chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Chills, Cough, Fatigue, Headache
Clinical narrative: sinus congestion; chest congestion; mild cough; laryngitis; loss of voice; nasal congestion; nasal congestion and drainage; mild sore throat; tired; headache; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in left arm on 27Mar2021 (age at vaccination was 42-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included seasonal allergies and allergy to penicillin and latex. Concomitant medications included biotin, cetirizine hydrochloride (ZYRTEC) and multivitamins; all from an unspecified date and unknown indication. The patient previously took amoxicillin and doxycycline and experienced allergy. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced tired, headache, muscle aches and chills on 28Mar2021; nasal congestion and drainage, and mild sore throat on 30Mar2021; laryngitis and loss of voice on 31Mar2021; and sinus congestion, chest congestion and mild cough on 01Apr2021. It was further reported that the patient experienced the following: tired, headache, muscle aches and chills on day 1 post vaccine; no symptoms on day 2 post vaccine; onset of nasal congestion and drainage, mild sore throat, headache and chills on day 3 post vaccine; nasal congestion, headache, onset of laryngitis, loss of voice on day 4 post vaccine; and nasal and sinus congestion, chest congestion, mild cough, full loss of voice and headache on day 5 post vaccine (day of report). No therapeutic measures were taken as a result of the events. The outcome of event tired and muscle aches was recovered on 28Mar2021; nasal congestion and drainage (rhinorrhea), mild sore throat and chills was recovered on 30Mar2021; laryngitis was recovered on 31Mar2021; while other reported events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Myalgia, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: sinus congestion; chest congestion; mild cough; laryngitis; loss of voice; nasal congestion; nasal congestion and drainage; mild sore throat; tired; headache; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in left arm on 27Mar2021 (age at vaccination was 42-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included seasonal allergies and allergy to penicillin and latex. Concomitant medications included biotin, cetirizine hydrochloride (ZYRTEC) and multivitamins; all from an unspecified date and unknown indication. The patient previously took amoxicillin and doxycycline and experienced allergy. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced tired, headache, muscle aches and chills on 28Mar2021; nasal congestion and drainage, and mild sore throat on 30Mar2021; laryngitis and loss of voice on 31Mar2021; and sinus congestion, chest congestion and mild cough on 01Apr2021. It was further reported that the patient experienced the following: tired, headache, muscle aches and chills on day 1 post vaccine; no symptoms on day 2 post vaccine; onset of nasal congestion and drainage, mild sore throat, headache and chills on day 3 post vaccine; nasal congestion, headache, onset of laryngitis, loss of voice on day 4 post vaccine; and nasal and sinus congestion, chest congestion, mild cough, full loss of voice and headache on day 5 post vaccine (day of report). No therapeutic measures were taken as a result of the events. The outcome of event tired and muscle aches was recovered on 28Mar2021; nasal congestion and drainage (rhinorrhea), mild sore throat and chills was recovered on 30Mar2021; laryngitis was recovered on 31Mar2021; while other reported events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus congestion
Clinical narrative: sinus congestion; chest congestion; mild cough; laryngitis; loss of voice; nasal congestion; nasal congestion and drainage; mild sore throat; tired; headache; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in left arm on 27Mar2021 (age at vaccination was 42-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included seasonal allergies and allergy to penicillin and latex. Concomitant medications included biotin, cetirizine hydrochloride (ZYRTEC) and multivitamins; all from an unspecified date and unknown indication. The patient previously took amoxicillin and doxycycline and experienced allergy. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced tired, headache, muscle aches and chills on 28Mar2021; nasal congestion and drainage, and mild sore throat on 30Mar2021; laryngitis and loss of voice on 31Mar2021; and sinus congestion, chest congestion and mild cough on 01Apr2021. It was further reported that the patient experienced the following: tired, headache, muscle aches and chills on day 1 post vaccine; no symptoms on day 2 post vaccine; onset of nasal congestion and drainage, mild sore throat, headache and chills on day 3 post vaccine; nasal congestion, headache, onset of laryngitis, loss of voice on day 4 post vaccine; and nasal and sinus congestion, chest congestion, mild cough, full loss of voice and headache on day 5 post vaccine (day of report). No therapeutic measures were taken as a result of the events. The outcome of event tired and muscle aches was recovered on 28Mar2021; nasal congestion and drainage (rhinorrhea), mild sore throat and chills was recovered on 30Mar2021; laryngitis was recovered on 31Mar2021; while other reported events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal X-ray, Blood test, Gait disturbance, Generalised oedema, Localised oedema
