chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Eczema
Clinical narrative: "Developed Eczema on my ears and chest"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Vegetable allergy" (unspecified if ongoing), notes: Spinach Allergy; "Sinus tachycardia" (unspecified if ongoing); "AFib" (unspecified if ongoing), notes: lone afib. The patient's concomitant medications were not reported. Past drug history included: Streptomycin, reaction(s): "Drug allergy". The following information was reported: ECZEMA (non-serious) with onset May2021, outcome "recovering", described as ""Developed Eczema on my ears and chest"". The event ""developed eczema on my ears and chest"" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of eczema on ears and chest and included treatment with steroidal cream from an unknown date. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Its something in my leg, its in my arm/Its a lot inside of my arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: EW0169) 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: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Its something in my leg, its in my arm"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Its a lot inside of my arm.". Therapeutic measures were not taken as a result of limb discomfort, limb discomfort.  Additional information: The patient stated on the treatment for side effect was the patient was going to the hospital."Comment: as consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 (Lot number: EW0176) at the age of 37 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: HEADACHE (non-serious), outcome "not recovered", described as "Headache".  Additional information: Patients Headache was Ongoing. The reporter reports on herself then handed the phone to her husband who then provided the details for his experience in this report. The patient said he does not had a primary care provider right now. The patient said the headache started the day he had the shot and then afterwards it was on and off. He says it started within 3 or 4 hours after the first dose. Patient received Second dose on 18May2021, Lot number EW0176, right arm, NDC number unknown, expiration date unknown. Vaccine did Administered at a Facility. Patient received First and second doses Pfizer vaccine received. Time of Onset was (24-hour clock) within 3 or 4 hours after the first dose. Event did not result into Emergency room and Physician office visit. patient was not hospitalized. Prior Vaccinations, patient did not received any other medication within 4 weeks. patient did not experience any prior vaccinations. The patient denies being sick a the time of either dose. Patient did not have any Allergies and did not undergo any Surgery. Patient did not have any family medical history relevant. The patient asked what is next in this process, what's the next action. He asks if the headaches become worse should he be going to regular doctor any other place and He asks what Pfizer recommends.  Follow-up attempts are completed. No further information is expected. .
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Panic attack, SARS-CoV-2 test
Clinical narrative: Substantial elevation in anxiety; Panic attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KLONOPIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN), administration date: 2021, when the patient was 43 years old, for COVID-19 immunisation. The following information was reported: ANXIETY (non-serious) with onset 25Apr2021 15:00, outcome "not recovered", described as "Substantial elevation in anxiety"; PANIC ATTACK (non-serious) with onset 25Apr2021 15:00, outcome "not recovered", described as "Panic attacks". The events "substantial elevation in anxiety" and "panic attacks" were 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 anxiety, panic attack.  Additional Information:The patients medical history was not reported. He had no known allergies. Concomitant medications included clonazepam (KLONOPIN), taken from an unknown date for an unspecified indication. Prior to the vaccination, he was not diagnosed with COVID-19. Since the vaccination, he had been tested for COVID-19. He did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 15:00, he experienced substantial elevation in anxiety and panic attacks and had continued post one month after the second dose. The events resulted in doctor or other healthcare professional office/clinic visit. On 17May2021, the patient underwent Binax COVID-19 test (nasal swab) and was tested negative. The clinical outcome of the events substantial elevation in anxiety and panic attacks were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Tremor
Clinical narrative: shakiness/she had been real shaky; was getting a little bit of anxiety; 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 (BNT162B2), administered in arm right, administration date 25May2021 13:00 (Lot number: EZ0185, Expiration Date: 31Aug2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Panic attack" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset May2021, outcome "unknown", described as "shakiness/she had been real shaky"; ANXIETY (non-serious) with onset May2021, outcome "unknown", described as "was getting a little bit of anxiety".  Additional information: She said she did not call her own facility because she thought the manufacturer of the COVID-19 Vaccine would have the information she was looking for. She stated she had anxiety, panic attacks, depression, and all that. She asked if the COVID-19 vaccine would make her have any that. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Reported the face sheet she was given with the COVID-19 Vaccine did not say anything about the COVID-19 vaccine causing anxiety or anything like that, and she was wondering if the COVID-19 vaccine would bring it on because she had been real shaky and was getting a little bit of anxiety.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Leg, ankle and feet cramps; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 26Feb2021 (Lot number: EN6200) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Time: 05:15 PM, Lot number: EL3246, Anatomical Location: Arm Right), administration date: 05Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 26Feb2021 18:45, outcome "recovering", described as "Leg, ankle and feet cramps". Therapeutic measures were not taken as a result of muscle spasms.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Product administered at inappropriate site
