chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Headache, Illness
Clinical narrative: abdominal pain; ill; faints during the swimming practice/ faints during the swimming practice; chest pain; fever; headache; neck pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on unspecified date in Jul2021 (at the age of 12 years) as dose 2, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. No covid prior vaccination. No Known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously patient took first dose of BNT162B2 (lot number: EW0196) on 09Jul2021 24:00 PM (at the age of 12 years), administered in Left arm as dose 1, single for COVID-19 immunisation and experienced fever, headache, chest pain and difficulty in breathing. The patient experienced fever, headache and neck pain on 31Jul2021, chest pain on 01Aug2021, difficulty breathing on unspecified date in 2021, faints during the swimming practice/ faints during the swimming practice on 27Oct2021 18:00, abdominal pain and ill on 28Oct2021. Seriousness criteria-Disabling/Incapacitating. It was reported that on the second day 31Jul2021, patient had a fever, neck pain, and headache. He slept for more than 24 hours. After he wakes up, he complained of chest pain and difficulty breathing. Since then he had chest pain and difficulty breathing till now. About 18:00 pm on 27Oct2021, he faints during the swimming practice/ faints during the swimming practice. At about 11:30 am on 28Oct2021, he experiences severe abdominal pain at school and is sent back home earlier. Since then he was very ill and has not been able to return to school. On the night of 05Nov2021, again he faints in the middle of the running 1/2 miles. Adverse events resulted in healthcare professional office visit and Emergency room visit. No covid tested post vaccination. No treatment was received. The clinical outcome of the events was unknown for fever, headache, neck pain, faints during the swimming practice/ faints during the swimming practice, abdominal pain, ill; not recovered for chest pain and difficulty breathing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Pyrexia, Syncope
Clinical narrative: abdominal pain; ill; faints during the swimming practice/ faints during the swimming practice; chest pain; fever; headache; neck pain; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on unspecified date in Jul2021 (at the age of 12 years) as dose 2, single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. No covid prior vaccination. No Known allergies were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Previously patient took first dose of BNT162B2 (lot number: EW0196) on 09Jul2021 24:00 PM (at the age of 12 years), administered in Left arm as dose 1, single for COVID-19 immunisation and experienced fever, headache, chest pain and difficulty in breathing. The patient experienced fever, headache and neck pain on 31Jul2021, chest pain on 01Aug2021, difficulty breathing on unspecified date in 2021, faints during the swimming practice/ faints during the swimming practice on 27Oct2021 18:00, abdominal pain and ill on 28Oct2021. Seriousness criteria-Disabling/Incapacitating. It was reported that on the second day 31Jul2021, patient had a fever, neck pain, and headache. He slept for more than 24 hours. After he wakes up, he complained of chest pain and difficulty breathing. Since then he had chest pain and difficulty breathing till now. About 18:00 pm on 27Oct2021, he faints during the swimming practice/ faints during the swimming practice. At about 11:30 am on 28Oct2021, he experiences severe abdominal pain at school and is sent back home earlier. Since then he was very ill and has not been able to return to school. On the night of 05Nov2021, again he faints in the middle of the running 1/2 miles. Adverse events resulted in healthcare professional office visit and Emergency room visit. No covid tested post vaccination. No treatment was received. The clinical outcome of the events was unknown for fever, headache, neck pain, faints during the swimming practice/ faints during the swimming practice, abdominal pain, ill; not recovered for chest pain and difficulty breathing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: I lost my consciousness and collapsed; collapsed; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old male patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 05Nov2021 (at the age of 55-year-old) (Batch/Lot Number: FH8030) as dose 3 (booster), single for COVID-19 immunisation, administered at Pharmacy or Drug Store.  Medical history included diabetes mellitus. No known allergies. The patient's concomitant medications were not reported. Historical vaccina included: MODERNA COVID-19 VACCINE (MODERNA COVID-19 VACCINE), dose 1 on an unknown date (Batch/Lot Number: 038AZ1A), dose 1 on an unknown date (Batch/Lot Number: 004MZ0A) for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. The patient lost his consciousness (medically significant) on 06Nov2021 13:00 with outcome of recovering, collapsed (medically significant) on 06Nov2021 13:00 with outcome of recovering.  No treatment received. Covid was not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Peripheral circulatory failure
