chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue
Clinical narrative: Fatigue; Abnormal body temperature for more than one week. 99.5 F.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Apr2021 00:45 (Batch/Lot number: unknown) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Fatigue"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Abnormal body temperature for more than one week. 99.5 F.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, body temperature abnormal.  Additional information: no other vaccine in four weeks was received, no COVID prior vaccination, it was unknown if patient was tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: severe chills; She was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 15:00 (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: CHILLS (non-serious), outcome "unknown", described as "severe chills"; ILLNESS (non-serious), outcome "unknown", described as "She was so sick". Therapeutic measures were taken as a result of chills, illness. Additional information: The patient was advised by the pharmacists to take Tylenol. The patient stated that this was from the vaccine and wanted to confirm if this is really because of it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: right ear is ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Apr2021 12:30 (Lot number: EW0170) at the age of 34 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: TINNITUS (non-serious) with onset 23Apr2021, outcome "unknown", described as "right ear is ringing". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within 4 week prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. The event happened couple of times and ringing last about a minute.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: after she took the 2nd dose, she felt nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (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, single), administration date: 01Apr2021, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "after she took the 2nd dose, she felt nauseous".  Additional Information: The patient was asking if she can take an anti-nausea pill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Visual impairment
Clinical narrative: tired; I can't see all that well; can't move that well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "I can't see all that well"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't move that well".  Additional information: Patient had to stop taking Xeljanz due to taking the vaccine. Patient was taking Xeljanz 5 MG.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: He is asking if he can have the steroid antibiotic today because of his sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (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: SINUSITIS (non-serious) with onset 28Apr2021, outcome "unknown", described as "He is asking if he can have the steroid antibiotic today because of his sinus infection". Therapeutic measures were not taken as a result of sinusitis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Suppressed lactation
Clinical narrative: Milk supply dropped drastically; Breast feeding mother; Breast feeding mother; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 08Apr2021 13:00 (Lot number: EP7533) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Breast feeding" (unspecified if ongoing). There were no concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 08Apr2021 13:00, outcome "unknown" and all described as "Breast feeding mother"; SUPPRESSED LACTATION (non-serious) with onset 09Apr2021, outcome "unknown", described as "Milk supply dropped drastically". Therapeutic measures were not taken as a result of suppressed lactation.  Additional Information: The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The patient had no other vaccine in four weeks. The patient had not been tested for COVID-19 post vaccination. The patient was a breastfeeding mother. After the first shot, the patient's milk supply dropped drastically. The patient had to start supplementing formula.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476327 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: I think she said that she has pain in her legs and cramping; couldn't talk because of her throat; I think she said that she has pain in her legs and cramping; 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 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: PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "I think she said that she has pain in her legs and cramping"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "couldn't talk because of her throat".  Additional information: The patient was barely audible. She said she could not talk because of her throat and a reaction to the vaccine. I think she said that she has pain in her legs and cramping.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: painful joint pain in the neck; painful joint pain in arms, legs; painful joint pain in arms, legs and joints; 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 female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (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: NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "painful joint pain in the neck"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "painful joint pain in arms, legs"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "painful joint pain in arms, legs and joints".  Additional information: Caller mentions that on April 14th she got the second dose of the Pfizer Covid vaccine and almost 2 weeks after she is getting painful joint pain in the neck, arms, legs and joints. She just wants to know if this is normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I have been sick/I am still not feeling right; 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) (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: MALAISE (non-serious), outcome "unknown", described as "I have been sick/I am still not feeling right".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Ist. Dose - Sore arm. No worse than when I receive a Flu shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 14:00 (Lot number: EW0150) at the age of 57 years as single dose for covid-19 immunisation. Relevant medical history included: "Psoriasis/  migraines" (unspecified if ongoing); "Some medications" (unspecified if ongoing); "Psoriasis/  migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Apr2021 04:30, outcome "recovering", described as "Ist. Dose - Sore arm. No worse than when I receive a Flu shot". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aches all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 14Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Back surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches all over his body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; had sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing); "thyroid problem" (unspecified if ongoing); "blood clotting" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for coagulopathy, start date: 01Jun2020, stop date: 16Mar2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "unknown", described as "had sore in the arm"; FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: he was highly confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 49 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: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "he was highly confused".  Additional information: According to reporter his brother, 15 mins after the first dose he was highly confused, his brother thinks it is still the year 2018, he forgot that his pet is dead already, forgot the name of his daughter, forgot that he and his fiancé separated already, he thinks that he is still working from his previous job. No transfer and manual done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Fatigue, Palpitations, Urine analysis
Clinical narrative: racing heart; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bartter Syndrome" (unspecified if ongoing); "previous Broken Syndrome" (unspecified if ongoing), notes: other medical history: previous Broken Syndrome; "GERD" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: SPIRONOLACTONE; TOPROL XL; SLOW MAG B6. The following information was reported: PALPITATIONS (non-serious) with onset Mar2021, outcome "not recovered", described as "racing heart"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue". The events "racing heart" and "fatigue" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations, fatigue.   Additional information: The patient took second dose of vaccine on 09Apr2021.  Reported verbatim: First dose racing heart and severe fatigue during first week with 1 emergency room visit. Second dose caused racing heart and much, much more severe pounding heart and overwhelming fatigue with 2 emergency room visits. I am 19 days out from second dose and still feeling deep fatigue and not able to resume normal activities. I feel as bad as I did within the first week of reactions. No other vaccine in four weeks. Other medications in two weeks included unspecified multivitamins. Ae treatment included replenishing electrolytes, ekg, blood tests, urine tests. No covid prior vaccination. No covid tested post vaccination. Known allergies: Yes    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Fatigue; he had headaches; Achiness; 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 65 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Apr2021 13:30 (Lot number: EW0170) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "he had headaches"; PAIN (non-serious), outcome "unknown", described as "Achiness".  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Emotional distress, Pain
Clinical narrative: I'm suffering; I'm in a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "I'm suffering"; PAIN (non-serious), outcome "unknown", described as "I'm in a lot of pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Pain at injection site; Nausea; Tiredness; Metallic taste in mouth; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 20Apr2021 10:45 (Lot number: EW0158) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medications included: VALACYCLOVIR [VALACICLOVIR]; MONTELUKAST; CITALOPRAM. Vaccination history included: BNT162B2 (DOSE 1; Lot Number: ER2613; 10:45 AM; intramuscular in left leg), administration date: 30Mar2021, when the patient was 61 years old, for COVID-19 immunization, reactions: "Pain at injection site", "Administered intramuscularly in left leg". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Pain at injection site"; NAUSEA (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Nausea"; FATIGUE (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Tiredness"; DYSGEUSIA (non-serious) with onset 20Apr2021 23:45, outcome "not recovered", described as "Metallic taste in mouth". Therapeutic measures were not taken as a result of vaccination site pain, nausea, fatigue, dysgeusia.  Additional Information: The patient was not diagnosed with COVID-19 prior vaccination. The patient was not administered with other vaccine in four weeks. Adverse events were after around 12 hours of injection of the second dose. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455566 Same reporter, patient, and product; different events and dose
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (148871). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: reports that on the sixth or seventh day she started to get achy; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "joints were swollen" (not ongoing), notes: Knees, ankles, knuckles, almost all joints were swollen.; "psoriasis" (not ongoing). The patient's concomitant medications were not reported. Past drug history included: Xeljanz for psoriasis; Xeljanz for joint pain. The following information was reported: PAIN (non-serious), outcome "unknown", described as "reports that on the sixth or seventh day she started to get achy". Therapeutic measures were taken as a result of pain.  Additional information: The patient reported that on the sixth or seventh day she started to get achy and took Tylenol. The patient "Xeljanz" had worked perfect. The patient could jump right out of bed now. The joint pain was much better. It was 8 or 9 out of 10, now it's about 1/10. The patient's knees, ankles, knuckles, almost all joints were swollen, it took about 3 months to fully kick in. The patient reports having psoriasis after being on previous medication, psoriasis went away after about 5 months on Xeljanz. Patient reported stopping Xeljanz for one week after receiving COVID vaccination, no date given. She stated, it wasn't too bad. It was tolerable. MD aware. Patient reported start of therapy about a year ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: She called because she is getting over stomach flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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: GASTROENTERITIS VIRAL (non-serious) with onset Apr2021, outcome "unknown", described as "She called because she is getting over stomach flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: muscle soreness; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  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: MYALGIA (non-serious), outcome "recovered", described as "muscle soreness"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Facial pain, Musculoskeletal discomfort, Neck pain, SARS-CoV-2 test