Clinical narrative: edema on thighs made it difficult for the patient to walk; edema in stomach which persisted and moved around to other parts of the body; edema in stomach which persisted and moved around to other parts of the body; left arm soreness; edema in hip/ edema on thighs made it difficult for the patient to walk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 02:30 PM (Batch/Lot Number: EN6205) (at the age of 77 years old) as dose 2, single for COVID-19 immunisation. Medical history included pulmonary arterial hypertension on Jul2020. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2, intramuscularly, administered in left arm, on 21Feb2021 (Lot Number: EN6200) (at the age of 76 years old) as dose 1, single for COVID-19 immunisation. On an unspecified date in Mar2021, the patient experienced edema in stomach which persisted and moved around to other parts of the body, left arm soreness, and edema in hip. On 01Apr2021, the patient's edema on thighs made it difficult for the patient to walk. Clinical course of the events was as follows: The patient reported that she had edema in her stomach. She clarified the edema started a day or two after she had her second COVID-19 Vaccine shot on 17Mar2021, and the edema had persisted since that time. The patient said the edema had moved around since it started, from her stomach to her hip. She said last night (31Mar2021) she had elevated her feet and legs when she went to sleep, and when she woke up this morning, the liquid (edema) was located on the inside of her thighs. The patient said the edema on the inside of her thighs made it difficult for her to walk this morning. She said she was now lying on the sofa with her legs elevated, trying to see if the liquid (edema) would keep moving from the inside of her thighs. The patient went to a doctor, and the doctor had her scheduled for a sonogram of her tummy (abdomen) on 05Apr2021. The patient also had left arm soreness for about a week which completely resolved. Treatment: Declined any. The doctor won't do anything for her until all the test results are in. The patient underwent lab tests and procedures on 29Mar2021 which included unknown results of abdominal x-ray and blood work. The outcome of events edema in stomach which persisted and moved around to other parts of the body and edema in hip/edema on thighs made it difficult for the patient to walk was not recovered; the event left arm soreness was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: edema on thighs made it difficult for the patient to walk; edema in stomach which persisted and moved around to other parts of the body; edema in stomach which persisted and moved around to other parts of the body; left arm soreness; edema in hip/ edema on thighs made it difficult for the patient to walk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 02:30 PM (Batch/Lot Number: EN6205) (at the age of 77 years old) as dose 2, single for COVID-19 immunisation. Medical history included pulmonary arterial hypertension on Jul2020. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2, intramuscularly, administered in left arm, on 21Feb2021 (Lot Number: EN6200) (at the age of 76 years old) as dose 1, single for COVID-19 immunisation. On an unspecified date in Mar2021, the patient experienced edema in stomach which persisted and moved around to other parts of the body, left arm soreness, and edema in hip. On 01Apr2021, the patient's edema on thighs made it difficult for the patient to walk. Clinical course of the events was as follows: The patient reported that she had edema in her stomach. She clarified the edema started a day or two after she had her second COVID-19 Vaccine shot on 17Mar2021, and the edema had persisted since that time. The patient said the edema had moved around since it started, from her stomach to her hip. She said last night (31Mar2021) she had elevated her feet and legs when she went to sleep, and when she woke up this morning, the liquid (edema) was located on the inside of her thighs. The patient said the edema on the inside of her thighs made it difficult for her to walk this morning. She said she was now lying on the sofa with her legs elevated, trying to see if the liquid (edema) would keep moving from the inside of her thighs. The patient went to a doctor, and the doctor had her scheduled for a sonogram of her tummy (abdomen) on 05Apr2021. The patient also had left arm soreness for about a week which completely resolved. Treatment: Declined any. The doctor won't do anything for her until all the test results are in. The patient underwent lab tests and procedures on 29Mar2021 which included unknown results of abdominal x-ray and blood work. The outcome of events edema in stomach which persisted and moved around to other parts of the body and edema in hip/edema on thighs made it difficult for the patient to walk was not recovered; the event left arm soreness was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion, Paraesthesia, Rash erythematous
