chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: extreme fatigue; cramping for a couple of days; diarrhea; early period that's been much heavier and longerthan usual; early period that's been much heavier and longerthan usual; early period that's been much heavier and longerthan usual; This is a spontaneous report from a contactable consumer, the patient. A 34-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 11May2021 at 14:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food or other products. Concomitant medications included ethinylestradiol, norethisterone acetate (MICROGESTIN) and escitalopram oxalate (ESCITALOPRAM). 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 extreme fatigue along with cramping for a couple of days, diarrhoea then an early period that's been much heavier and longer than usual. 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 extreme fatigue, cramping for a couple of days, diarrhoea, early period that's been much heavier and longer were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: felt like I had lost body mass and I was flat as cardboard.; felt like an elephant was sitting on me; vivid, bizarre dreams; interrupted sleep; Sinking feeling at times; Feeling of having full blown viral infection; could not sleep well at all due to crazy body ache; could not sleep well at all due to crazy body ache; Fever 100.7F; massive fatigue; Every muscle ached; joint pain all over; persistent headache; shoulder pain; Neck pain; Distended Stomach; This is a spontaneous report from a contactable healthcare professional. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 14May2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included occasional migraines and the patient was allergic to penicillin and sulfa drugs. Concomitant medications included regular multivitamins (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. The patient previously took ciprofloxacin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 21Apr2021 at 10:30 (at the age of 52-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. On 14May2021 at 21:30, the patient experienced fever 100.7 degrees Fahrenheit for 24 hours and massive fatigue, every muscle ached, joint pain all over, persistent headache, shoulder and neck pain, distended stomach. On 14May2021, the first night, he could not sleep well at all due to crazy body ache. On 15May2021, as the fever subsided, the patient felt like he had lost body mass and he was flat as card board, also felt like an elephant was sitting on him for 36 hours. On 15May2021, the second night, the patient had very vivid, bizarre dreams, interrupted sleep and the same dreams continued after falling back to sleep, the patient felt sinking at times and felt of having full blown viral infection. 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. Therapeutic measure was taken for fever and included treatment with tylenol. The clinical outcome of the events fever and felt like an elephant was sitting were resolved on 15May2021 and 16May2021 respectively, while the clinical outcome of the events massive fatigue, every muscle ached, joint pain all over, persistent headache, shoulder and neck pain, distended stomach, crazy body ache, lost body mass, vivid, bizarre dreams, interrupted sleep, felt sinking at times and felt of having full blown viral infection were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Taste disorder
Clinical narrative: Altered taste; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179, expiration date: 31Aug2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date, the patient experienced altered taste and headache after a week and still going on. Patient did a COVID-19 test on an unspecified date and result was negative. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the events altered taste and headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus since first dose, similar to feel I have after driving long distances; 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 arm left on an unknown date in Mar2021 at 09:00 (at the age of 51-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 22Apr2021 at 09:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, high uric acid and penicillin allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously took codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. 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 26Mar2021, the patient experienced tinnitus since first dose which was similar what patient experienced after driving long distances. 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 event tinnitus since first dose which was similar to the patient had after driving long distances was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Wheezing
Clinical narrative: cough; wheezing; Major congestion; This is a spontaneous report from a contactable consumer, the patient. A 57-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 arm left on 13May2021 at 08:15(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included colecalciferol (manufacturer-VITAMIN D3), cyanocobalamin (manufacturer-VITAMIN B12), calcium (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN)and glucose (manufacturer-GLUCOS) and multivitamin all taken from an unknown date for 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. Since the vaccination, the patient had not been tested for COVID-19. On 14May2021 at 08:00 the patient experienced Major congestion(Nasal congestion), cough and wheezing. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Major congestion(nasal congestion)  cough and wheezing were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: has a fever; This is a spontaneous report from a contactable consumer (parent) reporting for her daughter (patient).  A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, patient experienced fever. Patient was scheduled for second dose on 14May2021, and her parent (reporter) wanted to know if she could postpone the appointment. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Joint swelling
Clinical narrative: Headache; Fatigue; Swollen knee joint; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0183) via an unspecified route of administration in the left arm on 10May2021 at 12:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL). Prior to vaccination, it was unknown whether 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 11May2021 at 13:00, the patient experienced headache, fatigue and swollen knee joint. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events headache and fatigue were recovered on an unknown date in May2021. The clinical outcome of the event swollen knee joint was not recovered (as of 6 days later as reported) at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Oropharyngeal pain, Rhinorrhoea, Vaccination site pain
