chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness,; Arm sore, warm and it has quite red around it; Her upper arm is red in a circle and tender to touch and a little bit swollen; Redness, sorenss and pain in her arm and it may be getting little bit worse; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller received her second dose of Pfizer's COVID vaccine on Sunday. She still has redness, soreness, and pain in her arm, and it may be getting a little bit worse. Caller stated it's been 5 days. Her upper arm is red in a circle and tender to the touch and a little bit swollen. The outcome of the events was unknown on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Illness
Clinical narrative: Sickness; vaccination site pain; tiredness; cough; muscle pain; chills; joint pain; shaking last night; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp.   A 66-year-old male patient received bnt162b2 (BNT162B2(Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included influenza. There were no concomitant medications.  Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered (Batch/Lot Number was unknown) as single dose for covid-19 immunisation. It was reported that, Caller would state that he received the second dose of the Pfizer Covid-19 vaccine yesterday morning (9 o clock) On unknown date of 2021 and he has been experiencing injection site pain, tiredness, cough, muscle pain, chills, joint pain, feeling unwell, he was shaking last night and took some Aspirin. Stated that he does not have a fever today and he did not experience this symptom after receiving the first dose. The first dose he had almost no symptoms other than tiredness which was manageable. He says yesterday and all night he had them. Vaccine clarified to have been the second dose of the Pfizer COVID-19 vaccine. He says he has almost every single one of the side effects listed on the brochure in the last 24 hours, and he would like to know if he should panic now or wait. He says that the last time he was this sick was when he got a case of the flu. Therapeutic measures were taken as a result of, shaking last night (tremor). The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Tremor, Vaccination site pain
Clinical narrative: Sickness; vaccination site pain; tiredness; cough; muscle pain; chills; joint pain; shaking last night; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp.   A 66-year-old male patient received bnt162b2 (BNT162B2(Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 29Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included influenza. There were no concomitant medications.  Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered (Batch/Lot Number was unknown) as single dose for covid-19 immunisation. It was reported that, Caller would state that he received the second dose of the Pfizer Covid-19 vaccine yesterday morning (9 o clock) On unknown date of 2021 and he has been experiencing injection site pain, tiredness, cough, muscle pain, chills, joint pain, feeling unwell, he was shaking last night and took some Aspirin. Stated that he does not have a fever today and he did not experience this symptom after receiving the first dose. The first dose he had almost no symptoms other than tiredness which was manageable. He says yesterday and all night he had them. Vaccine clarified to have been the second dose of the Pfizer COVID-19 vaccine. He says he has almost every single one of the side effects listed on the brochure in the last 24 hours, and he would like to know if he should panic now or wait. He says that the last time he was this sick was when he got a case of the flu. Therapeutic measures were taken as a result of, shaking last night (tremor). The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis flare up; This is a spontaneous report from a contactable other hcp.   A 73-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Deltoid Right on 17Apr2021 as 2nd dose, single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease States she was diagnosed in her 50's. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in left arm (Batch/Lot Number was EP6955) as single dose for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Caller said she received the second dose last 17Apr2021. She did not take her steroids for her bronchitis yet. She wants to know if it's going to impact the efficacy of the vaccine if she takes her medication. She got the first dose last 27Mar2021. On 24Apr2021 the patient experienced bronchitis flare up with outcome of not recovered.  Follow-up (09Jul2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Lymphadenopathy, Poor quality sleep, Sensitive skin
Clinical narrative: Minor upper shoulder aches; Severe skin sensitivity in my arm pits, and the area where your armpit connects to your back; Tender to touch even lightly; Discomfort eases slightly with heat but returns quickly; Last night woke up hourly due to discomfort; Slight bumpiness under skin. (Feels like lymph nodes); Slight bumpiness under skin. (Feels like lymph nodes); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 21Feb2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included splenectomy, controlled type II diabetes, hypothyroidism, gun shot wound (GSW), motor vehicle accident (MVA), carried triplets to 32 weeks, C-section and abdominoplasty, allergic to penicillin and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), exenatide (BYDUREON), levothyroxine sodium (SYNTHROID) and liothyronine (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 30Jan2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, three weeks after the second dose, the patient experienced minor upper shoulder aches and a severe skin sensitivity in arm pits, and the area where armpit connects to the back. The patient had never experienced this before. The shoulder pain was a 2 out of 10, sensitivity was a 9 out of ten, tender to touch even lightly. There was no visible rash. The patient had discomfort that eased slightly with heat but returned quickly. The patient was on the fourth day of the symptoms. On an unknown date in Mar2021, the patient woke up hourly due to discomfort. There was no fever and bumps on skin. There was slight bumpiness under skin (felt like lymph nodes). The patient did not have any rash or injection site issues after the first or second dose. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events minor upper shoulder aches and severe skin sensitivity in arm pits, tender to touch even lightly, discomfort and woke up hourly due to discomfort, slight bumpiness under skin (felt like lymph nodes) were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Tenderness
