chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she went to sit up and get out of bed/ Her head feels like it is swimming mostly when she gets in and out of bed. When she lays her head down and picks her head up; foggy headed/ floaty heady feeling/ she puts her head down, it is like woah this is strange; arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for 2 patients. This is the first of 2 reports. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiration date: 30Apr2021), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient is taking medication for ongoing blood pressure and ongoing thyroid. Ongoing concomitant medication included metoprolol succinate for blood pressure and levothyroxine sodium (SYNTHROID) for thyroid. She received the vaccine on Saturday 16Jan2021. It went very well. On 16Jan2021, she had a little bit of arm tenderness that lasted for 24-36 hours. Her arm was a little sore. The odd thing is that something took place when she got into bed on Sunday night 17Jan2021 which was 30 hours after the vaccine. Her head started to spin when she put her head down on the pillow. She was very dizzy. She was light headed/ foggy headed. That passed until she went to sit up and get out of bed. It happened again. It has been happening on and off for the last 3 days. She has checked her blood pressure because she is on a low dose blood pressure medicine. Her blood pressure was okay. Everything else seems to be normal. She gets that dizziness for a very short period of time. Her head is not a headache. It is so hard to explain. It is like a floaty heady feeling. She did have a little achiness in her arm. When she puts her head down, it is like woah this is strange. Her head feels like it is swimming. It is mostly when she gets in and out of bed. When she lays her head down and picks her head up. She provided that her height as 5'1" to 5'1.5".  The event arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm recovered on 18Jan2021; outcome for all other events was not recovered.; Sender's Comments: Linked Report(s) same reporter/drug, similar event,  different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever and myalgias persistent 48 hours after vaccination, no SOB, no cough, no abdominal pain, no loss of smell. treated with tylenol.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Formication, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling fingertips/gets bouts of tingling or being numb/neuropathy type, numb tingling sensation; like a traveling sensation; her joints, later clarified that she has to keep opening and closing her left hand; This is a spontaneous report from a contactable consumer.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 15Jan2021 10:00 at SINGLE DOSE, for covid-19 immunization. The patient is right-handed which is why she got the vaccine in her left arm. Medical history included ongoing high blood pressure since an unknown date in 2011 (diagnosed about 10 years ago).  There were no concomitant medications used. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient was experiencing numbness from her hand, wrist, and fingers up to her elbows in her left arm, she described it as "a neuropathy type of feeling"; tingling at her fingertips, her joints, later clarified that she has to keep opening and closing her left hand. All of these has been continuous, and it seems like it was getting worse not better. It was uncomfortable and hard to explain, it was weird. She describes that it was like "a pain that travels from her elbow to wrist but its numb at the same time". Her left hand gets bouts of tingling or being numb. She has to open and close her hand. Her left arm feels essentially numb from her wrist to the elbow region. She knew there was something going on the day of the injection like a traveling sensation, but she started to really notice the neuropathy type, numb tingling sensation on Saturday (16Jan2021). She clarified that she was not in pain. She did not have any of these symptoms prior to getting the vaccine She was hoping it will go away because it was concerning since it has been about a week since the vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Hormone level abnormal, Menstrual disorder, Premenstrual syndrome
Clinical narrative: felt like her hormones have been off; PMS syndromes; They have been breaking out after having the COvID-19 vaccine. She said usually they have clear skin.; had her period 3 times already after getting the vaccine; This is a spontaneous report from contactable consumers. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Her workplace got their first dose of the vaccine in late Dec2020 and they just got the second vaccine about a week ago. She was in the military. Consumer reported that her co-worker had menstrual problems after getting the vaccine. The patient had asked her if she felt like her hormones have been off. The patient had her period 3 times already after getting the first vaccine in Dec2020; she had her first period at the end of Dec2020 which was weird, then she got her period again a week later, and she got her period again today. On an unspecified date, the patient also experienced premenstrual syndrome (PMS) symptoms and had been breaking out after having the Covid-19 vaccine. She said, usually they have clear skin. The reporter wanted to know if this has been reported in the clinical trials. She received her second dose on 12Jan2021. Outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer reported that an adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On Dec2020, the patient experienced fever which was resolved within 24 hours. Unknown if the patient received any treatment for the event. The outcome of the event was recovered on Dec2020.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hot flush, Malaise, Myalgia