Clinical narrative: I lost my consciousness and collapsed; collapsed; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old male patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 05Nov2021 (at the age of 55-year-old) (Batch/Lot Number: FH8030) as dose 3 (booster), single for COVID-19 immunisation, administered at Pharmacy or Drug Store.  Medical history included diabetes mellitus. No known allergies. The patient's concomitant medications were not reported. Historical vaccina included: MODERNA COVID-19 VACCINE (MODERNA COVID-19 VACCINE), dose 1 on an unknown date (Batch/Lot Number: 038AZ1A), dose 1 on an unknown date (Batch/Lot Number: 004MZ0A) for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. The patient lost his consciousness (medically significant) on 06Nov2021 13:00 with outcome of recovering, collapsed (medically significant) on 06Nov2021 13:00 with outcome of recovering.  No treatment received. Covid was not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood test, Colitis, Colonoscopy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200), via an unspecified route of administration on 10Mar2021 13: 15 (age at vaccination: 52 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported and had known allergies to Augmentin, Penicillin, lactose intolerance, mild allergy of eggplant & food ingredients. other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications in two weeks included OTC multivitamin one per day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269), dose 1 via an unspecified route of administration on 17Feb2021 01:15 PM (at the age of 52 years) as DOSE 1, SINGLE for COVID-19 immunisation and experienced I noticed minor digestive problems before the 2nd shot. It was reported that Four days after the 2nd shot (on 15Mar2021), he noticed severe digestive problems. Every time he eat or drink anything other than water, he got stomach ache. His bowl movement increases from 1 per day before the 2nd shot to 2-3 per day. He also was having excessive stomach gas. During every bowl movement, his stool was neither hard nor liquid but it was little soft and would come out in many chunks instead of a few large pieces. He started to loose weight very fast. In the next 10 days (around 25Mar2021), he lost 12 lbs (122 lbs to 110 lbs). This may be because he couldn't digest my food and he was eating much less because of fear. He was feeling much weaker and tired even though he was resting most of the time except going to work full time which wasn't physically challenging.  The events resulted in Doctor or other healthcare Professional office/clinic visit. The lab test included Weight lost 12 lbs (I lost 12 lbs (122 lbs to 110 lbs)) on 24Mar2021. Therapeutic measures were taken as a result of events and included medications. The outcome of events was resolving.No follow-up attempts are needed. No further information is expected
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Faeces soft, Fatigue, Fear, Flatulence, Frequent bowel movements
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200), via an unspecified route of administration on 10Mar2021 13: 15 (age at vaccination: 52 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported and had known allergies to Augmentin, Penicillin, lactose intolerance, mild allergy of eggplant & food ingredients. other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications in two weeks included OTC multivitamin one per day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269), dose 1 via an unspecified route of administration on 17Feb2021 01:15 PM (at the age of 52 years) as DOSE 1, SINGLE for COVID-19 immunisation and experienced I noticed minor digestive problems before the 2nd shot. It was reported that Four days after the 2nd shot (on 15Mar2021), he noticed severe digestive problems. Every time he eat or drink anything other than water, he got stomach ache. His bowl movement increases from 1 per day before the 2nd shot to 2-3 per day. He also was having excessive stomach gas. During every bowl movement, his stool was neither hard nor liquid but it was little soft and would come out in many chunks instead of a few large pieces. He started to loose weight very fast. In the next 10 days (around 25Mar2021), he lost 12 lbs (122 lbs to 110 lbs). This may be because he couldn't digest my food and he was eating much less because of fear. He was feeling much weaker and tired even though he was resting most of the time except going to work full time which wasn't physically challenging.  The events resulted in Doctor or other healthcare Professional office/clinic visit. The lab test included Weight lost 12 lbs (I lost 12 lbs (122 lbs to 110 lbs)) on 24Mar2021. Therapeutic measures were taken as a result of events and included medications. The outcome of events was resolving.No follow-up attempts are needed. No further information is expected
