chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Sneezing, Vaccination site pain
Clinical narrative: not feeling that great; his arm hurts where he was given the shot/left arm sore; two nosebleeds; headache; sneezed; medical history included: real bad arthritis and adrenal insufficiency; medical history included: real bad arthritis and adrenal insufficiency; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via intramuscular route of administration on 19Jan2021 at 14:30 in the arm left at a single dose to prevent covid. The patient's medical history included high blood pressure from Feb2019, cancer (three times, for clarification), real bad arthritis and adrenal insufficiency. Also, the patient had lost a kidney, two adrenal glands, and part of his prostate. Concomitant medications included hydrocortisone (strength: 10 mg) for adrenal insufficiency, amlodipine (strength: 5 mg) for high blood pressure, colchicine (strength: 0.6 mg), irbesartan (strength: 150 mg), and fludrocortisone (strength: 0.1 mg) for adrenal insufficiency. The patient previously took a flu shot in Oct (as reported) and experienced sore arm. Patient goes to the doctor to get the flu shot each year. On 20Jan2021, the patient had two nosebleeds and headache. He has never had a nose bleed and could not remember the last time he had a nose bleed. The first nose bleed was worse and was concerning. He sneezed and that is what started the second nose bleed. The first nose bleed was worse than the second one. He asked if nosebleed was one of the side effects of the vaccine. It was not listed as side effect on the website when he looked it up. He also stated that his arm hurts where he was given the shot/left arm sore and was not feeling that great on an unspecified date. His height was 5'10'' or 5'11'' on an unspecified date. The outcome of the events two nosebleeds and  headache was recovered on 21Jan2021; events not feeling that great and his arm hurts where he was given the shot/left arm sore was recovering; while unknown for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: loud noise in ear, that comes and goes; This is a spontaneous report from a non-contactable consumer (patient). This female patient of an unspecified age (age: 55, unit: unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 20Jan2021 17:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced loud noise in ear, that comes and goes on 21Jan2021 10:00 with outcome of unknown. The reporter wanted to know if this has been reported before and wanting guidance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: chills; nausea; It goes from mild then goes to a point where she feels really tired; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 13Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, after receiving the first dose of the vaccine, the patient experienced chills and nausea. The event nausea does not go away. It was mild then it goes to a point where she felt really tired. The patient wanted to know if it is normal for her nausea to last for 7 days. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Lethargy, Limb discomfort
Clinical narrative: Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic; Injection site pain; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm, on 16Jan2021 17:15, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive other vaccines in four weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date unknown), via an unspecified route of administration in the left arm, on 28Dec2020 16:45, for COVID-19 immunization. The patient did not test for COVID-19 post vaccination. On 17Jan2021 at 08:00, the patient experienced extreme fatigue, heavy and achy legs, headache, no appetite, nausea, lethargic and injection site pain. No treatment was provided for the events. The outcome of the events was resolved on an unspecified date.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic; Injection site pain; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm, on 16Jan2021 17:15, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive other vaccines in four weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date unknown), via an unspecified route of administration in the left arm, on 28Dec2020 16:45, for COVID-19 immunization. The patient did not test for COVID-19 post vaccination. On 17Jan2021 at 08:00, the patient experienced extreme fatigue, heavy and achy legs, headache, no appetite, nausea, lethargic and injection site pain. No treatment was provided for the events. The outcome of the events was resolved on an unspecified date.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: Headache; Body aches; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine (unspecified Pfizer vaccine) on 30Dec2020 within 4 weeks prior to the COVID vaccine. On 20Jan2021 the patient experienced headache and body aches. No treatment was received for the events. Post vaccination, the patient has been tested for COVID-19 (Nasal swab) on 21Jan2021, test result was negative. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovering.   Information on lot number/batch number was requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Fatigue, Headache, Hypertension
Clinical narrative: feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. 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 been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, SARS-CoV-2 test, Thinking abnormal
Clinical narrative: feeling tired but also edgy; edgy/ nervous; anxious; unable to focus; headaches; blood pressure was much higher than normal; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284) via an unspecified route of administration on the left arm on 11Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included hypothyroidism and back pain. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen and ergocalciferol (VIT D). The patient previously received 1st dose of BNT162B2 on 20Dec2020 for COVID-19 immunization (left arm, lot number: EH9899). After receiving second dose on 11Jan2021 the patient was feeling tired but also edgy, nervous, anxious, unable to focus, some headaches. Discovered 18Jan2021 that blood pressure was much higher than normal and associated with the way I was feeling. Had to go to primary care to have medication prescribed. The events resulted to a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. Patient was not pregnant. No known allergies. The facility where the vaccine was administered was in a workplace clinic. 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 been tested for COVID-19 (Nasal swab), on 13Jan2021 and 16Jan2021 both test results were negative. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: having a rash all over her body; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient experienced having a rash all over her body on 20Jan2021. The outcome of the event was unknown.   Information on lot and batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: fatigued and tired; weak; This is a spontaneous report from a contactable consumer (patient's wife). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (arm) on 19Jan2021 at single dose for Covid-19 immunization (also reported as Covid protection). The patient has no medical history. The patient's concomitant medications were not reported. The reporter confirmed that the patient does take other medications, but they never make him tired or weak. The reporter also confirmed that the patient did not receive any other vaccines on the same day as the COVID vaccine. It was reported that the patient took the Covid 19 vaccine on Tuesday (19Jan2021). The patient was fatigued and tired on 21Jan2021. It was further reported that the patient was tired and weak on 21Jan2021. The reporter added that that she knows tiredness and weakness are known side effects of the product, but she wanted to know how long after they get the vaccine those side effects last, and to what degree do they occur. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: her arm where she had the vaccine is still sore and tingling; her arm where she had the vaccine is still sore and tingling; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration into the arm on Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm where she had the vaccine was still sore and tingling on an unspecified date. Outcome of events was unknown.  Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: his shoulder hurt when he received the vaccine because of the needle; This is a spontaneous report from a non-contactable consumer (patient himself) via Medical Information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, expiration date was unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that his shoulder hurt when he received the vaccine because of the needle on 20Jan2021, but no other symptoms. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymph node pain, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Left side Swollen Lymph nodes was reported as worsned.; Left Forearm hurting and swelling; forearm hurts super bad; the lymph nodes were really tender, she would push it and it would hurt; lymph nodes on her arms got swollen to softball size/ Left side Swollen Lymph nodes/ the lymph nodes getting bigger; This is a spontaneous report from a contactable consumer reporting for herself. A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 19Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included etonogestrel (NEXPLANON) for contraceptive implant. The patient received the first dose of BNT162B2 on 29Dec2020. The patient reported a side effect from receiving the vaccine, lymph nodes on her arms got swollen to "softball size" since 19Jan2021 when she received the second dose of the vaccine and wants to know if this was normal. She understands that the arm was going to hurt, but she was noticing that her forearm hurts super bad and it a bit swollen, just on the side of the forearm its swollen, but under that arm her lymph nodes are swollen, she can barely pick up the arm and it just hurts on 20Jan2021. She noticed yesterday (19Jan2021), the lymph nodes were really tender, she would push it and it would hurt. Then when she got home from work, she lifted the arm to look at it, and she could see the swollen lymph nodes, the longer she kept the arm up, she could see the lymph nodes getting bigger. She wants to know how long this will last. She was talking to her mom and she was freaking out saying that people are dying from covid and the swollen lymph nodes, and that's why she has called today. She also stated that her left side swollen lymph nodes was worsened on an unspecified date. The outcome of the event swollen lymph nodes was not recovered, left forearm hurting and swelling and forearm hurts super bad was recovering while other events were unknown.   Information on the Lot/Batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Feeling cold, Headache
Clinical narrative: cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Nausea, Pain, Pyrexia
Clinical narrative: cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: 24 hours later I came down with diarrhea; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 20Jan2021 11:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the vaccine yesterday morning at 11 o'clock, and 24 hours later I came down with diarrhea (21Jan2021). How long will it last? Okay... other than contacting the doctor, do you have Diet recommendations? I haven't eaten anything." The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe forehead and scalp itching 1h after vaccination; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had severe forehead and scalp itching, 1 hour after vaccination. The pharmacist gave the patient Benadryl and it cleared up. The pharmacist followed up with the patient and the patient was not having any more issues. He just wanted to know if the patient should get the second dose after the event. The outcome of the event was recovered on unspecified date.Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Dyspnoea, Headache
Clinical narrative: Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and low back pain; headache; concomitant medications included mercaptopurine; concomitant medications included mercaptopurine; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular at right arm on 19Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications included mercaptopurine, mirtazapine (REMERON), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC). The patient previously took ADDERALL, HUMIRA and REMICADE and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at right arm on 30Dec2020 at 15:45 at single dose for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced hives, itching, shortness of breath, chest tightness, severe hip and low back pain and headache.  Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine, EPI PEN, TORADOL, acetaminophen, DECADRON, DILAUDID. The patient outcome of the events was resolved with sequel.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Pruritus, Urticaria
