chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Rash
Clinical narrative: Moderate back pain and shooting pain up and down legs; Rash on abdomen.; 24 hours after vaccine had moderate back pain; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the arm right on 06May2021 (at the age of 62-year-old) and second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the arm right on 28May2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease. Concomitant medications were not reported. 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 an unknown date in 2021, 24 hours after vaccine, the patient had moderate back pain and shooting pain up and down legs which lasted for 24 hours and 48 hours after vaccine, the patient had rash on abdomen. The patient did not receive any treatment for the reported events. The adverse 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 back pain, shooting pain up and down in legs and rash on abdomen were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Amnesia, Chills, Computerised tomogram normal, Headache, Needle issue
Clinical narrative: Chills; Headache; Memory loss; Thought he was having a panic attack; This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of an unspecified age received unknown dose of meningococcal group B RLP2086 (TRUMENBA), via an unspecified route of administration on 21Sep2016 (Batch/Lot Number: N16808; Expiration Date: 31Jul2017) as SINGLE for meningococcal immunisation. The patient medical history and concomitant medications were not reported. Caller said that the reporter said that the patient had the vaccine and went to a buffet and experienced headache, chills, thought he had memory loss. He went to the hospital and they did a CT scan and it was normal. The patient stayed in the hospital overnight. The caller said that the reporter said that the nurse who gave the shot put the shot in the patients arm and went to push and nothing came out. She took the needle out of the patient's arm and inspected it and removed the needle. She gave him a different dose of the vaccine, not the one that would not push. The caller said that the reporter also reported that the patients mom thought he was having a panic attack and she thought he had anxiety before. The mom thinks he had 2 doses of the vaccine, but with the first one the needle was not working. The patient underwent lab tests and procedures which included computerised tomogram as normal. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Panic attack
Clinical narrative: Chills; Headache; Memory loss; Thought he was having a panic attack; This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of an unspecified age received unknown dose of meningococcal group B RLP2086 (TRUMENBA), via an unspecified route of administration on 21Sep2016 (Batch/Lot Number: N16808; Expiration Date: 31Jul2017) as SINGLE for meningococcal immunisation. The patient medical history and concomitant medications were not reported. Caller said that the reporter said that the patient had the vaccine and went to a buffet and experienced headache, chills, thought he had memory loss. He went to the hospital and they did a CT scan and it was normal. The patient stayed in the hospital overnight. The caller said that the reporter said that the nurse who gave the shot put the shot in the patients arm and went to push and nothing came out. She took the needle out of the patient's arm and inspected it and removed the needle. She gave him a different dose of the vaccine, not the one that would not push. The caller said that the reporter also reported that the patients mom thought he was having a panic attack and she thought he had anxiety before. The mom thinks he had 2 doses of the vaccine, but with the first one the needle was not working. The patient underwent lab tests and procedures which included computerised tomogram as normal. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Arm soreness; Chest tightness; Chills; Stomach cramp on same side of injection site; Minor headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 30May2021 at 11:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 09May2021 at 16:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. 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 30May2021 at 15:00 the patient experienced arm soreness, chest tightness, chills, stomach cramp on same side of injection site, minor headache and fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor 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-19. The clinical outcome of the events arm soreness, chest tightness, chills, stomach cramp on same side of injection site, minor headache and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; Chest tightness; Chills; Stomach cramp on same side of injection site; Minor headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 30May2021 at 11:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient has no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 09May2021 at 16:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. 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 30May2021 at 15:00 the patient experienced arm soreness, chest tightness, chills, stomach cramp on same side of injection site, minor headache and fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor 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-19. The clinical outcome of the events arm soreness, chest tightness, chills, stomach cramp on same side of injection site, minor headache and fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Condition aggravated, Discomfort, Illness, Throat irritation
Clinical narrative: today actually it becomes worse; The other one is like blurred vision like around 2 weeks after I took my shot like I am watching you tube, I noticed that all the pictures was blur; sensation of throat tightness; feeling like I am really sick; I also hives on my throat; it something like itching on my throat; experience the heavy arm; I have an abdominal pain for 2 weeks and it does not go away/weird sensation in the belly button area; This is a spontaneous report from a contactable consumer or other non hcp. A 49-Year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0617), via an unspecified route of administration, administered on left arm on 09May2021 (at the age of 49-Years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   Patient had Pfizer first shot on 09May2021 and ever since then she had an abdominal pain for 2 weeks and it does not go away. Patient experienced abdominal pain about 5 hours after getting her first shot of the Pfizer BioNTech Covid-19 Vaccine, but went away after 5 minutes. She also mentioned that at night, she is experiencing a weird sensation in the belly button area and almost everyday when she wakes up, she is experiencing the abdominal pain which feels slightly stronger as days went by. She also mentioned that she has no preexisting issues. She wanted to know if it would be safe to get the 2nd shot of the Pfizer Covid-19 Vaccine because she is experiencing abdominal pain. The abdominal pain was like since about 6 