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal disorder, Weight decreased, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200), via an unspecified route of administration on 10Mar2021 13: 15 (age at vaccination: 52 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported and had known allergies to Augmentin, Penicillin, lactose intolerance, mild allergy of eggplant & food ingredients. other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications in two weeks included OTC multivitamin one per day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269), dose 1 via an unspecified route of administration on 17Feb2021 01:15 PM (at the age of 52 years) as DOSE 1, SINGLE for COVID-19 immunisation and experienced I noticed minor digestive problems before the 2nd shot. It was reported that Four days after the 2nd shot (on 15Mar2021), he noticed severe digestive problems. Every time he eat or drink anything other than water, he got stomach ache. His bowl movement increases from 1 per day before the 2nd shot to 2-3 per day. He also was having excessive stomach gas. During every bowl movement, his stool was neither hard nor liquid but it was little soft and would come out in many chunks instead of a few large pieces. He started to loose weight very fast. In the next 10 days (around 25Mar2021), he lost 12 lbs (122 lbs to 110 lbs). This may be because he couldn't digest my food and he was eating much less because of fear. He was feeling much weaker and tired even though he was resting most of the time except going to work full time which wasn't physically challenging.  The events resulted in Doctor or other healthcare Professional office/clinic visit. The lab test included Weight lost 12 lbs (I lost 12 lbs (122 lbs to 110 lbs)) on 24Mar2021. Therapeutic measures were taken as a result of events and included medications. The outcome of events was resolving.No follow-up attempts are needed. No further information is expected
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Dyspepsia, Fatigue, Flatulence
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200), via an unspecified route of administration on 10Mar2021 13: 15 (age at vaccination: 52 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported and had known allergies to Augmentin, Penicillin, lactose intolerance, mild allergy of eggplant & food ingredients. other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications in two weeks included OTC multivitamin one per day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269), dose 1 via an unspecified route of administration on 17Feb2021 01:15 PM (at the age of 52 years) as DOSE 1, SINGLE for COVID-19 immunisation and experienced I noticed minor digestive problems before the 2nd shot. It was reported that Four days after the 2nd shot (on 15Mar2021), he noticed severe digestive problems. Every time he eat or drink anything other than water, he got stomach ache. His bowl movement increases from 1 per day before the 2nd shot to 2-3 per day. He also was having excessive stomach gas. During every bowl movement, his stool was neither hard nor liquid but it was little soft and would come out in many chunks instead of a few large pieces. He started to loose weight very fast. In the next 10 days (around 25Mar2021), he lost 12 lbs (122 lbs to 110 lbs). This may be because he couldn't digest my food and he was eating much less because of fear. He was feeling much weaker and tired even though he was resting most of the time except going to work full time which wasn't physically challenging.  The events resulted in Doctor or other healthcare Professional office/clinic visit. The lab test included Weight lost 12 lbs (I lost 12 lbs (122 lbs to 110 lbs)) on 24Mar2021. Therapeutic measures were taken as a result of events and included medications. The outcome of events was resolving.No follow-up attempts are needed. No further information is expected
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Frequent bowel movements, Weight, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200), via an unspecified route of administration on 10Mar2021 13: 15 (age at vaccination: 52 years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported and had known allergies to Augmentin, Penicillin, lactose intolerance, mild allergy of eggplant & food ingredients. other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient Concomitant medications in two weeks included OTC multivitamin one per day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269), dose 1 via an unspecified route of administration on 17Feb2021 01:15 PM (at the age of 52 years) as DOSE 1, SINGLE for COVID-19 immunisation and experienced I noticed minor digestive problems before the 2nd shot. It was reported that Four days after the 2nd shot (on 15Mar2021), he noticed severe digestive problems. Every time he eat or drink anything other than water, he got stomach ache. His bowl movement increases from 1 per day before the 2nd shot to 2-3 per day. He also was having excessive stomach gas. During every bowl movement, his stool was neither hard nor liquid but it was little soft and would come out in many chunks instead of a few large pieces. He started to loose weight very fast. In the next 10 days (around 25Mar2021), he lost 12 lbs (122 lbs to 110 lbs). This may be because he couldn't digest my food and he was eating much less because of fear. He was feeling much weaker and tired even though he was resting most of the time except going to work full time which wasn't physically challenging.  The events resulted in Doctor or other healthcare Professional office/clinic visit. The lab test included Weight lost 12 lbs (I lost 12 lbs (122 lbs to 110 lbs)) on 24Mar2021. Therapeutic measures were taken as a result of events and included medications. The outcome of events was resolving.No follow-up attempts are needed. No further information is expected
