chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Pain
Clinical narrative: Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.; Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.; Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Apr2021 11:45 (Lot number: ER8734) at the age of 47 years as dose 2, single and intramuscular, administered in arm left, administration date 19Mar2021 11:30 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s thyroiditis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "acetabular labral tears" (unspecified if ongoing); "uterine fibroids" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "ovarian cyst" (unspecified if ongoing); "exercise-induced reactive airway" (unspecified if ongoing); "hx of MVA/concussion" (unspecified if ongoing), notes: Other medical history: hx of MVA/concussion; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "IV CT contrast" (unspecified if ongoing), notes: Known allergies: IV CT contrast; "Latex" (unspecified if ongoing), notes: Known allergies: Latex; "Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives; "Cocoa butter" (unspecified if ongoing), notes: Known allergies: Cocoa butter. Concomitant medication(s) included: SYNTHROID; FAMOTIDINE; FISH OIL; VITAMIN D3. Past drug history included: Sporanox, reaction(s): "Known allergies"; Celebrex, reaction(s): "Known allergies"; Macrobid, reaction(s): "Known allergies".  The following information was reported: AXILLARY PAIN (non-serious), PAIN (non-serious), CONTUSION (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.". Therapeutic measures were not taken as a result of axillary pain, pain, contusion.  Additional information: The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Joint swelling, Myalgia, Peripheral swelling
Clinical narrative: hands were swollen/legs swollen/arms swollen; she cannot walk/could not walk; is in bed; super strong muscle pain so strong/muscle pain all over her body; her knee was swollen; 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 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X MANUFACTUERER UNKNOWN (where X=Unknown number)), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Jan2022, outcome "unknown", described as "hands were swollen/legs swollen/arms swollen"; JOINT SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "her knee was swollen"; GAIT DISTURBANCE (non-serious) with onset 13Jan2022, outcome "unknown", described as "she cannot walk/could not walk"; BEDRIDDEN (non-serious) with onset 13Jan2022, outcome "unknown", described as "is in bed"; MYALGIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "super strong muscle pain so strong/muscle pain all over her body".  Additional information: It was reported that she received her booster on Tuesday this week. She states that two days ago she felt like her hands were swollen but the next day her knee was swollen, and she has super strong muscle pain so strong she cannot walk and is in bed at a hotel. She was asking what she can do. The report not related to a study or programme. She wanted to know if okay or normal. Stated that it was because of the vaccine. Stated that she was 17.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was punched/arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER2613) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis", start date: Aug2004 (ongoing). The patient took concomitant medications. Vaccination history included: Hepatitis b vaccine, for Immunization, reaction(s): "Multiple Sclerosis"; Hepatitis b vaccine, administration date: Mar2003, when the patient was 40 years old, for Immunization, reaction(s): "neck and back swollen, extreme swelling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was punched/arm is sore". Additional Information: Caller states his arm is sore, like his arm was punched, and he felt this with the first Covid vaccine as well. Caller states he had an adverse event to a Hepatitis B vaccine years ago, and that caused Multiple Sclerosis. Multiple Sclerosis took 9 months to diagnose. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Eye aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jan2022 17:00 (Lot number: 3303680) at the age of 57 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. Past drug history included: Penicillin, notes: known allergies: penicillin. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose Number: 2), administration date: 31Mar2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (MANUFACTURER UNKNOWN, Dose Number: 1), administration date: Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "Headache"; EYE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Eye aches". The events "headache" and "eye aches" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eye pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19. The patient received eye drops as treatment for the event. Adverse event required a visit to Emergency Room/Physician Office.