chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Sluggishness
Clinical narrative: feeling pretty sluggish; achy; has not been himself; 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 male patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: Stated that he did have shingles a couple of years ago and was pretty bad. Stated that he has not had the shingles vaccine. The patient's concomitant medications were not reported. The following information was reported: SLUGGISHNESS (non-serious), outcome "unknown", described as "feeling pretty sluggish"; PAIN (non-serious), outcome "unknown", described as "achy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "has not been himself".  Additional information:  Caller stated that he had both shots of Pfizer and has been feeling pretty sluggish, achy and not himself for past couple of weeks. Stated that he had noticed there was question if he had the vaccine for shingles. Stated that he did have shingles a couple of years ago and was pretty bad. Stated that he has not had the shingles vaccine. Wanted to know if this had any impact on how bad the vaccine was. Stated that he had the second shot yesterday. Is for BioNTech Covid 19 vaccine.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: soreness at injection site; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 28Mar2021 10:30 (Lot number: ER8733) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Grapefuit allergy" (unspecified if ongoing); "chalazion" (unspecified if ongoing), notes: being treated with antibiotics (oral, ointment and eye drops). Concomitant medication(s) included: CEPHALEXIN [CEFALEXIN] taken for hordeolum; DOXYCYCLIN [DOXYCYCLINE] taken for hordeolum.  The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm".  Additional information: The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient had not been tested post-vaccination. The patient had no medication allergy.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: back pain; foot pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (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: BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "back pain"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "foot pain".  Is the Reporter a Healthcare Professional (HCP) was Unknown. Yea the Reporter's contact information available to you or a sub-contracted party. Is the Reporter the prescribing HCP wasUnknown  Suspect product(s): COVID-19 Vaccine   Additional information:  Interpreter/(language withheld)- swap from first time caller is consumer calling about side effects after receiving the first vaccine on 06Apr she has back pain and foot pain. Read social media. Due to long hold time. Will fax to Pfizer from an agency. For AE.  Medical Information Were not unaddressed medical questions referred or forwarded to Medical Information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headaches; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: vertigo 2 years ago. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headaches"; DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "dizziness".  Additional information: She received her first dose of the covid-19 vaccine on 31Mar2021, states 10-12 days later is experiencing headaches and dizziness, she stated that she was in good health and did not take any medications, had vertigo 2 years ago, second dose is scheduled for 21Apr2021 inquiring if symptoms will be worse, she received the shot because her husband was diagnosed with pancreatic cancer, relayed PMI number.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypomenorrhoea, Menstruation irregular, Pain, Pustule
Clinical narrative: My periods started occurring later and lighter, which is cause for concern because I'm usually very regular and heavy. I also started developing boil-like small pustules all over my body, which are painful and unseemly. The boil-like pustules are red on the outside and developed on my thigh, arms, abdomen, underarms, neck and shins.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling, Ultrasound scan normal
Clinical narrative: Significant axillary lymphadenopathy, swelling
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Fatigue; muscle soreness; headache; fuzzy headiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 16:15 (Lot number: EP6955) at the age of 25 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D; 5 HTP [OXITRIPTAN]. Past drug history included: Ciprofloxacin for Known allergies: Ciprofloxacin, notes: Known allergies: Ciprofloxacin. Vaccination history included: Bnt162b2 (Dose number: 1, Batch/lot number: EP6955, Anatomical Location: Arm Left), administration date: 23Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "Fatigue"; MYALGIA (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "muscle soreness"; HEADACHE (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "headache"; FEELING ABNORMAL (non-serious) with onset 14Apr2021 09:00, outcome "recovered", described as "fuzzy headiness". Therapeutic measures were not taken as a result of fatigue, myalgia, headache, feeling abnormal.  Follow up (20Apr2021): This is a follow-up spontaneous report received in response to the mail trail regarding the confirmation below mention Query the response included:  Query: The Pfizer Drug safety unit recently received the attached report submitted by via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events.  Please also help to confirm the primary reporter of the report (the patient of others) and provided relevant information for the reporter.  This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  Response: Patient   confirm became aware of this event the evening of 14Apr2021. the patient of is my son.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Cardioversion, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath, weakness, heart racing, fatigue 1 day after shot walked to neighbors house for Thanksgiving and felt the above symptoms. Ignored the symptoms for 2 weeks. Went to visit daughter and she called a cardiogist to evaluate. Diagnosed with a-fib. Never had a history of heart problems. Was put on 2 heart medications.(Diltiazem 180mg, Eliquis 5mg. Went into ER for a cardioversion. Returned to normal rhythm for only 2 days and back in afib. Went back to cardiologist who did an echocardiogram which showed afib, tachycardia, low ejection fracture 25%, Leakey mitral valve. Given another new medication Metoprol 25mg Amiodarone 200mg Told to stop taking Diliazem Going back home today where I live and made appointment for a cardiologist to continue my care. I currently still have fatigue, shortness of breath, weakness, lightheadedness, palpitations. Can't walk a few feet without needing to stop.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Fatigue, Gait disturbance
