chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidentally gave a 16 year old patient a vaccination; A spontaneous report was received from a nurse, concerning a 16-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) (lot number unknown), where nurse had accidentally gave a 16-year-old patient a vaccination.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   Nurse reported that they were doing vaccination for a large group of patients and on an unknown date, one of the nurses had accidentally administered vaccination for a 16-year-old patient. However, the patient had done well post vaccine without any issues. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event accidentally gave a 16-year-old patient a vaccination was considered to be resolved on unknown date.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration (16-year-old male patient, who received Moderna's vaccine) for mRNA-1273, lot # unknownThere were no reported AEs associated with this case of inappropriate age at vaccine administration. The reported event is unlisted and company causality was assessed s not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Influenza, Pyrexia
Clinical narrative: Flu symptoms:    Fever of 101.5 for several hours, stomach upset, headache, chills.  All last for several hours.
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Full dose of 0.5ml was not given due to the needle or syringe leak; Full dose of 0.5ml was not given due to the needle or syringe leak; A spontaneous report was received from a physician. concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine, where full dose of 0.5ml was not given due to the needle or syringe leak.  There was no medical history provided. There were no concomitant medications provided.  On an unspecified date in Jan 2021, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Jan 2021 (last week), the patient did not get full dose of 0.5ml vaccine due to the needle or syringe leak. No further information was provided at the time of this report. Reporter provided consent to follow up. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for event, full dose of 0.5ml was not given due to the needle or syringe leak was resolved on an unspecified date in Jan-2021.; Reporter's Comments: This report refers to a case of underdose and syringe issue (full dose of 0.5ml was not given due to the needle or syringe leak) for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of underdose and syringe issue. The reported event is unlisted and company causality was assessed s not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Received first shot and about half went in her as the syringe was not properly attached; Received first shot and about half went in her as the syringe was not properly attached; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received first shot of Moderna's COVID-19 vaccine and about half went in her as the syringe was not properly attached.  There was no medical history provided. There were no concomitant medications provided.  On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient received her first shot of vaccine and as the syringe was not properly attached, only about half of the vaccine went in her. Patient also stated that she was not sure how much of vaccine had went into her. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event received first shot and about half went in her as the syringe was not properly attached was considered to be resolved on an unspecified date.; Reporter's Comments: This concerns a female patient of unknown age who received the first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection and reported the syringe was not properly attached and only about half of the vaccine went in her. There were no reported adverse events of the syringe was not properly attached and only about half of the vaccine went in her.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Impaired work ability
Clinical narrative: Patient experienced fever with T=max of 101.7, fatigue, arthralgias, headache, and chills. Patent did not require emergency medical attention. Patient treated with acetaminophen and bedrest. Patient was unable to attend work for 24 hours.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient experienced fever with T=max of 101.7, fatigue, arthralgias, headache, and chills. Patent did not require emergency medical attention. Patient treated with acetaminophen and bedrest. Patient was unable to attend work for 24 hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Headache, Nausea
