chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Chills; Shakes; Fever; Insomnia; Trouble breathing; Cough; Diarrhea; Fatigue; Sweats and body aches including a headache; Sweats and body aches including a headache; Sweats and body aches including a headache; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 52-year-old-female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and gastroesophageal reflux disease, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX), lansoprazole (PREVACID), bupropion hydrochloride (WELLBUTRIN), and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6202) on 19Mar2021 at 09:00 (at the age of 52-years-old) for COVID-19 immunisation. On 09Apr2021 at 21:15 the patient experienced chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache. The events were reported as non-serious, and no treatment was received for the events. The clinical outcomes of chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Pain, Pyrexia
Clinical narrative: Chills; Shakes; Fever; Insomnia; Trouble breathing; Cough; Diarrhea; Fatigue; Sweats and body aches including a headache; Sweats and body aches including a headache; Sweats and body aches including a headache; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 52-year-old-female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and gastroesophageal reflux disease, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX), lansoprazole (PREVACID), bupropion hydrochloride (WELLBUTRIN), and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6202) on 19Mar2021 at 09:00 (at the age of 52-years-old) for COVID-19 immunisation. On 09Apr2021 at 21:15 the patient experienced chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache. The events were reported as non-serious, and no treatment was received for the events. The clinical outcomes of chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills; Shakes; Fever; Insomnia; Trouble breathing; Cough; Diarrhea; Fatigue; Sweats and body aches including a headache; Sweats and body aches including a headache; Sweats and body aches including a headache; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 52-year-old-female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and gastroesophageal reflux disease, both from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and did not receive any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included valaciclovir hydrochloride (VALTREX), lansoprazole (PREVACID), bupropion hydrochloride (WELLBUTRIN), and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number EN6202) on 19Mar2021 at 09:00 (at the age of 52-years-old) for COVID-19 immunisation. On 09Apr2021 at 21:15 the patient experienced chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache. The events were reported as non-serious, and no treatment was received for the events. The clinical outcomes of chills, shakes, fever, insomnia, trouble breathing, cough, diarrhea, fatigue, sweats and body aches including a headache were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: swollen/stiff/sore finger joints; swollen/stiff/sore finger joints; swollen/stiff/sore finger joints; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18Mar2021 at 16:30 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT), loratadine (CLARITIN), and vitamin B12 from unknown dates for unknown indications. The patient did not have any allergies to medications, food, or other products. On an unspecified date after dose 1 of BNT162B2, the patient experienced swollen, stiff, sore finger joints that had not fully recovered. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of swollen, stiff, and sore finger joints that had not fully recovered were recovering. The patient received dose 2 of BNT162B2 on 08Apr2021 at 16:00. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Body temperature, Dizziness, Headache
Clinical narrative: fever 99.7; nausea; stomach cramping; lower back pain; heart racing; dizziness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 09Apr2021 at 16:30 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and gluten. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included daily vitamins, fish oil, calcium, D, and probiotics from unknown dates for unknown indications. The patient previously received sulfamethoxazole, trimethoprim (BACTRIM) from an unknown date for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 on 19Mar2021 at 16:30 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2 on 09Apr2021 at 23:30 (also reported as about 8 hours post dose 2) the patient experienced fever 99.7, headache, nausea, stomach cramping, lower back pain and heart racing. At 36 hours post dose 2 symptoms started to reside. At 48 hours slight headache, heart racing, and dizziness remained. At 60 hours, heart racing and slight dizziness remained. The patient did not receive any treatment for the events. The outcomes of fever 99.7, headache, nausea, stomach cramping, and lower  back pain were recovered. The outcomes of dizziness and heart racing were unknown. It was also reported that since the vaccination the patient had not been diagnosed with COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pyrexia