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old) passed out; Vomited a few times; Skin was very pale and yellow; Skin was very pale and yellow; 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old); 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old); This is a spontaneous report from a contactable consumer (patient's parent). An 8-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 8-years, on 07Nov2021 15:30 (Lot Number: FK5127) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. No known allergies. Patient was not pregnant. Concomitant medications included influenza vaccine (FLU SHOT) at arm taken for an unspecified indication on 08Oct2021. And the patient received medications within 2 weeks of vaccination: Kids multi + Probiotic daily vitamin, vita fusion kids Elderberry. 5 minutes after injection of 1st dose of Covid vaccine my daughter (8 years old) passed out. She woke minutes later and vomited a few times. Skin was very pale and yellow. Took her to hospital by ambulance and they checked her all out and she was OK to be discharged. Adverse event start date reported as at 15:45 on 07Nov2021. The adverse events result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". There was no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Off label use, Pallor, Product use issue, Vomiting
Clinical narrative: 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old) passed out; Vomited a few times; Skin was very pale and yellow; Skin was very pale and yellow; 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old); 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old); This is a spontaneous report from a contactable consumer (patient's parent). An 8-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 8-years, on 07Nov2021 15:30 (Lot Number: FK5127) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. No known allergies. Patient was not pregnant. Concomitant medications included influenza vaccine (FLU SHOT) at arm taken for an unspecified indication on 08Oct2021. And the patient received medications within 2 weeks of vaccination: Kids multi + Probiotic daily vitamin, vita fusion kids Elderberry. 5 minutes after injection of 1st dose of Covid vaccine my daughter (8 years old) passed out. She woke minutes later and vomited a few times. Skin was very pale and yellow. Took her to hospital by ambulance and they checked her all out and she was OK to be discharged. Adverse event start date reported as at 15:45 on 07Nov2021. The adverse events result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". There was no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Yellow skin
Clinical narrative: 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old) passed out; Vomited a few times; Skin was very pale and yellow; Skin was very pale and yellow; 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old); 5 minutes after injection of 1st dose of Covid vaccine my daughter(8 years old); This is a spontaneous report from a contactable consumer (patient's parent). An 8-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 8-years, on 07Nov2021 15:30 (Lot Number: FK5127) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. No known allergies. Patient was not pregnant. Concomitant medications included influenza vaccine (FLU SHOT) at arm taken for an unspecified indication on 08Oct2021. And the patient received medications within 2 weeks of vaccination: Kids multi + Probiotic daily vitamin, vita fusion kids Elderberry. 5 minutes after injection of 1st dose of Covid vaccine my daughter (8 years old) passed out. She woke minutes later and vomited a few times. Skin was very pale and yellow. Took her to hospital by ambulance and they checked her all out and she was OK to be discharged. Adverse event start date reported as at 15:45 on 07Nov2021. The adverse events result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". There was no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Dyspnoea, Wheezing
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 14:30 (Lot Number: ER8735) (at age of 36-year-old) as DOSE 1, SINGLE for Covid-19 immunisation.  Medical history included Chronic migraines and epilepsy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included zonisamide (ZONISAMIDE); sumatriptan (SUMATRIPTAN); and diclofenac potassium (CAMBIA).  The patient previously took lamotrigine and experienced allergy. The patient experienced anaphylactic shock (medically significant) on 16Apr2021 with outcome of recovered in 2021. The adverse event result in emergency room/department or urgent care. Therapeutic measures were taken as a result of anaphylactic shock includes: 2 nebulizer treatments, IV benadryl and nausea med.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Apr2021 14:30 (Lot Number: ER8735) (at age of 36-year-old) as DOSE 1, SINGLE for Covid-19 immunisation.  Medical history included Chronic migraines and epilepsy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included zonisamide (ZONISAMIDE); sumatriptan (SUMATRIPTAN); and diclofenac potassium (CAMBIA).  The patient previously took lamotrigine and experienced allergy. The patient experienced anaphylactic shock (medically significant) on 16Apr2021 with outcome of recovered in 2021. The adverse event result in emergency room/department or urgent care. Therapeutic measures were taken as a result of anaphylactic shock includes: 2 nebulizer treatments, IV benadryl and nausea med.   Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Blood test, Chest pain, Decreased appetite
