chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: 8 days after injection, injection site became very itchy and somewhat swollen; 8 days after injection, injection site became very itchy and somewhat swollen; extreme vertigo so that walking was not possible without support; extreme vertigo so that walking was not possible without support; extreme nausea with empty stomach retching; extreme nausea with empty stomach retching; blood pressure high (160/90), pulse 80, blood oxygen 94%; This is a spontaneous report from a contactable consumer. A 74-years-non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration in arm left on Feb2021 at 12:00 as single dose for COVID-19 immunization at 74-years age. Medical history included Low thyroid, slight cholesterol, and iodine (shellfish) allergy. Concomitant medication included pravastatin sodium (PRAVASTATIN SODIUM), levothyroxine sodium (LEVOTHYROXINE SODIUM) within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. After 8 days of vaccination (07Mar2021 at 16:00) patient experienced injection site very itchy and somewhat swollen, extreme vertigo so that walking was not possible without support, and extreme nausea with empty stomach retching. It's now been 28 hours with these symptoms. These symptoms matched a reaction at day 2, though those symptoms were modest and resolved overnight. The patient underwent lab tests and procedures which included blood pressure measurement high: 160/90, Temperature: normal, Pulse: 80 and Blood oxygen: 94%. Patient didn't received treatment for the events. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Dyspnoea, Influenza like illness, Malaise
Clinical narrative: Extremely high sugar levels; Shortness of Breath (am COPD to begin with); flu-like symptoms; Malaise; Chills with no fever; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EN6198, expiration date not provided) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 02Mar2021 at 08:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The medical history included chronic obstructive pulmonary disease, diabetes mellitus, coronary artery disease, and reaction to preservatives (known allergy: Food sulfites (MSG)) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9269) administered in Right arm on 12Feb2021 at 08:00 AM for COVID-19 immunization. There was no COVID prior vaccination reported. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. On 03Mar2021 at 03:30 AM the patient experienced extremely high sugar levels, shortness of breath, flu-like symptoms, chills with no fever and malaise. It was reported that extreme onset of flu-like symptoms almost 20 hours after shoot. Chills with no fever. Shortness of Breath (am COPD to begin with). That relaxed after about 12 hours, but SOB continued. General malaise continued for a few days. Extremely high sugar levels persisted for a few days, readings over 500 and once even over 600 which is rare for me (diabetic). The patient underwent lab tests and procedures which included blood glucose increased: 500 (over 500) and blood glucose increased: 600 (over 600) on 03Mar2021. No treatment was received for the adverse events. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperaesthesia teeth, Pain in jaw, Teething, Tooth abscess
Clinical narrative: almost like abscess tooth or something; became very, very sensitive; severe headache; pain in the upper jaw/teeth; pain in the upper jaw/teeth; This is a spontaneous report from a contactable male consumer (patient) reported that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history included BNT162B2 for Covid- 19 Immunization as Dose 1 and experienced Severe headache, Nausea, Pain in the upper jaw/teeth, Teething, Almost like abscess tooth or something, Became very, very sensitive on an unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Severe headache on 03Mar2021, Pain in the upper jaw/teeth on 03Mar2021, Pain in the upper jaw/teeth on 03Mar2021, Almost like abscess tooth or something on an unspecified date, Became very, very sensitive on an unspecified date. Reporter was not a Healthcare Professional and was not a prescribing HCP. There were no unaddressed medical questions referred or forwarded to Medical Information. NDC and UPC number were not provided. Therapeutic measures were taken as Fiorinal for severe headache, Pain in the upper jaw/teeth. The outcome of event for Severe headache was recovering, The outcome for event for Severe headache, Pain in the upper jaw/teeth was unknown, The outcome for event Pain in the upper jaw/teeth (Teething), Became very, very sensitive and Almost like abscess tooth or something was not resolved.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Diarrhoea
Clinical narrative: Violently throwing up for 12 hours; Diarrhea; Chills; Sweats; tight chest; could not get out of bed for 3 days; don't feel myself; feeling achy; no energy; chest hurts; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6206) via an unspecified route of administration in left arm on 08Mar2021 01:45 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination. Patient was not tested for COVID-19, post vaccination.  Patient medical history was not reported. Patient had no known allergies. The concomitant medications included reflux medicines, hormones and allergy medicines. On 09Mar2021 at 04:00, patient started violently throwing up for 12 hours, diarrhea, chills, sweats, tight chest, could not get out of bed for 3 days. Even after 6 days from start of events on 09Mar2021 at 04:00, patient still did not feel herself, was still feeling achy, no energy, chest hurted. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received anti-nausea medicines to help with throwing up. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Loss of personal independence in daily activities, Pain, Vomiting