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (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: Covid-19 vaccine (Prev dose product=COVID 19,, Prev dose brand=True, Prev dose brand name unknown= COVID19 Vaccine,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose dose number= 2), for COVID-19 Immunization; Covid-19 vaccine (Prev dose product=COVID 19,, Prev dose brand=True, Prev dose brand name unknown= COVID19 Vaccine,, Prev dose lot unknown=True,, Prev dose lot unknown reason=Unable to locate or read the details, Prev dose dose number= 1), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report received from a noncontactable reporter other HCP. A 54-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD7218), at the age of 54, on Jan 12, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed pyrexia/fever, and nausea, onset Jan 2022, with outcome of unknown. Additional information: The case received via the regulatory authority reported as non-serious: no results in death, not life-threatening, no caused/prolonged hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: SARS-COV-2 test positive; co-administration flu and 3rd dose; co-administration flu and 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 16Nov2021 (Lot number: FG3527) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in arm, administration date 16Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Site and route of injection: , Anatomical site if injection: IM(Arm), Route of administration: Intramuscular, Batch/Lot number: # EP6955, Exp 30Jun2021), administration date: 11Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 02, Site and route of injection: , Anatomical site if injection: IM(Arm), Route of administration: Intramuscular, Batch/Lot number: # EP6955,Exp 30Jun2021), administration date: 07Apr2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "co-administration flu and 3rd dose"; COVID-19 (non-serious) with onset 20Dec2021, outcome "recovered", described as "SARS-COV-2 test positive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19.  Additional information: Prior vaccinations included Flu vaccine. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. No symptoms, but result was positive.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Painful swelling of lymph nodes under arm & into breast tissue; Dizziness; Light-headedness when standing; Booster; Pain at injection site; Painful swelling of lymph nodes under arm & into breast tissue; 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), intramuscular, administered in deltoid left, administration date 12Jan2022 16:30 (Lot number: FL3209) at the age of 46 years as dose numner unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer- Unknown, Dose number unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022 16:30, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "Pain at injection site"; LYMPHADENOPATHY (non-serious) with onset 20Jan2022, outcome "recovered" (24Jan2022), LYMPH NODE PAIN (non-serious) with onset Jan2022, outcome "recovered" (24Jan2022) and all described as "Painful swelling of lymph nodes under arm & into breast tissue"; DIZZINESS (non-serious) with onset 14Jan2022, outcome "recovered" (15Jan2022), described as "Dizziness"; DIZZINESS (non-serious) with onset 14Jan2022, outcome "unknown", described as "Light-headedness when standing". Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain. Therapeutic measures were not taken as a result of dizziness.    Follow-Up (25Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Headache
Clinical narrative: headache; sore armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 13 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, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; AXILLARY PAIN (non-serious), outcome "unknown", described as "sore armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single and administered in arm left, administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Food allergies", start date: 2012 (unspecified if ongoing), notes: She has minor food allergies diagnosed 10 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "unknown", described as "Sore left arm".  Additional information: Patient has minor food allergies diagnosed 10 years ago and follows a special diet. No prior Vaccinations within 4 weeks of Covid-19 vaccination. No Relevant Family Medical History. Reporter stated that she had no problem at all with first two doses, other than little soreness in left arm. No vaccinations were taken by her since she was a kid. It is assumed by her that everyone does have arm soreness. Patient stated she had her stay for 15 minutes and arm soreness started right away on the same day. Patient had sore arms with the first two, it was no biggie and it was in the left arm. She said it kind of matters that she did everything together with husband and she had no significant things. She did have a strange event. No Relevant Tests. Patient had no Emergency Room or Physician Office visit. Patient stated she just felt Pfizer should know there are people that are experiencing side effects. It is not mentioned and it may have changed their mind about it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Tinnitus
Clinical narrative: tinnitus after second dose that became worse after booster dose; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 13Jan2022 (Lot number: FJ3586) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing), notes: diagnosed about 10 years ago. Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Lot: EK9231, Expiration: unknown), administration date: 07Jan2021, when the patient was 53 years old, for Covid-19 Immunization; Bnt162b2 (DOSE: 2, Lot: EL3249, Expiration: unknown), administration date: 28Jan2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "Tinnitus", "like the ringing is causing pain"; Bnt162b2 (DOSE: 2, Lot: EL3249, Expiration: unknown), administration date: 28Jan2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "she could not sleep". The following information was reported: TINNITUS (non-serious) with onset 13Jan2022, outcome "not recovered", described as "tinnitus after second dose that became worse after booster dose". