chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Jul2021 12:30 (Lot number: ER8729) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Graves Disease both with Antibodies", start date: 2008 (ongoing); "APS Syndrome", start date: 2006 (ongoing); "Osteoarthritis all joints/ Neck", start date: 2009 (ongoing); "Degenerative spine - Thoracic", start date: 2000 (ongoing); "Osteopenia", start date: 2016 (ongoing); "Invasive Breast cancer", start date: 13Oct2013 (ongoing); "Lumpectomy", start date: 13Oct2013, stop date: Apr2020; "2nd surgery lymph nodes removed", start date: 26Oct2013 (ongoing); "APS" (ongoing); "HP" (ongoing); "DVT" (ongoing); "PE" (ongoing); "Inflammatory" (ongoing); "Osteo/ Degenerative arthritis" (ongoing); "Fibromyalgia" (ongoing). Family history included: "Cancer/ Bone/ Breast" (unspecified if ongoing); "Parkinson's" (unspecified if ongoing); "RHA" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for antiphospholipid syndrome, hypersensitivity pneumonitis, deep vein thrombosis, pulmonary embolism (ongoing); IBUPROFEN taken for inflammation (ongoing); TRAMADOL taken for inflammation (ongoing); GABAPENTIN taken for osteoarthritis, spinal osteoarthritis (ongoing); TIZANIDINE taken for osteoarthritis, spinal osteoarthritis (ongoing); VIT. D3 taken for fibromyalgia (ongoing); TYLENOL taken for fibromyalgia (ongoing); BENADRYL taken for fibromyalgia (ongoing). The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 26Jul2021 14:00, outcome "recovered" (2021), described as "Rt Arm Red inj. site". Therapeutic measures were taken as a result of vaccination site erythema. Additional information: Vaccine was not administered at military facility. The patient was not administered with prior vaccinations. The patient stated that the listed conditions for arthritis etc., are ongoing several years the side effects were seriously painful then what she usually experience often. So, she would recommend physicians to review with patients to expect SE with Auto immune conditions as she was listed with meds on hand. As she doubled upon dosages and time. Cool compress in safe. The reporter considered "rt arm red inj. site" not related to bnt162b2. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the close temporal association the possibility of causal association between the event vaccination site erythema and the suspect drug BNT162B2 cannot be ruled out.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product temperature excursion issue
Clinical narrative: expired dose that was given inadvertently; The Pfizer vaccine was diluted #19:15 yesterday and left out next to the computer and given to a patient today #13:00. The dose was left in the syringe for longer than 6 hours; The Pfizer vaccine was diluted #19:15 yesterday and left out next to the computer and given to a patient today #13:00. The dose was left in the syringe for longer than 6 hours; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 13:00 (Lot number: FC3182, Expiration Date: 30Aug2021) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 , Lot:  FC3180 Exp: Oct 2021), when the patient was 37 years old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 31Aug2021 13:00, outcome "unknown", described as "expired dose that was given inadvertently"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 31Aug2021 13:00, outcome "unknown" and all described as "The Pfizer vaccine was diluted #19:15 yesterday and left out next to the computer and given to a patient today #13:00. The dose was left in the syringe for longer than 6 hours".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101138103 Same reporter/event , different  patient
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: EW0173, Expiration Date: 21Aug2021) at the age of 76 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing); "diabetic" (ongoing); "Neuropathy" (ongoing), notes: direct result of Chemo in the beginning; "Triglycerides high" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "immunocompromised" (ongoing); "multiple myeloma" (ongoing). Concomitant medication(s) included: Darzalex; Dexamethasone; Singulair; Benadryl; Tylenol; Insulin taken for neuropathy peripheral (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Anatomical location: Right Arm), administration date: 25Mar2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "swollen lymph node"; Bnt162b2 (Dose: 2, Batch/Lot No. EP7534, Expiry date: Jul2021, Anatomical location: Right Arm), administration date: 12Apr2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Aug2021, outcome "recovering", described as "Fatigue"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 27Aug2021, outcome "unknown", described as "The expiration date was 21Aug2021 and they took the vaccine on 27Aug2021". Additional information: The caller was calling about the Covid- 19 vaccine. The caller and her husband had their third vaccine on Saturday. The patient was immunocompromised and has cancer, the caller is his caregiver. When the caller looked at her record cards after they got home. The caller realized the sticker gave the lot number, but the expiration date was 21Aug2021 and they took the vaccine on 27Aug2021. The patient got the two doses and had a swollen lymph node under the right arm which is the same arm he received the vaccines in. The lymph node swelling started a couple of days after the first day after the patient received the first dose. It comes and goes and the Nurse Practitioner said it was not unusual. This never went away before the second dose. They ordered an ultrasound for it but they haven't scheduled it yet. After the third dose the patient has had fatigue. The patient has ongoing fatigue with the cancer and treatment but he slept a good bit on Saturday and yesterday. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: tongue; I guess it's reap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 (Lot number: EW0175, Expiration Date: Nov2021) at the age of 41 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 DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "tongue; I guess it's reap". Therapeutic measures were not taken as a result of tongue disorder.  