chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Myalgia
Clinical narrative: hot flashes; Muscle Pain, particularly in neck, arms and back/ Muscular pain in lower back that is gradually getting worse; persistent and constant headaches, particularly after awaking from sleep and near bedtime; shivers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 07:30 (Lot number: FF8841) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 07:00, Route of Administration: Intramuscular), administration date: 02Feb2021, when the patient was 27 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 07:00, Route of Administration: Intramuscular), administration date: 14Jan2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 04Nov2021 18:00, outcome "unknown", described as "hot flashes"; MYALGIA (non-serious) with onset 04Nov2021 18:00, outcome "unknown", described as "Muscle Pain, particularly in neck, arms and back/ Muscular pain in lower back that is gradually getting worse"; HEADACHE (non-serious) with onset 04Nov2021 18:00, outcome "unknown", described as "persistent and constant headaches, particularly after awaking from sleep and near bedtime"; CHILLS (non-serious) with onset 04Nov2021 18:00, outcome "unknown", described as "shivers". It was unknown if therapeutic measures were taken as a result of hot flush, myalgia, headache, chills.  Additional information: The patient did not have covid prior vaccination and covid was not tested post vaccination and did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: 2nd shot, BP high again for 48 hours 164/107; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2021 15:00 (Lot number: EN6202) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "A-Flutter", start date: 11Mar2021 (unspecified if ongoing), notes: Pertinent details: 04Aug2021 had ablation to correct atrial flutter; "Inflamation of shoulder" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN taken for inflammation (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot Number: EL9265, Anatomical Site of Injection: Left arm, Route of administration: Intramuscular), administration date: 10Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "felt extremely unwell", "no appetite", "felt sick", "no energy", "BP 194/110". The following information was reported: HYPERTENSION (non-serious), outcome "recovered", described as "2nd shot, BP high again for 48 hours 164/107". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Family Medical History Relevant to AE(s) reported as no previous high BP nor A-Flutter . Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
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 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Nov2021 19:30 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Intolerance to peanuts (not anaphylactic)" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Nov2021 23:30, outcome "recovered", described as "Nausea"; VOMITING (non-serious) with onset 07Nov2021 23:30, outcome "recovered", described as "vomiting". Therapeutic measures were not taken as a result of nausea, vomiting. Additional information: No other vaccine in four weeks and no other medications in two weeks. No Covid prior vaccination and No Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: stomach discomfort; 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 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to penicillin" (unspecified if ongoing), notes: allergic to aspirin and penicillin. The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "allergic to aspirin", notes: allergic to aspirin and penicillin. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach discomfort". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient took Prilosec for stomach discomfort for the past five days now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Musculoskeletal pain
Clinical narrative: Neuropathy got terrible; pain in the butt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 83-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Mar2021 (Lot number: ER8730) at the age of 83 years as dose 2, single for covid-19 immunisation; insulin glargine (LANTUS) (Batch/Lot number: unknown) for diabetes mellitus. Relevant medical history included: "diabetic" (unspecified if ongoing), notes: It has worsened. He has been on diabetic medication for 15 years including Losartan and Lantus pen (insulin).; "had a touch of neuropathy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (The First dose, Lot number EN6202; in his right arm.), administration date: 27Feb2021, when the patient was 83 years old, for COVID-19 Immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "Neuropathy got terrible"; MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain in the butt". No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Musculoskeletal pain
Clinical narrative: It kicked caller's butt when caller got hers; she was already run down and tired; The pectoralis minor muscle that runs from arm pit to chest was so tense and she couldn't get it to relax; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8734) at the age of 37 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: MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "It kicked caller's butt when caller got hers"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "she was already run down and tired"; MUSCLE TIGHTNESS (non-serious) with onset 2021, outcome "unknown", described as "The pectoralis minor muscle that runs from arm pit to chest was so tense and she couldn't get it to relax". The event "the pectoralis minor muscle that runs from arm pit to chest was so tense and she couldn't get it to relax" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of muscle tightness.  