chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Spinal pain
Clinical narrative: back and spine started hurting; back and spine started hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Auto Immune Disorder" (unspecified if ongoing), notes: verbatim:Auto Immune Disorder. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), SPINAL PAIN (non-serious), outcome "unknown" and all described as "back and spine started hurting". Additional Information: Caller says that when she got the 1st shot, she had some reactions with it, her back and spine started hurting and some other things. Caller was very vague.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 16 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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient mother was calling on behalf of her daughter who was 16 and was scheduled to get vaccinated today but she has a sore throat and they don't know if she can get the vaccine today or if they will have to reschedule it. Agent said the caller was reporting that her daughter had test for COVID-19 yesterday that was negative, and she got first dose of the Pfizer COVID-19 vaccine on the 8Apr. Dates for sore throat was unspecified. Reporter seriousness for COVID-19 vaccination was unspecified. She says she just wants to know, can her daughter take the shot if her throat is hurt or do they need to reschedule.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some pain in her arm/It really wasn't her arm, it was just where she got the needle that hurt (injection site); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 09:30 (Lot number: EW0161, Expiration Date: Jul2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cirrhosis", start date: 2021 (ongoing). Concomitant medication(s) included: FUROSEMIDE taken for hepatic cirrhosis (she takes it for her cirrhosis to keep liquid out of her abdomen), start date: 2020 (ongoing); LEVOTHYROXINE taken for thyroiditis, start date: 2020 (ongoing); HYDROXYCHLOROQUINE taken for hepatic cirrhosis, start date: Nov2020 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Apr2021, outcome "recovered" (28Apr2021), described as "Some pain in her arm/It really wasn't her arm, it was just where she got the needle that hurt (injection site)".  Additional information: The reporter was the patients husband. The patient sore arm went away after an hour or so. She had her vaccine on 28Apr2021. It really was not her arm, it was just where she got the needle that hurt (injection site). She has recovered completely. She had no problems at all. Maybe the medication she was on helped. She was on "Hydrochloroquine" because they suspected she might have had lupus, but now they are leaning away from Lupus because they found out she does have cirrhosis, or fatty liver disease. She was still on "Hydrochloroquine" and some other stuff. The patient took none of the other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had no AE(s).   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: First dose: Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8737) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back pain" (ongoing), notes: Verbatim: Back pain, Caller reported that she began experiencing back pain years ago.; "Arthralgia" (ongoing), notes: Verbatim: Knee pain, Caller reported that she has been experiencing knee pain for a few years.; "Diabetes mellitus" (ongoing), notes: Verbatim: Diabetes, Caller reported that she was diagnosed with diabetes 10-15 years ago. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); GABAPENTIN (ongoing); ATORVASTATIN (ongoing); WELLBUTRIN (ongoing); TRAZODONE (ongoing); LEVOTHYROXINE (ongoing). The following information was reported: FATIGUE (non-serious) with onset 02Apr2021, outcome "recovered" (03Apr2021), described as "First dose: Tired".  Additional information: The patient reported that she did pretty good with the first dose, her arm was not really sore or anything, she was tired and that was about it. First dose: Tired: She reported that she was always tired but she was extra tired. The patient reported that the physician that she had been seeing left the practice and she does not know who the replacement was. Adverse event did not require a visit to emergency room, or physician office. The patient did not receive any vaccinations within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity, Peripheral swelling
Clinical narrative: my whole arm is swollen like not just the injection site but the lower whole arm is swollen and hurting; my whole arm is swollen like not just the injection site but the lower whole arm is swollen and hurting; Have metallic taste in my mouth; 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) (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), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my whole arm is swollen like not just the injection site but the lower whole arm is swollen and hurting"; DYSGEUSIA (non-serious), outcome "unknown", described as "Have metallic taste in my mouth".  Additional information: When probed for the concern, consumer stated, Patient got the first dose of Covid Vaccine Pfizer on Tuesday and whole arm is swollen like not just the injection site but the lower whole arm is swollen and hurting, Patient also have like metallic taste in mouth like few hours after, patient would like to know is that normal side effects from the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at Vaccination site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:45 (Lot number: Ew0158) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa medication" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "sore arm at Vaccination site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any list of other medications within 2 weeks of vaccination. Event onset was about six hours after vaccination as she went to bed and lasted approximately 48 hours. Facility where the most recent COVID-19 vaccine administered is reported as available. Patient did not have covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy
Clinical narrative: neck and under the arm lymph nodes got swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 13:15 (Lot number: EN6206) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: NO. The patient's concomitant medications were not reported. Past drug history included: No, notes: No. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovering", described as "neck and under the arm lymph nodes got swelled up". The event "neck and under the arm lymph nodes got swelled up" 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 lymphadenopathy.  Additional information: It was reported that patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination patient was not tested for COVID-19. Patient was Visited to Physician or Other Health Professional Office for neck and under the arm lymph nodes got swelled up. Patient had had a chest and neck CT scan done.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Caller said it has worsened into vertigo; dizziness; This is a spontaneous report received from a 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, administration date 23Feb2021 (Lot number: EN6200) at the age of 70 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: DIZZINESS (non-serious) with onset 24Feb2021, outcome "unknown", described as "dizziness"; VERTIGO (non-serious), outcome "unknown", described as "Caller said it has worsened into vertigo".  Additional Information: Patient never had medical history relevant to AE(s) personally or anyone in his family, Caller stated that the vertigo happens at various times. Several times a day. From the time he wakes up until he goes to sleep. Caller stated the same thing for the dizziness. The reason is calling is to get help and he has done research. And a lot of people get vertigo after getting the vaccine. Asked caller if he would like to complete an additional safety report on behalf of the people that he researched getting vertigo after the vaccine. Caller stated he does not want to file anymore reports that he wants to talk with someone about how he is having side effects and that something needs to be done.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: chills; headache; tired; I was tired and weak; Hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2021 08:30 (Lot number: EL3246) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: has blood pressure problems, her blood pressure goes up and goes down; "COVID-19", start date: 09Nov2020 (unspecified if ongoing), notes: She reports she did have the Covid 19 virus. She was diagnosed with the Covid 19 virus on 09Nov2020. Concomitant medication(s) included: ASPIRIN (E.C.) (ongoing); LOVASTATIN taken for blood cholesterol (ongoing); METOPROLOL taken for blood pressure abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); LOSARTAN (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); ESTRADIOL (ongoing). The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ASTHENIA (non-serious), outcome "unknown", described as "I was tired and weak"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose, Patient hair was coming out. Patient had chills, hair loss, headache and was tired and weak, but not real bad. Patient was 81 years old and her hair was thin anyway but it has gotten a lot thinner. The chills lasted up until this past month (at the time of report). She'd maybe have headaches off and on. Maybe a day she'd have a headache, then she'd be fine for a day or two, then she'd get a headache again. When probing medical history and concomitant medications, she reports she has blood pressure problems, her blood pressure goes up and goes down. She also reports she had a steroid injection in her right knee on 20Jan2021. Patient was having bad hair loss. So, that was the thing that she was concerned about was hair loss, will it comeback or will it continue going on or what. No additional vaccines administered on same date with the Pfizer vaccine. No Emergency Room and Physician Office due to events.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, SARS-CoV-2 test