Clinical narrative: administration site was too high to the arm; bruises on her shoulder; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Apr2021 (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: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 19Apr2021, described as "administration site was too high to the arm"; CONTUSION (non-serious) with onset Apr2021, described as "bruises on her shoulder".  Additional information: The administration site was too high to the arm. That caused bruises on her shoulder. Wanted to know if she could continue on the 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 07May2021 (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pain in jaw
Clinical narrative: Weird jaw pain and stiffness. Caller states it feels like her jaw is tight constantly, after the second vaccine.; Weird jaw pain and stiffness. Caller states it feels like her jaw is tight constantly, after the second vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 17:35 (Lot number: EW0177) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: Apr2020 (ongoing), notes: Verbatim: Anxiety; "Depression", start date: Apr2020 (ongoing), notes: Verbatim: Depression; "stomach pain" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM taken for anxiety, abdominal pain upper, start date: 14May2021 (ongoing); ESCITALOPRAM taken for anxiety, depression, start date: 14May2021 (ongoing). Vaccination history included: Bnt162b2 (LOT: Caller reports as EW02 or 07, 15., Time the Vaccination Was Given:5:35 pm , Anatomical Location of Administration of Pfizer vaccine considered as suspect: left upper arm, sick feeling in her stomach and stomach pain), administration date: 21Apr2021, for COVID-19 immunization, reaction(s): "sick feeling in her stomach", "stomach pain". The following information was reported: JOINT STIFFNESS (non-serious), PAIN IN JAW (non-serious) all with onset 21May2021 18:30, outcome "not recovered" and all described as "Weird jaw pain and stiffness. Caller states it feels like her jaw is tight constantly, after the second vaccine.".  Additional information: Reporter states it feels like her jaw is tight constantly, after the second vaccine. Reporter stated that she got her second vaccine on Friday and she just told her doctor, her effect was not going away. Reporter stated that ever since she got the shot, she had been having weird jaw pain and stiffness. Reporter further stated that it feels like her jaw is tight constantly. she didn't had any other side effects, but this effect has been very noticeable and hasn't eased up. Prior Vaccinations within 4 weeks patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Electronystagmogram, Insomnia, Magnetic resonance imaging, Vertigo, Vomiting
Clinical narrative: Experienced vertigo exactly one week after receiving each dose of the COVID vaccine.; Couldnt sleep for 36 hours; Vomiting for 6 hours straight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 13:15 (Lot number: EW0162) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient took concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 24Apr2021 07:00, outcome "unknown", described as "Experienced vertigo exactly one week after receiving each dose of the COVID vaccine."; INSOMNIA (non-serious) with onset 24Apr2021 07:00, outcome "unknown", described as "Couldnt sleep for 36 hours"; VOMITING (non-serious) with onset 24Apr2021 07:00, outcome "unknown", described as "Vomiting for 6 hours straight". The events "experienced vertigo exactly one week after receiving each dose of the covid vaccine.", "couldnt sleep for 36 hours" and "vomiting for 6 hours straight" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, insomnia, vomiting.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electronystagmogram, Magnetic resonance imaging, Vertigo
Clinical narrative: vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer, lot number: Ew0162, lot unknown: False, administration date: 17Apr2021, administration time: 01:15 PM, dose number: 1, vaccine location: Left arm, vertigo exactly one week after receiving each dose of the covid vaccine.), administration date: 17Apr2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "vertigo", "couldnt sleep", "vomiting". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo". The event "vertigo" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo.  Additional information: Adverse event: The patient experienced vertigo exactly one week after receiving each dose of the covid vaccine. Following the vertigo episodes the patient had an MRI and a VNG exam done and both came back normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 24May2021 (Batch/Lot number: unknown) at the age of 56 years 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: FATIGUE (non-serious) with onset 24May2021, outcome "unknown", described as "tired"; HEADACHE (non-serious) with onset 24May2021, outcome "unknown", described as "headache".  