Clinical narrative: Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; aching teeth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:00 (Lot number: ER 8737) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Chronic Inflammation" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN. Past drug history included: Novocaine, reaction(s): "allergies". The following information was reported: FACIAL PAIN (non-serious), NECK PAIN (non-serious), FACIAL DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "Slight pain and discomfort up left side of neck and face"; TOOTHACHE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "aching teeth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial pain, neck pain, facial discomfort, musculoskeletal discomfort, toothache.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination: Nasal Swab on 22Apr202 was negative. Slight pain and discomfort up left side of neck and face; aching teeth with first dose.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493950 Same reporter/vaccine/patient, different dose/events
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; Slight pain and discomfort up left side of neck and face; aching teeth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:00 (Lot number: ER 8737) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Chronic Inflammation" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN. Past drug history included: Novocaine, reaction(s): "allergies". The following information was reported: FACIAL PAIN (non-serious), NECK PAIN (non-serious), FACIAL DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "Slight pain and discomfort up left side of neck and face"; TOOTHACHE (non-serious) with onset 26Apr2021, outcome "not recovered", described as "aching teeth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of facial pain, neck pain, facial discomfort, musculoskeletal discomfort, toothache.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination: Nasal Swab on 22Apr202 was negative. Slight pain and discomfort up left side of neck and face; aching teeth with first dose.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493950 Same reporter/vaccine/patient, different dose/events
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: improvement of symptoms without nasty side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "severe narcolepsy" (unspecified if ongoing); "cataplexy" (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 "improvement of symptoms without nasty side effects".  Additional information: Patient wish to share experience of the first COVID vaccine and iatrogenic side effect and as much as patient was incredibly phobic, Patient wanted to thank for providing this necessary, preventive care. Patient have severe narcolepsy with cataplexy and have had a significant improvement of symptoms without nasty side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site pain
Clinical narrative: mild lethargy; Mild soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0162) at the age of 40 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, SINGLE (Lot No: EN6202) in left arm, at 01:30 PM), administration date: 24Mar2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Mild soreness at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Apr2021 12:00, outcome "recovered" (Apr2021), described as "Mild soreness at injection site"; LETHARGY (non-serious) with onset 15Apr2021 13:30, outcome "recovered" (Apr2021), described as "mild lethargy". Therapeutic measures were not taken as a result of vaccination site pain, lethargy. 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Oropharyngeal pain
Clinical narrative: flu; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a =sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (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: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "flu"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: Scar from ear to mouth, on her face, a wide scar; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:00 (Lot number: ER8731) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sporadic scarring" (ongoing), notes: Diagnosed with Sporadic Scarring, about 28 years ago. Concomitant medication(s) included: CORTISONE, start date: 13Apr2021. Vaccination history included: Bnt162b2 (First dose, Lot: EP6955, Location: left arm, Time: 2 pm.), administration date: 28Mar2021, for COVID-19 immunization. The following information was reported: SCAR (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Scar from ear to mouth, on her face, a wide scar".  Additional information:patient states she got her second vaccine on Tuesday. Patient states that she was diagnosed with Sporadic Scarring, about 28 years ago. and it is scarring, that occurs for no reason. Patient states 50 people in the world were diagnosed with this, disorder. Patient reclarified, at the time she was diagnosed, she spoke to a Dermatologist, at (withheld) about her diagnosis. and it has not reoccurred again in 28 years. Patient mentioned that her son, developed a swollen arm after getting the Pfizer Covid vaccine, after his second shot. Patient states she has been taking the same medicine for many years and she hasn't had an incident, of scarring, so she does not think her medications are relevant to the report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. 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: Since the vaccination the patient was not tested for COVID-19. Patient had no known allergies and no other medical history.  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-2021457060 same report/drug/AE, different patient
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, Nausea
