chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling
Clinical narrative: swelling in his arm; a little headache; This is a spontaneous report from a contactable consumer or other non hcp (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling in his arm and a little headache on an unspecified date. It was reported that, my family member just got the vaccine yesterday, and all he had was swelling in his arm, and a little headache. Caller enquired what are the risks of the pfizer-biontech covid-19 vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Pyrexia
Clinical narrative: Fever; loss of taste; This is a spontaneous report from a contactable consumer. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 24May2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date and any other relevant medical history was reported as unknown. It was unknown if the patient had any known allergies. It was unknown if the patient had received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021 at 07:00, the patient experienced fever and loss of taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if any therapeutic measures were taken for the events. The clinical outcome of the events fever and loss of taste were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Skin burning sensation
Clinical narrative: Full-body skin pain/burning without rash; Full-body skin pain/burning without rash; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 23Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergies from an unknown date. The patient had known allergies to erythromycin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D3) and krill oil (MANUFACTURER UNKNOWN); both taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced full-body skin pain/burning without rash. 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 full-body skin pain/burning without rash was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: "Stomach cramps. Not severe enough to cause bad pain, but severe enough to keep me from eating more than a bite here and there".; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 24May2021 at 08:15(at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies to food, medications or other products. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA) for unspecified indication from an unknown start date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. On 24May2021 at 13:00, the patient reported that she had stomach cramps not severe enough to cause bad pain, but severe enough to keep her from eating more than a bite here and there. The patient did not receive any treatment for the adverse event. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event stomach cramps not severe enough to cause bad pain, but severe enough to keep her from eating more than a bite here and there was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Headache, Menstrual disorder
Clinical narrative: Multiple days of bad headache; fatigue; "foggy brain"; muscle aches; muscle aches and weakness; diarrhea; potential menstrual period change; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0176) via an unspecified route of administration in the right arm on 20May2021 at 19:30 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications in two weeks of vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient experienced multiple days of bad headache, fatigue, foggy brain, muscle aches and weakness, diarrhea and potential menstrual period change. No therapeutic measures were taken as a result of the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events multiple days of bad headache, fatigue, foggy brain, muscle aches and weakness, diarrhea, and potential menstrual period change were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Multiple days of bad headache; fatigue; "foggy brain"; muscle aches; muscle aches and weakness; diarrhea; potential menstrual period change; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0176) via an unspecified route of administration in the right arm on 20May2021 at 19:30 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications in two weeks of vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient experienced multiple days of bad headache, fatigue, foggy brain, muscle aches and weakness, diarrhea and potential menstrual period change. No therapeutic measures were taken as a result of the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events multiple days of bad headache, fatigue, foggy brain, muscle aches and weakness, diarrhea, and potential menstrual period change were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Poor quality sleep
Clinical narrative: Insomnia; Wide awake in the middle of the night; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 14May2021 09:15 (at the age of 27-year-old) as a single dose for COVID-19 immunization. Medical history included no other health issues. Patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 27-year-old) as a single dose for COVID-19 immunization. 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. On 14May2021 at 23:00, the patient had insomnia which was really frustrating. She would be wide awake in the middle of the night and it had been 10 days already. The patient never ever had issues sleeping and she experienced this only after taking 2nd shot. The events result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken and included treatment with melatonin 1mg (MANUFACTURER UNKNOWN) medication which didn't help much in falling asleep. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia and will be wide awake in the middle of the night was not recovered 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: Eye inflammation, Eye irritation, Eye pruritus, Ocular hyperaemia, Periorbital swelling
Clinical narrative: Skin under and around Both EYEsred, itching, swollen/Puffy; Skin under and around Both EYEsred, itching; Skin under and around Both EYEsred, itching, swollen, burning; Skin under and around Both EYEsred, itching, swollen, burning, puffy,inflamed; Skin under and around Both EYEsred, itching, swollen, burning, puffy,inflamed and irritated; Skin under and around Both EYEs red; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 00:00, the patient experienced skin under and around both eyes red, itching, swollen, burning, puffy, inflamed and irritated. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Eyedrops and hydrocortisone. The clinical outcome of the events skin under and around both eyes red, itching, swollen, burning, puffy, inflamed, and irritated was not recovered. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 23May2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding, Hidradenitis
