chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Dizziness
Clinical narrative: Dizziness; Chills; Everything I eat and drink tastes like chemicals/I tried other peoples food items as well they all tasted, off; This is a spontaneous report from a contactable Other HCP. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration single dose left arm on 10Feb2021 07:30 for covid-19 immunisation. The patient received the first dose (Lot # EL3249) left arm on 20Jan2021 07:30 AM. Medical history included type 2 diabetes mellitus. Concomitant medication included metformin, insulin glargine (LANTUS). The patient experienced dizziness on 10Feb2021 20:00, chills on 10Feb2021 20:00, everything I eat and drink tastes like chemicals/i tried other people food items as well they all tasted, off (ageusia) on 10Feb2021 20:00. The events outcome was not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Migraine, Pain
Clinical narrative: Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included depression-anxiety and birth control use; the patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included vilazodone hydrochloride (VIIBRYD), drospirenone/ethinylestradiol betadex clathrate (YAZ) for birth control, clonazepam (KLONOPIN). The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 04Feb2021 at 15:00 (also reported as within 3 minutes post vaccination), the patient experienced headache as a sharp pain across the forehead. On 04Feb2021 at 15:00, the patient also experienced chills, body aches and tiredness that lasted 24 hours. The headache remained 6 days post vaccination as a severe migraine, as of an unspecified date in Feb2021, for which no medications worked. The patient iced, applied heat to the area, dark room, no sound for 2 days and finally was relieved with acupuncture. This headache was like no headache the patient had ever had and she had come very close to an emergency room visit but realized it was from the vaccine. The events "Headache/Sharp pain across the forehead" and severe migraine resulted in a healthcare professional visit and the patient was treated for these events with acupuncture. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "Headache/Sharp pain across the forehead" and severe migraine was resolving; chills, body aches and tiredness were resolved on 05Feb2021 at 15:00.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: fever; cough; This is a spontaneous report from a contactable consumer. A 73-year-old male consumer (Patient) received second dose BNT162B2 (Solution for injection, lot number: EL3246) via an unspecified route of administration in Arm Left on 03Feb2021 at single dose for Coronavirus Vaccination. The patient medical history was not reported. Patient had historical vaccine at 73-year-old BNT162B2 on 13Jan2021 for Coronavirus Vaccination and had just fatigued the rest of the day and heart palpitations (Admission to hospital due to the event was No, Any treatment Received was No, Still Experiencing was Fine now) and heart palpitations stated as he woke up early 14Jan2021 with some minor heart palpitations/they got more frequent and lasted longer (had one every hour and half and they lasted 20 to 30 minutes). Concomitant medication included dexlansoprazole (DEXILANT) on 2016 and enalapril maleate (ENALAPRIL MALEATE) on 2004 and both were ongoing. He had his 2nd vaccination 03Feb2021. He woke up 04Feb2021 with a 101 fever. He also had a cough. By the end of the day fever was down to 99.5. When he woke up 05Feb2021 his fever was gone. Outcome of event fever was recovered on 05Feb2021, while with other event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Covid positive after getting the 1st dose of the Pfizer Vaccine; This is a spontaneous report from a Pfizer-sponsored program.   A male patient (reporter) of an unspecified age received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, via an unspecified route of administration from 31Jan2021 at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced tested covid positive after getting the 1st dose of the Pfizer vaccine on an unspecified date.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive, Tested Covid positive after getting the 1st dose of the Pfizer Vaccine on an unspecified date.  Outcome of tested Covid positive after getting the 1st dose of the Pfizer Vaccine was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Demyelinating polyneuropathy, Inappropriate schedule of product administration, Off label use
Clinical narrative: Acute demyelinating polyneuropathy-in hospital getting IVIG; Dose number=1, 20Jan2021; Dose number=2, 06Feb2021; Dose number=1, 20Jan2021; Dose number=2, 06Feb2021; This is a spontaneous report from a contactable physician. A 25-year-old female patient received second dose of BNT162B2 (lot number and expiry date unknown), intramuscular on 06Feb2021 13:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (1st dose), Lot number unknown, intramuscular on 20Jan2021 17:00 in the left arm for COVID-19 immunization. On 06Feb2021 20:00, the patient experienced acute demyelinating polyneuropathy-in hospital getting IVIG. The patient was hospitalized for acute demyelinating polyneuropathy for 6 days. Therapeutic measures were taken as a result of acute demyelinating polyneuropathy which includes IVIG. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event "acute demyelinating polyneuropathy" was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported acute demyelinating polyneuropathy cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Flank pain, Limb injury
