chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: brain fog; headache/in the back of the head, but moved around too, sometimes in the front. Has affected his balance; headache/in the back of the head, but moved around too, sometimes in the front. Has affected his balance; dizziness/had to stop driving a couple times/Had to stop a couple times while driving home from vaccine facility; Aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 19Feb2021, outcome "recovered" (2021), described as "brain fog"; HEADACHE (non-serious), BALANCE DISORDER (non-serious) all with onset 19Feb2021, outcome "recovered" (2021) and all described as "headache/in the back of the head, but moved around too, sometimes in the front. Has affected his balance"; DIZZINESS (non-serious) with onset 19Feb2021, outcome "recovered" (2021), described as "dizziness/had to stop driving a couple times/Had to stop a couple times while driving home from vaccine facility"; PAIN (non-serious) with onset 19Feb2021, outcome "recovered" (2021), described as "Aches and pains".   Additional information: Patient started developing symptoms like brain fog, headache, and dizziness within a day after first dose. He had to stop driving a couple times. When he had Brain fog symptom, he felt like at times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is but can't find the words to say. He cannot carry on a conversation intelligently. Brain fog Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. All symptoms from the first dose went away within 3-4 days. Reporter said patient recovered completely from symptoms associated with first dose. Reporter seriousness for First dose events Brain fog, headache, dizziness, aches and pains was unspecified. He had not received any prior vaccinations within 4 weeks and no adverse evets occurred after prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at injection site".  Additional Information: It was reported that, she experienced a reaction after getting the Pfizer Covid-19 vaccine. She reports that on Monday morning, she received the second dose at privacy centre. Like the first time she had pain at the injection site. The pain did go away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: First dose: felt gross; First dose: felt groggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: EW0150) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing), notes: From ages 3 years to 5 years. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Apr2021, outcome "unknown", described as "First dose: felt gross"; SOMNOLENCE (non-serious) with onset 03Apr2021, outcome "unknown", described as "First dose: felt groggy".  Additional information: The patient had the first Covid 19 vaccine he just felt pretty gross, and groggy the rest of the day after receiving the vaccine. The patient took First dose, early in the day. No vaccine administered on same date with the Pfizer vaccine. AE(s) did not require to visit Emergency Room/Physician Office. The patient had not received any other vaccination within 4 weeks prior Vaccination. The patient had no AE(s) following prior vaccination. No other products, no relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Neck pain, Pain, Pain in extremity
Clinical narrative: not feeling well; headache a pain in her left head; Body Aches; Pain in left arm; Neck Ache on Left Side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical Location of Administration: Right Arm, Outcome of reaction: Recovered/Resolved), administration date: 28Mar2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Flu Like Symptoms", "Fever", "Body Aches". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious) with onset 20Apr2021, outcome "not recovered", described as "headache a pain in her left head"; PAIN (non-serious) with onset 20Apr2021, outcome "recovered" (2021), described as "Body Aches"; PAIN IN EXTREMITY (non-serious) with onset 20Apr2021, outcome "recovered" (2021), described as "Pain in left arm"; NECK PAIN (non-serious) with onset 20Apr2021, outcome "unknown", described as "Neck Ache on Left Side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain, pain in extremity, neck pain.  Additional Information : Patient clarified after the first dose of the vaccine, she had flu like symptoms of fever and body aches that lasted for 3-4 days, exact dates unknown. Patient stated after the second dose of the Covid vaccine she had aches in her body and a headache on the left side and her neck and had pain in her arm for 2-3 days. Exact dates are unknown. Patient stated she hasn't gotten the flu for about 10 years. States she never gets sick. Treatment: Amoxicillin and Ibuprofen  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: not feeling well; headache a pain in her left head; Body Aches; Pain in left arm; Neck Ache on Left Side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical Location of Administration: Right Arm, Outcome of reaction: Recovered/Resolved), administration date: 28Mar2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Flu Like Symptoms", "Fever", "Body Aches". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious) with onset 20Apr2021, outcome "not recovered", described as "headache a pain in her left head"; PAIN (non-serious) with onset 20Apr2021, outcome "recovered" (2021), described as "Body Aches"; PAIN IN EXTREMITY (non-serious) with onset 20Apr2021, outcome "recovered" (2021), described as "Pain in left arm"; NECK PAIN (non-serious) with onset 20Apr2021, outcome "unknown", described as "Neck Ache on Left Side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain, pain in extremity, neck pain.  