chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea
Clinical narrative: Narrative:  75 year old male admitted on 2/4/22 with SOB and treatment of COVID-19 infection. He had been vaccinated x 3 with Moderna (1st dose: 2/23/21, 2nd dose 3/23/21, 3rd dose 9/29/21). He received 3 days of remdesivir and 3 days of IV dexamethasone for treatment and was discharged on 2/7/22.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Chest X-ray abnormal, Cough, Fibrin D dimer
Clinical narrative: Narrative: COVID infection following COVID vaccine series 05/12, Pfizer, dose #1 Non-clinic facility. 06/02, Pfizer, dose #2 12/30 COVID swab, result: detected 12/30 pt cc: cough, with wheezing, and congestion. exposure: unknown 12/30 pt admit ED cc: cough, with wheezing, and congestion. dx: COVID 19 LOS: 1 DAY 1/11 DDIMER: <0.215 1/11 CXR impression: Bronchitis changes. No pneumonic infiltrate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Wheezing
Clinical narrative: Narrative: COVID infection following COVID vaccine series 05/12, Pfizer, dose #1 Non-clinic facility. 06/02, Pfizer, dose #2 12/30 COVID swab, result: detected 12/30 pt cc: cough, with wheezing, and congestion. exposure: unknown 12/30 pt admit ED cc: cough, with wheezing, and congestion. dx: COVID 19 LOS: 1 DAY 1/11 DDIMER: <0.215 1/11 CXR impression: Bronchitis changes. No pneumonic infiltrate.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein, Chest discomfort, Haematocrit normal, Haemoglobin
Clinical narrative: Pt states she developed itching all over her body right after receiving the vaccine on her right deltoid. Symptoms of itching subsided within few hours. Also c/o numbness, tingling in both hands & right foot which still continues also chest tightness that comes and  goes since the vaccination. Chest tightness feel like lightning through her Chest lasting few seconds & Intermittent up to now. Pt c/o right foot leg as well
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume, Paraesthesia
Clinical narrative: Pt states she developed itching all over her body right after receiving the vaccine on her right deltoid. Symptoms of itching subsided within few hours. Also c/o numbness, tingling in both hands & right foot which still continues also chest tightness that comes and  goes since the vaccination. Chest tightness feel like lightning through her Chest lasting few seconds & Intermittent up to now. Pt c/o right foot leg as well
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt states she developed itching all over her body right after receiving the vaccine on her right deltoid. Symptoms of itching subsided within few hours. Also c/o numbness, tingling in both hands & right foot which still continues also chest tightness that comes and  goes since the vaccination. Chest tightness feel like lightning through her Chest lasting few seconds & Intermittent up to now. Pt c/o right foot leg as well
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: Lip numbness and swelling
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine given.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCIN GIVEN.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Exercise tolerance decreased, Painful respiration, Vertigo, Vision blurred
Clinical narrative: Had a physical around the same time as second dose of series. 20/15 vision, no complaints. A couple of weeks after, I started to noticed that my vision was blurry and that reading near and far was difficult. Also started to experience chest pain not reproducable to movement/palpation, but to deep inspiration. This was intermittent and not directly correlated to exercise or strenuous activity. This persisted for months. Has improved over past 2-3 months. Also have been experiencing vertigo I never had before. Also intermittent w/o correlation to anything. I also noticed throughout the follwoing several months that exercise was at times more difficult. One day could not run 4 miles w/o stopping for breaks. Other days I 10-12 miles w/o difficulty. This continues to this day. Vision disturbances also continue to this day. Visited my eye doctor and no major issues discovered during exam. Vision disturbances are intermittent as well. Some days I can see clear, other days very difficult to read signs especially in low light situations.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Had a physical around the same time as second dose of series. 20/15 vision, no complaints. A couple of weeks after, I started to noticed that my vision was blurry and that reading near and far was difficult. Also started to experience chest pain not reproducable to movement/palpation, but to deep inspiration. This was intermittent and not directly correlated to exercise or strenuous activity. This persisted for months. Has improved over past 2-3 months. Also have been experiencing vertigo I never had before. Also intermittent w/o correlation to anything. I also noticed throughout the follwoing several months that exercise was at times more difficult. One day could not run 4 miles w/o stopping for breaks. Other days I 10-12 miles w/o difficulty. This continues to this day. Vision disturbances also continue to this day. Visited my eye doctor and no major issues discovered during exam. Vision disturbances are intermittent as well. Some days I can see clear, other days very difficult to read signs especially in low light situations.