chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pruritus, Rash, Skin induration
Clinical narrative: Symptoms like an allergic reaction; Flu like symptoms; Tiredness in her muscles; Shortness of breath (she feels it in her chest); Skin is itchy and feels as if she had a rash; A spontaneous report was received from a 50 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced flu like symptoms, symptoms like an allergic reaction, tiredness in her muscles, shortness of breath (she feels it in her chest), and skin is itchy and feels as if she had a rash.    The patient's medical history included allergies. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (batch number 025J20-2A) intramuscularly for COVID-19 for infection prophylaxis.  On 30 Dec 2020, the patient received her first dose of the vaccine and later in the day she presented flu like symptoms and symptoms like an allergic reaction. She also reported she felt tiredness in her muscles, shortness of breath (she feels it in her chest), her skin is itchy and feels as if she had a rash but she didn't have a rash. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, symptoms like an allergic reaction, tiredness in her muscles, shortness of breath (she feels it in her chest), and skin is itchy and feels as if she had a rash, was considered not resolved.; Reporter's Comments: This case concerns a 50 year old female patient with medical history of allergies, who experienced a serious unexpected event of Hypersensitivity and NS unexpected events of Influenza like illness, Muscular weakness, Dyspnoea, and Pruritus. The events occurred on the same day when the patient received the first of two planned doses of mRNA-1273 (batch number 025J20-2A). Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Eating disorder, Fatigue, Gastrointestinal sounds abnormal
Clinical narrative: Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: felt kind of tired; Tested positive for COVID after receiving the first dose of the COVID Vaccine; Tested positive for COVID after receiving the first dose of the COVID Vaccine; slight fever; body aches; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (the patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730) via unspecified route of administration on the left arm/shoulder on 22Dec2020 at single dose for COVID-19 immunisation.  Medical history included gained weight since the pandemic started. The patient's concomitant medications were not reported.  Patient received first dose of the vaccine. She had symptoms right after she got the vaccine the next day, on 23Dec2020. She had a slight fever, body aches, and a headache, which she never gets. She had these for about 2-3 days, they lingered around, and kicked back up around 26Dec2020/27Dec2020. She also felt kind of tired. She got covid 19 infection tested on 02Jan2021 and the results came back positive on 03Jan2021. Patient was calling to report this and see what to do about the second dose. She was supposed to get her second dose next Tuesday. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak 5 days after vaccination; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscular on 22Dec2020 at single dose on the right arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID-19 vaccine was administered in the hospital.  The patient experienced shingles outbreak 5 days after vaccination on 27Dec2020. The event was assessed as non-serious. Acyclovir pills were given as treatment. Since the vaccination, the patient has not been tested for COVID-19. It was also reported that "Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit". Outcome of the event was not recovered.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Gastrointestinal disorder, Nausea, Pain in extremity
Clinical narrative: Felt like a fever; super hot; nauseous; GI issues; fatigued; Arm was sore; This is a spontaneous report from a contactable healthcare professional reporting for himself. A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 07Jan2021 12:30 PM (at the age of 25 years old) as a single dose in the right arm for COVID-19 vaccination. Relevant medical history included known allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) included lisdexamfetamine mesilate (VYVANSE) 20 mg once daily, and paroxetine hydrochloride (PAXIL) 20 mg once daily. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: not provided), via an unspecified route of administration, on 19Dec2020 04:00 PM (at the age of 25 years old) as a single dose in the right arm for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the second dose of COVID vaccine (except for the first dose of BNT162B2). On 07Jan2021, the patient's arm was sore at night. The patient woke up in the morning on 08Jan2021 at 03:00 AM morning and was super hot. He reported that it felt like a fever. The patient also felt super fatigued, nauseous and had gastrointestinal (GI) issues. The patient drank water and took 400 mg of ibuprofen. The patient reported that this did not happen during the first dose. The patient reported that he felt fine at 09:00 AM on 08Jan2021. Treatment for these events included 400 mg of ibuprofen. The outcome of the events arm was sore, was super hot, felt like a fever, fatigued, nauseous, and GI issues was recovered on 08Jan2021 at 09:00 AM. Since the vaccination, the patient had not been tested for COVID-19.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt like a fever; super hot; nauseous; GI issues; fatigued; Arm was sore; This is a spontaneous report from a contactable healthcare professional reporting for himself. A 25-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 07Jan2021 12:30 PM (at the age of 25 years old) as a single dose in the right arm for COVID-19 vaccination. Relevant medical history included known allergies to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) included lisdexamfetamine mesilate (VYVANSE) 20 mg once daily, and paroxetine hydrochloride (PAXIL) 20 mg once daily. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: not provided), via an unspecified route of administration, on 19Dec2020 04:00 PM (at the age of 25 years old) as a single dose in the right arm for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the second dose of COVID vaccine (except for the first dose of BNT162B2). On 07Jan2021, the patient's arm was sore at night. The patient woke up in the morning on 08Jan2021 at 03:00 AM morning and was super hot. He reported that it felt like a fever. The patient also felt super fatigued, nauseous and had gastrointestinal (GI) issues. The patient drank water and took 400 mg of ibuprofen. The patient reported that this did not happen during the first dose. The patient reported that he felt fine at 09:00 AM on 08Jan2021. Treatment for these events included 400 mg of ibuprofen. The outcome of the events arm was sore, was super hot, felt like a fever, fatigued, nauseous, and GI issues was recovered on 08Jan2021 at 09:00 AM. Since the vaccination, the patient had not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram normal, Confusional state, Dyspnoea, Electrocardiogram normal