Clinical narrative: Allergic reaction; I felt some very light tingling on my face,; My cheeks got little blushed; it felt like inside my nostrils it got closed up a little bit; This is a spontaneous report from a contactable consumer (Patient himself).    A 61-year-old male patient received first dose of BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot Number: EN6207 Expiration Date: Unknown) via an unspecified route of administration, in Arm Left on 23Mar2021 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, the patient Stated that she wanted to report a very slight allergic reaction to vaccine that she received last week and she thought it was best to do it here. Patient stated, "About the half hour after the shot she felt some very light tingling on her face, her cheeks got little blushed and it felt like inside her nostrils it got closed up a little bit, she was allergic to beestings but she never had a reaction to medicine or a vaccine that she was known of before. she did not break out in hives or rash, no fever, no trouble breathing or anything like that she would say these symptoms lasted less than an hour and said it was very minor. Second due date of vaccine: 16Apr2021. No treatment received. Outcome of events was recovered on an unspecified date in Mar2021.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Vaccination site rash
Clinical narrative: rash on my arm where I had the shot between my wrist and my elbow and my left hand; My arms a little bit tired; My chest is little bit tight; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613), via an unspecified route of administration, administered in arm on 21Mar2021 as Dose 2, Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ENG202), via an unspecified route of administration on 25Feb2021 as Dose 1, single for COVID-19 immunization. On 30Mar2021, the patient was feeling like the patient did a little bit of lifting of couple of boxes the patient normally do the work and his arms a little bit tired and he had rash on his arm where he had the shot between his wrist and his elbow and his left hand little bit of he don't know it was allergy and his chest is little bit tight, the patient don't had any cough or anything. The patient don't had trouble breathing the patient think I was under the weather and I think went through all possible side effect, the patient don't know why it was suddenly just notice the rash today. the patient need to go to professional or medical doctor if he had any kind of reaction he don't know. The patient left arm between his elbow and his wrist had some dark rash. Would the patient had to go to doctor or don't feel like going to emergency room. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Tightness in my chest; Every time I am walking around or doing anything I am quite winded and then I need to sit down, just to catch my breath; This is a spontaneous report from a contactable consumer, (the patient, reported for self). A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8733), via an unspecified route of administration on 28Mar2021 11:00 (at the age of 34-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patent received any other vaccine in four weeks and other medications in two weeks. It was unknown if patient had COVID prior to vaccination. Patient stated that he had vaccine shot 2 days ago and today he had tightness in the chest. Every time patient walked around or did anything he quite winded and then need to sit down, just to catch breath through. The patient did not receive any treatment for the events. It was unknown if patient had tested for COVID post vaccination. The outcome of the events was unknown.  No follow-up attempts were needed.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Physical examination, Pruritus, Urine analysis
Clinical narrative: Where they give the shot it started become red and that part is getting bigger; it's red and itches; Where they give the shot it started become red and that part is getting bigger; it's red and itches; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date in Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Bad knees/my knees are bad and don't have a cartilage from an unknown date and unknown if ongoing (Bad knees, but patient was not taking anything for it but patient have not had once since march because patient knees were bad and was not had a cartilage). Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and acetylsalicylic acid (ASAPRIN) drugs were taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 administered in right arm on an unspecified date for covid-19 immunisation. It was reported that, where they gave the shot it started become red and that part was getting bigger, it was red and itches on an unspecified date in Mar2021. It was reported that, it was started probably patient was not sure, an hour after the shot. It just seemed like after two days it was going bigger. Just wanted to know is it the normal side effect that it is still get bigger (reporter question). The patient underwent lab tests and procedures which included physical examination: unknown result (there was a Physical a week before) and urine test was normal on an unspecified date in Mar2021. Patient did not receive any treatment for the events. Outcome of events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Angiopathy, Body temperature, Fatigue, Hyperhidrosis, Paraesthesia