Clinical narrative: intense chills; fever up to 101.7; body aches; headache; nausea; lack of appetite; This is a spontaneous report from a non-contactable health care professional.  A 33-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK9231), in a Health Clinic  via intramuscular route of administration on 12Jan2021 at 01:00 PM at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899), on 22Dec2020 at 08:00 AM, intramuscular on the left arm for COVID-19 immunization. The patient experienced intense chills, fever up to 101.7, body aches, headache, nausea and lack of appetite all on 12Jan2021 at 11:30 PM. The patient did not receive treatment for any of the events. The outcome of the events was recovering. The patient has not been tested for COVID-19 post vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: intense chills; fever up to 101.7; body aches; headache; nausea; lack of appetite; This is a spontaneous report from a non-contactable health care professional.  A 33-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK9231), in a Health Clinic  via intramuscular route of administration on 12Jan2021 at 01:00 PM at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899), on 22Dec2020 at 08:00 AM, intramuscular on the left arm for COVID-19 immunization. The patient experienced intense chills, fever up to 101.7, body aches, headache, nausea and lack of appetite all on 12Jan2021 at 11:30 PM. The patient did not receive treatment for any of the events. The outcome of the events was recovering. The patient has not been tested for COVID-19 post vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Illness, Skin warm
Clinical narrative: Feels like arm on fire (causing sickness); area warm to touch; fatigue
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Headache, Hypopnoea
Clinical narrative: fever; chills; severe headache; severe muscle and joint pain; chest tightness; mild nausea; lungs felt inflamed, making it difficult to take deep breaths; unable to sleep; severe muscle and joint pain; This is a spontaneous report from a contactable health care professional (patient).  A 29-year-old female patient recived the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK4176) via an unspecified route of administration on 12Jan2021 at 08:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies.  Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL], manufacturer unknown), vitamin B12 (manufacturer unknown), vitamin c  (manufacturer unknown), melatonin (manufacturer unknown), biotin (manufacturer unknown) and elderberry [sambucus nigra] (manufacturer unknown). The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EJ1685) on 22Dec2020 at 9:00 PM on the left arm. The patient did not receive other vaccines in four weeks. The patient reported that after her second dose, she began experiencing severe side effects around 5:00 pm the same day (about 7 hours after the dose was administered). These side effects were fever, chills, severe headache, severe muscle and joint pain, chest tightness, and mild nausea. She also added a difficult symptom to describe, but her lungs felt inflamed, making it difficult to take deep breaths. These symptoms lasted for 36 hours unabated, and she was unable to sleep, go to work, eat, or go about daily activities during this time. After 36 hours, the fever, chills, headache, and nausea subsided, but the muscle and joint pain and chest tightness persisted. It has been 50 hours since her second dose and the muscle and joint pain and chest tightness still persists, although its severity is reduced and it is not preventing her from work or daily activities.  The patient did not receive any treatment for all the events. The outcome of the events severe muscle and joint pain and chest tightness was not recovered while the outcome of the other events was recovering.The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: fever; chills; severe headache; severe muscle and joint pain; chest tightness; mild nausea; lungs felt inflamed, making it difficult to take deep breaths; unable to sleep; severe muscle and joint pain; This is a spontaneous report from a contactable health care professional (patient).  A 29-year-old female patient recived the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK4176) via an unspecified route of administration on 12Jan2021 at 08:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies.  Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL], manufacturer unknown), vitamin B12 (manufacturer unknown), vitamin c  (manufacturer unknown), melatonin (manufacturer unknown), biotin (manufacturer unknown) and elderberry [sambucus nigra] (manufacturer unknown). The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EJ1685) on 22Dec2020 at 9:00 PM on the left arm. The patient did not receive other vaccines in four weeks. The patient reported that after her second dose, she began experiencing severe side effects around 5:00 pm the same day (about 7 hours after the dose was administered). These side effects were fever, chills, severe headache, severe muscle and joint pain, chest tightness, and mild nausea. She also added a difficult symptom to describe, but her lungs felt inflamed, making it difficult to take deep breaths. These symptoms lasted for 36 hours unabated, and she was unable to sleep, go to work, eat, or go about daily activities during this time. After 36 hours, the fever, chills, headache, and nausea subsided, but the muscle and joint pain and chest tightness persisted. It has been 50 hours since her second dose and the muscle and joint pain and chest tightness still persists, although its severity is reduced and it is not preventing her from work or daily activities.  The patient did not receive any treatment for all the events. The outcome of the events severe muscle and joint pain and chest tightness was not recovered while the outcome of the other events was recovering.The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site induration, Pain
