chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: her arm is red and swollen; her arm is red and swollen; arm feels warm not hot but warm; This is a spontaneous report received from a non-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), administered in arm (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: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "her arm is red and swollen"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "arm feels warm not hot but warm".  Additional Information: The patient wanted to know if she should put ice or heat on the injection site.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 10:00 (Lot number: EL3247) at the age of 48 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Covid-19 immunization, lot number= EL3247, administration time=01:15 PM,, vaccine location=Left arm,, dose number=1), administration date: 09Mar2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Apr2021, outcome "not recovered", described as "Swollen lymph nodes in my neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information- It was reported that patient administered vaccine at clinic .The patient  did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other  medications  within 2 weeks of vaccination.Prior to vaccination,  the patient  was not diagnosed with COVID-19 and  Since the vaccination,  the patient  had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: it cleared up patient's asthma, after getting the shot, half hour later patient's lungs opened way up and patient could finally breathe really good and haven't breathe that good in years; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) 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: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "it cleared up patient's asthma, after getting the shot, half hour later patient's lungs opened way up and patient could finally breathe really good and haven't breathe that good in years". Additional Information: Patient's friend had a cloudy mind for years and he told the patient it cleared up his mind as well.  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-2021373341 same reporter and drug; similar event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: had a cloudy mind for years and he told me it cleared up his mind as well; had a cloudy mind for years and he told me it cleared up his mind as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Cloudy mind" (unspecified if ongoing), notes: for years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "had a cloudy mind for years and he told me it cleared up his mind as well". 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-2021373334 same reporter and drug; similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: super sleepy. Can't keep my eyes open.; sore arm at the injection site; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Apr2021 (reported as either 01Apr2021 or 02Apr2021) (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: Covid 19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "super sleepy. Can't keep my eyes open."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at the injection site".  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Gait disturbance, Headache, Malaise
Clinical narrative: first shot has had several adverse reactions and there not getting better; feeling exhausted; headaches; not feeling well; couldn't sit up for awhile to get out of bed; sleep apnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 78 -old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 77 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: ADVERSE EVENT (non-serious), outcome "unknown", described as "first shot has had several adverse reactions and there not getting better"; FATIGUE (non-serious), outcome "unknown", described as "feeling exhausted"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't sit up for awhile to get out of bed"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome
Clinical narrative: first shot has had several adverse reactions and there not getting better; feeling exhausted; headaches; not feeling well; couldn't sit up for awhile to get out of bed; sleep apnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 78 -old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 77 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: ADVERSE EVENT (non-serious), outcome "unknown", described as "first shot has had several adverse reactions and there not getting better"; FATIGUE (non-serious), outcome "unknown", described as "feeling exhausted"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't sit up for awhile to get out of bed"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: nausea; Headache; Chills; Sweats; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Dec2020 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; DULOXETINE; KYLEENA; IUD NOS. The following information was reported: NAUSEA (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (14Dec2020 22:00), described as "nausea"; HEADACHE (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (14Dec2020 22:00), described as "Headache"; CHILLS (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (17Dec2020), described as "Chills"; HYPERHIDROSIS (non-serious) with onset 14Dec2020 16:00, outcome "recovered" (17Dec2020), described as "Sweats". Therapeutic measures were taken as a result of nausea, headache, chills, hyperhidrosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: 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 did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The pa-tient took tylenol and calcium carbonate to alleviate symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Vision problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 02Apr2021, outcome "unknown", described as "Vision problems".