chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Fatigue; body achiness; Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th January 2021, 1 days after receiving Shingrix, the patient experienced fatigue, general body pain and injection site pain. On an unknown date, the outcome of the fatigue, general body pain and injection site pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, general body pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. On 4th January 2021, the patient stated that he had soreness at the injection site, body achiness, and fatigue. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Inflammation, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: painfull soreness at injection site; swelling; knee swelling; inflammation on knee; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, swelling, swelling of knees and knee arthritis. On an unknown date, the outcome of the injection site pain, swelling, swelling of knees and knee arthritis were unknown.   It was unknown if the reporter considered the injection site pain, swelling, swelling of knees and knee arthritis to be related to Shingrix.  Additional details were provided as follows:  No any patient demographics was given. The age at vaccination was not reported.  After receiving dose of Shingrix, the patient experienced painful soreness, swelling and knee swelling. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site pain
Clinical narrative: soreness in the area where the shot was given; increase in his blood pressure / blood pressure is higher than normal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 1st November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and increased blood pressure. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the increased blood pressure was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient experienced an increase in his blood pressure and his blood pressure was higher than normal.  The patient also experienced soreness in the area where the shot was given. The patient refused to provide any additional details. The follow-up would not possible as no contact details were available.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue
Clinical narrative: feeling exhausted the day after the shivering stopped; the shivering lasted for about 4 hours; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 73-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2020, the patient received FluLaval Tetra 2020-2021 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. In October 2020, 48 hrs after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced shivering and exhaustion. On an unknown date, the outcome of the shivering and exhaustion were recovered/resolved.   It was unknown if the reporter considered the shivering and exhaustion to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had reported the case for himself. The patient had a reaction 48 hours after receiving vaccine on 9th October 2020, shivering lasted for about 4 hours and felt exhausted was stopped the day after the shivering stopped. The reporter did not consent to follow-up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle pain; extreme fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 1 days after receiving Shingrix, the patient experienced fever, chills, muscle pain and fatigue. On an unknown date, the outcome of the fever, chills, muscle pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the fever, chills, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced fever, chills, fatigue and muscle pain on the 1st day after vaccination, which resolved after 2 days. For tolerance of 2nd  dose, refer case US2021013454.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013454:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Middle insomnia, Pain in extremity
Clinical narrative: sore arm / after the first dose; chill after the first dose; I woke up in the middle of the night; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, chills and nocturnal awakening. On an unknown date, the outcome of the pain in arm, chills and nocturnal awakening were recovered/resolved.   It was unknown if the reporter considered the pain in arm, chills and nocturnal awakening to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced woke up in the middle of the night with the chills and a sore arm. The caller declined to participate in this report. The reporter did not consent to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR016683.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016683:Same reporter
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain
Clinical narrative: dose 1 of Shingrix sometime in October of 2019, and has yet to receive dose 2; pain at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site erythema and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for the 2nd dose. The patient received 1st dose of Shingrix and experienced redness and pain at injection site, which resolved after about 3 days. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Skin induration
Clinical narrative: radiating pain; raised area on the skin; This case was reported by a consumer and described the occurrence of radiating pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced radiating pain and skin induration. On an unknown date, the outcome of the radiating pain and skin induration were recovered/resolved.   It was unknown if the reporter considered the radiating pain and skin induration to be related to Shingrix.  Additional details were reported as follows: The case was reported by family member of patient. The age at vaccination was not reported. The age group of patient was not reported but was captured as an adult as per vaccine indication. The patient experienced radiating pain and a raised area on the skin, but raised area was not a blister.  The reporter declined to provide any of the patient's information. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: dizziness; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Shingrix. On 1st February 2021, less than a day after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but it could be 68 to 69 year. The patient received Shingrix and experienced dizziness. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster
Clinical narrative: Experienced a bad episode of shingles on the eye after / first dose; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. In February 2019, between 2 and 4 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad episode of shingles on the eye after receiving the first dose of Shingrix. The patient was late for the 2nd dose and did not receive 2nd dose due to shingles case post 1st dose. No other information was provided. The consent to follow-up was granted.
