chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Dysphagia, Feeling jittery
Clinical narrative: Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Balance disorder, Blood test
Clinical narrative: weight declined very fast; her jaw was clenched shut; she was very unstable and weak and we had o carry her in; numbness and tingling in her feet and legs; numbness and tingling in her feet and legs; abdominal pain; stomach pain when eating; she is very weak; Information was obtained on request by the Company from the FDA (VAERS # 851320) under the Freedom of Information Act on 20-NOV-2020.   This spontaneous report was received from a consumer, referring to a female patient who was 13 years old at vaccination and not pregnant. Chronic or long-standing health conditions included environmental mold, cedar allergies and eczema. There was no prescriptions, over the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products, no other illness at the time of vaccination and up to one month prior.  On 01-AUG-2019, PM, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis.  On 05-AUG-2020, PM, the patient started to have stomach pain when eating. She got to the point where eating any food made her stomach worse, so her weight declined very fast. To date, he had lost 18+ lbs. She was very weak. On the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling inher feet and legs. She was very unstable and weak and we had to carry her in. She was still in abdominal pain and weak. The patient was hospitalized for 2 days. Abdominal ultrasound  (multitude of tests in Hospital Stay), abdominal magnetic resonance imaging (MRI), gastric emptying study and blood work were performed without results. The outcome of all events was reported as not recovered. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all events was not reported.  As of 17-DEC-2020, the telephone attempt trying to obtain additional information have been unsuccessful.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Gastric emptying study, Hypoaesthesia, Magnetic resonance imaging abdominal, Musculoskeletal disorder, Paraesthesia
Clinical narrative: weight declined very fast; her jaw was clenched shut; she was very unstable and weak and we had o carry her in; numbness and tingling in her feet and legs; numbness and tingling in her feet and legs; abdominal pain; stomach pain when eating; she is very weak; Information was obtained on request by the Company from the FDA (VAERS # 851320) under the Freedom of Information Act on 20-NOV-2020.   This spontaneous report was received from a consumer, referring to a female patient who was 13 years old at vaccination and not pregnant. Chronic or long-standing health conditions included environmental mold, cedar allergies and eczema. There was no prescriptions, over the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products, no other illness at the time of vaccination and up to one month prior.  On 01-AUG-2019, PM, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis.  On 05-AUG-2020, PM, the patient started to have stomach pain when eating. She got to the point where eating any food made her stomach worse, so her weight declined very fast. To date, he had lost 18+ lbs. She was very weak. On the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling inher feet and legs. She was very unstable and weak and we had to carry her in. She was still in abdominal pain and weak. The patient was hospitalized for 2 days. Abdominal ultrasound  (multitude of tests in Hospital Stay), abdominal magnetic resonance imaging (MRI), gastric emptying study and blood work were performed without results. The outcome of all events was reported as not recovered. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all events was not reported.  As of 17-DEC-2020, the telephone attempt trying to obtain additional information have been unsuccessful.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Trismus, Ultrasound abdomen, Weight decreased
Clinical narrative: weight declined very fast; her jaw was clenched shut; she was very unstable and weak and we had o carry her in; numbness and tingling in her feet and legs; numbness and tingling in her feet and legs; abdominal pain; stomach pain when eating; she is very weak; Information was obtained on request by the Company from the FDA (VAERS # 851320) under the Freedom of Information Act on 20-NOV-2020.   This spontaneous report was received from a consumer, referring to a female patient who was 13 years old at vaccination and not pregnant. Chronic or long-standing health conditions included environmental mold, cedar allergies and eczema. There was no prescriptions, over the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products, no other illness at the time of vaccination and up to one month prior.  On 01-AUG-2019, PM, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis.  On 05-AUG-2020, PM, the patient started to have stomach pain when eating. She got to the point where eating any food made her stomach worse, so her weight declined very fast. To date, he had lost 18+ lbs. She was very weak. On the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling inher feet and legs. She was very unstable and weak and we had to carry her in. She was still in abdominal pain and weak. The patient was hospitalized for 2 days. Abdominal ultrasound  (multitude of tests in Hospital Stay), abdominal magnetic resonance imaging (MRI), gastric emptying study and blood work were performed without results. The outcome of all events was reported as not recovered. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all events was not reported.  As of 17-DEC-2020, the telephone attempt trying to obtain additional information have been unsuccessful.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Erythema, Feeling abnormal, Pruritus, Rash