Clinical narrative: chills; headache; tired; I was tired and weak; Hair loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2021 08:30 (Lot number: EL3246) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: has blood pressure problems, her blood pressure goes up and goes down; "COVID-19", start date: 09Nov2020 (unspecified if ongoing), notes: She reports she did have the Covid 19 virus. She was diagnosed with the Covid 19 virus on 09Nov2020. Concomitant medication(s) included: ASPIRIN (E.C.) (ongoing); LOVASTATIN taken for blood cholesterol (ongoing); METOPROLOL taken for blood pressure abnormal (ongoing); PANTOPRAZOLE taken for abdominal discomfort (ongoing); LOSARTAN (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); ESTRADIOL (ongoing). The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ASTHENIA (non-serious), outcome "unknown", described as "I was tired and weak"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose, Patient hair was coming out. Patient had chills, hair loss, headache and was tired and weak, but not real bad. Patient was 81 years old and her hair was thin anyway but it has gotten a lot thinner. The chills lasted up until this past month (at the time of report). She'd maybe have headaches off and on. Maybe a day she'd have a headache, then she'd be fine for a day or two, then she'd get a headache again. When probing medical history and concomitant medications, she reports she has blood pressure problems, her blood pressure goes up and goes down. She also reports she had a steroid injection in her right knee on 20Jan2021. Patient was having bad hair loss. So, that was the thing that she was concerned about was hair loss, will it comeback or will it continue going on or what. No additional vaccines administered on same date with the Pfizer vaccine. No Emergency Room and Physician Office due to events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Loss of personal independence in daily activities, Pain
Clinical narrative: I couldn't get out of bed for 10 hours the day after; super body aches; my head was so lightheaded; I couldn't focus on anything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular (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, Batch/lot number: Unknown), for COVID-19 immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "I couldn't get out of bed for 10 hours the day after"; PAIN (non-serious), outcome "recovered", described as "super body aches"; DIZZINESS (non-serious), outcome "recovered", described as "my head was so lightheaded"; DISTURBANCE IN ATTENTION (non-serious), outcome "recovered", described as "I couldn't focus on anything". Therapeutic measures were not taken as a result of loss of personal independence in daily activities, pain, dizziness, disturbance in attention.  Additional information: Pfizer did not give the permission to contact the reporter about this event. The reason for batch number is unknown reported as not available to reporter at the time of report completion and unknown if facility where the most recent COVID-19 vaccine was administered. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown and any other medications received within 2 weeks of vaccination was unknown, prior to vaccination the patient diagnosed with COVID-19 and since the vaccination the patient has been tested for COVID-19 was unknown. The reporter stated that he became aware of the information about fifteen minutes before the patient reported it on April 29, 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: having tinnitus or ringing in ears, which is continual; This is a spontaneous report received from a 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 16Feb2021 13:30 (Lot number: EN6200) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Vaccine location: Left arm, Time at the Vaccination 13:30 , Batch/lot number: EL9265), administration date: 26Jan2021, when the patient was 70 years old, for covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "having tinnitus or ringing in ears, which is continual".  Additional information: No additional Vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient (Pt) has been having side effects since receiving the second dose Pfizer Covid Vaccine and doesn't know if related. After reading online, he thinks maybe the side effects are related. Pt doesn't know exactly when this began but was thinking within 2 weeks of second dose Pfizer Covid Vaccine or maybe even less. It began the first part of March, which would have been two weeks after the second dose Pfizer Covid Vaccine. Pt states it is ongoing and persisting. No Relevant Tests. No Emergency room or Physician office visit due to events.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The soreness in her arm was the same as the first injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EN6205) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "melanoma and removal of lymph nodes" (unspecified if ongoing), notes: two melanomas in that arm. She has Had Melanoma 4 times all on her left side.; "surgeries in her left arm" (unspecified if ongoing); "melanoma and removal of lymph nodes" (unspecified if ongoing); "breast surgery was on her right side" (unspecified if ongoing); "mastectomy" (unspecified if ongoing); "nerve damage from 20 years ago" (unspecified if ongoing); "pain" (ongoing); "had 10 surgeries in the past" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE taken for pain (ongoing). Past drug history included: Flu vaccine, reaction(s): "aggravated the nerve damage", notes: four years ago in that arm, and she gave it too high; Flu vaccine for she couldn't use her arm for a year. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The soreness in her arm was the same as the first injection".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: After 5-6 days of 1st dose injection, I was occasionally experiencing irregular heartbeat. It can stop itself after taking a rest.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 12:30 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure under controlled" (unspecified if ongoing), notes: high blood pressure under controlled. Concomitant medication(s) included: LISINOPRIL. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset Apr2021, outcome "not recovered", described as "After 5-6 days of 1st dose injection, I was occasionally experiencing irregular heartbeat. It can stop itself after taking a rest.". The event "after 5-6 days of 1st dose injection, i was occasionally experiencing irregular heartbeat. it can stop itself after taking a rest." 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 heart rate irregular.  Additional information: The patient received second dose of vaccine on 27Apr2021. No other vaccine in four weeks. Other medications in two weeks: Lisinopril. The event does not affect her daily activities. No covid prior vaccination and no covid tested post vaccination. Allergies were not known.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Myalgia, Neck pain