Clinical narrative: By 12:30am I had fever of 100.4, my injection site was rock hard and I was sweating with chills. Throughout the night I began having severe body aches. My fever came and went several times, at one point hitting 103 degrees. I had extreme swelling in my face, hands and feet. On the 27th my fever broke and hasn't returned. I'm still fatigued but getting better.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: By 12:30am I had fever of 100.4, my injection site was rock hard and I was sweating with chills. Throughout the night I began having severe body aches. My fever came and went several times, at one point hitting 103 degrees. I had extreme swelling in my face, hands and feet. On the 27th my fever broke and hasn't returned. I'm still fatigued but getting better.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Pain, SARS-CoV-2 test
Clinical narrative: Moderate general body pain; Mild Headache; chills; Mild abdominal pain; received the first dose of bnt162b2 on left arm/ left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 13Jan2021 07:00 PM at a single dose on left arm for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. The patient did not receive other vaccines in four weeks. The patient did not have covid prior to vaccination. Medical history included Diabetic type 2 and HBP (high blood pressure). She had no known allergies. Concomitant medications (other medications in two weeks) included losartan 100mg qd (once a day) and escitalopram 10mg qd (once a day). On 13Jan2021 10:00 PM, the patient experienced moderate general body pain, mild headache, chills, mild abdominal pain, left arm pain. The patient had undergone laboratory tests and procedures which included: covid test type = Blood test, covid test name = Serology, covid test date = 16Jul2020, covid test result=Negative; covid test date = 05Aug2020, covid test type = Nasal Swab, covid test name = Nasopharyngeal, covid test result = Negative. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Serology test, Vaccination site pain
Clinical narrative: Moderate general body pain; Mild Headache; chills; Mild abdominal pain; received the first dose of bnt162b2 on left arm/ left arm pain; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 13Jan2021 07:00 PM at a single dose on left arm for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. The patient did not receive other vaccines in four weeks. The patient did not have covid prior to vaccination. Medical history included Diabetic type 2 and HBP (high blood pressure). She had no known allergies. Concomitant medications (other medications in two weeks) included losartan 100mg qd (once a day) and escitalopram 10mg qd (once a day). On 13Jan2021 10:00 PM, the patient experienced moderate general body pain, mild headache, chills, mild abdominal pain, left arm pain. The patient had undergone laboratory tests and procedures which included: covid test type = Blood test, covid test name = Serology, covid test date = 16Jul2020, covid test result=Negative; covid test date = 05Aug2020, covid test type = Nasal Swab, covid test name = Nasopharyngeal, covid test result = Negative. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red itchy bumps on feet, legs, hands, and arms
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Sweating; 38 degrees fever; Feverish chill; Shaking; This is a spontaneous report from a contactable pharmacist (patient). A 29-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 11Jan2021 16:45 at a single dose for COVID-19 immunization. The patient has no medical history and concomitant medications. Previously, the patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm on 23Dec2020 14:45 for COVID-19 immunization. It was reported that approximately starting 10 hours after the patient received the vaccine (reported as 12Jan2021 03:00) he woke up in the middle of the night feeling feverish chill, but had no fever at the moment. Took Tylenol 1000 mg and slept, but still shaking. Starting around 11:00, he had 38 degrees fever, chill, and sweating for next 18 hours, where Tylenol 1000 mg q (every) 6h briefly dropped temperature to 37 degrees but spiked again when drug is excreted out. Then he maintained with 37 degrees for 12 more hours, then came back to normal. The patient reported that it looks like he had hyperimmune reactions. The events recovered on an unspecified date in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable Other HCP (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was supposed to go back on 13Jan2021 for second dose, but the week before, in Jan2021, she tested positive COVID-19. She had an appointment for the 15Jan2021. The patient wanted to know how many days she has to wait to get second dose.  Information on Lot/ Batch number requested.; Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after three weeks from the second dose.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Disorientation, Electrocardiogram normal, Fatigue, Heart rate increased