Clinical narrative: fever 99.7; nausea; stomach cramping; lower back pain; heart racing; dizziness; slight headache; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration on 09Apr2021 at 16:30 (at the age of 43-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and gluten. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included daily vitamins, fish oil, calcium, D, and probiotics from unknown dates for unknown indications. The patient previously received sulfamethoxazole, trimethoprim (BACTRIM) from an unknown date for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 on 19Mar2021 at 16:30 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2 on 09Apr2021 at 23:30 (also reported as about 8 hours post dose 2) the patient experienced fever 99.7, headache, nausea, stomach cramping, lower back pain and heart racing. At 36 hours post dose 2 symptoms started to reside. At 48 hours slight headache, heart racing, and dizziness remained. At 60 hours, heart racing and slight dizziness remained. The patient did not receive any treatment for the events. The outcomes of fever 99.7, headache, nausea, stomach cramping, and lower  back pain were recovered. The outcomes of dizziness and heart racing were unknown. It was also reported that since the vaccination the patient had not been diagnosed with COVID-19.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Vaccination site nodule
Clinical narrative: patient presents nodular reaction on injection site of the filler but they are not visible but palpable; This is a spontaneous report from a non-contactable other Health Professional. A patient of unspecified age and gender received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation; lidocaine hcl via an unspecified route of administration on an unspecified date at an unknown dose for an unspecified indication. Medical history included that patient had Covid-19 a year ago (in 2020) with a positive PCR test. Concomitant medication included hyaluronic acid. The patient was vaccinated for Covid-19 with the Pfizer vaccine 10 days ago (on 30Mar2021), since then the patient presented nodular reaction on injection site of the filler but they are not visible but palpable. HCP had put patient on Corticosteroids. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Vaccination site pain
Clinical narrative: left arm was sore; muscle spasm in her left arm; arm twitching; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left arm on 05Apr2021 09:50 (Lot Number: ER2613) as 1st dose, single for covid-19 immunisation. Medical history included Migraine, orthopedic issues. The patient's concomitant medications were not reported. Patient experienced twitching muscle spasm in her left arm post-vaccination (Apr2021). The twitching was on and off at the beginning but has been persistent for the last 8 days. She added she took Ibuprofen, used deep tissue massages, and contracted her muscle. She stated she is now looking into using lidocaine patches. She said she contacted her doctors office. She said she was not having a lot of pain, but the arm she had the COVID-19 Vaccine injection in was having twitching, muscle spasms. She said it is like her arm muscle was dancing. She said the twitching, muscle spasms were not painful, but she has had the twitching, muscle spasms going on 8 days now. She said her left arm twitching, muscle spasms were more of an annoyance. Patient asked what she could do for the twitching, muscle spasms, and how long would the muscle spasms last. She had tried to relax her left arm muscle as much as she could. She said she had alternated ice and heat, and had done frequent deep tissue massage to her left arm. She said she tried to "Hulk-out" (contract) her left arm muscle, and that didn't work for the twitching, muscle spasm. She said she took 3-4 generic (Brand Name) Ibuprofen (Expiration Date: Jul2020) 200mg tablets at a time. Reported she had not used any other over-the-counter products to treat her left arm twitching muscle spasms. Reported when she spoke to her doctor, she had mentioned she would like to try placing a Lidocaine patch on her left arm to see if that would stop the twitching, muscle spasms. She said her Lidocaine patches were used for other orthopedic issues, and her doctor told her to give the Lidocaine patch a try, if she had a Lidocaine patch available. She said she hadn't tried the Lidocaine patch yet. She said she wanted to talk to Pfizer first before she tried the Lidocaine 750mg patch 5% (Expiration Date: May2009). She said the Lidocaine patch was a prescription. Reported her left arm was sore the first day she received her COVID-19 Vaccine (05Apr2021). She said within 24 hours of getting her COVID-19 Vaccine, her left arm pain went away, and the twitching muscle spasms in her left arm started on and off. She said her left arm twitching muscle spams had become more persistent now. She said her left arm twitching muscle spasms were more of an annoyance. The outcome of the event vaccination pain was recovered on Apr2021, other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Illness