Clinical narrative: tension headache since vaccine (5 months); esophagus issues; chest discomfort/pain; chest discomfort/pain; throat irritated; can't eat (lost 10 pounds); can't eat (lost 10 pounds); pain in groin area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the right arm on 17May2021 12:00 (at the age of 19-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies to penicillin, HALDOL, legumes and soy, EOS 3 years prior the report, in 2018. The patient had not Covid prior vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient experienced tension headache since vaccine (5 months), esophagus issues, chest discomfort/pain, throat irritated, could not eat (lost 10 pounds) and pain in groin area on 31May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious due to disability or permanent damage. Many medications were received in response to the events. The patient was tested for COVID post vaccination via nasal swab, rapid test on 10Aug2021, that resulted negative. The patient then received the second dose of BNT162b2 in the right arm on 07Jun2021 at 12:00 for COVID-19 immunisation. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear, nose and throat examination, Endoscopy, Groin pain, Magnetic resonance imaging, Ophthalmological examination
Clinical narrative: tension headache since vaccine (5 months); esophagus issues; chest discomfort/pain; chest discomfort/pain; throat irritated; can't eat (lost 10 pounds); can't eat (lost 10 pounds); pain in groin area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the right arm on 17May2021 12:00 (at the age of 19-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies to penicillin, HALDOL, legumes and soy, EOS 3 years prior the report, in 2018. The patient had not Covid prior vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient experienced tension headache since vaccine (5 months), esophagus issues, chest discomfort/pain, throat irritated, could not eat (lost 10 pounds) and pain in groin area on 31May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious due to disability or permanent damage. Many medications were received in response to the events. The patient was tested for COVID post vaccination via nasal swab, rapid test on 10Aug2021, that resulted negative. The patient then received the second dose of BNT162b2 in the right arm on 07Jun2021 at 12:00 for COVID-19 immunisation. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tension headache, Throat irritation, Weight decreased
Clinical narrative: tension headache since vaccine (5 months); esophagus issues; chest discomfort/pain; chest discomfort/pain; throat irritated; can't eat (lost 10 pounds); can't eat (lost 10 pounds); pain in groin area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the right arm on 17May2021 12:00 (at the age of 19-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies to penicillin, HALDOL, legumes and soy, EOS 3 years prior the report, in 2018. The patient had not Covid prior vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient experienced tension headache since vaccine (5 months), esophagus issues, chest discomfort/pain, throat irritated, could not eat (lost 10 pounds) and pain in groin area on 31May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious due to disability or permanent damage. Many medications were received in response to the events. The patient was tested for COVID post vaccination via nasal swab, rapid test on 10Aug2021, that resulted negative. The patient then received the second dose of BNT162b2 in the right arm on 07Jun2021 at 12:00 for COVID-19 immunisation. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Feeding disorder, Groin pain, Oesophageal disorder
Clinical narrative: tension headache since vaccine (5 months); esophagus issues; chest discomfort/pain; chest discomfort/pain; throat irritated; can't eat (lost 10 pounds); can't eat (lost 10 pounds); pain in groin area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the right arm on 17May2021 12:00 (at the age of 19-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies to penicillin, HALDOL, legumes and soy, EOS 3 years prior the report, in 2018. The patient had not Covid prior vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient experienced tension headache since vaccine (5 months), esophagus issues, chest discomfort/pain, throat irritated, could not eat (lost 10 pounds) and pain in groin area on 31May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious due to disability or permanent damage. Many medications were received in response to the events. The patient was tested for COVID post vaccination via nasal swab, rapid test on 10Aug2021, that resulted negative. The patient then received the second dose of BNT162b2 in the right arm on 07Jun2021 at 12:00 for COVID-19 immunisation. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tension headache, Throat irritation, Weight, Weight decreased
