chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Folliculitis, Headache, Hot flush, Malaise
Clinical narrative: not feeling well with diarrhea; not feeling well with diarrhea; nausea; hot/cold flashes (was unable to take temperature); hair follicles to be achy; severe migraine; mentioned a slight sore throat that lasted a few hours; By Sunday 8:30pm started feeling better with just a small headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This 44-year-old Female consumer reported for herself that: A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Friday 26Mar2021 (age at vaccination 44-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 28Mar2021 after the second dose of vaccination, the patient experienced not feeling well with diarrhea, nausea, hot/cold flashes (was unable to take temperature), hair follicles to be achy, severe migraine, mentioned a slight sore throat that lasted a few hours and by Sunday 8:30pm started feeling better with just a small headache. It was reported that, the patient on Sunday 28Mar2021 was woken up early 5ish am not feeling well with diarrhea. Started experiencing nausea, hot/cold flashes (was unable to take temperature) and described hair follicles to be achy. Started to experience severe migraine. The migraine escalated hour later and described it almost as unbearable at one point. Also, mentioned a slight sore throat that lasted a few hours. By Sunday 8:30pm started feeling better with just a small headache. Patient mentioned the only medication she taken for her migraines. Her Dr. prescribed a few migraine medications as it's ongoing problem. She also mentioned that she did not have a reaction to the first dose of Pfizer covid vaccine. Patient indicated she was taking many migraine medication. Only meds she taken. Her migraines was easily triggered by stress. Event took place after use of product. The outcome of event headache was reported unknown, while outcome other events was recovering at the time of last observation.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Oropharyngeal pain
Clinical narrative: not feeling well with diarrhea; not feeling well with diarrhea; nausea; hot/cold flashes (was unable to take temperature); hair follicles to be achy; severe migraine; mentioned a slight sore throat that lasted a few hours; By Sunday 8:30pm started feeling better with just a small headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This 44-year-old Female consumer reported for herself that: A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Friday 26Mar2021 (age at vaccination 44-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 28Mar2021 after the second dose of vaccination, the patient experienced not feeling well with diarrhea, nausea, hot/cold flashes (was unable to take temperature), hair follicles to be achy, severe migraine, mentioned a slight sore throat that lasted a few hours and by Sunday 8:30pm started feeling better with just a small headache. It was reported that, the patient on Sunday 28Mar2021 was woken up early 5ish am not feeling well with diarrhea. Started experiencing nausea, hot/cold flashes (was unable to take temperature) and described hair follicles to be achy. Started to experience severe migraine. The migraine escalated hour later and described it almost as unbearable at one point. Also, mentioned a slight sore throat that lasted a few hours. By Sunday 8:30pm started feeling better with just a small headache. Patient mentioned the only medication she taken for her migraines. Her Dr. prescribed a few migraine medications as it's ongoing problem. She also mentioned that she did not have a reaction to the first dose of Pfizer covid vaccine. Patient indicated she was taking many migraine medication. Only meds she taken. Her migraines was easily triggered by stress. Event took place after use of product. The outcome of event headache was reported unknown, while outcome other events was recovering at the time of last observation.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose; it was a muscle and joint pain and it was the same type of pain she experienced with the 1st dose; This is a spontaneous report from a contactable consumer (patient) via  Regulatory Authority. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration, in left arm on 02Mar2021 17:00 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was reported as none. The patient experienced muscle and joint pain after the first dose in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Oropharyngeal pain
Clinical narrative: sore scratchy throat; slight cough; it feels like he has a cold; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date in 2021 the patient experienced sore scratchy throat, slight cough, it feels like he has a cold. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: reports the arm she received her shot in is always sore; Arthritic like pain; This is a spontaneous report from a non-contactable consumer or other non hcp (reporter husband's grandmother). This consumer reported for 94-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 2, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that the arm she received her shot in is always sore, arthritic like pain that wasn't present before shot and not subside now 1 month post 2 doses. Event took place after use of product. The outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection via an unspecified route of administration on 28Mar2021, at 13:45 (Batch/Lot number was not reported, expiry date: unknown) as dose 2, single (age at time of vaccination in years: 52-years-old) for COVID-19 immunisation. Medical history included ongoing Complex partial seizures. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, (Batch/Lot Number: unknown , expiry date: unknown) via unspecific route of administration on 07Mar2021 as dose 1, single for COVID-19 immunisation. There was no history of all previous immunization with the Pfizer vaccine considered as suspect, and Additional Vaccines Administered on Same Date of the Pfizer Suspect. On 29Mar2021, 1 day after vaccination the patient experienced itching, rash, and arm hurting. She woke at 4 woke up itching. She also had a rash. Her arm doesn't hurt as much as it did yesterday. She was also itching in other parts of her body such as her shoulder. The rash started on left side of neck. She also had it on the right jaw. She was going to drive herself to urgent care. When she lifted her arm she realized she was unable to drive. She got prescribed for prednisone ointment by her family doctor. She asked if the rash is normal or is it a documented side effect. The events did not result in doctor or other healthcare professional office/clinic visit. The outcome of arm hurting: recovering, and outcome of others events: not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Inflammation, Myalgia, Nodule, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 31-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EP6955, expiry date: not reported), at the vaccination age of 31, via an unspecified route of administration, on Mar 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Mar 30, 2021 (on the arm she received the vaccine), patient experienced muscle soreness on armpit and felt a nodule inflammation in her armpit, with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling under the armpit/only swelling under the armpit on the same arm the injection was given; This is a spontaneous report from a contactable consumer (patient) from medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in arm, on an unspecified date, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced swelling under the armpit; there is no swelling at the site of the injection, only swelling under the armpit on the same arm on the injection was given, and it was continuing. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021353914 Same reporter/drug, different patient/events
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: a bit more stiffness and achiness in my knees/ regained some severity after the second; a bit more stiffness and achiness in my knees/ regained some severity after the second; This is a spontaneous report from a contactable consumer reported that. A 61-years-old female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization(Age at vaccination 61 years). The patient past medical history included breast cancer from an unknown date and unknown if ongoing three years ago. The patient's concomitant medications were not reported.  Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23 ("Yes, a 19-day cycle my shots were administered by Hospital"). It was unknown that patient was tested for COVID-19 after the vaccination or not. It was unknown if the patient received any treatment for the reported adverse event or not. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pyrexia, Somnolence
Clinical narrative: received second dose 2.5 weeks after first; fever; tired; slept a lot; This is a spontaneous report from a non-contactable consumer via a sales representative. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced received second dose 2.5 weeks after first, fever, tired, and slept a lot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash pruritic
Clinical narrative: Rash all over her belly below her navel, on her back on both sides of her spine, and right above her buttocks,rash itches like crazy; Chills; Fever; Achiness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization and experienced discoloration on her breast and immediately felt the vaccine in arm. On an unspecified date, after her second dose, the patient experienced rash all over her belly below her navel, on her back on both sides of her spine, and right above her buttocks, rash itches like crazy. Caller stated that she hasn't changed anything such as laundry detergent. The patient stated she went to a dermatologist. The patient was given samples of cream to try on it. The patient stated that she also had chills, fever, and achiness on an unspecified date. The patient would like to know, if there has been a lot of reports of something like this going on. The outcome of the event Itchy rash was unknown, Chills, Fever and Ache was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Injection site redness; Itching; This is a spontaneous report from a contactable consumer. This consumer reported for a 60-year-old female patient (Reporter mother) that who received bnt162b2 (BNT162B2) solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration at arm right on 26Mar2021 as dose 1 single for covid-19 immunisation. Medical history included thyroid disorder from an unknown date and unknown if ongoing Verbatim: thyroid it was diagnosed many years ago, reporter said his mom takes medication for this, and it was diagnosed many years ago. No further details provided about this medication, blood pressure abnormal from an unknown date and unknown if ongoing Verbatim: Blood pressure reporter said his mom takes medication for this, and it was diagnosed many years ago. No further details provided about this medication. The patient's