, burning sensation on rib cage going to back. On 17-APR-2021, the patient experienced collapsed lung on same day the patient visited emergency room and the doctor gave something for pain via intravenous. The doctor has said to take deep breaths every hour on the hour and to drink lots of water. Laboratory data included: CT scan (NR: not provided) NOT REPORTED, Chest X-ray (NR: not provided) NOT REPORTED, EKG (NR: not provided) NOT REPORTED, and Laboratory test (NR: not provided) NOT REPORTED. On 22-APR-2021, the patient experienced allergic reaction to vaccine. The patient has visited the family doctor on 22-Apr-2021 and doctor gave Gabapentin 100mg 3 times a day and Tramadol every 6 hours for pain. The patient called the doctor as the patient was having pain and is taking 300 mg of gabapentin twice a day and it was still not working. The patient was having an appointment with Dr. again on 30-Apr-2021. Treatment medications (dates unspecified) included: tramadol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, hurt to breathe, burning sensation on rib cage going to back, hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain, and the outcome of very cold, teeth shattering, severe headache, knees breaking, not feeling good, collapsed lung and allergic reaction to vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210456498-COVID-19 VACCINE AD26.COV2.S-collapsed lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Impaired driving ability, Laboratory test, Malaise, Nasopharyngitis
Clinical narrative: ALLERGIC REACTION TO VACCINE; COLLAPSED LUNG; HURT TO BREATHE; BURNING SENSATION ON RIB CAGE GOING TO BACK; NOT FEELING GOOD; WEAKNESS; SEVERE HEADACHE; KNEES BREAKING; TEETH SHATTERING; VERY COLD; HURT TO WALK; BLURRED VISION; SHAKY; DIZZINESS; HURT TO TALK; HURT TO DRIVE; PAIN; This spontaneous report received from a patient via email concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry : unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Apr-2021, the patient experienced hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain. On 08-APR-2021, the patient experienced very cold, knees breaking, teeth shattering, severe headache. On 09-APR-2021, the patient experienced not feeling good, weakness. On 15-APR-2021, the patient experienced hurt to breathe, burning sensation on rib cage going to back. On 17-APR-2021, the patient experienced collapsed lung on same day the patient visited emergency room and the doctor gave something for pain via intravenous. The doctor has said to take deep breaths every hour on the hour and to drink lots of water. Laboratory data included: CT scan (NR: not provided) NOT REPORTED, Chest X-ray (NR: not provided) NOT REPORTED, EKG (NR: not provided) NOT REPORTED, and Laboratory test (NR: not provided) NOT REPORTED. On 22-APR-2021, the patient experienced allergic reaction to vaccine. The patient has visited the family doctor on 22-Apr-2021 and doctor gave Gabapentin 100mg 3 times a day and Tramadol every 6 hours for pain. The patient called the doctor as the patient was having pain and is taking 300 mg of gabapentin twice a day and it was still not working. The patient was having an appointment with Dr. again on 30-Apr-2021. Treatment medications (dates unspecified) included: tramadol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, hurt to breathe, burning sensation on rib cage going to back, hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain, and the outcome of very cold, teeth shattering, severe headache, knees breaking, not feeling good, collapsed lung and allergic reaction to vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210456498-COVID-19 VACCINE AD26.COV2.S-collapsed lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Painful respiration, Pneumothorax, Speech disorder, Tremor
Clinical narrative: ALLERGIC REACTION TO VACCINE; COLLAPSED LUNG; HURT TO BREATHE; BURNING SENSATION ON RIB CAGE GOING TO BACK; NOT FEELING GOOD; WEAKNESS; SEVERE HEADACHE; KNEES BREAKING; TEETH SHATTERING; VERY COLD; HURT TO WALK; BLURRED VISION; SHAKY; DIZZINESS; HURT TO TALK; HURT TO DRIVE; PAIN; This spontaneous report received from a patient via email concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry : unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Apr-2021, the patient experienced hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain. On 08-APR-2021, the patient experienced very cold, knees breaking, teeth shattering, severe headache. On 09-APR-2021, the patient experienced not feeling good, weakness. On 15-APR-2021, the patient experienced hurt to breathe, burning sensation on rib cage going to back. On 17-APR-2021, the patient experienced collapsed lung on same day the patient visited emergency room and the doctor gave something for pain via intravenous. The doctor has said to take deep breaths every hour on the hour and to drink lots of water. Laboratory data included: CT scan (NR: not provided) NOT REPORTED, Chest X-ray (NR: not provided) NOT REPORTED, EKG (NR: not provided) NOT REPORTED, and