chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Malaise, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling at the injection site; red and swollen and painful at the injection site; red and swollen and painful at the injection site; did not feel well; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 13:00 (Lot number: FF8841) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose- 03Feb2021, it was in the afternoon in her left arm, Lot- EL9269, There were no problems after these shots.), administration date: 03Feb2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "There were no problems after these shots."; Bnt162b2 (Second dose- 24Feb2021, it was given in the afternoon in her left arm, Lot- EN6202., There were no problems after these shots.), administration date: 24Feb2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "There were no problems after these shots.". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 11Oct2021, outcome "not recovered", described as "swelling at the injection site"; MALAISE (non-serious) with onset 10Oct2021, outcome "not recovered", described as "did not feel well"; INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "red and swollen and painful at the injection site". Therapeutic measures were not taken as a result of vaccination site swelling, malaise, injection site erythema, vaccination site pain.  Additional information: The patient had swelling at the injection site for 2 days and she has never reported anything like this before.The swelling was just noticed today and she remarks it is red and swollen and painful at the injection site.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30155BA) at the age of 65 years as dose 1, single for covid-19 immunization. Relevant medical history included: "AFib" (unspecified if ongoing), notes: other medical history AFib, "hyperlipidemia" (unspecified if ongoing), notes: other medical history hyperlipidemia. The patient's concomitant medications were not reported. Past drug history included: Oseltamivir, reaction(s): "known allergies: Oseltamivir", notes: known allergies Oseltamivir. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "recovering", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: COVID-19 vaccine was administered in Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: had the same reaction, she was shaking all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation. The following information was reported: TREMOR (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "had the same reaction, she was shaking all over".  Additional information: she said after her second shot of the Pfizer COVID-19 she had the same reaction, she was shaking all over and it went away.  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 fluctuation
Clinical narrative: had fluctuating blood sugar readings (going up and down); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE FLUCTUATION (non-serious), outcome "unknown", described as "had fluctuating blood sugar readings (going up and down)". The patient underwent the following laboratory tests and procedures: blood glucose: fluctuating/ (going up and down), notes: had fluctuating blood sugar readings.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test
Clinical narrative: having pain on both sides/back area (kidney area?); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Oct2021 17:00 (Lot number: FF2587) at the age of 44 years as DOSE 1, SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 11Oct2021 11:00, outcome "not recovered", described as "having pain on both sides/back area (kidney area?)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of back pain.  Additional Information: The patient received the PFIZER COVID-19 vaccine on 08Oct2021. On 11Oct2021, started having pain on both sides/back area (kidney area). She had no known allergies and no other medical history. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness, wiped out, after all 3 vaccines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Jan2021 (Lot number: EL9261) at the age of 81 years as dose 1, single and administered in arm right, administration date 12Feb2021 (Lot number: EN6201) 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: Fatigue(non-serious), outcome "recovering", described as "Tiredness, wiped out, after all 3 vaccines".  Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.  Additional Information:Caller states she had some side effects. Caller states with the first shot, she was very tired and wiped out, and with the second shot it was a little bit better.Caller states her son works at (withheld) and he wanted her to report her events. Caller states she is doing her duty. Specifically, the Caller reports:First vaccine: she was very tired and wiped out. Second vaccine: she wasn't quite so tired, only part of the day.Reportum number provided to patient. The caller was provided with phone number of #, option 1, and hours of operation, is she would like to call back to complete report.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: she felt different/her brain felt weird; she could not concentrate; a pain wave going to the brain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 11Feb2021, outcome "recovered" (11Feb2021), described as "she felt different/her brain felt weird"; DISTURBANCE IN ATTENTION (non-serious) with onset 11Feb2021, outcome "recovered" (11Feb2021), described as "she could not concentrate"; HEADACHE (non-serious) with onset 11Feb2021, outcome "recovered" (11Feb2021), described as "a pain wave going to the brain".  Additional information: The Lot was handwritten so she was unsure if it was EN9810 or CM9810. After the first dose she felt different after 1 hour, it was weird, her brain felt weird, it was like she was coming down with something but it was only effecting the brain, it was a pain wave going to the brain. This had never happened before. It lasted, the weird feeling, lasted for a while but the pain went away, she could not concentrate, it all ended after 2 hours and she was fine after that.    Follow-up attempts completed. No further information is expected. lot/batch number is not available despite the follow-up attempts made.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt bad; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "heart failure" (unspecified if ongoing), notes: heart failure. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin discolouration, Tenderness
