chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: took the band aid off ant it was red exact length and width of the band aid; took the band aid off ant it was / swollen exact length and width of the band aid; took the band aid off ant it was / hot exact length and width of the band aid; This case was reported by a consumer via interactive and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The next day, the patient took the band aid off and it was red and swollen and hot the exact length and width of the band aid.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Erythema, Incorrect route of product administration, Pain
Clinical narrative: I got cills; low grade fever; achy; arm is still is red; arm is still /swollen; 1st dose given subcutaneously; I did get diarrhea / (have had that for two days); This case was reported by a other health professional and described the occurrence of erythema of extremities in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix (subcutaneous). In December 2020, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain, diarrhea and intramuscular formulation administered by other route. On 19th December 2020, the patient experienced chills and low grade fever. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the chills, low grade fever, pain and intramuscular formulation administered by other route were unknown and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, chills, low grade fever, pain and diarrhea to be related to Shingrix.  Additional details were reported as follows: The reporter was an office supervisor. The reporter stated, they found the massage about the patient who got the Shingrix shot subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. On 21st December 2020, the patient contacted through patient satisfaction survey and stated that, the nurse gave Shingrix dose in the back side of arm and said it needed to be in a fatty part of arm and not in the muscle. The patient added, she never got a shot there. The patient searched about this and got to know that, the shingles shot needs to be given in the arm muscle. The patient asked if this shot remain effective since it was not given in the muscle. The patient had side effects like her arm was still red and swollen. On Saturday, she got chills and a low grade fever and was achy. She got diarrhea for two days. The patient stated it might be due to the shot was working.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: I got cills; low grade fever; achy; arm is still is red; arm is still /swollen; 1st dose given subcutaneously; I did get diarrhea / (have had that for two days); This case was reported by a other health professional and described the occurrence of erythema of extremities in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix (subcutaneous). In December 2020, less than a week after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain, diarrhea and intramuscular formulation administered by other route. On 19th December 2020, the patient experienced chills and low grade fever. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved and the outcome of the chills, low grade fever, pain and intramuscular formulation administered by other route were unknown and the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, chills, low grade fever, pain and diarrhea to be related to Shingrix.  Additional details were reported as follows: The reporter was an office supervisor. The reporter stated, they found the massage about the patient who got the Shingrix shot subcutaneously instead of intramuscular route, which led to intramuscular formulation administered by other route. On 21st December 2020, the patient contacted through patient satisfaction survey and stated that, the nurse gave Shingrix dose in the back side of arm and said it needed to be in a fatty part of arm and not in the muscle. The patient added, she never got a shot there. The patient searched about this and got to know that, the shingles shot needs to be given in the arm muscle. The patient asked if this shot remain effective since it was not given in the muscle. The patient had side effects like her arm was still red and swollen. On Saturday, she got chills and a low grade fever and was achy. She got diarrhea for two days. The patient stated it might be due to the shot was working.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site reaction, Pruritus, Rash erythematous, Skin swelling
Clinical narrative: Red rash appeared on upper arm approximately 7 inches by 5 inches in size. It was very itchy and had burning sensation and skin was swollen and warm to touch. It appeared suddenly on 6th day after date of vaccine. Treated with oral antihistamine, cool compresses and hydrocortisone cream. Symptoms have diminished on day 4 of occurence. Consulted with medical professional about it on Jan 29, 2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Red rash appeared on upper arm approximately 7 inches by 5 inches in size. It was very itchy and had burning sensation and skin was swollen and warm to touch. It appeared suddenly on 6th day after date of vaccine. Treated with oral antihistamine, cool compresses and hydrocortisone cream. Symptoms have diminished on day 4 of occurence. Consulted with medical professional about it on Jan 29, 2021.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Headache, Hyperhidrosis, Nausea