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: I had a headache that lasted a few hours; slight arm soreness in my left arm which is the arm I got the vaccine administered in; I had very slight arm soreness in my left arm; 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. Other Case identifier(s): US-PFIZER INC-2021374888 (Pfizer).  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EP6955) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin for Allergy to Augmentin, notes: Augmentin. Vaccination history included: Bnt162b2 (Dose No.1, vaccine location= Left arm, lot number= EL3247), administration date: 11Mar2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "I had a headache that lasted a few hours"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "slight arm soreness in my left arm which is the arm I got the vaccine administered in"; PAIN IN EXTREMITY (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "I had very slight arm soreness in my left arm". Therapeutic measures were taken as a result of headache.  Additional information: The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. A few hours after my second COVID vaccine dose the patient had a headache that lasted a few hours and took tylenol to relieve. The headache did go away less than 12hrs after the vaccine was administered. Also the patient had very slight arm soreness in my left arm which was the arm where got the vaccine administered in. The arm soreness was much less than the arm soreness the patient experienced after the first dose of the vaccine and has already resolved.   No follow-up attempts were needed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: I have pain underneath my arm and going down my side; It was very painful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), outcome "unknown", described as "I have pain underneath my arm and going down my side; It was very painful".  Additional information: Clinical course: It was reported that patient got second covid vaccine on Wednesday and have pain underneath arm and going downside is all that wanted to know. Patient do not know if that was a normal side effect or what. It was very painful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea on and off for 2 weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 13:15 (Lot number: EN6201) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometrial cancer" (unspecified if ongoing); "Melanoma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; HYDROCHLOROTHIAZIDE; VITAMIN D NOS. The following information was reported: DIARRHOEA (non-serious) with onset Feb2021, outcome "unknown", described as "Diarrhea on and off for 2 weeks".  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness at injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 11:00 (Lot number: EP7533) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Wheat allergy" (unspecified if ongoing), notes: Known allergies: Wheat allergy; "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Ibuprofen, reaction(s): "Drug allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Mar2021, outcome "recovered" (09Mar2021), described as "Arm soreness at injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Reporter stated that, the patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness at injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 11:00 (Lot number: EP7533) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "wheat allergy" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Ibuprofen, reaction(s): "known allergies: ibuprofen". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Mar2021, outcome "recovered" (09Mar2021), described as "arm soreness at injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 11:00 (Lot number: EN6200) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild stroke", start date: 18Jan2021, stop date: 18Jan2021, notes: Stroke-minor /No recurrence; "Carcinoid tumor on appendix", start date: 31Mar2006, stop date: 01Apr2006, notes: Removal of appendix on 31Mar2006. No recurrence; "Hypothyroidism", start date: 12Jul2012 (ongoing), notes: Take Levothyroxine daily; "she had Atrial Fibrillation" (unspecified if ongoing), notes: She had a heart monitor placed 21Feb2020. Her heart monitor never showed Atrial Fibrillation after one year of being monitored.; "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); SYNTHROID taken for hypothyroidism, start date: Jul2012 (ongoing); ATORVASTATIN taken for blood cholesterol abnormal, start date: Jan2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: Vaccination facility type was Doctor's office/Urgent care. Vaccine was not administered at a Facility. No prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021373556 same patient/drug, different event/dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: When they heard she was on chemotherapy, they did not give it to her; losing her voice; This is a spontaneous report of a contactable consumer (patient). A 75-year-old patient received first dose of BNT162B2 (solution for injection; Batch/Lot Number: EN5310) via an unspecified route of administration in left arm on 27Feb2021 as single dose for covid-19 immunisation. Medical history included neoplasm malignant. Concomitant medications were not reported. The patient did not have any problem with the first dose of vaccine, the patient was having problem getting appointment for second shot, as she was on chemotherapy for treating the cancer, they did not give her second dose, the patient was panicking because she is a senior with high risk, and it was making her crazy that she cannot get second dose. It was unknown if reporter was a healthcare professional and prescribing HCP. Patient had her first dose of the Pfizer covid-19 vaccine on 27Feb2021 and had been trying to find a place for the second dose of Pfizer, patient stated her area only has Moderna right now, patient had already called the health department and doesn't know what to do, patient was a senior with cancer on chemo, clarified this was before first dose, patient stated she was also losing her voice, was tested 2 days ago for covid-19 and test was negative. The outcome of the events were unknown.  