chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Hepatic pain
Clinical narrative: Pain in liver area after each injection; I have cyst that is 5.7 cm in size and now is causing increased pain since getting injections; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Oct2021 (Lot number: 30155BA) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing); "seizure", start date: 1986 (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX. Past drug history included: Novocaine, reaction(s): "known allergies: Novocaine"; Lidocaine, reaction(s): "known allergies: Lidocaine"; Celebrex, reaction(s): "known allergies: celebrex". Vaccination history included: Bnt162b2 (dose 1, single, product= COVID 19, brand= Pfizer, lot number= EL1284, administration date= 06Jan2020,, vaccine location= Left arm), administration date: 06Jan2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (dose 2, single, product= COVID 19, brand= Pfizer, lot number= EL9261, administration date= 27Jan2021, vaccine location= Left arm), administration date: 27Jan2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: HEPATIC PAIN (non-serious) with onset 03Oct2021, outcome "recovered with sequelae", described as "Pain in liver area after each injection"; CYST (non-serious) with onset 03Oct2021, outcome "recovered with sequelae", described as "I have cyst that is 5.7 cm in size and now is causing increased pain since getting injections". Therapeutic measures were taken as a result of hepatic pain, cyst.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. Patient had not received any other vaccines within 4 weeks before COVID vaccine and patient was not diagnosed with COVID-19 prior or post vaccination. Pain in liver area after each injection. She had cyst that was 5.7 cm in size and now was causing increased pain since getting injections. She had thought it was an inflammatory response until she sought treatment for pain and weight loss. She was reporting as she did not correlate until after her most recent injection as her symptoms were resolved and within hours of injection pain resurfaced in liver area. The patient recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: Just arm color and sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 12:15 (Lot number: EW0185) at the age of 49 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 (Dose 2; Batch/Lot Number: Unknown; Location of injection: Arm Left), administration date: 20Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose 1; Batch/Lot Number: Unknown; Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "Just arm color and sleepy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of somnolence.  Additional information: The patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported just arm color (not specified) and sleepy. The patient had been tested for COVID-19 post vaccination he underwent Nasal swab (sample) test on 19Sep2021 with negative result.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Sensitive to the touch; Arm of injection was very sore days 2-4; vaccination site erythema; Injection site is red, warm, and swollen days 2-4, still a little red and swollen today, but improving; Injection site is red, warm, and swollen days 2-4, still a little red and swollen today, but improving; 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 (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 10:30 (Lot number: EW0217) at the age of 52 years as dose 3 (booster), single. for covid-19 immunisation; influenza vaccine (FLU), administration date 27Oct2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "Congestive heart failure" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "polyarthralgia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; PREGABALIN; TORSEMIDE; METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]; CYCLOBENZAPRINE; FELDENE; VITAMIN D2. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Right, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: SENSITIVE SKIN (non-serious) with onset 28Oct2021 12:00, outcome "recovered" (Oct2021), described as "Sensitive to the touch"; VACCINATION SITE PAIN (non-serious) with onset 28Oct2021 12:00, outcome "recovered" (Oct2021), described as "Arm of injection was very sore days 2-4"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Oct2021 12:00, outcome "recovered" (Oct2021), described as "vaccination site erythema"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 28Oct2021 12:00, outcome "recovered" (Oct2021) and all described as "Injection site is red, warm, and swollen days 2-4, still a little red and swollen today, but improving". Therapeutic measures were not taken as a result of sensitive skin, vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site swelling.  Additional Information: No other vaccine in four weeks. No Covid prior vaccination. Covid not tested post vaccination. No known Allergies.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Menstratution straight for 14 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (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: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 17Sep2021, outcome "unknown", described as "Menstratution straight for 14 days".  Additional information: This report was to capture information for reporter's friend. Caller mentioned that she had a friend that also had the same issue. She did not wish to complete a report for her. Reporter did not wish to provide her address, email, or date of birth. This report was not related to a study or programme. Reporter seriousness for Menstruation straight for 14 days was unspecified. Investigation Assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Nov2021): 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.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: body aches; nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male 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 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; NAUSEA (non-serious), outcome "recovered", described as "nausea".  Additional information: Symptoms began 6 hours after injection and lasted for 12 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Everybody I knew got tired from the Covid-19 vaccines. One friend received the Pfizer vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-158427 (regulatory authority).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Everybody I knew got tired from the Covid-19 vaccines. One friend received the Pfizer vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Full blood count normal, Metabolic function test, Pain in extremity, Platelet factor 4