Clinical narrative: tension headache since vaccine (5 months); esophagus issues; chest discomfort/pain; chest discomfort/pain; throat irritated; can't eat (lost 10 pounds); can't eat (lost 10 pounds); pain in groin area; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), in the right arm on 17May2021 12:00 (at the age of 19-years-old) at dose 1, single for COVID-19 immunisation. Medical history included known allergies to penicillin, HALDOL, legumes and soy, EOS 3 years prior the report, in 2018. The patient had not Covid prior vaccination. Concomitant medications were reported as none; no other vaccine in four weeks and no other medications in two weeks. The patient experienced tension headache since vaccine (5 months), esophagus issues, chest discomfort/pain, throat irritated, could not eat (lost 10 pounds) and pain in groin area on 31May2021 at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious due to disability or permanent damage. Many medications were received in response to the events. The patient was tested for COVID post vaccination via nasal swab, rapid test on 10Aug2021, that resulted negative. The patient then received the second dose of BNT162b2 in the right arm on 07Jun2021 at 12:00 for COVID-19 immunisation. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received a booster shot of Pfizer vaccine. The recommendation for booster is >18 & above. She hasn't shown any symptoms, signs yet.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Syncope
Clinical narrative: PATIENT FAINTED AFTER RECEIVED THE PEDIATRIC PFIZER VACCINE.  PATIENT WAS PALE.  WE LET PATIENT REST ON FLOOR FOR FEW MINUTES. THEN PATIENT WAS LIFTED UPRIGHT AND SAT IN THE CHAIR FOR A FEW MORE MINUTES. THEN PATIENT SAT IN THE WAITING AREA AND PATIENT WAS MONITORED FOR 30 MINUTES.  PATIENT WAS FINE AFTERWORDS AND PALE FACE RETURNED NORMAL AND THE PATIENT WHEN HOME WITH FAMILY. NO OTHER TREATMENT WAS NEEDED.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Limb discomfort, Lymphadenopathy, Pain
Clinical narrative: Lymphadenopathy in injection (left) arm. Also body aches and fatigue but mostly swollen, painful and uncomfortable left deltoid and armpit.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Lymphadenopathy in injection (left) arm. Also body aches and fatigue but mostly swollen, painful and uncomfortable left deltoid and armpit.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness
Clinical narrative: Patient started getting extremely dizzy and started getting cold sweats after vaccine administration and feels like she is going to faint
Age: 8.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Extra dose administered, Fatigue, Pain in extremity, Skin burning sensation
Clinical narrative: On Thursday, 11/18/21, I used the walk in service for vaccinations/immunizations. It was understood that my 8yo daughter was given the COVID Jr vaccine in the right arm and seasonal flu shot in the left arm. Today, 11/19/2021, I received a phone call from my local Pharmacy Manager,  calling to report that there was human error and that in fact my daughter DID NOT get the Covid vaccine but was given 2 flu shots. He asked about any symptoms which I explained that she reported right there after her shot in the right arm that her arm was burning. I gave my daughter Tylenol when we got home and she went straight to bed tired. She woke up this morning with sore arms and given another dose of Tylenol. Once I had received this information from pharmacist, I called Public Health, my child's school, and my daughters drs office for guidance. The school nurse took her vitals and screened her and reported that there were no other symptoms but soreness. Public Health informed me that they would be reaching out to the office to inquire if they would be completing a VARES but that either way they would do the same. At this time there have been no other symptoms but was told by pharmacist and Public Health that it can be 24-48hrs after.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 24 hrs after the shot, I threw up for 5 hrs straight. There were some 20 min breaks but violently throwing up even after nothing was in my stomach
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received Moderna booster dose from a Moderna vial that was punctured over 20 times.  Talked to the patient today and advice patient to monitor for any side effects.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Haematuria, Pain, Pyrexia
Clinical narrative: My first dose of Moderna had little to no symptoms. My 2nd dose of Moderna (administered 04/13/2021) came with heavy side-effects, which included about 48 hours of fever, body aches, and chills.  Following the clearing of the fever, I experienced gross hematuria which lasted about 5 days.  Very dark brown to red urine, but with no pain.  This was treated as a UTI through my local urgent care.  On 11/17/2021, I received my booster shot of Moderna and experienced the same symptoms with similar severity for about 48 hours.  Following the clearance of the fever and chills, I again experienced the gross hematuria.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: My first dose of Moderna had little to no symptoms. My 2nd dose of Moderna (administered 04/13/2021) came with heavy side-effects, which included about 48 hours of fever, body aches, and chills.  Following the clearing of the fever, I experienced gross hematuria which lasted about 5 days.  Very dark brown to red urine, but with no pain.  This was treated as a UTI through my local urgent care.  On 11/17/2021, I received my booster shot of Moderna and experienced the same symptoms with similar severity for about 48 hours.  Following the clearance of the fever and chills, I again experienced the gross hematuria.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Electric shock sensation, Injection site pain
