chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Paraesthesia, Pruritus, Rash
Clinical narrative: was very itchy; her hand started tingling; I broke out with the rash; it got worse; I broke out with the rash; it got worse; I can't sleep; It's driving patient crazy; 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. Other Case identifier(s): US-PFIZER INC-202101352055 (PFIZER).  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: EW0196) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose:2), administration date: 2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "I broke out with the rash; it got worse"; SLEEP DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "I can't sleep"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "unknown", described as "It's driving patient crazy"; PRURITUS (non-serious), outcome "unknown", described as "was very itchy"; PARAESTHESIA (non-serious) with onset 04Oct2021, outcome "unknown", described as "her hand started tingling". The event "i broke out with the rash; it got worse" and "i broke out with the rash; it got worse" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, condition aggravated, pruritus.  Additional Information: she took the booster shot last Monday 04Oct2021, she rested for a couple of minutes after receiving the shot and when she's leaving the parking lot, her hand started tingling, her hands got really itchy, and after couple of minutes it started breaking out to different parts of her body. She also added that she's been to her doctor already couple of times and gave her Prednisone, Benadryl and some Claritin but it's not working. Per caller, she had no problem or side effects to the 1st 2 doses of Pfizer BioNTech Covid19 Vaccine that she received and she's calling asking what to do with this terrible very itchy rash. Patient taking other unspecified concomitant medications . Patient had no any lab work after the shot. Patient had not prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: was very itchy; her hand started tingling; I broke out with the rash; it got worse; I broke out with the rash; it got worse; I can't sleep; It's driving patient crazy; 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. Other Case identifier(s): US-PFIZER INC-202101352055 (PFIZER).  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: EW0196) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), administration date: 2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose:2), administration date: 2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "I broke out with the rash; it got worse"; SLEEP DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "I can't sleep"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "unknown", described as "It's driving patient crazy"; PRURITUS (non-serious), outcome "unknown", described as "was very itchy"; PARAESTHESIA (non-serious) with onset 04Oct2021, outcome "unknown", described as "her hand started tingling". The event "i broke out with the rash; it got worse" and "i broke out with the rash; it got worse" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, condition aggravated, pruritus.  Additional Information: she took the booster shot last Monday 04Oct2021, she rested for a couple of minutes after receiving the shot and when she's leaving the parking lot, her hand started tingling, her hands got really itchy, and after couple of minutes it started breaking out to different parts of her body. She also added that she's been to her doctor already couple of times and gave her Prednisone, Benadryl and some Claritin but it's not working. Per caller, she had no problem or side effects to the 1st 2 doses of Pfizer BioNTech Covid19 Vaccine that she received and she's calling asking what to do with this terrible very itchy rash. Patient taking other unspecified concomitant medications . Patient had no any lab work after the shot. Patient had not prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling & slight soreness at site of injection.; Swelling & slight soreness at site of injection.; Goose egg size swelling.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Oct2021 11:00 (Lot number: 30155BA) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation; tetanus vaccine (TETANUS VACCINE), administered in arm left, administration date 07Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "Mild asthma" (unspecified if ongoing); "Mild hypertension" (unspecified if ongoing); "Chronic pain due to arthritic knees" (unspecified if ongoing); "Excessive PVCs currently under control through medication" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Back Pain" (unspecified if ongoing); "Back stenosis" (unspecified if ongoing); "some finger joints pain" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: El3259, Location of injection: Arm Left, Did not have any adverse reaction to the first two Pfizer COVID-19 shots), administration date: 08Feb2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "Did not have any adverse reaction to the first two Pfizer COVID-19 shots"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9265, Location of injection: Arm Left, Did not have any adverse reaction to the first two Pfizer COVID-19 shots), administration date: 18Jan2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "Did not have any adverse reaction to the first two Pfizer COVID-19 shots".  The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "Swelling & slight soreness at site of injection."; SWELLING (non-serious) with onset Oct2021, outcome "not recovered", described as "Goose egg size swelling.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, swelling.  Additional information: Adverse event start time: 07:00 PM. Hospitalization was not Prolonged. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: my armpit to left breast is tender and swollen; intermittent pain under left breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 15:30 (Lot number: EW0179) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, Prev dose brand unknown=True,, prev dose brand name unknown=COVID19 Vaccine,, Prev dose lot unknown=True,, prev dose lot unknown reason=Unable to locate or read the details,, prev dose number=1,, prev dose vaccine location=Left arm), when the patient was 46 years old, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset 08Oct2021 15:00, outcome "not recovered", described as "my armpit to left breast is tender and swollen"; PAIN (non-serious) with onset 08Oct2021 15:00, outcome "not recovered", described as "intermittent pain under left breast". Therapeutic measures were not taken as a result of swelling, pain.  Additional Information: Patient did not take other vaccine in four weeks. Patient did not take other medication in two weeks.Patient did not receive any treatment for AE. Patient did not have covid prior to vaccination. Patient did not tested covid post vaccination. No known allergies are reported.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eye pain, Headache, Hyperhidrosis
