chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pain
Clinical narrative: It is kind of like my body is sore like when I am exercising or doing something; From the second one, I am just not myself at all; Muscle ache; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 13:15 (Formulation; solution for injection, Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 (from the  first one, I didn't have any reaction and everything was okay), administration date: 01Apr2021, for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 23Apr2021, outcome "recovering", described as "Muscle ache"; CHILLS (non-serious) with onset 23Apr2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 23Apr2021, outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "It is kind of like my body is sore like when I am exercising or doing something"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "From the second one, I am just not myself at all". Therapeutic measures were taken as a result of myalgia. Therapeutic measures were not taken as a result of chills, headache.  Additional information: Treatment: Patient further stated, she had to take Tylenol for the muscle ache and she took the first one before she went to bed and then she woke up in the morning and took another one, so, probably 4 to 6 times. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, and patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19, and Since the vaccination, patient not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: B-lymphocyte count decreased, Potentiating drug interaction
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. A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RITUXIMAB. Vaccination history included: Bnt162b2 (1st dose), administration date: 27Jan2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: B-LYMPHOCYTE COUNT DECREASED (non-serious), outcome "unknown", described as "B cells are low"; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Taking another drug that is proven to compromise the effectiveness of the vaccine which is called Rituximab". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter wanted to know how you measure the antibodies and B cell level in the person after vaccination. How much it should be for the vaccine to be effective. Reporter wanted to know if his wife can take the series again/booster dose if it was not effective before due to interaction. Reporter (withheld) called on behalf of his wife who got the first dose of the vaccine on January 27th and the second dose on February 18th. His wife has been taking another drug that is proven to compromise the effectiveness of the vaccine which is called Rituximab for several years now every 6 months. He wants to talk to a health professional who can assist him regarding his concern. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: A got vaccinated 2 weeks ago and yesterday I started with an extreme headache and body pain.; A got vaccinated 2 weeks ago and yesterday I started with an extreme headache and body pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Apr2021 11:30 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: Prior vaccination. The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset 23Apr2021 05:00, outcome "not recovered" and all described as "A got vaccinated 2 weeks ago and yesterday I started with an extreme headache and body pain.". Therapeutic measures were not taken as a result of headache, pain.  Additional information: The patient was not tested for Covid-19 post vaccination. The patient was not aware of known allergies and past drug history. The reporter reported that It has been two weeks since she got the vaccine and yesterday, 15 days later, she started with an extreme headache and body pain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: Migrane; throwing up; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: MIGRAINE (non-serious), outcome "unknown", described as "Migrane"; VOMITING (non-serious), outcome "unknown", described as "throwing up".  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Logorrhoea
Clinical narrative: can't stop talking as one of the after effects; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  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: LOGORRHOEA (non-serious), outcome "unknown", described as "can't stop talking as one of the after effects".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Chills; Tiredness; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Apr2021 16:15 (Lot number: unknown) at the age of 45 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 23Apr2021 06:45, outcome "recovered" (Apr2021), described as "Headache"; CHILLS (non-serious) with onset 23Apr2021 06:45, outcome "recovered" (Apr2021), described as "Chills"; FATIGUE (non-serious) with onset 23Apr2021 06:45, outcome "recovered" (Apr2021), described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 23Apr2021 06:45, outcome "recovered" (Apr2021), described as "Sore arm". Therapeutic measures were not taken as a result of headache, chills, fatigue, pain in extremity. Additional information: 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 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: made her go to sleep peacefully/ Had a full nights sleep; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "made her go to sleep peacefully/ Had a full nights sleep".  Additional information: Caller declined to provide phone number as she did not remember since she just recently changed it. Caller stated she was calling to report that everything was fine and her only reaction she had after receiving the first dose of the Pfizer COVID vaccine on 20Apr2021 was that it made her go to sleep peacefully and she had a full nights sleep. Caller stated she did not have a question and just wanted to report that everything was okay.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite
Clinical narrative: i was bitten by a tick 3 weeks after 2nd shot. the tick died. i have never had a tick die after biting me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:30 (Lot number: en6208) at the age of 56 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 number=1,, vaccine location=Left arm}], lot number=en6208,), administration date: 09Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ARTHROPOD BITE (non-serious) with onset 21Apr2021 08:00, outcome "recovered", described as "i was bitten by a tick 3 weeks after 2nd shot. the tick died. i have never had a tick die after biting me". Therapeutic measures were taken as a result of arthropod bite.  Additional information: The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination and had not been tested for Covid-19 since vaccination. The patient had not received any other vaccine in two weeks or four weeks prior to Covid-19 vaccine. The patient had received treatment with  doxycycline to counteract potential infection from  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid prior vaccination: Yes" (unspecified if ongoing). The patient concomitant medications were not reported.  The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Heart palpitations". Therapeutic measures were not taken as a result of palpitations.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.  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-2021476995 same report/drug/AE, different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: facial twitching; Muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: ER8735, Expiration Date: 31Jul2021) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder. Vaccination history included: Bnt162b2 (Lot number: EW0150 and Expiration date: 31Jul2021 as dose 1, single), for COVID-19 immunisation. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 18Apr2021, outcome "not recovered", described as "facial twitching"; MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "Muscle spasm". Therapeutic measures were not taken as a result of muscle spasms.  Additional information: Patient had the second dose of the Pfizer vaccine on the 17Apr2021 and for the past three days patient have been exhibiting facial twitching.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes under my left arm; Aches in my breasts; Stinging in the nipple on my left breast; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and administered in arm left, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin allergy; "Type 2 diabetes mellitus" (unspecified if ongoing), notes: Type 2 diabetes. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "unknown", described as "Swollen lymph nodes under my left arm"; BREAST PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Aches in my breasts"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Stinging in the nipple on my left breast". The events "swollen lymph nodes under my left arm", "aches in my breasts" and "stinging in the nipple on my left breast" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, breast pain, pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021, the patient experienced swollen lymph nodes under left arm, aches in breasts, mainly in the left one, since about a week after the first shot. A couple of weeks before the report, patient started feeling a stinging in the nipple on her left breast in addition to the swollen lymph nodes and achiness, etc. it has now been five weeks exactly since the second shot. Patient had read that this was a normal side effect but was concerned when it persisted. She went to see a doctor today who said it is likely a vaccine side effect and she worked with a woman who still has swollen lymph nodes three months after getting the vaccine. The doctor could feel the swollen lymph node under her arm. The adverse event resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: fingers started swelling, like my hand; 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), administration date 19Apr2021 (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: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "fingers started swelling, like my hand". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vomiting
Clinical narrative: Ringing in the ears; dizziness a few minutes after the vaccine; vomiting / vomited; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient in his 30's received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: ER8731) 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: TINNITUS (non-serious) with onset 20Apr2021, outcome "unknown", described as "Ringing in the ears"; DIZZINESS (non-serious) with onset 20Apr2021, outcome "unknown", described as "dizziness a few minutes after the vaccine  "; VOMITING (non-serious) with onset 20Apr2021, outcome "unknown", described as "vomiting / vomited". Therapeutic measures were not taken as a result of tinnitus, dizziness, vomiting. Additional information: The patient did not have any medical treatment and were just given some water. The Relatedness of drug to reactions/events Ringing in the ears and dizziness a few minutes after the vaccine with Primary Source Reporter as source of assessment and as method of assessment was related.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438548 Same reporter, drug and events; different patient.;US-PFIZER INC-2021457291 Same reporter, drug and events; different patient.;US-PFIZER INC-2021457177 Same reporter, drug and events; different patient.