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional information: The tinnitus was ten times worse within a day of getting the booster. She can still hear the ringing even if she has the TV on. She could not sleep since it was so loud. She sat on the couch till 23:30 and then finally went to bed since she was so tired. She gets up super early. It is super loud today, she has to get the ball in motion. The patient did not receive any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling, soreness and redness at the site of injection; swelling, soreness and redness at the site of injection; swelling, soreness and redness at the site of injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 14Jan2022 15:00 (Lot number: FL 3197) 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, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 15Jan2022, outcome "unknown" and all described as "swelling, soreness and redness at the site of injection".  Additional information: 35 year old female patient received booster Pfizer-BioNTech Covid-19 vaccine around 3pm Friday 14Jan. The day after she experienced swelling, soreness and redness at the site of injection. No fever and site was not warm to the touch. Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: Sore arm; got my Pfizer booster shot; This 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), administration date 14Jan2022 17:00 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022 17:00, outcome "unknown", described as "got my Pfizer booster shot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Investigation, Pain, Weight
Clinical narrative: I have like the normal pain and stuff; I notice that my heart rate continues to rise like right now I am just sitting on the couch and its 111; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Jan2022 11:00 (Lot number: FL3198, Expiration Date: 30Jun2022) at the age of 58 years as dose 3, (booster dose), single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Verbatim: Hypothyroid; "High blood pressure" (ongoing), notes: Verbatim: High blood pressure; "Barrett's oesophagus" (unspecified if ongoing), notes: Verbatim: Barrett''s esophagus. Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism; ZOLOFT; PANTOPRAZOLE; LISINOPRIL taken for hypertension; VITAMIN D NOS. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "I have like the normal pain and stuff"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "I notice that my heart rate continues to rise like right now I am just sitting on the couch and its 111". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, heart rate increased.  Additional information: Patient taking things like Vitamin D and Multivitamin but no other medicine. On last Monday they draw blood to test pancreas.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lymph nodes was swollen; The whole side of the body hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph nodes was swollen"; PAIN (non-serious), outcome "unknown", described as "The whole side of the body hurt".  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: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pain in extremity
Clinical narrative: I was cold and having chills; I was cold and having chills; My arm was hurting real bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (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, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 15Jan2022 02:00, outcome "unknown" and all described as "I was cold and having chills"; PAIN IN EXTREMITY (non-serious) with onset 15Jan2022 02:00, outcome "unknown", described as "My arm was hurting real bad". Therapeutic measures were taken as a result of chills, nasopharyngitis, pain in extremity.  Additional information: Patient started taking Tylenol because he talked to her daughter and she told him to take Tylenol every four hours.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: armpits start hurting; body ache; swollen right arm and it is tender; I do not know if it is my lymph node; swollen right arm and it is tender; I do not know if it is my lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FJ6369) 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 (1ST DOSE, Lot number: EW0176 (first shot).), for covid-19 immunization; Bnt162b2 (2ND DOSE), for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 16Jan2022, outcome "unknown", described as "armpits start hurting"; PAIN (non-serious) with onset 16Jan2022, outcome "unknown", described as "body ache"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Jan2022, outcome "unknown" and all described as "swollen right arm and it is tender; I do not know if it is my lymph node". Therapeutic measures were taken as a result of axillary pain, pain, peripheral swelling, pain in extremity.  Additional information: Drug Code number, Product Code number and expiry date of COVID-19 vaccine was unknown. No any other product. Patient had no history. She got the booster pfizer shot on Saturday morning (not clarified further hence, not captured in tab) morning. She felt fine and then the next day Sunday, she felt okay, she did not had you know not a lot of body ache but last night she mean yeah, last night Sunday she noticed, actually afternoon, she noticed that her armpits start hurting. she looked at it and it is swollen right arm and it is tender. So, she was  thinking, she don't know if it is her lymph nodes. So, she want to know if that is like a side effect of that but it is like it is tender and then it is swollen. She dont know lot number of second shot. No nay other medical conditions. Lab tests reported as no. The birth control reported as no. Treatment received for event she just took Ibuprofen and Tylenol. Sunday she took 650 milligrams twice and then Ibuprofen she did not take Ibuprofen until like Monday morning or night, fell like it, sick, really swollen arm, Ibuprofen 600 milligrams.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt; 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 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 (First Dose), for Covid-19 Immunization, reaction(s): "felt "under the weather"". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "her arm hurt".  Additional information:  Reporter mentioned as well that they took 2 Covid19 tests and the result was negative. She asks if it's okay for her to take a booster shot since she got exposed to her husband.  She stated that she had no symptoms but did not get tested. How long after him testing positive should she wait to get a booster dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in my ears, tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 10:30 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "other medical history: AFIB" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; XARELTO. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EN6204, Prev dose lot unknown=False, Prev dose administration date=12Mar2021, Prev dose administration time=04:00PM, Prev dose dose number=2,, Prev dose vaccine location=Left arm), administration date: 12Mar2021, when the patient was 68 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=FJ1611,, Prev dose lot unknown=False,, Prev dose administration date=19Feb2021, Prev dose administration time=04:00PM,  Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 19Feb2021, when the patient was 68 years old, for COVID-19 immunization.  The following information was reported: TINNITUS (non-serious) with onset 02Jan2022 12:00, outcome "not recovered", described as "ringing in my ears, tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Additional information: If COVID prior vaccination: No. If COVID tested post vaccination: No  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Diarrhoea, Erythema, Headache
Clinical narrative: Diarrhea; Erythema; Cephalea; Arthritis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 17Jan2022 19:15 (Lot number: FE3594) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1 manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 manufacturer unknown), for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; ERYTHEMA (non-serious), outcome "unknown", described as "Erythema"; HEADACHE (non-serious), outcome "unknown", described as "Cephalea"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis". Therapeutic measures were not taken as a result of diarrhoea, erythema, headache, arthritis. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: got bruising on the injection site after the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE BRUISING (non-serious), outcome "unknown", described as "got bruising on the injection site after the booster dose".  Additional information: The reporter had a general concern with the booster shot. He mentioned with any other vaccination in his life, this was the first time he had witnessed slight bruising on the arm. He wanted to understand why this had occurs with the covid vaccine. Why was the booster causing bruising on arms. He also added, he did research and saw some have and refer to it as covid arm.   Follow-up(18Jan2022): This is a follow-up spontaneous report from a Pfizer-sponsored program.  Updated information included no new safety information.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Platelet count decreased
Clinical narrative: His platelets had dropped to slightly below normal range; 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 (002191). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: Caller has had cancer in the past and finished his chemotherapy regimen approximately 18 months ago.; "Chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 2), administration date: 27May2021, for COVID-19 immunization; Bnt162b2 (dose 1), for COVID-19 immunization.  The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "His platelets had dropped to slightly below normal range". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Five days after receiving his booster dose, he had blood work done and he noted that his platelets had dropped to slightly below normal range. He would like to find out if his decreased platelet value could be attributable to the Pfizer booster vaccine that he recently received.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Weight
Clinical narrative: numbness in my arm; chest feels tight; pretty heavily swollen lymph nodes in my armpit left arm pit same side as injected in; they were tender; woke up in pool of sweat; headache; aches; 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 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 13Jan2022 (Lot number: FJ5683) at the age of 34 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "aches"; HEADACHE (non-serious) with onset 13Jan2022, outcome "unknown", described as "headache"; HYPOAESTHESIA (non-serious) with onset 16Jan2022, outcome "recovering", described as "numbness in my arm"; CHEST DISCOMFORT (non-serious) with onset 16Jan2022, outcome "not recovered", described as "chest feels tight"; HYPERHIDROSIS (non-serious) with onset 13Jan2022, outcome "unknown", described as "woke up in pool of sweat"; LYMPHADENOPATHY (non-serious) with onset 15Jan2022, outcome "recovering", described as "pretty heavily swollen lymph nodes in my armpit left arm pit same side as injected in; they were tender". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, headache, hypoaesthesia, chest discomfort, hyperhidrosis, lymphadenopathy.  