Clinical narrative: feels like the blood vessels in his hands are restricted, feel each blood drop moving through his veins, sensation like someone taps their finger on a table and they are tapping out; tingling in both his hands; soreness at the injection site; profusely sweating; Fatigue; Fever (100.4, 101.0); This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration (administered on left shoulder as reported) on 31Mar2021 07:10 (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. Medical history included penicillin, aspirin, and codein allergy, high blood pressure, and cholesterol. It was reported that the only medications the patient takes are for high blood pressure and cholesterol (concomitant medication unspecified). Prior vaccinations (within 4 weeks) was reported as none. On 31Mar2021, the patient experienced profusely sweating fatigue, fever (100.4, 101.0), tingling in both his hands, soreness at the injection, and felt like the blood vessels in his hands are restricted and he can feel each blood drop moving through his veins in his hands and the sensation is like if someone taps their finger on a table and they are tapping out Morse code even thought his hands are still it was like rapid tapping and a tingling sensation coming through as if someone is impatient and they are tapping their hand waiting for time to go by (as reported). Patient did not require emergency room or physician office for the events. Treatment of Pedialyte was received for the event fatigue. The outcome of the event profusely sweating was recovered; outcome of the event fatigue, feels like the blood vessels in his hands are restricted and he can feel each blood drop moving through his veins in his hands was unknown; outcome of event fever was recovering; outcome of event tingling in both his hands, soreness at the injection site was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: feels like the blood vessels in his hands are restricted, feel each blood drop moving through his veins, sensation like someone taps their finger on a table and they are tapping out; tingling in both his hands; soreness at the injection site; profusely sweating; Fatigue; Fever (100.4, 101.0); This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration (administered on left shoulder as reported) on 31Mar2021 07:10 (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. Medical history included penicillin, aspirin, and codein allergy, high blood pressure, and cholesterol. It was reported that the only medications the patient takes are for high blood pressure and cholesterol (concomitant medication unspecified). Prior vaccinations (within 4 weeks) was reported as none. On 31Mar2021, the patient experienced profusely sweating fatigue, fever (100.4, 101.0), tingling in both his hands, soreness at the injection, and felt like the blood vessels in his hands are restricted and he can feel each blood drop moving through his veins in his hands and the sensation is like if someone taps their finger on a table and they are tapping out Morse code even thought his hands are still it was like rapid tapping and a tingling sensation coming through as if someone is impatient and they are tapping their hand waiting for time to go by (as reported). Patient did not require emergency room or physician office for the events. Treatment of Pedialyte was received for the event fatigue. The outcome of the event profusely sweating was recovered; outcome of the event fatigue, feels like the blood vessels in his hands are restricted and he can feel each blood drop moving through his veins in his hands was unknown; outcome of event fever was recovering; outcome of event tingling in both his hands, soreness at the injection site was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash not around immediate area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown, Expiration Date: 03Sep2020, as reported), via an unspecified route of administration, administered in the left arm (also reported as left upper shoulder) on 23Mar2021, at 17:40 (at the age of 19 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing asthma, which she has had since birth. The patient also reported that her mother has multiple sclerosis and immunosuppressed so she was not sure if that came down to her since usually skips a generation. There were no concomitant medications. The patient did not have prior vaccinations within four weeks. On 01Apr2021, the patient had a rash but it was not around the immediate injection site. The patient stated she has not been checking since she thought she was past having the symptoms but it was fading a bit. The patient stated she has not been going to her practice as she was not happy with how she was doing her practice. She