chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Day after first dose- paresthesia in hands and feet; moderate to severe headache; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 03Mar2021 10:00, outcome "not recovered", described as "Day after first dose- paresthesia in hands and feet"; HEADACHE (non-serious) with onset 03Mar2021 10:00, outcome "not recovered", described as "moderate to severe headache". The events "day after first dose- paresthesia in hands and feet" and "moderate to severe headache" were evaluated at the physician office visit.  Additional information: On 03Mar2021 at 10:00 (a day after vaccination), the patient experienced paraesthesia in hands and feet and moderate to severe headache which were persistent 3 weeks after first dose. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products and was not diagnosed with other illness, medical history and chronic health conditions.  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-2021351480 same patient, different drug/AE
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia
Clinical narrative: headache; generalized muscle aches; brain fog; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "generalized muscle aches"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog". Additional information: The patient experienced mild headache and generalized muscle aches on the day after the second dose of Pfizer COVID-19 vaccine and experienced "brain fog" the day after and day 3. The events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral pain, Pain in extremity
Clinical narrative: mouth sore; arm sore; excessive fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "PCV" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ORAL PAIN (non-serious), outcome "unknown", described as "mouth sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm sore"; FATIGUE (non-serious), outcome "unknown", described as "excessive fatigue ". Additional information: the patient received covid vaccine yesterday and reported mouth sore, arm sore and excessive fatigue today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: Bottom lip began to tingle and then the tip of the tongue did that, then that continued to half of my tongue; Bottom lip began to go numb, then the tip of the tongue did that, then that continued to half of my tongue; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe Allergies" (unspecified if ongoing); "Ragweed allergy" (unspecified if ongoing); "Food allergy" (unspecified if ongoing), notes: Allergies: Egg whites, Corn, Oats, Cinnamon, Safflower; "NSAID Allergy" (unspecified if ongoing). Concomitant medications included: FLONASE [FLUTICASONE PROPIONATE]; CLARITIN-D; MUCINEX; PREDNISONE. Past drug history included: Aspirin, reaction: "Drug allergy". The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 07Mar2021, outcome "recovered" (Mar2021), described as "Bottom lip began to tingle and then the tip of the tongue did that, then that continued to half of my tongue"; HYPOAESTHESIA ORAL (non-serious) with onset 07Mar2021, outcome "recovered" (Mar2021), described as "Bottom lip began to go numb, then the tip of the tongue did that, then that continued to half of my tongue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of paraesthesia oral, hypoaesthesia oral.  Additional Information: On 07Mar2021, the patient experienced that her bottom lip began to tingle and go numb, then the tip of the tongue did that, then that continued to half of her tongue. She immediately took diphenhydramine (BENADRYL) and famotidine (PEPCID) then once got home, she added prednisone. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via nasal swab and the result found to be negative   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-2021351524 Same patient and drug; Different dose and event
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort
Clinical narrative: Chills; other discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, unknown manufacturer), for Covid-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; DISCOMFORT (non-serious), outcome "unknown", described as "other discomfort". Additional information: Patient had chills and other discomfort after 2nd COVID-19 Vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Almost like a tension headache, back of neck and across head; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 50 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Lot number: EN6199) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "sleeping poorly" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol for almost like a tension headache, starts in back of neck and goes up and across the head. The following information was reported: TENSION HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Almost like a tension headache, back of neck and across head". Therapeutic measures were taken as a result of tension headache.  The reporter considered "almost like a tension headache, back of neck and across head" not related to BNT162B2. Additional information: Patient reported that she was due to have her second vaccine on 28Mar2021. Patient reported experiencing the event for the past week to 10 days. She said this was not an abnormal issue for her but usually she can take Tylenol and it goes away, or that she can massage it and it goes away. With this current issue, she had been taking Motrin and it still kept on coming back. Her friend, who went the same day, was having the same complaint. Patient stated it could be a coincidence because they were sleeping poorly, working from home. Patient inquired if this was an event disconnected from her first vaccine, associated, maybe a delayed adverse event. She declined to complete report and stated she didn't feel it's needed since it may not be connected.