concomitant medications were not reported. Reason for no lot number: of Pfizer COVID-19 vaccine: Complainant does not have the product with them at the time of call. Consumer said he was called about his mom; she got the Pfizer COVID-19 vaccine shot Friday and she had one of the side effects called injection site redness. He said that she was also having itching a little bit, so he was wondering is there any cream or something she could take for that, reporter says his mom has her vaccine card with her and she was not there with him, they do not live together. He said his mom got her first dose Friday during the early morning around 08:00-08:30AM in her right arm. He said that her itching and injection site redness began yesterday (29Mar2021). He said he doesn't think his mom has done treatment yet, he doesn't think she used anything though he thinks she took a Cerlatin, NDC/LOT/EXP unknown, this medication was with his mom. Medication name spelling documented as provided by reporter. Outcome of the events was unknown    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Bad Headache; body aches; fatigue; 101 fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number: EP7534; expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad headache, body aches, fatigue, and 101 fever. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: the vaccine has increased his confusion.; This is a spontaneous report from a non-contactable consumer. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 at 10:30 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included alzheimer's disease and COVID-19. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications for Alzheimers from an unknown date and unknown if ongoing. On 31Mar2021 at 07:00, the patient experienced increased confusion. The patient previously had COVID and patient had experienced same symptoms. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event increased confusion was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Fatigue, Gait disturbance
Clinical narrative: pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; feeling very tired; can't hardly walk; it feels like she was hit by a truck; This is a spontaneous report from a contactable consumer (patient) via a  sponsored program  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and expiration date: not reported), via an unspecified route of administration, on 22Mar2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included fibromyalgia from 10Jan2000 to Jul2015, spinal operation on Mar2015: Fused and spacers, spinal operation on Jul2018: Spacers removed, spinal operation on Sep2019: Fused and pins. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 23Mar2021, the patient experienced pain on her elbows, knee, back, legs and clavicle, feeling very tired, can't hardly walk, and it felt like she was hit by a truck.  Therapeutic measures were taken as a result of events included Aspirin. The outcome of the events was recovered in 28Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; feeling very tired; can't hardly walk; it feels like she was hit by a truck; This is a spontaneous report from a contactable consumer (patient) via a  sponsored program  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and expiration date: not reported), via an unspecified route of administration, on 22Mar2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included fibromyalgia from 10Jan2000 to Jul2015, spinal operation on Mar2015: Fused and spacers, spinal operation on Jul2018: Spacers removed, spinal operation on Sep2019: Fused and pins. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 23Mar2021, the patient experienced pain on her elbows, knee, back, legs and clavicle, feeling very tired, can't hardly walk, and it felt like she was hit by a truck.  Therapeutic measures were taken as a result of events included Aspirin. The outcome of the events was recovered in 28Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: chills; fever; body ache; This is a spontaneous report from a Pfizer-sponsored program via a Contactable female consumer (patient, self-reported). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiration date were not reported) via an unspecified route of administration, on 19Mar2021 (age at vaccination was 54 years) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, 'She received her first dose of Pfizer Vaccine (COVID 19 vaccine) on 19Mar and she had no side effects but then 7 days later on 26Mar she had chills, body ache and fever and she was wondering if you have heard of any-one experiencing a delayed adverse reaction like that because if it happens, it happens within first couple of days and she thought if it is because of the vaccine or can't think of any other reason. Patient was informed about Medical information department and was provided with the number. In response to further probing, Patient stated, she had already called, and they have got lot of information from her and right now she needs to drove home. She would call back in a little while. Lot: Patient stated, ENG208 or it could be EN6208. It was hard to read. Event date, Patient stated, It started on the first day I got the Vaccine and it lessen on each day, but I kept carrying a low-grade fever around 99.7. So, she was just trying to figure out if it from the vaccine or is it from something else. The outcome of the event body ache and chills was unknown and for fever was not resolved.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest pain