Follow-up (02Apr2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that: new event "losing her voice" added, dose description and narrative updated.  No follow up attempts are possible. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 06Mar2021 11:30 (Lot number: EN6199) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). Concomitant medication(s) included: OXYBUTYNIN; FLUTICASONE; PREMARIN. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headache". Additional information: After first shot, patient had a headache for 9 days. 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. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: felt so tired; some pain in the arm where got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:30 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "Sulpha" (unspecified if ongoing), notes: Sulpha allergy; "food allergy" (unspecified if ongoing), notes: food Allergy. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 01Apr2021, outcome "recovered", described as "felt so tired"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovered", described as "some pain in the arm where got the vaccine". Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  Additional information: Adverse event- 24 hours after the vaccination felt so tired and got a nap for almost three hours. After that he felt well. In addition, some pain in the arm where got the vaccine. The patient had allergy to medications, food, or other products included penicillin, sulphas and certain foods. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have Lyme disease and It really helped out with my Lyme disease symptoms, so I would like you to know that; 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 number, unknown, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (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 "I have Lyme disease and It really helped out with my Lyme disease symptoms, so I would like you to know that".  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; DULOXETINE; KYLEENA; IUD NOS. Vaccination history included: Bnt162b2 (Lot unknown: True, Lot unknown reason: Misplaced/discarded, Administration time: 12:00 PM, Administrator route: Intramuscular, Vaccine location: Right arm, Dose number: 1), administration date: 14Dec2020, when the patient was 23 years old, for covid-19 immunisation, reaction(s): "nausea", "headache", "chills", "sweats". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild soreness in upper left arm,near injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 53-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EP6955) at the age of 53 years as unk unk, single for covid-19 immunisation. Relevant medical history included: "glaucoma" (unspecified if ongoing); "IBD" (unspecified if ongoing). Concomitant medication(s) included: TUMS CHEWIES; IBUPROFEN; COMBIGAN; ROCKLATAN; AMITRIPTYLINE. Vaccination history included: Bnt162b2 (Dose:1), when the patient was 53 years old. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Apr2021, outcome "recovering", described as "mild soreness in upper left arm, near injection site".  Additional Information: The patient had no allergies to medications, food, or other products. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications he received within 2 weeks of vaccination were MULTIVITAMIN, Probiotic, TUMS chewable (PRN), Ibuprofen (PRN), COMBIGAN eye drops BID, ROCKLATAN eye drops QD, amitriptyline QD. Other medical history: Glaucoma, IBD. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not diagnosed with COVID-19. No treatment was received for the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Electrocardiogram, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Unwell feeling; Heart palpitation; numbness on toes, fingers; Numbness on lips; Burning sensation on hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 11:00 (Lot number: EN6207) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: All fruits except bananas" (unspecified if ongoing), notes: known allergies: All fruits except bananas; "Allergies: Dust" (unspecified if ongoing), notes: known allergies: Dust; "Allergies: Pollen" (unspecified if ongoing), notes: known allergies:pollen; "Allergies: Grass" (unspecified if ongoing), notes: known allergies: grass; "Allergies: Ragweed" (unspecified if ongoing), notes: known allergies: ragweed. Concomitant medication(s) included: ALLEGRA; AZELASTINE; TRIAMTERENE. The following information was reported: MALAISE (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Unwell feeling"; PALPITATIONS (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Heart palpitation"; HYPOAESTHESIA (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "numbness on toes, fingers"; HYPOAESTHESIA ORAL (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Numbness on lips"; BURNING SENSATION (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Burning sensation on hands and feet". The events "unwell feeling", "heart palpitation", "numbness on toes, fingers", "numbness on lips" and "burning sensation on hands and feet" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, palpitations, hypoaesthesia, hypoaesthesia oral, burning sensation.  Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, X-ray