Clinical narrative: This morning the pain has dropped to my right buttock and is radiating down my right leg; This morning the pain has dropped to my right buttock and is radiating down my right leg; a weakness in my right leg; right leg has buckled a couple times; Weakness; tiredness; Chills; right flank pain that seemed to be over the right kidney; It seemed to me to be muscular so I dismissed it. This morning the pain has dropped to my right buttock and is radiating down my right leg; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 71-years-old), for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications and no other vaccine was administered on the same date. Exactly one week after the injection, on 17Feb2021, the patient began having routine symptoms including weakness, tiredness, and chills. The unusual and unexpected symptom was a right flank pain that seemed to be over the right kidney. According to the patient, it seemed to be muscular, so he dismissed it. On the morning of 21Feb2021, the pain had dropped to his right buttock and was radiating down his right leg. The patient also reported a weakness in his right leg and that his right leg had buckled a couple times this morning (21Feb2021). The patient did not receive treatment for weakness, tiredness, chills, right flank pain, muscular (pain), pain had dropped to his right buttock and was radiating down right leg, weakness in right leg, and right leg had buckled. The clinical outcome of weakness, tiredness, chills, right flank pain, muscular (pain), pain had dropped to his right buttock and was radiating down right leg, weakness in right leg, and right leg had buckled was not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: This morning the pain has dropped to my right buttock and is radiating down my right leg; This morning the pain has dropped to my right buttock and is radiating down my right leg; a weakness in my right leg; right leg has buckled a couple times; Weakness; tiredness; Chills; right flank pain that seemed to be over the right kidney; It seemed to me to be muscular so I dismissed it. This morning the pain has dropped to my right buttock and is radiating down my right leg; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 10Feb2021 (at the age of 71-years-old), for COVID-19 immunization. There was no medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications and no other vaccine was administered on the same date. Exactly one week after the injection, on 17Feb2021, the patient began having routine symptoms including weakness, tiredness, and chills. The unusual and unexpected symptom was a right flank pain that seemed to be over the right kidney. According to the patient, it seemed to be muscular, so he dismissed it. On the morning of 21Feb2021, the pain had dropped to his right buttock and was radiating down his right leg. The patient also reported a weakness in his right leg and that his right leg had buckled a couple times this morning (21Feb2021). The patient did not receive treatment for weakness, tiredness, chills, right flank pain, muscular (pain), pain had dropped to his right buttock and was radiating down right leg, weakness in right leg, and right leg had buckled. The clinical outcome of weakness, tiredness, chills, right flank pain, muscular (pain), pain had dropped to his right buttock and was radiating down right leg, weakness in right leg, and right leg had buckled was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Musculoskeletal stiffness, Myalgia, Rash
Clinical narrative: severe pain in shoulders and hips; muscle pain; stiffness; rash on scalp, forehead arms, chest and forearms; extensive bruising of rt arm; This is a spontaneous report from a contactable physician (patient). This 69-year-old male physician received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0142) via an unspecified route of administration in the right arm on 08Jan2021 at 09:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (DM), hypertension (HTN), obesity, and remote testicular cancer, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASA), metoprolol, colchicine, glimepiride, and enalapril, all from unknown dates for unknown indications. The patient previously received tetracycline from an unknown date for an unknown indication and experienced allergies; and received the first dose of BNT162B2 (lot number EJ1685) in the right arm on 21Dec2020 at 09:45 (at the age of 68-years-old) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 the patient experienced severe pain in shoulders and hips and muscle pain as well as stiffness and rash on scalp, forehead, arms, chest, and forearms. He also reported muscle pain and extensive bruising of right arm. The events were reported as non-serious and did not require hospitalization. The events resulted in a doctor/other healthcare professional office/clinic visit and the patient received steroids for treatment. The outcomes of severe pain in shoulders and hips; muscle pain; stiffness; rash on scalp, forehead, arms, chest and forearms; and extensive bruising of right arm were not recovered. It was also reported that since vaccination the patient tested negative for COVID via polymerase chain reaction (PCR) test on 25Dec2020.