Clinical narrative: Dizziness; Dizziness / she fell down as a result; severe vertigo / room is spinning; can't focus her eyes; headache; Fever of 101 degrees F; Nausea; Sweating; This case was reported by a consumer via and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 15th August 2020 in left arm).   On 28th November 2020, the patient received the 2nd dose of Shingrix. On 29th November 2020, 1 days after receiving Shingrix, the patient experienced fever, nausea, sweating and headache. On 30th November 2020, the patient experienced dizziness, fall, vertigo and difficulty focusing eyes. On an unknown date, the outcome of the fever, nausea and sweating were recovered/resolved and the outcome of the dizziness, fall, vertigo and difficulty focusing eyes were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the fever, nausea, sweating, dizziness, fall, headache, vertigo and difficulty focusing eyes to be related to Shingrix.  Additional details were provided as follows:   The patient received 2nd dose of shingrix and next day experienced fever of about 101 degree F, nausea and sweating. 2 days after receiving 2nd dose of Shingrix, patient experienced severe vertigo and she was unable to focus her eyes and fell down. The patient experienced spinning room which she had never experienced in her life. The patient saw neurologist and currently was in doctor's office to look at her inner eye. MRI was scheduled 1 week from the time of reporting. On 30th November 2020, patient experienced dizziness and fell down and were not resolved. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vertigo, Vision blurred
Clinical narrative: Dizziness; Dizziness / she fell down as a result; severe vertigo / room is spinning; can't focus her eyes; headache; Fever of 101 degrees F; Nausea; Sweating; This case was reported by a consumer via and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 15th August 2020 in left arm).   On 28th November 2020, the patient received the 2nd dose of Shingrix. On 29th November 2020, 1 days after receiving Shingrix, the patient experienced fever, nausea, sweating and headache. On 30th November 2020, the patient experienced dizziness, fall, vertigo and difficulty focusing eyes. On an unknown date, the outcome of the fever, nausea and sweating were recovered/resolved and the outcome of the dizziness, fall, vertigo and difficulty focusing eyes were not recovered/not resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the fever, nausea, sweating, dizziness, fall, headache, vertigo and difficulty focusing eyes to be related to Shingrix.  Additional details were provided as follows:   The patient received 2nd dose of shingrix and next day experienced fever of about 101 degree F, nausea and sweating. 2 days after receiving 2nd dose of Shingrix, patient experienced severe vertigo and she was unable to focus her eyes and fell down. The patient experienced spinning room which she had never experienced in her life. The patient saw neurologist and currently was in doctor's office to look at her inner eye. MRI was scheduled 1 week from the time of reporting. On 30th November 2020, patient experienced dizziness and fell down and were not resolved. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain around injection site x 5 days; resolved. Bruising around injection site x15 days; still present.  Redness, warm to touch and mild itching around injeciton site x15 days; still present.
Sex: F
Vaccine: VARZOS
Symptoms: Epstein-Barr virus antibody positive
Clinical narrative: raisised EBV antibodies but no sxs; This case was reported by a pharmacist and described the occurrence of epstein-barr virus antibody positive in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced epstein-barr virus antibody positive. On an unknown date, the outcome of the epstein-barr virus antibody positive was unknown.   It was unknown if the reporter considered the epstein-barr virus antibody positive to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The shingrix dose caused raise in Epstein barr antibodies. The patient had raised Epstein-Barr Virus antibodies but no symptoms and had recent Shingrix. The reporter consented to follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Employee reports not being able to sleep night of vaccination, injection site pain.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Coronavirus infection, Social problem
Clinical narrative: second has not been administered; Covid-19; This case was reported by a pharmacist and described the occurrence of coronavirus infection in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 14th November 2020, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced coronavirus infection. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the coronavirus infection and social problem were unknown.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose. The patient missed to receive the second dose of Shingrix at appropriate time, probably due to pandemic. It should have received until December 2019. Additionally, the patient was recently diagnosed with Covid-19. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, SARS-CoV-2 test, Syncope
Clinical narrative: SARS-CoV-2 test positive; Faints; Chills; Headache; A spontaneous report  was received from a consumer concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine and experienced faints, headache, chills, and COVID-19.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm for prophylaxis of COVID-19 infection.    On 30 Dec 2020, prior to vaccination, the patient took a COVID-19 test and results were negative.   On 31 Dec 2020, the day after vaccination, the patient got instantly sick, she had a headache, chills, and faints.   On 03 Jan 2021, the patient went to the emergency room (ER) where she received unspecified treatment for the symptoms she was experiencing.  On 04 Jan 2021, the patient received a second COVID-19 test and received a positive result on 08 Jan 2021.   On 08 Jan 2021, the patient was hospitalized with reported COVID-19 symptoms of dehydration, cough, no appetite, and no taste. Treatment for the event included fluids, oxygen, and steroids.   On 11 Jan 2021, the patient was discharged from the hospital.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, faints, headache, chills, and COVID-19, was not reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Visual impairment
Clinical narrative: Employee states that later that eveningwhen she got home she began having some lightheadedness and describes feeling loopy. She described seeing stars at times and then her vision would go black. A friend came over to stay with her and did say that at one point she became unresponsive for about 45 sec to 1 minute. The second day she still had the lightheadedness and felt loopy. On the 3rd day she felt completely fine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertensive crisis, Oxygen saturation