Clinical narrative: Chest pain; The pain is under the sternum; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8732, expiration date was not reported) via an unspecified route of administration, on 31Mar2021 10:00, at dose 2, single for covid-19 immunization. Medical history included, epilepsy, chronic obstructive pulmonary disease (COPD) and mitochondrial disease. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6206, expiration date was not reported) via an unspecified route of administration, on 10Mar2021, at dose 1, single for covid-19 immunization and had chest pain a little trouble breathing and she had COPD and used inhaler. On 31Mar2021, three hours after the vaccine, the patient experienced chest pain; she was fine during the 30 minutes waiting at the facility; chest pain is atypical and resolved last time during first vaccination and should resolve this time, the patient knew that she should follow up with her doctor or go to the emergency room if not resolved. It was also reported that the patient heart is not racing and she did not think anything is going on, and the pain is under the sternum (31Mar2021). The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain
Clinical narrative: body, muscle and joint aches; body, muscle and joint aches; body, muscle and joint aches; a "very bad" fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. In the past, (less than 10 years ago) she had an anaphylactic reaction to shellfish, the reaction went down pretty fast, she can't remember if she took medication, her doctor told her that if she eats shellfish again she should have Benadryl. The patient's medical history included diabetes, high blood pressure, high cholesterol, psoriasis, diabetic neuropathy and sometimes when her blood sugar levels are high it makes her skin itch. Also, she is allergic to iodine (in shellfish) and latex. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.); insulin; ergocalciferol (VIT D) all for an unspecified indication and was taking unspecified blood pressure medications. On an unspecified date, after the injection, she had muscle, joint and body aches and a very bad fatigue for 2 days. Also, she felt so tired. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pain
Clinical narrative: Red and sore shoulder; Pain at the top of shoulder/sore shoulder; lot of pain when trying to lift his arm and it hurt extremely bad; This is a spontaneous report received from a contactable consumer or other non hcp. An 83-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9262) via an unspecified route of administration in Arm Left on 02Feb2021 (age at vaccination 83years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not re-ported. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL1284) via an unspecified route of administration in Arm Left on 13Jan2021 (age at vaccination 83years old) as single dose for covid-19 immunisation. On 27Mar2021 the patient experienced red and sore shoulder, pain at the top of shoulder/sore shoulder, lot of pain when trying to lift his arm and it hurt extremely bad. Additional information reported as he was calling about the Pfizer covid19 vaccine. He received the first vaccine on 13Jan2021, and the second vaccine on 02Feb2021. On Saturday he started to have pain right at the top of his shoulder and it is kind of red and real sore. It has gotten worse. He was wondering since his last shot was 02Feb2021, whether this could be a result of the vaccination. He has been treating the symptoms with Aleve, which his doctor had prescribed for other pains. He took the first pill on Sunday. He also tried heat, ice, and pain-relieving cream; he does not know the name. He experienced a lot of pain when trying to lift his arm and it hurt extremely bad. He explains the area is not extremely red. He weighs around 150 pounds, but weight could vary a pound or two. The patient received treatment for the adverse events. The clinical outcome of the events was not recovered. Therapeutic measures were taken as a result of red and sore shoulder, pain at the top of shoulder/sore shoulder, lot of pain when trying to lift his arm and it hurt extremely bad.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Limb discomfort, Musculoskeletal stiffness, Sensitisation
Clinical narrative: Unable to raise upper left arm above her head, up above her shoulder; left arm has two huge bruises; she can raise her arm up now, but can't reach her right ear, it's still a little sensitive- the bruised part is.; having some stiffness; This is a spontaneous report from a contactable 84-year-old female consumer (patient). An 84-year-old female patient unknown dose of bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Batch/lot number: EP7534, Expiry date: unknown), via an unspecified route in the upper left shoulder on 19Mar2021 at 11:20 (age at vaccination: 84-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included unknown medication for her heart and blood. Patient declines to provide further details about her medications, stating she does not want to raise any eyebrows that are not necessary. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, patient was unable to raise upper left arm above her head, up above her shoulder, left arm has two huge bruises that are now black and maroon in color. The bruises are about 3 inches long in a horizontal way. It looks like one big blob. She will see her see her primary physician tomorrow; she has been told to do that. She clarified she can raise her arm up now, but cannot reach her right ear, it was still a little sensitive, the bruised part is. She mentions having some stiffness. Therapeutic measures taken as a result of the events included, she initially applied ice, and then a small amount of heat 2 days later. States that it has been 10 days since she had side effects. No relevant tests were done. The clinical Outcome of unable to raise upper left arm above her head, up above her shoulder was recovering; left arm has two huge bruises, it was still a little sensitive, the bruised part was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; difficulty breathing; fever; This is a spontaneous report from a contactable other health care professional. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 26Mar2021 (at the age of 83-year-old), as dose 2, single, for COVID-19 immunisation. Medical history included ongoing breast cancer. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation and experienced cold, swollen neck lymph nodes and fatigue. On an unspecified date in Mar2021, the patient had flu-like symptoms, difficulty breathing, and fever. On an unspecified date in Mar2021, the patient recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest pain, Dyspnoea, Heart rate abnormal
Clinical narrative: Chest pain; The caller's heart is not racing and she does not think anything is going on; The pain is under the sternum; trouble breathing; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration on 10Mar2021 as dose 1, single for covid-19 immunisation  .  Medical history included epilepsy, mitochondrial disease, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient received her first dose on 10Mar2021 and was waiting in the waiting area she had chest pain and a little trouble breathing, she has COPD and they let her use her inhaler. The chest pain, which is atypical, resolved. Patient's heart is not racing and she does not think anything is going on. The pain is under the sternum. The outcome of chest pain was recovered while outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Pain, Pyrexia
Clinical narrative: more sick; body aches; weakness; fever; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported 3 reports. This is the first report. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204, Expiration Date: 03May2021), intramuscularly, administered on left deltoid, on 03Mar2021 at 12:00 (age at vaccination was 45-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included heart burn. Concomitant medications included esomeprazole 20 mg taken for heart burn from an unspecified date of 2019 and ongoing. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EM9810, Expiration Date: 02Nov2021), intramuscularly, administered on left arm, on 02Feb2021 at 11:30 (age at vaccination was 45-year-old) as dose 1, single for COVID-19 immunization and experienced being sick, body aches, fever and headache. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On 04Mar2021, the patient experienced being more sick, body aches, weakness, fever and headache. It was further reported that the patient was more sick than the first dose that the patient could not get out of bed for a night. The events started 12 hours after vaccination and lasted another 3 days. Therapeutic measures were taken as a result of the events included paracetamol (TYLENOL); ibuprofen and diphenhydramine citrate (ADVIL PM) and vitamin C. The outcome of the events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363289 same reporter and drug, similar events, different patients.;US-PFIZER INC-2021363288 same reporter and drug, similar events, different patients.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Injection site redness; Injection site swelling; Injection site hives; she had a few lumps further down her left arm; Injection site itching; This is a spontaneous report from a contactable consumer (patient).  A 90-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8727, expiry date: unknown) via an unspecified route of administration, administered in arm left on 23Mar2021 12:20 as DOSE 1, SINGLE (age at the of vaccination was 90-years-old) for COVID-19 immunization. The patient's medical history included aneurysm of heart since either 1982 or 1983 and unknown if ongoing. Concomitant medications were not reported. Patient did not receive any vaccination within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. On 28Mar2021, the patient experienced injection site redness, injection site swelling, injection site hives, she had a few lumps further down her left arm, injection site itching. Patient reported her arm was a little red, the swelling was gone and there were a few lumps on her arm. Patient reported she had not been itching and patient thought allergic reaction has gone. Patient reported that her second COVID-19 VACCINE slot was scheduled on 17Apr2021 and was past 21 days recommended between first and second dose. Patient was not taken to Emergency Room and Physician Office. Patient received the treatment for events/therapeutic measures were taken patient took Benadryl 25mg tablet, Expiration Date: Oct2023. The outcome of events was injection site redness, injection site swelling was recovered on 29Mar2021, the outcome of event injection site itching was recovered on 30Mar2021, the outcome of she had a few lumps further down her left arm, injection site hives was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Fatigue, Feeling abnormal, Restlessness