Clinical narrative: Pain at injection site; Back pain; Extreme fatigue; Runny nose; Sore throat; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-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 arm left on 14May2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, hypothyroidism and depression. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication was unknown if ongoing. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. 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 15May2021 at 14:00, the patient experienced pain at the injection site, back pain, extreme fatigue, runny nose, sore throat. 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. The clinical outcome of the events pain at the injection site, back pain, extreme fatigue, runny nose, sore throat was recovering at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Pain, Skin burning sensation
Clinical narrative: Body aches; Immediately on injection arm burned from shoulder to elbow; Headache; Dizzy started late that night; Foggy started late that night; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the right arm on 15May2021 at 14:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Feb2021, the patient reported that due to COVID-19 she experienced loss of taste, loss of smell and long-term fatigue. 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 COVID-19 vaccination.  Concomitant medications included an intrauterine device- levonorgestrel (MIRENA) for an unknown indication form an unknown date. On 15May2021 at 14:00, the patient reported that her arm burned from shoulder to elbow immediately on injection. On 15May2021, the patient experienced headache and dizzy/foggy which started late that night. On 16May2021 at 07:15, the patient woke up from body aches and had to keep "stretching" like she had a fever but none was present. The patient reported that these events experienced after the vaccination felt similar to the events, she previously experienced when she had COVID-19. The patient hoped that after she got the vaccine, it would bring back her taste and smell and help with the long-term fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events headache and body aches and included treatment with ibuprofen which the patient took around midnight on 15Apr2021. The patient reported that she took ibuprofen and TYLENOL every 3 hours alternating. The clinical outcome of the events immediately on injection arm burned from shoulder to elbow, headache, dizzy/foggy and body aches was not resolved 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: Gait inability, Pain in extremity
Clinical narrative: stabbing pain in the opposite arm where shot was administered. The pain was in the upper arm in the same vacinity but on the other arm, a month later started to get stabbing pain in that same left arm, same location, and it is very painful; difficult to move and do things; This is a spontaneous report from a 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: EW0151) via an unspecified route of administration in the right arm on 15Apr2021 at 12:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications in two weeks of vaccination. 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 right arm on 24Mar2021 at 12:30 (at the age of 50-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. Initially within a few days of the second shot, the patient experienced stabbing pain in the opposite arm where shot was administered and the pain was in the upper arm in the same vacinity but on the other arm and had no other side effects and the pain went away in a few days. On 15May2021 at 20:00, now a month later, the patient experienced to get stabbing pain in that same left arm, same location, and it was very painful and difficult to move and do things and had a very high tolerance for pain but the fact that this was surfacing over a month later and with more pain than before was concerning. No therapeutic measures were taken as a result of reported events. 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 events stabbing pain in the opposite arm where shot was administered and the pain was in the upper arm in the same vacinity but on the other arm and had no other side effects and the pain went away in a few days. Now, a month later, started to get stabbing pain in that same left arm, same location, and it was very painful and was difficult to move and do things and had a very high tolerance for pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza, Nasal congestion, Nasopharyngitis
Clinical narrative: vomitting; cold; Diarrhea; I began experiencing symptoms of flu,; congestion; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0185) via an unspecified route of administration in the left arm on 09May2021 at 16:00(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, pre-diabetic and insect bite allergy. Concomitant medications included pharmacy. Prior to the vaccination, the patient had not been 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 COVID vaccine. On 11May2021, after two days of vaccination, the patient experienced symptoms of flu, congestion and headache. On 14May2021 after five days, experienced  strong headache and went to seek urgent care, they did a COVID-19 test and it was negative. On day seventh day, on 16May2021, the symptoms continued like vomiting, cold, diarrhea and severe headache. The patient went to urgent care again and got a check-up and was provided with an antibiotic. The events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken which included antibiotics for the reported events. On 14May2021, patient underwent a COVID-19 test and the result was negative. The clinical outcome of the events symptoms of flu, congestion, headache, vomiting, cold, and diarrhea was not recovered, at the time of this report.     No follow-up attempts are possible; No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: vomitting; cold; Diarrhea; I began experiencing symptoms of flu,; congestion; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0185) via an unspecified route of administration in the left arm on 09May2021 at 16:00(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, pre-diabetic and insect bite allergy. Concomitant medications included pharmacy. Prior to the vaccination, the patient had not been 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 COVID vaccine. On 11May2021, after two days of vaccination, the patient experienced symptoms of flu, congestion and headache. On 14May2021 after five days, experienced  strong headache and went to seek urgent care, they did a COVID-19 test and it was negative. On day seventh day, on 16May2021, the symptoms continued like vomiting, cold, diarrhea and severe headache. The patient went to urgent care again and got a check-up and was provided with an antibiotic. The events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken which included antibiotics for the reported events. On 14May2021, patient underwent a COVID-19 test and the result was negative. The clinical outcome of the events symptoms of flu, congestion, headache, vomiting, cold, and diarrhea was not recovered, at the time of this report.     No follow-up attempts are possible; No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash macular, Rash papular, Vaccination site erythema