Clinical narrative: Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and low back pain; headache; concomitant medications included mercaptopurine; concomitant medications included mercaptopurine; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular at right arm on 19Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications included mercaptopurine, mirtazapine (REMERON), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC). The patient previously took ADDERALL, HUMIRA and REMICADE and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at right arm on 30Dec2020 at 15:45 at single dose for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced hives, itching, shortness of breath, chest tightness, severe hip and low back pain and headache.  Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine, EPI PEN, TORADOL, acetaminophen, DECADRON, DILAUDID. The patient outcome of the events was resolved with sequel.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Mouth swelling, Swollen tongue, Visual impairment
Clinical narrative: swelling of tongue and mouth; swelling of tongue and mouth; Trouble swallowing normally; dizzy; seeing stars; This is a spontaneous report from a contactable consumer (the patient).  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL8982), via an unspecified route of administration in the left arm on 21Jan2021 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included allergies when growing up: food allergies, allergic to pollens, allergic to iodine. The patient took allergy shots for years. The patient did not have trouble very often anymore. The patient stated she was healthy. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included: clarithromycin (CLARITIN). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced a little swelling of tongue and mouth, trouble swallowing normally, and dizzy and seeing stars. For treatment of these events, the patient took diphenhydramine hydrochloride (BENADRYL). The clinical outcome a little swelling of tongue and mouth, trouble swallowing normally, and dizzy and seeing stars was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Headache, Nausea
Clinical narrative: Severe headache; nausea; dry mouth; chills without fever; This is a spontaneous report from a contactable pharmacist. A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3246), intramuscular on 19Jan2021 on the right arm at a single dose for COVID-19 immunization.  The patient had no relevant medical history and no known allergies.  The patient's concomitant medications were not reported.  It was unknown if the patient had COVID-19 prior to vaccination. It was unknown if the patient had other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 post vaccination. It was reported that the patient experienced severe headache, nausea, dry mouth and chills without fever all on 20Jan2021. Treatment for the events was acetaminophen and diphenhydramine. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Nausea, Oxygen saturation, Pain
Clinical narrative: headache; nauseated; achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 73 [unit unspecified]) received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 16Jan2021 at a single dose for covid-19 immunization. Medical history included SARS-Cov-2 from 09Dec2020 to an unknown date and IBS (irritable bowel syndrome). The patient's concomitant medications were not reported. The patient reported that she had the injection which was basically painless. The patient reported that she had headache, nauseated and achy on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included blood pressure was fine, oxygen saturation (pulse ox) was fine, and weight was 99 lbs., all on an unspecified date. The outcome of the events was unknown.   The following information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: headache; nauseated; achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 73 [unit unspecified]) received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 16Jan2021 at a single dose for covid-19 immunization. Medical history included SARS-Cov-2 from 09Dec2020 to an unknown date and IBS (irritable bowel syndrome). The patient's concomitant medications were not reported. The patient reported that she had the injection which was basically painless. The patient reported that she had headache, nauseated and achy on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included blood pressure was fine, oxygen saturation (pulse ox) was fine, and weight was 99 lbs., all on an unspecified date. The outcome of the events was unknown.   The following information on the batch/lot number has been requested.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up; This is a spontaneous report from a contactable consumer (patient's wife). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in left arm, on 21Jan2021 at 10:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine along with his wife this morning, at 10 AM. They were both monitored for 15 minutes post-vaccination (waited 15 minutes). Shortly after being home on 21Jan2021 (10 minutes after getting home), the patient started throwing up and seemed to be alright now. The patient's wife asked if she should be concerned and if this experience was reported as a side effect after vaccination; if the patient's vomiting is from the shot or not. The patient recovered from the event on 21Jan2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Vertigo
Clinical narrative: Vertigo; Ataxia; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A 64-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2 also reported as product COVID 19 vaccine brand Pfizer, lot EL3302), intramuscularly in the left arm on 20Jan2021 10:15 at SINGLE DOSE for Covid-19 vaccination. The patient's medical history was not reported. No known allergies. No Covid prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), naproxen sodium (NAPROSYN), sertraline hydrochloride (ZOLOFT) and esomeprazole sodium (NEXIUM). The patient experienced vertigo and ataxia on 21Jan2021 08:30. No treatment was given. The outcome of events was recovering.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration at right arm on 20Jan2021 at a single dose for COVID-19 immunization  The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient was having a bad headache on unspecified date. The outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Petechiae, Platelet count decreased, SARS-CoV-2 test negative