Additional information: no prior vaccinations within 4 weeks. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: Sore arm; went for a flu shot and walked out with a Pfizer COVID vaccine; not approved yet for that age group; Off-Label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "went for a flu shot and walked out with a Pfizer COVID vaccine; not approved yet for that age group"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off-Label use ".  Additional information: Reporter stated, "So today I went  for a flu vaccination and received a Pfizer COVID vaccination instead which is the third and my 11 year old son also went for a flu shot and walked out with a Pfizer COVID shot (AE filed), again he is a 11 year old not approved yet for that age group."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: On 01Mar2021 she had her 2nd vaccine and it was again irritating/ could see a lot of white mucous in there; 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 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 14:30 (Lot number: EN6198) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, 6pm in her left arm, Lot #: EM9808), administration date: 09Feb2021, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "experienced peeling in her mucosa", "really groggy", "ANA screen and it was positive", "her mouth has not stopped since she got the 1st vaccine, it's just there and it's irritating", "had a hard time swallowing anything", "has a constant feeling of peeling in her mouth and it irritates her tongue and is sensitive", "has a constant feeling of peeling in her mouth and it irritates her tongue and is sensitive". The following information was reported: STOMATITIS (non-serious) with onset Mar2021, outcome "unknown", described as "On 01Mar2021 she had her 2nd vaccine and it was again irritating/ could see a lot of white mucous in there". The event "on 01mar2021 she had her 2nd vaccine and it was again irritating/ could see a lot of white mucous in there" was evaluated at the physician office visit. Therapeutic measures were taken as a result of stomatitis.  Additional information: It was reported that, after dose 2 it was again irritating a week after and went to ENT. He looked at it and could see, right now it was not as visible, he could see a lot of white mucous in there and gave steroids. Patient took that for 2 and a half weeks the complete dose and even after that she did not see any difference in there. She was treated with dexamethasone liquid 5mg and rinsed 4 times a day for 2 weeks. She started using on 5May2021 or 6May2021. It was stated that, ENT then said to go and check with dental and oral pathology and around the time she started to realize the vaccine and looked at the dates and that just may be a coincidence but it started right after the dose 1. She stated that "her brain is always there, her mouth is irritated". Additional vaccines administered on same date of the Pfizer suspect were none. Adverse events did not result in emergency room visit. Prior vaccinations within 4 weeks were none hence, adverse events following them were none. Patients medical history (including any illness at time of vaccination) were none.  No follow-up attempts are possible. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea
Clinical narrative: Bowel movements have been very watery and not solid at all; Bowel movements have been very watery and not solid at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Aug2021 (Batch/Lot number: unknown) at the age of 92 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. The patient took concomitant medications. The following information was reported: DIARRHOEA (non-serious), BOWEL MOVEMENT IRREGULARITY (non-serious) all with onset 27Aug2021, outcome "unknown" and all described as "Bowel movements have been very watery and not solid at all". Therapeutic measures were taken as a result of diarrhoea, bowel movement irregularity.  Additional information: Patient reported that patient received first dose on Thursday last week and starting Friday her bowel movements had been very watery, it was not solid and was not diarrhea but when she went that was the way it was, patient took Pepto-Bismol and that did not do anything. Patient takes Vitamins and high blood pressure medications. Patient was due for second dose on 16Sep2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Gait disturbance
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-healthcare professional (patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced  gait disturbance/having trouble walking and bone pain/patient's bones hurt, onset 2021, with outcome of unknown. Additional information: Reporter stated he was getting the same symptoms his sister got, his bones were hurting. He also had trouble walking. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Tachyarrhythmia, Urethral syndrome, Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (Weight (kg) 58.97, Height (cm) 168) received BNT162B2, intramuscular, administered in arm left, administration date 11Apr2021 09:10 (Batch/Lot number: unknown, Expiration Date: Unknown) at the age of 54 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: VACCINATION SITE PAIN (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "feel pain in my left arm, at site of injection"; HEART RATE INCREASED (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "my heart began beating very fast"; URETHRAL SYNDROME (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "I began to urinate, quite forcefully"; TACHYARRHYTHMIA (non-serious) with onset 11Apr2021 21:30, outcome "recovered" (12Apr2021), described as "Tachyarrhythmia lasted roughly 6 hours". Therapeutic measures were not taken as a result of vaccination site pain, heart rate increased, urethral syndrome, tachyarrhythmia. Additional Information: Consumer stated lot number of Covid-19 Vaccine not available as she did not have that with her, she was out walking and she can probably look at up