chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Malaise
Clinical narrative: about two weeks after second vaccine her blood sugar was low, lot of trouble getting it to stabilize; struggled little bit with blood sugar sometimes dropping, was more intense; Only thing she figured out was her body was fighting hard to build the antibody and that's how it affected it; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955, 55-years-old at the time of vaccination), via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunization. Medical history included menopause and low thyroid (had low thyroid. She had a little bit of subpar thyroid, mild like borderline hypothyroid). Concomitant medications included fluoxetine (took a very low dose, that was 16 mg total, a 10 mg capsule and 6 mg liquid) and thyroid (ARMOUR THYROID) (took little, tiny bit of thyroid medication and thyroid was almost nothing, she took about 5 mcg a day. It was a natural thyroid). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199, 55-years-old at the time of vaccination), via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunization and experienced hypoglycaemia. On an unknown date in 2021, She reported that, about two weeks after second vaccine her blood sugar was low, lot of trouble getting it to stabilize; struggled little bit with blood sugar sometimes dropping, was more intense and the only thing she figured out was her body was fighting hard to build the antibody and that's how it affected it. Consumer stated, she was not diabetic, but she did get hypoglycemic at times. She just had like this thing with low where she got, it's not true hypoglycemia because she didn't go super low. Not really, she had a single mutation for iron so it's not clear because she had gone through menopause, it's not clear if she was going to have trouble with holding too much iron so they were just watching it, it was nothing diagnosed. She didn't undergo any laboratory test. Patient did not receive any treatment for the events. Outcome of the events was resolved on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Feeling burning sensation going through my body, Its been coming and going its been on different spot ,feels like its just moving around; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 36-year-old), via an unspecified route of administration on 22May2021 at 05:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient got the vaccine around 5 o'clock on 22May2021 and not more than like minute she started showing like a feeling burning sensation going through her body, it's been coming and going it's been on different spot, feels like it's just moving around and she just thinking now if that was something other people have experienced or is it something she should be concerned about. The patient doesn't know what to take as corrective treatment. The outcome of event was unknown.   Information about the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Headache; Tiredness; Muscle pain; Chills; I am so painful in my joints, all muscle ache; I was so tired and weak; I am not feeling well; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EW0167, Expiration date: Aug2021), via an unspecified route of administration, administered in Arm Left on 20May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from 26Apr2021 to 26Apr2021. Concomitant medications included metformin, lisinopril and glipizide. Historical vaccine included first dose of BNT162B2 (Lot number: EW0171) via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient got the vaccine second dose and patient was not feeling well. patient got the vaccine in the morning and midday patient was having like headache, tiredness, muscle pain and last night, patient was not shivering but patient was feeling chills inside her body like patient was under the layers of blanket, but patient did not have fever. My temperature patient kept taking it was last 98 to 97.9 something like that. Patient kept taking her temperature, but patient so painful in her joints, all muscle aches. Patient was so tired and weak on an unspecified date in 2021, for headache patient have taken Tylenol (Treatment) it comes in and goes. The outcome of the events headache, tiredness was not recovered while unknown for another events.  Information on Lot/Batch number was available. Additional information has been requested
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Headache; Tiredness; Muscle pain; Chills; I am so painful in my joints, all muscle ache; I was so tired and weak; I am not feeling well; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EW0167, Expiration date: Aug2021), via an unspecified route of administration, administered in Arm Left on 20May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from 26Apr2021 to 26Apr2021. Concomitant medications included metformin, lisinopril and glipizide. Historical vaccine included first dose of BNT162B2 (Lot number: EW0171) via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient got the vaccine second dose and patient was not feeling well. patient got the vaccine in the morning and midday patient was having like headache, tiredness, muscle pain and last night, patient was not shivering but patient was feeling chills inside her body like patient was under the layers of blanket, but patient did not have fever. My temperature patient kept taking it was last 98 to 97.9 something like that. Patient kept taking her temperature, but patient so painful in her joints, all muscle aches. Patient was so tired and weak on an unspecified date in 2021, for headache patient have taken Tylenol (Treatment) it comes in and goes. The outcome of the events headache, tiredness was not recovered while unknown for another events.  Information on Lot/Batch number was available. Additional information has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Muscle fatigue, Pain