Clinical narrative: bit nauseas; Not been feeling well; he still feel sick; Not been feeling well; he still feel sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: ER8729, Expiration Date: 31Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pain" (unspecified if ongoing), notes: He is on medications for pain and Prostrate. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 15Apr2021, outcome "unknown", described as "bit nauseas"; ILLNESS (non-serious), MALAISE (non-serious) all with onset 15Apr2021, outcome "unknown" and all described as "Not been feeling well; he still feel sick". Therapeutic measures were taken as a result of nausea, illness, malaise.  Additional Information: The consumer (Patient's wife) reported that, He was on medications for pain and Prostrate. Me and my husband had the shot on 15th and my husband since 15th he's not been feeling well and my question is everything, I read about taking the shot says 2-3 days like, 24-48 hours, a few days but now we're at a week later and he still feel sick. Reporter stated, "We both got but I already said I didn't get sick and he has not felt well since then, the first day he came out with felling a bit nauseas, you know nausea and then he had a lot of issues and I am not sure what is going on here." Reporter stated, "I just want to know if this is normal or not." Treatment was given with, "Compazine." Reporter seriousness for the events were unspecified.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Tremor on my torso on my left side, and now, as of today I'm getting tremor on my right side of the torso; my body is moving, its literally making movements; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (When probed for the Date of vaccination for 1st shot, Consumer  stated, "February 26th 2021.", Lot number:EL3302, NDC number:59267100001), administration date: 26Feb2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: TREMOR (non-serious) with onset 10Apr2021, outcome "unknown", described as "Tremor on my torso on my left side, and now, as of today I'm getting tremor on my right side of the torso; my body is moving, its literally making movements"; CHILLS (non-serious) with onset 10Apr2021, outcome "unknown", described as "chills". Therapeutic measures were taken as a result of tremor.  Additional information: It was stated, "he had some reactions, he was assuming its reaction to the second shot he had on 26Mar, 2 weeks later on 10Apr, he started developing, what he refer to as tremors or what happens when you get chills. A kind of movement in the torso of his body to the left side and for the last 2 weeks, almost 2 weeks and today was the 22nd, 24th will be 2 weeks, he have continued to get this sensations. Other way he can explain was when you get cold and when you get tremor or when you are scared, when you get chills. It was not the same kind of chills you get when you have a fever. He was not talking about that. It was the way the torso, his body was moving, it was literally making movements and it does this quiet often during day but not all the time and he just wanted to know if that was a somehow related to the 2nd shot or the 2 shots that he had, 1st shot was in 26Feb, 2nd shot was 26Mar, and 10Apr, beginning of this cycle. The movement of he do not know how to repeat this, like tremor on his torso on his left side, and now, as of today he was getting tremor on his right side of the torso, but not in the arms, not in the legs." When clarified if the consumer wants to know if the event was due to the covid19 vaccine dose, consumer stated, "Yes, they did start 2 weeks after 2nd shot, they could be from 1st shot, he do not what it was from, but he was calling to report it." The patient lab test in December 2020 and It was just to see if everything was normal. It was stated as adverse event comes and goes. The patient took baby aspirin orally (take 1 everyday, 10Apr) for treatment.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Pain in extremity, Somnolence
Clinical narrative: sleepy; 2 waves of nausea; chills; feeling"out of it"; arm ache and soreness for 2 days; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Mar2021 16:30 (Lot number: Er8730) at the age of 64 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Reflux" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medications included: LISINOPRIL; ESOMEPRAZOLE; CLARITIN [LORATADINE]. The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "sleepy"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "2 waves of nausea"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling"out of it""; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm ache and soreness for 2 days".  Additional information: Medications received within 2 weeks included Lisinopril 10mg, Esomeprazole 40mg, Claritin and Vita. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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 "I was sick". Patient had an appointment yesterday for second shot of the Covid-19 and was not able to get there. Patient was sick and could not get there.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: Chills; Headache; Pain in arm; Body aches; not feeling good; Feeling bad; Muscle pain in my arm; injection site is pretty sore; a little swelling there; injection site is pretty sore; a little swelling there; Dizziness ; I think that is the pain.; driving me crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; PAIN (non-serious), outcome "unknown", described as "Body aches"; MALAISE (non-serious), outcome "unknown", described as "not feeling good"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain in my arm"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "injection site is pretty sore; a little swelling there"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness ; I think that is the pain."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "driving me crazy".  Additional information: Consumer took the second dose (Unspecified Medication) yesterday and you know this is day 2, I am experiencing chills, headache, I think no more side effects. And pain in arm but that is getting better, I know that is getting better. The side effects the chills and headache, how long does it take, like you know, my body aches. Got her second vaccination yesterday and was experiencing some side effects. They are not real bad, the one that is driving her crazy is the headache and the chills. having of course some muscle pain in arm and the injection site is pretty sore and it's getting better and little swelling there and stated that it is not a big deal but troubling with the dizziness and thinks no more side effects and pain in arm but that is getting better. Consumer asked how long it takes for the side effects chills and headache and her body aches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.