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported event 'tension headache' is considered an intercurrent medical condition and assessed not related to vaccination with BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: had tingling of lip and tongue but it was much less this time; felt some difficulty swallowing; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: egg whites" (unspecified if ongoing), notes: Egg whites; "Food Allergy" (unspecified if ongoing), notes: Corn, Oats, Cinnamon; "Known allergies: Ragweed" (unspecified if ongoing), notes: Ragweed; "Known allergies: Safflower" (unspecified if ongoing), notes: Safflower; "severe allergies" (unspecified if ongoing), notes: Other medical history: Severe allergies; "Known allergies: all NSAIDS" (unspecified if ongoing), notes: all NSAIDS. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; CLARITIN-D; MUCINEX; PREDNISONE; BENADRYL; PEPCID [FAMOTIDINE]. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for COVID-19 immunisation, reaction(s): "my bottom lip began to tingle and go numb, then the tip of the tongue did that, then that continued to half of my tongue", "my bottom lip began to tingle and go numb, then the tip of the tongue did that, then that continued to half of my tongue". The following information was reported: PARAESTHESIA ORAL (non-serious), outcome "recovered", described as "had tingling of lip and tongue but it was much less this time"; DYSPHAGIA (non-serious), outcome "recovered", described as "felt some difficulty swallowing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of paraesthesia oral, dysphagia. Additional Information: On the first dose, the patient experienced her bottom lip began to tingle and went numb, then the tip of the tongue did that, then that continued to half of her tongue (immediately took Benadryl and Pepcid, once home added Prednisone). For the second dose, she took "cocktail" of Prednisone, Benadryl, and Pepcid before she went in to get vaccine. She also experienced, like 1st shot, tingling of lip and tongue but it was much less this time because she was proactive and also felt some difficulty swallowing but never lost ability to swallow, talk, or sing. The patient has not been diagnosed with COVID prior vaccination. The patient has been tested for COVID post vaccination through nasal swab with negative results.  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-2021351467 Same patient, same drug with different vaccine dose, different AE.;US-PFIZER INC-2021351467 Same patient and drug; Different dose and event
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at jab site; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 16 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at jab site".  Additional information: The patient has no health issues. Takes multi vitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: left arm like the area got really big and swelled up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "heart problems" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "left arm like the area got really big and swelled up". Therapeutic measures were taken as a result of vaccination site swelling.  Additional information: It was reported that the patient was on a lot of medicine since she has heart problems, was on oxygen and has a lot of other medical issues. It was reported that the patient received antibiotics for the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Chills, Fatigue, Pain in extremity
Clinical narrative: chills; blood glucose was up the next morning; sore arm; tiredness; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 66 year-old female patient received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 12:00 (Lot number: ER8730) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 27Sep2006 (ongoing); "Retired" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumonia vaccine (Injection, left arm), administration date: 09Mar2021, for immunisation, reaction(s): "sore arm", "Fatigue"; Flu vaccine (received the flu last fall, in Sep2020 or Oct2020), administration date: 2020, for Immunisation, reaction(s): "tiredness", "sore arm". The following information was reported: FATIGUE (non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "tiredness"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 20:00, outcome "recovered", described as "sore arm"; BLOOD GLUCOSE INCREASED (non-serious) with onset 25Mar2021, outcome "recovering", described as "blood glucose was up the next morning"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient had chills but stated that the patient is always chilly off and on. Patient's arm is good today. Blood glucose is a little higher the last few days. Patient has health issues and thought to get the Covid-19 vaccine. Patient has not started any new medications. Patient's blood sugar went from 113 before eating to 249 after eating a bread pizza. Patient experienced the same thing with the flu vaccine and pneumonia vaccine, tiredness and sore arm. Patient had to wait 2 weeks after the pneumonia vaccine to get her Covid-19 vaccine. Patient inquired if a call and filing of a safety report is needed after they received their second dose of the Covid-19 vaccine in 3 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the non-serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021351658 same reporter different patient;US-PFIZER INC-2021351658 same reporter different patient