Clinical narrative: Violently throwing up for 12 hours; Diarrhea; Chills; Sweats; tight chest; could not get out of bed for 3 days; don't feel myself; feeling achy; no energy; chest hurts; This is a spontaneous report from a contactable consumer (patient herself). A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6206) via an unspecified route of administration in left arm on 08Mar2021 01:45 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination. Patient was not tested for COVID-19, post vaccination.  Patient medical history was not reported. Patient had no known allergies. The concomitant medications included reflux medicines, hormones and allergy medicines. On 09Mar2021 at 04:00, patient started violently throwing up for 12 hours, diarrhea, chills, sweats, tight chest, could not get out of bed for 3 days. Even after 6 days from start of events on 09Mar2021 at 04:00, patient still did not feel herself, was still feeling achy, no energy, chest hurted. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received anti-nausea medicines to help with throwing up. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Tooth abscess, X-ray
Clinical narrative: abscess tooth; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Right on 10Mar2021 17:45 as 1st dose, single (age at vaccination 77 year old) for covid-19 immunization (Covid protection) at hospital. Medical history included osteopenia and has trouble with her spine from an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced abscess tooth on 15Mar2021. Caller mentions that she got the first dose of the Pfizer covid 19 vaccine last Wednesday and yesterday she started feeling like an "abscess tooth" in her cheek. She was wondering if this was something that the vaccine could caused. She saw her dentist a month ago and had X-rays. She did not have an abscess at that time. The adverse event did not require emergency room or physician office. The patient underwent lab tests and procedures which included body height: shrinking and x-ray: did not have an abscess at that time on an unknown date. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Chills, Diarrhoea, Pain, Secretion discharge
Clinical narrative: slight chills; diarrhea; sore; heavy mucus/getting mucus in the back of the throat; weight went down; This is a spontaneous report from a contactable consumer (patient). A 84-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route on 09Mar2021 at 13:30 (at the age of 84-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included high blood pressure, high cholesterol. The patient concomitant medications included losartan with dose 100 mg, 1x/day for high blood pressure and rosuvastatin with dose 20 mg, 1x/day for high cholesterol and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced getting a lot more mucus in the back of the throat. Patient stated it had been getting a lot more in the last couple of days. On 10Mar2021, the patient experienced sore the next day a little bit, on 17Mar2021 patient experienced diarrhoea and at 03:00 in the morning slight chills. He said that his weight went down since the diarrhoea. He said that he usually weighs around 220llbs. He said that he had shrunk with his age. Patient stated that he had to get up every hour at night and found a book called Remedies and it said something about carrot juice and also said something about blueberries. He said that he crushed up some blueberries and ate them and it went through him like roto-rooter. He said that he only had one episode of diarrhoea last night. He said that it seems more semi solid now and had slowed down. He said that the mucus seems to have slowed down now. He said that his second dose is due on the 30Mar2021. The patient did not visited emergency room or physician office. The outcome of events getting mucus in the back of the throat, diarrhoea was recovering, chills was recovered on 17Mar2021 and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: slight chills; diarrhea; sore; heavy mucus/getting mucus in the back of the throat; weight went down; This is a spontaneous report from a contactable consumer (patient). A 84-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route on 09Mar2021 at 13:30 (at the age of 84-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included high blood pressure, high cholesterol. The patient concomitant medications included losartan with dose 100 mg, 1x/day for high blood pressure and rosuvastatin with dose 20 mg, 1x/day for high cholesterol and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced getting a lot more mucus in the back of the throat. Patient stated it had been getting a lot more in the last couple of days. On 10Mar2021, the patient experienced sore the next day a little bit, on 17Mar2021 patient experienced diarrhoea and at 03:00 in the morning slight chills. He said that his weight went down since the diarrhoea. He said that he usually