Clinical narrative: tiredness(like previous 2 shots); soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jan2021 12:00 (Lot number: EI3248) as dose 1, single and intramuscular, administered in arm left, administration date 20Feb2021 12:00 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Celiac disease", start date: 1949 (ongoing), notes: On gluten free diet for many years; "GERD" (ongoing), notes: Had 2 endoscopies to dilate esophagus(past year); "Antiphospholipid syndrome" (ongoing), notes: Aspirin (Excedrine everyday 1/2-1 tablet), in my 40s; "SIBOS" (ongoing), notes: Onset date: discovered about 10 years ago; "DVT", start date: 29Sep2021 (ongoing); "prevent migraine and arrythmia" (unspecified if ongoing); "arrhythmia" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "prevent headache antiphospholipid syndrome" (unspecified if ongoing). Family history included: "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: INDERAL taken for migraine, arrhythmia (ongoing); EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE] taken for headache, antiphospholipid syndrome (ongoing); TUMS 500 CALCIUM taken for gastrooesophageal reflux disease (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness(like previous 2 shots)"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was not received any prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: tiredness(like previous 2 shots); soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jan2021 12:00 (Lot number: EI3248) as dose 1, single and intramuscular, administered in arm left, administration date 20Feb2021 12:00 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Celiac disease", start date: 1949 (ongoing), notes: On gluten free diet for many years; "GERD" (ongoing), notes: Had 2 endoscopies to dilate esophagus(past year); "Antiphospholipid syndrome" (ongoing), notes: Aspirin (Excedrine everyday 1/2-1 tablet), in my 40s; "SIBOS" (ongoing), notes: Onset date: discovered about 10 years ago; "DVT", start date: 29Sep2021 (ongoing); "prevent migraine and arrythmia" (unspecified if ongoing); "arrhythmia" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "prevent headache antiphospholipid syndrome" (unspecified if ongoing). Family history included: "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: INDERAL taken for migraine, arrhythmia (ongoing); EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE] taken for headache, antiphospholipid syndrome (ongoing); TUMS 500 CALCIUM taken for gastrooesophageal reflux disease (ongoing). The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness(like previous 2 shots)"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was not received any prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: felt fatigued; nauseous; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (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, (She didn't feel well after her second, dose either but only for 1 day).), for Covid-19 immunization, reaction(s): "Did not feel well". The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovering", described as "felt fatigued"; NAUSEA (non-serious) with onset Oct2021, outcome "recovering", described as "nauseous"; HEADACHE (non-serious) with onset Oct2021, outcome "recovering", described as "headache".  Additional information: Clinical course: About 12 hours post injection, age felt fatigued, nauseous and had a headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was mildly sore ( less than shots 1 & 2); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 12:00 (Lot number: EW0172) at the age of 64 years as dose 2, single and administered in arm left, administration date 05Apr2021 12:30 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was mildly sore ( less than shots 1 & 2)".  Additional information: No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination nor tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Pain in extremity, Vaccination site pain
Clinical narrative: I got pains from shoulder to shoulder; After booster, arm was mildly sore ( less than shots 1 & 2).; injection site began to hurt more; injection site began to hurt more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 15:15 (Lot number: FG3527) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, COVID 19 Pfizer Dose,, lot number=ER8734,, administration date=05Apr2021,, administration time=12:30, location=Left arm), administration date: 05Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2, COVID 19, Pfizer,, lot number=EW0172,, administration date=26Apr2021,, administration time=12:00, location=Left arm), administration date: 26Apr2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 31Oct2021 15:00, outcome "not recovered", described as "I got pains from shoulder to shoulder"; PAIN IN EXTREMITY (non-serious) with onset 31Oct2021 15:00, outcome "not recovered", described as "After booster, arm was mildly sore ( less than shots 1 & 2)."; VACCINATION SITE PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 31Oct2021 15:00, outcome "not recovered" and all described as "injection site began to hurt more". Therapeutic measures were not taken as a result of arthralgia, pain in extremity, vaccination site pain, condition aggravated.  