Clinical narrative: little itchy bumps in left hand; little itchy bumps in left hand; finger was swollen and itchy; big red itch splotch; injection site is incredibly huge swollen and very red; injection site is incredibly huge swollen and very red; This is a spontaneous report from a contactable consumer, the patient. A 27-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 13May2021 at 16:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none that the patient knows of. Known allergies were reported as none that the patient knows of. 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 14May2021, the day after the patient got the shot, the patient started to get little itchy bumps in her left hand. The patient didn't think anything of it. On Saturday (as reported) the patient had to take off her wedding ring because her finger was swollen and itchy. The patient had a big red itch splotch on her ring finger with a few itchy bumps on her left hand and also her injection site was incredibly huge swollen and very red. 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 little itchy bumps in left hand, finger was swollen and itchy, big red itch splotch, injection site incredibly huge swollen and very red were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: little itchy bumps in left hand; little itchy bumps in left hand; finger was swollen and itchy; big red itch splotch; injection site is incredibly huge swollen and very red; injection site is incredibly huge swollen and very red; This is a spontaneous report from a contactable consumer, the patient. A 27-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 13May2021 at 16:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none that the patient knows of. Known allergies were reported as none that the patient knows of. 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 14May2021, the day after the patient got the shot, the patient started to get little itchy bumps in her left hand. The patient didn't think anything of it. On Saturday (as reported) the patient had to take off her wedding ring because her finger was swollen and itchy. The patient had a big red itch splotch on her ring finger with a few itchy bumps on her left hand and also her injection site was incredibly huge swollen and very red. 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 little itchy bumps in left hand, finger was swollen and itchy, big red itch splotch, injection site incredibly huge swollen and very red were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: My cycle, which is routinely 21-26 days has been 37 and 42 days.; Flow is also much heavier/ My periods are always 3 days. The last two have been 6 and 8 (and counting).; This is a spontaneous report from a contactable consumer, the patient. A 42-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 06Apr2021 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient also 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 12Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergy, hypertension. The patient had no known allergies. Concomitant medications included montelukast sodium (SINGULAIR), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC), fluticasone propionate; salmeterol xinafoate (ADVAIR), multivitamin (MANAFACTURER UNKNOWN) all from an unknown date for an 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. On 29Mar2021 at 00:00, the patient experienced periods had been affected by each dose. Her cycle which was routinely 21-26 days had been 37 and 42 days. periods were always 3 days. The last two have been 6 and 8 (and counting). The flow was also much heavier and the side effects more intense. The patient did not receive any treatment 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 cycle which was routinely 21-26 days had been 37 and 42 days, periods were always 3 days, the last two have been 6 and 8 (and counting), the flow was also much heavier and the side effects more intense was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vaccination site pain
Clinical narrative: Severe joint pain in both knees; Painful to bend and straighten legs; Soreness in vaccination location; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 12May2021 at 13:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included prediabetes, depression, graves' disease, dermatitis herpetiformis. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), and vitamin d nos (VITAMIN D) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the right arm on 21Apr2021 at 13:00 (at the age of 52-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. On 13May2021 at 12:00, the patient experienced severe joint pain in both knees starting the day after second shot. Same type of pain, same location. Painful to bend and straighten legs. Lasted for 3 days. Almost gone on fourth day. No other joint or muscle pain, other than soreness in injection location. The patient did not receive any treatment 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 events severe joint pain in both knees, Painful to bend and straighten legs, soreness in injection location was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Ear pain
Clinical narrative: Bad rash all over body; Dizziness; weakness; Jaw pain; Ear pain; Severe pain at injection site; Tiredness; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; injection site redness; nausea; Feeling unwell; Swollen lymph nodes under right arm; Headache; 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: ER8736) via an unspecified route of administration in the right arm on 14May2021 at 13:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient not had any allergies to medication, food or any other products. Concomitant medications included zinc (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) for unknown indications from unknown start dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 44-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 14May2021 at 21:00 the patient experienced bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm. The events did not result in doctor or other health care 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 events of bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: Bad rash all over body; Dizziness; weakness; Jaw pain; Ear pain; Severe pain at injection site; Tiredness; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; injection site redness; nausea; Feeling unwell; Swollen lymph nodes under right arm; Headache; 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: ER8736) via an unspecified route of administration in the right arm on 14May2021 at 13:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient not had any allergies to medication, food or any other products. Concomitant medications included zinc (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) for unknown indications from unknown start dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 44-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 14May2021 at 21:00 the patient experienced bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm. The events did not result in doctor or other health care 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 events of bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in jaw, Pyrexia, Rash, Vaccination site erythema