Additional information: reporter (patient) stated had a weird thing happen after the first one. Patient teaches dance and pole dance requires upper body strength and arm strength. She taught a dance class the night she got her vaccine. It stretched her arms out. At one point, she is strong willed, she was not sure if it was in her head. The pectoralis minor muscle that runs from arm pit to chest was so tense and she couldn't get it to relax. She went to urgent care and they gave her a muscle relaxer. Patient thinks it was more of a life style issue instead of a vaccine issue. She knows she shouldn't have done dance the same day as the vaccine. Vaccines were given at (withheld) pharmacy. She doesn't take anything. Sometimes she takes Osteo Biflex which is a supplement. Caller clarified that she wasn't taking Osteo Biflex at the time of the vaccine. No further details provided.  Patient states her left arm is her decoration arm for balance. It is not her strong arm. Patient had also received the second dose.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: patient only had mild tenderness at injection site after her first dose; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 14Aug2021 (Lot number: FA7485) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: 2006 (ongoing); "Vertigo", start date: 2010 (ongoing); "Fibromyalgia", start date: 2007 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "patient only had mild tenderness at injection site after her first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any prior vaccination (within 4 weeks). Reporter considered the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
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).  A 10-years-old female patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Lot number: FK5618) at the age of 10 years as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 11Oct2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient had other vaccine in four weeks. Other vaccine in 4 weeks product = Flu shot. Other medications the patient received within 2 weeks of vaccination: No. No treatment was received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: my Blood Pressure went back down to normal but has since gone back up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 78 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 (1st dose), for Covid-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "my Blood Pressure went back down to normal but has since gone back up". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting 4 hours after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non- HCP). The reporter is the patient.  A 9-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 16:45 (Batch/Lot number: unknown) at the age of 9 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 09Nov2021 20:45, outcome "recovering", described as "Vomiting 4 hours after vaccination". Therapeutic measures were not taken as a result of vomiting.  Additional Information: The patient had other medical history: Asthma. He had no other vaccines in 4 weeks. No treatment received for adverse event. He did not have COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: then tingling similar to what she experienced in pre menopause; she got a warm feeling; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "then tingling similar to what she experienced in pre menopause"; FEELING HOT (non-serious), outcome "unknown", described as "she got a warm feeling".  Additional Information: Pfizer representative stated that the patient got a warm feeling and then tingling similar to what she experienced in pre menopause. About date of birth: Pfizer representative stated no idea. About age when patient experienced adverse event: Pfizer representative stated, I have no idea, no, I did not ask her any personal question. Knowing date was recorded when I received the information and what she told me that was it. I didn't ask her any additional question. About Height, weight and ethnicity: Pfizer representative stated no. About start date for adverse event: Pfizer representative stated, whenever she got the first dose for Pfizer vaccine. She told me she didn't get the second dose. About date for first dose: Pfizer representative stated, I do not know that. About treatment for adverse event: Pfizer representative stated, she did not tell me if she did or not. About medical condition and other medication, Pfizer representative stated, no, I do not know anything about her personal medical history at all. When got to know about adverse event, Pfizer representative stated, she told me this morning, let me look and I can tell you. It was around 10am today, 09Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore arm that went up her shoulder and to her neck; sore arm that went up her shoulder and to her neck; sore arm that went up her shoulder and to her neck; Sore throat; Ringing in ears/ My ears has been ringing; sore arm that went up her shoulder and to her neck was reported as worsened/ Sore throat was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101557359 (Pfizer).  A 57 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Nov2021 11:00 (Lot number: 320308D) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Flu vaccine (she has a reaction to a flu vaccine 17 years ago). The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 09Nov2021, outcome "not recovered" and all described as "sore arm that went up her shoulder and to her neck"; OROPHARYNGEAL PAIN (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Sore throat"; TINNITUS (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Ringing in ears/ My ears has been ringing"; CONDITION AGGRAVATED (non-serious) with onset Nov2021, outcome "not recovered", described as "sore arm that went up her shoulder and to her neck was reported as worsened/ Sore throat was reported as worsened". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, neck pain, oropharyngeal pain, tinnitus, condition aggravated.  Additional information: Patient is taking Multi Vitamins. She wanted to know if ever she receives the 2nd dose, will the ringing of ears be worse and if it will go away. Any AE(s) did not require a visit to Emergency Room/Physician Office. No Prior Vaccinations (within 4 weeks).    Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: sore arm that went up her shoulder and to her neck; sore arm that went up her shoulder and to her neck; sore arm that went up her shoulder and to her neck; Sore throat; Ringing in ears/ My ears has been ringing; sore arm that went up her shoulder and to her neck was reported as worsened/ Sore throat was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101557359 (Pfizer).  A 57 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Nov2021 11:00 (Lot number: 320308D) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Flu vaccine (she has a reaction to a flu vaccine 17 years ago). The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 09Nov2021, outcome "not recovered" and all described as "sore arm that went up her shoulder and to her neck"; OROPHARYNGEAL PAIN (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Sore throat"; TINNITUS (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Ringing in ears/ My ears has been ringing"; CONDITION AGGRAVATED (non-serious) with onset Nov2021, outcome "not recovered", described as "sore arm that went up her shoulder and to her neck was reported as worsened/ Sore throat was reported as worsened". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, neck pain, oropharyngeal pain, tinnitus, condition aggravated.  Additional information: Patient is taking Multi Vitamins. She wanted to know if ever she receives the 2nd dose, will the ringing of ears be worse and if it will go away. Any AE(s) did not require a visit to Emergency Room/Physician Office. No Prior Vaccinations (within 4 weeks).    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product use issue
Clinical narrative: felt sick; after getting the flu vaccine and the Pfizer booster vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 20211007294.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation; OZEMPIC. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "felt sick"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "after getting the flu vaccine and the Pfizer booster vaccine".  Additional Information: A patient receiving therapy with Ozempic reported they felt sick after getting the flu vaccine and the Pfizer booster vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Insomnia, Tremor
Clinical narrative: became chilled again and started having shaking in both arms; Tuesday throughout the day I felt chilled but had no fever; On Monday night I had trouble sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:00 (Lot number: FG3529) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "chronic myeloid leukemia" (unspecified if ongoing). Concomitant medication(s) included: SPRYCEL. Vaccination history included: Bnt162b2 (Dose 2, Lot Number: EN6203, Dose administration time: 09:00AM, Anatomical location: Left arm), administration date: 09Mar2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Lot Number: EL9266, Dose administration time: 10:00AM), administration date: 16Feb2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 08Nov2021, outcome "unknown", described as "On Monday night I had trouble sleeping"; FEELING COLD (non-serious) with onset 09Nov2021, outcome "unknown", described as "Tuesday throughout the day I felt chilled but had no fever"; TREMOR (non-serious) with onset 10Nov2021 10:00, outcome "unknown", described as "became chilled again and started having shaking in both arms". It was unknown if therapeutic measures were taken as a result of insomnia, feeling cold, tremor. Additional information: Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Other medications in two weeks are one a day vitamins.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Severe vomiting after the vaccine, headache, and fatigue; Severe vomiting after the vaccine, headache, and fatigue; Severe vomiting after the vaccine, headache, and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 9 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: VOMITING (non-serious), HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Severe vomiting after the vaccine, headache, and fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Humming tinnitus in left ear after every dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 17:30 (Lot number: FH8020) at the age of 36 years as dose 3 (booster dose), single, administered in arm left, administration date 22Mar2021 (Lot number: EP7534) as dose 2, single and administered in arm left, administration date 28Feb2021 15:30 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicilin"; Cefclor, reaction(s): "Known allergies: Cefclor". The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "Humming tinnitus in left ear after every dose". The event "humming tinnitus in left ear after every dose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of tinnitus. Additional information: No vaccine in 4 weeks. Vitamin B in 2 weeks. Humming tinnitus in left ear after every dose. Onset 1-5 days after. Continued on and off for months after first two doses. After booster dose 3 weeks ago, I am still having daily tinnitus  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Vomiting