Clinical narrative: skin discoloration inside of bicep near the injection site; was tender and sore; was tender and sore; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Aug2021 (Lot number: fc3181) at the age of 34 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 Number: 1, Batch/Lot No: fa7485, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05Aug2021, when the patient was 34 years old, for COVID-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 30Aug2021, outcome "recovering", described as "skin discoloration inside of bicep near the injection site"; PAIN (non-serious), TENDERNESS (non-serious) all with onset 30Aug2021, outcome "recovering" and all described as "was tender and sore". Therapeutic measures were not taken as a result of skin discolouration, pain, tenderness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: declined in energy and stamina; declined in energy and stamina; barely can get to bathroom by self; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Aug2021 (Lot number: FC3182) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes II" (ongoing); "arthritis" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "post hero neur" (unspecified if ongoing); "recent ILD" (unspecified if ongoing); "St 3 CKD" (unspecified if ongoing). Concomitant medication(s) included: NABUMETONE; VIT D [COLECALCIFEROL]; ALLEGRA; DEXILANT; ALLOPURINOL. Vaccination history included: Bnt162b2 (verbatim: First diagnosed with pneumonia 23Feb2021 (subsequent multiple times), Dose number: 1, lot number=EL9269, Expiration date: 31May2021), administration date: 06Feb2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "pneumonia"; Bnt162b2 (verbatim: hospitalized with low oxygenation/high pulse, Dose number: 2, lot number=EN6203, Expiration date: 30Jun2021), administration date: 25Feb2021, when the patient was 71 years old, for Covid-19 immunization, reaction(s): "hospitalized with low oxygenation/high pulse", "hospitalized with low oxygenation/high pulse", "interstitial lung disease".  The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 31Aug2021, outcome "not recovered" and all described as "declined in energy and stamina"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 31Aug2021, outcome "not recovered", described as "barely can get to bathroom by self". The events "declined in energy and stamina", "declined in energy and stamina" and "barely can get to bathroom by self" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, fatigue, loss of personal independence in daily activities.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Antibiotic received as treatment for events.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: just a slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2021 (Lot number: EL3246) at the age of 76 years as dose 1, single and (Lot number: EN9581) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "allergic to dust" (unspecified if ongoing), notes: she is allergic to dust and has environmental allergies; "environmental allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "just a slightly sore arm".  Additional information: Patient had a medication for Blood Pressure, but she had taken that for years and it was nothing new. she was allergic to dust and had environmental allergies.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Pain in extremity
Clinical narrative: Eyes started burning a lot; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6208) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Has allergies" (unspecified if ongoing); "anaphylactic shock a lot" (unspecified if ongoing), notes: 40 years ago used to go into anaphylactic shock a lot, was treated. The patient's concomitant medications were not reported. The following information was reported: EYE IRRITATION (non-serious) with onset 2021, outcome "unknown", described as "Eyes started burning a lot"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: At least half an hour after the dose. Eyes started burning a lot. Wanted to pull over and close them.  Kept trying and opening one eye at time. Kept burning. Took an antihistamine prior to vaccination just in case. Laid down and feel asleep for about an hour. When he woke up it was gone. Had the usual sore arm. Had other vaccines: Shingles on 03Sp2021. Second dose schedule for 03Nov2021. Flu on unknown date. One time had flu vaccine on a Sunday. Felt pretty lousy heading into work. The patient also received 2nd dose of BNT162B2 on 06Apr2021 and Booster on 06oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Eye irritation, Myalgia, Pain in extremity
Clinical narrative: Had mild eye burning; muscle pain; Arm was more sore than the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EP7533, Expiration Date: 30Dec2021) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing; "anaphylactic shock" (unspecified if ongoing), notes: 40 years ago used to go into anaphylactic shock a lot, was treated. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: Ether EN6208 or FN6208, providing from patient record card, Received in left arm), administration date: 16Mar2021, for Covid-19 Immunization, reaction(s): "Eyes started burning a lot", "Sore arm"; Shingles, administration date: 03Sep2021, for Immunization; Flu, for Immunization, reaction(s): "Felt pretty lousy heading into work". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "Arm was more sore than the first dose"; EYE IRRITATION (non-serious) with onset 06Apr2021, outcome "recovered", described as "Had mild eye burning"; MYALGIA (non-serious) with onset 06Apr2021, outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Had mild reactions with the first two doses, one was discomfort in the arm. He reported his reactions with first two doses. Didn't call Pfizer. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen under arm pit in left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]; GINKO BILOBA [GINKGO BILOBA]. Past drug history included: Demerol, reaction(s): "known allergies", notes: known allergies: Demerol.  The following information was reported: SWELLING (non-serious) with onset 10Oct2021 08:00, outcome "not recovered", described as "Swollen under arm pit in left arm". Therapeutic measures were not taken as a result of swelling.  Additional information: The patient did not take any other vaccine in four weeks. The patient took Lotrel, apple cider vinegar gummies, ginko biloba in two weeks. The patient did not have Covid prior vaccination and not Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 (COMIRNATY), administration date Oct2021 (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: HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "headache".  The lot number for BNT162b2 was not provided and will be requested during follow up.  Follow-up (21Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: Light headed and dizziness for 1week; rapid heart rate; Right arm pit swelled for 5 days with pain; Right arm pit swelled for 5 days with pain; Left calf muscle twitching and pain; Left calf muscle twitching and pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Sep2021 12:15 (Lot number: fC3184) at the age of 45 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: DIZZINESS (non-serious) with onset 27Sep2021 01:00, outcome "not recovered", described as "Light headed and dizziness for 1week"; HEART RATE INCREASED (non-serious) with onset 27Sep2021 01:00, outcome "not recovered", described as "rapid heart rate"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 27Sep2021 01:00, outcome "not recovered" and all described as "Right arm pit swelled for 5 days with pain"; MUSCLE TWITCHING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Sep2021 01:00, outcome "not recovered" and all described as "Left calf muscle twitching and pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, heart rate increased, lymphadenopathy, axillary pain, muscle twitching, pain in extremity.  Additional Information: It was reported that Light headed and dizziness for 1week, rapid heart rate, Right arm pit swelled for 5 days with pain,Left calf muscle twitching and pain started the day after vaccine and Has persisted now for over two weeks. Facility type vaccine: Pharmacy or Drug Store. if other vaccine in four weeks: No. No other medications in two weeks: None. ae treatment: Phycologist visit, magnesium. if covid prior vaccination:Yes. if covid tested post vaccination: No. known allergies :None. other medical history None.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: Light headed and dizziness for 1week; rapid heart rate; Right arm pit swelled for 5 days with pain; Right arm pit swelled for 5 days with pain; Left calf muscle twitching and pain; Left calf muscle twitching and pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Sep2021 12:15 (Lot number: fC3184) at the age of 45 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: DIZZINESS (non-serious) with onset 27Sep2021 01:00, outcome "not recovered", described as "Light headed and dizziness for 1week"; HEART RATE INCREASED (non-serious) with onset 27Sep2021 01:00, outcome "not recovered", described as "rapid heart rate"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 27Sep2021 01:00, outcome "not recovered" and all described as "Right arm pit swelled for 5 days with pain"; MUSCLE TWITCHING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 27Sep2021 01:00, outcome "not recovered" and all described as "Left calf muscle twitching and pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, heart rate increased, lymphadenopathy, axillary pain, muscle twitching, pain in extremity.  Additional Information: It was reported that Light headed and dizziness for 1week, rapid heart rate, Right arm pit swelled for 5 days with pain,Left calf muscle twitching and pain started the day after vaccine and Has persisted now for over two weeks. Facility type vaccine: Pharmacy or Drug Store. if other vaccine in four weeks: No. No other medications in two weeks: None. ae treatment: Phycologist visit, magnesium. if covid prior vaccination:Yes. if covid tested post vaccination: No. known allergies :None. other medical history None.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin disorder, Vaccination site erythema
Clinical narrative: arm a little swollen; where she received the vaccine there is a pale pink area/about the size of a quarter; arm was kind of sore; She said her arm is more swollen than the last two times. It was red, pinkish, blotchy, and had a circle. She also said there was a knot under her skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 08Oct2021 (Lot number: EW0177) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Heart Rhythm" (unspecified if ongoing), notes: Verbatim: Heart Rhythm; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: XARELTO; FLECAINIDE; ATORVASTATIN taken for blood cholesterol; AMLODIPINE taken for blood pressure measurement. Vaccination history included: Bnt162b2 (1st dose., fine after her first two doses with no reaction.), when the patient was 68 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose, fine after her first two doses with no reaction.), when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 09Oct2021, outcome "recovered" (Oct2021), described as "arm a little swollen"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "where she received the vaccine there is a pale pink area/about the size of a quarter"; PAIN IN EXTREMITY (non-serious) with onset 09Oct2021, outcome "recovered", described as "arm was kind of sore"; SKIN DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "She said her arm is more swollen than the last two times. It was red, pinkish, blotchy, and had a circle. She also said there was a knot under her skin". Therapeutic measures were not taken as a result of peripheral swelling, vaccination site erythema, pain in extremity.  