chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Illness, Moaning, Rash
Clinical narrative: felt really sick/ had not been that sick before in her life; Chest pain; Rash; moaning in her sleep; This is a spontaneous report from a contactable consumer (patient's coworker). A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient felt really sick and had not been that sick before in her life. She had chest pain, a rash on her legs, and her husband said that she was moaning in her sleep. The patient did not have a cough. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood iron, Chills, Eye disorder
Clinical narrative: chills; sweats; tiredness; headache; eyes affected; nausea; joint pain; muscle pain; weakness in my legs and body.; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENG6200TA), dose 1 via an unspecified route of administration, in left arm on 17Feb2021 at 10:00 (at 67-years age) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, BPH, low iron, COVID-19 in 2020 and seasonal allergy. Concomitant medication(s) included clopidogrel, Tamsulosin, levothyroxine sodium, magnesium sulfate and ergocalciferol (VIT D) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have side effects until 8-10 hours after the shot. He previously had COVID last year, and it felt like he had it all over again. On 17Feb2021 at 18:45, the patient experienced chills, sweats, tiredness, headache, eyes affected, nausea, joint and muscle pain, and total weakness in my legs and body, but did not had fever. No treatment received for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: chills; sweats; tiredness; headache; eyes affected; nausea; joint pain; muscle pain; weakness in my legs and body.; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ENG6200TA), dose 1 via an unspecified route of administration, in left arm on 17Feb2021 at 10:00 (at 67-years age) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, BPH, low iron, COVID-19 in 2020 and seasonal allergy. Concomitant medication(s) included clopidogrel, Tamsulosin, levothyroxine sodium, magnesium sulfate and ergocalciferol (VIT D) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have side effects until 8-10 hours after the shot. He previously had COVID last year, and it felt like he had it all over again. On 17Feb2021 at 18:45, the patient experienced chills, sweats, tiredness, headache, eyes affected, nausea, joint and muscle pain, and total weakness in my legs and body, but did not had fever. No treatment received for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbness to her lower lip and half of her tongue.; numbness to her lower lip and half of her tongue.; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021(at 65-years-old) as single dose for COVID-19 immunization. The patient's medical history included monoclonal B-cell lymphocytosis and ongoing hypertension has had for a couple of years. The concomitant medication included prednisone from 05Feb2021 to 09Feb2021 as taper dose for swelling, she was prescribed it for swelling due to a reaction from tape that was on her face after having cosmetic surgery and ongoing hydrochlorothiazide 2.5mg daily from an unspecified date in 2018 as diuretic. Patient did not take any medications within four weeks, Prior to vaccination. On 09Feb2021, a half an hour later she had numbness to her lower lip and half of her tongue. Patient can move her mouth fine, but the numbness was persisting. It feels more like a nerve issue. There were no additional vaccines administered on same date of the suspect and patient did not visited the emergency room or physician office. Patient was unsure about Lot number whether it was EL9269, E19269 or EI9269.The outcome of the event was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Vaccination site pain
Clinical narrative: pain at injection site started within 24 hours; Chills; sore throat; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided), first dose via an unspecified route of administration, in Arm Left, on 17Feb2021, 01:45 PM as a single dose for COVID-19 immunisation at Workplace clinic. Patient medical history included like elevated cholesterol, blood Pressure, Generalized Anxiety Disorder (GAD). No allergies reported. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced pain at injection site(within 24 hours), Chills(within 24 hours), Sore throat(within 24 hours) on 18Feb2021, 08:00 AM. The events are subsided within the next 24 hours. No treatment received for the events. Outcome of the events were recovered on an unspecified Feb2021.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: bad sore throat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program . A female patient of an unspecified age (69 (units not reported)) received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, 4 days later after the 1st dose she experienced a very bad sore throat on an unspecified date in 2021. Stated she received her first dose of the Pfizer covid vaccine on 28Jan2021 and she was scheduled for the second 2nd dose this Thursday. Her doctor prescribed her prednisone to be started today. Caller wanted to know if she can take the prednisone are there any interactions with covid vaccine. The outcome of event was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: bad sore throat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program . A female patient of an unspecified age (69 (units not reported)) received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, 4 days later after the 1st dose she experienced a very bad sore throat on an unspecified date in 2021. Stated she received