hours after the shot it was like soft pain in her belly, then was just for few minute since then almost like daily, she felt abdominal pain near her belly button area and it would be like night time and day time it comes and goes and the day of reporting it actually became worse because ever since she woke up in the morning 8 O' clock it was like it doesn't go away. The pain is not is about like a 3 to 4 scale out of the 10. So it started on the belly button like the few days ago. When she was trying to push her hands like lightly on right side of belly button she felt the 'dull pain' in her abdominal area. Patient had abdominal pain besides other little ones that she won't mention like the minor one's they kind of already went away. The other ones are like blurred vision like around 2 weeks after she took her shot like when she is watching you tube, she noticed that all the pictures were blurred. Other than blur vision it was sensation of throat tightness, feeling like she was really sick and also hives on her throat, its something like itching on her throat and her arm which is normal and she thinks everybody experience the heavy arm for few days. Abdominal pain is one very much concern about. Treatment was reported as patient want to find out what she is going to do. The outcome of the events were reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria, Vision blurred
Clinical narrative: today actually it becomes worse; The other one is like blurred vision like around 2 weeks after I took my shot like I am watching you tube, I noticed that all the pictures was blur; sensation of throat tightness; feeling like I am really sick; I also hives on my throat; it something like itching on my throat; experience the heavy arm; I have an abdominal pain for 2 weeks and it does not go away/weird sensation in the belly button area; This is a spontaneous report from a contactable consumer or other non hcp. A 49-Year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0617), via an unspecified route of administration, administered on left arm on 09May2021 (at the age of 49-Years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   Patient had Pfizer first shot on 09May2021 and ever since then she had an abdominal pain for 2 weeks and it does not go away. Patient experienced abdominal pain about 5 hours after getting her first shot of the Pfizer BioNTech Covid-19 Vaccine, but went away after 5 minutes. She also mentioned that at night, she is experiencing a weird sensation in the belly button area and almost everyday when she wakes up, she is experiencing the abdominal pain which feels slightly stronger as days went by. She also mentioned that she has no preexisting issues. She wanted to know if it would be safe to get the 2nd shot of the Pfizer Covid-19 Vaccine because she is experiencing abdominal pain. The abdominal pain was like since about 6 hours after the shot it was like soft pain in her belly, then was just for few minute since then almost like daily, she felt abdominal pain near her belly button area and it would be like night time and day time it comes and goes and the day of reporting it actually became worse because ever since she woke up in the morning 8 O' clock it was like it doesn't go away. The pain is not is about like a 3 to 4 scale out of the 10. So it started on the belly button like the few days ago. When she was trying to push her hands like lightly on right side of belly button she felt the 'dull pain' in her abdominal area. Patient had abdominal pain besides other little ones that she won't mention like the minor one's they kind of already went away. The other ones are like blurred vision like around 2 weeks after she took her shot like when she is watching you tube, she noticed that all the pictures were blurred. Other than blur vision it was sensation of throat tightness, feeling like she was really sick and also hives on her throat, its something like itching on her throat and her arm which is normal and she thinks everybody experience the heavy arm for few days. Abdominal pain is one very much concern about. Treatment was reported as patient want to find out what she is going to do. The outcome of the events were reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; Diarrhea; Fatigue; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 30May2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 31May2021 at 00:30, the patient experienced headache, diarrhea, fatigue and pain at injection site. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events headache, diarrhea, fatigue and pain at injection site was resolved on31May2021.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: All-body hives; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20May2021 at 16:30 (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 was allergic to lamb and exposure to UV light for hours. Prior to 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 28May2021, the patient experienced all-body hives which was occurred 8 days after the first shot, but almost went away after 1-2 days. Therapeutic measures were taken as a result of the adverse events and included treatment with ZYRTEC. The adverse event resulted in a visit to the emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19.  The clinical outcome of the event all-body hives was recovering at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported) dose 2 via an unspecified route of administration in the arm left on 30Jan2021 at 16:45 (at the age of 48-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient had no known allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number was not reported) dose 1 via an unspecified route of administration in the left arm on 09Jan2021 at 16:45 (at the age of 48-year-old) as dose 1, single 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 20Feb2021, the patient experienced outbreak of shingles about 3-4 weeks after second dose of vaccination. The event resulted in physician office visit. Therapeutic measures were taken as the result of adverse event included treatment with FAMVIR 500mg twice a day for seven days. The outcome of the event was recovered on an unspecified date of 2021.  The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain / arthritic symptoms 12 hours - 36 hours post injection in hands (specifically within the knuckles and thumbs) and lingering pain in some joints; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female 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 08May2021 (at the age of 37-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29May2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 09May2021, the patient experienced severe joint pain / arthritic symptoms 12 hours - 36 hours post injection in hands (specifically within the knuckles and thumbs) and lingering pain in some joints. Not one to experience these symptoms usually and they did subside after 36 hours. 