stated her doctor did not recommend her to get the vaccine and the doctor has not been contacted. The patient has been doing the daily COVID check in with the  app. The patient also reported that the expiry was 03Sep2020 and thought it was strange since she got the shot this year (2021). She said she was looking at the vaccination record card. The patient has not taken anything for the rash. She did take paracetamol (TYLENOL) and ibuprofen for period cramps and she only got the shot a week the day before and she did not see rash. The patient was not sure why the rash appeared. She was not thinking she would find a rash so she did not look. She also stated she did not think her asthma would cause the rash. The patient did not visit an emergency room or a physician office. The patient has not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: had a rash covering the arm on the side where got the shot; This is a spontaneous report from a contactable consumer (patient) reported for self. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 30Mar2021 08:30 as dose number unknown, single (at the age of 58) for COVID-19 immunisation. The patient medical history reported as patient used to smoke for 10 years. There were no concomitant medications. The patient had a rash covering the arm on the side where got the shot on 30Mar2021 09:00. Event occurred about 30 minutes after the shot. It was not worse and was not increasing. Patient has not received any treatment for the event. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Joint swelling
Clinical narrative: joint pain; knees swelled; headache; nausea; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 at 09:30 (age at vaccination was 62-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included pain in legs (undiagnosed), lyme disease and allergic to most narcotic pain meds. The patient's concomitant medications included baclofen 5 mg, gabapentin 300 mg and eye drops (as reported) for glaucoma; all from an unspecified date. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The patient's historical vaccine included  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at vaccination was 62-year-old) as dose 1, single for COVID-19 immunization and experienced migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills, and fatigue. On an unspecified date of 2021, the patient experienced joint pain, knees swelled, headache (less severe), nausea, dizziness, and fatigue. It was reported that the events in dose 1 was worse than dose 2. No therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: joint pain; knees swelled; headache; nausea; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Mar2021 at 09:30 (age at vaccination was 62-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included pain in legs (undiagnosed), lyme disease and allergic to most narcotic pain meds. The patient's concomitant medications included baclofen 5 mg, gabapentin 300 mg and eye drops (as reported) for glaucoma; all from an unspecified date. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The patient's historical vaccine included  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at vaccination was 62-year-old) as dose 1, single for COVID-19 immunization and experienced migraine, nausea, hot flashes, leg pain, dizziness, sinus running, chills, and fatigue. On an unspecified date of 2021, the patient experienced joint pain, knees swelled, headache (less severe), nausea, dizziness, and fatigue. It was reported that the events in dose 1 was worse than dose 2. No therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Scratch
Clinical narrative: itching on torso, both arms, and on back of legs; marks from scratching/ scratched didn't itch, it just hurt; Arm was a little bit sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 20Mar2021 at 13:40 (Batch/Lot Number: EN6208) (at the age of 80 years old) as dose 2, single for COVID-19 immunisation in a hospital. Medical history included allergies to sulfa, penicillin and nitrofurantoin (MACROBID). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered the first dose of BNT162B2, via an unspecified route of administration, administered in left arm, on 25Feb2021 at 11:30 (Batch/Lot Number: EM9809) (at the age of 80 years old) as dose 1, single for COVID-19 immunisation. On an unspecified dates in Mar2021, the patient experienced itching on torso, both arms, and on back of legs; marks from scratching/ scratch didn't itch, it just hurt; and arm was a little bit sore. Clinical course of events was as follows: The patient had itching after first dose and came back after receiving the second dose but does not have a rash anywhere. The itching was on torso, sometimes on both arms, and sometimes on back of legs, but no rash. The patient felt like she has been poisoned. There were marks from scratching only. The patient had an itching attack while she was in the doctor's office. The dermatologist switched the patient's medication to Clobetasol propionate 0.5% (previously from triamcinolone acetonide 0.1%). The patient tried taking non-drowsy loratadine (CLARITIN), but this made her drowsy and reported that