Additional Information: The patient was only experiencing headache and tired, he was doing better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Tinnitus; Fullness in ears; This is a spontaneous report received from 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 29Mar2021 11:30 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Tetracycline, reaction(s): "Drug allergy", notes: known allergies: tetracycline. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical location: Arm Left, Administered time: 11:30), administration date: 01Mar2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 07May2021 22:00, outcome "not recovered", described as "Tinnitus"; EAR DISCOMFORT (non-serious) with onset 07May2021 22:00, outcome "not recovered", described as "Fullness in ears". The events "tinnitus" and "fullness in ears" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, ear discomfort.  Additional information: The event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Treatment included unspecified antibiotic. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 26May2021.  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, Pain in extremity
Clinical narrative: Feeling like she had a cold; Arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vape" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Feeling like she had a cold"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore".  Additional information: Reporter stated, she just had a concern, her teenager she got the COVID Vaccine and she was having normal side effects at this point, feeling like she had a cold and her arm was sore, that one thing that she was concerned about reading about teenagers having heart problem with the vaccine. It came to her mind one thing that she was to know if you at Pfizer (Incomprehensible voice) paying attention to she was not a therapist or, the main issue in this age group they have been using vape. They are vaping and it was like another epidemic problem. So she wanted to call you guys to check if you are considering vaping because a lot of time like her daughter has been using vape and that's been a concern for her because of her lung condition lots of problem in the vaping, they have heart condition too. So she just wanted to call you to talk about this if she was in the (Incomprehensible voice) of researchers because many people asked if they are taking any medication or if they have any health problem, that many parents do not know that their kids are using. And there was a lot of different chemicals in the vape not only we could see they have lots of other chemicals that could possibly be a reaction with all those other things that are there. So she was not sure exactly who to talk to but she thought it would be better to just contact Laboratory directly in mention about this.   Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: she experienced arm sore and upset stomach after the 1st dose; she experienced arm sore and upset stomach after the 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). 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: PAIN IN EXTREMITY (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "she experienced arm sore and upset stomach after the 1st dose".  Additional information-The patient received her 2nd dose of the vaccine on (25May2021) morning. Wants to know if she can take Advil in case she experiences headache, nausea. She experienced arm sore and upset stomach after the 1st dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vasodilatation
Clinical narrative: I have a protruding vein connected from breast to stomach.; Lymph node under arms, on shoulder and neck. Now I have a protruding vein connected from breast to stomach.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 10:00 (Lot number: EWO175) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01May2021, outcome "not recovered", described as "Lymph node under arms, on shoulder and neck. Now I have a protruding vein connected from breast to stomach."; VASODILATATION (non-serious), outcome "unknown", described as "I have a protruding vein connected from breast to stomach.". The event "lymph node under arms, on shoulder and neck. now i have a protruding vein connected from breast to stomach." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received hydrochlorothiazide blood pressure medicine within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling jittery, Headache, Menstruation delayed
Clinical narrative: Menstrual cycle is late; sharp shooting pains in stomach - feels like birth contractions; nausea; extreme fatigue; dizziness; jitters; headache; skin feels like it's sunburned- mostly on arms and back; sharp pains in left leg and foot.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 17:00 (Batch/Lot number: unknown) at the age of 38 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: MENSTRUATION DELAYED (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "Menstrual cycle is late"; PAIN (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "sharp shooting pains in stomach - feels like birth contractions"; NAUSEA (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "extreme fatigue"; DIZZINESS (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "dizziness"; FEELING JITTERY (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "jitters"; HEADACHE (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "headache"; SUNBURN (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "skin feels like it's sunburned- mostly on arms and back"; PAIN IN EXTREMITY (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "sharp pains in left leg and foot.". Therapeutic measures were not taken as a result of menstruation delayed, pain, nausea, fatigue, dizziness, feeling jittery, headache, sunburn, pain in extremity.  Additional information: The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.  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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Sunburn