her first dose of the Pfizer covid vaccine on 28Jan2021 and she was scheduled for the second 2nd dose this Thursday. Her doctor prescribed her prednisone to be started today. Caller wanted to know if she can take the prednisone are there any interactions with covid vaccine. The outcome of event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Extremely bad sore throat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9269) via an unspecified route of administration in left arm on 28Jan2021 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Feb2021 (reported as on Monday), the patient experienced extremely bad sore throat and had COVID-19 test and that was negative. The patient didn't do too much about it but it kept on lasting and so finally she called her doctor and even though she haven't seen it is a side effect of the Pfizer Vaccine, she thought it was and she prescribed the Prednisone for her to take. The second dose was scheduled on 18Feb2021 and she was wondering if taking the Prednisone is a good idea before getting the second shot of the vaccine. She wanted to know if they contraindicated getting the second dose of the vaccine. The outcome for the event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Extremely bad sore throat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9269) via an unspecified route of administration in left arm on 28Jan2021 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Feb2021 (reported as on Monday), the patient experienced extremely bad sore throat and had COVID-19 test and that was negative. The patient didn't do too much about it but it kept on lasting and so finally she called her doctor and even though she haven't seen it is a side effect of the Pfizer Vaccine, she thought it was and she prescribed the Prednisone for her to take. The second dose was scheduled on 18Feb2021 and she was wondering if taking the Prednisone is a good idea before getting the second shot of the vaccine. She wanted to know if they contraindicated getting the second dose of the vaccine. The outcome for the event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Rash on both of my arms; It does feel like there is a little burning to it; This is a spontaneous report received from a contactable consumer (reporting on herself). A 69-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EL9269 and Expiry date was not reported), via intramuscular route of administration in Deltoid Left on 06Feb2021 as single dose for COVID-19 immunization. Medical history included urticaria from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that patient have had a reaction to this vaccine. She did a little survey thing and then when she was going to bed, she noticed that she had a rash on both of my arms and its was not terrible, mean she have had hives (Intent: History) before but had a rash on both arms and its was not terribly itchy but basically she want to look at the severity of the reaction and that's one of the most weird one, patient don't have any shortness of breath or swelling of tongue or any of that, just the rash and she am just wondering if I should be concerned about this. It does feel like there was a little burning to it that's the only other thing Ishecan tell. Patient was a medical assistant. Patient going to get the second shot, the second vaccine because now she was at more risk from what she understand. Patient stated, she don't know that either because she don't have the card with her and stated, It doesn't give her the expiration date. The only number which was on the card was the LOT#. Causality mention Yes, most definitely. Patient think it was improving. The outcome of the vents was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Influenza
Clinical narrative: she has been exposed to her colleague that was tested positive; experienced the flu after the 1st dose; This is a spontaneous report from contactable consumer (patient reported) and received from Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 MRNA Vaccine, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the flu after the 1st dose, and she has been exposed to her colleague that was tested positive. Outcome of other events was unknown.  No further follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: The caller said his wife got the first vaccine an hour ago then experiencing multiple sneezes.; This is a spontaneous report from a Pfizer-sponsored program . A contactable reporter reported for a female patient (wife). An unspecified age of female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: Unknown), via unspecified route of administration in left arm on 13Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Feb2021, the patient experienced the caller said his wife got the first vaccine an hour ago then experiencing multiple sneezes. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Aches within 12 hours of dosing.; Fever (100.4F) 28 hours post dosing; This is a spontaneous report received from a contactable consumer (patient). A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on left arm on 16Feb2021 at 07:45 as a single dose for COVID-19 immunization in workplace clinic. The patient's medical history included IBS (Irritable bowel syndrome). The patient had no known allergies. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN5318) on 26Jan2021 07:30 AM on Left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. The patient did not receive other vaccine in four weeks. On 16Feb2021 at 19:45, the patient experienced aches within 12 hours of dosing and fever (100.4F) 28 hours post dosing with body aches. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a Pfizer-sponsored program . A contactable Consumer reported for his wife, that the patient had received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: unknown) on an unspecified date via an unspecified route of administration and for covid-19 immunization (Age at vaccination: unknown). The patient's medical history and concomitant medications was not reported. On an unspecified date the patient experienced sinus and had received unspecified antibiotic as treatment. It was reported that the patient was scheduled for her second COVID shot tomorrow. Outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Pain in extremity