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.A male patient in his 30's received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Apr2021 (Lot number: ER8731) 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: TINNITUS (non-serious), DIZZINESS (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "Ringing in the ears and dizziness a few minutes after the vaccine"; VOMITING (non-serious) with onset 20Apr2021, outcome "unknown", described as "vomited". Therapeutic measures were not taken as a result of tinnitus, dizziness, vomiting.Additional information: The patient did not have any medical treatment; they were just given some water.No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457276 same reporter/drug/AE with different patient;US-PFIZER INC-2021457177 same reporter/drug/AE with different patient;US-PFIZER INC-2021438548 same reporter/drug/AE with different patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination site discomfort, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: swollen lymph nodes in axillary under right arm where had shot at and armpit area as well; pain; cannot raise her arm all of the way up / where she had the shot; having pain or pressure in the arm area / where she had the shot; having pain or pressure in the arm area / where she had the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Apr2021 11:30 (Lot number: ER8731) at the age of 50 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 (Lot number: EM8733 in left arm at 11:30 as dose 1, single), administration date: 27Mar2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 17Apr2021, outcome "not recovered", described as "swollen lymph nodes in axillary under right arm where had shot at and armpit area as well"; PAIN (non-serious) with onset 17Apr2021, outcome "not recovered", described as "pain"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 17Apr2021, outcome "not recovered", described as "cannot raise her arm all of the way up / where she had the shot"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 17Apr2021, outcome "not recovered" and all described as "having pain or pressure in the arm area / where she had the shot". The events "swollen lymph nodes in axillary under right arm where had shot at and armpit area as well", "pain", "cannot raise her arm all of the way up / where she had the shot", "having pain or pressure in the arm area / where she had the shot" and "having pain or pressure in the arm area / where she had the shot" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, pain, vaccination site movement impairment, vaccination site pain, vaccination site discomfort.  Additional information: It was further reported that the lymph node swelling has gotten larger and patient was in pain. Patient cannot raise her arm all of the way up without having pain or pressure in the arm area. Patient stated that she cannot wear her bra. The patient called her physician (where she got the vaccine) and her doctor said to wait a week because it may not be from the vaccine. Patient stated she doesn't know how she stated that, because she was healthy, and she has been working with no problems until she took the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: sudden onset of confusion, mild but noticeable; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 24Apr2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 03Apr2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Apr2021 at 22:00, the patient experienced sudden onset of confusion, mild but noticeable and sudden enough that the patient believe it could be from the vaccine. She was sitting at home reading and looked up and was confused to find herself in her own home and then it happened about 5 more times within the hour. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event sudden onset of confusion, mild but noticeable was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment(24-APR-2021): This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: light headache; arm hurt; 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.  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: HEADACHE (non-serious), outcome "unknown", described as "light headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt".  Additional information: It was reported that events was not that bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: Sensitive front teeth; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Sometimes gets weak" (unspecified if ongoing); "Back problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "Sensitive front teeth". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: sensitive teeth; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8733) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cataract" (unspecified if ongoing), notes: cataract surgery in a few months; "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ESTRACE (ongoing). Vaccination history included: Zostavax (dose 1, lot number: unknown), for immunisation; Shingles vaccine (dose 2, lot number: unknown), administration date: Oct2018, for immunisation, reaction(s): "her arm hurt". The following information was reported: HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "sensitive teeth".  Additional Information: The patient mentioned that she remembered having sensitive teeth because she started a new tooth paste. Event did not require visit to emergency room nor physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: consumer wants to know if neck pain is a normal after getting the shot a few hours later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 (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: NECK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "consumer wants to know if neck pain is a normal after getting the shot a few hours later".  Additional information: The patient wasn't sure if it was stress or the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hyperaesthesia teeth