Clinical narrative: 12/19/2021 Injection @ 9:30am. Around 3:30pm I started aching in my joints and feeling mild soreness in the injection site arm. Around 7:30pm the aches became more intense and widespread as well as some chills. Around 10:00pm I started getting withdrawal symptoms of not taking my sertraline medication on time, which is an electric shock feeling through my body. Have only tried applying heat to areas, not much help. Symptoms still ongoing (currently 10:36pm). This all also happened after my second dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received Moderna booster dose from a Moderna vial that was punctured over 20 times.  Talked to the patient today and advice patient to monitor for any side effects.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received Moderna booster dose from a Moderna vial that was punctured over 20 times.  Talked to the patient today and advice patient to monitor for any side effects.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a Moderna booster from a vial punctured for over 20 times. Talked to the patient today to monitor any side effects.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dysphonia, Headache, Hypersensitivity
Clinical narrative: 12.5 hours after vaccine:  Body Aches, @ 18 hrs:  severe sleepiness and slight headache, @24 hours:  body aches, sleepiness, headache, chills, fever 101, scratchy throat with slight cough and hoarseness in throat, @31 hours all side effects lifted except scratchy throat and slight cough with hoarseness, @ 72 hours still have scratchy throat with slight cough and runny, itchy nose begins and continues for 5 more days, ending 1 week and 1 day after Moderna shot. Visited a local health care facility for COVID-19 test and diagnosis on day 5. Covid-19 test results were negative and diagnosis was reaction to 2nd Moderna shot. Advised to use Nasacort to control itchy and runny nose, which did help.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Pyrexia, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: 12.5 hours after vaccine:  Body Aches, @ 18 hrs:  severe sleepiness and slight headache, @24 hours:  body aches, sleepiness, headache, chills, fever 101, scratchy throat with slight cough and hoarseness in throat, @31 hours all side effects lifted except scratchy throat and slight cough with hoarseness, @ 72 hours still have scratchy throat with slight cough and runny, itchy nose begins and continues for 5 more days, ending 1 week and 1 day after Moderna shot. Visited a local health care facility for COVID-19 test and diagnosis on day 5. Covid-19 test results were negative and diagnosis was reaction to 2nd Moderna shot. Advised to use Nasacort to control itchy and runny nose, which did help.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Throat irritation
Clinical narrative: 12.5 hours after vaccine:  Body Aches, @ 18 hrs:  severe sleepiness and slight headache, @24 hours:  body aches, sleepiness, headache, chills, fever 101, scratchy throat with slight cough and hoarseness in throat, @31 hours all side effects lifted except scratchy throat and slight cough with hoarseness, @ 72 hours still have scratchy throat with slight cough and runny, itchy nose begins and continues for 5 more days, ending 1 week and 1 day after Moderna shot. Visited a local health care facility for COVID-19 test and diagnosis on day 5. Covid-19 test results were negative and diagnosis was reaction to 2nd Moderna shot. Advised to use Nasacort to control itchy and runny nose, which did help.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Choking, Cough, Extrasystoles, Myocardial infarction
Clinical narrative: 1. Sporadic palpitations,  skipping heart beats associated with chest pressure and choking sensation on throat lasting a few seconds, causing a sense of impending doom.  2. Cough with wheezing
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Wheezing
Clinical narrative: 1. Sporadic palpitations,  skipping heart beats associated with chest pressure and choking sensation on throat lasting a few seconds, causing a sense of impending doom.  2. Cough with wheezing
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Within minutes after vaccination, client reported dizziness. Client only ate breakfast and had not eaten for several hours. The client reported dizziness that slowly resolved itself. Client provided with snack and juice. The clients symptoms were completely resolved within 30 minutes.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: Two weeks after my 2nd shot my period started twice as heavy as normal. Since having children I have had relatively light and short mentrual cycles with no cramping. June July and august were very heavy and accompanied by painful cramps. I was changing regular tampons out every 2-3 hours. Nothing else changed in my life, same diet etc., I?ma stay at home mom. September and October cycles seem to be getting back to normal; September being heavier. June - August , the bleeding lasted 5 -6 days. It is now back to 3-4 days which is how it has been for the last 9 years.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: Patient came to hospital with reports of numness, tingling, & loss of sensation to bilateral hands. Patient also reported sharp/stabing chest pains. All symptoms ongoing for 1 week before she came to the ER