Clinical narrative: Shingles; he got real sick; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) as 1st dose, single for covid-19 immunization. Medical history blood pressure and high cholesterol. Concomitant medications included valsartan for blood pressure and simvastatin for high cholesterol The patient got his vaccine on 20Feb2021 and two days later he got real sick and broke out with shingles. The reporter stated that they are still improving. The patient was treated with valacyclovir 1000mg. The patient did not go to hospital. He did not get the second shot that is why the reporter was calling for. She doesn't know if the patient should get the second shot. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 0.3 ml injection, Lot#: EW0162, Expiration Date: 31Jul2021) at single dose on 18Apr2021 12:50 in left upper arm muscle for COVID-19 immunization. The first dose was on 28Mar2021 (Expiry Date: 31Jul2021) at 1400 or 1500, and experienced shingles, arm pain, headache, fatigue and some chills. Medical history included shingles in the past, with the second vaccine patient had just cleared up from the shingles. Patient clarified shingles was pretty cleared up, it was not active and doctor said she could get the second vaccine. There was on other products taken. Prior vaccinations (within 4 weeks) was no. Patient experienced swollen lymph glands on 20Apr2021; arm pain, chills and headache on 18Apr2021; fatigue and soreness behind her eyes on 19Apr2021. Days later she got the second vaccine, patient was having regular side effects of arm pain, fatigue, and swollen lymph glands. She had gotten shingles before, and sometimes it popped up at different times. She didn't have other underlying condition like some people who had immunodeficiencies or arthritis. The arm pain after first and the second vaccine started the day of the vaccine. That arm pain from the second vaccine woke her up at 3am, it was so bad. It seemed to subside more quickly. Today it's still there, but not as bad. It was almost not noticeable. Patient felt more fatigue after the second vaccine today and yesterday. She felt more fatigued today and clarified it was persisting as of now. The lymph glands felt tender in her neck, which started today and was ongoing. Patient also had chills after the second vaccine, but was improving. Patient also had a headache after the second vaccine, which resolved today. It also felt sore behind her eyes. Patient stated it had to happen with her in the past as a flu symptoms. They were light sensitive, and if she moved them to the right and left she had soreness behind her eyes. This started yesterday and was ongoing. She did not have the soreness behind her eyes with first dose. She was not sure if it's associate with the headache. The outcome of events arm pain and chills was recovering. The outcome of event headache was recovered on 20Apr2021. The outcome of rest events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia
Clinical narrative: Swollen lymph glands; fatigue; soreness behind her eyes; light sensitive; Arm pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 0.3 ml injection, Lot#: EW0162, Expiration Date: 31Jul2021) at single dose on 18Apr2021 12:50 in left upper arm muscle for COVID-19 immunization. The first dose was on 28Mar2021 (Expiry Date: 31Jul2021) at 1400 or 1500, and experienced shingles, arm pain, headache, fatigue and some chills. Medical history included shingles in the past, with the second vaccine patient had just cleared up from the shingles. Patient clarified shingles was pretty cleared up, it was not active and doctor said she could get the second vaccine. There was on other products taken. Prior vaccinations (within 4 weeks) was no. Patient experienced swollen lymph glands on 20Apr2021; arm pain, chills and headache on 18Apr2021; fatigue and soreness behind her eyes on 19Apr2021. Days later she got the second vaccine, patient was having regular side effects of arm pain, fatigue, and swollen lymph glands. She had gotten shingles before, and sometimes it popped up at different times. She didn't have other underlying condition like some people who had immunodeficiencies or arthritis. The arm pain after first and the second vaccine started the day of the vaccine. That arm pain from the second vaccine woke her up at 3am, it was so bad. It seemed to subside more quickly. Today it's still there, but not as bad. It was almost not noticeable. Patient felt more fatigue after the second vaccine today and yesterday. She felt more fatigued today and clarified it was persisting as of now. The lymph glands felt tender in her neck, which started today and was ongoing. Patient also had chills after the second vaccine, but was improving. Patient also had a headache after the second vaccine, which resolved today. It also felt sore behind her eyes. Patient stated it had to happen with her in the past as a flu symptoms. They were light sensitive, and if she moved them to the right and left she had soreness behind her eyes. This started yesterday and was ongoing. She did not have the soreness behind her eyes with first dose. She was not sure if it's associate with the headache. The outcome of events arm pain and chills was recovering. The outcome of event headache was recovered on 20Apr2021. The outcome of rest events was not recovered.  No follow up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Herpes zoster, Rash
Clinical narrative: morning there was the "face" (not clarified) like rash/ rash es was spread; Dizzy; kind of shingles; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 13Apr2021 at 16:05 (reported as 4:05 o'clock in the afternoon) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On the morning of 14Apr2021, the patient reported to experience "face" (not clarified) like rash "10:30" (not clarified) and by end of the day the patient felt dizzy, rashes was spread, kind of shingles (as reported). Outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tumour pain, Uterine pain