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe pain in shoulders and hips; muscle pain; stiffness; rash on scalp, forehead arms, chest and forearms; extensive bruising of rt arm; This is a spontaneous report from a contactable physician (patient). This 69-year-old male physician received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0142) via an unspecified route of administration in the right arm on 08Jan2021 at 09:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (DM), hypertension (HTN), obesity, and remote testicular cancer, all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASA), metoprolol, colchicine, glimepiride, and enalapril, all from unknown dates for unknown indications. The patient previously received tetracycline from an unknown date for an unknown indication and experienced allergies; and received the first dose of BNT162B2 (lot number EJ1685) in the right arm on 21Dec2020 at 09:45 (at the age of 68-years-old) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 the patient experienced severe pain in shoulders and hips and muscle pain as well as stiffness and rash on scalp, forehead, arms, chest, and forearms. He also reported muscle pain and extensive bruising of right arm. The events were reported as non-serious and did not require hospitalization. The events resulted in a doctor/other healthcare professional office/clinic visit and the patient received steroids for treatment. The outcomes of severe pain in shoulders and hips; muscle pain; stiffness; rash on scalp, forehead, arms, chest and forearms; and extensive bruising of right arm were not recovered. It was also reported that since vaccination the patient tested negative for COVID via polymerase chain reaction (PCR) test on 25Dec2020.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 09Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were unknown. Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient experienced chills and fever of 100.4 F in Feb2021. Treatment for the events chills and fever included two acetaminophen (TYLENOL extra strength). The outcome of the events chills and fever was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: I have been tested for COVID and was positive; Headache; fever; head and chest congestion; head and chest congestion; sneezing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EN5318; expiration date: unknown) at 46-year-old vaccination age via an unspecified route of administration in the left arm on 24Feb2021 13:15 at a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included vitamin D nos (VITAMIN D) and birth control medication. The patient reported that she received the vaccine in her workplace clinic. She reported that she had headache, fever, head and chest congestion, sneezing, and nausea. The events did not require treatment. The patient further mentioned that she had been tested for COVID and was positive on an unspecified date (also reported as has not been tested post vaccination, pending clarification). She believes that is why she had those symptoms, not because of the vaccine itself. She received the vaccine on 24Feb2021 with symptoms appearing the following day (25Feb2021). She and her friend were with the day prior to getting the vaccine has tested positive for COVID as well (also reported as covid prior vaccination, pending clarification). The outcome of the events was recovering.; Sender's Comments: The patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE) on 24Feb2021 with symptoms appearing the following day on 25Feb2021.   She tested for COVID and was likely positive on an unspecified date. The reported events including suspected COVID-19 test positive were unrelated to the vaccine bnt162b2.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Upper respiratory tract congestion
Clinical narrative: I have been tested for COVID and was positive; Headache; fever; head and chest congestion; head and chest congestion; sneezing; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EN5318; expiration date: unknown) at 46-year-old vaccination age via an unspecified route of administration in the left arm on 24Feb2021 13:15 at a single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included vitamin D nos (VITAMIN D) and birth control medication. The patient reported that she received the vaccine in her workplace clinic. She reported that she had headache, fever, head and chest congestion, sneezing, and nausea. The events did not require treatment. The patient further mentioned that she had been tested for COVID and was positive on an unspecified date (also reported as has not been tested post vaccination, pending clarification). She believes that is why she had those symptoms, not because of the vaccine itself. She received the vaccine on 24Feb2021 with symptoms appearing the following day (25Feb2021). She and her friend were with the day prior to getting the vaccine has tested positive for COVID as well (also reported as covid prior vaccination, pending clarification). The outcome of the events was recovering.; Sender's Comments: The patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE) on 24Feb2021 with symptoms appearing the following day on 25Feb2021.   She tested for COVID and was likely positive on an unspecified date. The reported events including suspected COVID-19 test positive were unrelated to the vaccine bnt162b2.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Communication disorder, Jaundice, Seizure