Clinical narrative: Chills; Body/muscle aches; Body/muscle aches; hot flashes; fatigue; malaise; nasal drainage; arm soreness in injection arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included Acid Reflux. Concomitant medication included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) and famotidine. On 16Jan2021 19:00, the patient experienced chills, body/muscle aches, hot flashes, fatigue, malaise, nasal drainage and arm soreness in injection arm. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. 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. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Vaccination site pain
Clinical narrative: Chills; Body/muscle aches; Body/muscle aches; hot flashes; fatigue; malaise; nasal drainage; arm soreness in injection arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included Acid Reflux. Concomitant medication included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) and famotidine. On 16Jan2021 19:00, the patient experienced chills, body/muscle aches, hot flashes, fatigue, malaise, nasal drainage and arm soreness in injection arm. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. 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. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations/racing heart.  Dr. Appointment scheduled.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Ongoing cough; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program. A 65-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration from 06Jan2021 to 06Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient also stated that he is scheduled of second dose for 27Jan2021 and he had ongoing cough on an unspecified date for five weeks and was asking if it is okay to get the second dose of vaccine while taking prednisone (treatment for his ongoing cough). Outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm hurt for about a week; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685, expiration date: unknown), via an unspecified route of administration on the right arm on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetes, ongoing hypothyroidism, high cholesterol and allergy. Concomitant medications included mometasone furoate (FLONASE [MOMETASONE FUROATE]) and montelukast sodium (SINGULAIR) - both ongoing and for allergy. No other vaccines administered on the same date with the Pfizer vaccine. The patient stated that she did okay with the first dose, and her arm hurt for about a week on an unspecified date. The outcome of the event was unknown.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Malaise, Paraesthesia, Pyrexia
Clinical narrative: Brain felt tingly like I had a fever; mild generalized malaise, arm/injection site soreness.  Slept it off that night and was better the next day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Jan2021 at 12:30 PM (at the age of 64 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included anemia, hemachromatosis, and penicillin allergy. The patient previously received the first dose of BNT162B2 on 29Dec2020 at 12:15 PM (at the age of 64 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Concomitant medication included epoetin alfa (PROCRIT) and deferasirox (JADENU). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:00 PM, the patient experienced fever, chills, headache, and extreme bodyaches. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, and extreme bodyaches was recovering. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Nurse(patient). A 47-year old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscularly on 16Jan2021 08:00 at single dose left arm, and first dose(lot number EK5730), intramuscularly on 29Dec2020 08:00 at single dose, left arm for covid-19 immunization. The patient's medical history and concomitant medications reported as no. Family medical history reported as no. Patient had a negative COVID test on 29Dec2020 prior to receiving the COVID-19 Vaccine. She received first dose of Pfizer COVID-19 Vaccine on 29Dec2020. Second dose of COVID-19 Vaccine received on 16Jan2021. She said that she tested negative after the 1st dose. The patient had a positive COVID test on 18Jan2021. The patient had not had any contact with positive patients or people. Seriousness reported as medically significant because she didn't know what comes of it. Causality reported as yes because she had no contact with anyone who had been COVID positive. Her whole family had been tested and were COVID negative. The patient tried to google it and even a couple nurses wondered if caller's positive COVID test had anything to do with caller's COVID-19 Vaccines. Caller stated she was asymptomatic. She only received the COVID-19 test because she was testing her children. Her children's COVID tests were negative. Caller was highly suspicious it came back as a positive result. Patient didn't know if it was a lab error or the vaccination process and the way the immune system works. COVID test performed was a PCR nasal swab. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest tightness - relieved with use of rescue inhaler.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration on 21Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included seasonal allergy and mild jackfruit allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included finasteride and testosterone. The patient experienced arm pain and fatigue on an unspecified date. Clinical outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is sore; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunisation. Medical history included the patient had a broken clavicle. The patient's concomitant medications were not reported. On an unknown date the patient experienced his arm is sore. The patient stated that he has a broken clavicle that is healing, and he is supposed to have Physical Therapy today for that, and he is wondering if the stretching and pulling that they would do during physical therapy will be okay after getting the vaccine yesterday. The patient stated that his arm is sore, and he anticipated that. The patient also inquired what he can take for the pain.  The clinical outcome of the arm is sore was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Fatigue, Heart rate
Clinical narrative: Migraine Headache; Body aches; Joint Pain; Chills; Night sweats; Anxiety; Fatigue; feeling as if heart is racing but when pulse was taken it was normal; This is a spontaneous report from a contactable nurse, who is also the patient.  A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231), via intramuscular route of administration in the right arm on 19Jan2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and the patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR), both from unknown dates, at unknown doses, for an unknown indications.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via intramuscular route of administration, in the right deltoid on 29Dec2020 for COVID-19 immunisation.  On 20Jan2021 at 06:00 the patient experienced migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal. The patient did not receive any treatment for the events. The clinical outcomes of the migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal  were recovered with sequelae (reported as "recovered with lasting effects") on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Night sweats, Pain, Palpitations
Clinical narrative: Migraine Headache; Body aches; Joint Pain; Chills; Night sweats; Anxiety; Fatigue; feeling as if heart is racing but when pulse was taken it was normal; This is a spontaneous report from a contactable nurse, who is also the patient.  A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231), via intramuscular route of administration in the right arm on 19Jan2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and the patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR), both from unknown dates, at unknown doses, for an unknown indications.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via intramuscular route of administration, in the right deltoid on 29Dec2020 for COVID-19 immunisation.  On 20Jan2021 at 06:00 the patient experienced migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal. The patient did not receive any treatment for the events. The clinical outcomes of the migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal  were recovered with sequelae (reported as "recovered with lasting effects") on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Stent placement
Clinical narrative: COVID vaccine] treatment under Emergency Use Authorization(EUA): patient experienced shortness of breath and chest pain the day following the vaccine. The patient was hospitalized and received a stent. Unable to rule out vaccine playing a role, so it is being reported.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports pain around the injection site that started on the day of vaccination.  The pain seems to be getting worse and is spreading.  The painful area is approximately 4 inches in diameter centered around the deltoid muscle of the left arm.  There is no redness or swelling in the area.  The patient has tried to massage the area, but the pain has not resolved.  The patient no longer has a family doctor, so he is considering seeing a walk-in clinic for treatment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Chills/Teeth chattering; Phlegm congestion in nose and throat; Phlegm congestion in nose and throat; Felt shaky/nervous; She felt fatigue; Tightening her muscles; Her joints ached; Muscle and body aches; Muscle and body aches; Brain fog; She then started to have a headache after that; This is a spontaneous report from a contactable consumer, the patient.  