Clinical narrative: she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; she felt chills, weakness, soreness in the arm, and lower back pain after the first dose; This is a spontaneous report received from a contactable consumer (reporting on herself) via Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she felt chills, weakness, sore-ness in the arm, and lower back pain after the first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain
Clinical narrative: injection site pain; nausea; tiredness; This is a spontaneous case is received from a contactable consumer, a patient. A 70-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Left arm on 15Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included allergies to Penicillin from an unknown date and unknown if ongoing. Historical vaccine included first dose of COVID vaccine on Jan2021. Concomitant medications included ibuprofen and vitamins. on 15Feb2021 14:15, the patient experienced injection site pain, tiredness, nausea. 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. Since vaccination, patient had not tested for COVID-19. Patient did not receive any treatment for the events. The reported assessed the event as non-serious. On unspecified date, outcome for the events was recovered.  Information about lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Fatigue, Lethargy, Malaise
Clinical narrative: bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's  medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Night sweats
Clinical narrative: bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's  medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: muscle ache; Chills; soreness at site of injection; headache; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: el3247) via an unspecified route of administration in the left arm on 18Feb2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el3247), via an unspecified route of administration in the left arm on 28Jan2021 at 10:15 as a single dose for COVID-19 immunization. On 18Feb2021 at 21:00 (reported as 12 hrs after injection), the patient experienced chills, soreness at site of injection, muscle ache, headache and fatigue. The patient did not receive any treatment for the events. The outcome for the events was recovered on an unspecified date in Feb2021(reported as symptoms lasted 18 hrs).  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report from a consumer (patient) to a Pfizer-sponsored Program . A female patient of an unspecified aged received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN Expiration date: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bladder infection. Therapeutic measures were taken as a result of bladder infection treatment included with medication Nitrofurantoin and patient wanted to know if it will affect the efficacy of the covid-19 vaccine. The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed a rash on the palms/side of both hands. Subcutaneous bumps that were mildly itchy. Disappeared after about a week. Used Benadryl to alleviate but did not seem to have any effect on diminishing the rash.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Condition aggravated, Dyspnoea, Heart rate increased
Clinical narrative: Woke from a deep at 3am gasping for breath. I have very labored breathing and racing heart. Feels like a heavy weight on my chest making it hard to breathe.  I have had very labored breathing for 75 minutes now and if gets any worse I will seek medical attention. I am allergic to Tetanus and had respiratory distress similar to this. I am a very fit, healthy woman at 5?1? and 115 lbs with no medical conditions.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bone pain, Chest pain, Injection site erythema, Injection site pain
Clinical narrative: Started to feel nauseous, weak with body aches. The entire left side of my body felt paralyzed and hot. The pain went into my chest and was tingling. My bones felt like they had stabbing sharp pains. The injection site then became red and almost the size of a golf ball and tender to touch.  Overnight I could not fall asleep as I felt immense pain in my arm and over my entire body.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Nausea, Pain, Paraesthesia, Skin warm
Clinical narrative: Started to feel nauseous, weak with body aches. The entire left side of my body felt paralyzed and hot. The pain went into my chest and was tingling. My bones felt like they had stabbing sharp pains. The injection site then became red and almost the size of a golf ball and tender to touch.  Overnight I could not fall asleep as I felt immense pain in my arm and over my entire body.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Chills, fever, headache, muscle ache, swollen lymph nodes (deep pain in left breast)
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, fever, headache, muscle ache, swollen lymph nodes (deep pain in left breast)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Photophobia, Tremor