Clinical narrative: Blood pressure 210/120; A spontaneous report was received from a consumer concerning a 79-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced a hypertensive crisis.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14-Jan-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 14-Jan-2021 A patient received the Moderna vaccine. On 15-Jan-2021, the patient experienced a blood pressure of 210/120.  The friend reported that the patient's baseline blood pressure is 124/74.  Patient's reported heart rate was 75 and her oxygen saturation was 100%.  Patient visited the emergency room on 15-Jan-2021.  No additional details were provided.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, a hypertensive crisis, was not provided.   The outcome of the event, a hypertensive crisis, was not reported.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of hypertensive crisis. The event of hypertensive crisis occurred 2 days after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations, Paraesthesia, Vomiting
Clinical narrative: Pt developed palpitations, tingling of left sided face,  vomiting
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor, Vomiting
Clinical narrative: Unconscious; Turned Pale; Threw up; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and turned pale, threw up, and was unconscious.  The patient's medical history was not provided. No concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient turned pale, threw up and was unconscious. The patient was taken to the emergency department (ED). No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, turned pale, threw up, and unconscious, was unknown.; Reporter's Comments: This spontaneous report refers to a case a patient who experienced events turned pale, threw up and was unconscious on the same day after the administration of the first and only dose of mRNA-127 (Lot number 025L20A, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events and vaccine administration cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; A spontaneous report was received from a nurse who was an 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event of diverticulitis.  The patient's medical history was not provided. No concomitant medications were reported.  On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011S20G) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced diverticulitis.  She was hospitalized and the treatment of the event given was iv antibiotics.   On 15 Jan 2021, the patient reported that the symptoms started again.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, diverticulitis, was not resolved.; Reporter's Comments: This case concerns a 53-year-old, female patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of diverticulitis. The event occurred the same day the patient received the first dose of mRNA-1273 (Lot number: 011S20G). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test, Chest X-ray, Electrocardiogram, Palpitations
Clinical narrative: Arrhythmia; Heart palpitations; A spontaneous report was received from a 42 year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart palpitations and arrhythmia.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021 at 14:30, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient went to the emergency room (ER) because he had heart palpitations and an arrhythmia for about 5 hours. Blood tests, electrocardiogram (EKG) and a chest x-ray were normal.  On 10 Jan 2021, the patient's heart palpitations came back again. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, heart palpitations and arrhythmia, was not reported.; Reporter's Comments: This case concerns a  42-year old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Arrhythmia and an unexpected non-serious event of Heart palpitations approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown).  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Today 01/29/2021 I noticed swelling and redness around injection site. Warm to touch. baseball size
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received a 0.25ml dose; A spontaneous report was received from a consumer who was also a 59-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced received a 0.25 milliliter (mL) dose.  The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications reported included unspecified diabetes medication.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient noticed that he received a 0.25 mL dose rather than the full 0.5 mL dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, received a 0.25ml dose, was considered resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 59-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: ventral tongue and lip tingling, beginning 20 min after vaccination,  improving over hours beginning prior to and continuing after Diphenhydramine, 50-75% resolved after 2 hrs and fully resolved on awakening this am, no SOB, no lip swelling, no rash, no nausea, no throat fullness, no fever
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Impaired work ability, Vertigo
Clinical narrative: Induced a bout of vertigo which lasted 11 days, although a vertigo sufferer no prevous bout has gone more than about 3 days.  the dizziness was severe enough it prevented patient from working for at l9 days
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Injection site rash, Myalgia, Pain in extremity
Clinical narrative: 1/15/21 sore arm 3 days later, 24 hours after pressure on head, 30 mins of being lightheaded, later on muscle aches, 1/21 pt started to experience low grade fever, 1/22 called PCP; PCP recommended COVID test. 1/23 COVID test, 1/24 injection site and below rash, low grade fever continued, 1/27 rash/fever gone
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 1/15/21 sore arm 3 days later, 24 hours after pressure on head, 30 mins of being lightheaded, later on muscle aches, 1/21 pt started to experience low grade fever, 1/22 called PCP; PCP recommended COVID test. 1/23 COVID test, 1/24 injection site and below rash, low grade fever continued, 1/27 rash/fever gone
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Nausea, Neck pain