Clinical narrative: On day 2 following the vaccine began to have the following symptoms:  Fatigue, disorientation, increased pulse, numbness and tingling on left side of body  and symptoms continue to come and go as of 1/28/2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: On day 2 following the vaccine began to have the following symptoms:  Fatigue, disorientation, increased pulse, numbness and tingling on left side of body  and symptoms continue to come and go as of 1/28/2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Fatigue, Neck pain, Pain in extremity
Clinical narrative: tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself).  A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route 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. On an unknown date, the patient experienced sore arm. The outcome of the event sore arm was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Nausea, Pain
Clinical narrative: Fever; body chills; body aches; headache; sore arm; nausea; second dose given on 16Jan2021; This is a spontaneous report from a contactable Other HCP (patient).  This 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # E71686), via an unspecified route of administration, 16Jan2021 at 03:00 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at Health Clinic, age at vaccination was 25-years-old. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (Lot # EL1284), on 31Dec2020 at 01:00 PM, intramuscular. On 16Jan2021 at 04:00 PM, the patient developed fever, body chills, body aches, headache, sore arm and nausea. No treatment was received for the event. Outcome was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; body chills; body aches; headache; sore arm; nausea; second dose given on 16Jan2021; This is a spontaneous report from a contactable Other HCP (patient).  This 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # E71686), via an unspecified route of administration, 16Jan2021 at 03:00 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at Health Clinic, age at vaccination was 25-years-old. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (Lot # EL1284), on 31Dec2020 at 01:00 PM, intramuscular. On 16Jan2021 at 04:00 PM, the patient developed fever, body chills, body aches, headache, sore arm and nausea. No treatment was received for the event. Outcome was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Began feeling dizzy shortly after receiving the vaccine. I notified the workers. They took my blood pressure  and found it was hig. They took it several times and when it was 210/110 they called an ambulance to take me to the emergency room.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site pain, Injection site rash, Lymphadenopathy
Clinical narrative: Rash/Rash extended to chest and down to stomach; Rash and pain at injection site; Rash and pain at injection site; Significant swelling in armpit with warmth; Significant swelling in armpit with warmth; pain; Swelling of lymph nodes under arm and into chest. All on L arm side where injection was administered; Significant fatigue for 4 days following; This is a spontaneous report from a contactable contactable Other-HCP (patient) .  A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 13Jan2021 09:30 AM at SINGLE DOSE for COVID-19 immunization.No pregnant.Medical history included asthma. The patient had COVID prior vaccination .Facility where the most recent COVID-19 vaccine was administered was Living Facility.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) fexofenadine hydrochloride (ALLEGRA) paracetamol (TYLENOL). On 14Jan2021 16:00  the patient developed  Rash and pain at injection site, rash extended to chest and down to stomach, significant swelling in armpit with warmth and pain, swelling of lymph nodes under arm and into chest. All on Left arm side where injection was administered  and significant fatigue for 4 days following. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit.No treatment received.The events were assessed as non-serious. The patient had been tested for COVID post vaccination on 17Jan2021 (test type = Nasal Swab Covid test name post vaccination= Rapid). The outcome of the events was recovering  Information on lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Rash, SARS-CoV-2 test
Clinical narrative: Rash/Rash extended to chest and down to stomach; Rash and pain at injection site; Rash and pain at injection site; Significant swelling in armpit with warmth; Significant swelling in armpit with warmth; pain; Swelling of lymph nodes under arm and into chest. All on L arm side where injection was administered; Significant fatigue for 4 days following; This is a spontaneous report from a contactable contactable Other-HCP (patient) .  A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 13Jan2021 09:30 AM at SINGLE DOSE for COVID-19 immunization.No pregnant.Medical history included asthma. The patient had COVID prior vaccination .Facility where the most recent COVID-19 vaccine was administered was Living Facility.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) fexofenadine hydrochloride (ALLEGRA) paracetamol (TYLENOL). On 14Jan2021 16:00  the patient developed  Rash and pain at injection site, rash extended to chest and down to stomach, significant swelling in armpit with warmth and pain, swelling of lymph nodes under arm and into chest. All on Left arm side where injection was administered  and significant fatigue for 4 days following. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit.No treatment received.The events were assessed as non-serious. The patient had been tested for COVID post vaccination on 17Jan2021 (test type = Nasal Swab Covid test name post vaccination= Rapid). The outcome of the events was recovering  Information on lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Headache, Muscle disorder, Myalgia, Neck mass