Clinical narrative: admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: chills; body aches; low grade temperature; left axilla has become very swollen and painful; left axilla has become very swollen and painful; fluid accumulation in the subcutaneous tissue; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL3247; expiration date: unknown), via an unspecified route of administration left arm on 17Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included known penicillin allergies. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were none. The patient previously took sulfamethoxazole-trimethoprim (BACTRIM) but had allergies. The patient historically vaccine included first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL0140; expiration date: unknown) at the age of 43-year-old via an unspecified route of administration right arm on 29Dec2020 10:00 AM at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the vaccine in a hospital but 36 hours after the vaccine (18Jan2021), the patient developed chills, body aches and low-grade temperature. Then 48 hours later, her left axilla has become very swollen and painful. The pain has subsided but remains mild and swelling persists. The area seems to show fluid accumulation in the subcutaneous tissue but no erythema or e/o [evidence of (pending confirmation)] abscess infection noted. It's now been present for 4 days. The patient received treatment which included NSAIDs. The patient had not been COVID tested post vaccination. The outcome of the events was not recovered.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Skin oedema, Swelling
Clinical narrative: chills; body aches; low grade temperature; left axilla has become very swollen and painful; left axilla has become very swollen and painful; fluid accumulation in the subcutaneous tissue; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL3247; expiration date: unknown), via an unspecified route of administration left arm on 17Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included known penicillin allergies. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were none. The patient previously took sulfamethoxazole-trimethoprim (BACTRIM) but had allergies. The patient historically vaccine included first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL0140; expiration date: unknown) at the age of 43-year-old via an unspecified route of administration right arm on 29Dec2020 10:00 AM at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the vaccine in a hospital but 36 hours after the vaccine (18Jan2021), the patient developed chills, body aches and low-grade temperature. Then 48 hours later, her left axilla has become very swollen and painful. The pain has subsided but remains mild and swelling persists. The area seems to show fluid accumulation in the subcutaneous tissue but no erythema or e/o [evidence of (pending confirmation)] abscess infection noted. It's now been present for 4 days. The patient received treatment which included NSAIDs. The patient had not been COVID tested post vaccination. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache
Clinical narrative: Headache; Chills; Fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular, on 20Jan2021, at a single dose for COVID-19 immunization. The vaccine was administered at a nursing home/senior living facility. The patient was not pregnant at the time of vaccination. Medical history included COVID-19. The patient had covid prior to vaccination. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), on 30Dec2020 for COVID-19 immunization. The patient experienced headache, chills, fatigue on 21Jan2021. The patient was tested for COVID-19 post vaccination: Nasal Swab (covid test name post vaccination=Abbott POC) on 21Jan2021 with result of negative. No treatment was received for the reported events. Outcome of the events was recovering.   Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: Very sore right arm; large lump in right armpit; This is a spontaneous report from a contactable other healthcare professional (HCP reported for self). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3246, expiry date not reported), via an unspecified route of administration on 19Jan2021 at a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient had no COVID prior to vaccination. Concomitant medications included vitamins nos (DAILY VITAMINS), and atorvastatin; both reported as other medications in two weeks.  The patient received the first dose of BNT162B2 (brand: Pfizer, Lot: EK 9231, expiry date not reported), on 29Dec2020 at 08:00 PM in the left arm. The patient had no other vaccine in four weeks. On 21Jan2021 11:00 AM, the patient had very sore right arm after shot; and large lump in right armpit formed about 20 hours after 2nd dose (20Jan2021). The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatments were received in related to the reported events. The patient was not tested for COVID post vaccination. The outcome of the events very sore right arm and large lump in right armpit was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test, Vaccination site swelling
Clinical narrative: Headache; Body aches; Swelling at site; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 20Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Nursing Home/Senior Living Facility. On 20Jan2021, the patient experienced headache, body aches and swelling at site. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient underwent nasal swab on 21Jan2021 and showed a negative COVID test result.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting after 48 hours of the second COVID-19 vaccination dose; This is a spontaneous report from a contactable consumer (parent of patient). This 35-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date as single dose for COVID-19 immunisation.  No medical history or concomitant medication was reported.  The patient previously took COVID-19 vaccination dose 1.  The patient experienced vomiting after 48 hours of the second COVID-19 vaccination dose on unspecified date.  Outcome of event vomiting was unknown.  Information on the Lot/Batch number has been requested
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain for two weeks so far since second dose/started by aching then becomes extremely sore and then goes away in one day; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 08Jan2021 08:30 at a single dose for COVID-19 immunization on a hospital. Medical history included ADHD. The patient has no known allergies and no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 18Dec2020 at 13:00 in the right arm for COVID-19 immunization. The patient experienced joint pain for two weeks so far since second dose (08Jan2021 09:30). It started in the left shoulder of the arm she received it in. That same day, it started in her knee on the left side, then went to both knees, moved to her right shoulder then left shoulder then to her right elbow for one day. Now it's her left shoulder again for one day. It started by aching then becomes extremely sore and then goes away in one day. The event was not treated.  The patient was not tested for Covid post vaccination. The outcome of the event was recovering.