A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration on 19Jan2021 (at the age of 52-years-old) in the left arm as a single dose for COVID-19 immunization.  Medical history was not reported.  Ongoing concomitant medications included biotin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN),and cyanocobalamin (VITAMIN B12); all from unknown dates. The patient also took multivitamins from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (at the age of 52-years-old; Lot Number: EL942 or EL0142) on 29Dec2020 in the left arm for COVID-19 immunization and experienced headache and fatigue.  The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccine. On 19Jan2021, the patient experienced shaky/nervous, chills/teeth chattering, muscle and body aches, fatigue, tightening her muscles, brain fog, phlegm congestion in her nose and throat, joints aches, and headache. On 20Jan2021, she stayed well hydrated, but she slept a lot. However, she felt fatigue, had the headache off and on, tight and sore from muscle aches. Therapeutic measures were taken for the chills/teeth chattering, muscle and body aches, joint aches, and headache and included treatment with ibuprofen (ADVIL LIQUIGELS).  The clinical outcomes of chills/teeth chattering and phlegm congestion in her nose and throat, were recovered on 21Jan2021 and Jan2021, respectively.  The clinical outcomes of the felt shaky/nervous, fatigue, tightening her muscles, and joint aches were unknown; while that of the muscle and body aches, headache, and brain fog were not recovered.; Sender's Comments: Linked Report(s) : same reporter/patient, different vaccine dose and event.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Nasal congestion, Nervousness, Pain
Clinical narrative: Chills/Teeth chattering; Phlegm congestion in nose and throat; Phlegm congestion in nose and throat; Felt shaky/nervous; She felt fatigue; Tightening her muscles; Her joints ached; Muscle and body aches; Muscle and body aches; Brain fog; She then started to have a headache after that; This is a spontaneous report from a contactable consumer, the patient.  A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration on 19Jan2021 (at the age of 52-years-old) in the left arm as a single dose for COVID-19 immunization.  Medical history was not reported.  Ongoing concomitant medications included biotin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN),and cyanocobalamin (VITAMIN B12); all from unknown dates. The patient also took multivitamins from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (at the age of 52-years-old; Lot Number: EL942 or EL0142) on 29Dec2020 in the left arm for COVID-19 immunization and experienced headache and fatigue.  The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccine. On 19Jan2021, the patient experienced shaky/nervous, chills/teeth chattering, muscle and body aches, fatigue, tightening her muscles, brain fog, phlegm congestion in her nose and throat, joints aches, and headache. On 20Jan2021, she stayed well hydrated, but she slept a lot. However, she felt fatigue, had the headache off and on, tight and sore from muscle aches. Therapeutic measures were taken for the chills/teeth chattering, muscle and body aches, joint aches, and headache and included treatment with ibuprofen (ADVIL LIQUIGELS).  The clinical outcomes of chills/teeth chattering and phlegm congestion in her nose and throat, were recovered on 21Jan2021 and Jan2021, respectively.  The clinical outcomes of the felt shaky/nervous, fatigue, tightening her muscles, and joint aches were unknown; while that of the muscle and body aches, headache, and brain fog were not recovered.; Sender's Comments: Linked Report(s) : same reporter/patient, different vaccine dose and event.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Chills/Teeth chattering; Phlegm congestion in nose and throat; Phlegm congestion in nose and throat; Felt shaky/nervous; She felt fatigue; Tightening her muscles; Her joints ached; Muscle and body aches; Muscle and body aches; Brain fog; She then started to have a headache after that; This is a spontaneous report from a contactable consumer, the patient.  A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), via an unspecified route of administration on 19Jan2021 (at the age of 52-years-old) in the left arm as a single dose for COVID-19 immunization.  Medical history was not reported.  Ongoing concomitant medications included biotin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN),and cyanocobalamin (VITAMIN B12); all from unknown dates. The patient also took multivitamins from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (at the age of 52-years-old; Lot Number: EL942 or EL0142) on 29Dec2020 in the left arm for COVID-19 immunization and experienced headache and fatigue.  