Clinical narrative: Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed "off" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Joint injury, Laboratory test normal, Limb injury
Clinical narrative: Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed "off" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Myalgia, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed "off" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: Myalgia chills, fatigue, syncope vs seizure 43 yo employee falt fatigue on 12/24 and again on 12/25/20. The patients husband reports she was walking down the stairs, seemed "off" and missed the step/slid on step injuring both feet/ankles. Pt got up and was able to stand for a few minutes. Husband reports that he than sat her on the steps-few minutes later she had syncope with convulsions vs seizure. Per his report this lasted over a minute, she stopped breathing and was unresponsive. He reports she was confused while he was on the phone with 911 operator (3 minutes). Patient was taken to Health Center for work up. The head CT, labs, X-rays, EKG were unremarkable. Followed up her physician Dr. and was referred to neurologist. She had a MRI without contrast which was unremarkable and is scheduled to undergo a sleep deprived EEG. She is undergoing physical therapy at this time for injury to bilateral feet/ankles.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Illness, Injection site pain, Somnolence
Clinical narrative: very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy.  The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very weak and sleepy; very weak and sleepy; Vomiting; Shivers; had gotten sick; Pain injection site; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3246, expiry date not reported), intramuscular on 05Jan2021 13:30 at a single dose in the upper left arm for COVID-19 prophylaxis. There were no medical history and concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient asked if there was any contraindication to getting the second dose. Patient reported having vomiting and shivers the day after receiving the vaccine as well as pain at injection site which was reportedly now resolved. Patient was calling about the Covid-19 vaccine and reported that she received the vaccine this past Tuesday 05Jan2021. She said that she was very sick the next day (06Jan2021). She said that 5 people went with her to get the vaccine and she was the only one who had gotten sick. Patient clarified that she had vomiting throughout the day the next day after receiving the vaccine. She also reported that she had shivers for hours and hours. She said that she had blankets and quilts on her and she could not stop shivering. She said that when she went to the doctor, the doctor thought it was because of the vaccine. Patient wanted to know if she should she take the second shot and if these will happen to her again or not and asked if there are any contraindications. She said that the vomiting started in the morning around 10:00 on 06Jan2021. It lasted a couple of hours until about 13:00 06Jan2021. She said that the shivers were bad, and she had big time shivering and there was nothing she could do to stop the shivering. The shivering lasted from 10:00 06Jan2021 until about 5-6 in the evening 06Jan2021. As the day progressed the pain where they gave her the shot was very bad on 05Jan2021. She said that she had pain at the injection site (pain injection site) on 05Jan2021. She said that it only hurts now if she touches the area. She said that the site previously it hurt without touching it. Patient was very weak and sleepy the next day. She said that she felt very weak and sleepy on 07Jan2021. She said that it lasted throughout the entirety of the day and she fell asleep and felt better today (at the time of the report). She said that today she felt fine. The events did not require emergency room visit but events required physician's office visit. The events were reported as not serious. Therapeutic measures were taken as a result of the events weak and sleepy.  The patient recovered from vomiting on 06Jan2021 13:00, from shivers on 06Jan2021, from weak and sleepy on 07Jan2021. The patient was recovering from pain injection site. The outcome of the event sick was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye irritation, Influenza like illness, Nausea, Pain
Clinical narrative: experienced soreness in her arm; experienced being achy like she was having the flu; experienced being achy like she was having the flu; fever; palpitation; shortness of breath; nausea; her eyes were burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at 8AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not feel anything until 5PM. At 5PM, she experienced soreness in her arm until the next day at 6:30PM or 7PM. At this time, she also experienced being achy like she was having the flu. In addition to that, she also experienced having fever, palpitation, shortness of breath, nausea, and her eyes were burning. That night, she took 2 paracetamol (TYLENOL) and got up fine. Outcome of all events was recovered on unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: experienced soreness in her arm; experienced being achy like she was having the flu; experienced being achy like she was having the flu; fever; palpitation; shortness of breath; nausea; her eyes were burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at 8AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not feel anything until 5PM. At 5PM, she experienced soreness in her arm until the next day at 6:30PM or 7PM. At this time, she also experienced being achy like she was having the flu. In addition to that, she also experienced having fever, palpitation, shortness of breath, nausea, and her eyes were burning. That night, she took 2 paracetamol (TYLENOL) and got up fine. Outcome of all events was recovered on unspecified date.   Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: feeling lightheaded; dizzy; nauseous; diarrhea; This is a spontaneous report from an Other Healthcare Professional, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose 1 , single dose via an unspecified route of administration in the left arm on 07Jan2021 at 03:45 PM (at the age of 23 years-old) for COVID-19 vaccination.  There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 05:00 AM, the patient woke up feeling lightheaded, dizzy, nauseous and experienced diarrhea. The report was reported as non-serious. The patient was not treated for feeling lightheaded, dizzy, nauseous and experienced diarrhea. The clinical outcome of feeling lightheaded, dizzy, nauseous and experienced diarrhea was recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the Lot/Batch Number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the first dose of the vaccine on 21Dec2020 and tested positive for Covid-19; received the first dose of the vaccine on 21Dec2020 and tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date was not provided) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020 and tested positive for covid-19 on 07Jan2021. The patient was isolated for 10 days. Outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Exposure to SARS-CoV-2