Clinical narrative: Menstrual period lasting in excess of two weeks, and counting.; Hidridenitis supperativa flared up the day after vaccine.; Hidridenitis supperativa flared up the day after vaccine.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 09:15 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hidridenitis supprativa. On 12May2021, the patient experienced Menstrual period lasting in excess of two weeks, and counting and Hidridenitis supperativa flared up the day after vaccine. Injection of cortisone to hidridenitis cyst Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: elevated heart rate; During one event I had to stop the workout to catch my breath; This is a spontaneous report from a contactable consumer (reported for self). A 41-years-old male patient received second dose of BNT162B2 ((COMIRNATY); Formulation: Solution for injection; Lot/Batch number: Not reported), via an unspecified route of administration on an unspecified date in 2021 (at the of 41-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 ((COMIRNATY); Formulation: Solution for injection; Lot number: EN6204), via an unspecified route of administration in the Left arm on 08Apr2021 12:00 as dose 1, single for COVID-19 immunization and experienced elevated heart rate and Dyspnoea. Prior to vaccination, the patient was not diagnosed with COVID-19. Known allergies and other medical history were none. On an unspecified date in 2021 the patient noticed elevated heart rate when he worked out. The patient's fitness watch tracked 15-20BPM higher than normal (I do the exact same workout almost everyday) for 48 hours after both doses. During one event he had to stop the workout to catch his breath (reported as "During one event I had to stop the workout to catch my breath"). Given some of the reporting of heart inflammation patient thought this would be helpful. Since the vaccination, the patient has not been tested for COVID-19. The lab data includes: Heart rate 15-20BPM higher than normal on an unspecified date in 2021. Patient received no treatment for the adverse events. The events were assessed as non serious. The outcome of events was reported as recovered on unknown date.  Device Date : 25May2021  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Noticed elevated heart rate when I worked out for 48 hours after both doses; During one event I had to stop the workout to catch my breath; This is a spontaneous report from a contactable consumer (patient husband) or other non-healthcare professional. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) dose 2 via an unspecified route of administration on an unspecified date as single dose and dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6204 and expiration dates were not reported) dose 1 via an unspecified route of administration in arm left on 08Apr2021 at 12:00 as single dose COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had not taken any vaccination in four weeks duration neither any other medications prior to two weeks of vaccination. Patient did not have COVID-19 prior to vaccine and neither tested for COVID-19 post vaccination. It was reported that the patient had noticed elevated heart rate when she worked out. Her watch tracked 15- 20BPM (beats per minute) higher than normal (she does the exact same workout almost everyday) for 48 hours after both doses. During one event patient had to stop the workout to catch her breath. Given some of the reporting of heart inflammation reporter thought this would be helpful. Reporter wife had the exact same reaction. The patient underwent lab test procedure include Heart rate results elevated 15-20 BPM higher than normal. The events were reported as non-serious. No treatment was taken as a result of events. The outcome of all the events were reported as recovered on unknown date.   Follow-Up (01Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021598382 same reporter/AE/SD, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Fatigue, Headache, Illness
Clinical narrative: Fever; Sick all the night; I was off balance; Feeling unwell; Headache; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24May2021 08:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 24May2021 18:00 consumer stated, I don't know if I'm directed to the correct person. Yesterday, I took my second shot of Covid19 Pfizer vaccine. I took at 8 in the morning and at 6, I started feeling unwell, I start having headache, I was off balance, I may be tired. At around 9, so it starts happening with me, high fever, I'm so tired and sick all the night. I took Tylenol at 8 and Advil at 12. The temperature is between 101.9 and it doesn't go down it was like 100.7 and I'm not feeling well. The patient received treatment with Tylenol and Advil. The patient underwent lab tests and procedures which included body temperature: 101.9 on an unspecified date, body temperature: 100.7 on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever; Sick all the night; I was off balance; Feeling unwell; Headache; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24May2021 08:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 24May2021 18:00 consumer stated, I don't know if I'm directed to the correct person. Yesterday, I took my second shot of Covid19 Pfizer vaccine. I took at 8 in the morning and at 6, I started feeling unwell, I start having headache, I was off balance, I may be tired. At around 9, so it starts happening with me, high fever, I'm so tired and sick all the night. I took Tylenol at 8 and Advil at 12. The temperature is between 101.9 and it doesn't go down it was like 100.7 and I'm not feeling well. The patient received treatment with Tylenol and Advil. The patient underwent lab tests and procedures which included body temperature: 101.9 on an unspecified date, body temperature: 100.7 on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain night after shot arm was unable to move/ moderate/mild pain in the upperarm; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173 8/21) via an unspecified route of administration in the arm left on 12May2021 at 16:00(at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease from unknown date and unknown if ongoing. Concomitant medications included only vitamins/supplements (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 the patient experienced severe arm pain night after shot, all night long her whole arm was unable to move. This strong pain subsided in about 2 days. Now 2 weeks later, she still have moderate/mild pain in the upper arm. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe arm pain night after shot arm was unable to move was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Flushing