Clinical narrative: Headache; Body ache; Muscle pain/muscle soreness; Feeling down; feels may be like it's a knot in the muscle; Like a lump like at the bottom of my neck; This is a spontaneous report from a contactable consumer reporting for herself (Medical Assistant). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient stated, "I just wanted to ask about, I just received my second dose of the vaccine and I was having some adverse effects. I had headache yesterday when I got it. And body ache and muscle pain today and then I'm feeling down, and kind of like a lump like at the bottom of my neck, like to the side, on the left side, the arm that I got the (incomplete sentence). It feels may be like it's a knot in the muscle. I don't know if that is normal." The patient asked and stated, "If anybody else has had any of those symptoms? I know that the headache and the muscle pain is normal, I don't know about the like a lump or anything." The patient further stated, "It's been pretty constant headache, second day was body ache and right now just like muscle soreness." The patient stated, "I took some Tylenol, acetaminophen. And I think I had one Ibuprofen last night." The outcome of the event headache was not recovered and the outcome of the remaining events was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Body ache; Muscle pain/muscle soreness; Feeling down; feels may be like it's a knot in the muscle; Like a lump like at the bottom of my neck; This is a spontaneous report from a contactable consumer reporting for herself (Medical Assistant). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient stated, "I just wanted to ask about, I just received my second dose of the vaccine and I was having some adverse effects. I had headache yesterday when I got it. And body ache and muscle pain today and then I'm feeling down, and kind of like a lump like at the bottom of my neck, like to the side, on the left side, the arm that I got the (incomplete sentence). It feels may be like it's a knot in the muscle. I don't know if that is normal." The patient asked and stated, "If anybody else has had any of those symptoms? I know that the headache and the muscle pain is normal, I don't know about the like a lump or anything." The patient further stated, "It's been pretty constant headache, second day was body ache and right now just like muscle soreness." The patient stated, "I took some Tylenol, acetaminophen. And I think I had one Ibuprofen last night." The outcome of the event headache was not recovered and the outcome of the remaining events was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disorientation, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Depressed mood, Fatigue, Malaise, Nausea
Clinical narrative: Horrible arm pain; Depressed, sad; does not feel well; fatigue; crying; Nauseous; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's parent stated, "I have a question. My daughter (patient), she had a vaccine this last Monday and she was nauseous today. How long does it last? One person said she is OK. She is kind of have horrible arm pain which is pretty normal and today she feels pretty depressed, sad, she went on crying and crying and she does not feel well. She felt nauseous and kind of fatigue and she is not herself". The events was experienced on 14Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Horrible arm pain; Depressed, sad; does not feel well; fatigue; crying; Nauseous; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's parent stated, "I have a question. My daughter (patient), she had a vaccine this last Monday and she was nauseous today. How long does it last? One person said she is OK. She is kind of have horrible arm pain which is pretty normal and today she feels pretty depressed, sad, she went on crying and crying and she does not feel well. She felt nauseous and kind of fatigue and she is not herself". The events was experienced on 14Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient was given the diluent DTaP-IPV portion of Pentacel in the left deltoid without mixing with the Hib powder portion/no AE; Initial information regarding an unsolicited valid non-serious case via Medical Information (Reference number- 00431824) was received from an other health professional and transmitted to Sanofi on 15-Jan-2021.  This case involved a six-month-old female patient who was given 0.5 ml of the diluent dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6842BA and expiry date: 05-Jul-2021) on 04-Jan-2021 via unknown route in the left deltoid for prophylactic vaccination without mixing with the Hib powder portion (Product preparation issue).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) both for prophylactic vaccination.  