Clinical narrative: Menstrual cycle is late; sharp shooting pains in stomach - feels like birth contractions; nausea; extreme fatigue; dizziness; jitters; headache; skin feels like it's sunburned- mostly on arms and back; sharp pains in left leg and foot.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 17:00 (Batch/Lot number: unknown) at the age of 38 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: MENSTRUATION DELAYED (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "Menstrual cycle is late"; PAIN (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "sharp shooting pains in stomach - feels like birth contractions"; NAUSEA (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "extreme fatigue"; DIZZINESS (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "dizziness"; FEELING JITTERY (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "jitters"; HEADACHE (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "headache"; SUNBURN (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "skin feels like it's sunburned- mostly on arms and back"; PAIN IN EXTREMITY (non-serious) with onset 20May2021 03:00, outcome "not recovered", described as "sharp pains in left leg and foot.". Therapeutic measures were not taken as a result of menstruation delayed, pain, nausea, fatigue, dizziness, feeling jittery, headache, sunburn, pain in extremity.  Additional information: The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.  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: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Both shots made my daughter very sick.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "ALLERGIES". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Both shots made my daughter very sick.".  Additional information: Patient had not received any other vaccines in four weeks. It was reported that exact symptoms as covid in Feb nausea, body aches, earache, sore throat, eyes burning, fever(had no fever with covid) extreme fatigue, heaviness in chest. It lasted 48 hours. This was with the first shot and reporter stated that was unsure to make take the second. Both shots made reporter daughter very sick. Patient not tested to COVID post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Feeling like a little pain in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25May2021 11:00 (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: NECK PAIN (non-serious) with onset 25May2021, outcome "unknown", described as "Feeling like a little pain in my neck".  Additional Information: Patient state that  patient just got a Pfizer Vaccination (Unspecified Vaccine) today about 11.00 and now the patient was feeling like a little pain in neck and patient did not t know if that was caused because of that or that normal. Consumer stated that the patient took should any medication like Tylenol if the patient needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: feet are swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021606922 (Pfizer).   A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) at the age of 79 years 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: PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "unknown", described as "feet are swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Insomnia
Clinical narrative: It was the first vaccine flu; Could not sleep; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17May2021 (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: INFLUENZA (non-serious), outcome "unknown", described as "It was the first vaccine flu"; INSOMNIA (non-serious), outcome "unknown", described as "Could not sleep".  Additional information: I just had the Covid vaccine from Pfizer and you know what, instead of me getting the what you call this plan it only become bigger and bigger and then I could not sleep that night. I do not know why. It was the first vaccine flu. I did not get the second one yet and then I feel so different.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced slight headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "experienced slight headache".  Additional information: caller clarifies they put the needle in her arm, and he says it sounds like maybe the vaccine came out around the hub, there was a significant amount leaking down her arm. Warm transfer from (###), CEP 159558. He is calling to ask for his patient that was supposed to have second dose 21May2021 however the syringe or the needle had a malfunction and the vaccine leaked out and they decided not to take the second dose that day. Now the patient is scheduled to have her second dose today and this caller wants to ask if that's okay. Agent says the administration of the vaccine was not succeeded. This patient mentioned that she experienced slight headache and she was not sure if it's from the vaccine. Agent clarifies she mentioned it to the pharmacist and said she was not sure if it's from the first dose or somewhere else. The caller confirms the details provided by the transfer agent. He confirms product as Pfizer COVID 19 vaccine. He clarifies the dose was attempted to administer. He clarifies they put the needle in her arm, and he says it sounds like maybe the vaccine came out, instead of going to through the needle, something happened maybe at the hub of the syringe and needle, the vaccine leaked out. They said there was a significant amount on the patient's arm, leaking down her arm, is what the caller gathers. Caller says he is not sure he is the appropriate person to give information about the event because he is receiving information fairly second hand from the patient and the pharmacist, he doesn't know that he would have a lot of detail to provide. Caller says he is going to defer the report for 2 reasons, one for lack of information and number 2 he is working otherwise, he is doing other things right now.  Follow-up attempts completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium decreased, SARS-CoV-2 antibody test, Visual impairment, Weight increased
