chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching sensation on his nose; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for (reporter's son) that:   A 16-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (age at vaccination 16 years) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine on Monday and the next day he woke up with an itching sensation on his nose, when he scratched it caused a lot of bleeding on his nose, after cleaning up the patient and holding his nose with a towel the bleeding stopped 5 minutes later. They were worried because something like that never happened before. Since the patient had an appointment to receive the second dose in two weeks caller wants to know if they should discuss this with the vaccination provider. No reports of nose bleeding after receiving the vaccination, referred to his physician for treatment recommendation. This does not mean the medication could not cause this but it was not something reported in the information of the product. The outcome if event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness all over her body; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 23-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EW0183, Expiration date: was not reported) via an unspecified route of administration, administered in right arm, on 19May2021, at 08:00 (at the age of 23-year-old), as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 19May2021, after vaccination patient experienced Itchiness all over her body. The patient stated, she does not have rash or anything, but her body has been itching for the past 10 hours. The patient stated, she does not know if that was an effect or that's normal, she would like to know. As reported, the patient got the first dose today (19May2021) this early morning and after three hours the patient experienced itchiness all over her body. The outcome of event itchiness all over her body was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Odynophagia
Clinical narrative: Woke up in the middle of the night with a very terrible chest pain with a tight pressure; Woke up in the middle of the night with a very terrible chest pain with a tight pressure; Hurt like when I swallow eating they hurt; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: ER8729) as DOSE 1, SINGLE for covid-19 immunisation..The patient medical history and concomitant medications was not reported. The patient experienced woke up in the middle of the night with a very terrible chest pain with a tight pressure causing chest pain on an unspecified date with outcome of unknown, woke up in the middle of the night with a very terrible chest pain with a tight pressure with  chest discomfort on an unspecified date with outcome of unknown, hurt like when she swallow eating they hurt causing odynophagia on an unspecified date with outcome of unknown.  No Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: Delayed hypersensitivity reaction after 1st Covid immunization. Swelling of eyes, numbness around mouth 40 minutes after vaccine; Swelling of eyes / swelling around eyes; Numbness around mouth; This is a spontaneous report from contactable consumer (patient, self-reported).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and dose 2, single for COVID-19 immunization. Medical history included that the patient had appt with allergist and peg allergy was confirmed. Concomitant medications were not reported. The patient experienced delayed hypersensitivity reaction after 1st Covid immunization, swelling of eyes, numbness around mouth 40 minutes after vaccine on an unspecified date. Took Benadryl prior to second shot and symptoms limited to swelling around eyes. The patient received treatment for the events with Benadryl. Outcome of the events were unknown.  Information about lot/batch number has been requested. No follow-up attempts are completed, information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Inappropriate schedule of product administration, SARS-CoV-2 test, Vomiting
Clinical narrative: Violent vomiting; Extreme body weakness; Inappropriate schedule of vaccine administered to Dose 1: 28May2021; Dose 2: 11Jun2021; This is a spontaneous report from a non-contactable nurse, the patient. A 35-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 11Jun2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 28May2021 at 16:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 13Jun2021 at 02:30, the patient experienced violent vomiting and extreme body weakness. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with medicine which was unspecified. Since the vaccination, the patient had been tested for COVID-19. On 13Jun2021, the patient underwent nasal swab, SARS CoV-2 test and the result was negative. The clinical outcome of the events violent vomiting and extreme body weakness were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen lymph node in my left armpit which has been causing pain all day if arm is at side; Fever 100.6 one day after vaccine; Extreme fatigue resulting in having difficulty caring for my children; Sore arm; Headache; Back pain; Neck pain; Nausea roughly an hour after vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 14Jun2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received clarithromycin (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy. The patient previously 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 24May2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 14Jun2021 at 18:30, roughly an hour after vaccination, the patient experienced nausea. On 15Jun2021, one day after vaccination, the patient experienced fever of 100.6, extreme fatigue which resulted in having difficulty caring for her children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. These effects only lasted about 24 hours. On 16Jun2021, the next day, the patient awoke with a swollen lymph node in her left armpit which had been causing pain all day, if her arm was at her side. It required ibuprofen and cold compresses to treat. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 nausea was resolved on 15Jun2021 at 18:30 while fever 100.6, extreme fatigue, sore arm, headache, back and neck pain were resolved on 16Jun2021. The clinical outcome of the swollen lymph node in her left armpit which had been causing pain all day was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Swollen lymph node in my left armpit which has been causing pain all day if arm is at side; Fever 100.6 one day after vaccine; Extreme fatigue resulting in having difficulty caring for my children; Sore arm; Headache; Back pain; Neck pain; Nausea roughly an hour after vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 14Jun2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received clarithromycin (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy. The patient previously 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 24May2021 at 17:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 14Jun2021 at 18:30, roughly an hour after vaccination, the patient experienced nausea. On 15Jun2021, one day after vaccination, the patient experienced fever of 100.6, extreme fatigue which resulted in having difficulty caring for her children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. These effects only lasted about 24 hours. On 16Jun2021, the next day, the patient awoke with a swollen lymph node in her left armpit which had been causing pain all day, if her arm was at her side. It required ibuprofen and cold compresses to treat. The events did not result in a visit to the doctors or other healthcare professional office/clinic, 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 nausea was resolved on 15Jun2021 at 18:30 while fever 100.6, extreme fatigue, sore arm, headache, back and neck pain were resolved on 16Jun2021. The clinical outcome of the swollen lymph node in her left armpit which had been causing pain all day was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Extremely heavy menstrual period since my 1st dose.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to antibiotics since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 the patient experienced extremely heavy menstrual period since her 1st dose. 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. Therapeutic measures were not taken for the event. The clinical outcome of the event extremely heavy menstrual period since her 1st dose was unknown at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Mar2021 at 08:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to tree nut fruit (apples). The patient previously took codeine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication  and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jun2021, the patient began bleeding through a pad and a pair of period panties every two hours the first two days and every four hours the last day. The blood was thin, bright red and had many chunks, which is not usual to the browner thicker and chunk less period she had. She normally had a very light three day period. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event began bleeding through a pad and a pair of period panties every two hours the first two days and every four hours the last day, the blood was thin, bright red and had many chunks was resolved on an unknown date in Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Irregular menstrual period; spotting, which has never occurred to her before. Both of her menstrual periods since time of vaccination have been irregular, preceded by and followed by spotting; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 18May2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 08Jun2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included social anxiety disorder. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included mirtazapine (REMERON) for an unknown indication from an unknown date and unknown if ongoing. On an unknown date in May2021, the patient experienced irregular menstrual period and spotting, which has never occurred to her before. Both of her menstrual periods since time of vaccination have been irregular, preceded by and followed by spotting. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular menstrual period and spotting, which has never occurred to her before. Both of her menstrual periods since time of vaccination have been irregular, preceded by and followed by spotting was unknown at the time of this report.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain in center of chest along with sternum popping; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sour cream and certain pain killers. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control received within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 03May2021, the patient experienced chest pain in center of chest along with sternum popping. The event had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event chest pain in center of chest along with sternum popping was not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intermenstrual bleeding, Irritability, Menstruation delayed, Muscle spasms
Clinical narrative: Late period; Spotting between periods; Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 01May2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 12Jun2021, the patient had late period, spotting between periods and increased PMS (Premenstrual syndrome) symptoms (severe nausea, cramps, fatigue, irritability). The events did not result in doctor/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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events late period, spotting between periods and increased PMS (Premenstrual syndrome) symptoms (severe nausea, cramps, fatigue, irritability) were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Premenstrual syndrome
Clinical narrative: Late period; Spotting between periods; Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); Increased PMS symptoms (severe nausea, cramps, fatigue, irritability); This is a spontaneous report from a non-contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 01May2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 12Jun2021, the patient had late period, spotting between periods and increased PMS (Premenstrual syndrome) symptoms (severe nausea, cramps, fatigue, irritability). The events did not result in doctor/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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events late period, spotting between periods and increased PMS (Premenstrual syndrome) symptoms (severe nausea, cramps, fatigue, irritability) were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: "I" have gone months without having a period/ "I" am back to not having period; then went one month having two really heavy periods in the same month; Gone months without having a period, and then went one month having two really heavy periods in the same month.; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 13Feb2021 at 07:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history included allergy to latex and sulfonamide. 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. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 23Jan2021 at 07:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had gone months without having a period and then on an unknown date in 2021, one month, the patient went having two really heavy periods in the same month and at the time of report she was back to not having a period. The patient reported that she had not been sexually active in the months prior receiving the vaccines and in the months following the vaccine so she knew it was not pregnancy/STI (Sexually transmitted infections) related. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events months without having a period, heavy periods in the same month and went one month having two really heavy periods in the same month were unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Vomiting; Mild Fever; Headache/Dizziness; Headache/Dizziness; Severe waves of nausea; Congestion (feels like sinus infection); Severe sore throat; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 03Jun2021 at 17:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 24Jun2021 at 17:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included birth control  for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021, (12-24 hours later), the patient experienced vomiting and mild fever. On an unknown date in Jun2021 (12-92 plus hours later), the patient experienced headache/dizziness. On an unknown date in Jun2021 (12-96 plus hours later), the patient experienced severe waves of nausea. On an unknown date in Jun2021 (24-92 plus hours later), the patient experienced congestion (felt like sinus infection). On an unknown date in Jun2021 (24-96 plus hours later), the patient experienced severe sore throat. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, mild fever, headache/dizziness, severe waves of nausea, congestion (feltlike sinus infection) and severe sore throat was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Vomiting
Clinical narrative: Vomiting; Mild Fever; Headache/Dizziness; Headache/Dizziness; Severe waves of nausea; Congestion (feels like sinus infection); Severe sore throat; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 03Jun2021 at 17:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 24Jun2021 at 17:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included birth control  for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021, (12-24 hours later), the patient experienced vomiting and mild fever. On an unknown date in Jun2021 (12-92 plus hours later), the patient experienced headache/dizziness. On an unknown date in Jun2021 (12-96 plus hours later), the patient experienced severe waves of nausea. On an unknown date in Jun2021 (24-92 plus hours later), the patient experienced congestion (felt like sinus infection). On an unknown date in Jun2021 (24-96 plus hours later), the patient experienced severe sore throat. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting, mild fever, headache/dizziness, severe waves of nausea, congestion (feltlike sinus infection) and severe sore throat was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Amenorrhoea
Clinical narrative: It is been 44 days since my last dose and I still have not had my cycle.; I have belly pain constantly like I am going menstruate but did not; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 15May2021 at 13:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 13:45, (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 15May2021 at 13:45, she got her last dose and its been 44 days she still had not got her cycle. She had belly pain constantly like she was going to menstruate but did not. 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 the events she still had not got her cycle and belly pain constantly like she was going to menstruate but did not were not resolved at the time of this report.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Shortness of breath; Heart racing; Tightness in chest; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 09Jun2021 at 16:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included isotretinoin (MYORISAN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 15Jun2021 at 03:00, the patient experienced shortness of breath, heart racing and tightness in chest. The events 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. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events shortness of breath, heart racing and tightness in chest were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Palpitations
Clinical narrative: Heart palpitations; Pressure in chest when exercising; Pain in chest when exercising; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration  in the left arm on 18Jun2021 at 09:00(at the age of 26-years-old) as a single dose for COVID-19 immunisation. No medical history or known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication of the patient included finasteride (MANUFACTURER UNKNOWN); on an unknown date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jul2021, at 10:00, the patient experienced heart palpitations, pressure and pain in chest when exercising.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events heart palpitations, pressure in chest when exercising and pain in chest when exercising was not resolved at the time of this report.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Feeling abnormal, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: About a week after the 2nd shot. Ibegan to experience headaches that lasted all day; Felt like I was walking through a fog; A few days later my left legs went numb; I was walking with family when it happened and I stumbled; The next day my leg hurt, leg just stopped working; I think I pulled a muscle when I stumbled; Mild depression; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 26Jun2021 at 13:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 03Jun2021 at 14:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 02Jul2021, about a week after the 2nd shot, the patient began to experience headache that lasted all day and the patient felt like she was walking through a fog. A few days later, on an unknown date in Jul2021, her left leg went numb. It was numb for 2 days and went back to normal. It went numb again and had been for most of the day when her leg just stopped working. She was walking with family when it happened and stumbled. The next day her leg hurt. She thought she pulled a muscle when she stumbled. Her headache, foggyness, mild depression and numb left leg continued to be an issue at the time of report, 16 days after the 2nd shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache that lasted all day, the patient felt like was walking through a fog, left leg went numb and had been for most of the day when her leg just stopped working, stumbled and mild depression was not resolved at the time of this report.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity
Clinical narrative: About a week after the 2nd shot. Ibegan to experience headaches that lasted all day; Felt like I was walking through a fog; A few days later my left legs went numb; I was walking with family when it happened and I stumbled; The next day my leg hurt, leg just stopped working; I think I pulled a muscle when I stumbled; Mild depression; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 26Jun2021 at 13:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 03Jun2021 at 14:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. On 02Jul2021, about a week after the 2nd shot, the patient began to experience headache that lasted all day and the patient felt like she was walking through a fog. A few days later, on an unknown date in Jul2021, her left leg went numb. It was numb for 2 days and went back to normal. It went numb again and had been for most of the day when her leg just stopped working. She was walking with family when it happened and stumbled. The next day her leg hurt. She thought she pulled a muscle when she stumbled. Her headache, foggyness, mild depression and numb left leg continued to be an issue at the time of report, 16 days after the 2nd shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache that lasted all day, the patient felt like was walking through a fog, left leg went numb and had been for most of the day when her leg just stopped working, stumbled and mild depression was not resolved at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Dysmenorrhoea, Menstruation irregular
Clinical narrative: Irregular menstrual cycle; Extreme abdominal cramping and pain; Absent period; This is a spontaneous report from a non-contactable consumer, the patient. A 38-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 27May2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 06May2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 11Jun2021 at 08:00, the patient experienced irregular menstrual cycle, extreme abdominal cramping and pain and absent period. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as result of events. The clinical outcome of the events irregular menstrual cycle, extreme abdominal cramping and pain, absent period was unknown 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Constipation, Diverticulitis, Dyspepsia, Gastrooesophageal reflux disease
Clinical narrative: It's led to diverticulosis inflammation in my large and small intestine extreme constipation; Gastrointestinal issues, I have GERD now; I have extreme constipation; My stomach swelled up; My stomach is not digesting food properly; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIOTNECH COVID-19 VACCINE, lot number EW0191), administered in right arm on 08Jun2021 12:00 PM (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. Vaccine facility type was reported as pharmacy or drug store. The patient's medical history included epilepsy, and hernia from unspecified date. The patient had not COVID prior vaccination. No known allergies were reported. The patient's concomitant medications included lamotrigine and zonisamide, both from unspecified date. It was unknown if patient received other vaccine within four weeks. Patient experienced gastrointestinal issues. He had GERD now (as reported). He had extreme constipation. A lot of people reporting gastrointestinal issues after vaccination. His stomach swelled up. He had to go to the emergency room. His stomach was not digesting food properly. Anything he ate seemed to hurt his stomach now (as reported). He had taken his prescribed medications for years this only occurred after this vaccine was taken. It was led to diverticulosis inflammation in his large and small intestine extreme constipation, and it seemed like there was no end in sight. He was going to wither away because eating only made things worse, or his stomach was going to rupture because no matter how much fiber or polyethylene glycol (MIRALAX) ingest his stomach was not doing what it was supposed to do. The adverse events onset date was reported as 21Jun2021 at 02:30 PM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received due to the events included pregabalin (LYRICA), MIRALAX and ibuprofen. Patient was not tested for COVID since vaccination. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Generalised tonic-clonic seizure, Urinary tract infection
Clinical narrative: Feeling hot; Grand Mal Seizure/ seizure w/ Injuries requiring stitcher; Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure/ seizure w/ Injuries requiring stitcher) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure/ seizure w/ Injuries requiring stitcher) (seriousness criterion medically significant) and URINARY TRACT INFECTION (Urinary Tract Infection). On an unknown date, the patient experienced FEELING HOT (Feeling hot). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (Grand Mal Seizure/ seizure w/ Injuries requiring stitcher), URINARY TRACT INFECTION (Urinary Tract Infection) and FEELING HOT (Feeling hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. The patient felt hot, and after that remembered being strapped to a stretcher and getting oxygen put in her nose. On 30-Aug-2021, she done with UTI test three times where result were unknown. On 20-Oct-2021, she had seizure with injuries requiring stitches.  Company Comment :  This case refers to a 43-year-old female patient with no relevant medical history who experienced the unexpected event of Generalized Tonic -Clonic Seizure approximately 25 days after the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as the event occurred after the first dose. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow up received on 04-SEP-2021 contains No new information. However, updated reporter type to Non-Health Professional, missed in earlier step. On 22-Oct-2021: Follow-up received on 22-Oct-2021 included updated Adverse event.; Sender's Comments: This case refers to a 43-year-old female patient with no relevant medical history who experienced the unexpected event of Generalized Tonic -Clonic Seizure approximately 25 days after the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as the event occurred after the first dose. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.