Clinical narrative: Sweats; chills; headache; kidney pain; difficulty taking deep breaths; pain in eyes when looking to the side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 10:45 (Lot number: FF2588) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 21Aug2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "Sweats"; CHILLS (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "headache"; RENAL PAIN (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "kidney pain"; DYSPNOEA (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "difficulty taking deep breaths"; EYE PAIN (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "pain in eyes when looking to the side". Therapeutic measures were not taken as a result of hyperhidrosis, chills, headache, renal pain, dyspnoea, eye pain.  Additional information: Facility type for Vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination. Did not test for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Sweats; chills; headache; kidney pain; difficulty taking deep breaths; pain in eyes when looking to the side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 10:45 (Lot number: FF2588) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3181, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 21Aug2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "Sweats"; CHILLS (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "headache"; RENAL PAIN (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "kidney pain"; DYSPNOEA (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "difficulty taking deep breaths"; EYE PAIN (non-serious) with onset 11Sep2021 22:00, outcome "recovered" (2021), described as "pain in eyes when looking to the side". Therapeutic measures were not taken as a result of hyperhidrosis, chills, headache, renal pain, dyspnoea, eye pain.  Additional information: Facility type for Vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination. Did not test for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: She had chills; Aches; Low grade fever; 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 70 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Mar2021 10:30 (Lot number: EN6208) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: EN6202, Given about 8:30am,in the left arm,), administration date: 25Feb2021, when the patient was 70 years old, for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "She had chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Aches"; PYREXIA (non-serious) with onset Mar2021, outcome "unknown", described as "Low grade fever". Therapeutic measures were taken as a result of chills, pain, pyrexia.  Additional information: Patient stated that after the second dose, she had chills, aches, and a low grade fever.  She took Tylenol 500 mg, went to bed and woke up the next day and was fine. The same thing happened that next evening after shot. She took another Tylenol and when she woke up that was the end of it. The events lasted for a couple days, but not all day just in the evenings. Patient did not receive any other vaccine within 4 weeks prior to covid vaccination.  Follow-up attempts completed. No further information expected
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Hot flush, Pain
Clinical narrative: body aches; shortness of breath; general weakness; chills; hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 18:00 (Lot number: ff2589) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "body aches"; DYSPNOEA (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "shortness of breath"; ASTHENIA (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "general weakness"; CHILLS (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "chills"; HOT FLUSH (non-serious) with onset 09Oct2021 10:00, outcome "recovering", described as "hot flashes". Therapeutic measures were not taken as a result of pain, dyspnoea, asthenia, chills, hot flush.  Additional information:  Patient had no known allergies. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Gait disturbance, Headache
Clinical narrative: Chills; Headache; Nasal congestion; body aches; Chest congestion; Very shallow breathing; Cough; she had to walk around a bit and was a little unsteady; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Sep2021 15:00 (Lot number: FE3592) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Onset Date: 12 years old; "anxiety" (unspecified if ongoing); "congestion" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: MEDROL [METHYLPREDNISOLONE]; ZANAFLEX; CLOBETASOL 0.05%; VAGIFEM; BUSPAR taken for anxiety; ESOMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for nasal congestion; IBUPROFEN taken for pain; TYLENOL taken for pain. Vaccination history included: Flu vaccine (It was last year.), administration date: 2020, reaction(s): "little ache or sore throat". The following information was reported: HYPOPNOEA (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Very shallow breathing"; COUGH (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Cough"; GAIT DISTURBANCE (non-serious) with onset 23Sep2021 15:10, outcome "recovering", described as "she had to walk around a bit and was a little unsteady"; CHILLS (non-serious) with onset 23Sep2021 18:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Headache"; NASAL CONGESTION (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Nasal congestion"; PAIN (non-serious) with onset 23Sep2021 18:00, outcome "recovering", described as "body aches"; CHEST DISCOMFORT (non-serious) with onset 23Sep2021 18:00, outcome "recovering", described as "Chest congestion". Therapeutic measures were taken as a result of hypopnoea, cough, gait disturbance, chills, headache, nasal congestion, pain, chest discomfort.  