Clinical narrative: Bad rash all over body; Dizziness; weakness; Jaw pain; Ear pain; Severe pain at injection site; Tiredness; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; injection site redness; nausea; Feeling unwell; Swollen lymph nodes under right arm; Headache; 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: ER8736) via an unspecified route of administration in the right arm on 14May2021 at 13:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient not had any allergies to medication, food or any other products. Concomitant medications included zinc (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) for unknown indications from unknown start dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 44-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 14May2021 at 21:00 the patient experienced bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm. The events did not result in doctor or other health care 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 events of bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Bad rash all over body; Dizziness; weakness; Jaw pain; Ear pain; Severe pain at injection site; Tiredness; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; injection site redness; nausea; Feeling unwell; Swollen lymph nodes under right arm; Headache; 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: ER8736) via an unspecified route of administration in the right arm on 14May2021 at 13:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient not had any allergies to medication, food or any other products. Concomitant medications included zinc (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) for unknown indications from unknown start dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 22Apr2021 at 13:00 (at the age of 44-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 14May2021 at 21:00 the patient experienced bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm. The events did not result in doctor or other health care 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 events of bad rash all over body, dizziness, weakness, jaw pain, ear pain, severe pain at injection site, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling and redness, nausea, feeling unwell, swollen lymph nodes under right arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: The subject received his first shot at scheduled time from a female staff. During his 15 minutes observation period, another male staff gave him a second full dose shot by accident.; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) in the arm left on 15May2021 at 14:15 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. Prior to the vaccination, the patient had not been 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 15May2021 at 14:30, the patient had received first shot at scheduled time from a female staff. During the fifteen minutes observation period, another male staff gave a second full dose shot by accident. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of this event. The clinical outcome of the event medication error occurred as another male staff gave him a second full dose shot by accident was unknown at this time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Tiredness; Headache; Chills; 100.5 fever; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 15May2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient had no known allergies. The patient did not receive any concomitant medications. 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 16May2021 at 07:00 the patient experienced tiredness, headache, chills and 100.5 fever. Therapeutic measures were not taken as a result of these events. 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 events tiredness, headache, chills and 100.5 fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cerebral disorder, Dysarthria, Fatigue, Memory impairment
Clinical narrative: Balance off; Tiredness; Having trouble moving/Having trouble getting up and down; Sore arm at injection site; Having trouble speaking(Slurring words); Forgetfulness; Mushy brain; This is a spontaneous report from a contactable consumer.  A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 14:15 at age of 68-year-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included diabetic, chronic heart disease, chronic kidney failure, blood clot in lung. Known allergies included warfin. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021 04:45 PM, at age of 68-year-old in Right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); bumetanide (BUMEX); gabapentine (GABAPENTINE).  The patient experienced balance off, tiredness, having trouble moving/having trouble getting up and down, sore arm at injection site, having trouble speaking(Slurring words), forgetfulness, mushy brain on 14May2021 with outcome of not recovered. No treatment was received, the events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Vaccination site pain
Clinical narrative: Balance off; Tiredness; Having trouble moving/Having trouble getting up and down; Sore arm at injection site; Having trouble speaking(Slurring words); Forgetfulness; Mushy brain; This is a spontaneous report from a contactable consumer.  A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 14:15 at age of 68-year-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included diabetic, chronic heart disease, chronic kidney failure, blood clot in lung. Known allergies included warfin. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021 04:45 PM, at age of 68-year-old in Right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); bumetanide (BUMEX); gabapentine (GABAPENTINE).  The patient experienced balance off, tiredness, having trouble moving/having trouble getting up and down, sore arm at injection site, having trouble speaking(Slurring words), forgetfulness, mushy brain on 14May2021 with outcome of not recovered. No treatment was received, the events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable consumer, the patient. A 39-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 16Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Sep2020, the patient underwent nasal swab test for COVID-19 and the result was negative. 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 19Mar2021 at 16:00 (at the age of 39-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 30Apr2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included unspecified treatment. The clinical outcome of the event shingles was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.