Clinical narrative: chills; muscle aches, like someone plugging him into an electric outlet; strong pain in his neck and back bone; strong pain in his neck and back bone; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: ER8736) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing), notes: sometimes, but he believed this was normal of all people. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; IBUPROFEN taken for headache, neck pain, back pain. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number:ER8737), administration date: 31Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 22Apr2021 03:00, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 22Apr2021 03:00, outcome "not recovered", described as "muscle aches, like someone plugging him into an electric outlet"; BONE PAIN (non-serious), NECK PAIN (non-serious) all with onset 22Apr2021 03:00, outcome "not recovered" and all described as "strong pain in his neck and back bone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, myalgia, bone pain, neck pain.  Additional information: The concomitant medication included multivitamins. The patient stated that he got his second shot a week ago, on 22 APR 2021, and almost every night since then, around 3 am, he got chills, but he had no fever. His temperature has stayed below 37 degrees Celsius. But even with no fever, patient had had chills, and muscle aches, like someone plugging him into an electric outlet. Patient had a strong pain in his neck and back bone. Patient reported this was all just happened at night, and he would take Ibuprofen and the symptoms go away within an hour. Patient stated that when he got the vaccine, he was told symptoms could last for 2 to 3 days, but it had been almost 7 days now that the patient had been having these side effects and he was wondered if that was normal. The patient stated that he took no prescription medications and was otherwise healthy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, SARS-CoV-2 test
Clinical narrative: nerve pain in left leg, similar to sciatic nerve pain/i received my second shot and immediately felt the nerve pain return; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE. Vaccination history included: Bnt162b2 (product=COVID 19,, lot number=EP6955, dose number=1,, vaccine location=Left arm), administration date: 17Mar2021, when the patient was 34 years old, for Covid-19 immunisation, reaction(s): "small episode of sciatica", "nerve pain in left leg, similar to sciatic nerve pain".  The following information was reported: NEURALGIA (non-serious), outcome "recovering", described as "nerve pain in left leg, similar to sciatic nerve pain/i received my second shot and immediately felt the nerve pain return". The event "nerve pain in left leg, similar to sciatic nerve pain/i received my second shot and immediately felt the nerve pain return" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not take other vaccine in four weeks. Patient had COVID prior vaccination. Patient had COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 37 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Apr2021 (Lot number: EP7534, Expiration Date: 31Jul2021) at the age of 37 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication included: MULTIVITAMIN N [ASCORBIC ACID;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE]. The following information was reported: DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "Dizziness". The event "dizziness" was evaluated at the physician office visit and emergency room visit.  Additional information: Consumer have been having dizziness ever since she got the vaccine which was on 05Apr2021. She went to urgent care, to a chiropractor and to an ENT and have not taken any actual medication. She was on multivitamins.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 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 29Apr2021 (Lot number: EW0175) 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: 01, No events), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 29Apr2021, outcome "unknown", described as "Dizziness". Additional information: The patient enquired whether dizziness was a common side effect. There was no expiration date. No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: moderate pain in arm; general unwell feeling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 14:15 (Lot number: EW0150) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD; "IBS" (unspecified if ongoing), notes: Verbatim: IBS; "Mildly lactose intolerant" (unspecified if ongoing), notes: Mildly lactose intolerant; "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE taken for attention deficit hyperactivity disorder; BUSPIRONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "moderate pain in arm"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "general unwell feeling". Therapeutic measures were not taken as a result of pain in extremity, malaise.  