The patient did not receive the Hib portion at all. The practice is aware of the video and has their staff review it annually. The caller stated that in this case, the mistake was human error and they are reviewing details to determine the contributing causes. The caller stated that in addition to this event, the same situation happened once before, a few years ago. Details were not asked for the previous case, as it was a few years ago. The caller was not at the location of the office today and was not able to pull the actual product for the lots numbers from other components). Administering physician Vaccine was administered by a Medical Assistant. Product used : Used First time product used : No Still using product : No.  It was an actual medication error case due to Inappropriate reconstitution technique (latency same day).   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Injection site erythema, Injection site pruritus
Clinical narrative: The patient was set to receive the second dose of the series on 1/25/21 and instead received it on 1/19/21. The patient experienced a headache and chills lasting a few hours. The patient also reported redness/itchiness/warmth at the injection site for 72 hours following the injection.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: The patient was set to receive the second dose of the series on 1/25/21 and instead received it on 1/19/21. The patient experienced a headache and chills lasting a few hours. The patient also reported redness/itchiness/warmth at the injection site for 72 hours following the injection.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Inflammation
Clinical narrative: Nausea, brain fog, headache, lethargy, chills, fever, weakness, local inflammation, pain
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, brain fog, headache, lethargy, chills, fever, weakness, local inflammation, pain
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness at injection site
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Fatigue, Muscular weakness
Clinical narrative: Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain  we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and  sore  after the first shot .today I go for the second one.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain  we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and  sore  after the first shot .today I go for the second one.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Sensitive skin
Clinical narrative: My arms starting feeling sensitive 1/27/21, like it felt the 1st day kinda sore, later in the day when I look at my arm there were a lot of bumps near the site of the shot and still sore. Today 1/28/21the bumps are gone but it's still a little sore to the touch.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Discomfort, Fatigue, Headache
Clinical narrative: Nausea started first then a head ache and chills shortly afterwards along with body aches and general discomfort. After taking 3 ibuprofen (200mg ea) and a half hour later my temperature was 101.7 (9 pm)  and the headache never went away. I continued with Ibuprofen every 4 hours which helped temperature but not very strong headache.  The nausea subsided by 11 pm. The next morning (today) my temperature is 100.3 without any ibuprofen but fatigue and body aches remain. I have not contacted my doctor yet but will sent a note through patient portal. ( I checked off Doctor visit on Item 21 because I had to enter something. )
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Nausea started first then a head ache and chills shortly afterwards along with body aches and general discomfort. After taking 3 ibuprofen (200mg ea) and a half hour later my temperature was 101.7 (9 pm)  and the headache never went away. I continued with Ibuprofen every 4 hours which helped temperature but not very strong headache.  The nausea subsided by 11 pm. The next morning (today) my temperature is 100.3 without any ibuprofen but fatigue and body aches remain. I have not contacted my doctor yet but will sent a note through patient portal. ( I checked off Doctor visit on Item 21 because I had to enter something. )
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On the morning of 1/27/2021 patient noted redness and swelling at the injection site.  Area is approximately 2"x2" is red and warm to touch.  Discomfort is also reported.  No other symptoms are reported.  No pain in neck area.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: About one hour after the shot I experienced a very mild, but noticeable, tingling sensation on my lips/mouth.  I did not notice any tingling on my tongue or throat, or anywhere else on my body.  The tingling sensation  last about three hours and never recurred.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Severe diarrhea, stomach cramps, headache, fatigue, sore injection site.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: severe body aches, fever 100.2, chills, headache
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Normal pain after injection, but after a week my upper arm swelled up, skin was hot, itchy and painful.  It lasted a week and dissipated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, chills, muscle aches, "foggy". No treatment