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 adverse events. The clinical outcome of the event severe joint pain / arthritic symptoms 12 hours - 36 hours post injection in hands (specifically within the knuckles and thumbs) and lingering pain in some joints was recovered with sequelae on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node on neck on same side; Painful lymph node on neck on same side; This is a spontaneous report from a non-contactable consumer, the patient. An unspecified aged non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunisation. The patient had history of known allergies to eggs. The patient did not take any concomitant medication. The patient previously took sulphur (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. 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 four weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced swollen painful lymph node on neck on same side where injected. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen painful lymph node on neck on same side where injected was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27May2021 at 12:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 29May2021 at 12:00, 48 hours after receiving vaccine the patient experienced severe headache. Pains did not stay all the time but instead pains hit the left back of patient's head every 3 to 5 seconds. Patient reported that the pains lasted at least 36 hours. Patient took 2 Tylenols every 8 hours to relieve the pains. Patient had minor headache 2 to 3 more times last week but they did not last long. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with 2 tylenols. The clinical outcome of the event severe headache was recovering 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles on right side of upper back shoulder area; This is a spontaneous report from a contactable consumer (patient).A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Arm Right on 14May2021 at 16:00 (age at vaccination 26-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no known allergies. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm right on 23Apr2021 at 16:00 as a dose 1, single for COVID-19 immunization. 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 27May2021, the patient developed shingles on right side of upper back shoulder area. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not yet recovered from the event.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Chills; full body aches; fatigue; loss of apatite; light fever; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0182) via an unspecified route of administration in the left arm on 25May2021(at the age of 26 years) at 19:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had known allergies to shellfish, lithium, and lactose all since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26May2021 at 04:00 the patient experienced chills, full body aches, fatigue, loss of appetite, light fever, and sore throat. The events had not resulted 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. The clinical outcome of the events chills, full body aches, fatigue, loss of appetite, light fever, and sore throat were recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; full body aches; fatigue; loss of apatite; light fever; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0182) via an unspecified route of administration in the left arm on 25May2021(at the age of 26 years) at 19:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had known allergies to shellfish, lithium, and lactose all since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26May2021 at 04:00 the patient experienced chills, full body aches, fatigue, loss of appetite, light fever, and sore throat. The events had not resulted 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. The clinical outcome of the events chills, full body aches, fatigue, loss of appetite, light fever, and sore throat were recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: The first period  after the second vaccine was extra heavy and prolonged.; Had some spotting; no period for six weeks; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received an unknown dose dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 27Apr2021 at 15:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 47-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. The patient did not receive any concomitant medications within two weeks of vaccination. On an unknown date in Apr2021, the first period after the second vaccine was extra heavy and prolonged. The patient had some spotting and then no period for six weeks. The patient was on regular spot for entire life and believe that the vaccine affected the period. 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 reported events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "the first period after the second vaccine was extra heavy and prolonged", "had some spotting" and no period for six weeks was recovering 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: Parosmia, Taste disorder
Clinical narrative: Bad smell in nose, especially with hot things/  Smell is very acrid and sharp - like something burnt; Also affects taste to some extent; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) in the right arm on 18Mar2021 at 12:15 (at the age of 50-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 19Mar2021, the patient experienced primarily bad smell in nose, especially with hot things, also affected taste to some extent, but primarily smell. Smell was very acrid and sharp - like something burnt. The adverse event did not result in a visit to the doctors 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. The clinical outcome of the event primarily bad smell in nose, especially with hot things, smell is very acrid and sharp - like something burnt and also affects taste to some extent was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Ear, nose and throat examination, Fatigue, Fine motor skill dysfunction, Malaise
Clinical narrative: Dexterity issues in both hands; Tingling in fingers and forearms; Minor balance issues; Sensation in bony part of nose; General fatigue; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 26Apr2021 at 13:00 (at the age of 51-years-old) as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ?W0161) via an unspecified route of administration in the right arm on 18May2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history.  The patient had no known allergy other than possibly lobster (shellfish allergy). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and multivitamins; all for unknown indication from unknown dates and unknow if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced dexterity issues in both hands, tingling in fingers and forearms, minor balance issues, sensation in bony part of nose, general fatigue and malaise. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included  examination and rule out of vertigo by ENT on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of  dexterity issues in both hands, tingling in fingers and forearms, minor balance issues, sensation in bony part of nose, general fatigue and malaise were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Paraesthesia