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCIN GIVEN.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on  January 19th were efficacious or not. "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. "  No known sequela from the event.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on January 19th were efficacious or not "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2(COVID-19) virus at time of administration. "No known sequela from the event.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on January 19th were efficacious or not. Moderna Case CEA-1680 was reviewed.  "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. " No known sequela from the event.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: No adverse side effects from vaccine administration error. This is an error only report for expired vaccine given. Moderna was contacted in efforts to conclude if the vaccines administered on January 19th were efficacious or not. "The vaccine administered on January 19, 2022 from lot number 077C21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. " No known sequela from the event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Inappropriate schedule of product administration, Lymphadenopathy, Ultrasound scan
Clinical narrative: postponed 2nd shot; Upper left swollen lymph nodes/Lymphadenopathy; This is a spontaneous report from a contactable other hcp. A 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left (Deltoid Left) on 05Jan2021 05:30 (Batch/Lot Number: EL0142) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included asthma from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing and ongoing HLD. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestrel (CRYSELLE) taken for an unspecified indication, start and stop date were not reported and ATORVASTATIN 40 mg taken for HLD indication, start from unknown date to ongoing. The patient did not have any prior vaccination within 4 weeks. On 05Jan2021, within 24 hours the patient had upper left swollen lymph nodes/Lymphadenopathy and so until this the patient had postponed the 2nd shot (coded as inappropriate schedule of drug administration). Event left swollen lymph nodes/Lymphadenopathy leads to physician office. The patient has undergone ultrasound and the physician has told biopsy would be needed next. On 02Feb2021, patient underwent lab test: enlarged lymph nodes. On 09Feb2021, patient underwent lab test CBC: PL+ 450 bq/l (normal range: 140 to 440). The patient did not receive any treatment for the event left swollen lymph nodes/Lymphadenopathy. It was unknown that whether the patient had any vaccination prior to COVID-19 vaccination and whether the patient had been tested for COVID-19. The outcome of the events was unknown.  Reporter consider the Pfizer product had a casual effect to the adverse event.  Follow-up (05Apr2021): New information received from a contactable Physician. This Physician reported for the patient in response to HCP letter sent which included that: Updated lab tests, concomitant medication, onset date and treatment received as no for the event upper left swollen lymph nodes/Lymphadenopathy.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Tinnitus
Clinical narrative: tinnitus in ears; hypoesthesia located in head, neck, both shoulders arms and hands./Paraesthesia in head, upper torso, shoulders, arms and hands; Acute paraesthesia and hypoesthesia located in head, neck, both shoulders arms and hands./Paraesthesia in head, upper torso, shoulders, arms and hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 10:00 (Lot number: EN6205) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "skin - squamous cell carcinoma" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN D NOS; VITAMIN C ACID. The following information was reported: PARAESTHESIA (non-serious) with onset 01Mar2021 18:00, outcome "recovered", described as "Acute paraesthesia and hypoesthesia located in head, neck, both shoulders arms and hands./Paraesthesia in head, upper torso, shoulders, arms and hands"; TINNITUS (non-serious), outcome "recovered", described as "tinnitus in ears"; HYPOAESTHESIA (non-serious) with onset 01Mar2021 18:00, outcome "recovered", described as "hypoesthesia located in head, neck, both shoulders arms and hands./Paraesthesia in head, upper torso, shoulders, arms and hands". Therapeutic measures were not taken as a result of paraesthesia, tinnitus, hypoaesthesia.  Additional information: Other medications in Two weeks was Zinc, Vitamin D, Vitamin C. Patient had covid prior vaccination. Patient was not tested for covid post vaccination. When asked about known allergies response was No, Not tested. Paraesthesia in head, upper torso, shoulders, arms and hands starting about 6 to 8 hours after vaccine was injected, and lasting about 16 to 20 hours. Acute paraesthesia and hypoesthesia located in head, neck, both shoulders arms and hands. Onset at 8 hours after injection and intermittently for following 22 hours.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Peripheral swelling