Additional Information:The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. No treatment was received for adverse events. The patient had no COVID-19 prior to vaccination and post the vaccination was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling in lymph nodes; Both locations are tender and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 13:30 (Lot number: FF2890) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Bees" (unspecified if ongoing); "known allergies: Strawberries" (unspecified if ongoing); "known allergies: Onion" (unspecified if ongoing); "known allergies: Garlic" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; CALCIUM; CRANBERRY; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 16Mar2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 05:45 PM), administration date: 08Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Swelling in lymph nodes"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Both locations are tender and sore". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: Swelling in lymph nodes around left collarbone and in left armpit. Both locations are tender and sore. The vaccine was administered at public health clinic/veterans administration facility. 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: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphoedema
Clinical narrative: I have swollen lymph nodes that have turned in the what seems like lymph edema that is under the arm and then to the left breast.; I have swollen lymph nodes that have turned in the what seems like lymph edema that is under the arm and then to the left breast.; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 15:00 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing); The patient's concomitant medications were not reported. Vaccination history included: Moderna, for Covid-19 Immunization; Flu shot, for Immunization.The following information was reported: LYMPHADENOPATHY (non-serious), LYMPHOEDEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "I have swollen lymph nodes that have turned in the what seems like lymph edema that is under the arm and then to the left breast.". Therapeutic measures were taken as a result of lymphadenopathy, lymphoedema.  Additional information: Patient received the Pfizer booster on Saturday have to give a little bit of history I am a breast cancer survivor (History) so put it in the arm that was not affected in the left arm. also received the flu shot (Unknown when was consumer received the shot hence captured as Unspecified flu shot conservatively) and patient had Moderna prior (Not Clarified hence captured as unspecified Product), swollen lymph nodes that have turned in the what seems like lymph edema that is under the arm and then to the left breast want to find out if this is, something that you heard reported before. Patient took its naproxen sodium as treatment.   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: Arthralgia, Axillary pain, Breast pain, Breast swelling, Fatigue
Clinical narrative: tiredness; left axillary pain; lymphadenopathy and swelling; left arm pain; left breast pain and swelling; left breast pain and swelling; Joint pain; body aches; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 13:30 (Lot number: 301358A) at the age of 66 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 Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 66 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "tiredness"; AXILLARY PAIN (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "left axillary pain"; LYMPHADENOPATHY (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "lymphadenopathy and swelling"; PAIN IN EXTREMITY (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "left arm pain"; BREAST PAIN (non-serious), BREAST SWELLING (non-serious) all with onset 09Oct2021 01:00, outcome "recovered" (Oct2021) and all described as "left breast pain and swelling"; ARTHRALGIA (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "Joint pain"; PAIN (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "body aches"; HEADACHE (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "headaches". The events "tiredness", "left axillary pain", "lymphadenopathy and swelling", "left arm pain", "left breast pain and swelling", "left breast pain and swelling", "joint pain", "body aches" and "headaches" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, axillary pain, lymphadenopathy, pain in extremity, breast pain, breast swelling, arthralgia, pain, headache.  Additional information: Other medications in two weeks: yes.  No follow-up attempts are possible. No further information was expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: tiredness; left axillary pain; lymphadenopathy and swelling; left arm pain; left breast pain and swelling; left breast pain and swelling; Joint pain; body aches; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 13:30 (Lot number: 301358A) at the age of 66 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 Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 66 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 06Mar2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "tiredness"; AXILLARY PAIN (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "left axillary pain"; LYMPHADENOPATHY (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "lymphadenopathy and swelling"; PAIN IN EXTREMITY (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "left arm pain"; BREAST PAIN (non-serious), BREAST SWELLING (non-serious) all with onset 09Oct2021 01:00, outcome "recovered" (Oct2021) and all described as "left breast pain and swelling"; ARTHRALGIA (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "Joint pain"; PAIN (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "body aches"; HEADACHE (non-serious) with onset 09Oct2021 01:00, outcome "recovered" (Oct2021), described as "headaches". The events "tiredness", "left axillary pain", "lymphadenopathy and swelling", "left arm pain", "left breast pain and swelling", "left breast pain and swelling", "joint pain", "body aches" and "headaches" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, axillary pain, lymphadenopathy, pain in extremity, breast pain, breast swelling, arthralgia, pain, headache.  