now. she just wanted to confirm to receive vaccine or not. She got the 1st Pfizer vaccination and 12 hours later experienced an adverse co-reaction, her simple question is should she go and get the 2nd vaccine. Consumer was informed about the Pfizer Medical Information and provided with the number. Follow-up (13Sep2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 13Sep2021, this case now contains all required information to be considered valid. Event experienced by patient are added. Follow-up (18Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Vision changes; blurriness, unable to visually focalize; Tingling & numbness traveling down shoulder into lower back; pain and soreness; Nausea; vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Aug2021 14:00 (Batch/Lot number: unknown) at the age of 23 years 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: VISION BLURRED (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Vision changes; blurriness, unable to visually focalize"; HYPOAESTHESIA (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Tingling & numbness traveling down shoulder into lower back"; PAIN (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "pain and soreness"; NAUSEA (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "vomiting"; HEADACHE (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vision blurred, hypoaesthesia, pain, nausea, vomiting, headache. Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. known allergies: No. other medical history: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Vision changes; blurriness, unable to visually focalize; Tingling & numbness traveling down shoulder into lower back; pain and soreness; Nausea; vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Aug2021 14:00 (Batch/Lot number: unknown) at the age of 23 years 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: VISION BLURRED (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Vision changes; blurriness, unable to visually focalize"; HYPOAESTHESIA (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Tingling & numbness traveling down shoulder into lower back"; PAIN (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "pain and soreness"; NAUSEA (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "vomiting"; HEADACHE (non-serious) with onset 31Aug2021 14:15, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vision blurred, hypoaesthesia, pain, nausea, vomiting, headache. Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. known allergies: No. other medical history: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: My first dose, my arm was just sore and I was tired.; My first dose, my arm was just sore and I was tired.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 15:45 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pregnancy" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing); "known allergies:Rosemary" (unspecified if ongoing). Date of last menstrual period: 24Jan2021. The patient was 27 weeks pregnant at the time of exposure to bnt162b2. The patient was 30 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 01Nov2021. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "My first dose, my arm was just sore and I was tired.". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: If other vaccine in four weeks: No. Other medications in two weeks: Prenatal vitamins. Adverse event: My first dose, my arm was just sore and I was tired. My second dose, I woke up around 3:30 in the morning shaking so bad I started having Braxton Hicks contractions. My nail beds were blue and I couldn't stop the chills. I ached all over and was running a fever. Then I started vomiting. The chills and shaking stopped after about three hours (with the help of a hot shower, lots of blankets, and a heating pad). The Braxton Hicks contractions stopped after the shaking stopped. I was achy and feverish for over 24 hours though every time the Tylenol wore off. If covid prior vaccination: No. If covid tested post vaccination: No.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Reports ackey flu like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain". Additional information: 77 year old Male 169 lb. 5'6". 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-202101138190.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. A 45 year-old 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 Immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headache".  Additional information: Caller on behalf of her 45 year old female relative who states that after her second dose of the Pfizer Biontech covid 19 vaccine she has had a headache lasting more than 10 days that caller describes as "bothersome" Seeking information and reports about this. Caller states she has a concern. She has a relative who has had a persistent headache lasting longer than 10 days after their second dose of the 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: Hypoaesthesia
Clinical narrative: Half her face was numb; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Half her face was numb".  Additional Information: Reporter Subtype: General Public. Reporter (A 60 year old healthy male) that takes no medication, has concerns about receiving the Pfizer COvid-19 Vaccine asks question: If I get the vaccine, who will be responsible if I have an injury? Is the drug safe? I have heard of a lot of people getting bad effects from it. There was a lady who came to work and half her face was numb. No further details provided. What are the 6 months topline analysis results of the Pfizer-BioNTech COVID-19 Vaccine? Response received as On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine Study. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the Centers for Disease Control and Prevention (CDC) and 95.3% effective in preventing severe disease as defined by the Food and Drug Administration (FDA). Vaccine was 100% effective in preventing COVID-19 cases internationally, where the B.1.351 lineage is prevalent. Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose. Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at: withheld: Please note that the "Pfizer-BioNTech COVID-19 Vaccine - Antibody Persistence and Duration of Immunity" SRD has been updated to include the Press Release information. Information received was helpful states reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth loss