Clinical narrative: Unwell feeling; Heart palpitation; numbness on toes, fingers; Numbness on lips; Burning sensation on hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 11:00 (Lot number: EN6207) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: All fruits except bananas" (unspecified if ongoing), notes: known allergies: All fruits except bananas; "Allergies: Dust" (unspecified if ongoing), notes: known allergies: Dust; "Allergies: Pollen" (unspecified if ongoing), notes: known allergies:pollen; "Allergies: Grass" (unspecified if ongoing), notes: known allergies: grass; "Allergies: Ragweed" (unspecified if ongoing), notes: known allergies: ragweed. Concomitant medication(s) included: ALLEGRA; AZELASTINE; TRIAMTERENE. The following information was reported: MALAISE (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Unwell feeling"; PALPITATIONS (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Heart palpitation"; HYPOAESTHESIA (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "numbness on toes, fingers"; HYPOAESTHESIA ORAL (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Numbness on lips"; BURNING SENSATION (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Burning sensation on hands and feet". The events "unwell feeling", "heart palpitation", "numbness on toes, fingers", "numbness on lips" and "burning sensation on hands and feet" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, palpitations, hypoaesthesia, hypoaesthesia oral, burning sensation.  Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Peripheral swelling
Clinical narrative: heel got reddened and swollen; heel got reddened and swollen; she had a hard time walking; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 68 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: ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Mar2021, outcome "recovered" (Mar2021) and all described as "heel got reddened and swollen"; GAIT DISTURBANCE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "she had a hard time walking".  Additional information: Patient had her first COVID-19 Vaccine 3 weeks ago and 36 hours after she received her first COVID-19 Vaccine, her heel got reddened and swollen. The patient said she had a hard time walking for a couple days. It was reported that her symptoms went away after 3 days. The patient received her second BNT162B2 (Lot number: EP7534 and Expiration Date: Jul2021) today (01Apr2021) at 14:30 in her left arm.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EM9810) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "has had ringing in the right ear for years" (ongoing), notes: has had ringing in the right ear for years/ been real quiet and never bothers her except at night. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Lot No: EI3249   , Dosage text: first dose, left arm, injection), administration date: 19Jan2021, when the patient was 68 years old, for Covid-19 Immunization; Flu shot (after a flu shot she got a fever in the middle of the night but by the morning it was gone.), for immunization, reaction(s): "fever". The following information was reported: TINNITUS (non-serious) with onset 01Apr2021, outcome "not recovered", described as "ringing in right ear".  Additional information: Patient was calling about the COVID 19 vaccine. Patient received the first shot on 19Jan2021 and the second dose on 09Feb2021. Patient stated everything has been more or less fine, however something happened last night. She has had ringing in the right ear for years but it has been real quiet and never bothers her, except at night, but she sleeps with a sound machine to mask the sound and she sleeps fine. But all of a sudden last night, she was watching television - it was a regular show and was not loud or anything - and the tinnitus in her right ear got really loud. The tinnitus got better an hour or so later but then the tinnitus woke her up during the night. The noise maker/sound machine was not loud enough to overcome it. She is afraid it might be long term or a side effect of some kind from the vaccine. So, she wanted to report it just for everyone's sake. Patient stated she is not sure if there is any medication for the ringing in ear. Vaccination Facility Type: Hospital. Vaccine Administered at Military Facility: No. Additional Administered Vaccines: None. Other Products: No. Patient History: No. Prior Vaccinations (within 4 weeks): None. Patient stated once many years ago after a flu shot she got a fever in the middle of the night but by the morning it was gone. Caller stated she always gotten flu shot every year more or less of her life and with her being 68 that was the only time she felt anything.  No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Muscular weakness