weighs around 220llbs. He said that he had shrunk with his age. Patient stated that he had to get up every hour at night and found a book called Remedies and it said something about carrot juice and also said something about blueberries. He said that he crushed up some blueberries and ate them and it went through him like roto-rooter. He said that he only had one episode of diarrhoea last night. He said that it seems more semi solid now and had slowed down. He said that the mucus seems to have slowed down now. He said that his second dose is due on the 30Mar2021. The patient did not visited emergency room or physician office. The outcome of events getting mucus in the back of the throat, diarrhoea was recovering, chills was recovered on 17Mar2021 and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Pain in extremity
Clinical narrative: The caller's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm.; The caller's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm.; Woke up this morning and her armpit/breast area is in agony; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced the caller's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm, woke up this morning and her armpit/breast area is in agony on an unspecified date in 2021. The patient is calling about the Pfizer covid 19 vaccine. The patient's armpit started to hurt really bad and the pain is now radiating down her arm and she can't lift her arm. The patient took Tylenol but it is still sore, the Tylenol dulled down the pain a little bit but it is still there. When the patient's arm touches her body it is aggravating. Its a deep tissue pain. The patient wants to know if this could be from the vaccine. The patient received the second dose of the vaccine Tuesday late afternoon, 16Mar2021. Patient received 2nd dose on Tuesday. Woke up this morning and her armpit/breast area is in agony. The patient received treatment medication for the events. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose fluctuation, Urticaria
Clinical narrative: after1st dose broke out in hives all over the trunk of her body and down both forearms; Elevated blood sugars(340), then extreme low blood sugar (58)-Exactly 38 Hours; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received the first does of BNT162B2 via an unspecified route of administration on the right arm on 19Mar2021 at 08:15 AM (Batch/lot number :EN6199) at the age of 16-year-old as single dose for COVID-19 immunization. Medical history included type 1 diabetes. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication included insulin. On 19Mar2021 at 20:15, 12 hours after the shot, the patient elevated blood sugars(340), then extreme low blood sugar (58). On 20Mar2021 at 22:15, exactly 38 hours after 1st dose, broke out in hives all over the trunk of her body and down both forearms. A dose of antihistamine was given and within 1 hour her hives had disappeared with no other symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Antihistamine  was taken as treatment for events. The outcome of hives was recovered on 20Mar2021 at 23:15. The outcome of blood sugar level fluctuation was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Paraesthesia oral, Periorbital swelling, SARS-CoV-2 test, Swelling of eyelid
Clinical narrative: Eyelids started to swell up/swell up a little bit; Eyes were still a little puffy; My eyelids started to get hives; My lips started tingling; my throat start to tighten; This happened after my first dose that my immune system is just more hypersensitive to my allergies; This is a spontaneous report from a contactable consumer (patient). A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 16Mar2021 10:00 (age at vaccination was 22 years) (Batch/Lot number: EL8982) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergies to pure soy (ie. Soybeans, soy milk), pollen, itchy red eyes and eyelid probably due to mild to moderate pollen allergies. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that before getting the vaccine at 10AM, she woke up with itchy red eyes and eyelid probably due to mild to moderate pollen allergies. On 17May2021 (The next day at 3pm), after patient got the first dose her eyelids started to swell up so she took Benadryl that night. 48 hours after the first dose (17Mar2021 at 15:00), her eyes were still a little puffy so she took 2 Benadryl. At around 6-7pm, eyelids started to get hives and swell up a little bit and about an hour later lips started tingling and felt her throat started to tighten. She immediately took another Benadryl and went to the hospital as the swelling started to subside. Patient was possibly thinking that maybe since that happened after her first dose that her immune system was just more hypersensitive to her allergies. The adverse events required emergency room/department or urgent care and Physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Covid test: negative on 18Mar2021. Therapeutic measures were taken as a result of the events with diphenhydramine (BENADRYL) and prednisone (DELTASONE). The outcome of the events was recovering.  Follow up attempts are needed; Additional information has been requested.