Laboratory test (NR: not provided) NOT REPORTED. On 22-APR-2021, the patient experienced allergic reaction to vaccine. The patient has visited the family doctor on 22-Apr-2021 and doctor gave Gabapentin 100mg 3 times a day and Tramadol every 6 hours for pain. The patient called the doctor as the patient was having pain and is taking 300 mg of gabapentin twice a day and it was still not working. The patient was having an appointment with Dr. again on 30-Apr-2021. Treatment medications (dates unspecified) included: tramadol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, hurt to breathe, burning sensation on rib cage going to back, hurt to walk, blurred vision, shaky, dizziness, hurt to talk, hurt to drive, and pain, and the outcome of very cold, teeth shattering, severe headache, knees breaking, not feeling good, collapsed lung and allergic reaction to vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210456498-COVID-19 VACCINE AD26.COV2.S-collapsed lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Pain, Swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient already reported her reaction but I just wanted to fill out a report as well. She was fine waiting the 30 minutes after her vaccine however started to have symptoms about 4 hours later which took about 5 days to completely clear back up. She has swelling at the site which went up into her lymph nodes. She took benadryl and ibuprofen to control her symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient already reported her reaction but I just wanted to fill out a report as well. She was fine waiting the 30 minutes after her vaccine however started to have symptoms about 4 hours later which took about 5 days to completely clear back up. She has swelling at the site which went up into her lymph nodes. She took benadryl and ibuprofen to control her symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal exploration, Abdominal pain upper, Arthralgia, Back pain, Headache
Clinical narrative: A patients caregiver received a dose of Janssen COVID-19 vaccine at this facility on 3/24/2021. He was monitored for 20 minutes and there were no adverse reactions noted at that time.  Family reported to the facility that the patient was subsequently admitted to the hospital and expired approximately 10 days post-vaccine.   *Item #5 date entered to allow form submission, onset of adverse reaction unknown.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Nausea, Vomiting
Clinical narrative: A patients caregiver received a dose of Janssen COVID-19 vaccine at this facility on 3/24/2021. He was monitored for 20 minutes and there were no adverse reactions noted at that time.  Family reported to the facility that the patient was subsequently admitted to the hospital and expired approximately 10 days post-vaccine.   *Item #5 date entered to allow form submission, onset of adverse reaction unknown.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: A patients caregiver received a dose of Janssen COVID-19 vaccine at this facility on 3/24/2021. He was monitored for 20 minutes and there were no adverse reactions noted at that time.  Family reported to the facility that the patient was subsequently admitted to the hospital and expired approximately 10 days post-vaccine.   *Item #5 date entered to allow form submission, onset of adverse reaction unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Throat clearing, Urticaria
Clinical narrative: Within 3 minutes my ear began to itch and swell. The swelling went down my neck into my throat. Anaphylactic results.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Ear swelling, Pharyngeal swelling, Pruritus, Swelling
Clinical narrative: Within 3 minutes my ear began to itch and swell. The swelling went down my neck into my throat. Anaphylactic results.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and rash developed within 48 hours. Was prescribed Methylprednisolone pack to combat it
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash developed within 48 hours. Was prescribed Methylprednisolone pack to combat it
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Mesenteric vein thrombosis, Portal vein thrombosis, Splenic vein thrombosis
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Mesenteric vascular occlusion, Mesenteric vein thrombosis, Portal vein occlusion, Portal vein thrombosis
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Splenic thrombosis, Splenic vein occlusion
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Ascites, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Gastrointestinal oedema, Gastrointestinal wall thickening, Haematemesis, Magnetic resonance imaging head normal
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mesenteric vein thrombosis, Pain, Platelet count decreased, Pleural effusion, Portal vein thrombosis
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Splenic vein thrombosis, Venogram normal
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Computerised tomogram, Factor VII deficiency, Fibrin D dimer increased, Haemoglobin