Clinical narrative: Minor upper shoulder aches; Severe skin sensitivity in my arm pits, and the area where your armpit connects to your back; Tender to touch even lightly; Discomfort eases slightly with heat but returns quickly; Last night woke up hourly due to discomfort; Slight bumpiness under skin. (Feels like lymph nodes); Slight bumpiness under skin. (Feels like lymph nodes); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 21Feb2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included splenectomy, controlled type II diabetes, hypothyroidism, gun shot wound (GSW), motor vehicle accident (MVA), carried triplets to 32 weeks, C-section and abdominoplasty, allergic to penicillin and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), exenatide (BYDUREON), levothyroxine sodium (SYNTHROID) and liothyronine (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 30Jan2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, three weeks after the second dose, the patient experienced minor upper shoulder aches and a severe skin sensitivity in arm pits, and the area where armpit connects to the back. The patient had never experienced this before. The shoulder pain was a 2 out of 10, sensitivity was a 9 out of ten, tender to touch even lightly. There was no visible rash. The patient had discomfort that eased slightly with heat but returned quickly. The patient was on the fourth day of the symptoms. On an unknown date in Mar2021, the patient woke up hourly due to discomfort. There was no fever and bumps on skin. There was slight bumpiness under skin (felt like lymph nodes). The patient did not have any rash or injection site issues after the first or second dose. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events minor upper shoulder aches and severe skin sensitivity in arm pits, tender to touch even lightly, discomfort and woke up hourly due to discomfort, slight bumpiness under skin (felt like lymph nodes) were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever (38.1C); Muscle pain in the lower body; Fatigue; Headache; Sensitive skin; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the right arm on 29Apr2021 at 16:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERE733) via an unspecified route of administration in the left arm on 08Apr2021 at 16:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced fever (38.1C), muscle pain in the lower body, fatigue, headache and sensitive skin. On the same day, the patient underwent body temperature test and the result was 38.1 centigrade. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (38.1C), muscle pain in the lower body, fatigue, headache and sensitive skin were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Fever (38.1C); Muscle pain in the lower body; Fatigue; Headache; Sensitive skin; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the right arm on 29Apr2021 at 16:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERE733) via an unspecified route of administration in the left arm on 08Apr2021 at 16:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced fever (38.1C), muscle pain in the lower body, fatigue, headache and sensitive skin. On the same day, the patient underwent body temperature test and the result was 38.1 centigrade. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever (38.1C), muscle pain in the lower body, fatigue, headache and sensitive skin were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Lethargy, Migraine
Clinical narrative: Chills; Sweating; Dizzy; Nauseous; Fever; Extreme lethargy.; Severe migrane headache; Pain on right side of neck; 18 hrs after shot I began vomiting. Anything I drank I threw up for the next 24 hrs; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 27Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included multivitamins (unspecified), dienogest, ethinylestradiol (LARISSA) and cetirizine hydrochloride (ZYRTEC); all for unknown indication on unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0151) via an unspecified route of administration in the right arm on 06Apr2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 05:45, the patient experienced severe migraine headache with pain on right side of neck, chills, sweating, dizzy, nauseous, fever and extreme lethargy. On 28Apr2021, 18 hours after shot, the patient began vomiting and threw up everything she drank for the next 24 hrs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nauseous, severe migraine headache, pain on right side of neck, vomiting, chills, sweating, dizzy, fever and extreme lethargy was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Chills; Sweating; Dizzy; Nauseous; Fever; Extreme lethargy.; Severe migrane headache; Pain on right side of neck; 18 hrs after shot I began vomiting. Anything I drank I threw up for the next 24 hrs; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 27Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included multivitamins (unspecified), dienogest, ethinylestradiol (LARISSA) and cetirizine hydrochloride (ZYRTEC); all for unknown indication on unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0151) via an unspecified route of administration in the right arm on 06Apr2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 05:45, the patient experienced severe migraine headache with pain on right side of neck, chills, sweating, dizzy, nauseous, fever and extreme lethargy. On 28Apr2021, 18 hours after shot, the patient began vomiting and threw up everything she drank for the next 24 hrs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nauseous, severe migraine headache, pain on right side of neck, vomiting, chills, sweating, dizzy, fever and extreme lethargy was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: widespread hives with urticaria onset approx. 4 days after receiving first dose; Severe urticaria on legs, arms, torso, neck, and scalp occurred 4 days after the 1st dose.; This is a spontaneous report from a contactable consumer or other non hcp.   A 35-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0169), dose 1 intramuscularly, administered in Arm Left on 18Apr2021 15:00 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included multivitamins. The patient previously took Augmentin [amoxicillin; clavulanic acid] for hypersensitivity and experienced rash. The patient was not pregnant at the time of vaccination.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, on 22Apr2021 17:00, Severe urticaria on legs, arms, torso, neck, and scalp occurred 4 days after the 1st dose. Required medical attention (steroids). widespread hives with urticaria onset approx. 4 days after receiving first dose. treated with prednisone tablets 5 mg x 7 days with outcome of recovered. Therapeutic measures were taken prednisone 5mg tablets as a result of severe urticaria on legs, arms, torso, neck, and scalp occurred 4 days after the 1st dose. (urticaria), widespread hives with urticaria onset approx. 4 days after receiving first dose (urticaria).  No further follow up attempts is needed. No further information is expected