Clinical narrative: left arm swelling; numbness of left arm, neck, and lower left quarter of face; extreme lethargy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 17:00 (Lot number: En6206) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes simplex type II" (unspecified if ongoing), notes: HSV2. Concomitant medication(s) included: IBUPROFEN.  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "left arm swelling"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "numbness of left arm, neck, and lower left quarter of face"; LETHARGY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "extreme lethargy".  Additional Information: The patient had no known allergies to medications, food, or other products. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021364271 Same reporter, patient, product/ 2nd dose
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus ringing, high pitched ringing in both ears; 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 08Mar2021 (Lot number: EN6206, Expiration Date: 30Jun2021) 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: TINNITUS (non-serious) with onset 09Mar2021, outcome "unknown", described as "tinnitus ringing, high pitched ringing in both ears".  Additional Information: When probed for Concern: Consumer stated, The question patient had got and patient had not been able to get any answer. Patient had the first dose of Pfizer vaccine on 08Mar and the next morning patient woke and had tinnitus ringing, high pitched ringing in both ears and patient had no prior history of that. Patient had reported that through the various sites. What patient had been trying was find any direction whether or not patient should move forward  with a second dose. Then the concern becomes if that was triggered by the vaccine or may be a response of the vaccine. Patient was concerned if the second dose would make that worse. Second due date: consumer stated, patient had passed on second shot initially. Patient had a second shot scheduled for this week Saturday, patient think that would put me in 40 day mark.When probed for product details NDC#, UPC # for first dose vaccination:  consumer stated, There is no UPC# on my card. Consumer was informed about Pfizer Medical information. Reassurance: consumer sated, No, That is it.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Tinnitus
Clinical narrative: Scared; Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: TINNITUS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped"; NERVOUSNESS (non-serious), outcome "unknown", described as "Scared".  Additional information: Pfizer 1st shot gave him loud Tinnitus and hasn't stopped. He knew 2 other people personally that have this same side effect and they never had Covid ever. This was really scary stuff and stop blaming it on Covid. Since day 2 of his shot which he got on 17Mar2021. Patient was on day 13 of this new hell with no end in site. So far patient filed a VAERS report and notified his Primary care Dr (doctor) and ENT (ear, nose, throat). Patient said he would not get the 2nd shot as he was too scared.  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-2021359745 Same reporter/drug/AE, different patient; US-PFIZER INC-2021366082 Same reporter/drug/AE, different patient
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Movement disorder, Pain
Clinical narrative: lost the ability to use my legs resulting in being wheel chaired to my ride/no mobility; aches; fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL, start date: 10Mar2021, stop date: 10Mar2021; ADELLA; XANAX; LAMICTAL; ADDERALL. The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "lost the ability to use my legs resulting in being wheel chaired to my ride/no mobility"; PAIN (non-serious), outcome "unknown", described as "aches"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "fast heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional details: No new adverse event was noticed after second shot of covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6208) 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: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional information: The patient received the first dose of the Pfizer COVID-19 vaccine on 12Mar2021. She had mild tinnitis and this got worse on left ear and had not gotten better. She canceled second covax on 02Apr2021 as she did not want it to get worse. Now rescheduled for 15Apr2021. She was due to get the second dose on 02Apr2021 but postponed it until 15Apr2021 due to pre-existing tinnitus that "went crazy and has not subsided" after receiving the first dose. The patient wanted to know if she takes the second shot would it get worse and what she had now would subside. The patient couldn't hardly sleep. She wanted to know whether there was anything about acute hearing loss. She felt like she was flipping a coin on her life and quality of her life. Her primary care physicians nurse stated the doctor said she should take the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysgeusia
Clinical narrative: anxiety increased; strong metallic taste in mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: ER8730) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: 1997 (ongoing), notes: Verbatim: Anxiety. Family history included: "High blood pressure" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "cancer" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM taken for anxiety, start date: 1997 (ongoing); ATENOLOL taken for hypertension. The following information was reported: DYSGEUSIA (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "strong metallic taste in mouth"; ANXIETY (non-serious), outcome "unknown", described as "anxiety increased".  Additional information: The patient was taking Concomitant Product Atenolol for high blood pressure due to anxiety. she received her first dose on 25MAR2021, and within a minute or two after receiving the vaccine, she had a strong metallic taste in her mouth. States as quickly as it came, it went away. States she wanted to report it and see if it is okay to move forward with the second dose or has it been reported as new symptom or side effect. she stated she could taste it in her mouth for 30 sec to 1 minute and then it went away. Time of onset of metallic taste was 09:46. she stated that she didn't tell the pharmacist it happened because it went away and her anxiety increased about it as her second dose was approaching so she wanted to call and report it and ask about it. There were no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional Vaccines Administered on Same Date of the Pfizer Suspect and there no prior vaccination within 4 weeks. She stated that first time she got the flu vaccine, Nov 2020, she feels like she may have had a similar thing, metallic taste. States her partner thinks that it happened, but she doesn't remember it being that strong. States she also had fatigue, sore arm, and nausea. NDC, Lot, Expiration Unknown. She stated that High Blood Pressure, Heart Disease, Cancer runs in family.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Perfume sensitivity
Clinical narrative: soreness of the arm; weakness; tiredness; smelling perfume; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6208) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease", start date: 2010 (ongoing), notes: Verbatim: Hashimoto's disease. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "not recovered", described as "soreness of the arm"; ASTHENIA (non-serious) with onset 29Mar2021, outcome "not recovered", described as "weakness"; FATIGUE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "tiredness"; PERFUME SENSITIVITY (non-serious) with onset 29Mar2021, outcome "not recovered", described as "smelling perfume". Additional information: Patient said she is having soreness of the arm, weakness, tiredness, and smelling perfume. She said she had been smelling perfume some kind of perfume soap shortly after she had got the vaccine. She smells it especially when she is wearing her mask. Reporter assessment for events soreness of the arm, weakness, tiredness and smelling perfume is unspecified. Events soreness of the arm, weakness, tiredness and smelling perfume was reported as worsened.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Really bad chills; Fatigue; Low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Feb2021 09:30 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 10:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 15Feb2021 13:30, outcome "recovered" (15Feb2021), described as "Fatigue"; ASTHENIA (non-serious) with onset 15Feb2021, outcome "recovered" (15Feb2021), described as "Low energy"; PYREXIA (non-serious) with onset 16Feb2021 09:00, outcome "recovered" (16Feb2021), described as "Fever"; CHILLS (non-serious) with onset 16Feb2021, outcome "recovered" (16Feb2021), described as "Really bad chills". Therapeutic measures were not taken as a result of fatigue, asthenia, pyrexia, chills.  Additional information: Vaccination facility type was workplace clinic. Prior vaccinations (within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Oral pruritus