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control
Clinical narrative: ability to regulate their diabetes with insulin was negatively affected; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on unknown date as a single dose for COVID-19 immunization at Nursing Home/Senior Living Facility. Relevant medical history and concomitant medications were unknown. Patient was not pregnant at time of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after receiving the COVID-19 vaccine, it was reported that the patient's ability to regulate her diabetes with insulin was negatively affected. The adverse event resulted in the doctor or other HCP's office/clinic visit. The outcome of the event was unknown. It was unknown if the patient received any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Headache, Nausea, Pain of skin, SARS-CoV-2 test
Clinical narrative: Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP.  A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation.  Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing.  Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine.   The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced " Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021.  Therapeutic measures were taken as a result of the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded.  The case will be reassessed if additional information becomes available.  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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP.  A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation.  Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing.  Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine.   The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced " Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021.  Therapeutic measures were taken as a result of the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded.  The case will be reassessed if additional information becomes available.  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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dysphagia, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity.  Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pain in extremity, Pruritus, Throat tightness, Vaccination site pain
Clinical narrative: Chest pains by heart once in the car; Itching by neck, shoulders, upper arms, legs, back; Throat closed up a bit; Sore upper left arm at injection site; Headache; Fatigue; Later on sharp pains in left calf upon walking; Numbness in left facial cheek and left side of tongue; Numbness in left facial cheek and left side of tongue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies or hypersensitivity.  Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a health facilty. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received second dose of varicella zoster vaccine (lot number and expiry date not reported) on 18Jan2021 at single dose for immunization. Five minutes after first shot of Pfizer Covid 19 vaccine, on 02Feb2021 13:35, it began itching by neck, shoulders, upper arms, legs, back; throat closed up a bit. The patient was administered 50 mg Benadryl, but itching continued. The patient had sore upper left arm at injection sight. They waited at the vaccination facility under care of 3 nurses for one hour. The patient was offered Epi-pen, but did not administer Epi-pen. The patient's husband drove her home. She had chest pains by heart once in the car. The patient had headache, fatigue, and later on sharp pains in left calf upon walking, numbness in left facial cheek and left side of tongue and difficulty swallowing. Clinical outcome of the events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, COVID-19, Disturbance in attention, Feeling abnormal, Head discomfort
Clinical narrative: inability to multitask, difficultly with problem solving, significant reduction task completion; Slow mental processing; reduced concentration; significant reduction in memory; dense Brain fog set in; This combined with an increasing pressure at the center of my head pushing out.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included low back pain, and allergy to peanuts, gluten and nickel. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX), egcg (EGCG), colecalciferol (VITAMIN D) and vitamin c [ascorbic acid] (VITAMIN C). The patient did not receive other vaccine in four weeks. The patient previously took ketorolac tromethamine (TORADOL) but had allergies. The patient recieved her most recent COVID-19 vaccine in her workplace clinic. On 26Jan2021 05:30 PM (reported as 3.5 hours after the vaccination), the patient had a dense brain fog set in, slow mental processing, reduced concentration, inability to multitask, difficultly with problem solving, significant reduction in memory and task completion. This has remained unchanged for 8 days. This combined with an increasing pressure at the center of her head pushing out. The patient reported that she received treatment for the adverse events and the events resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19 test with negative results on an unspecified date. The outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mental impairment / mental disorders cannot be excluded, considering the plausible temporal relationship. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Mental impairment
Clinical narrative: inability to multitask, difficultly with problem solving, significant reduction task completion; Slow mental processing; reduced concentration; significant reduction in memory; dense Brain fog set in; This combined with an increasing pressure at the center of my head pushing out.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included low back pain, and allergy to peanuts, gluten and nickel. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX), egcg (EGCG), colecalciferol (VITAMIN D) and vitamin c [ascorbic acid] (VITAMIN C). The patient did not receive other vaccine in four weeks. The patient previously took ketorolac tromethamine (TORADOL) but had allergies. The patient recieved her most recent COVID-19 vaccine in her workplace clinic. On 26Jan2021 05:30 PM (reported as 3.5 hours after the vaccination), the patient had a dense brain fog set in, slow mental processing, reduced concentration, inability to multitask, difficultly with problem solving, significant reduction in memory and task completion. This has remained unchanged for 8 days. This combined with an increasing pressure at the center of her head pushing out. The patient reported that she received treatment for the adverse events and the events resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19 test with negative results on an unspecified date. The outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mental impairment / mental disorders cannot be excluded, considering the plausible temporal relationship. 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown.   Information about Lot/batch no has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown.   Information about Lot/batch no has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pruritus, Pyrexia, Sensation of foreign body
Clinical narrative: Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown.   Information about Lot/batch no has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown.   Information about Lot/batch no has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Fall, Influenza
Clinical narrative: fall; flu; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Adult patient who experienced fall and flu (influenza), while he/she received vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious fall and flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  Information on batch number will not be available