Additional Information : Patient clarified after the first dose of the vaccine, she had flu like symptoms of fever and body aches that lasted for 3-4 days, exact dates unknown. Patient stated after the second dose of the Covid vaccine she had aches in her body and a headache on the left side and her neck and had pain in her arm for 2-3 days. Exact dates are unknown. Patient stated she hasn't gotten the flu for about 10 years. States she never gets sick. Treatment: Amoxicillin and Ibuprofen  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "a little chills and tiredness". Additional information: Caller stated that she does not want to file a report because her daughter and granddaughter are younger, 50 and 22, and it was just one day - a little chills and tiredness. Caller stated younger people seem to have more of an issue because people have immune system build up over the years. Both her daughter and granddaughter had similar side effects, but her daughter got the Pfizer vaccine. It was a day after or two days after, mild with no concern. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She moved it to May 15 due to her colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She moved it to May 15 due to her colds".  Additional Information: Patient got the first dose last 20Apr and second dose was scheduled on 11May however patient moved it to 15May due to colds and now patient wants to move it a week after 15May.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Euphoric mood, Somnolence
Clinical narrative: I got really high 20 minutes after my shot/ euphoria; Heavy eyelids; Slightly sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 09:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit disorder" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues); "Depression" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues); "Anxiety" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues); "Adhesive tape allergy" (unspecified if ongoing), notes: Known allergies: plastic medical tape; "Allergy to surgical sutures" (unspecified if ongoing), notes: Known allergies: black stitches; "Gluten intolerance" (unspecified if ongoing), notes: Known allergies: Gluten; "Tremor of hands" (unspecified if ongoing), notes: Hand tremors; "Insomnia" (unspecified if ongoing); "Bipolar disorder" (unspecified if ongoing), notes: Bipolar disorder, (anxiety, depression, attention issues). Concomitant medication(s) included: LAMOTRIGINE; WELLBUTRIN; PROPRANOLOL; KLONOPIN. Vaccination history included: Bnt162b2 (DOSE 1 SINGLE; Lot number: Unknown, I got really high after my shot. First dose lasting about 30 minute), administration date: Apr2021, when the patient was 26 years old, for COVID-19 immunisation, reaction(s): "got really high". The following information was reported: EUPHORIC MOOD (non-serious) with onset 07May2021 09:00, outcome "recovered" (07May2021 10:00), described as "I got really high 20 minutes after my shot/ euphoria"; ASTHENOPIA (non-serious) with onset 07May2021 09:00, outcome "recovered" (07May2021), described as "Heavy eyelids"; SOMNOLENCE (non-serious) with onset 07May2021 09:00, outcome "recovered" (07May2021), described as "Slightly sleepy". Therapeutic measures were not taken as a result of euphoric mood, asthenopia, somnolence.  Additional information: The patient was not pregnant at the time 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. It was reported that, the second dose lasted about an hour. On 07May2021 at 09:00, the patient had heavy eyelids, euphoria, slightly sleepy, no disorientation or loss of reactivity or depth perception, no visual or audio changes, no light headedness or physical/body high. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Migraine
Clinical narrative: We're having some side effects; Pounding migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE EVENT (non-serious), outcome "unknown", described as "We're having some side effects"; MIGRAINE (non-serious), outcome "unknown", described as "Pounding migraine".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Additional Information:  The patient taking the Pfizer-BioNTech COVID-19 Vaccine. she stated "I'm calling because we got the shot yesterday and we're having some side effects, my boyfriend is having a lot more. He has a pounding migraine.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Ache/Pains; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Ache/Pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Patients states has 2nd dose of COVID-19 Vaccine and was under the weather like Flulike symptoms, aches, Pains.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, SARS-CoV-2 antibody test
Clinical narrative: ond dose in her muscle at all but that it might have gone into the fat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and administered in arm left, administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Cholesterol high" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol increased; AMLODIPINE taken for hypertension. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Apr2021, outcome "unknown", described as "ond dose in her muscle at all but that it might have gone into the fat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: big toe swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "big toe swelled up".  Additional information: He said that he took the first dose of the vaccine on 23FEB2021 and the second dose was given on the 30th (month not confirmed). He said he has a wounded leg from [PRIVACY] and that after the first dose of the vaccine his big toe swelled up.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sleep disorder