Clinical narrative: Itchiness on her mouth and lips; Itchiness on her mouth and lips; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 31Mar2021 (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: ORAL PRURITUS (non-serious), LIP PRURITUS (non-serious) all with onset 2021, outcome "unknown" and all described as "Itchiness on her mouth and lips".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Pain in injection area; Swelling and pain in the lymph node area/armpit of the right arm; Swelling and pain in the lymph node area/armpit of the right arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 11:30 (Lot number: EP7534) at the age of 53 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT D and Multivitamins. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 23:00, outcome "recovering", described as "Pain in injection area"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 31Mar2021 23:00, outcome "recovering" and all described as "Swelling and pain in the lymph node area/armpit of the right arm". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy, lymph node pain. Course information: The patient has not been COVID-9 tested since the vaccination. The patient stated, "I noticed the very slight swelling very late on 31Mar2021, but it didn't occur to me that it could be vaccine related until late the next day 01Apr2021."  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia, Vaccination site pain
Clinical narrative: Arm became mildly painful at injection site; Tingling radiating down to the fingertips; Sometimes feel likearm/hand weakness. Not constant butis frequent.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 13:30 (Lot number: EN6202) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; POTASSIUM CHLORIDE; LOSARTAN POTASSIUM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Arm became mildly painful at injection site"; PARAESTHESIA (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Tingling radiating down to the fingertips"; MUSCULAR WEAKNESS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Sometimes feel likearm/hand weakness. Not constant butis frequent.". Therapeutic measures were not taken as a result of vaccination site pain, paraesthesia, muscular weakness.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters along her lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 11:45 (Lot number: EP7533) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE taken for seasonal allergy. Vaccination history included: Tetanus. The following information was reported: BLISTER (non-serious) with onset 01Apr2021, outcome "not recovered", described as "blisters along her lip". Therapeutic measures were taken as a result of blister. Caller received the COVID 19 vaccine on Wednesday. Caller was not sure if this was related or not to the vaccine but she had blisters along her lip. After looking online it did seem this could potentially be a side effect. She did not had a doctor so she figured she should call Pfizer and see if it could potentially be related and if it could impact her ability of getting the second dose or what. Blisters along lip: Caller stated she only slightly noticed the blisters/bumps yesterday. Today, they feel like more burning and some of the bumps feel like was draining. The blisters was tiny, tiny. At first, she thought they were zits along her lip and she thought to herself "that was really weird". But then today, they looked different and she now thinks they was more like blisters, than zits. Time the Vaccination Was Given: Caller stated her appointment was for 11:50 but she was actually done by then, so she thinks it was around 11:45. The patient did not had additional administered vaccines as she thinks the last time she had any shot or any vaccine of any kind was a tetanus shot 5 years ago, and probably 20 years before that, she had any others. The patient did not visit to the emergency room and physician office.    No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: "Breast pain right breast"; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 11Mar2021 13:30 (Lot number: EN6199) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anemia" (unspecified if ongoing); "Tachycardia" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; BABY ASPIRIN; MAGNESIUM; TURMERIC [CURCUMA LONGA]. Past drug history included: Amoxicillin, reaction(s): "Drug allergy". The following information was reported: BREAST PAIN (non-serious) with onset 2021, outcome "unknown", described as ""Breast pain right breast"". Therapeutic measures were not taken as a result of breast pain. Additional Information: The patient was allergic to "omitted" (as reported). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021400083 same drug/reporter/patient, different dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Malaise, SARS-CoV-2 test, Vertigo