Additional Information: He got his booster of the Pfizer covid 19 vaccines, last Thursday and had typical side effects. He had aches, headache, woke up in pool of sweat, the following night on Friday night. On Saturday, woke up with some pretty heavily swollen lymph nodes in armpit left arm pit same side as injected in. They were tender, and then the next day Sunday, he woke up with a little bit of numbness in his arm, same left arm, felt as if when you get your BP taken with blood cuff, it restricts the blood flow, it felt like that. Patient reported arm was a little numb kind of felt like when one gets blood like they put the arm cup on to take your blood pressure, it felt like the blood has been strain of it. This could be related or unrelated, his chest feels tight started, Sunday, Monday, and Tuesday. Lymph nodes not as bad, the numbness he was feel it a little bit, not as noticeable today, but still having the chest tightness. He had read about a lot of the side effects, but he didn't see anything about numbness in arm, some site said it could be an allergic reaction to talk to doctor about. The time of the vaccination was reported as probably noon. No prior vaccination (within 4 weeks). He was not taking other medication.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Muscle spasms, Myalgia, SARS-CoV-2 test
Clinical narrative: Severe muscle pain in both legs; Thighs feel heavy; fatigued; tender to the touch; deep muscle pain and cramps; This is a spontaneous report received from 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 22Sep2021 16:45 (Lot number: FF2590) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN9581, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 12Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 22Jan2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "Severe muscle pain in both legs"; LIMB DISCOMFORT (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "Thighs feel heavy"; FATIGUE (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "fatigued"; TENDERNESS (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "tender to the touch"; MUSCLE SPASMS (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "deep muscle pain and cramps". The events "severe muscle pain in both legs", "thighs feel heavy", "fatigued", "tender to the touch" and "deep muscle pain and cramps" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of myalgia, limb discomfort, fatigue, tenderness, muscle spasms.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Severe muscle pain in both legs. Thighs feel heavy, fatigued, tender to the touch, deep muscle pain and cramps. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient has no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Severe muscle pain in both legs; Thighs feel heavy; fatigued; tender to the touch; deep muscle pain and cramps; This is a spontaneous report received from 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 22Sep2021 16:45 (Lot number: FF2590) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN9581, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 12Feb2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 22Jan2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "Severe muscle pain in both legs"; LIMB DISCOMFORT (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "Thighs feel heavy"; FATIGUE (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "fatigued"; TENDERNESS (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "tender to the touch"; MUSCLE SPASMS (non-serious) with onset 01Nov2021 02:00, outcome "not recovered", described as "deep muscle pain and cramps". The events "severe muscle pain in both legs", "thighs feel heavy", "fatigued", "tender to the touch" and "deep muscle pain and cramps" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of myalgia, limb discomfort, fatigue, tenderness, muscle spasms.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Severe muscle pain in both legs. Thighs feel heavy, fatigued, tender to the touch, deep muscle pain and cramps. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient has no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives type rash on face, lips, neck, chest, forearms, under arms, left side of stomach, left outside thigh, and bottom front right leg.; hives type rash on face, lips, neck, chest, forearms, under arms, left side of stomach, left outside thigh, and bottom front right leg.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Lot number: 330308D) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Vitamin D Deficiency" (unspecified if ongoing). Concomitant medication(s) included: PROLIA, administration date 17Nov2021. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer, previous dose brand unknown=False, previous dose lot number=EN6202, previous dose lot unknown=False, previous dose administration date=01Mar2021 , previous dose dose number=2, previous dose vaccine location=Left arm), administration date: 01Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=EL8982, Previous dose lot unknown=False, previous dose administration date=08Feb2021, previous dose dose number=1, previous dose vaccine location=Left leg), administration date: 08Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), RASH (non-serious) all with onset 30Nov2021, outcome "not recovered" and all described as "hives type rash on face, lips, neck, chest, forearms, under arms, left side of stomach, left outside thigh, and bottom front right leg.". The event "hives type rash on face, lips, neck, chest, forearms, under arms, left side of stomach, left outside thigh, and bottom front right leg." and "hives type rash on face, lips, neck, chest, forearms, under arms, left side of stomach, left outside thigh, and bottom front right leg." was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, rash.  Additional information:The patient took other vaccine in fourweeks and other medications in twoweeks and known allergies :Yes and the patient was not tested positive for COVID-19 before and after the vaccination.  Follow-up attempts are completed. No further information is expected.