Clinical narrative: Shortness of breath, weakness, heart racing, fatigue 1 day after shot walked to neighbors house for Thanksgiving and felt the above symptoms. Ignored the symptoms for 2 weeks. Went to visit daughter and she called a cardiogist to evaluate. Diagnosed with a-fib. Never had a history of heart problems. Was put on 2 heart medications.(Diltiazem 180mg, Eliquis 5mg. Went into ER for a cardioversion. Returned to normal rhythm for only 2 days and back in afib. Went back to cardiologist who did an echocardiogram which showed afib, tachycardia, low ejection fracture 25%, Leakey mitral valve. Given another new medication Metoprol 25mg Amiodarone 200mg Told to stop taking Diliazem Going back home today where I live and made appointment for a cardiologist to continue my care. I currently still have fatigue, shortness of breath, weakness, lightheadedness, palpitations. Can't walk a few feet without needing to stop.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart valve incompetence, Palpitations, Tachycardia
Clinical narrative: Shortness of breath, weakness, heart racing, fatigue 1 day after shot walked to neighbors house for Thanksgiving and felt the above symptoms. Ignored the symptoms for 2 weeks. Went to visit daughter and she called a cardiogist to evaluate. Diagnosed with a-fib. Never had a history of heart problems. Was put on 2 heart medications.(Diltiazem 180mg, Eliquis 5mg. Went into ER for a cardioversion. Returned to normal rhythm for only 2 days and back in afib. Went back to cardiologist who did an echocardiogram which showed afib, tachycardia, low ejection fracture 25%, Leakey mitral valve. Given another new medication Metoprol 25mg Amiodarone 200mg Told to stop taking Diliazem Going back home today where I live and made appointment for a cardiologist to continue my care. I currently still have fatigue, shortness of breath, weakness, lightheadedness, palpitations. Can't walk a few feet without needing to stop.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Influenza like illness, Pyrexia
Clinical narrative: Very high fever of 103 and flu like symptoms for 24 hours following second shot.  After having a normal and regular menstrual cycle with no perimenopausal  symptoms in August, received the second dose on August 25, 2021 and have not had a menstrual period since receiving the second dose. I have no other systems that would indicate that this is a result of menopause due to my age. I am healthy, active and have no known health issues. I  do not have a history of irregular, or changes in, menstruation leading up to the complete absence of menstruation following the second vaccination shot.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: The patient was 12 years old at the time of the vaccination, however, they received the pediatric dose of pfizer for their second shot.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspepsia, Laboratory test, Mechanical urticaria, Rash
Clinical narrative: First, a very large rash all over my body (diagnosed by doctor on 12/17/2021). Later diagnosed with dermatographic urticaria on 1/18/2022. The urticaria is still ongoing and causing me considerable discomfort. It has substantially degraded my quality of life. There does not seem to be any perceivable improvement. It has caused me significant anxiety and some digestive problems too.  It is unclear if the digestive problems are related to the anxiety or the reaction to the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Computerised tomogram normal, Electrocardiogram normal, Erythema
Clinical narrative: On 12/6/21, I broke out with full body hives starting as spontaneous  round, intensely itchy red wheels that spread to parts of my body throughout the day, especially if I scratched them. I have not changed soaps, detergents, or anything about my daily living prior to this event that would signify a new allergy. Every inch of my body broke out, with the worst being my scalp and ears. This reaction continued for two days, maintained with some Benadryl every 6 hours. On 12/8/21, I experienced intense throbbing chest pain over my heart while also still dealing with the hives. Since this chest pain was unchanged by antacids, I was afraid of internal swelling, so I went to the Emergency Department. They found no cause for the hives and chest pain, placed me on 5 days of 50mg Prednisone and recommended daily Zyrtec and  Pepcid to contain the itching and hives. I am still taking Zyrtec to this day but have been able to reduce from 10mg a day to 5mg a day. I cannot go without a dose of Zyrtec or the itching comes back so intensely that I can?t focus on working.  I have notified my PCP of my condition but have not been seen by her due to the Zyrtec and Pepcid offering relief.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial necrosis marker normal, Pain, Pruritus, Troponin normal, Urticaria