Clinical narrative: not feeling good; throwing up/ vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (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: FEELING ABNORMAL (non-serious) with onset 10Nov2021, outcome "unknown", described as "not feeling good"; VOMITING (non-serious) with onset 10Nov2021, outcome "unknown", described as "throwing up/ vomiting"; HEADACHE (non-serious) with onset 10Nov2021, outcome "unknown", described as "headache". Additional information: Patient was reporter's wife. Wife received the Pfizer COVID-19 vaccine couple hours ago on 10Nov2021. She was throwing up and not feeling good on 10Nov2021. She had a headache on 10Nov2021. She kept on vomiting. Husband also asked how long these symptoms can be last. It was informed to him headaches and vomiting have been reported with Pfizer COVID-19 vaccine. This is a normal immune response. However, if you notice these symptoms are progressively getting worse please consult your health care provider. Informed him these symptoms may vary from one person to another. The symptoms can last for a few days. Should he notice these symptoms are not getting any better please contact your health care provider for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  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 have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; 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 37 year-old male patient received bnt162b2 (COMIRNATY) (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 "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional Information: Caller reports that both of her adult sons received the Pfizer covid 19 vaccine. Caller said both sons had to "stay home all day from work". One son had a headache and fatigue, the other son felt hot and cold, and body aches. Caller said her sons felt this way after the second dose of the vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: He has tremors in his right hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6208) at the age of 69 years as dose 2, single for covid-19 immunisation; aciclovir (ZOSTER), administration date 28Jun2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lisinopril, notes: Has been taking Lisinopril for years. Vaccination history included: Bnt162b2 (1st Dose, Right arm in the morning, lot EN6201), administration date: 25Feb2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Sore arm"; Shingles (1st shingles shot, Shingles), administration date: 04Jan2021, when the patient was 69 years old. The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "He has tremors in his right hand".  Additional information: It is unknown if additional vaccines Administered on Same Date of the Pfizer Suspect. Prior vaccinations patient had a sore arm with the 1st COVID shot that started right away and lasted about 4 days and the 2nd one patient had no side effects at all.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 70-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 (Lot number: EN6201) at the age of 69 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Shingles shot (1st shingles shot, Anatomical location: Left arm), administration date: 04Jan2021, when the patient was 69 years old, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (01Mar2021), described as "He had a sore arm". No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Not able to walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 (Lot number: EN6207) at the age of 73 years as dose 1, single and administered in arm left, administration date 16Apr2021 (Lot number: FWC153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "she broke her left femur", start date: 28Mar2020 (unspecified if ongoing); "She had Transgender surgery 20 years ago" (unspecified if ongoing), notes: She had Transgender surgery 20 years ago.; "epilepsy" (unspecified if ongoing), notes: She has epilepsy and has not had a seizure in 40 years; "glasses" (unspecified if ongoing), notes: When reading her vaccine card/needed to get on her glasses. There were no concomitant medications. Past drug history included: Baby aspirin; Centrum silver. Vaccination history included: Flu vaccine (prior to the first administration date of the suspect vaccine(s) was Flu vaccine dated unknown.  ), for Immunization. The following information was reported: GAIT INABILITY (non-serious) with onset 20Mar2021 11:00, outcome "not recovered", described as "Not able to walk".  Additional information: When reading her vaccine card, she stated she needed to get on her glasses. When you wear contacts, they give you one for distance and one for closeness. When you have cataracts, they give you both. This was all before the vaccine. The last 12 years of working were with University, and she put in 8-12 miles a night and worked 5 nights a week. She reiterated it was only noticeable after she got the injection and it could be for other reasons. Just prior in Jan or Feb2021, he felt really sick and crawled to the bathroom and threw up and walked downstairs and called for an ambulance. This occurred prior to vaccine. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was Flu vaccine dated unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (004756; 159558).  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: ALOPECIA (non-serious), outcome "unknown", described as "Hair loss". Therapeutic measures were taken as a result of alopecia.  Additional information Patient taking treatment with Xeljanz for hair loss.  Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 16:50 (Lot number: FK5127) at the age of 6 years as dose 2, single and intramuscular, administered in arm left, administration date 10Nov2021 18:15 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Born prematurely at 27 weeks" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 10Nov2021 19:15, outcome "recovered" (2021), described as "Vomited". Therapeutic measures were not taken as a result of vomiting.  Additional information: Adverse event About 30 min after receiving the first dose of paediatric COVID vaccine, (name withheld) (my son) had sushi for dinner. About 30 minutes later (1 hour after the vaccine dose), he vomited. There was a single vomiting incident, and he said he felt better. So far, he has not had any other adverse events. Facility where the most recent COVID-19 vaccine was administered was School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 14:25 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization; Bnt162b2 (DOSE 1, Batch/Lot No: Unknown. Misplaced/discarded), for COVID-19 immunization; Flu. The following information was reported: DIARRHOEA (non-serious) with onset 10Nov2021 16:15, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 10Nov2021 16:15, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, vomiting.