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient could not got injections It was live injections give me the illness; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) in United States.  This case involved a patient of unknown age who could not get injections it was live injections give me the illness (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient could not get injections it was live injections give me the illness (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient was sickest kid; Initial information received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patients parents.  This case involved a male patient of unknown age who was sickest kid (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient was sickest kid (illness), (latency: unknown) following the administration of suspect vaccine.  Never again. If patient was over there blowing up gloves and causing trouble reporter told he's not super sick and was lucky to have natural immunity from getting sick. Sickness finds all, vaccinated or not but it was a part of life that programs the immune system to be better.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick for a month; Initial information was received on 11-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional. (reference number: US-SA-SAC20210217000572).  This case involves an adult patient who was sick for a month (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick for a month (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information of batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu was after he had the flu shot; Initial information received on 13-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patients parents).  This case involved a male patient of unknown age who got the flu was after he had the flu shot (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient got the flu was after he had the flu shot (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Local Redness of Swelling 50 to 120 mm, but not below the elbow.  Itching but no other symptoms reported. 50mgs diphenhydramine given IM Right Arm. Observation started for 60 mins. All symptoms subsided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Diarrhoea, Feeling cold, Gait inability, Joint swelling
Clinical narrative: Attacked all joints. Could BARELY walk, move head, use hands( started 8pm stop 9am). Excessively freezing (8pm-7am).  Fever(101.3). Nausea (8:30pm - 2am).   Diarrhea (second day - (lasted 6hrs).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: Attacked all joints. Could BARELY walk, move head, use hands( started 8pm stop 9am). Excessively freezing (8pm-7am).  Fever(101.3). Nausea (8:30pm - 2am).   Diarrhea (second day - (lasted 6hrs).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Syringe issue
Clinical narrative: Patient was injected with 1 syringe that was believed to be empty. This was recognized by patient and the shot administrator. Immediately after, decision was made to re-administer vaccine. A second injection was then performed, the second time with Moderna COVID vaccine 0.5 mL. Patient was counseled
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After receiving the vaccine client stated shat she feels dizzy.  Vital signs obtained by EMS  Bp 113/78, O2 sat 100%, Blood sugar 118. Client states she feels better.  Client discharged home by EMS.  Client advised to call EMS if symptoms worsen.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall, Feeling abnormal
Clinical narrative: I have been dizzy and my head feels cloudy and I can't stand up well without falling over.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt. in tent 23 at 2:05 pm at observation line.  Complained of right eye.  Paramedic assessed the pat. Once symptoms subsided pt. was released to leave.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea
Clinical narrative: headache, sweats, nausea (feeling)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Gaze palsy
Clinical narrative: Around 5:30 PM I began experiencing normal symptoms like headache and muscle ache. At 8:15 PM I began to feel light headed, nauseous, and short of breath. Around 8:20 I needed to lay on the floor to prevent myself from fainting. My eyes were rolling back because I was borderline unconscious. I felt like I had no control of my body and had to go to the bathroom. For around 15 minutes I was on the floor convulsing, shaking as if I had chills and my muscles were involuntarily tensing. My pulse was extremely low. After the convulsions stopped I remained on the floor an additional 15 minutes.  Around 8:45 PM I was able to return into my bed with assistance. My nauseous remained and I began experiencing chills. I slept on an off the entire night. At about 1 AM what I suspect was a fever began to break and I was extremely sweaty. For the following day I experienced exhaustion and muscle soreness. I am still experiencing exhaustion. I recognize a bulk of my symptoms were normal but the convulsions, losing consciousness, and inability to control my body seemed worth reporting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate decreased, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Around 5:30 PM I began experiencing normal symptoms like headache and muscle ache. At 8:15 PM I began to feel light headed, nauseous, and short of breath. Around 8:20 I needed to lay on the floor to prevent myself from fainting. My eyes were rolling back because I was borderline unconscious. I felt like I had no control of my body and had to go to the bathroom. For around 15 minutes I was on the floor convulsing, shaking as if I had chills and my muscles were involuntarily tensing. My pulse was extremely low. After the convulsions stopped I remained on the floor an additional 15 minutes.  Around 8:45 PM I was able to return into my bed with assistance. My nauseous remained and I began experiencing chills. I slept on an off the entire night. At about 1 AM what I suspect was a fever began to break and I was extremely sweaty. For the following day I experienced exhaustion and muscle soreness. I am still experiencing exhaustion. I recognize a bulk of my symptoms were normal but the convulsions, losing consciousness, and inability to control my body seemed worth reporting.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Around 5:30 PM I began experiencing normal symptoms like headache and muscle ache. At 8:15 PM I began to feel light headed, nauseous, and short of breath. Around 8:20 I needed to lay on the floor to prevent myself from fainting. My eyes were rolling back because I was borderline unconscious. I felt like I had no control of my body and had to go to the bathroom. For around 15 minutes I was on the floor convulsing, shaking as if I had chills and my muscles were involuntarily tensing. My pulse was extremely low. After the convulsions stopped I remained on the floor an additional 15 minutes.  Around 8:45 PM I was able to return into my bed with assistance. My nauseous remained and I began experiencing chills. I slept on an off the entire night. At about 1 AM what I suspect was a fever began to break and I was extremely sweaty. For the following day I experienced exhaustion and muscle soreness. I am still experiencing exhaustion. I recognize a bulk of my symptoms were normal but the convulsions, losing consciousness, and inability to control my body seemed worth reporting.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Pruritus, Rash
Clinical narrative: Painful itching rash left arm, torso . Nerve pain left arm
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, headache, chills, fatigue