Clinical narrative: extreme soreness in the area of uterus; sore arm; has fibroid tumors and on Saturday night, she experienced very severe cramping from them; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 23Apr2021 at 11:30 AM (at the age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  Medical history included chronic pain, fibromyalgia, ongoing fibroid tumors, and penicillin allergy. Concomitant medications included pregabalin (LYRICA); diazepam; ibuprofen; morphine; and multivitamins.  The patient received the shot on Friday on 23Apr2021. The patient experienced sore arm on Saturday (24Apr2021), which is expected. The patient also has pre-existing fibroid tumors, and on Saturday night (24Apr2021), she experienced very severe cramping from them. On Sunday (25Apr2021) and Monday morning now (26Apr2021), the patient is experiencing extreme soreness in the area of uterus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fall, Feeling cold, Hypoaesthesia, Investigation
Clinical narrative: she ended up on the floor at the store; Whole left side; radial pulse and everything was gone; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 12:30 (Lot Number: EL9269) 1ST DOSE, single for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and asthma. There were no concomitant medications. The patient not received prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. The patient reported that she received her first vaccine dose on 05Feb2021 and initially was instructed to get the second dose 2 weeks later. 30 minutes after getting the first dose she experienced a reaction, she thought she was having a stroke and she was transported to the ER for evaluation and found out it wasn't a stroke. Reports that because of her reaction, her ER doctor advised her not to get the second dose. But her primary doctor advised her to get the second dose at 3 weeks instead of 2 weeks after the first. She was planning to get her second dose 3 weeks after the first dose but her son died and she missed her appointment. Since then she has relocated to other state. It was further reported as follows: she waited 15 minutes after the vaccine and felt fine. She then went to the store and ended up on the floor at the store and had to be taken out of the store by ambulance. Her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She thought she was having a stroke but all of her tests at the hospital were negative. She was freezing and could not get warm. They put warming blankets on her. They did an MRI and a CT Scan and everything was fine. Symptoms lasted a couple of hours, then were gone. Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The patient wants to be fully vaccinated. From the time she got her vaccine to the time they had to call the ambulance, it was about an hour. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. Outcome of events recovered on 05Feb2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Radial pulse, Radial pulse abnormal
Clinical narrative: she ended up on the floor at the store; Whole left side; radial pulse and everything was gone; Whole left side; radial pulse and everything was gone; Freezing, could not get warm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05Feb2021 12:30 (Lot Number: EL9269) 1ST DOSE, single for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and asthma. There were no concomitant medications. The patient not received prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. The patient reported that she received her first vaccine dose on 05Feb2021 and initially was instructed to get the second dose 2 weeks later. 30 minutes after getting the first dose she experienced a reaction, she thought she was having a stroke and she was transported to the ER for evaluation and found out it wasn't a stroke. Reports that because of her reaction, her ER doctor advised her not to get the second dose. But her primary doctor advised her to get the second dose at 3 weeks instead of 2 weeks after the first. She was planning to get her second dose 3 weeks after the first dose but her son died and she missed her appointment. Since then she has relocated to other state. It was further reported as follows: she waited 15 minutes after the vaccine and felt fine. She then went to the store and ended up on the floor at the store and had to be taken out of the store by ambulance. Her whole left side; her radial pulse per the Emergency Medical Technicians, was gone. She thought she was having a stroke but all of her tests at the hospital were negative. She was freezing and could not get warm. They put warming blankets on her. They did an MRI and a CT Scan and everything was fine. Symptoms lasted a couple of hours, then were gone. Emergency Room Nurses and Paramedics said she should get the second dose of the vaccine. The patient wants to be fully vaccinated. From the time she got her vaccine to the time they had to call the ambulance, it was about an hour. The patient missed her appointment for her second dose of the vaccine and still has not gotten it. Outcome of events recovered on 05Feb2021.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 14:30 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for Covid-19 since the vaccination. Medical history included Anxiety, depression and known allergies: Tree nuts. Concomitant medication included duloxetine (DULOXETINE), mirtazapine (MIRTAZAPINE), lamotrigine (LAMICTAL) and gabapentin (GABAPENTIN) all taken for unspecified indications, start and stop dates were not reported. The patient experienced bells palsy on 24Apr2021 at 19:00. Therapeutic measures were taken as a result of bell's palsy which included Prednisone and Valyacyclovir. The patient received first dose of BNT162B2 on 29Mar2021 (lot ER8730) at 15:30 administered to right arm. Outcome of the event was recovering.    Follow up attempts needed. Further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Movement disorder, Nausea