Additional information: The patient reported that she was scheduled to get second one the end of this week and was concerned because she was still having shallow breathing. Patient was concerned and thinks it was typical. Everything was worse on Right side and that is the side she received vaccine on. She also had nasal and chest congestion for a week. The chest has improved because there is nothing there when she coughs.  The nasal congestion is persistent. There was no emergency or physician visit. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The events require the initiation of new medication or other treatment or procedure.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Nasal congestion, Pain
Clinical narrative: Chills; Headache; Nasal congestion; body aches; Chest congestion; Very shallow breathing; Cough; she had to walk around a bit and was a little unsteady; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Sep2021 15:00 (Lot number: FE3592) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Onset Date: 12 years old; "anxiety" (unspecified if ongoing); "congestion" (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: MEDROL [METHYLPREDNISOLONE]; ZANAFLEX; CLOBETASOL 0.05%; VAGIFEM; BUSPAR taken for anxiety; ESOMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for nasal congestion; IBUPROFEN taken for pain; TYLENOL taken for pain. Vaccination history included: Flu vaccine (It was last year.), administration date: 2020, reaction(s): "little ache or sore throat". The following information was reported: HYPOPNOEA (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Very shallow breathing"; COUGH (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Cough"; GAIT DISTURBANCE (non-serious) with onset 23Sep2021 15:10, outcome "recovering", described as "she had to walk around a bit and was a little unsteady"; CHILLS (non-serious) with onset 23Sep2021 18:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Headache"; NASAL CONGESTION (non-serious) with onset 23Sep2021 18:00, outcome "not recovered", described as "Nasal congestion"; PAIN (non-serious) with onset 23Sep2021 18:00, outcome "recovering", described as "body aches"; CHEST DISCOMFORT (non-serious) with onset 23Sep2021 18:00, outcome "recovering", described as "Chest congestion". Therapeutic measures were taken as a result of hypopnoea, cough, gait disturbance, chills, headache, nasal congestion, pain, chest discomfort.  Additional information: The patient reported that she was scheduled to get second one the end of this week and was concerned because she was still having shallow breathing. Patient was concerned and thinks it was typical. Everything was worse on Right side and that is the side she received vaccine on. She also had nasal and chest congestion for a week. The chest has improved because there is nothing there when she coughs.  The nasal congestion is persistent. There was no emergency or physician visit. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The events require the initiation of new medication or other treatment or procedure.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching; Swelling; At the vaccine it''s the area spread you know redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FF8841) 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: PRURITUS (non-serious), outcome "unknown", described as "Itching"; SWELLING (non-serious), outcome "unknown", described as "Swelling"; ERYTHEMA (non-serious), outcome "unknown", described as "At the vaccine it''s the area spread you know redness".  Additional information: patient received the Pfizer COVID-19 Vaccine had non serious allergic reaction, the itching and the swelling and at the vaccine it is the area spread you know redness wanted to know if it normal to have these allergic reactions.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Pyrexia, Swelling
Clinical narrative: Swollen; red; itching; warm; tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Oct2021 12:00 (Lot number: FF2587) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; METOPROLOL; GABAPENTIN; OLMESARTAN/HYDROCHLOROTHIAZIDE. Past drug history included: Ees, reaction(s): "known allergies: EES"; Pcn, reaction(s): "known allergies: PCN". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose lot number=ER8730,, prev dose dose number=2), administration date: 01Apr2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer,, prev dose lot number=EN6199,, prev dose dose number=1), administration date: 11Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "Swollen"; ERYTHEMA (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "red"; PRURITUS (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "itching"; FEELING HOT (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "warm"; TENDERNESS (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "tender". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, erythema, pruritus, feeling hot, tenderness.  Additional information: Patient stated events Swollen, red, warm and tender area approximately 2.5 inches x 1.5 inches with itching. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Swollen; red; itching; warm; tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Oct2021 12:00 (Lot number: FF2587) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; METOPROLOL; GABAPENTIN; OLMESARTAN/HYDROCHLOROTHIAZIDE. Past drug history included: Ees, reaction(s): "known allergies: EES"; Pcn, reaction(s): "known allergies: PCN". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose lot number=ER8730,, prev dose dose number=2), administration date: 01Apr2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer,, prev dose lot number=EN6199,, prev dose dose number=1), administration date: 11Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "Swollen"; ERYTHEMA (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "red"; PRURITUS (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "itching"; FEELING HOT (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "warm"; TENDERNESS (non-serious) with onset 08Oct2021 16:00, outcome "not recovered", described as "tender". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, erythema, pruritus, feeling hot, tenderness.  Additional information: Patient stated events Swollen, red, warm and tender area approximately 2.5 inches x 1.5 inches with itching. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Pruritus