Clinical narrative: Severe chills, tremors for 8 hrs.. TX.  Advil, mild relief  Severe frontal lobe headache with light sensitivity for 24 hrs.  TX.  ALEVE, no relief
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Fever, chills, muscle aches, headache, fatigue, nausea, dizziness, pain in arm (injection site).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, muscle aches, headache, fatigue, nausea, dizziness, pain in arm (injection site).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: i had regular symptoms the day of and after my vaccine. Headaches, body ache, tired, sore arm, slight difficulty breathing, and slightly faster heart rate. Those didn't really concern me since i took it as the vaccine is working like it?s supposed to. but starting yesterday when i woke up until this moment i?ve had a really weird pinching feeling by my heart and the side of my rib cage on the left side of my chest. that?s the only thing scaring me now since my other side effects have already gone away.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: i had regular symptoms the day of and after my vaccine. Headaches, body ache, tired, sore arm, slight difficulty breathing, and slightly faster heart rate. Those didn't really concern me since i took it as the vaccine is working like it?s supposed to. but starting yesterday when i woke up until this moment i?ve had a really weird pinching feeling by my heart and the side of my rib cage on the left side of my chest. that?s the only thing scaring me now since my other side effects have already gone away.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Bone pain, Chills, Dehydration, Headache
Clinical narrative: on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches .  Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration ,  continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with  headache everyday and at night headaches are bad .  i drink plenty of fluids all day , should not be feeling dehydrated .  its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Neck pain, Pain, Pain of skin
Clinical narrative: on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches .  Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration ,  continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with  headache everyday and at night headaches are bad .  i drink plenty of fluids all day , should not be feeling dehydrated .  its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Tongue discolouration
Clinical narrative: on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches .  Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration ,  continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with  headache everyday and at night headaches are bad .  i drink plenty of fluids all day , should not be feeling dehydrated .  its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: 99.9 fever taken at 2am 4/21/21, noted again above 99 evening of 4/21/21.   Chills, aches, fatigue, headache, lower back pain,  pain at site of injection / left arm, increase in sensitivity to light and sound  observed until 9am Friday 4/24/21.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oversensing, Pain, Photophobia, Pyrexia
Clinical narrative: 99.9 fever taken at 2am 4/21/21, noted again above 99 evening of 4/21/21.   Chills, aches, fatigue, headache, lower back pain,  pain at site of injection / left arm, increase in sensitivity to light and sound  observed until 9am Friday 4/24/21.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ear ringing
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Pt complained of 5/10 chest tightness and no other symptoms at 1211. Pt reported similar episodes when under stress. Pt asked for water. Pt given water. Pt vitals assessed: 125/80 BP, 65 BPM, 98% SpO2.  Pt reported hx of atrial tachycardia and no current medications. Pt AxO x4 with unlabored respirations. Pt offered EMS. Pt declined EMS. Pt advised to wait 30 mins.  Patient reassessed at 1219. Pt reported chest tightness at 4/10.  Pt reassessed at 1230. Vitals were 120/80 BP, 60 BPM, SpO2 98%. Pt rated chest tightness at 2/10. Pt reassessed at 12:45. Pt was AxO x4 with unlabored respirations. Pt rated chest tightness at 1/10. Patient offered EMS again. Pt declined EMS. Pt  offered transportation. Pt declined transportation. At 1245, pt left facility to self with steady gait and unlabored breathing.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Swelling and extreme pain in thumbs, index fingers and wrists as well as pain in right arm and both knees.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Approximately a week after getting the shot I started to experience tinnitus (pulsatile) in both ears.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Injection site pain, Pain
Clinical narrative: Mild cough, mild sneezing, moderate headache, very mild body aches, moderate to severe arm pain at injection sight. Mild chills. Onset of arm pain immediate. Arm sight is still painful. Mild cough. But remaining symptoms resolved within 12 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Mild cough, mild sneezing, moderate headache, very mild body aches, moderate to severe arm pain at injection sight. Mild chills. Onset of arm pain immediate. Arm sight is still painful. Mild cough. But remaining symptoms resolved within 12 hours.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Lip swelling, Swelling face
Clinical narrative: Diarrhea, swollen of lips and face , stomach pain. Second day now