Clinical narrative: awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Within 2 hours of shot extreme soreness in arm, around 6pm shooting pain across forehead, nausea, chills, low grade fever, body aches.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself).  A 53-years-old female patient received second dose of BNT162B2 ( COVID-19 VACCINE, Solution for injection, lot number EL3248, expiry date not reported), intramuscular in the right arm on 13Jan2021 11:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient had no covid prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medications included first dose of varicella zoster vaccine rge (cho) (SHINGRIX) on 07Dec2020 at a single dose in the left arm for immunization; bupropion hydrochloride (WELLBUTRIN); and unspecified hormone replacement.  The first dose of BNT162B2 for COVID-19 immunization (lot EK5730; brand Pfizer,) was on 22Dec2020 07:15 AM via intramuscular route in the left arm. The patient was having sharp stabbing pains every 5-10 seconds in the left parietal occipital area; started about 13 hours after second vaccine (14Jan2021 03:00 AM). No treatment received in relation to the reported event. The patient was not tested for covid post vaccination. The outcome of the event sharp stabbing pains every 5-10 seconds in the left parietal occipital area was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Heart rate, Nausea
Clinical narrative: dizzy; headache; nausea; puffy throat; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3249), intramuscular at Arm Left on 12Jan2021 at the 56 years old at single dose for COVID-19 immunization. The medical history included bronchitis and palpitations. The concomitant medications were not reported. The patient experienced dizzy, headache, nausea, "puffy throat" all on 12Jan2021. There was treatment received for events dizzy, headache, nausea, "puffy throat". The patient underwent lab tests and procedures, which included Blood pressure (BP) 123/59, O2 Saturation 100%, Heart Rate70 all on an unknown date. The outcome of all the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pharyngeal swelling
Clinical narrative: dizzy; headache; nausea; puffy throat; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3249), intramuscular at Arm Left on 12Jan2021 at the 56 years old at single dose for COVID-19 immunization. The medical history included bronchitis and palpitations. The concomitant medications were not reported. The patient experienced dizzy, headache, nausea, "puffy throat" all on 12Jan2021. There was treatment received for events dizzy, headache, nausea, "puffy throat". The patient underwent lab tests and procedures, which included Blood pressure (BP) 123/59, O2 Saturation 100%, Heart Rate70 all on an unknown date. The outcome of all the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Employee reports not being able to sleep at all night of injection, injection site pain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac flutter, Chills, Decreased appetite, Fatigue
Clinical narrative: COVID-19 Vaccine EUA; fever, chills, joint intense pain in hip joints and neck, headache, exhaustion, loss of appetite, nausea,  heart fluttered for a few seconds at various times throughout the day, swelling and pain at injection site.  Symptoms started around 9PM on the 26th, started to feel better at 8AM morning of the 28th.  Could not work or focus at all for the 27th.  Took tylenol, motrin, and aleve for pain, which eased some pain, but not full relief, constantly felt pain.  By 8AM on the 28th, pain, headache, exhaustion, appetite loss, nausea, and heart flutters stopped.  Pain at arm shot site diminished to only when touched, discomfort shifted to  right side of rib cage under the armpit, and is still present at 12:15pm on Jan 29th.   Called primary physician to verify all was OK, and as predicted it passed within 24-48hrs.  No allergic reactions ever.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Limb discomfort, Nausea
Clinical narrative: COVID-19 Vaccine EUA; fever, chills, joint intense pain in hip joints and neck, headache, exhaustion, loss of appetite, nausea,  heart fluttered for a few seconds at various times throughout the day, swelling and pain at injection site.  Symptoms started around 9PM on the 26th, started to feel better at 8AM morning of the 28th.  Could not work or focus at all for the 27th.  Took tylenol, motrin, and aleve for pain, which eased some pain, but not full relief, constantly felt pain.  By 8AM on the 28th, pain, headache, exhaustion, appetite loss, nausea, and heart flutters stopped.  Pain at arm shot site diminished to only when touched, discomfort shifted to  right side of rib cage under the armpit, and is still present at 12:15pm on Jan 29th.   Called primary physician to verify all was OK, and as predicted it passed within 24-48hrs.  No allergic reactions ever.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia, Tenderness
Clinical narrative: COVID-19 Vaccine EUA; fever, chills, joint intense pain in hip joints and neck, headache, exhaustion, loss of appetite, nausea,  heart fluttered for a few seconds at various times throughout the day, swelling and pain at injection site.  Symptoms started around 9PM on the 26th, started to feel better at 8AM morning of the 28th.  Could not work or focus at all for the 27th.  Took tylenol, motrin, and aleve for pain, which eased some pain, but not full relief, constantly felt pain.  By 8AM on the 28th, pain, headache, exhaustion, appetite loss, nausea, and heart flutters stopped.  Pain at arm shot site diminished to only when touched, discomfort shifted to  right side of rib cage under the armpit, and is still present at 12:15pm on Jan 29th.   Called primary physician to verify all was OK, and as predicted it passed within 24-48hrs.  No allergic reactions ever.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Malaise, Peripheral swelling