Additional information: Other medications in two weeks: yes.  No follow-up attempts are possible. No further information was expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: 2 and half inches and jabbed her, 2 to 3 inches away and just poked it into her arm and it hurt; injection hurt; shot jabbed her into her arm from 3 inches away; it hurt immediately and this thing was my arm hurt real bad;  it''s red and it''s warm; hurts me as soon as she gave it; still painful; I had just stay in bed for first two days because of the pain; it''s red all around and it''s swollen and it''s warm; she''s got a round circle around the injection site, 3 and 4 inches around; warm and it''s red; it was sored as soon as she administered the injection; she''s got a round circle around the injection site, 3 and 4 inches around; warm and it''s red; it was sored as soon as she administered the injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Lot number: 30145BA) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: she is suffering from asthma, moderate asthma with no general lungs. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01, My first and second one was done at another center and I felt muscle pain), for Covid-19 Immunization, reaction(s): "I felt muscle pain"; Bnt162b2 (Dose Number:02, My first and second one was done at another center and I felt muscle pain), for Covid-19 Immunization, reaction(s): "I felt muscle pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Oct2021, outcome "unknown" and all described as "she''s got a round circle around the injection site, 3 and 4 inches around; warm and it''s red; it was sored as soon as she administered the injection"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2021, outcome "not recovered", described as "2 and half inches and jabbed her, 2 to 3 inches away and just poked it into her arm and it hurt; injection hurt; shot jabbed her into her arm from 3 inches away"; PAIN (non-serious) with onset 26Oct2021, outcome "not recovered", described as "it hurt immediately and this thing was my arm hurt real bad;  it''s red and it''s warm; hurts me as soon as she gave it; still painful; I had just stay in bed for first two days because of the pain"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "it''s red all around and it''s swollen and it''s warm". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain, vaccination site warmth, pain, peripheral swelling.  Follow-Up (04Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Illness
Clinical narrative: dizziness; feeling lousy; flu-like symptoms; Is pretty sick; he has felt ill with muscle aches; nausea; weakness; fatigue; 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN9581) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Disease", start date: 2002 (ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 2021. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3249), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "feeling lousy"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "Is pretty sick"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "he has felt ill with muscle aches"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue". The events "dizziness", "feeling lousy", "flu-like symptoms", "is pretty sick", "he has felt ill with muscle aches", "nausea", "weakness" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient not visited emergency room.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: dizziness; feeling lousy; flu-like symptoms; Is pretty sick; he has felt ill with muscle aches; nausea; weakness; fatigue; 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN9581) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Disease", start date: 2002 (ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 2021. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL3249), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "feeling lousy"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "Is pretty sick"; MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "he has felt ill with muscle aches"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue". The events "dizziness", "feeling lousy", "flu-like symptoms", "is pretty sick", "he has felt ill with muscle aches", "nausea", "weakness" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient not visited emergency room.