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Rash
Clinical narrative: Heavy arm; Rash all over the body, the only place that do not have rash is the face and getting worse day after day; cannot sleep on night time and really bad; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included pre thyroid and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 23Apr2021 at 00:00, the patient experienced heavy arm then rash all over the body, the only place that do not have rash is the face and getting worse day after day and cannot sleep on night time and really bad. It was reported that the patient had stopped working, because he can't handle it. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heavy arm was resolved on 26Apr2021, after the duration of 3 days whereas the clinical outcome of the events rash all over the body, the only place that do not have rash is the face and getting worse day after day and cannot sleep on night time and really bad was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Oropharyngeal discomfort, Pollakiuria, Thirst
Clinical narrative: Extreme thirst started about a week or so after the first vaccine shot; It's an uncomfortale, annoying, desperate feeling from the back of your throat into mouth; I have to urinate about every two hours; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 17:00 (at the age of 50-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 14Apr2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy, hashimoto's disease, obesity, fibromyalgia and the patient was pre-diabetic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks prior to the vaccination. The patient previously received gadolinium (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, about a week or so after the first vaccine shot the patient experienced extreme thirst. The patient never experienced anything like this in life and it continued at the time of this reporting. It was an uncomfortable, annoying, desperate feeling from the back of throat into mouth. As soon as the patient had a drink of water, she was thirsty again within a few minutes. The patient drank only water and 2 cups of coffee a day. She was drinking so much water, that she had to urinate about every two hours. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The patient had a variety of labs done on 18Apr2021, the results of which were unknown. The patient was diabetic and they were all relatively consistent with labs done prior to vaccines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme thirst, uncomfortable, annoying, desperate feeling from the back of your throat into mouth, had to urinate about every two hours were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Nausea, Paraesthesia
Clinical narrative: I've experienced full body shakes; Diarrhea; Tingling in both my hands; Extreme pain in the injection site; Sweating; Severe headaches; I started feeling nausea in the evening and started throwing up continuously later in the evening; I started feeling nausea in the evening and started throwing up continuously later in the evening; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old patient of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 08:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (add), obsessive compulsive disorder (ocd), post-traumatic stress disorder (ptsd), broad spectrum disorder, unspecified allergies, graves disease and insomnia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonidine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC), paroxetine hydrochloride (PAXIL) and "pr"; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 08:30, the patient experienced full body shakes, diarrhea, tingling in both hands, extreme pain in the injection site, sweating and severe headaches. On the same day, the patient started feeling nausea in the evening and started throwing up continuously later in the evening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the patient started feeling nausea in the evening and started throwing up continuously later in the evening, the patient had experienced full body shakes, diarrhea, tingling in both hands, extreme pain in the injection site, sweating and severe headaches was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain, Vomiting
Clinical narrative: I've experienced full body shakes; Diarrhea; Tingling in both my hands; Extreme pain in the injection site; Sweating; Severe headaches; I started feeling nausea in the evening and started throwing up continuously later in the evening; I started feeling nausea in the evening and started throwing up continuously later in the evening; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old patient of an unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 08:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder (add), obsessive compulsive disorder (ocd), post-traumatic stress disorder (ptsd), broad spectrum disorder, unspecified allergies, graves disease and insomnia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonidine (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC), paroxetine hydrochloride (PAXIL) and "pr"; all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 08:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 08:30, the patient experienced full body shakes, diarrhea, tingling in both hands, extreme pain in the injection site, sweating and severe headaches. On the same day, the patient started feeling nausea in the evening and started throwing up continuously later in the evening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the patient started feeling nausea in the evening and started throwing up continuously later in the evening, the patient had experienced full body shakes, diarrhea, tingling in both hands, extreme pain in the injection site, sweating and severe headaches was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Pain, Tremor