Clinical narrative: tired; achy; total exhaustion; muscle fatigue; joint pain; joint tenderness; overall weakness; This is a spontaneous report from a contactable consumer or other non hcp.     A 49-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:15 as 2nd dose, single for covid-19 immunisation.Medical history included irritable bowel syndrome, spinal fusion surgery. Concomitant medication(s) included naproxen sodium (ALEVE).The patient had not known allergies.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the week following 2nd dose, tired &achy. Beginning 3 weeks after 2nd dose total exhaustion,muscle fatigue, joint pain, joint tenderness,and overall weakness which has persisted for more than 4 weeks. The events achy, total exhaustion on,muscle fatigue, joint pain, joint tenderness,overall weakness on 24Apr2021 12:00 with outcome of not recovered.Therapeutic measures were taken Iron & B12 supplements and Tylenol as a result of tired (fatigue), achy (pain), total exhaustion (fatigue), muscle fatigue (muscle fatigue), joint pain (arthralgia), joint tenderness (arthralgia), overall weakness (asthenia).  Follow-up actions required. Further information requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: the day after my second dose, I had one of the worst migraines of my life.; This is spontaneous report from contactable consumer or other non-HCP (patient). A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration in Arm Left on 23Apr2021 15:45 (age at the time of vaccination 19-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK8737), via an unspecified route in Arm Left on 01Apr2021 15:45 (age at the time of vaccination 19-years-old), as a single dose for COVID-19 immunization. The patient's medical history included chronic migraines. The patient's concomitant medication was not reported. 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 the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced the day after my second dose, I had one of the worst migraines of my life. No treatment was received. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision both eyes; This is a spontaneous report from a contactable consumer, reported for herself. A 55-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 29Apr2021 (at the age of 55-years-old) as a single dose for covid-19 immunization. Medical history included asthma, drug hypersensitivity, glaucoma, angle closure glaucoma. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. 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 had known allergies with sulfa. The patient's concomitant medications were not reported. On 29Apr2021 02:00, the patient experienced blurry vision both eyes and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment. Outcome of the event was recovered, on an unspecified date in Apr2021. Device Date was 22May2021.  Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Thinking abnormal
Clinical narrative: I felt very tired; Chills; Fever was 100.4; My fever is high and I am not thinking clear; Fever was 100.4; My fever is high and I am not thinking clear; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179 and expiry date: unknown), dose 1 via an unspecified route of administration on 20May2021 at 12:30 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced I felt very tired, chills and fever was 100.4; my fever is high and i am not thinking clear on an unspecified date (The patient don't know the patient feel very "drug out" (not clarified) right now). Outcome of all the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Arm is very sore, I cannot lift it; Nausea; Headache; Have feel the pain with first one, but with this one they put in the injection and I can feel the pain right away; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient felt like arm was very sore, nausea and headache for a duration of 2 days. Patient had felt pain for the first shot like that, but this one was when they put in the injection and the patient felt the pain right away. The clinical outcome of all the events was unknown.  Information on lot/batch number has been requested.  No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained. The case was closed for follow-up activities.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore Arm; Body Soreness; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was reported that, the patient experienced sore arm, body soreness on an unspecified date with outcome of unknown.   Information about batch/lot number not available. Further information has been requested.  Additional Context:  The report is cross referenced to report ID:(#)  When calling to report his own events the caller mentions that his wife also had the vaccine and she had a sore arm and some body soreness but she wasn't sick or anything like that.  He declines to complete a report for his wife. States it was just a normal reaction and she was back to normal the next day.   Communication:  Caller declined to complete report.  Report 2 of 2.  The report is cross referenced to report ID: (#)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: legs & feet swelled huge; Fever; chills; sleepy; legs & feet swelled huge; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Apr2021, as dose 2, single for COVID-19 Immunisation. The patient age at vaccination was 64 years. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose single for COVID-19 Immunisation. On an unknown date after 2nd vaccination, the patient experienced fever, chills, sleepy, last couple weeks, legs and feet swelled huge and can't put on shoes. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose. Have not had one in years; This is spontaneous report from contactable consumer or other non-HCP (patient). A 42-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 21May2021 (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 vaccine, via an unspecified route on an unspecified date (age at the time of vaccination 42-years-old), as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included Claritine (Loratadine). Patient had no known allergies. 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 the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced Bloody nose. Have not had one in years. No treatment was received. The outcome of the event was recovered on an unspecified date May2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache
Clinical narrative: Headache; Heat in my body; Very tired; tiredness; This is a spontaneous report from a contactable consumer or other non-health care Professional (Patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Expiry Date: unknown, Batch/Lot number: unknown), via an unspecified route of administration on 20May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated I had the vaccine Thursday last 3 days ago or 4 days, last Thursday I feel like just I feel like very tired on 21May2021 and some headache on an unspecified date, is that normal. Heat in my body on 21May2021. Consumer stated if its gonna go away, at the beginning there is nothing now it starts to feel like two days ago it starts to feel like heat, some heat in my body, now I feel like tiredness last two days. The outcome of event was unknown.  Information regarding lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Painful respiration
Clinical narrative: Chest was painful, after the first vaccine; Breath was hard, and it was painful, after the first vaccine; Breath was hard, and it was painful, after the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 20May2021 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In May2021 morning, the patient experienced chest was painful, after the first vaccine and breath was hard, and it was painful, after the first vaccine. The patient called about his situation and to ask for some advice. The patient did not know what to do. He read online that if people have had side effects like chest pain, they should go to the hospital. The patient asked if he should go to the hospital. He was outside of a hospital at the time of reporting. The patient reclarified that if people are young and under 25 years old, they do not have to worry and the side effects usually last for 2 or 3 days and then disappear. His effects have lasted for 4 days. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: woke up early this morning feeling sharp as a tack; This is a spontaneous report.    A contactable consumer (Patients daughter) reported for her father that a male patient of unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history included dementia. Concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced woke up early this morning feeling sharp as a tack. Her dad just got his second Pfizer shot yesterday and he had no side effects. He had early dementia and he woke up early this morning feeling sharp as a tack, feeling great. He was awesome. No swelling. No soreness in the arm yesterday and it was like wow. Every single person she knew was flat out in some way. Well praise the lord because that was what he needed. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report from a contactable pharmacist. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161 and Expiry date: Jul2021) dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 at the age of 29-years-old as 0.3 ML single dose for Covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On 02May2021, the patient experienced blurred vision. The caller was looking and didn't see where blurred vision was a side effect. The caller wants to know if it is okay for the patient to received the second dose. The patient can still see, the patient went to the doctor about this event and the doctor said it should go away with time. The outcome of event was not recovered.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chest pain, Oropharyngeal pain
Clinical narrative: He woke up with a lot of chest pain; It was a burning sensation and he did not feel okay; He feels weak; He's got a sore throat; This is a spontaneous report from a contactable consumer (patient's parent). A 13-year-old adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20May2021(at the age of 13 years old) as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On a unspecified date in May2021, reported as, four days ago my son received the Pfizer Covid 19 vaccine. This morning he woke up with a lot of chest pain, he said it was a burning sensation and he did not feel okay. He feels weak, he's got a sore throat and chest pain. It was also reported his chest started hurting. Outcome of the events were Unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Discomfort, Ear pain, Fatigue