Clinical narrative: Dexterity issues in both hands; Tingling in fingers and forearms; Minor balance issues; Sensation in bony part of nose; General fatigue; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 26Apr2021 at 13:00 (at the age of 51-years-old) as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ?W0161) via an unspecified route of administration in the right arm on 18May2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history.  The patient had no known allergy other than possibly lobster (shellfish allergy). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included finasteride (MANUFACTURER UNKNOWN) and multivitamins; all for unknown indication from unknown dates and unknow if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced dexterity issues in both hands, tingling in fingers and forearms, minor balance issues, sensation in bony part of nose, general fatigue and malaise. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included  examination and rule out of vertigo by ENT on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of  dexterity issues in both hands, tingling in fingers and forearms, minor balance issues, sensation in bony part of nose, general fatigue and malaise were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 30May2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included metformin (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN) and amlodipine besilate (AMLODIP); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 31May2021, the patient experienced chills and fever. The events did not result 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 chills and fever which included treatment with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the events chills and fever were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an intramuscular route of administration in the left arm on 29May2021 at 14:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation.  Medical history was not reported. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and ibuprofen (MANUFACTURER UNKNOWN) for unknown indications from an unknown date. The patient had no known allergies to medications, food and other products. 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 4 weeks prior to the COVID vaccine. On 29May2021 at 20:00, the patient had experienced extreme fatigue. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extreme fatigue was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 102.2; This is a spontaneous report from a contactable nurse. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 07:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohns and COVID-19 which was on Jul2020. Concomitant medications included ondansetron hydrochloride (ZOFRAN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 08May2021 at 07:00, the patient reported that she missed 2. 12 hour shifts after vaccine due to fever 102'.2 (UNSPECIFIED UNIT). The patient also reported that this vaccine was not free for her it cost her $954.96. may she be reimbursed for the 2 shifts? Nursing as we know is hard enough but to miss this amount on her pay was a struggle thank you. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever 102.2 (UNSPECIFIED UNIT) was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Headache, Myalgia
Clinical narrative: Soreness in arm; Intense burning in arm; Chills; Overall body weakness; Extreme muscle soreness; Lack of strength; Headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12May2021 in the morning (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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, post vaccination in the morning, the patient immediately noticed soreness which gradually increased throughout the day. By the evening, arm was so sore that she could barely move her arm and when did so, she experienced intense burning and pain. She also experienced chills and overall body weakness which she understood was to be expected. However, she realized that the extreme muscle soreness and lack of strength she experienced was rare and which was why she felt compelled to report this. Additionally, since she had received the vaccine, she had noticed an increase in headaches. The patient prayed for healing. On 13May2021, by morning, her arm was only mildly sore and she felt normal a couple of days later. Therapeutic measures were taken as a result of events and included treatment with ibuprofen pills and iced her shoulder. The events 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 headaches was not resolved. The clinical outcome of the events soreness in arm, intense burning in arm, chills, overall body weakness, extreme muscle soreness and lack of strength was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm; Intense burning in arm; Chills; Overall body weakness; Extreme muscle soreness; Lack of strength; Headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12May2021 in the morning (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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, post vaccination in the morning, the patient immediately noticed soreness which gradually increased throughout the day. By the evening, arm was so sore that she could barely move her arm and when did so, she experienced intense burning and pain. She also experienced chills and overall body weakness which she understood was to be expected. However, she realized that the extreme muscle soreness and lack of strength she experienced was rare and which was why she felt compelled to report this. Additionally, since she had received the vaccine, she had noticed an increase in headaches. The patient prayed for healing. On 13May2021, by morning, her arm was only mildly sore and she felt normal a couple of days later. Therapeutic measures were taken as a result of events and included treatment with ibuprofen pills and iced her shoulder. The events 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 headaches was not resolved. The clinical outcome of the events soreness in arm, intense burning in arm, chills, overall body weakness, extreme muscle soreness and lack of strength was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Swelling
Clinical narrative: Swelling below the armpit in chest area; pain as in muscle or vein pull; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male 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 27May2021 at 12:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient previously received paracetamol (PARACITAMOL) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications included colecalciferol (VIT D) of dose 5000 international unit per day. 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 04Apr2021 at 11:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination the patient had not been tested for COVID-19. On 28May2021 the patient experienced swelling below the armpit in chest area and  pain as in muscle or vein pull. 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 swelling below the armpit in chest area and pain as in muscle or vein pull was recovering at the time of report.