Clinical narrative: teeth falling out; 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 parent.  A male 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 Immunization. The following information was reported: TOOTH LOSS (non-serious), outcome "unknown", described as "teeth falling out".  Additional information: Reporter was concerned for her son who received the 2 dose vaccination. She asked to provide her information about side effects and any concerns with ingredients in it that would make teeth falling out. Regular dental care and now dentist is addressing to look into this vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen and incredibly painful lymph node in the left arm pit; Swollen and incredibly painful lymph node in the left arm pit; Swollen and incredibly painful lymph node in the left arm pit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 13:00 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Postural orthostatic tachycardia syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 17Aug2021, outcome "recovered" (Aug2021) and all described as "Swollen and incredibly painful lymph node in the left arm pit". Therapeutic measures were not taken as a result of peripheral swelling, lymph node pain, lymphadenopathy.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: need to sleep much more than normal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "need to sleep much more than normal".  Additional information: Reported need to sleep much more than normal. Event 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: Circumstance or information capable of leading to medication error, Illness
Clinical narrative: sick for a day; Caller stated she is worried that her daughter may have not gotten the correct vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for a day"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Caller stated she is worried that her daughter may have not gotten the correct vaccine.".  Additional information: Caller stated she is really confused about the approval of the Pfizer covid vaccine. Her 18 years old daughter received the first dose and was sick for a day. She has allergy and does not take flu vaccine due to her allergies. Caller stated she is worried that her daughter may have not gotten the correct vaccine. She has to take it to attend her collage. she is worried that her daughter may not be the candidate for this vaccine and may experience bad reaction. She queried is it COMIRNATY that is out there or Pfizer covid vaccine that people are getting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Heart rate, Heart rate increased, Lymphadenopathy, Oligomenorrhoea
Clinical narrative: Swollen lymph nodes; heart rate went faster; had her period (menstrual cycle) twice and it's been lasting longer than usual.; neck was swollen and tight; could not walk; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to sulfites" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Swollen lymph nodes"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "heart rate went faster"; OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "had her period (menstrual cycle) twice and it's been lasting longer than usual."; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "neck was swollen and tight"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "could not walk". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Asked whether she would have worse side effects after the 2nd dose, specifically regarding swollen lymph nodes. She had a side effect after the first dose of the vaccine. Asked whether she should get the second dose. She said she would call back later, she wanted to call her doctor. HCP stated that she received the 1st dose of the Pfizer COVID vaccine about 2 and 1/2 weeks ago. She experienced swollen lymph nodes that lasted more than 2 weeks. Her neck was swollen and tight, she could not walk. Her husband had a swollen lymph node in his hand after receiving the vaccine. She had to sit after she got her dose. Her heart rate went faster and felt like a rush of blood to my head. She had her period (menstrual cycle) twice and it had been lasting longer than usual. Asked regarding the efficacy after 1st dose and to give her a letter stating that she should not get the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen lymph nodes; heart rate went faster; had her period (menstrual cycle) twice and it's been lasting longer than usual.; neck was swollen and tight; could not walk; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to sulfites" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Swollen lymph nodes"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "heart rate went faster"; OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "had her period (menstrual cycle) twice and it's been lasting longer than usual."; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "neck was swollen and tight"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "could not walk". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Asked whether she would have worse side effects after the 2nd dose, specifically regarding swollen lymph nodes. She had a side effect after the first dose of the vaccine. Asked whether she should get the second dose. She said she would call back later, she wanted to call her doctor. HCP stated that she received the 1st dose of the Pfizer COVID vaccine about 2 and 1/2 weeks ago. She experienced swollen lymph nodes that lasted more than 2 weeks. Her neck was swollen and tight, she could not walk. Her husband had a swollen lymph node in his hand after receiving the vaccine. She had to sit after she got her dose. Her heart rate went faster and felt like a rush of blood to my head. She had her period (menstrual cycle) twice and it had been lasting longer than usual. Asked regarding the efficacy after 1st dose and to give her a letter stating that she should not get the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Condition aggravated, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: armpit is sore and swollen was reported as worsened; sore and swollen arm pit the same side/arm as the injection; sore and swollen arm pit the same side/arm as the injection; armpit is sore and swollen; armpit is sore and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 20:00 (Lot number: FF2588) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: she has mild asthma since she was a baby. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "sore and swollen arm pit the same side/arm as the injection"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "armpit is sore and swollen"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "armpit is sore and swollen was reported as worsened". Therapeutic measures were not taken as a result of axillary pain.  Additional information: The swelling and soreness is under her left arm which is the same arm she got the vaccine in. Her daughter first noticed the soreness and swelling yesterday 01Sep2021. The daughter just told the mother today. When she moves her arm around it was sore feeling. A girl at her schools armpit did the same thing, but hers already went away. She had not received treatment.  She did not required emergency room and physician office. No prior Vaccinations (within 4 weeks). No list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Couple hours of chills; a little bit of body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had allergic reactions" (unspecified if ongoing), notes: I had allergic reactions. Not to vaccines but to IV antibiotics; "anaphylactic reactions" (unspecified if ongoing), notes: I have had anaphylactic reactions. I seemed to do ok, no anaphylaxis; "type 1 diabetes" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Couple hours of chills"; PAIN (non-serious), outcome "recovered", described as "a little bit of body aches".  Additional information: It was reported that patient received both doses, one a month ago and one a week ago. Did pretty well considering she got them late because she had allergic reactions. Not to vaccines but to IV antibiotics. She had had anaphylactic reactions. she seemed to do ok, no anaphylaxis. Couple hours of chills and maybe a little bit of body aches then she was fine. She had question and wanted to report symptoms that may or may not be weird. She had her first dose of Pfizer Covid-19 Vaccine a month ago, and her second dose of Pfizer Covid-19 Vaccine a week ago today. After the first dose of Pfizer Covid-19 Vaccine she was fine, it doesn't matter, but she had a mild chill and a little bit of body aches for an hour and then she was good.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: the first dose his son had a sore arm that was better in less than 24 hours and nothing else; sore; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2) (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 IN EXTREMITY (non-serious), outcome "recovered", described as "the first dose his son had a sore arm that was better in less than 24 hours and nothing else"; PAIN (non-serious), outcome "recovered", described as "sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort, Pain in extremity
Clinical narrative: it's getting worse; now can barely lift her arm; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Lot number: ER8735) at the age of 51 years as dose 2, single and administered in arm left, administration date 06Apr2021 12:49 (Lot number: ER8734) as dose 1. single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "not recovered", described as "sore arm"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "it's getting worse"; LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "now can barely lift her arm". Therapeutic measures were not taken as a result of pain in extremity, condition aggravated, limb discomfort.  Additional information: Patient had some arm soreness at first and now can barely lift her arm was reported as worsened. Patient did not received any other vaccination with in four weeks of COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Bedridden, Bone pain, Dizziness
Clinical narrative: This is a spontaneous report received from a contactable other HCP. A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 58, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced asthenia (weak), neuralgia (nerve pain), bedridden (she was in bed for 15 days/could not get out of bed), with outcome of recovered; bone pain, dizziness (lightheaded), fall ("about to fall so many times"), amnesia (memory loss) and felt abnormal (had brain fogginess), with outcome of recovering. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Neuralgia
Clinical narrative: This is a spontaneous report received from a contactable other HCP. A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 58, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced asthenia (weak), neuralgia (nerve pain), bedridden (she was in bed for 15 days/could not get out of bed), with outcome of recovered; bone pain, dizziness (lightheaded), fall ("about to fall so many times"), amnesia (memory loss) and felt abnormal (had brain fogginess), with outcome of recovering. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Consumer has not menstruated in the 3 months since having comirnaty shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Consumer has not menstruated in the 3 months since having comirnaty shots".  Additional information: Patient not on birth control and definitely not pregnant. Event 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: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced illness (outcome unknown). Additional information: Reporter stated four people just got the booster and they are still sick four days later from Pfizer. Follow-up attempts completed. No further information expected.