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Swollen underarm area; Fever; soreness at injection site; 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 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Swollen underarm area"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness at injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tenderness, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness was reported as worsened.; itchiness/ the injection site has become itchy; Redness/ the injection site has become red; Swollen/ the injection site has become swollen; Tender to touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 13:00 (Lot number: FF2593) at the age of 68 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 (Dose:2, Date: 29Mar2021, LOT: EPG955 , administered in left arm), administration date: 29Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose:1, Date: 08Mar2021, LOT: EN6199, Expiration date: unknown, administered in left arm), administration date: 08Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 31Oct2021, outcome "not recovered", described as "itchiness/ the injection site has become itchy"; TENDERNESS (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Tender to touch"; VACCINATION SITE ERYTHEMA (non-serious) with onset 31Oct2021, outcome "not recovered", described as "Redness/ the injection site has become red"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Redness was reported as worsened."; VACCINATION SITE SWELLING (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Swollen/ the injection site has become swollen". Therapeutic measures were taken as a result of vaccination site pruritus, tenderness, vaccination site erythema, condition aggravated.  Additional information: No other products. No investigation assessment. She had at the injection site has become swollen, red, and itchy. The itchiness started yesterday. She added, the area was tender to touch. Tender to touch started soon as got injection, which was Wednesday 27Oct2021. Treatment was given as just apply ice on 27Oct2021. Additional vaccines administered on same date of the Pfizer Suspect was none. No emergency room, Physician Office visit. Prior Vaccinations (within 4 weeks) was None. Relevant Tests was None.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash from base of chin down her chest to below her breasts, nipples itch; 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), administration date 12Oct2021 (Batch/Lot number: unknown) as dose 3 (booster dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose-2), administration date: Jan2021, for Covid 19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash from base of chin down her chest to below her breasts, nipples itch". Therapeutic measures were taken as a result of rash. Additional Information: Patient had the Covid vaccines in Jan2021, and she just got the COVID booster shot on 12Oct2021, several days later she broke out in a rash, just put lotion on it, rash starts at base of her chin, goes down past her breasts, her nipples itch, states she is putting hand lotion to get some relief.   Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Polymenorrhoea, SARS-CoV-2 test, Weight, Weight increased
Clinical narrative: Very irregular menstrual cycle for about 6 months or so; Cycle is every other week, sometimes shorter between times; Weight gain of almost 20 pounds during this time as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Feb2021 (Lot number: EN9581) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: CELEXA [CELECOXIB]; ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer EN5318, Location of injection: Arm Left), administration date: 26Jan2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Very irregular menstrual cycle for about 6 months or so"; POLYMENORRHOEA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Cycle is every other week, sometimes shorter between times"; WEIGHT INCREASED (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Weight gain of almost 20 pounds during this time as well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular, polymenorrhoea, weight increased.  Additional information :Patient did not receive other vaccine in four weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Fatigue, Pain, Pruritus
Clinical narrative: fatigue intensified; I began having body aches; incessant itching on the right side of my body (head to toe); The most intense itching was at the injection site; Itching/hives spread to left side of face, arm and torso; I felt sudden extreme fatigue; mild chest pains; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Oct2021 10:30 (Lot number: FH8028) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "HSV2" (unspecified if ongoing), notes: other medical history: hypertension, HSV2, seasonal allergies/hayfever, lichen planus; "seasonal allergies" (unspecified if ongoing), notes: other medical history: hypertension, HSV2, seasonal allergies/hayfever, lichen planus; "Hay fever" (unspecified if ongoing); "lichen planus" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA 24 HOUR; FLONASE [FLUTICASONE PROPIONATE]; VALTREX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 23Feb2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 02Feb2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Oct2021 13:30, outcome "not recovered", described as "I felt sudden extreme fatigue"; CHEST PAIN (non-serious) with onset 28Oct2021 13:30, outcome "not recovered", described as "mild chest pains"; CONDITION AGGRAVATED (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "fatigue intensified"; PAIN (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "I began having body aches"; PRURITUS (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "incessant itching on the right side of my body (head to toe)"; VACCINATION SITE IRRITATION (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "The most intense itching was at the injection site"; URTICARIA (non-serious) with onset 28Oct2021 16:30, outcome "not recovered", described as "Itching/hives spread to left side of face, arm and torso". Therapeutic measures were not taken as a result of fatigue, chest pain, condition aggravated, pain, pruritus, vaccination site irritation, urticaria.  Follow-Up (04Nov2021): Follow-up attempts are completed. No further information is expected.