The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccine. On 19Jan2021, the patient experienced shaky/nervous, chills/teeth chattering, muscle and body aches, fatigue, tightening her muscles, brain fog, phlegm congestion in her nose and throat, joints aches, and headache. On 20Jan2021, she stayed well hydrated, but she slept a lot. However, she felt fatigue, had the headache off and on, tight and sore from muscle aches. Therapeutic measures were taken for the chills/teeth chattering, muscle and body aches, joint aches, and headache and included treatment with ibuprofen (ADVIL LIQUIGELS).  The clinical outcomes of chills/teeth chattering and phlegm congestion in her nose and throat, were recovered on 21Jan2021 and Jan2021, respectively.  The clinical outcomes of the felt shaky/nervous, fatigue, tightening her muscles, and joint aches were unknown; while that of the muscle and body aches, headache, and brain fog were not recovered.; Sender's Comments: Linked Report(s) : same reporter/patient, different vaccine dose and event.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Myalgia, Pain in extremity
Clinical narrative: Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all aches were gone
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site pain, Vaccination site swelling
Clinical narrative: got my vaccine yesterday/did have an allergy; my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot; my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included severe leg cramps. Concomitant medication included gabapentin. The patient previously took tetanus shot (TETANUS VACCINE) and flu shot (FLU VACCINE) on an unspecified date (reported as November) for immunisation. The patient verbalized, "I just wanted to make sure that this is normal. I got my vaccine yesterday. I waited for 30 minutes because I did have an allergy (further clarification was unknown, hence captured as event), to make sure everything was okay. Nothing happened but after I got home within 2 hours my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot. So, I just want to make sure that it's normal." When asked about the treatment, the patient stated, "No I did not I thought about taking some Aleve or whatever but my husband and I decided to wait till this morning and call to see that if it is normal like I said like a tetanus shot or flu shot. I am very sore in that area about 5 days but this was little different that it swelled from my shoulder to my elbow. I do not feel sick, I am not dizzy, and I am not short of breath. I read everything that they ask that they said you have a concern to call." Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: bump at the injection site; bump at the injection site/just a bump and it hurts; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route in the arm of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had his first COVID Vaccine and right now, he had a bump at the injection site. He was wondering if this is a normal reaction. He said it hurts to the touch or if he moves his arm. It was just a bump and it hurts. It hurts a little bit if he raise his arm up and down but right now it's not as bad as it was as patient had taken some Aspirin. When patient was asked about the lot number, patient stated "She gave me like 2 of them. She ran out of one bottle, so she had to get another bottle, she threw up the thing rest away. You know what I mean?". Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: My injection site has got a bump on it and I got a pain in it; My injection site has got a bump on it and I got a pain in it; It is injection site, it is little swollen up; muscle pain a little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient verbalized, "My injection site has got a bump on it and I got a pain in it. It seems to be gone away a little bit. I was just wondering if it is something to be concerned about. It is injection site, it is little swollen up. There's muscle pain a little bit. Clinical outcome of injection site bump and pain was recovering, while for the other events was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hypoglycaemia, Loss of consciousness
Clinical narrative: I have had a weekly routine of fasting one day a week for the last 20 years. Sometimes I would extend this to 3 days, water only. I am healthy, 6'1" weight 170-180 all of my adult life. Resting HR <56. 9 days after having my first vaccination, I did a 24 hour fast. I woke at 2 am to go to the bathroom. I became lightheaded and passed out while standing over the toilet. I layed on the floor for over 5 minutes with my head spinning. I then realized I was hypoglycemic. I have never had this issue. I took some orange juice and recovered my strength. I hit my head on the top of the toilet which required my to have 5 sutures in my chin at the ER that night.  Today I was working out for 30 minutes on an elliptical. I work out 4 to 5 times weekly.  10 minutes after returning to my room I noticed I was dizzy and checked my pulse from my watch. My HR was 210. this lasted for over 10 minutes. I have never had this issue.   I believe it would not be in my best interest to take the second vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Pruritus
Clinical narrative: headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.