Clinical narrative: Exhaustion-slept a lot; Exhaustion-slept a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 13:00 (Lot number: EN6078) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic low back pain", start date: Dec1979 (ongoing), notes: Pertinent Details: surgeries 1982, 1986,1988, 1989 Ongoing; "Hypertension", start date: 1990 (ongoing), notes: Ongoing, Pertinent Details: Oral treatment since 1990; "Hemorrhagic stroke", start date: 01Jun2015 (ongoing), notes: Ongoing, Long term symptoms-legs, June 2015-interventional radiology left occipital AVM; "osteoarthritis", start date: 1975 (ongoing), notes: Ongoing,Pertinent Details: chronic pain can be severe; "endometrial cancer", start date: 2015 (ongoing), notes: Ongoing,Pertinent Details: radial hysterectomy the chemo on radiation; "several drug allergies" (unspecified if ongoing), notes: Myself - several drug allergies. Family history included: "breast cancer" (unspecified if ongoing), notes: mother's side- breast cancer in 3 women. Concomitant medication(s) included: MELOXICAM taken for arthritis (ongoing); LEVETIRACETAM taken for seizure (ongoing); VERAPAMIL taken for hypertension (ongoing); HYDROCHOROTHIAZIDE taken for hypertension (ongoing); ACETAMINOPHEN taken for pain (ongoing); ATORVASTATIN CALCIUM taken for hyperlipidaemia (ongoing); K-TAB taken for hypokalaemia (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot number : EN6201,intramuscular, left upper arm), administration date: 20Feb2021, for COVID-19 immunization; Bnt162b2 (1st dose, Lot number : EN6201), for covid-19 immunization, reaction(s): "flu -like aches", "sore throat", "Fever low grade -990"; Bnt162b2 (1st dose,Lot number : EN6201), for covid-19 immunization, reaction(s): "congestion". The following information was reported: FATIGUE (non-serious), SLEEP DISORDER (non-serious) all with onset 14Mar2021, outcome "recovered" (14Apr2021) and all described as "Exhaustion-slept a lot". Therapeutic measures were not taken as a result of fatigue, sleep disorder. Additional information: The patient did not received any prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule, Pain in extremity
Clinical narrative: I had a not under my left arm for over a week; extremely tired; I still have sharp pains from my elbow to my mid part of my hand.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "knownallergies :pencycline" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; PROZAC; CLARITINE; BIOTIN. Past drug history included: Allergies: codine, reaction(s): "Allergies: codine"; Allergies: sulfar, reaction(s): "Allergies: sulfar". Vaccination history included: Bnt162b2 (Dose:1, lot number: EN6198, administration time: 08:00 AM, vaccine location: Left arm), administration date: 14Apr2021, when the patient was 54 years old, for COVID-19 Immunisation, reaction(s): "sever headache", "fatigued". The following information was reported: NODULE (non-serious) with onset 2021, outcome "recovering", described as "I had a not under my left arm for over a week"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "extremely tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "I still have sharp pains from my elbow to my mid part of my hand.". Therapeutic measures were not taken as a result of nodule, fatigue. Therapeutic measures were taken as a result of pain in extremity.  Additional information:The patient did not receive other vaccine in four weeks. No COVID prior vaccination and tested post vaccination. Facility type vaccine was workplace clinic. Patient had taken tylenol for the pain  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: After second dose reports the following two weeks having back pain and continuous fatigue; After second dose reports the following two weeks having back pain and continuous fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19 infection" (unspecified if ongoing), notes: Person that previously had covid-19 infection. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "fever"; Bnt162b2, for Covid-19 immunization, reaction(s): "weariness". The following information was reported: BACK PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "After second dose reports the following two weeks having back pain and continuous fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vision blurred
Clinical narrative: Headache; arm was aching a lot; have been experiencing cloudy vision in the left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 08May2021 (Lot number: ERZ613) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot No: ER8732, Unknown NDC and expiration.), administration date: 17Apr2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 08May2021, outcome "not recovered", described as "have been experiencing cloudy vision in the left eye"; HEADACHE (non-serious) with onset 09May2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 09May2021, outcome "recovering", described as "arm was aching a lot". Therapeutic measures were taken as a result of headache.  Additional Information: The caller (mother) was calling for her son (Withheld) . The patient got the second dose of the Pfizer covid vaccine on Saturday 08May2021. A few hours later, the patient's left eye started to get cloudy and it's still cloudy. The caller felt that this was from the vaccine and wants to know if it has happened to other people?  Was there anything the caller has to do? How long is this going to last? The patient is up to minus nine in his vision. The patient also had a bad headache and was in the bed and couldn't go to work on 09May2021, and his arm was aching a lot. The patient's left eye being cloudy started at about 6:00 or 7:00 pm that night he received the vaccine. The patient woke up at 5:00 am on Sunday with the headache and took some Tylenol and it went away. number of Pfizer covid vaccine: Unknown. Expiry Date of Pfizer covid vaccine: Unknown Other Products: No. Patient History: No. Investigation Assessment: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: Three days after shot began having problems with right leg behind the knee to the point that "it cannot be moved; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ARTHROPATHY (non-serious), outcome "unknown", described as "Three days after shot began having problems with right leg behind the knee to the point that "it cannot be moved".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  An 18-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Lot number: EW0171) at the age of 18 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 10May2021, outcome "unknown", described as "vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness". Therapeutic measures were not taken as a result of vertigo, dizziness.  