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Heparin-induced thrombocytopenia, Heparin-induced thrombocytopenia test, Imaging procedure, Oesophagogastroduodenoscopy, Platelet count
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet factor 4, Protein S, Thrombocytopenia, Venogram, Visceral venous thrombosis
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: He developed abdominal pain 10 days after vaccination that worsened despite antacids.  On 4/28/21 he had hematemesis and was evaluated in the ED with identification of acute portal, superior mesenteric and splenic venous thrombosis.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache, Platelet count normal, Sinus pain
Clinical narrative: taken to hospital for severe headache/emesis on 4/29 that started a couple days prior. 2 blood clots found in cerebral sinus cavity and moved to ICU. CT scan on Sat, 5/1, showed no improvements so titrated up treatment, 5/3 due for next CT scan but holding steady but having chills
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Chills, Computerised tomogram head abnormal, Headache, Intensive care
Clinical narrative: taken to hospital for severe headache/emesis on 4/29 that started a couple days prior. 2 blood clots found in cerebral sinus cavity and moved to ICU. CT scan on Sat, 5/1, showed no improvements so titrated up treatment, 5/3 due for next CT scan but holding steady but having chills
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: taken to hospital for severe headache/emesis on 4/29 that started a couple days prior. 2 blood clots found in cerebral sinus cavity and moved to ICU. CT scan on Sat, 5/1, showed no improvements so titrated up treatment, 5/3 due for next CT scan but holding steady but having chills
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cavernous sinus thrombosis, Computerised tomogram head, Computerised tomogram head abnormal, Heparin-induced thrombocytopenia test, Prothrombin time
Clinical narrative: taken to hospital for severe headache/emesis on 4/29 that started a couple days prior. 2 blood clots found in cerebral sinus cavity and moved to ICU. CT scan on Sat, 5/1, showed no improvements so titrated up treatment, 5/3 due for next CT scan but holding steady but having chills
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Cough, Metamorphopsia, Vision blurred
Clinical narrative: Admitted to hospital for stroke
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Admitted to hospital for stroke
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Headache
Clinical narrative: Headache onset 2 weeks after vaccination. Brain MRI on 4/30/2021 showed subacute dural venous sinus thrombosis affecting the superior sagittal, left transverse and sigmoid sinuses.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Blood fibrinogen normal, Cerebral venous sinus thrombosis, Fibrin D dimer increased, Full blood count
Clinical narrative: Headache onset 2 weeks after vaccination. Brain MRI on 4/30/2021 showed subacute dural venous sinus thrombosis affecting the superior sagittal, left transverse and sigmoid sinuses.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Headache, Heparin-induced thrombocytopenia test, International normalised ratio increased, Magnetic resonance imaging head abnormal
Clinical narrative: Headache onset 2 weeks after vaccination. Brain MRI on 4/30/2021 showed subacute dural venous sinus thrombosis affecting the superior sagittal, left transverse and sigmoid sinuses.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Superior sagittal sinus thrombosis, Transverse sinus thrombosis
Clinical narrative: Headache onset 2 weeks after vaccination. Brain MRI on 4/30/2021 showed subacute dural venous sinus thrombosis affecting the superior sagittal, left transverse and sigmoid sinuses.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Chest discomfort, Pharyngeal swelling, Swelling face
Clinical narrative: Patient reported feeling "a knot in my throat" and swollen lips approx 45 minutes after receiving vaccine. Pt had waited the recommended 30 minutes after the vaccine, per the RN on site, and then went to get an EKG done per her PCP. After patient was waiting in lobby and reported to nurse about her symptoms, RN gave report to Provider on site, who ordered Bedadryl 50 mg IM stat. Injection was given by RN, in L glute. Patient was monitored for another 20 minutes in the exam room, reported feeling tired but no longer had swelling in throat, no difficulty swallowing or breathing, and lip swelling had decreased.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lip swelling, Sensation of foreign body
Clinical narrative: Patient reported feeling "a knot in my throat" and swollen lips approx 45 minutes after receiving vaccine. Pt had waited the recommended 30 minutes after the vaccine, per the RN on site, and then went to get an EKG done per her PCP. After patient was waiting in lobby and reported to nurse about her symptoms, RN gave report to Provider on site, who ordered Bedadryl 50 mg IM stat. Injection was given by RN, in L glute. Patient was monitored for another 20 minutes in the exam room, reported feeling tired but no longer had swelling in throat, no difficulty swallowing or breathing, and lip swelling had decreased.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaesthesia oral, Asthenia, Dysgeusia, Fatigue, Paraesthesia