she has a poor tolerance to antihistamines. No mark where Pfizer Covid vaccine received and she wasn't puffy. Arm was a little bit sore. The patient took two ibuprofen (ADVIL) before she went to bed last night, because where she scratched didn't itch, it just hurt. It was the first the patient was able to sleep through the night and didn't not have to get up scratching in middle of night. The event itching on torso, both arms, and on back of legs resulted to physician office visit. The outcome of events itching on torso, both arms, and on back of legs; marks from scratching/ scratch didn't itch, it just hurt; arm was a little bit sore was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: She is not feeling well; She is feeling sore throat; I take her temperature; her temperature go around, 99.86 degree Fahrenheit 47.7 Celsius; She feel little pain in the arm; She has pain in all over body; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well, sore throat, temperature go around, 99.86-degree Fahrenheit 47.7 Celsius, little pain in the arm. On 29Mar2021, the patient experienced pain in all over body. It was reported that My mom to take this second dose of vaccine on Sunday and since yesterday she is not feeling well and today I take her temperature, she is feeling sore throat and her temperature go around, 99.86 degree Fahrenheit 47.7 Celsius. I need to know what to it, it could be some reaction from the vaccine. She starts not feeling well since yesterday, she has pain in all over body 29Mar2021.yesterday she feel pain in whole body. The patient underwent lab tests and procedures which included body temperature: 99.86 dg on an unknown date.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She is not feeling well; She is feeling sore throat; I take her temperature; her temperature go around, 99.86 degree Fahrenheit 47.7 Celsius; She feel little pain in the arm; She has pain in all over body; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not feeling well, sore throat, temperature go around, 99.86-degree Fahrenheit 47.7 Celsius, little pain in the arm. On 29Mar2021, the patient experienced pain in all over body. It was reported that My mom to take this second dose of vaccine on Sunday and since yesterday she is not feeling well and today I take her temperature, she is feeling sore throat and her temperature go around, 99.86 degree Fahrenheit 47.7 Celsius. I need to know what to it, it could be some reaction from the vaccine. She starts not feeling well since yesterday, she has pain in all over body 29Mar2021.yesterday she feel pain in whole body. The patient underwent lab tests and procedures which included body temperature: 99.86 dg on an unknown date.The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: Swelling in his knee and legs; Soreness; Swelling in his knee and legs; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband).   A male patient with an unspecified age received BNT162B2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: unknown) via unspecified route on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. It was reported he got the Pfizer shot last weeks. On an unknown date, the patient experienced swelling in his knee and legs and soreness from last couple of days. At the time of this report the outcome of the events were unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Rash
Clinical narrative: Rash on her face and scalp; had no energy; This is a spontaneous report received from a contactable Nurse. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history included diverticulitis reported as she was taking two antibiotics for 2 weeks for a diagnosis of diverticulitis. Patient states she stopped antibiotics last week. Concomitant medications included Montelukast sodium (SINGULAIR, 10 Mg Tablet), Metoprolol succinate, Pregabalin (LYRICA 100 Mg Capsule), Levothyroxine sodium (SYNTHROID, 50 Mcg Tablet), Cyclobenzaprine HCl 10 Mg Tablet, Diltiazem HCl 30 Mg Tablet, Duloxetine HCl 20 Mg Capsule, Omeprazole (PROTONIX 20 Mg Tablet), Cetirizine hydrochloride (ZYRTEC 10 Mg Capsule), Meclizine HCl 12.5 Mg Tablet, Fluticasone propionate (FLONASE ALLERGY RELIEF), Salbutamol sulfate (ALBUTEROL SULFATE HFA), Diclofenac sodium (VOLTAREN, 1 % Gel (Gram)), Fluticasone propionate (FLOVENT), Calcium carbonate (TUMS CHEWABLES 200(500) Mg Tab Chew), Betacarotene, Bioflavonoids nos, Biotin, Calcium ascorbate, Calcium pantothenate, Calcium phosphate, Choline bitartrate, Chromic chloride, Colecalciferol, Copper sulfate, Cyanocobalamin, Folic acid, Hesperidin, Inositol, Iron amino acid chelate, Lycopene, Lysine hydrochloride, magnesium oxide, Manganese sulfate, Molybdenum trioxide, Nicotinamide, Phytomenadione, Potassium iodide, Potassium sulfate, Pyridoxine hydrochloride, Retinol acetate, Riboflavin, Selenomethionine, Silicon dioxide, Colloidal Sodium borate decahydrate, Thiamine mononitrate, Tocopheryl acid succinate, Ubidecarenone, Zinc oxide (MULTIVITAMIN and MINERAL Capsule), Vitamin B12 5000 Mcg Tab Rapdis, Dr, Flovent Diskus 250 Mcg Blst W/Dev. It was reported that, the information about pregnancy was unknown.  On an unspecified date, the patient experienced rash on her face and scalp and had no energy. It was stated that, patient did not receive any instructions from her MD to hold Xeljanz to receive the vaccines. MD was aware. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation and experienced another rash and feels extreme exhaustion. The outcome of the event was not recovered.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021371887 same patient/ drug, different dose/ event