Clinical narrative: chest- tired dranaged; nauseous; slept with some discomfort; Left arm sore with rash; Left arm sore with rash and hot to touch; sore joints; arm sore/ arm pit sore; sinuses; tired/dragging; Headache; right temple vain throbbing/Body aches; ear and neck pain; ear and neck pain; Draining in throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO183), via intramuscular route of administration on 20May2021 at 14:30 (at the age of 64-year-old), as dose 2, single in left arm for COVID-19 immunisation. The patient's medical history included sinuses-GER. Concomitant medications included antihistamine simethicone 120 mg two times per day and nasal decongestant pseudoephedrine hydrochloride; for unknown indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO167), via an unspecified route of administration on 29Apr2021 at 14:30 (at the age of 64-year-old), as single dose in left arm for COVID-19 immunization and experienced left arm pain. The patient's past drugs included sulfur, codein and experienced allergy to both. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, 9 hours and 30 minutes after the administration of second dose of vaccine, the patient experienced tired, headache, right temple vain throbbing/body aches, ear and neck pain, nauseous at 20:30, slept with some discomfort, left arm sore with rash and hot to touch, sore joints, arm sore/ arm pit sore, sinuses, draining in throat and felt tired and dragging. On day 3, arm was still sore with rash, heat, headache, and sore joints. Patient called urgent care and told her to take Tylenol 2 times. On 24Jun2021, the patient experienced chest - tired dranaged. The events resulted in emergency room visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events tired, headache, right temple vain throbbing/body aches, sinuses, chest- tired dranaged was resolved on 24Jun2021. The clinical outcome of all other events was resolving.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Nausea, Neck pain, Oropharyngeal discomfort
Clinical narrative: chest- tired dranaged; nauseous; slept with some discomfort; Left arm sore with rash; Left arm sore with rash and hot to touch; sore joints; arm sore/ arm pit sore; sinuses; tired/dragging; Headache; right temple vain throbbing/Body aches; ear and neck pain; ear and neck pain; Draining in throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO183), via intramuscular route of administration on 20May2021 at 14:30 (at the age of 64-year-old), as dose 2, single in left arm for COVID-19 immunisation. The patient's medical history included sinuses-GER. Concomitant medications included antihistamine simethicone 120 mg two times per day and nasal decongestant pseudoephedrine hydrochloride; for unknown indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO167), via an unspecified route of administration on 29Apr2021 at 14:30 (at the age of 64-year-old), as single dose in left arm for COVID-19 immunization and experienced left arm pain. The patient's past drugs included sulfur, codein and experienced allergy to both. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, 9 hours and 30 minutes after the administration of second dose of vaccine, the patient experienced tired, headache, right temple vain throbbing/body aches, ear and neck pain, nauseous at 20:30, slept with some discomfort, left arm sore with rash and hot to touch, sore joints, arm sore/ arm pit sore, sinuses, draining in throat and felt tired and dragging. On day 3, arm was still sore with rash, heat, headache, and sore joints. Patient called urgent care and told her to take Tylenol 2 times. On 24Jun2021, the patient experienced chest - tired dranaged. The events resulted in emergency room visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events tired, headache, right temple vain throbbing/body aches, sinuses, chest- tired dranaged was resolved on 24Jun2021. The clinical outcome of all other events was resolving.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash, Sinusitis
Clinical narrative: chest- tired dranaged; nauseous; slept with some discomfort; Left arm sore with rash; Left arm sore with rash and hot to touch; sore joints; arm sore/ arm pit sore; sinuses; tired/dragging; Headache; right temple vain throbbing/Body aches; ear and neck pain; ear and neck pain; Draining in throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO183), via intramuscular route of administration on 20May2021 at 14:30 (at the age of 64-year-old), as dose 2, single in left arm for COVID-19 immunisation. The patient's medical history included sinuses-GER. Concomitant medications included antihistamine simethicone 120 mg two times per day and nasal decongestant pseudoephedrine hydrochloride; for unknown indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO167), via an unspecified route of administration on 29Apr2021 at 14:30 (at the age of 64-year-old), as single dose in left arm for COVID-19 immunization and experienced left arm pain. The patient's past drugs included sulfur, codein and experienced allergy to both. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, 9 hours and 30 minutes after the administration of second dose of vaccine, the patient experienced tired, headache, right temple vain throbbing/body aches, ear and neck pain, nauseous at 20:30, slept with some discomfort, left arm sore with rash and hot to touch, sore joints, arm sore/ arm pit sore, sinuses, draining in throat and felt tired and dragging. On day 3, arm was still sore with rash, heat, headache, and sore joints. Patient called urgent care and told her to take Tylenol 2 times. On 24Jun2021, the patient experienced chest - tired dranaged. The events resulted in emergency room visit. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events tired, headache, right temple vain throbbing/body aches, sinuses, chest- tired dranaged was resolved on 24Jun2021. The clinical outcome of all other events was resolving.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number EP6955, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 21May2021 11:00 as dose 1, single for covid-19 immunization (73 year when vaccinated). The patient medical history and concomitant medications were not reported. The patient took Polio vaccine and had a bad reaction at the age of 10-year-old. On 21May2021 at 19:00, the patient experienced sore arm. On 22May2021 around 14:00-15:00, the patient did not just have a little fatigue or tiredness. She had what she would call extreme exhaustion. States she was in bed for 24 hours and just slept. States she could hardly even lift her head. The patient took Tylenol and sleep for 24 hrs with a heating pad. Caller states she is in good health and has lots of energy and has never slept like that before. States that today it is gone, and she feels 100 percent better. The outcome of events was recovered on 24May2021.