Clinical narrative: are scabs; and minor itching / have been miserable with the itching; Not resting; still have purple areas on my legs, back and arm; still have red areas on my legs, back and arm; Lupus like rash; reports Rash / on her arms, legs, chest, and back; This case was reported by a consumer via call center representative and described the occurrence of rash lupus-like in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2020, 8 days after receiving Shingrix, the patient experienced rash lupus-like (serious criteria GSK medically significant) and rash. On an unknown date, the patient experienced scab, pruritus, restlessness, skin discoloration and erythema. The patient was treated with dexamethasone and prednisone. On an unknown date, the outcome of the rash lupus-like and rash were recovering/resolving and the outcome of the scab, pruritus and restlessness were unknown and the outcome of the skin discoloration and erythema were not recovered/not resolved.   The reporter considered the rash lupus-like, rash, scab, pruritus, restlessness and skin discoloration to be related to Shingrix. It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were reported as follows: She reported severe reaction to vaccine. She stated that the rash occurred on her arms, legs, chest, and back. The reporter reported Lupus like rash after Shingrix vaccine. The rash had lasted six weeks, but there were scabs and minor itching.  The rash was improving with prednisone dose pack, dexamethasone and treatments. She had been cared by a dermatologist who confirmed the rash was from Shingrix via biopsy. She still had red, purple areas on her legs, back and arms which the doctor said were healing.  She had been miserable with the itching and not resting. No more information was available. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Scab, Skin discolouration, Systemic lupus erythematosus rash
Clinical narrative: are scabs; and minor itching / have been miserable with the itching; Not resting; still have purple areas on my legs, back and arm; still have red areas on my legs, back and arm; Lupus like rash; reports Rash / on her arms, legs, chest, and back; This case was reported by a consumer via call center representative and described the occurrence of rash lupus-like in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th November 2020, 8 days after receiving Shingrix, the patient experienced rash lupus-like (serious criteria GSK medically significant) and rash. On an unknown date, the patient experienced scab, pruritus, restlessness, skin discoloration and erythema. The patient was treated with dexamethasone and prednisone. On an unknown date, the outcome of the rash lupus-like and rash were recovering/resolving and the outcome of the scab, pruritus and restlessness were unknown and the outcome of the skin discoloration and erythema were not recovered/not resolved.   The reporter considered the rash lupus-like, rash, scab, pruritus, restlessness and skin discoloration to be related to Shingrix. It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were reported as follows: She reported severe reaction to vaccine. She stated that the rash occurred on her arms, legs, chest, and back. The reporter reported Lupus like rash after Shingrix vaccine. The rash had lasted six weeks, but there were scabs and minor itching.  The rash was improving with prednisone dose pack, dexamethasone and treatments. She had been cared by a dermatologist who confirmed the rash was from Shingrix via biopsy. She still had red, purple areas on her legs, back and arms which the doctor said were healing.  She had been miserable with the itching and not resting. No more information was available. The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: developed nausea right after taking vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram abnormal, Flushing, Palpitations, Sinus tachycardia
Clinical narrative: Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Feeling abnormal, Hyperventilation, Urticaria
Clinical narrative: Hives, burning sensation in her arms, anxiety.  Noted she felt like she was hyperventilating.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Hyperventilation, Skin burning sensation, Urticaria
Clinical narrative: Hives, burning sensation in her arms, anxiety.  Noted she felt like she was hyperventilating.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Pharyngeal swelling
Clinical narrative: 5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell.  Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation.  Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Nausea
