chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: four people just got the booster and they are still sick four days later from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: ILLNESS (non-serious), outcome "unknown", described as "four people just got the booster and they are still sick four days later from Pfizer".  Up on Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: just a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing), notes: she is diabetic. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "just a little tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only side effect I had was pain in my left arm. Just a dull ache after the first and second shot that went away inn 24 hours or less.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202100999129 (Same patient, different drug, same event (split)).  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Lot number: FC3183) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 02:00 PM, Lot no: FA7485, Anatomical location: Left arm), administration date: 03Aug2021, when the patient was 57 years old, for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Sep2021 08:30, outcome "recovered" (Sep2021), described as "Only side effect I had was pain in my left arm. Just a dull ache after the first and second shot that went away inn 24 hours or less.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Pharmacy or Drug Store. If other vaccine in four weeks= No. Only side effect I had was pain in my left arm. Just a dull ache after the first and second shot that went away inn 24 hours or less. Since the vaccination, has the patient been tested for COVID-19:No   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Somnolence, Vomiting projectile
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent), for a Pfizer sponsored program (005570). An infant female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced projectile vomiting, somnolence (drowsiness) and exposure via breast milk (vaccine exposure via breast milk), with outcome of unknown. Additional information: Patient's mother reported for patient (daughter). She wanted to report adverse effects in her infant from the 1st Pfizer shot. She is a nursing mom. Her daughter had drowsiness and projectile vomiting. She was willing to take surveys, submit breastmilk samples and etc. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101150168 same reporter/drug, different patient/event (mother/baby case).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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), outcome "recovered", described as "Chills"; PAIN (non-serious), outcome "recovered", described as "Pain".  Additional information: Reporter stated that no one she knows with diabetes in her family, her mom and grandma don't had neuropathy and she has had it longer and acquired nerve damage. Reporter states her mom had chills and pain, no nerve pain maybe 2-3 weeks ago and it took about a week and a half and went away like all of a sudden she felt great. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I am experiencing numbness and tingling in both arms and occasionally in my leg; but it started with the arm opposite of the one I got the vaccine in; I am experiencing numbness and tingling in both arms and occasionally in my leg; but it started with the arm opposite of the one I got the vaccine in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 (Lot number: FC3181) at the age of 22 years as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 02Sep2021, outcome "unknown" and all described as "I am experiencing numbness and tingling in both arms and occasionally in my leg; but it started with the arm opposite of the one I got the vaccine in". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional information: The consumer stated, today experienced numbness and tingling in both arms and occasionally in leg and the pharmacist said that was not a normal side effect from the vaccine. When paraphrased the concern, Consumer stated, yes in both the arms but it started with the arm opposite of the one the patient got the vaccine in. Consumer stated that the second shot would be on 21Sep2021. The patient did not receive any other vaccines within 2 weeks prior to the COVID-19 vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Goitre, Myalgia, Peripheral swelling
Clinical narrative: 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 63 year-old male patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Chronic pulmonary lung blockage" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "I could not walk" (unspecified if ongoing), notes: I could not walk enough to do my job or breath. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Sep2021, outcome "unknown", described as "sore"; GOITRE (non-serious) with onset Sep2021, outcome "not recovered", described as "Right, Thyroid gland and under the left arm swelled"; PERIPHERAL SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "left arm swelled". Therapeutic measures were not taken as a result of myalgia, goiter, peripheral swelling. Additional information: No prior vaccination with in 4 week. Reporter stated, he was not taking any pain medication like tylenol or anything. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lower respiratory tract infection, Nasal congestion, Upper respiratory tract congestion