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dry mouth, Dyspnoea, Insomnia
Clinical narrative: Dizziness; Weakness; Difficulty breathing; Dry mouth; It was harder for her to go to sleep at night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Mar2021 (Lot Number: ER2613; Expiration Date: 31Jul2021) (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included COPD and CHF. She had bad labs in early February (2021) because of COVID and she is still fighting that with meds. The patient confirmed that she did not have COVID, but the bad labs were due to doing things to try to help make sure she did not get COVID like cough syrup, orange juice, chicken noodle soup. She was taking preventive measures, and that was bringing up bad labs. The patient was taking unspecified medications. The patient previously received the first dose of BNT162B2 on 26Feb2021 (Lot number: EN6202; Expiration date: 30Jun2021) (at the age of 74 years old) for COVID-19 immunisation. On 19Mar2021, the patient experienced dizziness, weakness, difficulty breathing, and dry mouth. The clinical course was reported as follows: The patient experienced dizziness and weakness 15 minutes after getting the shot. They brought her some apple juice and a granola bar and things started going away and she was able to drive home. She was just weak, but when she got home she started having some difficulty breathing. The difficulty breathing began on 19Mar2021, the same day as the dose, and was ongoing which has gotten worse and so has the weakness. The dizziness was every now and then. The dry mouth began about a couple of hours after she got home from getting the dose on the same day. She just did what she was told to do, they told her whatever she usually does to fight that, however, each of her symptoms from the first day to 12 or 13 days was still getting worse. On an unspecified date in Mar2021, it was harder for her to go to sleep at night and she was just weak all over. She was taking orange juice and eating a couple or 3 foods that she is not supposed to have, that she knows will get her up, but she cannot keep doing this much longer and running up her glucose. The patient recovered from dizziness on an unspecified date in 2021, recovering from the dry mouth, has not recovered from weakness and difficulty breathing, and the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: Dizziness; Weakness; Difficulty breathing; Dry mouth; It was harder for her to go to sleep at night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Mar2021 (Lot Number: ER2613; Expiration Date: 31Jul2021) (at the age of 74 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included COPD and CHF. She had bad labs in early February (2021) because of COVID and she is still fighting that with meds. The patient confirmed that she did not have COVID, but the bad labs were due to doing things to try to help make sure she did not get COVID like cough syrup, orange juice, chicken noodle soup. She was taking preventive measures, and that was bringing up bad labs. The patient was taking unspecified medications. The patient previously received the first dose of BNT162B2 on 26Feb2021 (Lot number: EN6202; Expiration date: 30Jun2021) (at the age of 74 years old) for COVID-19 immunisation. On 19Mar2021, the patient experienced dizziness, weakness, difficulty breathing, and dry mouth. The clinical course was reported as follows: The patient experienced dizziness and weakness 15 minutes after getting the shot. They brought her some apple juice and a granola bar and things started going away and she was able to drive home. She was just weak, but when she got home she started having some difficulty breathing. The difficulty breathing began on 19Mar2021, the same day as the dose, and was ongoing which has gotten worse and so has the weakness. The dizziness was every now and then. The dry mouth began about a couple of hours after she got home from getting the dose on the same day. She just did what she was told to do, they told her whatever she usually does to fight that, however, each of her symptoms from the first day to 12 or 13 days was still getting worse. On an unspecified date in Mar2021, it was harder for her to go to sleep at night and she was just weak all over. She was taking orange juice and eating a couple or 3 foods that she is not supposed to have, that she knows will get her up, but she cannot keep doing this much longer and running up her glucose. The patient recovered from dizziness on an unspecified date in 2021, recovering from the dry mouth, has not recovered from weakness and difficulty breathing, and the other event was unknown.  No follow-up attempts are possible. No further information is expected.