Clinical narrative: vertigo; Lethargy; Tiredness; both times feeling generally unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 16:15 (Lot number: EN6202) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA. The following information was reported: VERTIGO (non-serious) with onset 26Feb2021, outcome "not recovered", described as "vertigo"; LETHARGY (non-serious) with onset 26Feb2021, outcome "not recovered", described as "Lethargy"; FATIGUE (non-serious) with onset 26Feb2021, outcome "not recovered", described as "Tiredness"; MALAISE (non-serious) with onset 26Feb2021, outcome "not recovered", described as "both times feeling generally unwell". The events "vertigo", "lethargy", "tiredness" and "both times feeling generally unwell" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, lethargy, fatigue, malaise.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: numbness on her tongue and lips, like a tingling numbness; numbness on her tongue and lips, like a tingling numbness; numbness on her tongue and lips, like a tingling numbness; upsetting and frustrating/ States she is frustrated; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:10 (Lot number: EW0153, Expiration Date: 31Jul2021) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold urticaria" (ongoing). Concomitant medication(s) included: ANTIHISTAMINE ALLERGY RELIEF taken for cold urticaria.The following information was reported: HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 07Apr2021 15:20, outcome "recovered" (08Apr2021) and all described as "numbness on her tongue and lips, like a tingling numbness"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 2021, outcome "unknown", described as "upsetting and frustrating/ States she is frustrated". Therapeutic measures were not taken as a result of hypoaesthesia oral, paraesthesia, hypoaesthesia, frustration tolerance decreased. Additional information: She had vaccine on Wednesday and vaccine administrator massaged her arm after injection, and asked if this negatively effects her vaccine, she thought it was odd but did not think much of it, afterwards she experienced a reaction. She called her doctor and he said it might have been because of the administration of it and when she looked into it, it said not to massage the arm before the vaccine is delicate. She called the pharmacy and they said she should not have done that, they said if anything may be the vaccine does not reach full efficacy, and that was really upsetting and frustrating to her especially after this past year, she was frustrated. The patient had none treatment, she was on an antihistamine chronically for Cold Urticaria, which is an allergy to cold, she was taking that before and after the vaccine.  The AE(s) did not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Family Medical History Relevant to AE(s) was None. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypokinesia, Malaise, Oropharyngeal pain
Clinical narrative: Sore throat; Feels really drained, tired; Severe vomiting; Body aches; Severe headache/headachy; she couldn't get out of bed; feeling crummy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021404659 (Pfizer).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 11:30 (Lot number: ER8730, Expiration Date: Jul2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto Thyroiditis" (unspecified if ongoing); "Rheumotoid arthritis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for autoimmune thyroiditis (ongoing); ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF; ADVIL [IBUPROFEN] taken for arthritis (ongoing). The following information was reported: VOMITING (non-serious) with onset 10Apr2021 07:15, outcome "recovered" (Apr2021), described as "Severe vomiting"; PAIN (non-serious) with onset 10Apr2021 07:15, outcome "recovering", described as "Body aches"; HEADACHE (non-serious) with onset 10Apr2021 07:15, outcome "recovering", described as "Severe headache/headachy"; OROPHARYNGEAL PAIN (non-serious), outcome "recovering", described as "Sore throat"; FATIGUE (non-serious), outcome "recovering", described as "Feels really drained, tired"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "feeling crummy"; HYPOKINESIA (non-serious) with onset 10Apr2021, outcome "recovering", described as "she couldn't get out of bed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, pain, headache.  Additional information: Patient had no known llergies. Patient had been taking Armour Thyroid for 5 years and Advil for about a year. Patient had no other vaccine in four weeks and no COVID prior vaccination. Patient had been tested for covid post vaccination. Patient got her 1st dose on 26Mar2021 and two weeks after she started to have side effects. She went and got tested for Covid but haven't gotten her results yet. Also, she took her allergy shot on Tuesday, 23Mar2021 and started feeling crummy that following Saturday (27Mar2021). 2 weeks out, this past Saturday (10Apr2021), she couldn't get out of bed, vomiting, terrible headache, body aches, no fever, sore throat, still recovering. She had stopped throwing up but still felt really drained, tired and headachy. Patient would like to know whether her allergy shot which she received prior to the covid vaccine could have interacted in some way. Patient receive 2nd dose on Friday 16Apr2021 (Lot: EW0161, EXP: Jul2021).  Follow-up attempts are completed. No further information is expected.