Clinical narrative: Feeling stuffy; Congestion; Headache; He's been feeling like he's got a cold in his chest; Throat feels congested; 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 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 (Lot number: EW0168) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: diagnosed when he was little, he can't remember exactly when, he was probably young. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Feeling stuffy"; NASAL CONGESTION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Congestion"; HEADACHE (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Headache"; LOWER RESPIRATORY TRACT INFECTION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "He's been feeling like he's got a cold in his chest"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 29Aug2021, outcome "not recovered", described as "Throat feels congested".  Additional Information: The patient did not visited to the Emergency Room and Physician Office due to events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, onset 2021, with outcome of not recovered and injection site pain, onset 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Sinus Tachycardia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Covid prior vaccination: Yes" (unspecified if ongoing), notes: Covid prior vaccination: Yes; "autoimmune disorder" (ongoing). Concomitant medication(s) included: Humira; Sulfasalazine; Tizanidine; Alprazolam; Zyrtec [Cetirizine Hydrochloride]. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: EAR PAIN (non-serious), outcome "recovered", described as "stabbing, throbbing pain in and around my left ear". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This is a spontaneous report received from contactable pharmacist/consumer or other non-HCP. A 28-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 28, on Aug 31, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had visual impairment (changes in vision), onset Aug 31, 2021, with outcome of unknown; and blurred vision (blurry vision), onset 2021, with outcome of recovering. Additional Information: Patient experienced changes in vision immediately after vaccine administration. While he was sitting in the waiting area, he said he couldn't read the apps on his phone, but didn't mention anything at the time to the pharmacy staff. Now patient presented back to the pharmacy to report his symptoms. He has been "experiencing blurry vision, so he went to an eye doctor and got it checked." The doctor could not find anything out of the ordinary. The patient reported the blurry vision "seems like it's getting better" as more time passes. The patient has worn glasses since 2014, and reported "getting new glasses a couple of months ago." No other side effects reported. Follow-up (Nov 15, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he felt ill for a long period of time after the first dose; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received bnt162b2 (BNT162B2), 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: ILLNESS (non-serious), outcome "unknown", described as "he felt ill for a long period of time after the first dose".  Additional information: HCP states calling on behalf of her patient who had the first dose of pfizer covid vaccine in April but did not go back to get the second shot as he felt' ill for a long period of time after the first dose' (specific symptoms unclear). Now patient wanting to travel and must follow specific travel recommendations. Patient must have completed 2 dose series of pfizer covid vaccine or get the J and J vaccine. is it safe  to take J and J after having had one dose of pfizer covid vaccine.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The patient already has 2 antibody productions, shouldn't need more to provide more for a period of time after initial vaccine and acute illness; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COVID 19 Vaccine, mRNA-Solution for injection) (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: ILLNESS (non-serious), outcome "unknown", described as "The patient already has 2 antibody productions, shouldn't need more to provide more for a period of time after initial vaccine and acute illness". Additional information: Pharmacist, from withheld, calling for guidance on when the vaccine should be given to a patient following an active infection. He states he has seen both dose 1 and 2 information that "we need to defer 90 days if someone has received immunotherapy" but he has not been able to find information about a patient who received dose one of the vaccination and in between dose one and 2 contracted COVID 19. Caller would like to know how long to defer the patient before providing the 2nd dose of the vaccine. Advised caller per attached document with disclaimers; People with prior or current SARS-CoV-2 infection "People should be offered vaccination regardless of their history of symptomatic or asymptomatic SARS-CoV-2 infection; this includes people with prolonged post-COVID-19 symptoms. Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, people with a history of MIS-C or MIS-A should consider delaying vaccination until they have recovered from their illness and for 90 days after the date of diagnosis of MIS-C or MIS-A. Caller requests information "off the record" stating "shouldn't we defer, its counter intuitive. The patient already has 2 antibody productions, shouldn't need more to provide more for a period of time after initial vaccine and acute illness. You can extend the antibody production and protection for later if the vaccination is deferred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy stomach, Blood test, Endoscopy, Nausea, Vomiting
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 13-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8736), at the age of 13, on May 15, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had nausea and vomiting, onset May 15, 2021, with outcome of not recovered. Patient stated "I have been having nausea and throwing-up every evening. This never happened before the vaccine." The events evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures were taken as a result of nausea and vomiting. Additional information: The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. Patient did not have COVID-19 prior to vaccination, nor tested post vaccination. AE treatment included bloodwork, upper GI endoscopy/biopsies and series. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "heart rate is really fast and I noticed that, it got really fast like couple of days ago" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "Heart rate is really fast; was like sitting down watching TV and it was like 112". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, just want to report some side effects that having after the first dose of the vaccine. Patient heart rate was really fast and patient noticed that, it got really fast like couple of days ago, patient was like sitting down watching TV and it was like 112. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gastrointestinal disorder, Nausea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0181), on Sep 1, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had nausea, gastrointestinal disorder (had to use the bathroom a lot) and asthenia (felt weak), with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: After 1st shot, I start feeling soreness in my left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:00 (Lot number: Ep7534) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE; SPIRONOLACTONE. Past drug history included: Celebrex, reaction(s): "Known allergy-Celebrex". The following information was reported: BREAST PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "After 1st shot, I start feeling soreness in my left breast". Therapeutic measures were not taken as a result of breast pain.  Additional information: After 1st shot, patient started feeling soreness in his left breast, and after the 2nd shot an1/2" increase in size and soreness. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. 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. Other medical history: None.  No follow-up attempts are possible. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) 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: ILLNESS (non-serious), outcome "unknown", described as "He provided that his primary care provider is also sick". Additional information: Reporter's primary care provider was through the (State withheld). Declined to provide mailing address, phone number and email. Reporter provided that his primary care provider was also sick. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Breast enlargement, Breast pain
Clinical narrative: After 1st shot, I start feeling soreness in my left breast, and after the 2nd shot an1/2" increase in size and soreness.; After 1st shot, I start feeling soreness in my left breast, and after the 2nd shot an1/2" increase in size and soreness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 08:00 (Lot number: EP7534) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; SPIRONOLACTONE. Past drug history included: Celebrex, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (lot number Ep7534, administration time 09:00 AM, dose 1, single, vaccine location Left arm), administration date: 25Mar2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "soreness in my left breast". The following information was reported: BREAST PAIN (non-serious), BREAST ENLARGEMENT (non-serious) all with onset 2021, outcome "not recovered" and all described as "After 1st shot, I start feeling soreness in my left breast, and after the 2nd shot an1/2" increase in size and soreness.". Therapeutic measures were not taken as a result of breast pain, breast enlargement.  Additional information: Prior to vaccination patient was not tested with covid-19 and not been tested since the vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Amlodipine 10mg, Spironolactone 50mg.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Migraine
Clinical narrative: enhanced headaches/migraines; enhanced headaches/migraines; 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 left, administration date 05Aug2021 14:30 (Lot number: FC3183) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing), notes: known allergies: latex; "cornmeal" (unspecified if ongoing), notes: known allergies: cornmeal; "walnuts" (unspecified if ongoing), notes: known allergies: walnuts; "almonds" (unspecified if ongoing), notes: known allergies: almonds; "pecans" (unspecified if ongoing), notes: known allergies: pecans; "cats" (unspecified if ongoing), notes: known allergies: cats; "occipital neuralgia" (unspecified if ongoing), notes: other medical history: occipital neuralgia; "chronic migraines" (unspecified if ongoing), notes: other medical history: chronic migraines; "photophobia" (unspecified if ongoing), notes: other medical history: photophobia. The patient concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 05Aug2021 15:00, outcome recovering, and all described as "enhanced headaches/migraines". The event "enhanced headaches/migraines" and "enhanced headaches/migraines" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, condition aggravated. Additional information The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not have Covid prior vaccination. The patient had not tested for Covid post vaccination. The patient received dose 2, single for Covid -19 immunization product=COVID 19, brand=Pfizer, lot number= FA7485, lot unknown=False, administration date= 26Aug2021 administration time= 02:30 PM, dose number=2 vaccine location=Left arm. Adverse event- 1st dose enhanced headaches/migraines 2nd dose: swelling of face, tightness of jaw, dizziness, hardening of muscles and tissues on arm of injection, chills, bone pain, joint pain, headaches/migraines, diarrhea, nausea, left arm was hot to touch, numbness in left arm.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiffness in hands; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) for a Pfizer sponsored program.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 43 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ, stop date: 31Aug2021. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness in hands".  Additional information: patient reports last xeljanz was 31Aug21 patient was told by md to hold xeljanz for covid vaccine. patient got covid vaccine 02Sep21; reports stiffness in hands due to missed doses patient to speak to md prior to re-start.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Ophthalmic migraine, Visual impairment