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Extreme tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 28Apr2021 (at the age of 85-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported) for COVID-19 immunization received on 07Apr2021. On unspecified date the patient experienced extreme tiredness and muscle pain and would like to know how long these effects will last, patient states that the pain is worse in the morning than in the afternoon. Patient states just since the last shot, she received on 28Apr2021. she was just wondering how long she can expect these side effects to last if that is what this is, she has not had this problem before she took the last shot, she was assuming it had to do with it. She verifies she received both doses of the Pfizer Covid Vaccine. Patient wants to know how long that will go on for, it is been going on for about 4 weeks now. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that she received the first dose of vaccine, her arm hurt and then went away in one day. The patient was recovered from the event in 2021.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Vaccination site swelling
Clinical narrative: a painful lump that appears to be swollen; sore arm; sick a little bit; underarm was swelling/lump in underarm; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in right arm on 20May2021 as dose 1, single for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient did not received any other vaccine on same day or within four weeks prior to the first administration date of the suspect vaccine. Patient had no problems with vaccines in past. Family medical history relevant to AEwas none. The patient experienced a painful lump that appears to be swollen in which the lump was "very very obvious.", sore arm, sick a little bit, underarm was swelling/lump in underarm, swollen under the right arm where she got the vaccine on an unspecified date in May2021. It was reported that, patient received the first COVID vaccine last Thursday and she was told that it would be sore and she would be sick a little bit and experienced both and that was okay. 2 days after getting it her underarm was swelling in the same arm she got the vaccine and she felt pain and a lump in the underarm. Went to touch it and it was swollen under the right arm where she got the vaccine. She got it in the right arm since she was left handed. It was so weird and had not experienced any side effects like this before. Patient wanted to know what could she do about the pain and swelling and was this normal side effects she had since this was 2 days after the vaccine. Patient was unable to provide primary care provider. Got the first dose on 20May2021. Again mentioned felt the swelling in the underarm 2 days after getting it. She could feel the lump when she pushes one part of the underarm and saw a lump underneath it. She was scheduled for the second dose in 3 weeks. Patient reported that, she was super healthy person and had no problems. Did not even took any medication for headaches or anything, not even Motrin. No further details provided. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Eyelid function disorder, Headache, Hypoaesthesia
Clinical narrative: Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure behind eye; Tongue weakness in back of tongue on right side; bell's palsy; This is a spontaneous report from two contactable other health care professionals one of the (patient). A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0183), via intramuscular, administered in Deltoid Left on 20May2021 10:20 (age at the vaccination 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included been dealing with tinnitus for over a year and hypertension from 12Jul2017 and ongoing. There were no concomitant medications. The patient previously took flush from alcohol and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced bell's palsy on 20May2021 13:00, half of head became very numb, drooping eye lid, earache, sharp pain in head on right side, pressure behind eye, tongue weakness in back of tongue on right side on 20May2021 03:30 PM. Patient received treatment of Prednisone for the event Bell's palsy. Patient visit physician office for this event. Patient did not receive treatment for other events. The outcome of the event bell's palsy was recovering and not recovered for another events.  Follow up attempts are needed; further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the suspect product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to close temporal relationship. The case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Tongue movement disturbance
Clinical narrative: Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure behind eye; Tongue weakness in back of tongue on right side; bell's palsy; This is a spontaneous report from two contactable other health care professionals one of the (patient). A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0183), via intramuscular, administered in Deltoid Left on 20May2021 10:20 (age at the vaccination 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included been dealing with tinnitus for over a year and hypertension from 12Jul2017 and ongoing. There were no concomitant medications. The patient previously took flush from alcohol and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced bell's palsy on 20May2021 13:00, half of head became very numb, drooping eye lid, earache, sharp pain in head on right side, pressure behind eye, tongue weakness in back of tongue on right side on 20May2021 03:30 PM. Patient received treatment of Prednisone for the event Bell's palsy. Patient visit physician office for this event. Patient did not receive treatment for other events. The outcome of the event bell's palsy was recovering and not recovered for another events.  Follow up attempts are needed; further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the suspect product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to close temporal relationship. The case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Thinking abnormal, Vertigo