Clinical narrative: Sometimes feel like arm/hand weakness; Sometimes feel like arm/hand weakness; Has worsened since receiving the second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; POTASSIUM CHLORIDE; LOSARTAN POTASSIUM. Vaccination history included: Bnt162b2 (Lot number: EN6202, Administration time: 01:30 PM, Vaccine location: Left arm, Dose 1), administration date: 11Mar2021, when the patient was 50 years old, for Covid-19 immunisation, reaction(s): "The left arm became mildly painful at injection site with tingling radiating down to the fingertips", "The left arm became mildly painful at injection site with tingling radiating down to the fingertips", "The left arm became mildly painful at injection site with tingling radiating down to the fingertips", "Sometimes feel like arm weakness", "Sometimes feel like hand weakness". The following information was reported: MUSCULAR WEAKNESS (non-serious), ASTHENIA (non-serious), outcome "not recovered" and all described as "Sometimes feel like arm/hand weakness"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Has worsened since receiving the second dose". Therapeutic measures were not taken as a result of muscular weakness, asthenia, condition aggravated.  Additional information: The patient reported that she did not have any reactions until day 9 after first dose. The left arm became mildly painful at injection site with tingling radiating down to the fingertips. Sometimes feel like arm/hand weakness, not constant but is frequent and has worsened since receiving the second dose on 01Apr2021. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The AE did not result in emergency room or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Ligament sprain
Clinical narrative: sprained her ankle and it is a little swollen, not so much; sprained her ankle and it is a little swollen, not so much; 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) (Lot number: EN6204, Expiration Date: Jun2021) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIGAMENT SPRAIN (non-serious), outcome "unknown", JOINT SWELLING (non-serious), outcome "recovering" and all described as "sprained her ankle and it is a little swollen, not so much". Additional information- Patient stated that  she had her 1st dose of the vaccine and Monday she would to have her 2nd one. States last Monday she sprained her ankle and it is a little swollen, not so much. States she has been reading so much and she is scared and wanted to know if she had the sprain that was a little swollen could it be a problem if she got her next dose, was there any inconvenience because it is swollen. Stated  she had read about thrombosis that can be caused through the vaccine and the swelling is not too much, it is getting better.    No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:30 (Lot number: EN6205) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy issue" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; FLONASE [FLUTICASONE PROPIONATE]; CHLOR-TRIMETON taken for hypersensitivity. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The patient did not have any family medical history relevant to adverse event and did not additional vaccines on same date of the pfizer suspect. Patient was not having any prior vaccinations within 4 weeks. Clinical course: it was reported that with the first dose of the vaccine patient did not have any issues really and expected to have the sore arm. The patient received second dose of the Pfizer Vaccine on 30Mar2021 with lot ER8727, she had a lot of congestion, drainage and was coughing. Patient had contacted her HCP yesterday because she deals with a lot of allergies and kind of when she gets symptoms like this she sometimes gets what they call an allergy booster shot; states she has no name of the allergy booster shot, lot number or expiry date to provide and states she hasn't had an allergy booster shot in quite a while since Aug or Sept2020 and was trying to remember when her last one was and it was in 2020 when she had the last real big flare of allergies; her boss thought maybe her flare of allergies at that time was covid so she had to go test at that time and the covid test came back negative.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: bumps on the deltoid and they were experiencing side effects, such as chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: CHILLS (non-serious), outcome "unknown", described as "bumps on the deltoid and they were experiencing side effects, such as chills".  Additional Information: He states he has no bump on his arm and has no side effects. He feels it was given below the deltoid muscle. He wants to know if he should get another dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: increase in blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Lot number: ER8733) as dose number unknown, single for covid-19 immunization.   Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "increase in blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was diabetic and every morning he take his sugar count and it was always in 90s in that area. Caller stated after he got the shot which he got on Wednesday his blood sugar was 162 and then 148. Caller asked if there was an increase in sugar for the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I felt pain in my calf; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 17:45 (Lot number: EP7534) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Corneal abrasion" (unspecified if ongoing), notes: Other medications in two weeks: yes, eye drops for Corneal abrasion. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Apr2021, outcome "recovering", described as "I felt pain in my calf". The event "i felt pain in my calf" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Adverse event: I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant. At 40 hours after second vaccine dose, I went to the ER and was diagnosed with a DVT in my right calf and treated with blood thinners.  No follow-up attempts are possible. No further information is expected.