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very mild soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 13:00 (Lot number: EN6199) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "very mild soreness at injection site".  Additional information: The patient's concomitant medication included unspecified birth control and multivitamin. 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 was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness where the room spun around; Dizziness where the room spun around; Vomiting; when he vomited he broke out in a cold sweat; chills; Tiredness; Headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 24Mar2021 15:45 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "contracted COVID" (unspecified if ongoing). There were no concomitant medications. The patient did not have prior vaccinations (within 4 weeks). The following information was reported: CHILLS (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "chills"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Tiredness"; HEADACHE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Headache"; DIZZINESS (non-serious), VERTIGO (non-serious) all with onset 26Mar2021, outcome "recovered" (26Mar2021 09:00) and all described as "Dizziness where the room spun around"; VOMITING (non-serious) with onset 26Mar2021, outcome "recovered" (26Mar2021), described as "Vomiting"; COLD SWEAT (non-serious) with onset 26Mar2021, outcome "unknown", described as "when he vomited he broke out in a cold sweat". Therapeutic measures were not taken as a result of chills, fatigue, headache, dizziness, vertigo, vomiting, cold sweat. Additional information: Vaccine was administered on the patient's right shoulder. Patient reported he was not sure if he has recovered completely from the chills since when he vomited he broke out in a cold sweat. Patient was not sure when the tiredness stopped; he went to bed on 25Mar2021 and feeling fine when he got up. He stated he thought he had recovered completely but cannot say for sure as he was not feeling tired at the time of report. Patient reported when he went to bed on 25Mar2021, he had headache but the morning after it was not there. He thought he had recovered completely. Patient was not sure if he had recovered completely from dizziness but when he vomited the room quit spinning. Patient stated he contracted COVID and the Doctor said to wait until close to 01Apr2021 to get the vaccine. His wife signed up and was randomly selected by the computer to receive the shot. They went down there and they reviewed the information, asked how old he was. He told them that he was 74 so they told him he can also get the shot. Patient stated this had on his COVID 19 vaccine card the expiration of 31Jul2021 and asked exactly what does that mean and was that when the shot expires. The events did not require emergency room visit nor physician office visit. Health Department (as reported).  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Dizziness where the room spun around; Dizziness where the room spun around; Vomiting; when he vomited he broke out in a cold sweat; chills; Tiredness; Headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 24Mar2021 15:45 (Lot number: ER8727, Expiration Date: 31Jul2021) at the age of 74 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "contracted COVID" (unspecified if ongoing). There were no concomitant medications. The patient did not have prior vaccinations (within 4 weeks). The following information was reported: CHILLS (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "chills"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Tiredness"; HEADACHE (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Headache"; DIZZINESS (non-serious), VERTIGO (non-serious) all with onset 26Mar2021, outcome "recovered" (26Mar2021 09:00) and all described as "Dizziness where the room spun around"; VOMITING (non-serious) with onset 26Mar2021, outcome "recovered" (26Mar2021), described as "Vomiting"; COLD SWEAT (non-serious) with onset 26Mar2021, outcome "unknown", described as "when he vomited he broke out in a cold sweat". Therapeutic measures were not taken as a result of chills, fatigue, headache, dizziness, vertigo, vomiting, cold sweat. Additional information: Vaccine was administered on the patient's right shoulder. Patient reported he was not sure if he has recovered completely from the chills since when he vomited he broke out in a cold sweat. Patient was not sure when the tiredness stopped; he went to bed on 25Mar2021 and feeling fine when he got up. He stated he thought he had recovered completely but cannot say for sure as he was not feeling tired at the time of report. Patient reported when he went to bed on 25Mar2021, he had headache but the morning after it was not there. He thought he had recovered completely. Patient was not sure if he had recovered completely from dizziness but when he vomited the room quit spinning. Patient stated he contracted COVID and the Doctor said to wait until close to 01Apr2021 to get the vaccine. His wife signed up and was randomly selected by the computer to receive the shot. They went down there and they reviewed the information, asked how old he was. He told them that he was 74 so they told him he can also get the shot. Patient stated this had on his COVID 19 vaccine card the expiration of 31Jul2021 and asked exactly what does that mean and was that when the shot expires. The events did not require emergency room visit nor physician office visit. Health Department (as reported).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pain, Pollakiuria, Urine output increased
Clinical narrative: I do not think I have slept since last night; there was lot of fluid that I was constantly going to bathroom; there was lot of fluid that I was constantly going to bathroom; discomfort; pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing); "Fall" (unspecified if ongoing); "Headache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "I do not think I have slept since last night"; URINE OUTPUT INCREASED (non-serious), POLLAKIURIA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "there was lot of fluid that I was constantly going to bathroom"; DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "discomfort"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Mildly sore arm at injection site; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 09:15 (Lot number: EP6955) at the age of 55 years as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: ARIPIPRAZOL; LAMOTRIGINE; BUPROPION; CALCIUM+D. Past drug history included: Neomycin, reaction(s): "Allergies to medications, food, or other products". Vaccination history included: Bnt162b2 (product, COVID 19, lot number, EL3247, dose number, 1), administration date: 03Mar2021, when the patient was 55 years old, for Covid-19 immunization.   