Clinical narrative: Bell's palsy; jaundice looking legs; inability to communicate clearly; Seems to be experiencing numerous seizures; This is a spontaneous report from a non-contactable consumer. A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot and expiry unknown), via an unspecified route of administration on 26Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Bell's palsy, jaundice looking legs, inability to communicate clearly and seems to be experiencing numerous seizures on 04Mar2021. The events were considered serious due to hospitalization. The patient was hospitalized on 04Mar2021. It was unknown if patient received treatment for the events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Chest pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Feb2021 15:15 (batch/lot number: EN6198) as a single dose for COVID-19 immunization. Medical history included heart attack approximately 20 years ago). Family history included heart problems. Patient received unspecified concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. Patient experienced some side effects after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine. About 3-4 hour after she received the vaccine, on 03Feb2021 19:00, she had heart pain for around 5 hours, she also experienced shoulder and neck ache. These symptoms have resolved. She would like to know if she should receive the second dose of the vaccine, if these symptoms would be worse. Treatment for side effects: she put Spikenard, an oil, on the chest for the heart. At 15:10, she was fine, went home, had dinner, and then she first got shoulder pain/shoulder blade pain and then a stiff neck. Then she thought, she will go to bed and then had severe chest pain most of the night. Patient has never had flu or any vaccines. AEs did not require a visit to emergency room/physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event shoulder pain was recovering, of the event neck pain was recovered in 2021, and of the events heart pain, stiff neck, and chest pain was recovered on 23Feb2021.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disorientation, Dizziness, Dyspnoea, Eating disorder
Clinical narrative: dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Hallucination, Memory impairment, Musculoskeletal stiffness
Clinical narrative: dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Pain in extremity, Pneumonia, Pyrexia
Clinical narrative: dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Speech disorder, Tremor, Unresponsive to stimuli
Clinical narrative: dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Epstein-Barr virus infection reactivation, Fatigue
Clinical narrative: I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient).  The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00.  Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Nightmare, SARS-CoV-2 test
Clinical narrative: I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient).  The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00.  Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Chills, Dizziness, Head injury
Clinical narrative: dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: dizzy; Then I passed out; Headache; Nausea; Arm soreness 2 hours after injection.; Chills for well over 12 hours; stomach pain; big bump on my head where I hit the tile floor; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received the first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 05Mar2021, 16:30 as a single dose for covid-19 immunisation. The patient's medical history included allergies to Sulfa based meds from an unknown date and unknown if ongoing. The patient had Covid prior to vaccination. Concomitant medications included cranberry; colecalciferol (D3), fish oil, and multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 05Mar2021 at 18:30, the patient experienced headache, nausea, arm soreness 2 hours after injection. Chills for well over 12 hours. Most concerning, patient got up in the middle of the night. Used facilities. Washed hands, and was having stomach pain. Then she passed out. she came to, and have a big bump on her head where she hit the tile floor. Sunday Morning (07Mar2021) she was dizzy. Maybe from the bump on her head. The patient did not received treatment for the events. The outcome of the events was recovering at the time of the report. The has not tested positive for Covid-19 post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: I passed out; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot Number: EL3248), via an unspecified route of administration, administered in arm left on 05Mar2021 11:00 am as a single dose for COVID-19 immunization. Medical history included hypertension (blood pressure). The patient is not a pregnant. Concomitant medications in two weeks included ashwagandha taken for an unspecified indication, start and stop date were not reported, and blood pressure meds (unspecified). There is no other vaccine received in four weeks. The patient passed out Sunday night, 07Mar2021 23:00, she's not sure if it was related to the vaccine. The AE resulted in: Doctor or other healthcare professional office/clinic visit. No Covid prior vaccination. No Covid tested post vaccination. Therapeutic measures were taken for the AE. The outcome of event was recovered on an unspecified date in Mar2021.