Clinical narrative: On 12/6/21, I broke out with full body hives starting as spontaneous  round, intensely itchy red wheels that spread to parts of my body throughout the day, especially if I scratched them. I have not changed soaps, detergents, or anything about my daily living prior to this event that would signify a new allergy. Every inch of my body broke out, with the worst being my scalp and ears. This reaction continued for two days, maintained with some Benadryl every 6 hours. On 12/8/21, I experienced intense throbbing chest pain over my heart while also still dealing with the hives. Since this chest pain was unchanged by antacids, I was afraid of internal swelling, so I went to the Emergency Department. They found no cause for the hives and chest pain, placed me on 5 days of 50mg Prednisone and recommended daily Zyrtec and  Pepcid to contain the itching and hives. I am still taking Zyrtec to this day but have been able to reduce from 10mg a day to 5mg a day. I cannot go without a dose of Zyrtec or the itching comes back so intensely that I can?t focus on working.  I have notified my PCP of my condition but have not been seen by her due to the Zyrtec and Pepcid offering relief.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient called Saturday, 2/12/2022, and told pharmacist that after receiving the COVID-19 Pfizer vaccine the day before, her left arm had swollen to the size of a golf ball around the injection site, it was hot to the touch, and she had a rash all over her body. Pharmacist  initially instructed her to add ice to the injection site, and  take Diphenhydramine.  However, once the patient made it clear that this was a systemic reaction, the pharmacist instructed her to go to Urgent Care to be checked by attending provider.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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 71 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 71 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Lethargy
Clinical narrative: 24 hours, nausea, chills, aches, headache, weakness, exhaustion, lethargic.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: 24 hours, nausea, chills, aches, headache, weakness, exhaustion, lethargic.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: After getting Moderna booster, a few weeks later, the lymph node in my underarm on that side became swollen. It is still swollen, now 3 months later. Planned ultrasound March 4.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram PR segment depression, Electrocardiogram abnormal, Palpitations
Clinical narrative: Patient presented to the hospital with chest pain and palpitations one week after COVID vaccine.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever (100ºF  to 104ºF) and vomiting began 2/8/2022. Visited urgent care 2/11/2022.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I am now able to breath so much better. I am also able to hold my breath; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: I have been a smoker for over 40 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I am now able to breath so much better. I am also able to hold my breath".  Additional information: The patient just wanted to pass this information on since patient received 2nd Pfizer vaccine. Prior to 2nd vaccine patient would have trouble holding breath for a short period of time without starting to hyperventilate in order to catch breath. The patient also had raspy breathing when patient would lie down at night. The could hear the fluid in lung when patient would breath. Well, since patient received 2nd vaccine, now able to breath so much better also able to hold patient breath.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nasal congestion, Pain, Pain in extremity
Clinical narrative: Soreness in left arm (which is the arm that received the shot); fatigue; mild body aches; short-term diarrhea; nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: EP6955) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Date:22Mar2021 10:00, Lot:EP9655, Location: arm left), administration date: 22Mar2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "Soreness in left arm (which is the arm that received the shot)"; FATIGUE (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "fatigue"; PAIN (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "mild body aches"; DIARRHOEA (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "short-term diarrhea"; NASAL CONGESTION (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "nasal congestion". Therapeutic measures were not taken as a result of pain in extremity, fatigue, pain, diarrhoea, nasal congestion.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Patient had no known allergies. Patient other medical history was none. Patient was not pregnant at the time of vaccination. Yes, Pfizer have permission to contact you about this report. No, Pfizer have permission to contact your the patient's healthcare provider about this report. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. No, treatment received for the adverse event. Patient did not had allergies to medications, food, or other products. Vaccine Facility information was available. He was the primary reporter (patient's husband). The patient was his wife. He first became aware of the occurrence of the reported events on Tuesday, 13Apr.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I just want to know if I could take an extra strength of Tylenol for my headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: HEADACHE (non-serious), outcome "unknown", described as "I just want to know if I could take an extra strength of Tylenol for my headache.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Fatigue, Nausea
Clinical narrative: more of the exhaustion and nausea; more of the exhaustion and nausea; but it is now somewhat different as I have more energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 10:30 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CAD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Costracontritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: cats" (unspecified if ongoing); "Known allergies: Crabmeat" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL; AMLODIPINE; SIMVASTATIN; ALPRAZOLAM. Past drug history included: Prednisone, reaction(s): "Known Allergies: Prednisone"; Iron injections, reaction(s): "Know Allergies: Iron injection". Vaccination history included: Bnt162b2 (dose 1, single, administration time 15:30, vaccine location-Left arm, No treatment was received for AE), administration date: 09Feb2021, when the patient was 81 years old, for covid-19 immunization, reaction(s): "nausea", "exhaustion".  The following information was reported: NAUSEA (non-serious), FATIGUE (non-serious) all with onset Mar2021, outcome "recovering" and all described as "more of the exhaustion and nausea"; ENERGY INCREASED (non-serious) with onset 2021, outcome "recovering", described as "but it is now somewhat different as he have more energy".  Additional information: It was reported that, the patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dysgraphia, Muscle twitching, Panic reaction, Tremor