Age: 59.0
Sex: F
Vaccine: ADEN_4_7, COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Woke with lymphadenopathy and tenderness  left supraclavicular  area
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: my arm was swollen, hot and had a red rash. I took Ibuprofin.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fever, chills, fatigue starting ~4 hrs after 2nd dose. Diarrhea began next morning.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: severe arm pain with movement (7 out of 10 on pain scale), which began a few hours after the vaccine and lasted until mid-afternoon on 2/3/21.  Now it's dull and more consistent with the flu vaccine. Fatigue evening of 2/2 and lasting until mid-afternoon 2/3/21.  resolved. Body aches beginning on morning of 2/3 and lasting until mid-afternoon on 2/3.  resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: SHORTLY AFTER RECEIVING VACCINE, PT STARTED COMPLAINING OF PALPIATIONS AND LIGHT HEADNESS. PT TOOK GLUCAGON TABLET SHE HAD BECAUSE SHE THOUGHT HER SUGAR WAS LOW. PT SYMPTOMS DID NOT IMPROVE. PT HAD HISTORY OF AFIB SO SHE WAS TRANSFERRED TO ER
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Injection site pruritus, Skin reaction
Clinical narrative: Got Moderna covid vaccine 1/22/21 on 1/29 7 days later arm itching the next day red and itching on same arm as vaccine given. I will not get 2nd dose abd do not recommend vaccine due to delayed unknown reaction.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Rash
Clinical narrative: Day 1-3: pain, redness at injection site.  1/30/21  3x3 fire red, raised and bumpy, painful circle around injection site; additional red circle appeared outside initial circle 2/3/21  2nd circle with same characteristics appeared below initial rash site
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Day 1-3: pain, redness at injection site.  1/30/21  3x3 fire red, raised and bumpy, painful circle around injection site; additional red circle appeared outside initial circle 2/3/21  2nd circle with same characteristics appeared below initial rash site
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death </= 24 hours post-vaccination
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Cytokine storm, Gait disturbance, Tremor
Clinical narrative: shakes, tremors, difficulty walking, back pain, confirmed Cytokine storm by PCP
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Biliary colic, Full blood count, Full blood count normal, Metabolic function test
Clinical narrative: Client, who is a PA, reports severe gallbladder pain. that started about noon the day after vaccinated. He went to Urgent Care and examined by coworker, received Tordol IM, and had labs drawn which were WNL. He was diagnosed with gallbladder pain.The pain resolved after 5-6 hours.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Headache, Myalgia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: On day 5 post second dose of COVID vaccine- developed fever, headache and muscle aches. Continued on day 6 and required a doctors visit.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Injection site pain, Myalgia
Clinical narrative: After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain near the site of the injection. However, I went to sleep and at 2 AM on 02/04/20, I started having fever, a severe HA, and myalgia that hindered my sleep. I took 500 mg Tylenol at 6 AM and went back to sleep. When I woke up at 8:30 AM, I went to use the restroom and felt dizzy with hot flashes. Immediately afterwards, I noticed that I had fainted and my mother helped me to my bed. After drinking soup and juice and having a bowel movement, I felt normal and alerted my PCP.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Syncope
Clinical narrative: After receiving the second dosage of my COVID vaccine at 2 PM on 02/03/21, I only had left arm pain near the site of the injection. However, I went to sleep and at 2 AM on 02/04/20, I started having fever, a severe HA, and myalgia that hindered my sleep. I took 500 mg Tylenol at 6 AM and went back to sleep. When I woke up at 8:30 AM, I went to use the restroom and felt dizzy with hot flashes. Immediately afterwards, I noticed that I had fainted and my mother helped me to my bed. After drinking soup and juice and having a bowel movement, I felt normal and alerted my PCP.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia
Clinical narrative: around 12 hours post Moderna Covid vaccine Patient had a possible delayed anaphylactic reaction,  called an ambulance and was brought to hospital with Hypoxia and Hypotensive. He was transferred to hospital and is being treated by Dr.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Abnormal sensation in eye, Eye pain, Pain
Clinical narrative: L eye sharp pain: happened twice and after that my eye feels " not normal".   Dull throbbing pain in L lower abdomen quadrant ( under ribcage )
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pruritus, Nausea, Rash erythematous
Clinical narrative: Received 2nd Pfizer Covid vaccine on 1/26/21 experienced extreme headaches, nausea, chills, red rash itching on vaccine area which I still have today 2/2/21.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: day after vaccination pt experiencing leg severe muscle pains, pt is not able to move much without using a walking stick, and has to have assistance to get around