Clinical narrative: Vision problem; Styes in the eyes; Ocular migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "Vision problem"; HORDEOLUM (non-serious) with onset 2021, outcome "unknown", described as "Styes in the eyes"; OPHTHALMIC MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Ocular migraines".  Additional information: At this point he wanted to call Pfizer "you folks" to let you know what was going on and what's so interesting is that the same exact 2 events, the styes in the eyes and ocular migraines, were experienced by a female coworker of his. She had never had this before in her life also and described her vision problem and that was when he told her she has ocular migraines. These have been going on with her too and they both are about the same age. She had both of her Pfizer shots too. No further details provided.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: sick; on the 27Aug she got a cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: ILLNESS (non-serious) with onset 27Aug2021, outcome "unknown", described as "sick"; NASOPHARYNGITIS (non-serious) with onset 27Aug2021, outcome "unknown", described as "on the 27Aug she got a cold".  Additional information: Reporter missed 5 doses due to taking Covid vaccine. Reporter had used Methotrexate Claritin Tylenol extra strength folic acid extra sulfomethazole/trimetho. reporter stated that she wanted to take the Covid shot. Prescriber was advised to be off Xeljanz a week before she gets her shot. She did and she had been without medication still. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site pain
Clinical narrative: had very minimal pain; 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 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: EW0168) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "was a smoker" (unspecified if ongoing), notes: Verbatim: was a smoker. Concomitant medication(s) included: TRELEGY taken for ex-tobacco user (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "had very minimal pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Time the vaccination was given between 10:30 and 10:45 in them morning. Anatomical location of administration of piizer vaccine was left arm below the shoulder. They really haven't diagnosed her with COPD but, she thinks she has COPD. She had blood work and everything was perfect and that was about 6 months ago. No prior Vaccinations (within 4 weeks). She has never had a flu vaccine in life.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: armpit is sore and swollen / A girl at her schools armpit did the same thing,; armpit is sore and swollen / A girl at her schools armpit did the same thing,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "recovered" and all described as "armpit is sore and swollen / A girl at her schools armpit did the same thing,". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information: Reported that, a girl at her schools armpit did the same thing, but hers already went away. She had not received treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Ear pain, Fatigue, Headache
Clinical narrative: no energy; extreme fatigue; painful right arm; jawbone and teeth pain on left side; discomfort; stabbing ear pain; jawbone and teeth pain on left side; Head ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Aug2021 12:20 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. Relevant medical history included: "oesteoporosis and breast cancer (5 yrs free)" (unspecified if ongoing); "oesteoporosis and breast cancer (5 yrs free)" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer, start date: May2017 (ongoing); CALCIUM taken for osteoporosis, start date: Jan2020 (ongoing); VITAMIN A D taken for osteoporosis, start date: Nov2018 (ongoing); MULTI VIT (ongoing). The following information was reported: FATIGUE (non-serious) with onset 05Aug2021 13:00, outcome "recovered" (2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 05Aug2021 12:45, outcome "recovered" (2021), described as "painful right arm"; HEADACHE (non-serious) with onset 05Aug2021 12:35, outcome "recovered" (2021), described as "Head ache"; TOOTHACHE (non-serious) with onset 05Aug2021 12:45, outcome "recovered" (2021), EAR PAIN (non-serious) with onset 05Aug2021 12:35, outcome "recovered" (2021) and all described as "stabbing ear pain"; PAIN IN JAW (non-serious) with onset 05Aug2021 12:35, outcome "recovered", described as "jawbone and teeth pain on left side"; DISCOMFORT (non-serious) with onset 05Aug2021 12:45, outcome "recovered", described as "discomfort"; ASTHENIA (non-serious), outcome "recovered", described as "no energy". The events "extreme fatigue", "painful right arm", "head ache", "jawbone and teeth pain on left side", "stabbing ear pain", "jawbone and teeth pain on left side" and "discomfort" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, pain in extremity, headache, toothache, ear pain, pain in jaw, discomfort.  Additional information: Extreme fatigue came on fast and lasted 3 to 4 days. Head ache and fatigue occurred within 1 hour of injection, the jaw/ear issue 24 hours later and lasting 2 to 3 weeks easing in discomfort w/n that time. The second shot sore arm and tiredness for a couple of days. There was no patient medical history and no family medical history relevant to adverse event. Vaccination facility types pharmacy or drug store. There was no vaccination administered at military facility. No treatment for AE, no known allergy, no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Toothache
Clinical narrative: no energy; extreme fatigue; painful right arm; jawbone and teeth pain on left side; discomfort; stabbing ear pain; jawbone and teeth pain on left side; Head ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Aug2021 12:20 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. Relevant medical history included: "oesteoporosis and breast cancer (5 yrs free)" (unspecified if ongoing); "oesteoporosis and breast cancer (5 yrs free)" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN taken for breast cancer, start date: May2017 (ongoing); CALCIUM taken for osteoporosis, start date: Jan2020 (ongoing); VITAMIN A D taken for osteoporosis, start date: Nov2018 (ongoing); MULTI VIT (ongoing). The following information was reported: FATIGUE (non-serious) with onset 05Aug2021 13:00, outcome "recovered" (2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 05Aug2021 12:45, outcome "recovered" (2021), described