Clinical narrative: my left side lower have of my body has gone numb/Upper left leg has strange numbness center of thigh; a strange itching that does not seem to go away./Itching in left butt muscle. Left hip area also itching.; left arm hurts like I got hit by a rock.; 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 59 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 18:45 (Lot number: FF8837) as dose 3 (booster), single for covid-19 immunisation. Family history included: "Heart stint upper left artery" (unspecified if ongoing), notes: Family medical history relevant to AE(s): Heart stint upper left artery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Dose: 1st, Date/Time: 04Mar2021; Time: 11:15, Site and route of injection: Anatomical site of injection: Left upper arm, Batch/Lot number: EN6199), administration date: 04Mar2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, Dose: 2nd, Date/Time: 01Apr2021; Time: 11:00, Site and route of injection: Anatomical site of injection: Left upper arm, Batch/Lot number: ER8737), administration date: 01Apr2021, when the patient was 59 years old, for COVID-19 immunization; Flu shot (Vaccine name: Flu shot, Manufacturer: Unknown, Batch/Lot#: Unknown, Route: Unknown, Anatomical site of injection: Left upper arm, No. of previous dose: 1 one, Date: 15Sep2021), administration date: 15Sep2021. The following information was reported: HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "my left side lower have of my body has gone numb/Upper left leg has strange numbness center of thigh"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "a strange itching that does not seem to go away./Itching in left butt muscle. Left hip area also itching."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "left arm hurts like I got hit by a rock.".  Additional Information: Vaccination facility type was Pharmacy or drug store.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Injection site pain, Physical examination, Tachycardia
Clinical narrative: heart beat sky rocketed/Rapid heart rate; had chest pains (1st two hours after the shot); pain in the shot site; 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), intramuscular, administered in arm left, administration date 21Mar2021 13:00 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL, start date: 21Mar2021, stop date: 23Apr2021. The following information was reported: TACHYCARDIA (non-serious) with onset 21Mar2021 13:20, outcome "recovered" (2021), described as "heart beat sky rocketed/Rapid heart rate"; CHEST PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "had chest pains (1st two hours after the shot)"; INJECTION SITE PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "pain in the shot site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional information: Patient know that there was a site where patient can provide feedback regarding COVID shot. Patient just cant seem to find it. Patient wanted to report that after the first shot heart beat sky rocketed and had chest pains (1st two hours after the shot) and pain in the shot site (typical response). Patient was an athlete and workout daily. It kept patient awake for the 1st two weeks because it hurt. Relevant test was none (everything was normal at last physical). Rapid heart rate (about 3-5min after shot Rapid heart rate remained escalated for at least 2 hours.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: headache; fatigue; chills; fever; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Oct2021 09:00 (Lot number: FF8841) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: FLU VACCINE VII, administration date 20Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 13Jan2021, when the patient was 26 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 08:00 AM, Route of Administration: Intramuscular), administration date: 03Feb2021, when the patient was 26 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "headache"; FATIGUE (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "fatigue"; CHILLS (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "chills"; PYREXIA (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "fever"; MYALGIA (non-serious) with onset 07Oct2021 21:00, outcome "recovered" (Oct2021), described as "muscle aches". Therapeutic measures were not taken as a result of headache, fatigue, chills, pyrexia, myalgia.  Additional information : Patient did not met any seriousness criteria. The most recent COVID-19 vaccine was administered at workplace clinic. Other vaccine was administered in four weeks. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient was not tested positive for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: After her second dose, she experienced 3 -4 bloody noses for the first few days post jab; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 94 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Mar2021 10:30 (Batch/Lot number: unknown) at the age of 93 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, Time (24hrs): 10:00 am, Site and Route of injection:, Anatomical site of injection: Shoulder, Route of administration: Intramuscular), administration date: 15Feb2021, when the patient was 93 years old, for COVID-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 10Mar2021 03:00, outcome "recovered" (Jul2021), described as "After her second dose, she experienced 3 -4 bloody noses for the first few days post jab".  Additional information: It was unknown if patient had Prior vaccinations (within 4 weeks).No relevant test were done.Post 2nd Vax onset of bloody nose events daily for about 10 days, then only 4 or 5 /week-eventually tapering off to one event every 2-3 weeks-subsided completely by mid Jul2021.For Dose 2 Anatomical site of injection: Shoulder.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dry mouth, Nausea, Pyrexia