The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 10:00, outcome "not recovered", described as "Mildly sore arm at injection site"; INSOMNIA (non-serious) with onset 25Mar2021 10:00, outcome "not recovered", described as "insomnia". Therapeutic measures were not taken as a result of vaccination site pain, insomnia.  Additional information: 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 was not tested for COVID-19. Yes I am the person who received the vaccine and I became aware of the side effects on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: soreness at injection site; headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 25Mar2021 15:45 (Lot number: EK5730) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "known allergies: penicillins" (unspecified if ongoing); "known allergies: cephalosporins" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Mastisol, reaction: "known allergies"; Bactrim, reaction: "known allergies". Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EJ1685), administration date: 04Mar2021 15:45, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 21:00, outcome "recovering", described as "soreness at injection site"; HEADACHE (non-serious) with onset 25Mar2021 21:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of vaccination site pain, headache.  Additional information: Other medications the patient received within two weeks of vaccination included daily multivitamin. The patient also received a third dose of BNT162B2 (Lot number: FJ8762), administered in the right arm on 09Dec2021 13:00 for COVID-19 immunisation.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar has been elevated over 300; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 13:15 (Lot number: ER727) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure", start date: 2019 (ongoing), notes: diagnosed about 1.5 years ago; "Diabetes Type II", start date: 2019 (ongoing), notes: diagnosed two years ago; "migraine" (unspecified if ongoing), notes: every 28 days she takes a shot. Concomitant medication(s) included: CHLORTHALIDONE taken for blood pressure abnormal, start date: 2021 (ongoing); LANTUS taken for type 2 diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure abnormal, start date: 2019 (ongoing). The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 24Mar2021 16:00, outcome "not recovered", described as "blood sugar has been elevated over 300". The event "blood sugar has been elevated over 300" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: In Mar2021, prior to the vaccine the blood sugar was between 101 and 115. Ever since the patient received the vaccine the patient's blood sugar has been elevated over 300. She talked to an on call doctor who said since she only had two results over 300 in a 12 hours period and he said not to come in, it was reported that the patient had another. She had one or two results since 24Mar2021 that have been within normal range. It was reported that the event was ongoing.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms, Vaccination site pain
Clinical narrative: diarrhea; after the injection I got the soreness on the injection site; cramping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8733) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "unknown", described as "after the injection I got the soreness on the injection site"; DIARRHOEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "diarrhea"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "cramping". Therapeutic measures were not taken as a result of vaccination site pain, diarrhoea, muscle spasms.  Additional information: It was stated that the patient got cramps and then diarrhea and then diarrhea again and nothing else so far.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Vaccine burned going in arm; Whole body aches; headache; hard to sleep; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 44 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 15:00 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Colitis" (unspecified if ongoing), notes: None at moment but have had colitis, not present now or has been for over a decade. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown, Anatomical Location: Arm Left), administration date: 05Mar2021, when the patient was 44 years old, for COVID-19 immunization, reaction: "whole upper arm hurting". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 15:00, outcome "recovered" (Mar2021), described as "Vaccine burned going in arm"; PAIN (non-serious) with onset 26Mar2021 15:00, outcome "recovered" (Mar2021), described as "Whole body aches"; HEADACHE (non-serious) with onset 26Mar2021 15:00, outcome "recovered" (Mar2021), described as "headache"; INSOMNIA (non-serious) with onset 26Mar2021 15:00, outcome "recovered" (Mar2021), described as "hard to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain, headache, insomnia.  Additional information: On 26Mar2021 at 15:00, the patient experienced vaccine burned going in arm, whole body aches, headache that was so bad it was hard to sleep. Therapeutic measures were taken as a result of reported events and included treatment with Tylenol 500 mg which allowed sleep. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Wrong technique in product usage process