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Fever; cold chills; headache; body aches; arm pain   Left work early
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; cold chills; headache; body aches; arm pain   Left work early
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Malaise, Pain, Pruritus
Clinical narrative: Red spot on left arm where at injection site.  No pain but slight itching and slight pain when laying on arm at night.  Two days after the shot dizziness, light headed, sick at stomach which lasted about 15-20 minutes.  Started to subside about 6 minutes later.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER 101.4 F LASTING ABOUT 6 HOURS. TOOK 2 TABLETS  TYLENOL. RESOLVED
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Nausea, Urticaria
Clinical narrative: Vaccine administered at 0855, began to feel dizzy at 0906. Resp even and unlabored. Began having redness and whelps on bilateral forearms and chest. Vital signs stable. Administered Benadryl 50 mg IM. 0920 became nauseated, no vomiting. 0930 redness and whelps noted to be improving. Monitored x 1 hour. Condition improved. Declined evaluation and treatment in emergency department. Instructed to continue to take Benadryl for next 24 hours, and to add Claritin and Pepcid and to seek emergency care if symptoms worsened.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: rash developed one week after injection, surrounding the injection site...about 3 inches in diameter.  Itches and a little sore. vaccinated 1/19, rash started 1/26.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Rash developed near injection site approximately 12 days after vaccination. Circular rash was about 3 inches wide, sensitive to touch with very light pain (less than a bruise), but otherwise was not very noticeable. Rash is also slightly warm to the touch. Inside of circle fading faster than outer ring. Currently, rash is fading and a smaller rash appeared above the large circle.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hordeolum
Clinical narrative: headache, fatigue, and stye in eye
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Throat tightness
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Other- patient felt tightness in trachea; nurse practitioner ordered for administration of epipen
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Nausea, Pyrexia
Clinical narrative: He woke up with nausea, headache, very sore injection site, fever of 101. He couldn't move his left arm up higher than his waist. He took Ibuprofen OTC, rested, felt ok by evening. Next day, no side effects remained.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nasopharyngitis, Tremor
Clinical narrative: Lying in bed after midnight I got so cold my whole body was shaking. I had flannel sheets, an electric blanket on #4 and a heavy down comforter over me. I was still shivering and my teeth were chattering. Never been that cold in my life.  It is now 9:00 a.m. I am still cold but not shivering. Also feel weak.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Flat rash on chest, neck, and jawline that was not itchy or raised. Not hives.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: Patient had the usual sore arm for several days after injection but then she said she got a faint rash around injection site and it itched quite a bit.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: fever, joint pain, body aches, headache, baseball size knot at injection site, redness of injection site, injection site hot to touch
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever, joint pain, body aches, headache, baseball size knot at injection site, redness of injection site, injection site hot to touch
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: 103 fever starting at 1800 on 1/26 until 2000 on 1/27 101 fever starting at 2000 on 1/27 until 0600 on 1/28 extreme body aches and chills starting at 1600 on 1/26 until 0600 on 1/28 extreme headache stating at 1800 on 1/28 that is still ongoing (1/28, 1200) vomiting x1 around 2100 on 1/26
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Migraine, Pain
Clinical narrative: 8 hours post vaccination: severe arm pain, severe chills, severe body aches, fever 100; 13 hours post vaccination: fever 101, shortness of breath, headache; 21 hours post vaccination: migraine, persistent fever 100
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 8 hours post vaccination: severe arm pain, severe chills, severe body aches, fever 100; 13 hours post vaccination: fever 101, shortness of breath, headache; 21 hours post vaccination: migraine, persistent fever 100
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Body temperature increased, Cough, Dizziness, Pain
Clinical narrative: Had first vaccine 12/28/2020 only sore arm. 2nd vaccine 1/25/2021. She developed fever of 101.5 for 2 days, body aches, cough, dizziness, high BS, pale, tachycardia.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Tachycardia
Clinical narrative: Had first vaccine 12/28/2020 only sore arm. 2nd vaccine 1/25/2021. She developed fever of 101.5 for 2 days, body aches, cough, dizziness, high BS, pale, tachycardia.