Clinical narrative: dry mouth; fever reaching 102.8; nausea; chills; 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 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious), outcome "unknown", described as "dry mouth"; PYREXIA (non-serious), outcome "unknown", described as "fever reaching 102.8"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Higher Fever did not start until 24 hrs after dose. This was despite every 6 hr use of 1g Tylenol  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: dry mouth; fever reaching 102.8; nausea; chills; 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 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious), outcome "unknown", described as "dry mouth"; PYREXIA (non-serious), outcome "unknown", described as "fever reaching 102.8"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Higher Fever did not start until 24 hrs after dose. This was despite every 6 hr use of 1g Tylenol  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN6202) at the age of 84 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "bovine heart valve" (unspecified if ongoing); "CLL" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose product=COVID 19,, dose brand=pfizer,, dose lot  number=EN9581 0.3ML,, dose dose number=1,, prev dose vaccine location=Left arm), administration date: 04Feb2021, when the patient was 84 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 17Sep2021, outcome "recovered" (Sep2021), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient reported he had a slight fever on 17Sep2021 after he came from gym. He took tylenol and cleared. He spent Saturday and Sunday doing normal things. Patient reported he did not had COVID prior vaccination and was tested 'negative' for COVID post vaccination. Patient had no allergies. Patient received third dose of 20Sep2021 at 13.30 in left arm.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: many lymph nodes under his armpit; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "many lymph nodes under his armpit".  Additional Information: The patient had many lymph nodes under his armpit and they lasted a month. He had no other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Food allergy, Weight, Weight decreased
Clinical narrative: food sensitivities; loss of 10 lbs; Stomach upset; Heartburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Feb2021 (Lot number: EL9267, Expiration Date: 18Feb2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Time: 13:00, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9263), administration date: 28Jan2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 19Feb2021, outcome "recovering", described as "Stomach upset"; DYSPEPSIA (non-serious) with onset 19Feb2021, outcome "recovering", described as "Heartburn"; FOOD ALLERGY (non-serious), outcome "unknown", described as "food sensitivities"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "loss of 10 lbs". The events "stomach upset" and "heartburn" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal discomfort, dyspepsia.  Additional information: The patient had not received any other vaccine within 4 weeks. As of 10Apr2021 still dealing w/some food sensitivities loss of 10ibs in first 3weeks of onset symptoms.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity, Visual impairment
Clinical narrative: Diarrheas; Headaches; Vision changes; sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 65 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunization. Relevant medical history included: "allergies: Latex" (unspecified if ongoing); "Slight depression" (ongoing). Concomitant medication included: ACYCLOVIR [ACICLOVIR]. Past drug history included: Nsaids, reaction "allergies: NSAIDS"; Epinephrine, reaction: "allergies: Epinephrine"; Penicillin, reaction: "allergies: Penicillin". Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown, Anatomical location: Left arm, Administration time: 02:30 PM), administration date: 07Feb2021, when the patient was 64 years old, for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "sore arm"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrheas"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "Vision changes". The events "sore arm", "diarrheas", "headaches" and "vision changes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, diarrhoea, headache and visual impairment.  Additional information: The first and second days were sore arm. After each shot and until the 16th day, patient had ongoing diarrheas, headaches and vision changes. 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: light period roughly 3 weeks before I would have expected one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 12:00 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: PCOS but consistently controlled for 10 years with weight loss and metformin; "weight loss" (unspecified if ongoing), notes: PCOS but consistently controlled for 10 years with weight loss and metformin. No COVID prior vaccination. No known allergies. Concomitant medication(s)/Other medications in two weeks included: LEVOTHYROXINE; METFORMIN; SPIRONOLACTONE. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (brand= Pfizer, Administration time= 04:00 pm, location= Left arm, Dose 1, had a heavier than usual period two weeks early), administration date: 29Mar2021, when the patient was 39 years old, for Covid-19 Immunization, reaction(s): "After dose 1, patient had a heavier than usual period two weeks early. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 20Apr2021, outcome "unknown", described as "light period roughly 3 weeks before I would have expected one". Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Both doses affected her menstrual cycle. The day after dose 2, patient had a light period roughly 3 weeks before she would have expected one. Facility type vaccine: Hospital. COVID not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.