Additional information: The patient received the 1st dose on 08May2021. The patient experienced vertigo a few hours before getting the vaccine and it went away, but today he was experiencing vertigo again. He was just calling to report a possible side effect he was not sure if it was a side effect of the Pfizer vaccine. He thought was experiencing some side effect of the Pfizer vaccine however, he was not entirely sure if it was the vaccine or if it was just something else, he was going through, because he took the vaccine on the 8th (08May2021) which was Saturday and Saturday morning. She felt pretty dizzy for about 10 to 15 minutes and then than just kind of went away and then he went to get the vaccine and now Monday. The patient felt about the same dizziness on Saturday morning before he took the vaccine. So, he does not know if this was a side effect or if it was the same thing, he had Saturday morning. He thought it just be good idea to at least report this. The patient stated, "He believe last time he checked, he was about 5 (feet) 8 (inches) and weigh about 250 pounds. Also stated, "No he haven't used any treatment beside trying to keep him balance because he felt like falling every now and then, he usually he was sitting down so that he does not have to "stand".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Peripheral coldness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 74-year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills after her first dose for 15 mins then it resolved, From the past 3 days she is experiencing chills again but no fever"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "Hands is like ice". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had chills for 2 to 3 days, her hands were like ice, but she does not have fever. her hands were like ice. The patient had experienced chills after her first dose for 15 mins then it was resolved. She wanted to know if she should receive her 2nd dose of the vaccine today, 11May2021 or if she should reschedule it. She also added that she had a blood test last week to check her sugar and its normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing of the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8733) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose,, Lot: EN6207, Left Arm), administration date: 12Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "Ringing of the ears".  Additional information: Patient had the First Dose on 12Mar2021 around 9 or 10AM. She had the Second Dose on 02Apr2021 at around 9 or 10AM, the ringing in the ears started after the second dose, it was a few days after maybe 3-4 days, possibly the Monday after the second dose. Patient didn't write it on a calendar, she didn't believe it when it happened, but she has the ringing in the ears since then. The ringing happens in both ears, sometimes its both ears, sometime its alternating. Sometimes she'll wake up and noticed its only in the right ear, sometimes left.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Headache, Nausea
Clinical narrative: Having a stomach bug (feels like throwing up); Having a stomach bug (feels like throwing up); Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset May2021, outcome "unknown", HEADACHE (non-serious) with onset May2021, outcome "unknown" and all described as "Headache"; GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "Having a stomach bug (feels like throwing up)".  Additional Information: A contactable consumer (patients mother) reported for her son that he had taken the first dose and got symptoms as stomach bug, he woke up and he was throwing up and then he doesn't have a fever he has got a bit headache. Reporter queried whether patient can take 2nd one dose or can he wait a day, so that he feels a little better and then he can take 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "tiredness".  Additional information: Caller wants to know the side effects of the vaccine, especially tiredness. Caller got the first dose of the vaccine 02May2021. Caller wants to know how long the side effects will last.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hangover, Nasopharyngitis
Clinical narrative: I have had a lingering "Vaccine Brain Fog" since my shot - after the first shot, and it is noticeably worse after the 2nd shot.  It feels like I have a hangover or head cold, stuffy head.; tired; hangover or head cold, stuffy head; hangover or head cold, stuffy head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I have had a lingering "Vaccine Brain Fog" since my shot - after the first shot, and it is noticeably worse after the 2nd shot. It feels like I have a hangover or head cold, stuffy head."; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; HANGOVER (non-serious), NASOPHARYNGITIS (non-serious) all with onset 2021, outcome "unknown" and all described as "hangover or head cold, stuffy head".  Additional Information: Patient's mother (reporter) stated that both mother and her daughter felt the same way. Patient received her shots at the same location just a week after reporter. They had a lingering vaccine brain fog since first shot and its noticeably worse after second shot. It feels like they have hangover or head cold, stuffy head. They are constantly tired as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: sore in the arm; Off label use; Drug use in unapproved population; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore in the arm"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Pain; Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset May2021, outcome "unknown", described as "Pain"; NASOPHARYNGITIS (non-serious) with onset May2021, outcome "unknown", described as "Cold".  