Clinical narrative: She was dizzy for like the whole day; Vertigo; Low grade fever; Not thinking right# She was not acting normal; This is a spontaneous report. (CEP ID: 159558). A contactable consumer reported for a 93-year-old female patient (mother). A 93-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC and UPC number: unknown), via an unspecified route of administration, administered in left arm on 05May2021 as single dose for COVID-19 immunization. The patient medical history included COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported.   On 06May2021 the patient experienced vertigo, low grade fever and not thinking right and she was not acting normal on 05May2021. She was dizzy for like the whole day on an unspecified date. It was reported that call was transferred. Transferring agent stated, patient have a caller on the other line and he was calling on behalf of his mother. So, his mother has the first dose of the vaccine on 05May however after the day of having first dose, his mother experienced vertigo all day and had a fever.  So, he mentioned as well that his mother was not thinking right but after a day or after that day she felt better and second dose appointment will be on 07Jun. So, he wanted to know if his mother can take second dose of the vaccine and want to talk more about the adverse event. Reporter stated, patient. She got infected with Covid in Jan (as patient had Covid before taking the vaccine, hence not captured as event). The day after the vaccine she developed a low grade fever and vertigo for the whole day and she was not acting normal the first day and for the day after 48hours later she was feeling back to normal. So, reporter question was should she get the second shot because she did not want to get the second shot. When paraphrased the concern, reporter stated, She got little bit fever and she had vertigo, she was dizzy for like the whole day. Reporter was informed about Pfizer Medical Information department and provided with the number. Reporter further stated, patient would have to repeat the same thing again. reporter don't understand you are in safety, you are expert. I need to speak with a medical doctor who can give me some information. reporter cannot be just transferred from one place to another. Reporter was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. In response to further probing, reporter stated, No, reporter want to talk to someone please someone who have some feedback from all people getting the vaccine, let me call this other number. Further probing could not be done as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call.  The outcome of  events vertigo and low grade fever was recovered on 06May2021, whereas outcome for other events was unknown.  Information about lot/batch no has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pyrexia
Clinical narrative: Fever; Headache on the right side of head; Unable to sleep; This is a spontaneous report from a contactable patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0168; Expiration Date: Aug2021), via an unspecified route of administration on 13May2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On 14May2021, the patient experienced fever, headache on the right side of head and unable to sleep. Patient stated event occurs after taking the first shot that night on the following day for 2 days. On 16May2021, patient had recovered from all the events.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Neck pain, Oxygen saturation
Clinical narrative: He was having severe chest pain 10/10; Shortness of breath; Neck pain that radiated through his spine; This is a spontaneous report from a contactable physician (patients mother). A 15-years-old male patient received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 16May2021, the next night (second day) he was having severe chest pain 10/10, shortness of breath, neck pain that radiated through his spine, pulse oxygen level 98 percent and his heart rate was fine. Patient received the first dose of the covid vaccine on Saturday, and Sunday is when the severe symptoms started. Caller stated she gave him tylenol and then he was fine. On the third day symptoms improved. By Monday, patient was better. Caller stated her sons next dose is scheduled 05Jun2021. Reporter read new reports about myocarditis. Reporter does not know who to contact to figure out if patient should get the second dose of the covid vaccine. Reporter heard that after the second dose of the covid vaccine, symptoms get worse. Caller stated she had reported on V-safety. Reporter declined to complete a safety report. Reporter has already reported through VAERS. The outcome of events was recovered. Unable to clarify details provided or gather additional information.  Caller notified that medical advice is not able to be provided but may have resources to help answer questions. Caller was provided with phone number of (number withheld), option 3, and hours of operation of Monday through Friday, 8AM to 8PM, Saturday and Sunday 9AM to 3PM for COVID-19 vaccine inquiries, prior to attempted warm transfer. Unable to warm transfer due to high call volume. Caller agreed to cold transfer.  Information on the lot/batch number has been requested.