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: Eight days after the vaccine she had a welting around the vaccine site and it took about 8 days to go away.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lip swelling, Pain
Clinical narrative: states had 2nd covid vaccine yesterday (2/3/21), had cosmetic lip filler in November 2020. Noted/felt  lower L lip swelling this am which appears sl better, then noticed upper L lip swelling (nothing on R).  No itching or pain. No resp or thrt sx. Does have localized injection site redness and swelling, ? sl generalized body aches, otherwise no sx. Takes Zyrtec daily for other allergies. Did not have any lip reaction with 1st vaccine. 15 yo child at home does not notice any difference in her appearance. did do google search and there was reference to others who had lip filler having similar reaction s/p covid vaccine
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Rash erythematous, Rash papular, Skin warm
Clinical narrative: patient reported a possible injection site reaction. site was itchy a few days after injection and patient noticed a rash developing. patient contacted us on 02/02/2021 to notify us. patient came in on 02/03/2021 where we observed a rash that was about 15cm x 5 cm. the rash was slightly raised, slightly red, and slightly warm. we drew a border around the rash, advised patient to take diphenhydramine and asked the patient to contact us today with the rash's progress.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: About an hour or two after the injection I started to get a medium grade headache.  Then it progressed to a serve migraine, I was able to stay at work but went straight home after.  I started taking  Maxalt for my migraines and it didn't help any, I took this for two days. Mid day on the 31st I wasn't feeling to hot, laying around, couldn't shake the headache. The following day symptoms were the same but I was more ill, sick to my stomach, flu like symptoms I would say.  I had chills and night sweats during the evening , this went on for two evenings. Monday the physical effects went away but the headache was still there and concerned me because it was on my left said. I called my Neurologist and let her now my symptoms, she stated it was most likely from the vaccine. She was surprised my medication I was taking did not work but advised me to take Tylenol and it went away completely.  About a week and a day my head ace went away and I was ok.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Night sweats
Clinical narrative: About an hour or two after the injection I started to get a medium grade headache.  Then it progressed to a serve migraine, I was able to stay at work but went straight home after.  I started taking  Maxalt for my migraines and it didn't help any, I took this for two days. Mid day on the 31st I wasn't feeling to hot, laying around, couldn't shake the headache. The following day symptoms were the same but I was more ill, sick to my stomach, flu like symptoms I would say.  I had chills and night sweats during the evening , this went on for two evenings. Monday the physical effects went away but the headache was still there and concerned me because it was on my left said. I called my Neurologist and let her now my symptoms, she stated it was most likely from the vaccine. She was surprised my medication I was taking did not work but advised me to take Tylenol and it went away completely.  About a week and a day my head ace went away and I was ok.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Paraesthesia
Clinical narrative: Arm  sore about 3 days, then at day 9 itching, pain, swelling, and redness of arm muscle at injection site.  Feels like needle sticking in muscle.  Now day 10 and symptoms persist.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Lethargy, Pain
Clinical narrative: Increased lethargy, difficulty breathing, low stamina, overall body soreness and weakness.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling cold, Hypersomnia, Oral mucosal blistering
Clinical narrative: Received second Moderna Covid-19 shot on 1/22 @ 9:40 am. Around 8 pm that evening started feeling chilled and body felt "heavy". Took ibuprofen 400 mg and went to sleep. With the exception of getting up to urinate, slept 36 hours and woke up on 1/24 with no recollection of previous day. In addition there are small blisters around both corners of mouth.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate irregular, Nausea
Clinical narrative: Fast heartbeat, dizziness, weakness, nausea, fatigue
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: pt developed sharp chest pain to the right chest 6 minutes post vaccine denied radiation, 1341- 132/79 P-101 sat 99%, pain level 4/10, 1342- 119/86 Sat 98% P-99, 1345- 118/ 76 sat 98%  chest pain 0/10, 1348 -administered Benadryl, 25 mg by mouth per protocol, 1349-121/78 sat 98% P-95 chest pain 0/10, 1354- 120/82 sat 99% pain returned 3/10 called emergency medical services for transport, 1400-144/88 P-106 sat 95%, 1401- 129/84 sat 98% chest pain 0/10, 1402 emergency medical services arrived and took over care patient complained of intermittent chest pain with inspiration, pt signed medical waiver, then went to Urgent Care on her own with her clinical instructor (Nursing Student on Clinical Rotation)