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Eyelids started to swell up/swell up a little bit; Eyes were still a little puffy; My eyelids started to get hives; My lips started tingling; my throat start to tighten; This happened after my first dose that my immune system is just more hypersensitive to my allergies; This is a spontaneous report from a contactable consumer (patient). A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 16Mar2021 10:00 (age at vaccination was 22 years) (Batch/Lot number: EL8982) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergies to pure soy (ie. Soybeans, soy milk), pollen, itchy red eyes and eyelid probably due to mild to moderate pollen allergies. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that before getting the vaccine at 10AM, she woke up with itchy red eyes and eyelid probably due to mild to moderate pollen allergies. On 17May2021 (The next day at 3pm), after patient got the first dose her eyelids started to swell up so she took Benadryl that night. 48 hours after the first dose (17Mar2021 at 15:00), her eyes were still a little puffy so she took 2 Benadryl. At around 6-7pm, eyelids started to get hives and swell up a little bit and about an hour later lips started tingling and felt her throat started to tighten. She immediately took another Benadryl and went to the hospital as the swelling started to subside. Patient was possibly thinking that maybe since that happened after her first dose that her immune system was just more hypersensitive to her allergies. The adverse events required emergency room/department or urgent care and Physician office visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Covid test: negative on 18Mar2021. Therapeutic measures were taken as a result of the events with diphenhydramine (BENADRYL) and prednisone (DELTASONE). The outcome of the events was recovering.  Follow up attempts are needed; Additional information has been requested.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dizziness postural, Dry skin, Electrocardiogram
Clinical narrative: 156/106-b/p; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; skin pink; skin warm; skin dry; This is a spontaneous report from a contactable other health care professional. This Other HCP reported for a 61-year-old female patient that: A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via intramuscular route of administration on 06Mar2021 at 11:30 (at the age of 61-year-old) as dose 1, single for COVID-19 immunisation. Medical history included epstein-barr virus infection, bradycardia, tachycardia, nephropathy; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient allergies to medications, food, or other products were unknown. The treatment received for the adverse events was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient experienced dizziness approximately 15 minutes post vaccine. The patient stood up dizziness increased, and skin became pink, warm, and dry. EMS (emergency medical services) and physician on duty at bedside assessing patient. The patient advised to be evaluated in ED (emergency department). The patient was refused ambulance transport. Symptoms subsided, minimal at the time of departure approximately equal to 12:10. The patient taken to care via wheelchair. Daughter to transport to ED (emergency department) by patient's own vehicle. The adverse events were resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure: 154/104 on 03Jun2021 (1141 VS: 154/104), blood pressure: 146/98 on 03Jun2021 (Repeat 146/98), blood pressure: 156/106 on 03Jun2021 (VS:1127:156/106-b/p), EKG (electrocardiogram): unknown result on 03Jun2021, heart rate: 58 on 03Jun2021 (1141 VS: 58- HR), heart rate: 60 on 03Jun2021 (VS:1127 60-hr), oxygen saturation: 98 on 03Jun2021 (1141 VS: SaO2 98% on RA) , oxygen saturation: 96 on 03Jun2021 (VS:1127:SaO2 96% on RA), vital signs: normal on 03Jun2021 (Patient A and O x4  PERRLA approximately equal to 3mm, Speech clear and appropriate. The outcome of the events was reported as resolved on an unknown date.  Information on the lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Heart rate, Hypertension, Oxygen saturation, Skin warm
Clinical narrative: 156/106-b/p; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; skin pink; skin warm; skin dry; This is a spontaneous report from a contactable other health care professional. This Other HCP reported for a 61-year-old female patient that: A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via intramuscular route of administration on 06Mar2021 at 11:30 (at the age of 61-year-old) as dose 1, single for COVID-19 immunisation. Medical history included epstein-barr virus infection, bradycardia, tachycardia, nephropathy; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient allergies to medications, food, or other products were unknown. The treatment received for the adverse events was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient experienced dizziness approximately 15 minutes post vaccine. The patient stood up dizziness increased, and skin became pink, warm, and dry. EMS (emergency medical services) and physician on duty at bedside assessing patient. The patient advised to be evaluated in ED (emergency department). The patient was refused ambulance transport. Symptoms subsided, minimal at the time of departure approximately equal to 12:10. The patient taken to care via wheelchair. Daughter to transport to ED (emergency department) by patient's own vehicle. The adverse events were resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure: 154/104 on 03Jun2021 (1141 VS: 154/104), blood pressure: 146/98 on 03Jun2021 (Repeat 146/98), blood pressure: 156/106 on 03Jun2021 (VS:1127:156/106-b/p), EKG (electrocardiogram): unknown result on 03Jun2021, heart rate: 58 on 03Jun2021 (1141 VS: 58- HR), heart rate: 60 on 03Jun2021 (VS:1127 60-hr), oxygen saturation: 98 on 03Jun2021 (1141 VS: SaO2 98% on RA) , oxygen saturation: 96 on 03Jun2021 (VS:1127:SaO2 96% on RA), vital signs: normal on 03Jun2021 (Patient A and O x4  PERRLA approximately equal to 3mm, Speech clear and appropriate. The outcome of the events was reported as resolved on an unknown date.  