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Adacel use generally gives arm pain; Initial information was received on 12-Mar-2021 regarding an unsolicited valid non-serious case from a other health professiona ( Inquiry Number: 00516621)  This case involves an adult patient who experienced adacel use generally gives arm pain (injection site pain), while the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious adacel use generally gives arm pain (injection site pain) unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Body temperature increased, Chills, Headache
Clinical narrative: I have had a non-stop pressure headache since the second dose. I drink plenty of water. I take Tylenol / Ibuprofen daily. Nothing helps. Laying down makes it worse. It throbs in the roof of my mouth and my nose. It is nauseating. I feel like someone is squeezing my brain. My blood pressure, pulse, and oxygen are fine.   I did reach out to a neurologist about this. I was thought to have IIH over two years ago when I was 70 lbs heavier, but I have not had a symptom since losing weight. Opening pressures and scans show no evidence of it. The headaches I am having now are significantly worse than that was. It hurts down my neck as well.  The headaches began approximately 18 hours after the second dose. I was nauseated. I had chills. I had a temperature. My joints ached. My muscles ached. My body ached I was seen at the hospital twice for the seemingly common and expected side effects. I received IV medication for nausea and plenty of fluids. The headache, however, did not let up. 60ish hours after the second dose and all other symptoms ceased. The headache, however, remained. It persists. The headaches get so intense sometimes that my body feels like it needs to jerk, or twitch. I honestly cannot explain this sensation. I feel like I have to really focus to keep my body from moving impulsively.  It is bothersome, but I am concerned with how long it is lasting, especially with reports of strokes following the vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain, Sensation of foreign body
Clinical narrative: I have had a non-stop pressure headache since the second dose. I drink plenty of water. I take Tylenol / Ibuprofen daily. Nothing helps. Laying down makes it worse. It throbs in the roof of my mouth and my nose. It is nauseating. I feel like someone is squeezing my brain. My blood pressure, pulse, and oxygen are fine.   I did reach out to a neurologist about this. I was thought to have IIH over two years ago when I was 70 lbs heavier, but I have not had a symptom since losing weight. Opening pressures and scans show no evidence of it. The headaches I am having now are significantly worse than that was. It hurts down my neck as well.  The headaches began approximately 18 hours after the second dose. I was nauseated. I had chills. I had a temperature. My joints ached. My muscles ached. My body ached I was seen at the hospital twice for the seemingly common and expected side effects. I received IV medication for nausea and plenty of fluids. The headache, however, did not let up. 60ish hours after the second dose and all other symptoms ceased. The headache, however, remained. It persists. The headaches get so intense sometimes that my body feels like it needs to jerk, or twitch. I honestly cannot explain this sensation. I feel like I have to really focus to keep my body from moving impulsively.  It is bothersome, but I am concerned with how long it is lasting, especially with reports of strokes following the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Entire upper arm is swollen & hard.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hyperhidrosis, Hypoaesthesia, Injection site pain
Clinical narrative: 3/18/2021 12:00 PM- numbness in lower part of left arm from armpit to little finger, ended at approximately 2:00 PM 11:00PM-severe chills, severe pain in shot location, body muscle aches followed by nausea- took 1 Advil, chills went away 2:00 AM -severe chills, body aches,  followed by nausea-took 1 Advil, chills went away, able to sleep 5:00AM - nausea, body tried to vomit but nothing in my stomach so had dry heaves, lasting for about 30 minutes and profuse sweating                      body felt hot, nausea, and body aches continued for about 1/2 the day.  I took an Advil sinus and cold caplet that made me feel better.  5:00PM began feeling sick once again, body aches, chills, sweating.  took temperature 100.5.  (didn't take temperature before because too sick to look for thermometer.  Tried to sleep but too restless.  Took 2 Advil, fever went away as well as body aches and nausea.  slept through the night.  3/19/2021 Woke up approximately 6:00AM, left arm hurt about an 8 out of 10, very sore to move and swollen.  I felt very tired and lethargic.