Clinical narrative: Patient received 1st dose Moderna Covid vaccine at 4pm, sat in pharmacy for 15 minutes and was about to drive home with her mother.  She took off her mask in the car and noticed that her face was swollen and red so came back to pharmacy.  By 4:30pm patient stated that she felt constriction in the throat so I gave her 1 Epi-pen in the left thigh.  She felt better almost immediately and then felt jittery within 5 minutes but still had a lot of mucus in her throat. Checked in with patient periodically, patient seemed to feel significantly better. We had a conversation about contacting primary care provider, future COVID vaccines and the event that of the allergic reaction coming back in the next few hours, patient needs to go to ER, Patient's mother who was with her is a retired nurse and has an Epi-pen at home and both know to keep alert for return of symptoms. I also advised getting some liquid Benadryl to have on-hand.  By 5:15pm patient felt confident to leave.  At 5:20pm I called patient to let her know that she should go to ER per protocol and patient stated that she'll tell her mom.  I called patient again at 5:35pm to try to urge her to go to ER and patient state that she is heading to the ER and that she now noticed some red spots on her stomach.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Petechiae, Swelling face, Swollen tongue, Throat irritation
Clinical narrative: Patient received 1st dose Moderna Covid vaccine at 4pm, sat in pharmacy for 15 minutes and was about to drive home with her mother.  She took off her mask in the car and noticed that her face was swollen and red so came back to pharmacy.  By 4:30pm patient stated that she felt constriction in the throat so I gave her 1 Epi-pen in the left thigh.  She felt better almost immediately and then felt jittery within 5 minutes but still had a lot of mucus in her throat. Checked in with patient periodically, patient seemed to feel significantly better. We had a conversation about contacting primary care provider, future COVID vaccines and the event that of the allergic reaction coming back in the next few hours, patient needs to go to ER, Patient's mother who was with her is a retired nurse and has an Epi-pen at home and both know to keep alert for return of symptoms. I also advised getting some liquid Benadryl to have on-hand.  By 5:15pm patient felt confident to leave.  At 5:20pm I called patient to let her know that she should go to ER per protocol and patient stated that she'll tell her mom.  I called patient again at 5:35pm to try to urge her to go to ER and patient state that she is heading to the ER and that she now noticed some red spots on her stomach.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Patient received 1st dose Moderna Covid vaccine at 4pm, sat in pharmacy for 15 minutes and was about to drive home with her mother.  She took off her mask in the car and noticed that her face was swollen and red so came back to pharmacy.  By 4:30pm patient stated that she felt constriction in the throat so I gave her 1 Epi-pen in the left thigh.  She felt better almost immediately and then felt jittery within 5 minutes but still had a lot of mucus in her throat. Checked in with patient periodically, patient seemed to feel significantly better. We had a conversation about contacting primary care provider, future COVID vaccines and the event that of the allergic reaction coming back in the next few hours, patient needs to go to ER, Patient's mother who was with her is a retired nurse and has an Epi-pen at home and both know to keep alert for return of symptoms. I also advised getting some liquid Benadryl to have on-hand.  By 5:15pm patient felt confident to leave.  At 5:20pm I called patient to let her know that she should go to ER per protocol and patient stated that she'll tell her mom.  I called patient again at 5:35pm to try to urge her to go to ER and patient state that she is heading to the ER and that she now noticed some red spots on her stomach.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling jittery, Productive cough, Rash macular, Swelling face