Clinical narrative: Headache has continue and got much worse last night, left side of head and eyes hurting this morning; fever; chills; nausea; felt like he couldn't move; a sore arm; Headache has continue and got much worse last night, left side of head and eyes hurting this morning; This is a spontaneous report received from a contactable consumer (Calling on behalf of her son) reported for a 32-year-old male patient that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Apr2021 (Lot Number: EW0162) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 31Mar2021 (at age of 32 years old, Lot Number: EP7533) as a single dose for covid-19 immunization. The patient developed headache, fever, chills nausea, felt like he couldn't move, and a sore arm on Apr2021. Fever ended on Saturday (24Apr2021). Headache had continue and got much worse last night, left side of head and eyes hurting this morning (26Apr2021). He took two Advil this morning. The reporter asked how long will it last, if any info on severity, if Left side of the head- is that more of a migraine and what about eye pain. The outcome of event was "Fever" was recovered on 24Apr2021, outcome of "Headache aggravated" was not recovered and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache has continue and got much worse last night, left side of head and eyes hurting this morning; fever; chills; nausea; felt like he couldn't move; a sore arm; Headache has continue and got much worse last night, left side of head and eyes hurting this morning; This is a spontaneous report received from a contactable consumer (Calling on behalf of her son) reported for a 32-year-old male patient that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Apr2021 (Lot Number: EW0162) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 31Mar2021 (at age of 32 years old, Lot Number: EP7533) as a single dose for covid-19 immunization. The patient developed headache, fever, chills nausea, felt like he couldn't move, and a sore arm on Apr2021. Fever ended on Saturday (24Apr2021). Headache had continue and got much worse last night, left side of head and eyes hurting this morning (26Apr2021). He took two Advil this morning. The reporter asked how long will it last, if any info on severity, if Left side of the head- is that more of a migraine and what about eye pain. The outcome of event was "Fever" was recovered on 24Apr2021, outcome of "Headache aggravated" was not recovered and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Carcinoembryonic antigen, Carcinoembryonic antigen increased, Tumour marker increased, Tumour marker test
Clinical narrative: revealed Breast cancer biomarkers 3 fold elevated (81) and CEA was 3.0 which was doubled; revealed Breast cancer biomarkers 3 fold elevated (81) and CEA was 3.0 which was doubled; This is a spontaneous report received from a contactable physician. This physician (patient) reported for herself that a 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration in left arm on an unspecified date (reported as on 19Dec2020, pending clarification) at single dose for COVID-19 immunization, in hospital. Medical history included breast cancer survivor-Stage 1A, grade 1; was treated with surgery and radiation in 2017 and opposite side in 2018 with surgery and radiation; sulfa allergy and cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included anastrozole and atorvastatin (LIPITOR). The patient historically received first single dose of BNT162B2 (lot number: EJ1685) via intramuscular in left arm on 19Dec2020 10:00 for COVID-19 immunization. Patient reported that she had breast cancer and was treated with surgery and radiation in 2017 and opposite side in 2018 with surgery and radiation. Currently on anastrozole. On routine surveillance test 2 months after the vaccine revealed Breast cancer biomarkers 3 fold elevated (81) and CEA was 3.0 which was doubled. 5 weeks later repeat tests showed CA marker 77 and CEA 2.6. Normally her markers run between 22 and 30 and CEA between 1.5 and 2.2. Should she worried about this and recurrence. She was in a very good health otherwise post cancer treatment. The adverse event occurred on 15Mar2021 08:00, resulted in doctor or other healthcare professional office/clinic visit, no treatment was received. Outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events.  The reported events likely represent intercurrent medical conditions.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin injury
Clinical narrative: she cut her hand; Sore arm; This is a spontaneous report received from a contactable consumer reporting for herself.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history  and concomitant medications were not reported.  The patient  cut her hand  and had sore arm  on an unspecified date with outcome of unknown.  The event cut her hand was considered an Important Medical Event.  The patient  got stitches, a tetanus vaccine and was prescribed cephalexin as a result of the event.  The patient is wondering if she can take the 2nd dose as scheduled.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea
Clinical narrative: having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Gait disturbance, Loss of consciousness
Clinical narrative: Almost passing out; Very short of breath/Had trouble breathing; Coughing to the point of seeing black; Could not walk from one room to the next with out being out of breath; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:30 (Batch/Lot Number: EW0170) as UNKNOWN, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Medical history included asthma and sarcoidosis, drug hypersensitivity, allergies to cycline antibiotics. Concomitant medication included meloxicam (MELOXICAM) and omeprazole (PROTONIX [OMEPRAZOLE]). No Covid prior vaccination. Adverse event was reported as: Vaccine at 4:30 pm on Friday. Felt fine until later in the a.m. had trouble breathing. Very short of breath. Coughing to the point of seeing black and almost passing out. Could not walk from one room to the next without being out of breath. Adverse event start date: 24Apr2021, adverse event start time: 04:00 AM. Treatment received for events included nebulizer, rescue inhaler and Breo inhaler. The event outcome was recovering. No Covid tested post vaccination.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Limb discomfort, Muscle haemorrhage, Muscle injury
Clinical narrative: felt a cold and then hot burning mostly at night; like his legs were heavy; bad bruising on the deltoid muscle and bleeding; bad bruising on the deltoid muscle and bleeding; This is a spontaneous report from a non-contactable consumer reported for his son. A male patient in his 30's received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 (at age of 30's, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that his son had the first dose of the Covid-19 vaccine on 12Apr2021 and ten days later he presented "something like burning feet, felt a cold and then hot burning mostly at night, felt like he ran a marathon and felt like his legs were heavy". Stated that the side effects resolved after 24 hours. Added that his son was in his 30s. Stated that the vaccine administrator had a poor technique and his son presented bad bruising on the deltoid muscle and bleeding. He had no preexisting condition and would like to find out if this event has been reported. Reporter would like to consult if his son should get the second dose of the Pfizer Covid-19 vaccine if he presented side effects after the first dose. The outcome of the events "Feeling hot and cold/ Heaviness in limbs" was recovered on 23Apr2021. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Rash
Clinical narrative: chest pains; cough; rash; This is a spontaneous report from contactable consumer (patient) via Medical information Team.  A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 22Jan2021 at 14:15 (Lot Number: EL3248) as single dose; dose 2 via an unspecified route of administration, administered in right arm on 12Feb2021 at 14:30 (Lot Number: EN6201) at the age of 79 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 the patient experienced chest pains, and cough, which required hospitalization from 05Mar2021 to 08Mar2021. The patient informed that he had some stress with son and daughter to point where he had some chest pains. After a week or two of conversation involving patients son and granddaughter culminated into this. The patient informed that when he went to the hospital because of chest pains, patient was already use to that and wasn't worried about it. The patient stated he didn't want to go to the hospital, called the doctor but because of Covid, the doctor wouldn't see the patient. The patient stated he shouldn't have been in the hospital at all. In terms of the cough, he simply called the doctor because the patient wanted cough medicine or something for that, temporary thing coming on. Patient stated the cough did not linger, and it was never treated.  The hospital got into the chest pain and jumped on the heart situation and patient thinks they saw dollar signs or something.  The patient wasn't very happy with them. The patient informed that he was given a blood thinner, Heparin IV during time hospitalized. The hospital decided to hold the patient over and they gave the patient Heparin IV for a good part of three days. The patient reported that he was discharged on 08Mar2021, and on 10Mar2021 the patient noticed the rash. The patient reporting experiencing rash after receiving both doses of the Pfizer covid-19 vaccine. The patient was thinking the combination of Plavix and heparin only three weeks after having the Pfizer Covid Vaccine could possibly be a side effect of rash. Therapeutic measures were taken as a result of rash. The doctor gave the patient Clobetasol Propionate and patient did treat rash with that.  The doctor said to apply for 2 weeks and come in on one week.  It has already improved. The patient mentions that he was also taking Calamine lotion and some spray and they all seem to be working.  Patient didn't want to keep taking Clobetasol because it is a steroid and he had been using for a month and didn't want to do that. The clinical outcome of rash was recovering. The clinical outcome of the remaining events was unknown.