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No Covid prior vaccination. Covid not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: My left lymph node is inflamed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Nov2021 (Lot number: EW0186) as dose 3 (booster), 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; Bnt162b2 (dose 2, single), for COVID-19 immunization. The following information was reported: LYMPHADENITIS (non-serious) with onset Nov2021, outcome "unknown", described as "My left lymph node is inflamed".  Additional Information: It was reported that, she just calling to report a side effect, she received the booster on Sunday 07Nov, in her left arm and she noticed yesterday as she came in from work and shower, that her left lymph node is inflamed. Reporter seriousness for her left lymph node is inflamed: Unspecified. Expiry Date of COVID-19 Vaccine: Unknown. Batch/lot number: EW0186  QR comment: Reporter type was not available over the call, hence captured as consumer or non-health professional by default.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Insomnia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: experienced fatigue; runny nose; sore throat; experienced poor sleep; feeling cold; night terrors; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left (arm), administration date 06Nov2021 11:15 (Lot number: FK5127) at the age of 5 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: FATIGUE (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "experienced fatigue"; RHINORRHOEA (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "sore throat"; INSOMNIA (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "experienced poor sleep"; FEELING COLD (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "feeling cold"; SLEEP TERROR (non-serious) with onset 08Nov2021, outcome "recovered" (22Nov2021), described as "night terrors". Therapeutic measures were not taken as a result of fatigue, rhinorrhoea, oropharyngeal pain. Therapeutic measures were taken as a result of insomnia, feeling cold, sleep terror.No other vaccine in four weeks,o Other mediation in two weeks, No covid prior vaccination,  Additional information: It was reported that On 08Nov2021 she experienced runny nose and sore throat that resolved by 10Nov2021. On 08Nov2021 she experienced fatigue, feeling cold without chills, and poor sleep due to night terrors. On 09Nov2021 she was began treatment with Melatonin 1mg QHS. The night terrors resolved on 22Nov2021. On 10Nov2021 the fatigue and feeling cold resolved. The causality assessment was related due to the temporality of symptom onset. The severity of all symptoms diagnosed was mild. None of the adverse events were serious. No Covid prior vaccination,no covid tested post vaccination, no Known allergies, no medical history, no other vaccine in four weeks,no Other mediation in two weeks. patient was received Tylenol for adverse event. Pfizer product had a causal effect to the adverse event was reported as yes.Concomitant Drugs, family Medical History ,relevant Tests and Specific relevant test were reported as none   No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep terror
Clinical narrative: experienced fatigue; runny nose; sore throat; experienced poor sleep; feeling cold; night terrors; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left (arm), administration date 06Nov2021 11:15 (Lot number: FK5127) at the age of 5 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: FATIGUE (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "experienced fatigue"; RHINORRHOEA (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "sore throat"; INSOMNIA (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "experienced poor sleep"; FEELING COLD (non-serious) with onset 08Nov2021 06:00, outcome "recovered" (10Nov2021), described as "feeling cold"; SLEEP TERROR (non-serious) with onset 08Nov2021, outcome "recovered" (22Nov2021), described as "night terrors". Therapeutic measures were not taken as a result of fatigue, rhinorrhoea, oropharyngeal pain. Therapeutic measures were taken as a result of insomnia, feeling cold, sleep terror.No other vaccine in four weeks,o Other mediation in two weeks, No covid prior vaccination,  Additional information: It was reported that On 08Nov2021 she experienced runny nose and sore throat that resolved by 10Nov2021. On 08Nov2021 she experienced fatigue, feeling cold without chills, and poor sleep due to night terrors. On 09Nov2021 she was began treatment with Melatonin 1mg QHS. The night terrors resolved on 22Nov2021. On 10Nov2021 the fatigue and feeling cold resolved. The causality assessment was related due to the temporality of symptom onset. The severity of all symptoms diagnosed was mild. None of the adverse events were serious. No Covid prior vaccination,no covid tested post vaccination, no Known allergies, no medical history, no other vaccine in four weeks,no Other mediation in two weeks. patient was received Tylenol for adverse event. Pfizer product had a causal effect to the adverse event was reported as yes.Concomitant Drugs, family Medical History ,relevant Tests and Specific relevant test were reported as none   No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Weight
Clinical narrative: Menstrual cycle thrown off, duration is irregular/Irregular periods; 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. Other Case identifier(s): US-PFIZER INC-202101564005 (Pfizer Inc), US-PFIZER INC-202101564011 (Pfizer Inc).  A 14 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 26Jul2021 (Lot number: EW0168, Expiration Date: Aug2021) at the age of 14 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acne" (unspecified if ongoing). Concomitant medication(s) included: ERYTHROMYCIN taken for acne. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Aug2021, outcome "unknown", described as "Menstrual cycle thrown off, duration is irregular/Irregular periods". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation irregular.  No follow-up attempts are possible. No further information is expected.