Clinical narrative: administered far too up high my arm, almost next to my shoulder blade; hit a bone instead of a muscle, so high up; did not felt right; Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 24Mar2021 (Lot number: ER2613) at the age of 59 years as dose 1, 0.3 ml, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "administered far too up high my arm, almost next to my shoulder blade; hit a bone instead of a muscle, so high up"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "did not felt right"; PAIN (non-serious), outcome "not recovered", described as "Sore". Therapeutic measures were not taken as a result of wrong technique in product usage process, feeling abnormal, pain. The Consumer (patient) stated, "I had my shot yesterday, my first dose and it was administered far too up high my arm, almost next to my shoulder blade and I am worried about the effectiveness. I thought she hit a bone instead of a muscle, so high up. That's it, I still got the band aid on where it is and I got my card and I got the name of the hospital where it was administered." When asked if have any question regarding the concern, consumer stated, "Oh yes mam because I went to a nursing school years ago and she did not administered it correctly. I know what I am talking about, now just to get some RN, I got a medical sciences degree in RN (Further clarified as consumer hence not captured in tab) but I know what I am talking about. LOT numbers is ER2613. Expiration date was provided as Jul2021."(Further not clarified hence not captured in tab). : Consumer stated, "I had the shot at 10:10 yesterday and it did not felt right from the very beginning and at 9 0' clock last night I was trying to call you guys. It was not in the correct way you know, at 9 0' clock last night, I tried to call Pfizer but no one was there to answer the call.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: whole upper arm hurting (only at injection site 1st dose); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "colitis" (not ongoing), notes: not present now or has been for over a decade. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "whole upper arm hurting (only at injection site 1st dose)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: 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 was not been diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue discomfort
Clinical narrative: burning pizza sensation on tongue; tingling on the tongue; 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 64 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TONGUE DISCOMFORT (non-serious) with onset 24Mar2021, outcome "not recovered", described as "burning pizza sensation on tongue"; PARAESTHESIA ORAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "tingling on the tongue". Therapeutic measures were not taken as a result of tongue discomfort, paraesthesia oral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: sick; 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 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking what should she do since she was sick (just got it a few days ago) and today (day of report) was her second dose. It was reported that she can't get the second vaccine right now and wondered what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 14:00 (Lot number: EN6200, Expiration Date: Feb2022) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: diagnosed with diabetes 12 years ago; "MS" (ongoing), notes: diagnosed about 45 years ago . The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "fatigue". Therapeutic measures were taken as a result of fatigue.  Additional information: The fatigue resolved after a couple of days. It was reported that the patient was taking acetaminophen aspirin caffeine since day 1 (18Feb2021).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vomiting
Clinical narrative: major headache; vomiting; I can't get up and get the paper, I am too tired; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 24Mar2021 11:00 (Lot number: ER8727, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "major headache"; VOMITING (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "I can't get up and get the paper, I am too tired"; MALAISE (non-serious) with onset 25Mar2021 03:00, outcome "not recovered", described as "not feeling well".  Additional information: Patient got the vaccine yesterday (24Mar2021) at 11:00, during the day everything was okay, then patient go to bed  and still was okay and then events started around 3 o'clock in the morning.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some "injection site soreness"; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CAD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: Hypertension (controlled with Losartan and metoprolol); "Asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Losartan for Hypertension; Metoprolol for Hypertension. Vaccination history included: Bnt162b2 (dose 1 via intramuscular), administration date: 05Mar2021, when the patient was 72 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "Some "injection site soreness"". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: It was unknown if patient had allergies. 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 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: having pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "having pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Illness, Malaise, Nausea
Clinical narrative: he felt like he was unwell; sick; Nauseated but he is not going to throw up; feels like his head is stuffed up but he does not have a runny nose/  his head was getting ready to flood through his nose; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6208) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetic", start date: 2003 (ongoing); "Prostate cancer", start date: 2016 (unspecified if ongoing), notes: PSA test was like 0.05 so it is pretty much under control.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol abnormal, start date: 2018. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "he felt like he was unwell"; ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "sick"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Nauseated but he is not going to throw up"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset Mar2021, outcome "not recovered", described as "feels like his head is stuffed up but he does not have a runny nose/  his head was getting ready to flood through his nose"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "not recovered", described as "feeling bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events did not result to Emergency Room and Physician Office visit. The patient was scheduled on 31Mar2021 for the second dose.  No follow-up attempts are possible. No further information is expected.