Clinical narrative: Swelling and redness of the arm, the size of an orange; Swelling and redness of the arm, the size of an orange; Headaches; Tiredness; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 59-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ibuprofen. The patient previous received first dose of bnt162b2 (lot number: EK5730) intramuscularly in left arm on 21Dec2020 11:30 AM for COVID-19 immunization. The patient experienced swelling and redness of the arm, the size of an orange, headaches, tiredness, feeling unwell on 13Jan2021 06:00. No treatment received. The outcome of events was resolving. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No covid prior vaccination. No covid tested post vaccination. Not known allergies. Facility type vaccine was hospital. No other vaccine in four weeks.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia oral
Clinical narrative: "Staff member was receiving her first dose today. Staff member reported to fell sweaty, lightheaded, tongue felt tingling. Vaccine Staff took staff member back to vestibule, to have staff member to lay down.   Vital signs: 1535 HR 94 B/P 108/72  SpO2 100 1540 HR 92 B/P 109/72 SpO2 100 1550 HR 77 B/P 97/63 SpO2 100  Staff member reported feeling better after sitting for 5 min. Monitored staff member for about 20 min.  "
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Heart rate, Heart rate increased
Clinical narrative: Chills; sweats; rapid pulse; temp; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Jan2021 11:30 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant at the time of vaccination. Medical history included diagnosed with covid-19 from an unknown date. Patient tested for COVID-19 (Nasal Swab) on 11Jan2021, the result was negative. Concomitant medication included escitalopram oxalate (LEXAPRO), vitamin d [vitamin d nos] (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C). No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills, sweats, rapid pulse, temp on 16Jan2021 08:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. Since the vaccination in Jan2021, patient has been tested for COVID-19, the result was unknown. The events were reported as non-serious.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Chills; sweats; rapid pulse; temp; This is a spontaneous report from a contactable other health professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Jan2021 11:30 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant at the time of vaccination. Medical history included diagnosed with covid-19 from an unknown date. Patient tested for COVID-19 (Nasal Swab) on 11Jan2021, the result was negative. Concomitant medication included escitalopram oxalate (LEXAPRO), vitamin d [vitamin d nos] (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C). No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills, sweats, rapid pulse, temp on 16Jan2021 08:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. Since the vaccination in Jan2021, patient has been tested for COVID-19, the result was unknown. The events were reported as non-serious.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Mydriasis
Clinical narrative: Patient reported that both eyes dilated after the 15 minute wait period and that one returned to normal in about 5 hours and the other returned to normal by the next day. He also stated that her has noticed "irregular heart beats" since his vaccination and has an upcoming appt. with his cardiologist.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: Fatigue, sore left arm, and 2 episodes of diarrhea occurred about 24 hours after vaccination. All side effects  resolved 18 hours after first symptom onset.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Muscle atrophy, Pain, SARS-CoV-2 test
Clinical narrative: pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; gray discoloration; muscle atrophy; Indentation; This is a spontaneous report from a contactable 49-year-old female physician reported for herself. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via an unspecified route of administration on 23Dec2020 07:30 at single dose at left arm for covid-19 immunisation. Medical history included allergy: walnuts. Concomitant medication within 2 weeks of vaccination included medroxyprogesterone acetate (DEPO PROVERA). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced initial pain and small SQ bump. After 1 week, red and swollen 2x3cm, firm. No pain, no warmth. About 2 weeks after, swelling gone, but gray discoloration on 2x3 cm area. Now after 3 weeks, same area with muscle atrophy. Indentation and mildly achy. Adverse event start date was reported as 30Dec2020. Patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included nasal swab, SARS-CoV2, NAAT: negative on 05Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of event swelling was recovered, and outcome of other events was not recovered. The report is considered as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin disorder, Skin indentation, Swelling
Clinical narrative: pain/mildly achy; small SQ bump; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; red and swollen 2x3cm, firm; gray discoloration; muscle atrophy; Indentation; This is a spontaneous report from a contactable 49-year-old female physician reported for herself. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via an unspecified route of administration on 23Dec2020 07:30 at single dose at left arm for covid-19 immunisation. Medical history included allergy: walnuts. Concomitant medication within 2 weeks of vaccination included medroxyprogesterone acetate (DEPO PROVERA). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced initial pain and small SQ bump. After 1 week, red and swollen 2x3cm, firm. No pain, no warmth. About 2 weeks after, swelling gone, but gray discoloration on 2x3 cm area. Now after 3 weeks, same area with muscle atrophy. Indentation and mildly achy. Adverse event start date was reported as 30Dec2020. Patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included nasal swab, SARS-CoV2, NAAT: negative on 05Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive treatment for events. Outcome of event swelling was recovered, and outcome of other events was not recovered. The report is considered as non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, severe headache