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood uric acid normal, Gout, Inflammation, Red blood cell sedimentation rate increased, X-ray
Clinical narrative: Gout symptom (inflammation) flared up on right foot toe
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: 4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 hour
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache
Clinical narrative: Stomach pain, diarrhea,  headache
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Hardness and itchiness around the site. Tender to the touch. Redness about 1.5 inch in diameter around the site, hardness and redness area are the same size.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site discolouration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Approximated one week after administration the injection area became very itchy.  Upon briefly itching it and then inspecting it because it felt very warm I have a perfect rectangle raised above my skin.  The color is dark red / slightly bruised.  The area is warm to the touch.  There feels to be a knot underneath the injection site that is relatively large in comparison to the raised / welted rectangle.  The itch subsided after a few hours but it is still raised and warm to the touch.  It is now hour 14 after recognizing the reaction.  The area was painful in the days following administration of the vaccine, and I avoided touching or inspecting it at that point as it was reported to me to be normal to experience pain at the injection site.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Approximated one week after administration the injection area became very itchy.  Upon briefly itching it and then inspecting it because it felt very warm I have a perfect rectangle raised above my skin.  The color is dark red / slightly bruised.  The area is warm to the touch.  There feels to be a knot underneath the injection site that is relatively large in comparison to the raised / welted rectangle.  The itch subsided after a few hours but it is still raised and warm to the touch.  It is now hour 14 after recognizing the reaction.  The area was painful in the days following administration of the vaccine, and I avoided touching or inspecting it at that point as it was reported to me to be normal to experience pain at the injection site.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: about a month + I got Covid as did my daughter and her kids and it came from my other grandsons daycare  Shortness of breath Extreme tiredness Wheezing Cough
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: about a month + I got Covid as did my daughter and her kids and it came from my other grandsons daycare  Shortness of breath Extreme tiredness Wheezing Cough
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: After 9 months no period, suddenly next day after shot have menstruated
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea,  headache and extreme chills. Did not occur until over 12 hours after getting the vaccine. Mostly recovered, still a headache and mild nausea
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site urticaria, Pain in extremity, Pruritus
Clinical narrative: 24h post-injection: tired, injection arm very sore, painful to move 48h post-injection: no symptoms, arm soreness decreased from 36h onwards  64h post-injection: large hive at injection site and smaller hives around injection site; itchy, also body is itchy, mainly head and back (besides injection region), no hives or rash on head, back, or rest of body as of now
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrooesophageal reflux disease, Headache
Clinical narrative: Chills, headache at night and during the following  day. Severe acid reflux the following day starting in the evening which was an intensity I have not experienced before.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Oropharyngeal pain
Clinical narrative: Sore throat next day and for weeks afterwards (it has not gone away in 2 weeks). Depression since vaccine and continuing.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, Pain in extremity, Pulmonary embolism, Thrombosis
Clinical narrative: Severe pain in left leg, swelling, hot Sever pain in upper body-left side only--from jaw, to shoulder, to arm to side, front and back, all the way to the hip CT scan at hospital--pulmonary embolisms in both lungs, blood clot diagnosed in left leg at vascular surgeon's office before going to the ER Now on XARELTO for life.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, Ultrasound abdomen abnormal
Clinical narrative: Severe pain in left leg, swelling, hot Sever pain in upper body-left side only--from jaw, to shoulder, to arm to side, front and back, all the way to the hip CT scan at hospital--pulmonary embolisms in both lungs, blood clot diagnosed in left leg at vascular surgeon's office before going to the ER Now on XARELTO for life.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Dysuria, Micturition urgency, Pyrexia, Urinary tract infection
Clinical narrative: Low grade fever for 5 days (from 4/14-4/20 Urinary tract infection  (blood in urine, including clots, pain while urinating, strong, constant urge to urinate)
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue. Onset a few hours after the second shot and  lasted about 36 hours.  The fatigue was similar to that experienced when I had covid19 in March of 2020, but not as intense. Other information After the first shot I only experienced arm soreness in the arm that was injected.  I was donating antibodies to the through about September/October 2020.  I stopped donating for personal reasons, .