Clinical narrative: Patient received 1st dose Moderna Covid vaccine at 4pm, sat in pharmacy for 15 minutes and was about to drive home with her mother.  She took off her mask in the car and noticed that her face was swollen and red so came back to pharmacy.  By 4:30pm patient stated that she felt constriction in the throat so I gave her 1 Epi-pen in the left thigh.  She felt better almost immediately and then felt jittery within 5 minutes but still had a lot of mucus in her throat. Checked in with patient periodically, patient seemed to feel significantly better. We had a conversation about contacting primary care provider, future COVID vaccines and the event that of the allergic reaction coming back in the next few hours, patient needs to go to ER, Patient's mother who was with her is a retired nurse and has an Epi-pen at home and both know to keep alert for return of symptoms. I also advised getting some liquid Benadryl to have on-hand.  By 5:15pm patient felt confident to leave.  At 5:20pm I called patient to let her know that she should go to ER per protocol and patient stated that she'll tell her mom.  I called patient again at 5:35pm to try to urge her to go to ER and patient state that she is heading to the ER and that she now noticed some red spots on her stomach.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Full blood count, Haemoglobin decreased, International normalised ratio, Prothrombin level
Clinical narrative: Vaginal blood hemorrhaging started at 4am. Admitted to ER. Severe bleeding and passing of large blood clots. Required an emergency D&C and a blood transfusion, plus fluids.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound pelvis, Ultrasound scan vagina, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Vaginal blood hemorrhaging started at 4am. Admitted to ER. Severe bleeding and passing of large blood clots. Required an emergency D&C and a blood transfusion, plus fluids.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fluid replacement, Transfusion, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Vaginal blood hemorrhaging started at 4am. Admitted to ER. Severe bleeding and passing of large blood clots. Required an emergency D&C and a blood transfusion, plus fluids.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G decreased, Dyspnoea, Eye irritation, Fatigue, Joint swelling
Clinical narrative: chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at  the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation.  Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications.  The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Ocular hyperaemia
Clinical narrative: chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at  the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation.  Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications.  The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back injury, Eye irritation, Fatigue, Joint injury, Joint swelling
Clinical narrative: chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at  the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation.  Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications.  The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient).   A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at  the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation.  Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications.  The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Dizziness, Investigation, Loss of consciousness, Road traffic accident
Clinical narrative: Seizures; lost consciousnesses; vertigo; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vertigo the following morning (27Mar2021) after the first dose. It was "positional vertigo" and not something that patient have on a regular basis but usually when it did happen, she went to the ear specialist and the Epley maneuver was done and resolves it.  Patient have been having issues with vertigo since the first dose. She also developed a seizure, 11 days after the first dose. On 06Apr2021, she apparently had a seizure and have no history of seizures. Patient apparently lost consciousnesses and drove slowly and hit a pole. They had to break the window to get patient out of the car and she didn't remember any of it. It had to be less than an hour that I was out; from the time recorded on the incident report and patient waking up in the ER room and looking up at the clock in the room, it was under an hour. The outcome of event vertigo was recovered in 2021, the outcome of other events was unknown. Patient received the second dose on Friday, 16Apr2021.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Vertigo positional
Clinical narrative: Seizures; lost consciousnesses; vertigo; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vertigo the following morning (27Mar2021) after the first dose. It was "positional vertigo" and not something that patient have on a regular basis but usually when it did happen, she went to the ear specialist and the Epley maneuver was done and resolves it.  Patient have been having issues with vertigo since the first dose. She also developed a seizure, 11 days after the first dose. On 06Apr2021, she apparently had a seizure and have no history of seizures. Patient apparently lost consciousnesses and drove slowly and hit a pole. They had to break the window to get patient out of the car and she didn't remember any of it. It had to be less than an hour that I was out; from the time recorded on the incident report and patient waking up in the ER room and looking up at the clock in the room, it was under an hour. The outcome of event vertigo was recovered in 2021, the outcome of other events was unknown. Patient received the second dose on Friday, 16Apr2021.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Seizure, Vertigo