Clinical narrative: shortness of breath for 9days; Felt strange in my head for 2 days; Diarrhea; Flush; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 173), via an unspecified route of administration in the left arm on 04May2021 at 11:45 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, migraine and high cholesterol. The patient had a history of allergy to iodine dye. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) and herbal supplements (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04May2021, the patient experienced 3 very powerful weird sensations like a flush, shortness of breath for 9 days, diarrhea, the flush feeling had made the patient bend in half and take mask off and felt strange in head for 2 days. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events a flush, shortness of breath for 9 days, diarrhea and felt strange in head for 2 days were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck on side of shot; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177), via an unspecified route of administration on 18May2021 at 14:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. 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. On 21May2021, the patient experienced swollen lymph nodes in neck on side of shot and tiredness. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes in neck on side of shot and tiredness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Dysstasia, Pharyngeal swelling
Clinical narrative: Throat swelled; Had a very hard time breathing; She had a barking cough and couldn't stop; She was dizzy; Had a hard time standing; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left leg on 20May2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome. The patient had known allergies with gelatine, egg and other allergy (unspecified allergy). The patient did not receive any concomitant medication. It was unknown whether prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown whether since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20May2021, the patient experienced throat swelled, had a very hard time breathing, she had a barking cough and couldn't stop, she was dizzy and had a hard time standing. The events resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events throat swelled, had a very hard time breathing, she had a barking cough and couldn't stop. She was dizzy and had a hard time standing was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Very painful axillary (left) lymph node; Swollen axillary (left) lymph node; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 24May2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. The patient did not have allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25May2021 at 01:00, the patient experienced very painful and swollen axillary (left) lymph node. 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 adverse event. The clinical outcome of the event very painful and swollen axillary (left) lymph node was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Sharp R Breast pain (opposite side of where shot was given); Pins and needle-like pain at nipple and entire breast.; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and poly cystic ovarian syndrome (PCOS). Concomitant medications included metformin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY) all started from an unknown date for unspecified indication and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not tested positive for COVID-19. On 01Mar2021 at 23:45, the patient experienced sharp R breast pain (opposite side of where shot was given) and pins and needle-like pain at nipple and entire breast. No therapeutic measures were  taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test on 21Apr2021 which included the polymerase chain reaction (PCR) test and the result was found to be negative. The clinical outcome of the events sharp R breast pain (opposite side of where shot was given) and pins and needle-like pain at nipple and entire breast was recovered on 08Mar2021, seven days post the second injection date.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pains -fingers, toes, left elbow, knees; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0186) via an unspecified route of administration in the left arm on 14May2021 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. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 as a single dose for COVID-19 immunisation. On 18May2021 the patient experienced joint pains -fingers, toes, left elbow and knees. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event joint pains -fingers, toes, left elbow and knees was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node under left ear swelled and remains swollen as of 5/25.; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0187) via an unspecified route of administration in the right arm on 20May2021 at 15:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse and cholesterol high. The patient had no known allergies. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN); ezetimibe (ZETIA) and apixaban (ELIQUIS) from an unknown date, for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22May2021, the patient experienced lymph node under left ear swelled. The patient reported that she had lymph node under left ear swelled within 48 hours of vaccination and remained swollen as of 25May2021. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event lymph node under left ear swelled was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: ALT increased; AST increased; Vertigo; This is a spontaneous report from a contactable healthcare professional, the patient.  A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Jan2021 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included Megoblastic Macrocytic Anemia. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the arm left on 16Dec2020 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10May2021, 4 months later, patient had elevated liver enzymes ALT and AST. Patient had no known history and did not drink not obese, never elevated. Also the patient dealing with horrible vertigo. She spoke to 3 other people she know 2 in the same department that have the same thing going on and she was questioning whether it is a possible side effect? The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event ALT increased, AST increased and vertigo were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Flatulence