as "painful right arm"; HEADACHE (non-serious) with onset 05Aug2021 12:35, outcome "recovered" (2021), described as "Head ache"; TOOTHACHE (non-serious) with onset 05Aug2021 12:45, outcome "recovered" (2021), EAR PAIN (non-serious) with onset 05Aug2021 12:35, outcome "recovered" (2021) and all described as "stabbing ear pain"; PAIN IN JAW (non-serious) with onset 05Aug2021 12:35, outcome "recovered", described as "jawbone and teeth pain on left side"; DISCOMFORT (non-serious) with onset 05Aug2021 12:45, outcome "recovered", described as "discomfort"; ASTHENIA (non-serious), outcome "recovered", described as "no energy". The events "extreme fatigue", "painful right arm", "head ache", "jawbone and teeth pain on left side", "stabbing ear pain", "jawbone and teeth pain on left side" and "discomfort" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, pain in extremity, headache, toothache, ear pain, pain in jaw, discomfort.  Additional information: Extreme fatigue came on fast and lasted 3 to 4 days. Head ache and fatigue occurred within 1 hour of injection, the jaw/ear issue 24 hours later and lasting 2 to 3 weeks easing in discomfort w/n that time. The second shot sore arm and tiredness for a couple of days. There was no patient medical history and no family medical history relevant to adverse event. Vaccination facility types pharmacy or drug store. There was no vaccination administered at military facility. No treatment for AE, no known allergy, no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain in extremity
Clinical narrative: second shot sore arm and tiredness for a couple of days; second shot sore arm and tiredness for a couple of days; upset stomach -chills; upset stomach -chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Aug2021 10:15 (Lot number: EW0183) as dose 2, single for covid-19 immunisation. Relevant medical history included: "oesteoporosis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: 5 yrs free. Concomitant medication(s) included: TAMOXIFEN taken for breast cancer, start date: May2017 (ongoing); CALCIUM taken for osteoporosis, start date: Jan2020 (ongoing); VITAMIN D [VITAMIN D NOS] taken for bone disorder, start date: Nov2018 (ongoing); MULTIVITAMIN [VITAMINS NOS] taken for general physical condition (ongoing). Vaccination history included: Bnt162b2 (Event date: 05Aug2021, Product- COVID 19, Brand-Pfizer, Lot number- EW0187, Lot unknown- False, Administration date- 05-AUG-2021, Administration time-12:120 PM, Dose number- 1, Vaccine location- Upper right arm), administration date: 05Aug2021, for covid-19 immunisation, reaction(s): "Head ache", "painful right arm", "extreme fatigue", "stabbing ear pain", "jawbone and teeth pain on left side", "jawbone and teeth pain on left side", "no energy", "discomfort". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", FATIGUE (non-serious) with onset 26Aug2021 12:45, outcome "recovered" and all described as "second shot sore arm and tiredness for a couple of days"; ABDOMINAL DISCOMFORT (non-serious), CHILLS (non-serious) all with onset 26Aug2021, outcome "recovered" (Aug2021) and all described as "upset stomach -chills". The event "second shot sore arm and tiredness for a couple of days" and "second shot sore arm and tiredness for a couple of days" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19. It was reported that Upset stomach -Chills lasting less than a day  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Ocular discomfort
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 35-year-old patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD8448), at the age of 35, on Aug 30, 2021, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing). Concomitant medication included lisinopril for hypertension. The patient had ocular discomfort (whenever patient laid down, felt lots of pressure behind eyeballs) and headache (pressure headache), with outcome of unknown. Therapeutic measures were taken as a result of ocular discomfort and  headache. Additional information: Treatment received: Ibuprofen and Tylenol. No other prior vaccination (4 weeks). No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Sight disability
Clinical narrative: Fatigue; We can't hardly keep our eyes open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (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 (Dose: 1, No events reported), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue"; SIGHT DISABILITY (non-serious) with onset 2021, outcome "unknown", described as "We can't hardly keep our eyes open".  Additional information: 3 patient received  second COVID shot in Mar. They were still having fatigue. Is long term fatigue a side effect of the Pfizer vacation. There ages were 45-72. Some days they can't hardly keep their eyes open. Can't  find anything on social media.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101155391 same reporter, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (003110). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced fatigue (we are still having fatigue), with outcome of not recovered; and felt abnormal (can't hardly keep our eyes open), with outcome of unknown. Additional information: Reportedly, 3 patients received the second COVID-19 shot in March. They were still having fatigue. They wanted to know whether long-term fatigue was a side effect of the Pfizer vaccination. Some days they can't hardly keep their eyes open. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked reports: US-PFIZER INC-202101155279 same reporter/AE/SD, different patient; US-PFIZER INC-202101155417 same reporter/AE/SD, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Sight disability
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (003110). An adult patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient had fatigue and sight disability (can't hardly keep our eyes open), onset 2021, with outcome of not recovered. Follow-up attempts completed. No further information expected. Sender's comments: Linked reports: US-PFIZER INC-202101155279 same reporter/AE/SD, different patient; US-PFIZER INC-202101155391 same reporter/AE/SD, different patient.