Clinical narrative: Seizures; lost consciousnesses; vertigo; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vertigo the following morning (27Mar2021) after the first dose. It was "positional vertigo" and not something that patient have on a regular basis but usually when it did happen, she went to the ear specialist and the Epley maneuver was done and resolves it.  Patient have been having issues with vertigo since the first dose. She also developed a seizure, 11 days after the first dose. On 06Apr2021, she apparently had a seizure and have no history of seizures. Patient apparently lost consciousnesses and drove slowly and hit a pole. They had to break the window to get patient out of the car and she didn't remember any of it. It had to be less than an hour that I was out; from the time recorded on the incident report and patient waking up in the ER room and looking up at the clock in the room, it was under an hour. The outcome of event vertigo was recovered in 2021, the outcome of other events was unknown. Patient received the second dose on Friday, 16Apr2021.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; ill; bad headache; occasional diarrhea; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 10:30 intramuscular in arm left at single dose (first dose at 45 years; Lot Number: EL3248) and on 08Feb2021 at 12:30 intramuscular in arm left at single dose (second dose at 45 years ; Lot Number: EM9810) for covid-19 immunisation .Medical history included depression and cirrhosis-Stage IV (nonalcoholic). The patient previously took amoxicillin and experienced allergy-hives.  Concomitant medications included duloxetine hydrochloride (CYMBALTA) and phentermine (PHENTERMINE) taken for an unspecified indication, start and stop date were not reported. Patient became ill on 15Apr2021, experiencing a bad headache, which had continued since; also experiencing occasional diarrhea. She was tested positive for COVID-19 on 18Apr2021 via Nasal Swab (Rapid-PCR) . NO treatment given for the events. The final outcome of the events was recovering.; Sender's Comments: Based on available information a contributory  role of BNT162B2 to the reported vaccination failure and positive COVID-19 cannot be totally excluded.  case will be reassessed if additional information is received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Headache, Illness, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; ill; bad headache; occasional diarrhea; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 10:30 intramuscular in arm left at single dose (first dose at 45 years; Lot Number: EL3248) and on 08Feb2021 at 12:30 intramuscular in arm left at single dose (second dose at 45 years ; Lot Number: EM9810) for covid-19 immunisation .Medical history included depression and cirrhosis-Stage IV (nonalcoholic). The patient previously took amoxicillin and experienced allergy-hives.  Concomitant medications included duloxetine hydrochloride (CYMBALTA) and phentermine (PHENTERMINE) taken for an unspecified indication, start and stop date were not reported. Patient became ill on 15Apr2021, experiencing a bad headache, which had continued since; also experiencing occasional diarrhea. She was tested positive for COVID-19 on 18Apr2021 via Nasal Swab (Rapid-PCR) . NO treatment given for the events. The final outcome of the events was recovering.; Sender's Comments: Based on available information a contributory  role of BNT162B2 to the reported vaccination failure and positive COVID-19 cannot be totally excluded.  case will be reassessed if additional information is received.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; ill; bad headache; occasional diarrhea; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 10:30 intramuscular in arm left at single dose (first dose at 45 years; Lot Number: EL3248) and on 08Feb2021 at 12:30 intramuscular in arm left at single dose (second dose at 45 years ; Lot Number: EM9810) for covid-19 immunisation .Medical history included depression and cirrhosis-Stage IV (nonalcoholic). The patient previously took amoxicillin and experienced allergy-hives.  Concomitant medications included duloxetine hydrochloride (CYMBALTA) and phentermine (PHENTERMINE) taken for an unspecified indication, start and stop date were not reported. Patient became ill on 15Apr2021, experiencing a bad headache, which had continued since; also experiencing occasional diarrhea. She was tested positive for COVID-19 on 18Apr2021 via Nasal Swab (Rapid-PCR) . NO treatment given for the events. The final outcome of the events was recovering.; Sender's Comments: Based on available information a contributory  role of BNT162B2 to the reported vaccination failure and positive COVID-19 cannot be totally excluded.  case will be reassessed if additional information is received.