Clinical narrative: metallic taste; sensitive teeth; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm left, administration date 19Apr2021 14:15 (Lot number: EW0164) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "low thyroid" (unspecified if ongoing); "cataract" (unspecified if ongoing), notes: cataract surgery in a few months. Concomitant medications included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ESTRACE (ongoing). Vaccination history included: BNT162B2 (dose 1, Lot number: ER8733), administration date: 29Mar2021, for COVID-19 immunisation, reaction: "Sensitive teeth"; Zostavax (dose 1, Lot number: unknown, arm did not hurt), administration date: Oct2018, for immunisation; Shingrix (dose 2, Lot number: unknown), administration date: Oct2018, for immunisation, reaction: "arm hurt". The following information was reported: DYSGEUSIA (non-serious) with onset 19Apr2021 16:15, outcome "unknown", described as "metallic taste"; HYPERAESTHESIA TEETH (non-serious) with onset 19Apr2021, outcome "unknown", described as "sensitive teeth".  Additional information: The metallic taste started two hours after the second shot. It kind of went away. That could have been because she was eating and didn't notice it. It came back about 6 hours after she got the shot and then it went away and she went to sleep. Then it came back about 10:00 AM. She kept eating and it went away. She ate every few hours.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: with arthritis, that next day after shot, no swelling, tightness or pain.; This is a spontaneous report received from a 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. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "with arthritis, that next day after shot, no swelling, tightness or pain. ".  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-2021437461 Same reporter, suspect drug and event; different patient
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Lethargy, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: just a day after my second dose that area above my collarbone is super painful; lump has returned/Thinking its a swollen Lymph node now; extreme arm pain at injection site; swollen at injection site; Lethargy; This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: ER8735) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "allergies: Penicillins" (unspecified if ongoing); "allergies: mussels" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot number: ER8727), Administration time: 01:30 PM, Vaccine location: Left arm), administration date: 19Mar2021, when the patient was 30 years old, for COVID-19 immunisation, reactions: "extreme arm pain and swollen at injection site", "extreme arm pain and swollen at injection site", "a lump just above my left collarbone", "collar bone as it was super painful", "Lethargy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Apr2021 16:00, outcome "recovering", described as "extreme arm pain at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 19Apr2021 16:00, outcome "recovering", described as "swollen at injection site"; LETHARGY (non-serious) with onset 19Apr2021 16:00, outcome "recovering", described as "Lethargy"; BONE PAIN (non-serious) with onset 20Apr2021, outcome "recovering", described as "just a day after my second dose that area above my collarbone is super painful"; LYMPHADENOPATHY (non-serious) with onset 20Apr2021, outcome "recovering", described as "lump has returned/Thinking its a swollen Lymph node now". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, lethargy, bone pain, lymphadenopathy.  Additional Information: On the first and second dose, the patient experienced extreme arm pain and swollen at injection site. Lethargy during those first few hours as well. Now just a day (20Apr2021) after her second dose, that area above her collarbone was super painful and the lump had returned, thinking it's a swollen lymph node now. The patient did not receive other vaccine in four weeks. The patient received other medications in two weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438872 Same patient and drug, different dose and events
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Blood pressure went up; Rapid heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  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: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure went up"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Rapid heart beat". 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: break out on my forehead. Small red bumps/pimples; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 09:30 (Lot number: ER8732) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ACNE (non-serious) with onset 03Apr2021 12:00, outcome "recovering", described as "break out on my forehead. Small red bumps/pimples". Therapeutic measures were not taken as a result of acne.  Additional Information: The patient reported that she administered other pfizer vaccine on 02Apr2021 with Lot# EW0158 administered on left arm and she did not specify the vaccine name and other medications in two weeks were none. It was reported that the patient never had covid prior vaccination and not tested for covid post vaccination. Known allergies were no/unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Malaise, Product dose omission issue
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program "PRIVATE" support. This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had schedule for 2nd dose scheduled on 05Apr2021 but he missed it because he was not feeling well then. Moreover, on 27Mar2021, he said that he was not feeling so good and he was ill for 4 days. He said that he experienced a lack of energy for 4 days. The outcome of the events was unknown. Clinical Course stated by Patient was "he took the first test [shot] and he is looking at the Covid-19 Vaccination Record Card for his first one and it has been a total disaster after the first one. Stated he doesn't want to go through the whole thing but he was ill and didn't feel well at the date of the second one. Reporter stated that was where things went wrong because people have been taking him all over the place trying to get his second shot. Patient stated he was at the point now where he can get the second shot. States his primary doctor went through his entire body looking for everything and he is