Clinical narrative: restless; uncomfortable; Shortness of breath; tired; feeling different; This is a spontaneous report from a contactable consumer (patient). A 70-year-old  male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm on 03Mar2021 (age at vaccination was 69-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included heart condition and kidney condition; both started a couple years ago. There were no concomitant medications. The patient experienced being restless, uncomfortable, and shortness of breath on 11Mar2021 while tired and feeling different on Mar2021. It was further reported that on 11Mar2021, patient was feeling restless, uncomfortable, shortness of breath and stuff so he went to the ER. The patient told them that he got a shot of BNT162B2, but they gave him another unknown shot. It was reported that he was kind of feeling uncomfortable and tired so he doesn't know if he needs to take another BNT162B2 shot or not. The patient declined the second dose last 24Mar2021 since he doesn't know if they gave him the second shot at the ER or not. The patient reported that he has been feeling different since then and he doesn't know whether he should have taken it or not. It was also reported that for his shortness of breath he felt better, but he was feeling uncomfortable this day. He stated that he just went to the hospital but was not admitted. The outcome of the event uncomfortable was not recovered, shortness of breath was recovering while other reported events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pyrexia
Clinical narrative: previously received the full primary immunization series of BNT162b2 and received a third/booster dose; previously received the full primary immunization series of BNT162b2 and received a third/booster dose; fever; This is a spontaneous report from a contactable pharmacist received via medical information team. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 29Mar2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 13Feb2021 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 06Mar2021 as dose 2, single for COVID-19 immunization. The patient was previously received the full primary immunization series of BNT162B2 and received a third/booster dose on 29Mar2021 and fever on an unspecified date in Mar2021. Patient was currently experiencing fever. Pharmacist wanted to know when patient can receive his shingles vaccine. Outcome of fever was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disturbance in attention, Headache, Nausea
Clinical narrative: 103 fever; nausea; mouth watering; body aches; chills; difficulty focusing; headache; nerve pain; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Er8732), via an unspecified route of administration, administered in left arm on 31Mar2021 at 17:00 (age at vaccination was 35-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included HSV2 (Herpes simplex virus 2). The patient's concomitant medications included ibuprofen from an unspecified date and unknown indication. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: En6206), via an unspecified route of administration, administered in left arm on 10Mar2021 at 17:00 (age at vaccination was 35-year-old) as dose 1, single for COVID-19 immunization and experienced left arm swelling; numbness of left arm, neck, and lower left quarter of face; and extreme lethargy. The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021, the patient experienced nausea, mouth watering, body aches, chills, and difficulty focusing; all at 06:00, and 103 fever on 17:00 while headache and nerve pain on Apr2021. It was further reported that 18 hours later from vaccination the nausea has become extreme and 24 hours later from vaccination, 103 fever was experienced. Also, after taking both of ibuprofen and paracetamol (TYLENOL), headache and nerve pain was experienced. Therapeutic measures were taken as a result of the events (nausea, mouth watering, body aches, chills, difficulty focusing and 103 fever) included treatment with paracetamol while no treatment for other events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pyrexia, Salivary hypersecretion
Clinical narrative: 103 fever; nausea; mouth watering; body aches; chills; difficulty focusing; headache; nerve pain; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: Er8732), via an unspecified route of administration, administered in left arm on 31Mar2021 at 17:00 (age at vaccination was 35-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included HSV2 (Herpes simplex virus 2). The patient's concomitant medications included ibuprofen from an unspecified date and unknown indication. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: En6206), via an unspecified route of administration, administered in left arm on 10Mar2021 at 17:00 (age at vaccination was 35-year-old) as dose 1, single for COVID-19 immunization and experienced left arm swelling; numbness of left arm, neck, and lower left quarter of face; and extreme lethargy. The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021, the patient experienced nausea, mouth watering, body aches, chills, and difficulty focusing; all at 06:00, and 103 fever on 17:00 while headache and nerve pain on Apr2021. It was further reported that 18 hours later from vaccination the nausea has become extreme and 24 hours later from vaccination, 103 fever was experienced. Also, after taking both of ibuprofen and paracetamol (TYLENOL), headache and nerve pain was experienced. Therapeutic measures were taken as a result of the events (nausea, mouth watering, body aches, chills, difficulty focusing and 103 fever) included treatment with paracetamol while no treatment for other events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.