Clinical narrative: Magnesium was low on blood test; She gets a magnifying glass to refer to her medical notes; States she weighs a lot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: FL9262) at the age of 76 years as dose 1, single and administration date 26Mar2021 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood cancer" (unspecified if ongoing), notes: she has a history of a blood cancer.; "Essential thrombocythemia", start date: Oct2020 (ongoing); "Depression" (unspecified if ongoing); "High cholesterol" (ongoing); "Type II diabetes" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Heart murmurs", start date: 2012 (unspecified if ongoing); "herniated disc of neck", start date: 2016 (unspecified if ongoing); "herniated disc of back", start date: 1974 (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Peripheral neuropathy", start date: 2010 (unspecified if ongoing); "Mediastinal adenopathy" (unspecified if ongoing); "knees hurt" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE taken for depression (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing); ASPIRIN (E.C.) (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); CALCIUM PLUS VITAMIN D (ongoing); MAGNESIUM (ongoing); HYDROXYUREA, start date: Oct2020 (ongoing). Past drug history included: Hydroxyurea, start date: Oct2020, for Essential thrombocythemia, notes: 500 mg twice a day and then once a day, alternating. The following information was reported: BLOOD MAGNESIUM DECREASED (non-serious), outcome "unknown", described as "Magnesium was low on blood test"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "She gets a magnifying glass to refer to her medical notes"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "States she weighs a lot". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: pain to the upper arm and neck pain that is still present.; pain to the upper arm and neck pain that is still present.; 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 female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (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: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Mar2021, outcome "not recovered" and all described as "pain to the upper arm and neck pain that is still present."  Additional information: patient stated she received the first dose of the Pfizer Covid vaccine on 20Mar2021 and 2 days later began to experience pain to the upper arm and neck pain that is still present. Patient was concerned that she may not have received the vaccine in the muscle and was worried that she was not protected and wanted to know: "What happens if she did not get the vaccine in the muscle". Patient did not specify if she has received the second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site mass
Clinical narrative: a little swollen on her armpit on the opposite site; she has like a little lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "a little swollen on her armpit on the opposite site"; VACCINATION SITE MASS (non-serious) with onset 2021, outcome "unknown", described as "she has like a little lump".  Additional information: Reporter stated that had a question my daughter she was 16 years old and she received the Pfizer vaccine, she received the vaccine on the April 22nd that was the second dose but she told me that she had like a little lump, she received the vaccine on the left side her arm the left and that she had things like a little swollen on her armpit on the opposite site. No, it was not on the same side it was on the other side on the armpit of the left reporter mean on the right side and she received the vaccine on the left side. Reported was just going to know if that reaction was normal the effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Lymphadenopathy, Pain
Clinical narrative: sleeping for 48 hours; Felt more tired than usual; had generalized increased pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN D [VITAMIN D NOS]; XELJANZ XR taken for rheumatoid arthritis, start date: 09Mar2020. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunisation. The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "sleeping for 48 hours"; FATIGUE (non-serious), outcome "recovering", described as "Felt more tired than usual"; PAIN (non-serious), outcome "recovering", described as "had generalized increased pain"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph nodes". Therapeutic measures were taken as a result of fatigue, pain, lymphadenopathy.  Additional information: Patient missed two doses after receiving the second covid vaccine (13May2021) due to continuously sleeping for 48 hours. started prednisone (dose unspecified) on 15May2021 and md advised to take for 15 days. Feel better since starting prednisone but lymph nodes still feel swollen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Prolonged pain in arm where vaccine was administered for almost 7 weeks since getting the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 09:45 (Lot number: ER8730) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; GABAPENTIN; ALEVE; PROPRANOLOL; TYLENOL. Vaccination history included: Covid-19 vaccine (Lot number:ER8727, Administration time: 07:00 PM, Dose number: 1, Vaccine location:Left arm), administration date: 20Mar2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Prolonged pain in arm where vaccine was administered for almost 7 weeks since getting the second dose.". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up attempts are completed. No further information is expected.