clear. He stated now that he was clear, he needs to get second shot. Stated he was told to talk to the lady at the hospital and she said that he needs to get the information so that they can set him up for the second shot. Patient clarified that he had the first vaccine and he had no problem with it. States he was scheduled for a number of days after first shot for the second one but at the time the day before that he got sick and he couldn't go to it. States he has been trying to get someone to help him. States he is to the point where he can get an appointment for his second shot. States he has been going through this for 2.5 weeks now. Patient stated he knows where it is located in address. States he needs the phone number to make an appointment for the second dose. Stated this has been really frustrating and usually this is where things go wrong and he doesn't get the help he needs. Stated this was the first time someone has understood what he wants". No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (21Apr2021): Updated information: Vaccination date and Clinical course of the patient was updated. Additional Information: Vaccination date was changed from 15Mar2021 to 13Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Mobility decreased, Peripheral swelling
Clinical narrative: Extreme discomfort in armpit of right arm; Swollen and hard to lift arm; Swollen and hard to lift arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 14:15 (Lot number: EW0153) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Spice allergy" (unspecified if ongoing), notes: Known allergies: cinnamon; "Dermatitis contact" (unspecified if ongoing), notes: Known allergies: adhesive; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD; "Mast cell activation syndrome" (unspecified if ongoing), notes: MCAS; "Postural orthostatic tachycardia syndrome" (unspecified if ongoing), notes: POTS; "Ehlers-Danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA; LORATADINE; VITAMIN D [VITAMIN D NOS]; ZINC. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8730, Administration time:14:15), administration date: 02Apr2021, when the patient was 23 years old, for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 23Apr2021 18:00, outcome "not recovered", described as "Extreme discomfort in armpit of right arm"; PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious) all with onset 23Apr2021 18:00, outcome "not recovered" and all described as "Swollen and hard to lift arm". Therapeutic measures were not taken as a result of axillary pain, peripheral swelling, mobility decreased.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient reported, the first shot did not hurt her armpit that way. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were not taken as a result of the events.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: pain under my tongue on the right side; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 12Mar2021 (Lot number: EN6202) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1/20. The following information was reported: GLOSSODYNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "pain under my tongue on the right side". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The event occurred a few hours after receiving the first dose and resolved on its own a day later.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle strain
Clinical narrative: cramps in the left calf; strained left calf muscle while walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 16:00 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "treated high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: Q10; VIT D [COLECALCIFEROL]; VIT C; VIT B12. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "cramps in the left calf"; MUSCLE STRAIN (non-serious) with onset Mar2021, outcome "unknown", described as "strained left calf muscle while walking". Therapeutic measures were not taken as a result of muscle spasms, muscle strain. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies to medications, food, or other products. The patient was also concomitantly taking unspecified multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: got sick to his stomach; threw up; doesn't feel good; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 65 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 65 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: NAUSEA (non-serious), outcome "unknown", described as "got sick to his stomach"; VOMITING (non-serious), outcome "unknown", described as "threw up"; MALAISE (non-serious), outcome "unknown", described as "doesn't feel good". Additional information: Reporter is the patient's mother. Reporter stated that something the patient ate wasn't good and he got sick to his stomach and he doesn't feel good. Patient was supposed to get his shot at 3:30 if he feels alright. He has not yet received his second dose of the vaccine at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: developed pain in the arm where the injection was made; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Apr2021 10:00 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Apr2021, outcome "recovered" (17Apr2021), described as "developed pain in the arm where the injection was made". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Facility type vaccine was Workplace clinic. lot number was not available/provided to reporter at the time of report completion. Patient received second dose of Pfizer COVID19 vaccine. 2 hours after vaccination developed pain in the arm where the injection was made. The pain was relieved by rolling her arms and performing light exercises with the arm. The pain was completely recovered after 8 hours. The patient was not tested COVID prior vaccination. No Covid tested post vaccination. Patient did not take other vaccine in four weeks and any other medications in two weeks.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.