Information on the lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: 156/106-b/p; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; Dizziness approximately 15 minutes post vaccine. Patient stood up dizziness increased.; skin pink; skin warm; skin dry; This is a spontaneous report from a contactable other health care professional. This Other HCP reported for a 61-year-old female patient that: A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via intramuscular route of administration on 06Mar2021 at 11:30 (at the age of 61-year-old) as dose 1, single for COVID-19 immunisation. Medical history included epstein-barr virus infection, bradycardia, tachycardia, nephropathy; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient allergies to medications, food, or other products were unknown. The treatment received for the adverse events was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient experienced dizziness approximately 15 minutes post vaccine. The patient stood up dizziness increased, and skin became pink, warm, and dry. EMS (emergency medical services) and physician on duty at bedside assessing patient. The patient advised to be evaluated in ED (emergency department). The patient was refused ambulance transport. Symptoms subsided, minimal at the time of departure approximately equal to 12:10. The patient taken to care via wheelchair. Daughter to transport to ED (emergency department) by patient's own vehicle. The adverse events were resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure: 154/104 on 03Jun2021 (1141 VS: 154/104), blood pressure: 146/98 on 03Jun2021 (Repeat 146/98), blood pressure: 156/106 on 03Jun2021 (VS:1127:156/106-b/p), EKG (electrocardiogram): unknown result on 03Jun2021, heart rate: 58 on 03Jun2021 (1141 VS: 58- HR), heart rate: 60 on 03Jun2021 (VS:1127 60-hr), oxygen saturation: 98 on 03Jun2021 (1141 VS: SaO2 98% on RA) , oxygen saturation: 96 on 03Jun2021 (VS:1127:SaO2 96% on RA), vital signs: normal on 03Jun2021 (Patient A and O x4  PERRLA approximately equal to 3mm, Speech clear and appropriate. The outcome of the events was reported as resolved on an unknown date.  Information on the lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Eating disorder, Fatigue
Clinical narrative: vomiting; diarrhea; fatigue; weakness; chills; severe aches/pains; a "big welt" on her injection arm site; she can't keep food or water "down"; This is a spontaneous report from a contactable consumer via medical information team. This consumer reported for female (mother) patient that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 18Mar2021 (at the age of 73 years old) as single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the evening after receiving the dose she experienced fatigue/weakness, diarrhea, vomiting, chills and severe aches/pains. She had a big welt on her injection arm site, she can not keep food or water "down" on an unspecified date in Mar2021. She has been to the hospital 2 times. Each time she goes into the hospital, the MD gives her IV fluids and then sends her home. She wanted to know what to do to help her mother. The patient received treatment due to a diarrhea, vomiting with IV fluids and big welt on her injection arm site, she can't keep food or water down. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Pain, Vomiting
Clinical narrative: vomiting; diarrhea; fatigue; weakness; chills; severe aches/pains; a "big welt" on her injection arm site; she can't keep food or water "down"; This is a spontaneous report from a contactable consumer via medical information team. This consumer reported for female (mother) patient that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 18Mar2021 (at the age of 73 years old) as single for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the evening after receiving the dose she experienced fatigue/weakness, diarrhea, vomiting, chills and severe aches/pains. She had a big welt on her injection arm site, she can not keep food or water "down" on an unspecified date in Mar2021. She has been to the hospital 2 times. Each time she goes into the hospital, the MD gives her IV fluids and then sends her home. She wanted to know what to do to help her mother. The patient received treatment due to a diarrhea, vomiting with IV fluids and big welt on her injection arm site, she can't keep food or water down. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Soreness at injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955), via an unspecified route of administration in left arm on 23Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications received within two weeks of vaccination included multivitamin (MANUFACTURER UNKNOWN), vitamin d supplement (MANUFACTURER UNKNOWN), docosahexaenoic acid (DHA) (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN) from an unknown date for unknown indications. 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. Patient had not tested for COVID-19 since the vaccination. On 24Mar2021, the patient experienced soreness at injection site and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site pain and fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1.Patient initials updated as UNKNOWN.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac normal, Chest pain, Echocardiogram, Myocarditis