Clinical narrative: COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Nausea, Pain
Clinical narrative: Body aches; Low grade fever; Headache; Nausea; An elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 07Jan2021, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received COVID-19 vaccine yesterday (07Jan2021). Ten hours later, he noticed body aches, low grade fever, headache, nausea, and an elevated heart rate. He is concerned on how long these symptoms last. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches; Low grade fever; Headache; Nausea; An elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 07Jan2021, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received COVID-19 vaccine yesterday (07Jan2021). Ten hours later, he noticed body aches, low grade fever, headache, nausea, and an elevated heart rate. He is concerned on how long these symptoms last. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: facial twitching on the left side of the face which started with her lip which lasted for a couple of hours and moved to her left cheek the next day. These were resolved until she noticed left lower eyelid twitching last Sunday night; left lower eyelid twitching; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the first dose of the vaccine almost 3 weeks ago and it will be exactly 3 weeks on Monday. Last week on possibly Friday (Jan2021), she noticed facial twitching on the left side of the face which started with her lip which lasted for a couple of hours and moved to her left cheek the next day. These were resolved until she noticed left lower eyelid twitching last Sunday night which had happened about 30 times with durations of about 4 seconds until now since Sunday. She is asking if this was reported and if she was to proceed with 2nd dose. The patient recovered from facial twitching on the left side of the face which started with her lip which lasted for a couple of hours and moved to her left cheek while did not recover from left lower eyelid twitching.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: a little fuzzy in the head; This is a spontaneous report from a contactable consumer, the patient. A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. She is due to get the next dose on 27Jan2021. Relevant medical history was unknown. On an unknown date, the patient  was "a little fuzzy in the head" no other side effects reported, no injection sight pain. She carries an (epinephrine (EpiPen). The clinical outcome of fuzzy in the head  was unknown.    Information on Lot/Batch has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 08Jan2021 (lot number: EK9231) and first dose on 19Dec2020 (lot number: EN9899); both via unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced headache on 08Jan2021. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included COVID-19 test: negative on 17Dec2020. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste for about 1 1/2 hrs immediately following the injection.  It did go away.; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on her left arm on 31Dec2020 at 10:45 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had allergies to medications, food and other products; all unspecified. Prior to vaccination, the patient was not diagnosed with COVID-19. No vaccines received within 4 weeks prior to COVID vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID) which was received within 2 weeks of vaccination. The patient experienced metallic taste for about 1 1/2 hrs (hours) immediately following the injection on 31Dec2020 at 10:45. It did go away. The patient did not receive treatment for the adverse event. Outcome of the event was recovered on unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Myalgia
Clinical narrative: Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous report from a contactable other Health Care Professional (HCP).  A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown), intramuscularly, on 05Jan2021 (at the age of 35-years old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included Thalassaemia from an unknown date and COVID-19 on an unknown date. The patient's historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730) on 17Dec2020 (at the age of 35-years-old) at unspecified dose in the left arm for COVID vaccination.The patient has no allergies to medications, food, or other products. The patient was administered the vaccine in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had been diagnosed with COVID-19 on an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccinations. On 05Jan2021 at 23:30 the patient experienced chills, low-grade fever (100.9), muscle aches, weakness and diarrhea. The patient did not receive any treatment for the events. The clinical outcome of the events was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous report from a contactable other Health Care Professional (HCP).  A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown), intramuscularly, on 05Jan2021 (at the age of 35-years old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included Thalassaemia from an unknown date and COVID-19 on an unknown date. The patient's historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730) on 17Dec2020 (at the age of 35-years-old) at unspecified dose in the left arm for COVID vaccination.The patient has no allergies to medications, food, or other products. The patient was administered the vaccine in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had been diagnosed with COVID-19 on an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccinations. On 05Jan2021 at 23:30 the patient experienced chills, low-grade fever (100.9), muscle aches, weakness and diarrhea. The patient did not receive any treatment for the events. The clinical outcome of the events was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Fatigue
Clinical narrative: Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient).  A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021.  It is unknown if the patient has been tested for COVID-19 since the second vaccination.