Clinical narrative: During the night of the day I got the shot I woke up and had severe trembling, almost unable to stand/  I was shaking so hard.; During the night of the day I got the shot I woke up and had severe trembling, almost unable to stand I was shaking so hard.; No chills or fever at that time, but headache and body aches.; No chills or fever at that time, but headache and body aches.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: HER2613) via an unspecified route of administration in the left arm on 28Apr2021 at 10:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, thyroid disorder and known allergy to seafood. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), famotidine (FAMODINE), pantoprazole (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received pseudoephedrine hydrochloride (SUDAFED), nalbuphine hydrochloride (NUBAIN) and tetanus vaccine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 29Apr2021 at 03:00, in the night the patient woke up and had severe trembling, was almost unable to stand and was also shaking so hard. No chills or fever at that time, but experienced headache and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe trembling, almost unable to stand, shaking so hard, headache and body aches was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Spotting; Started to feel cramps; I feel the shot must have triggered a false menstruation; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), thyroid (ARMOUR THYROID) and birth control pills (MANUFACTURER UNKNOWN) all for an unknown indication started from an unknown date and unknown if ongoing. On 27Apr2021, the next day after receiving the second shot, the patient experienced spotting, started feeling cramps. The patient reported that she began spotting and then started to feel cramps as if the patient was about to start her period when she was bit due to start for another 2 weeks. The patient stated that she felt the shot must have triggered a false menstruation. She further stated that it was 30April2021 and was still spotting and having cramps(as reported). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events spotting, started to feel cramps and she felt the shot must have triggered a false menstruation were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Menstruation irregular, Paraesthesia oral
Clinical narrative: Swollen in lips about 8 hours after vaccine; Numb in lips about 8 hours after vaccine; Tingly sensation in lips about 8 hours after vaccine; Menstrual bleeding even though period not due for 10 days; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 at 13:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history had allergy to bee pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Apr2021 at 21:45, the patient experienced swollen, numb, tingly sensation in lips about 8 hours after vaccine. She also had menstrual bleeding even though period was not due for 10 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, numb, tingly sensation in lips about 8 hours after vaccine and menstrual bleeding even though period was not due for 10 days was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Eye swelling, Headache
Clinical narrative: Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Headache; Chills; Sore throat; coughing; Right side of neck (lymph nodes) swollen with trap area; Shoulder pain; Pain in bicep area; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 08:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder (OCD), major depression, attention deficit hyperactivity disorder (ADHD) and fruit allergy to fresh pineapple with reaction as swollen tongue. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluvoxamine maleate (LUVOX), aripiprazole (ABILIFY), lamotrigine (MANUFACTURER UNKNOWN), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and fish oil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021 at 14:45, the patient experienced face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Oropharyngeal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Headache; Chills; Sore throat; coughing; Right side of neck (lymph nodes) swollen with trap area; Shoulder pain; Pain in bicep area; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 08:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder (OCD), major depression, attention deficit hyperactivity disorder (ADHD) and fruit allergy to fresh pineapple with reaction as swollen tongue. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluvoxamine maleate (LUVOX), aripiprazole (ABILIFY), lamotrigine (MANUFACTURER UNKNOWN), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and fish oil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021 at 14:45, the patient experienced face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Face, Eye, Tongue Swelling; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Extreme arm pain (injection arm) swollen arm, including site of injection; Headache; Chills; Sore throat; coughing; Right side of neck (lymph nodes) swollen with trap area; Shoulder pain; Pain in bicep area; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 08:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder (OCD), major depression, attention deficit hyperactivity disorder (ADHD) and fruit allergy to fresh pineapple with reaction as swollen tongue. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluvoxamine maleate (LUVOX), aripiprazole (ABILIFY), lamotrigine (MANUFACTURER UNKNOWN), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and fish oil (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. On 29Apr2021 at 14:45, the patient experienced face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events face, eye, tongue swelling, extreme arm pain (injection arm) swollen arm, including site of injection, headache, chills, sore throat, coughing, shoulder pain, pain in bicep area and right side of neck (lymph nodes) swollen along with trap area were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Very bad fatigue; Joint soreness; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL) and sertraline (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 03Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 12:00, the patient experienced very bad fatigue, joint soreness and muscle soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad fatigue, joint soreness and muscle soreness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.