Clinical narrative: Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray abnormal, Computerised tomogram, Fibrin D dimer increased, Injection site pain
Clinical narrative: On the second day I took something for the pain around injection site. The third day started exp nausea and I went back to work on Sat/Sun. I received a call on Monday from my employer that a patient I was taking care of tested positive Covid 19. I went to t to ER to get a Covid swab, blood work , and D dimer was elevated, Chest X-ray(dense area on my left lung). I was admitted and hospitalized for 6 days on Oxygen(4 liters). Since the discharge I'm still on Oxygen but the room air is still fine for now waiting for my appt.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Nausea, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test positive, Thrombosis
Clinical narrative: On the second day I took something for the pain around injection site. The third day started exp nausea and I went back to work on Sat/Sun. I received a call on Monday from my employer that a patient I was taking care of tested positive Covid 19. I went to t to ER to get a Covid swab, blood work , and D dimer was elevated, Chest X-ray(dense area on my left lung). I was admitted and hospitalized for 6 days on Oxygen(4 liters). Since the discharge I'm still on Oxygen but the room air is still fine for now waiting for my appt.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: On the second day I took something for the pain around injection site. The third day started exp nausea and I went back to work on Sat/Sun. I received a call on Monday from my employer that a patient I was taking care of tested positive Covid 19. I went to t to ER to get a Covid swab, blood work , and D dimer was elevated, Chest X-ray(dense area on my left lung). I was admitted and hospitalized for 6 days on Oxygen(4 liters). Since the discharge I'm still on Oxygen but the room air is still fine for now waiting for my appt.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Laboratory test, Lip swelling, Nausea
Clinical narrative: Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache.  I have been taking Zyrtec, Benadryl as needed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache.  I have been taking Zyrtec, Benadryl as needed.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis, Otoacoustic emissions test, Tinnitus
Clinical narrative: One day after vaccine (12/25/20) patient woke up with ringing in her ears, echoing, and diminished hearing.  Ringing subsided 12/26/20 but diminished hearing continued.  Seen by ENT 12/30/20 and diagnosed with hearing loss, right, with restricted hearing, left.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 100 degrees for one week; This is a spontaneous report from contactable healthcare professional, the patient.  A 39-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Dec2020 at 09:00 (reported as at the age of 39-years-old) as a single dose for COVID-19 immunization.  The patient's medical history was not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced fever of 100 degrees Fahrenheit for one week. The patient went to the doctor for the event but was not given any treatment. The patient was tested twice for COVID-19 during the week of the fever in Dec2020 and both time the results were negative. The clinical outcome of fever of 100 degrees Fahrenheit for one week was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Palpitations, Pharyngeal paraesthesia
Clinical narrative: During post vaccination monitoring pt began to complain of tingling in her throat and palpitations.  Was sent from chair to gurney. At that time was evaluated. Symptoms included elevated BP and HR.  911 called at 1304 and pt sent to ED
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Nervousness
Clinical narrative: She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.   She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out."  Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12   911 called and arrived at 1643
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoscopy, Bradykinesia, Discomfort, Dizziness, Electric shock sensation
Clinical narrative: She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.   She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out."  Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12   911 called and arrived at 1643
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Emotional distress, Feeling abnormal, Hyperacusis, Tachycardia
Clinical narrative: She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.   She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out."  Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12   911 called and arrived at 1643
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: She arrive at 3:43 and she was nervous before the vaccination for COVID19 ( Morena) because has had anaphylactic reactions to Flonase. She was feeling well up to 15 min post vaccination when she felt she is going to pass out w/o loosing consciousness. She felt weak and feeling fainted when we transferred her to the stretcher.   Her BP was 163/106 P=112, Pulse Ox 100% at 16:09.   She was resting, received O2 lit per min, she was feeling chest tightness when she used her inhaler Albuterol 2 puffs X2 within 5 min. She was feeling weak and stating "I am going to pass out."  Her repeat BP=152/110, P=94 with pulse Ox 100% at 16:12   911 called and arrived at 1643