Additional information:The reporter  Wanted to know that patient can take cold medication or pain reliever. Cold transfer and created a manual AE form. It was unknown that the Reporter a Healthcare Professional HCP. It was unknown that the reporter the prescribing HCP.The reporter consent to further follow-up was  Unknown. The reporter's contact information available to you or a sub-contracted party was Yes. It was unknown that the patient/consumer/ caregiver provide consent to contact the prescribing HCP.There was not any unaddressed medical questions referred or forwarded to medical information.  Follow-up (12May2021): This is a follow up spontaneous report in response to m ail trail sent regarding the confirmation of below mentioned query. The response included that: Hello, Attached is an escalated comment from 09May2021 for CEP 159558.Please see the attached source document with a medical inquiry. AER# 2021530777.This is to confirm receipt of inquiry. Please document interaction number INT-00243597.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Flu like symptoms (chills and body aches and pains.); Flu like symptoms (chills and body aches and pains.); Flu like symptoms (chills and body aches and pains.); Flu like symptoms (chills and body aches and pains.); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), CHILLS (non-serious), PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Flu like symptoms (chills and body aches and pains.)".  Additional information :The symptoms occurred about 6-8 hours after taking the shot and lasted 1-2 days   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: her tongue is slippery or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 07May2021, outcome "unknown", described as "her tongue is slippery or something".  Additional Information: The patient received the first dose of the Pfizer COVID-19 vaccine. Unfortunately, about an hour ago, she was spraying Lysol spray in her son's room to eliminate odors and as she was spraying, she opened her mouth to call for her son and in that moment, the Lysol that she was putting into the air entered into her mouth. The caller explains she could feel the flavor of the Lysol on her mouth. After that, her tongue is slippery or something. She cannot describe it in this language, she can only describe it in her own language, she doesn't know. She clarifies it just feels weird. Her question for Pfizer is if the substances from the Lysol spray effect the vaccine? She mentions she read through the Lysol bottle, like the application and warnings, and everything she read is in regards to if something happens to the skin or eyes. Since she accidentally put some Lysol in her mouth, it doesn't say anything about if a little drip is swallowed/gets into your mouth. It only says something about the skin, nothing for swallowing. Caller doesn't had her vaccine record card with her. She mentions she received the first dose at Hospital. She knows that her second vaccine is scheduled for 27May2021. She states she only had a question in regards to the Lysol affecting the vaccine, nothing else is wrong  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Malaise, Pain, Renal pain
Clinical narrative: Mild body aches; tired; not feeling well; Loss appetite; kidney pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08May2021 10:15 (Lot number: Ew0185) at the age of 40 years as dose 1, single for covid-19 immunisation at other. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma, allergies, Herpes Virus; "allergies" (unspecified if ongoing), notes: other medical history: Asthma, allergies, Herpes Virus; "Herpes Virus" (unspecified if ongoing), notes: other medical history: Asthma, allergies, Herpes Virus; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin, amoxicillan. Concomitant medication(s) included: SINGULAIR; WIXELA INHUB; PROVENTIL HFA [SALBUTAMOL SULFATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; RHINOCORT [BUDESONIDE]. Past drug history included: Amoxicillan, reaction(s): "Allergies: Amoxicillan", notes: Known allergies: Penicillin, amoxicillan. The following information was reported: PAIN (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "Mild body aches"; FATIGUE (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "tired"; MALAISE (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "not feeling well"; DECREASED APPETITE (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "Loss appetite"; RENAL PAIN (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "kidney pain". Therapeutic measures were taken as a result of pain, fatigue, malaise, decreased appetite, renal pain.  Additional information: After first dose, the patient had mild body aches, no arm pain. After few days, tired and not wanting to do anything. Simply not feeling well. Loss appetite and kidney pain progressed from time 1st does to 2nd. The patient was treated with Vacyclovir. If Covid prior vaccination: No. If Covid tested post vaccination: No. If other vaccine in four weeks: No  No follow-up attempts are required. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: Metallic taste in mouth and dry mouth.; Metallic taste in mouth and dry mouth.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 22Jan2021 12:45 (Lot number: EL3249) at the age of 77 years as dose 1, single and administration date 15Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE; CALCIUM; AREDS. The following information was reported: DYSGEUSIA (non-serious), DRY MOUTH (non-serious), outcome "not recovered" and all described as "Metallic taste in mouth and dry mouth.". Therapeutic measures were not taken as a result of dysgeusia, dry mouth.  Additional information: Clinical course included 'Metallic taste in mouth and dry mouth. Not sure if this started with 1st or 2nd (15Feb2021) inoculation. Have been wondering what was causing this taste and dryness but didn't connect this initially with vaccination until I looked up the subject and found other people experiencing the same thing after the vaccinations'  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.