Additional information: The patient her arm a little swollen on Saturday that had gone down. However where she received the vaccine there is a pale pink area that was larger than where the vaccine was given about the size of a quarter, larger than it initially was with a firmness underneath. caller states that the knot doesn't hurt today and she feels fine. Caller also reports feeling fine after her first two doses with no reaction.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Unilateral axillary lymphadenopathy occurring on the left side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 06Oct2021 (Lot number: EW0170) at the age of 42 years 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 (product=COVID 19,, brand=PFIZER,, brand unknown=False,, lot number=EL1283,, lot unknown=False,, administration date=20Jan2021,, dose number=2), administration date: 20Jan2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (product=COVID 19,, brand=PFIZER,, brand unknown=False,, lot number=EK9231,, lot unknown=False,, administration date=30Dec2020,, dose number=1), administration date: 30Dec2020, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Oct2021 10:00, outcome "recovered", described as "Unilateral axillary lymphadenopathy occurring on the left side". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Facility type vaccine: Hospital. No other vaccine in four weeks. The patient experienced unilateral axillary lymphadenopathy occurring on the left side. The vaccine was also given in the left deltoid. No covid prior to vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product preparation issue
Clinical narrative: their nurses used a multi-dose diluent vial witto reconstitute h the Comirnaty vaccine; their nurses used a multi-dose diluent vial witto reconstitute h the Comirnaty vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "their nurses used a multi-dose diluent vial witto reconstitute h the Comirnaty vaccine".  Additional information: Question: E-transmitting AE information to DSU. Was not able to obtain patient age and gender. AE recognized after the call. Caller stated they are informed that the diluent should be disregarded after a single use but their clinic did not receive the single doses of diluent with every order they got so their nurses used a multi-dose diluent vial to reconstitute with the Comirnaty vaccine. Caller wanted to know if there are any ill effects from what they're doing or does that make the vaccine have less strength. Response: Spoke from attached FAQ  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Culture stool, Diarrhoea, Pain
Clinical narrative: developed explosive watery diarrhea-bad for 8 weeks; soreness; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 15:00 (Lot number: FC3181) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP", start date: 2016 (ongoing), notes: Reason for Use: HPB, Illness/ AE: HBP, BPH; "BPH", start date: 2016 (ongoing), notes: Reason for Use: BPH, Illness/ AE: HBP, BPH; "Bullous Pemphisoid", start date: 2019 (ongoing), notes: Reason for Use: Bullous Pemphisoid, Illness/ AE: Bullous pemphigoid; "Osteoarthritis", start date: 2000 (ongoing), notes: Reason for Use: Osteoarthritis, Illness/ AE: Osteoarthritis; "Weakened immune system" (unspecified if ongoing), notes: Weakened immune system: Checked. Concomitant medication(s) included: CELEBREX taken for osteoarthritis, start date: 1994 (ongoing); DUPIXENT taken for pemphigoid, start date: 2019 (ongoing); FLOMAX [MORNIFLUMATE] taken for benign prostatic hyperplasia, start date: 2016 (ongoing); LOSARTAN taken for hypertension, start date: 2019 (ongoing). Vaccination history included: Bnt162b2 (Dose number: 1, Time: 03: 00PM, Lot: EH9899, Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Date: 15Dec2020), administration date: 15Dec2020, for covid-19 immunization; Bnt162b2 (Dose number: 2, Time: 03: 00PM, Lot: EH9899, Anatomical Site of injection: Left upper arm, Route of administration: Intramuscular, Date: 04Jan2021), administration date: 04Jan2021, for covid-19 immunization.  The following information was reported: DIARRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "developed explosive watery diarrhea-bad for 8 weeks"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "soreness". The event "developed explosive watery diarrhea-bad for 8 weeks" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: colonoscopy: a year ago and negative of any gi problems; culture stool: wnl (within normal limits).  Additional information: Patient Age at Time of Vaccination: 67-68 (Years). Report is not related to a study or programme. He received the 3rd dose 8 weeks ago - He did not have any issues 4 or 5 days later and just experienced soreness - A week after he received the last dose, he started to experience diarrhea - It was really a bad diarrhea that really bursts if it comes out that lasted for 2 weeks - He had 1 stool culture and out of 5 bacteria result came negative - He is ready to go for colonoscopy for further examination - He had colonoscopy a year ago and negative of any GI problems - His colleagues mentioned that their patients also had protracted GI issues and gastritis when they had the vaccine.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Pain in extremity, Vaccination site swelling
Clinical narrative: The side effects bothered him so much that he could not do anything.; pain in his arm; swelling in the part of his arm were he received the vaccine; tiredness; weakness; 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 male patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (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 (Dose 1, first two doses he did not experience any side effect), for COVID-19 Immunization; Bnt162b2 (Dose 2, first two doses he did not experience any side effect), for COVID-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Oct2021, outcome "unknown", described as "The side effects bothered him so much that he could not do anything."; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "pain in his arm"; VACCINATION SITE SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "swelling in the part of his arm were he received the vaccine"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "tiredness"; ASTHENIA (non-serious) with onset Oct2021, outcome "unknown", described as "weakness".  