Clinical narrative: Chest pain with NSTEMI - troponin elevated to 6, downtrended. No EKG changes. TTE without reduced EF or wall motion abnormalities. Left heart cath did not show any significant CAD. Therefore, we believe this was a case of mRNA myocarditis from the 2ns Moderna dose 48 hours prior
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pain with NSTEMI - troponin elevated to 6, downtrended. No EKG changes. TTE without reduced EF or wall motion abnormalities. Left heart cath did not show any significant CAD. Therefore, we believe this was a case of mRNA myocarditis from the 2ns Moderna dose 48 hours prior
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: dizzy and sweating
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Headache, sore throat, cough, aches, fatigue
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Diarrhoea, Dyspnoea, Oropharyngeal pain
Clinical narrative: daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase, Full blood count, Limb discomfort
Clinical narrative: Leg weakness, heaviness. which appeared the next day in the evening after vaccination
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Metabolic function test, Muscular weakness, Platelet count decreased
Clinical narrative: Leg weakness, heaviness. which appeared the next day in the evening after vaccination
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: Sore arms. No other adverse reaction, however patient received Pfizer vaccine for 2nd dose. Patient received Moderna for her 1st dose of COVID vaccination series
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Alopecia, Amenorrhoea, Anaemia, Anisocytosis
Clinical narrative: To, The  Centers for Disease Control and Prevention The patients. I am a 27-year-old female residing since August 2019. I am a Resident and an immigrant. On the 20th of April, 2021 I took my first shot of the Pfizer-BioNTech COVID-19 vaccine in city where I reside. After 48 hours of taking the vaccine, I started experiencing extreme fatigue, dehydration, and chills. I also registered a fever of close to 101 on a few nights in the week after. I thought this was a temporary side-effect of the vaccine, but the side-effects persisted and was not dying down. Over the next 2-3 weeks my health condition waxed and waned. I was facing extreme fatigue to the extent it had disrupted my normal life, heavy dehydration, loss of appetite, feeling cold easily, especially in the evenings. I called up the center and asked if I could delay my 2nd COVID-19 Pfizer shot, but because it is generally advised to take the second shot within a 28-day period, I decided to go ahead and take my second shot on May 14th. I took a couple of Acetaminophen tablets this time to help reduce a possible fever. Over the next weeks, my condition did not seem to change, even though I was done with both my shots. I continued to face fatigue and weakness, I had lost 10-11 pounds, a huge loss in appetite, I started noticing heavy hairfall daily. My period had not come since taking the vaccine. In the early month of June, I noticed dark red blotchy marks that had appeared on both my arms. My health started deteriorating heavily in June, there were days when I could sleep all day. I started noticing a fever which climbed to 101-102 daily, especially in the evenings and continuous shivering. Seeing the signs of a serious medical condition, I filed for emergency leave from my workplace and decided to fly back to where my family resides. I landed in the 30th of June, 2021. I was admitted to a hospital in the Emergency Unit on the very same day and where I continued to remain hospitalized until the 9th of July. I was hospitalized for a period of 10 days, during which multiple blood tests, scans and procedures were run on me, at the end of which I was diagnosed with now having a chronic illness, an Autoimmune disorder called Systemic Lupus Erythematosus. I am currently, recouping from my illness and undergoing treatment for SLE. I do not know if there was a correlation between my taking this vaccine and the triggering of my illness, but if there is a possibility of the vaccine triggering an Autoimmune disorder in healthy individuals, I would like the concerned authorities to make a note of it. Symptoms: Extreme Fatigue, Continuous High Fever, Heavy Hairfall, Loss of Appetite, Feelings of Nausea, Red marks on arms, Weight Loss, No menstruation
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Aspartate aminotransferase increased, Asthenia, Biopsy bone marrow, Blood albumin decreased