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Electrocardiogram abnormal, Heart rate, Heart rate increased, Hypoglycaemia
Clinical narrative: heart palpitations; Hypoglycemia; Abnormal EKG; I had a near sick able episode and I had a rapid heart rate; I had a near sick able episode and I had a rapid heart rate; This is a spontaneous report from a contactable consumer.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EK5730, via an unspecified route of administration on 26Dec2020 as a single dose (age at vaccination: 40 years old), right arm for COVID -19 immunization. Medical history included chronic back pain.  Concomitant medication included amitriptyline (AMITRIPTYLINE), cyclobenzaprine (FLEXERIL) for chronic back pain, and hydrocodone bitartrate, paracetamol (NORCO) for chronic back pain. On 26Dec2020, the patient had a "near sick able episode" and a rapid heart rate.  The initial side effect was about 7 minutes after the patient had the vaccine, came on just very quickly. The place where they had the patient discharged him, allowed him to go home, but the rapid heart rate stayed with the patient for next 24 hours and he went to an urgent care and they sent him to emergency room. The patient went to the emergency room (27Dec2020) and they ran an EKG, X-ray, and did a COVID swab; everything came back negative. Lab work, X-ray everything came back fine, the only thing they found was hypoglycemia, heart palpitations, and abnormal EKG, which was described by the reporter as "normal sinus rhythm left axis deviation pulmonary disease pattern" and then at the bottom it said "abnormal EKG." Heart rate was 136/88 (as reported) so it was definitely improving, the highest it was at 189/110 (as reported). No treatment was received for the events. The clinical outcome of the events "near sick able episode," rapid heart rate, and palpitations was recovering, while the clinical outcome of hypoglycemia and abnormal ECG was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations, Presyncope, SARS-CoV-2 test, X-ray
Clinical narrative: heart palpitations; Hypoglycemia; Abnormal EKG; I had a near sick able episode and I had a rapid heart rate; I had a near sick able episode and I had a rapid heart rate; This is a spontaneous report from a contactable consumer.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EK5730, via an unspecified route of administration on 26Dec2020 as a single dose (age at vaccination: 40 years old), right arm for COVID -19 immunization. Medical history included chronic back pain.  Concomitant medication included amitriptyline (AMITRIPTYLINE), cyclobenzaprine (FLEXERIL) for chronic back pain, and hydrocodone bitartrate, paracetamol (NORCO) for chronic back pain. On 26Dec2020, the patient had a "near sick able episode" and a rapid heart rate.  The initial side effect was about 7 minutes after the patient had the vaccine, came on just very quickly. The place where they had the patient discharged him, allowed him to go home, but the rapid heart rate stayed with the patient for next 24 hours and he went to an urgent care and they sent him to emergency room. The patient went to the emergency room (27Dec2020) and they ran an EKG, X-ray, and did a COVID swab; everything came back negative. Lab work, X-ray everything came back fine, the only thing they found was hypoglycemia, heart palpitations, and abnormal EKG, which was described by the reporter as "normal sinus rhythm left axis deviation pulmonary disease pattern" and then at the bottom it said "abnormal EKG." Heart rate was 136/88 (as reported) so it was definitely improving, the highest it was at 189/110 (as reported). No treatment was received for the events. The clinical outcome of the events "near sick able episode," rapid heart rate, and palpitations was recovering, while the clinical outcome of hypoglycemia and abnormal ECG was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: heart palpitations; Hypoglycemia; Abnormal EKG; I had a near sick able episode and I had a rapid heart rate; I had a near sick able episode and I had a rapid heart rate; This is a spontaneous report from a contactable consumer.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EK5730, via an unspecified route of administration on 26Dec2020 as a single dose (age at vaccination: 40 years old), right arm for COVID -19 immunization. Medical history included chronic back pain.  Concomitant medication included amitriptyline (AMITRIPTYLINE), cyclobenzaprine (FLEXERIL) for chronic back pain, and hydrocodone bitartrate, paracetamol (NORCO) for chronic back pain. On 26Dec2020, the patient had a "near sick able episode" and a rapid heart rate.  