Additional information: Patient received the third dose of the Pfizers COVID-19 vaccine yesterday and presented the following side effects: pain in his arm, swelling in the part of his arm were he received the vaccine, tiredness and weakness. The side effects bothered him so much that he "could not do anything". Caller refused to make a report with DSU.  When he received the first two doses he did not experience any side effect. He also wants to know if he should wait for a couple of days before going to his physician. According to the CDC these side effects should go away on a few days. Referred to his physician for additional treatment recommendations.  Follow-up (21Oct2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: High blood pressure; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's 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: HYPERTENSION (non-serious) with onset 10Oct2021, outcome "unknown", described as "High blood pressure"; HEADACHE (non-serious) with onset 10Oct2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a 66 year-old female who received the booster dose of the Pfizer Covid-19 vaccine on 07Oct2021 and had complaints of headache and hypertension on 10 Oct 2021. states that her blood pressure reading was 130/84 and that the systolic number is usually 120 and the diastolic number usually runs lower. she got her booster shot last Thursday, and she started to experience a headache, and had high blood pressure by last Sunday. states she normally has high blood pressure which is controlled with medications, but as of Sunday night, she was experiencing a headache and high blood pressure. she does not specifically report her medication. Side effects that she experience throughout the rest of the body were first observed 1 to 2 days after vaccination and resolved shortly thereafter. Caller is asking if anyone else has reported hypertension after receiving the Pfizer Covid-19 vaccine?  Caller is asking if is common that a person doesn't get a side effect from the Pfizer Covid-19 vaccine until a few dose after the dose?  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia
Clinical narrative: Does not move as fast as she used to; 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 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: BRADYKINESIA (non-serious), outcome "unknown", described as "Does not move as fast as she used to".  Additional information: She stated she does not move as fast as she used to when going to get something to write with. The patient stated that she had not experienced any adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Hypoaesthesia, Investigation, Magnetic resonance imaging
Clinical narrative: felt like pins and needles and painful; felt like pins and needles and painful; numbness/Numbness on the left side of the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 16:30 (Lot number: EN6205) at the age of 29 years as dose 1, single and intramuscular, administered in arm left, administration date 22Mar2021 16:45 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL [FERROUS SULFATE;FOLIC ACID;ZINC]. The following information was reported: PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "felt like pins and needles and painful"; HYPOAESTHESIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "numbness/Numbness on the left side of the body". The events "felt like pins and needles and painful", "numbness/numbness on the left side of the body" and "felt like pins and needles and painful" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia. No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: felt like pins and needles and painful; felt like pins and needles and painful; numbness/Numbness on the left side of the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Mar2021 16:30 (Lot number: EN6205) at the age of 29 years as dose 1, single and intramuscular, administered in arm left, administration date 22Mar2021 16:45 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL [FERROUS SULFATE;FOLIC ACID;ZINC]. The following information was reported: PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 05Oct2021, outcome "not recovered" and all described as "felt like pins and needles and painful"; HYPOAESTHESIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "numbness/Numbness on the left side of the body". The events "felt like pins and needles and painful", "numbness/numbness on the left side of the body" and "felt like pins and needles and painful" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscles felt like they were on fire for the first three weeks/muscle burn; 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 22Apr2021 15:00 (Lot number: ER-8735) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL taken for prophylaxis, start date: 22Apr2021, stop date: 23Apr2021. Past drug history included: Tylenol, start date: 21Mar2021, stop date: 22Mar2021, notes: Reduce after effects. Vaccination history included: Bnt162b2 (Dose:1, Time: 13:00, Anatomical Site of injection: Left Arm, Route of administration: intramuscular, Batch/lot number: EN6203), administration date: 21Mar2021, for COVID-19 immunization, reaction(s): "heart beat sky rocketed", "had chest pains (1st two hours after the shot)", "pain in the shot site". The following information was reported: MYALGIA (non-serious) with onset 22Apr2021 17:00, outcome "not recovered", described as "muscles felt like they were on fire for the first three weeks/muscle burn". No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: redness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EM6205) at the age of 77 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 Number: 1, Batch/Lot No: EM9810), administration date: 04Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovered" (2021), described as "redness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient not affected with Covid prior vaccination and tested post vaccination.  No follow-up attempts are possible. No further information is expected.