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Blood test normal, Computerised tomogram normal, Dizziness, Head discomfort
Clinical narrative: Swollen lymph node in left breast. Painful, very swollen for 4 to 5 days, then slowly resolved over the next couple days. No doctor seen for this.   About one week after vaccination, i started to get headaches and feel dizzy on and off.  I did go to the hospital for this because I have never had anything like that happen before.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in left breast. Painful, very swollen for 4 to 5 days, then slowly resolved over the next couple days. No doctor seen for this.   About one week after vaccination, i started to get headaches and feel dizzy on and off.  I did go to the hospital for this because I have never had anything like that happen before.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient felt dizzy and lightheaded. Elevated his feet and had him drink water and eat a snack. He had not eaten beforehand. Monitored patient for 30 minutes. He reported feeling better and left with his wife.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe aches in back.  Mainly lower back around kidneys
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eye pain, Gait disturbance, Herpes ophthalmic, Pain in extremity
Clinical narrative: Herpes Simplex virus of the eye. Very painful and still not cleared. Began on day 6 after second vaccine. Had this 16 years ago and never again so I assume it is the vaccine or process that reactivated the virus in my eye. Also had lameness for a day, sore arm for 3 days vs the soreness I had for only 8 hrs after the first shot, lower legs burned for about a day
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Influenza like illness, Pain, Pain in extremity, Sleep disorder
Clinical narrative: on 4/9 He said he had flu like symptoms, and dizziness and pain to the point that he could not sleep(he said all of his teammates got sick) on 4/11 He had some much pain in left arm he could not play tennis. He had not been able to play tennis since its been two weeks on 4/17 He went to Urgent Care and they prescribed pain and anitinflammatories He still cannot play tennis
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: on 4/9 He said he had flu like symptoms, and dizziness and pain to the point that he could not sleep(he said all of his teammates got sick) on 4/11 He had some much pain in left arm he could not play tennis. He had not been able to play tennis since its been two weeks on 4/17 He went to Urgent Care and they prescribed pain and anitinflammatories He still cannot play tennis
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy
Clinical narrative: immune thrombocytopenic purpura (ITP); This spontaneous report as received from a consumer referring to a currently 25-year-old female patient. The patient concurrent conditions, concomitant therapies were not reported. The patient's medical history included Sulfa antibiotics allergy and allergy to nuts and shellfish.  On 20-DEC-1997, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration, formulation, lot number and expiration date were not reported.) for routine vaccination.  On the same date, after the administration of the suspect vaccine, the patient experienced immune thrombocytopenic purpura (ITP) "reaction from the vaccine". The reported mentioned that the patient was hospitalized for 3 nights and was treated with immunoglobulin (unspecified). It was not reported if the subject sought medical attention. On 24-DEC-1997, the subject was recovered from the event.  The causal relationship between the suspect vaccine and the event was not reported
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; Nurse requested an Expired/ Administered ROTATEQ Evaluation / Patient was administered Expired ROTATEQ; This spontaneous report was received from a licensed practical nurse via company representative referring to a 3-month-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 19-APR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot number 1660957 and expiration date of 07-APR-2021 for prophylaxis (dose was not reported).   Separate single dose tubes from the same lot number and expiration date were administered to separate patients at 9:30AM, and then at 10:30AM, on the same date. The nurse was not able to confirm corresponding patient to administration time. No additional adverse event. The nurse requested an expired / administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) evaluation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Diarrhoea, Migraine, Pain
Clinical narrative: RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.