Clinical narrative: To, The  Centers for Disease Control and Prevention The patients. I am a 27-year-old female residing since August 2019. I am a Resident and an immigrant. On the 20th of April, 2021 I took my first shot of the Pfizer-BioNTech COVID-19 vaccine in city where I reside. After 48 hours of taking the vaccine, I started experiencing extreme fatigue, dehydration, and chills. I also registered a fever of close to 101 on a few nights in the week after. I thought this was a temporary side-effect of the vaccine, but the side-effects persisted and was not dying down. Over the next 2-3 weeks my health condition waxed and waned. I was facing extreme fatigue to the extent it had disrupted my normal life, heavy dehydration, loss of appetite, feeling cold easily, especially in the evenings. I called up the center and asked if I could delay my 2nd COVID-19 Pfizer shot, but because it is generally advised to take the second shot within a 28-day period, I decided to go ahead and take my second shot on May 14th. I took a couple of Acetaminophen tablets this time to help reduce a possible fever. Over the next weeks, my condition did not seem to change, even though I was done with both my shots. I continued to face fatigue and weakness, I had lost 10-11 pounds, a huge loss in appetite, I started noticing heavy hairfall daily. My period had not come since taking the vaccine. In the early month of June, I noticed dark red blotchy marks that had appeared on both my arms. My health started deteriorating heavily in June, there were days when I could sleep all day. I started noticing a fever which climbed to 101-102 daily, especially in the evenings and continuous shivering. Seeing the signs of a serious medical condition, I filed for emergency leave from my workplace and decided to fly back to where my family resides. I landed in the 30th of June, 2021. I was admitted to a hospital in the Emergency Unit on the very same day and where I continued to remain hospitalized until the 9th of July. I was hospitalized for a period of 10 days, during which multiple blood tests, scans and procedures were run on me, at the end of which I was diagnosed with now having a chronic illness, an Autoimmune disorder called Systemic Lupus Erythematosus. I am currently, recouping from my illness and undergoing treatment for SLE. I do not know if there was a correlation between my taking this vaccine and the triggering of my illness, but if there is a possibility of the vaccine triggering an Autoimmune disorder in healthy individuals, I would like the concerned authorities to make a note of it. Symptoms: Extreme Fatigue, Continuous High Fever, Heavy Hairfall, Loss of Appetite, Feelings of Nausea, Red marks on arms, Weight Loss, No menstruation
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood smear test abnormal, Blood test, Chills, Coombs direct test positive, Decreased appetite
Clinical narrative: To, The  Centers for Disease Control and Prevention The patients. I am a 27-year-old female residing since August 2019. I am a Resident and an immigrant. On the 20th of April, 2021 I took my first shot of the Pfizer-BioNTech COVID-19 vaccine in city where I reside. After 48 hours of taking the vaccine, I started experiencing extreme fatigue, dehydration, and chills. I also registered a fever of close to 101 on a few nights in the week after. I thought this was a temporary side-effect of the vaccine, but the side-effects persisted and was not dying down. Over the next 2-3 weeks my health condition waxed and waned. I was facing extreme fatigue to the extent it had disrupted my normal life, heavy dehydration, loss of appetite, feeling cold easily, especially in the evenings. I called up the center and asked if I could delay my 2nd COVID-19 Pfizer shot, but because it is generally advised to take the second shot within a 28-day period, I decided to go ahead and take my second shot on May 14th. I took a couple of Acetaminophen tablets this time to help reduce a possible fever. Over the next weeks, my condition did not seem to change, even though I was done with both my shots. I continued to face fatigue and weakness, I had lost 10-11 pounds, a huge loss in appetite, I started noticing heavy hairfall daily. My period had not come since taking the vaccine. In the early month of June, I noticed dark red blotchy marks that had appeared on both my arms. My health started deteriorating heavily in June, there were days when I could sleep all day. I started noticing a fever which climbed to 101-102 daily, especially in the evenings and continuous shivering. Seeing the signs of a serious medical condition, I filed for emergency leave from my workplace and decided to fly back to where my family resides. I landed in the 30th of June, 2021. I was admitted to a hospital in the Emergency Unit on the very same day and where I continued to remain hospitalized until the 9th of July. I was hospitalized for a period of 10 days, during which multiple blood tests, scans and procedures were run on me, at the end of which I was diagnosed with now having a chronic illness, an Autoimmune disorder called Systemic Lupus Erythematosus. I am currently, recouping from my illness and undergoing treatment for SLE. I do not know if there was a correlation between my taking this vaccine and the triggering of my illness, but if there is a possibility of the vaccine triggering an Autoimmune disorder in healthy individuals, I would like the concerned authorities to make a note of it. Symptoms: Extreme Fatigue, Continuous High Fever, Heavy Hairfall, Loss of Appetite, Feelings of Nausea, Red marks on arms, Weight Loss, No menstruation