Clinical narrative: Fatigue; Dizziness; Diarrhea; Excessive gas; Nausea; Headaches; Chills; Night sweats; 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: EW0167) via an unspecified route of administration in the left arm on 09May2021 at 16:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and anxiety. The patient previously took Doxycycline and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) and buspirone (MANUFACTURER UNKNOWN) both for unknown indications from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 16:45 (at the age of 35-year-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 10May2021, for 14 days following the second dose the patient experienced fatigue, dizziness, diarrhea, excessive gas, nausea, headaches and on occasion had chills and night sweats. The events resulted in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. On 14May2021, the patient underwent PCR oral swab test and the result was negative. The clinical outcome of the events fatigue, dizziness, diarrhea, excessive gas, nausea, chills, night sweats and headaches were 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: Headache, Nausea, Night sweats
Clinical narrative: Fatigue; Dizziness; Diarrhea; Excessive gas; Nausea; Headaches; Chills; Night sweats; 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: EW0167) via an unspecified route of administration in the left arm on 09May2021 at 16:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and anxiety. The patient previously took Doxycycline and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) and buspirone (MANUFACTURER UNKNOWN) both for unknown indications from an unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 16:45 (at the age of 35-year-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 10May2021, for 14 days following the second dose the patient experienced fatigue, dizziness, diarrhea, excessive gas, nausea, headaches and on occasion had chills and night sweats. The events resulted in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. On 14May2021, the patient underwent PCR oral swab test and the result was negative. The clinical outcome of the events fatigue, dizziness, diarrhea, excessive gas, nausea, chills, night sweats and headaches were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Menstruation delayed, Pain
Clinical narrative: Body ache; Fatigue; Chills; Sweat; missed period over a week and is still missed which is unusual for me; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient 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 16May2021 at 14:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 25Apr2021 at 14:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced body ache, fatigue, chills, sweat, missed period over a week and is still missed which is unusual for the patient, but all other side effect only lasted two days. 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. The clinical outcome of the events body ache, fatigue, chills and sweat were resolved on 18May2021 and the clinical outcome of the event missed period over a week and is still missed which is unusual was not resolved at the time of reporting.   Information on lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes left armpit; Fatigue; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0191) via an unspecified route of administration in the left arm on 24May2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0176) in the left arm on 03May2021 at 11:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021 at 10:00 the patient experienced swollen lymph nodes left armpit, fatigue and body aches. No therapeutic measures were taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19The clinical outcome of the event swollen lymph nodes left armpit, fatigue and body aches was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Miosis, Tinnitus
Clinical narrative: High pitched tinnitus mostly affects left ear; left atypical/tonic pupil; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 10May2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not available. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 10:00, the patient experienced high pitched tinnitus mostly affects left ear and left atypical/tonic pupil. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high pitched tinnitus mostly affects left ear and left atypical/tonic pupil were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Musculoskeletal chest pain
Clinical narrative: Fatigue; soreness in left arm; soreness in shoulder; soreness in ribs; Body aches; headache; Trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ew0187) via an unspecified route of administration in the left arm on 24May2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to bay shrimp. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN); all from an unknown date, for an unknown indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8736) via an unspecified route of administration in the left arm on 03May2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021, the patient experienced fatigue, soreness in left arm, shoulders and ribs, body aches, headache and trouble sleeping. 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. The clinical outcome of the events fatigue, soreness in left arm, shoulders and ribs, body aches, headache and trouble sleeping were recovered on 25May2021.  No follow-up attempts are needed. No further information is expected.