Clinical narrative: hand shaking; eye twitching; he couldn't write normally; caller was confused; He panicked; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER6207) at the age of 68 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Blood sugar" (unspecified if ongoing); "heart attack and stroke" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN taken for blood pressure measurement, start date: 2004. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Mar2021, for COVID-19 Immunization, reaction(s): "shaking of hand".  The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "hand shaking"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "eye twitching"; DYSGRAPHIA (non-serious) with onset 2021, outcome "unknown", described as "he couldn't write normally"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "caller was confused"; PANIC REACTION (non-serious) with onset 2021, outcome "unknown", described as "He panicked".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Mild soreness in arm; Mild headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A male patient received bnt162b2 (BNT162B2) (Lot number: ER8734) 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 "Mild soreness in arm"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache".  Additional information: The patient's wife reported that her husband, the patient, experienced mild soreness in his arm and a mild headache following the Covid-19 vaccine. She declined to complete safety report for the patient, stating that the mild soreness in her husband arm and mild headache were not serious and were expected with a vaccine. She reported that he received his Covid-19 vaccine from the same lot number that she provided for her product details.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Fatigue; headache; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies penicillin. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills". The events "fatigue", "headache" and "chills" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue, headache, chills.  Additional Information: The patient had fatigue, headache, chills. Headache after 2nd shot and reoccurred two weeks after getting 2nd vaccine and have not gone away. Adverse event start date: 20Mar2021. The patient was not recovered. The patient does not had treatment. The patient has not had Covid prior vaccination and has not tested Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Really bad headache; Throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:50 (Lot number: Unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Verbatim: High blood pressure, Additional Information for Other Conditions: Caller reported that the patient was diagnosed with high blood pressure about a year ago.; "Flu shot" (unspecified if ongoing), notes: patient gets the flu shot yearly but never gets sick. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 16Apr2021 05:00, outcome "not recovered", described as "Really bad headache"; VOMITING (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Throwing up".  Additional Information: Reporter seriousness for Really bad headache: Unspecified. Reporter seriousness for Throwing up: Unspecified. The reporter is patient' daughter. The reporter said that she was calling on behalf of her mother because her mother doesn't speak English.  It was reported that the patient was really sick. The patient had a really bad headache and was throwing up. The patient contacted her physician and the physician instructed the patient to call Pfizer. The patient woke up around 5 AM on 16Apr2021 with a headache and that the headache has just gotten worse and worse.  The patient began taking the sleeping medication and blood pressure medication at the same time about a year ago. The patient was taking concomitant products- unspecified blood pressure medication (Start: Unspecified Stop: Ongoing) due to high blood pressure. The patient began taking blood pressure medication about a year ago. Investigation Assessment: not provided. The patient's physician said the blood pressure medication was not going to let the patient sleep so the physician prescribed the sleeping medication as well. Vaccine Lot Expire Date: Unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as N/A, first dose. There was no additional Administered Vaccines. There was not any AE(s) did not require a visit to Emergency Room and Physician Office. There were no prior Vaccinations (within 4 weeks). There were no AE(s) following prior vaccinations. There was no family Medical History Relevant to AE(s) and relevant Tests reported. The patient called her doctor to see what to do about the headache and vomiting but the patient's physician said they didn't have an answer for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 14:00 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: penicillin" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of vaccine, Fatigue, headache, chills.), for COVID-19 Immunisation, reaction(s): "chills", "Fatigue", "headache". The following information was reported: HEADACHE (non-serious) with onset 20Mar2021, outcome "not recovered", described as "headache". The event "headache" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache.  Additional Information: Headache after 2nd shot and reoccurred two weeks after getting 2nd vaccine and have not gone away. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Pain at site; Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 10:00 (Lot number: EN5318) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose: Date: 15Jan2021, Time: 10AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: PFIZER EL3248, ADVERSE EVENTS:, AE Term: Pain at site, Onset date: 15Jan2021, Onset time: 9 hours, Seriousness criteria: Not serious, AE Outcome: Recovered, If recovered or recovered with sequelae, Date of recovery: 17Jan2021, Treatment: Did the adverse event require the initiation of new medication/ other treatment/ procedure?: No), administration date: 15Jan2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "Pain at site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Feb2021, outcome "recovered" (07Feb2021), described as "Pain at site"; FATIGUE (non-serious) with onset 06Feb2021, outcome "recovered" (15Feb2021), described as "Fatigue"; HEADACHE (non-serious) with onset 06Feb2021, outcome "recovered" (15Feb2021), described as "Headache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache.  Additional information: patient had Pain at site on 15Jan2021 9 hours, outcome was Recovered on 17Jan2021 and 08Feb2021. No treatment was received. Patient's Medical history including any illness at time of vaccination was reported as None. Family medical history and relevant tests were reported as none.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Not adverse at all in fact I typically use inhaler 3 times day, for following 4 days did not require at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Apr2021 12:00 (Lot number: ER8734) at the age of 63 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Low Thyroid" (unspecified if ongoing). Concomitant medication(s) included: PLAVIX; SYNTHROID; LIPTOR [ATORVASTATIN]. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 Immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 05Apr2021 11:45, outcome "unknown", described as "Not adverse at all in fact I typically use inhaler 3 times day, for following 4 days did not require at all".  Additional information: The patient was not pregnant at time of vaccination. The patient had no COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks. Clinical course: Not adverse at all in fact, patient typically used inhaler 3 times day, for following 4 days did not require at all, and know ones with arthritis, that next day after shot, no swelling, tightness or pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021457421 Same reporter, suspect drug and event; different patient
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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". Additional information: The person reported having a sore arm after the vaccine was administered. 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6202) at the age of 73 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension.  The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "Dizziness".  Additional information: When probed for the start date of dizziness: Consumer stated, "The dizziness started after the 1st dose of vaccine like I said I did not take any attention that was approximately the end of the 1st week. Also patient did not pay any attention to that because it was very mild okay.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) 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: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint range of motion decreased, Muscular weakness, Peripheral swelling
Clinical narrative: Intense headache frontal lobe; Intense swelling of legs; hard to bend weakness in legs; hard to bend weakness in legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 13:30 (Lot number: EN6207) at the age of 64 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. The following information was reported: HEADACHE (non-serious) with onset 28Mar2021 13:30, outcome "recovering", described as "Intense headache frontal lobe"; PERIPHERAL SWELLING (non-serious) with onset 28Mar2021 13:30, outcome "recovering", described as "Intense swelling of legs"; MUSCULAR WEAKNESS (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset 28Mar2021 13:30, outcome "recovering" and all described as "hard to bend weakness in legs". Therapeutic measures were not taken as a result of headache, peripheral swelling, muscular weakness, joint range of motion decreased.  Additional information: The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in 4 weeks. The event happened 10 days after 1st vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: experiencing sharp pain in the lower abdomen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 53 year-old female 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: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "experiencing sharp pain in the lower abdomen.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Apr 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced tremors (really bad tremors), onset Apr 2021, with outcome of unknown. Additional information: Patient received COVID-19 vaccine yesterday. Last night he had really bad tremors to the point he couldn't even hold a glass of water. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spasms in her thighs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasms in her thighs".  Additional information: The patient due to take second dose tomorrow. Has been experiencing muscle spasms in her thighs and wants to see a physician. Wants to know if she can delay getting her second dose of Covid Vaccine for a week or so.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Caller is battleing a cold.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Caller is battleing a cold.". Additional information: She was due to take second dose today at noon. She was not running a fever.  No follow up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: deveopled a cold; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "deveopled a cold". Patient's second dose was scheduled on 17Apr2021.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: His wife has pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "His wife has pain at the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: She is now experiencing nausea, fatigue and body pain.; She is now experiencing nausea, fatigue and body pain.; She is now experiencing nausea, fatigue and body pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: NAUSEA (non-serious), FATIGUE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "She is now experiencing nausea, fatigue and body pain.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.