The initial side effect was about 7 minutes after the patient had the vaccine, came on just very quickly. The place where they had the patient discharged him, allowed him to go home, but the rapid heart rate stayed with the patient for next 24 hours and he went to an urgent care and they sent him to emergency room. The patient went to the emergency room (27Dec2020) and they ran an EKG, X-ray, and did a COVID swab; everything came back negative. Lab work, X-ray everything came back fine, the only thing they found was hypoglycemia, heart palpitations, and abnormal EKG, which was described by the reporter as "normal sinus rhythm left axis deviation pulmonary disease pattern" and then at the bottom it said "abnormal EKG." Heart rate was 136/88 (as reported) so it was definitely improving, the highest it was at 189/110 (as reported). No treatment was received for the events. The clinical outcome of the events "near sick able episode," rapid heart rate, and palpitations was recovering, while the clinical outcome of hypoglycemia and abnormal ECG was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Electrocardiogram abnormal, Heart rate, Heart rate increased, Hypoglycaemia
Clinical narrative: Dizziness Lightheadedness  Chills Sweating Hypotensive  Monitored for 45 minutes.  Placed in Trendelenberg position.  BP 142/100 EMS was called to evaluated. Patient refused to go with.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations, Presyncope, SARS-CoV-2 test, X-ray
Clinical narrative: Dizziness Lightheadedness  Chills Sweating Hypotensive  Monitored for 45 minutes.  Placed in Trendelenberg position.  BP 142/100 EMS was called to evaluated. Patient refused to go with.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Dizziness Lightheadedness  Chills Sweating Hypotensive  Monitored for 45 minutes.  Placed in Trendelenberg position.  BP 142/100 EMS was called to evaluated. Patient refused to go with.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a contactable pharmacist.  An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0140), intramuscular into the left arm on 29Dec2020, at 11:30 as first single dose for COVID-19 immunization.  Medical history included dementia, aphasia, type 2 diabetes mellitus, iron deficiency, asthenia, osteoporosis, polyneuropathy, anxiety, major depressive disorder and penicillin allergy, all from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19 on an unspecified date.  The patient's concomitant medications were not reported.  The patient previously took codeine and phenobarbital and experienced allergies. The patient passed away on 29Dec2020, at 13:30. Description was as follows: the vaccine  was administered with no immediate adverse reaction at 11:30 am; the vaccine screening questions were completed and the patient was not feeling sick and temperature was 98 Fahrenheit. The patient passed away on 29Dec2020, at 13:30. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient died on 29Dec2020.  It was not reported if an autopsy was performed.; Sender's Comments: Current limited information in this report precludes a full assessment of the case.  The advance old patient was infected with COVID-19 prior to vaccination, having multiple underlying diseases including diabetes mellitus and drug allergies.  The pre-exiting medical conditions might be contributory factors towards the patient death.  Further details especially death cause and autopsy results are needed for meaningful medical assessment.  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.; Reported Cause(s) of Death: passed away
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Lymphadenopathy, Nausea
Clinical narrative: Cervical lymphadenopathy; Chills; Nausea; Feeling lightheaded; This is a spontaneous report from a contactable physician (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/4130421), via an unspecified route of administration on 29Dec2020 10:00 in left arm at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included linaclotide (LINZESS) and a combination birth control pill both received within 2 weeks of vaccination. On 29Dec2020 at 10:00 PM (22:00), the patient experienced chills, nausea, feeling lightheaded and cervical lymphadenopathy. The symptoms were severe enough that the patient needed to leave work in the middle of her shift (primarily due to the lightheadedness). The patient tried drinking juice, water, etc but it kept getting worse so after a few hours the patient decided she needed to leave work. The patient did not received treatment for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Insomnia, Malaise, Movement disorder, Nasopharyngitis
Clinical narrative: Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; cold; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; feeling unwell that night, unable to sleep, tossing and turning all night; feeling unwell that night, unable to sleep, tossing and turning all night; This is a spontaneous report from a contactable nurse (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included food allergy (known allergies: raw bananas, avocados, melons, kiwi, tomatoes, oranges, grapes-make her mouth and lips itch). Concomitant medications were not reported. The patient previously received ibuprofen 400mg, a couple doses week prior. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Patient is not pregnant at the time of vaccination. On 29Dec2020, at 21:00, patient experienced worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dreams. When she was able to sleep, she was still feeling unwell the next morning like she was recovering from a cold. The patient did not receive treatment for the events. Outcome of the events was recovering. Since the vaccination, patient has not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; cold; Worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dream; feeling unwell that night, unable to sleep, tossing and turning all night; feeling unwell that night, unable to sleep, tossing and turning all night; This is a spontaneous report from a contactable nurse (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration (left arm), on 29Dec2020 at 15:15, at a single dose, for COVID-19 immunization. Relevant medical history included food allergy (known allergies: raw bananas, avocados, melons, kiwi, tomatoes, oranges, grapes-make her mouth and lips itch). Concomitant medications were not reported. The patient previously received ibuprofen 400mg, a couple doses week prior. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Patient is not pregnant at the time of vaccination. On 29Dec2020, at 21:00, patient experienced worsening pain at injection site that night, inability to raise arm to shoulder height due to pain, feeling unwell that night, unable to sleep, tossing and turning all night with very disturbing dreams. When she was able to sleep, she was still feeling unwell the next morning like she was recovering from a cold. The patient did not receive treatment for the events. Outcome of the events was recovering. Since the vaccination, patient has not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Head discomfort, Rash, Rash erythematous
Clinical narrative: Swollen neck, head  "heavy" dizzy, thick tongue, flushed red rash to neck and chest.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tongue disorder
Clinical narrative: Swollen neck, head  "heavy" dizzy, thick tongue, flushed red rash to neck and chest.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Muscle tightness, Paraesthesia
Clinical narrative: LEFT  SHOULDER AND NECK TIGHTNESS WITH FACIAL TINGLING AFTER LEAVING CLINIC. REFERED TO PRIVATE PHYSICIAN
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure abnormal, Dizziness, Electrocardiogram normal, Immediate post-injection reaction
Clinical narrative: 12/24/2020 I started with a wooshing feeling immediately after the vaccine, I sat down for 15 mins and felt dizzy so I stayed another 15 mins. BP was 140 and abnormal I had juice and felt better and went back to work and I felt tingling all over my body and fainty and my legs felt very heavy. I went upstairs and my BP was 160's and heart rate was 120 and I went to the ER. My face appeared to be swollen and my tounge felt tingly and I was given fluids and benadryl and solumedrol . My BP was in the 140's I went home to get rest and I still felt tingly for a couple days. The next day I felt feverish my arm was sore and I went to doctor gave me a rx for anxiety and I stayed home and rested from work for a few days. My tinglyness subsided after the medication
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test normal, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: 12/24/2020 I started with a wooshing feeling immediately after the vaccine, I sat down for 15 mins and felt dizzy so I stayed another 15 mins. BP was 140 and abnormal I had juice and felt better and went back to work and I felt tingling all over my body and fainty and my legs felt very heavy. I went upstairs and my BP was 160's and heart rate was 120 and I went to the ER. My face appeared to be swollen and my tounge felt tingly and I was given fluids and benadryl and solumedrol . My BP was in the 140's I went home to get rest and I still felt tingly for a couple days. The next day I felt feverish my arm was sore and I went to doctor gave me a rx for anxiety and I stayed home and rested from work for a few days. My tinglyness subsided after the medication
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, Sensory disturbance, Swelling face
Clinical narrative: 12/24/2020 I started with a wooshing feeling immediately after the vaccine, I sat down for 15 mins and felt dizzy so I stayed another 15 mins. BP was 140 and abnormal I had juice and felt better and went back to work and I felt tingling all over my body and fainty and my legs felt very heavy. I went upstairs and my BP was 160's and heart rate was 120 and I went to the ER. My face appeared to be swollen and my tounge felt tingly and I was given fluids and benadryl and solumedrol . My BP was in the 140's I went home to get rest and I still felt tingly for a couple days. The next day I felt feverish my arm was sore and I went to doctor gave me a rx for anxiety and I stayed home and rested from work for a few days. My tinglyness subsided after the medication
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious.  Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood gonadotrophin, Electrocardiogram, Full blood count, Hypoaesthesia oral, Metabolic function test
Clinical narrative: palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious.  Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious.  Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.