Additional information: The Facility where patient administered the most recent COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: My level of taste buds has decreased it's not the normal taste bud; maybe I am sick; 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 13Apr2021 (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: TONGUE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "My level of taste buds has decreased it's not the normal taste bud; maybe I am sick".  Additional information: It was reported that dates for level of taste buds have decreased it's not the normal taste bud; maybe patient was sick. Reporter seriousness for level of taste buds has decreased it's not the normal taste bud. The reason for no lot number was unspecified Vaccine: Complainant hung up abruptly/transfer incomplete patient stated, got Pfizer vaccine on the 13th of this month and for about a week and half level of taste buds has decreased it's not the normal taste bud, wanted to know it is one of the side effects or is it because of maybe patient sick or something else. Patient was informed about the Pfizer Medical Information and provided with the number and requested to dial the option 3. Further probing could not be done as consumer hung up the call abruptly. Hence, limited information available over the call.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little pain on his arm after the first; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergic to motrin for allergy, reaction(s): "lip swells", notes: Verbatim: allergic to Motrin. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "little pain on his arm after the first".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: After the second the pain was less than the first; got hit in the injection site, and now there is numbness an inch and a half around the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 (Lot number: Unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to Motrin" (unspecified if ongoing), notes: Verbatim: allergic to Motrin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Anatomical Location: Right Arm), administration date: 04Apr2021, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "After the second the pain was less than the first"; HYPOAESTHESIA (non-serious) with onset 27Apr2021, outcome "not recovered", described as "got hit in the injection site, and now there is numbness an inch and a half around the site".   Additional Information: Caller got his second dose of the Pfizer COVID vaccine last Saturday, 24Apr2021. He had little pain on his arm after the first. After the second the pain was less than the first. He had no other symptoms. He was playing around with his wife, and she hit him on the arm with a closed fist. Since then, an inch and a half around it has a numb sensation. She hit him with the closed fist on the injection site. It had been like that the last couple of days. She had her second dose today, and she asked the site if they knew. They gave her this number to call for more information. Caller did not have a prescribing doctor. He worked as Truck driver for the food service. His workplace sent him a letter to go to (withheld) to get the vaccine. With his first vaccine, he had a little pain in his arm which he felt was normal. With the second vaccine, he had less pain in his arm. He had no other symptoms. His daughter laid on his arm once, and it bothered him a little, but when his wife hit him, it made a light numbness. The light numbness has been there for the past two days since 27Apr2021. It persisted. In the morning he did not really feel it, but if he starts to move it he feels it. It is just an inch and a half around the shot. He got the first dose 04Apr2021 in his right arm, and the second dose 23Apr2021 in the right arm. He did not have his card with the lot number with him. He was allergic to Motrin. If he took it his lip swells. The patient had not taken it since.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Agitation, Fatigue, Malaise
Clinical narrative: I was extremely exhausted; tummy upset; general malaise; extremely agitated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 14:30 (Lot number: ER8727) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic fatigue" (unspecified if ongoing); "insulin resistance" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing); "chocolate allergy" (unspecified if ongoing), notes: chocolate allergy. Concomitant medication(s) included: TRAZODONE. The following information was reported: FATIGUE (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "I was extremely exhausted"; ABDOMINAL DISCOMFORT (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "tummy upset"; MALAISE (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "general malaise"; AGITATION (non-serious) with onset 20Mar2021 18:00, outcome "recovering", described as "extremely agitated". Therapeutic measures were not taken as a result of fatigue, abdominal discomfort, malaise, agitation.  Additional Information: After the first vaccine patient was extremely exhausted for about two weeks after the vaccine with tummy upset and general malaise. Patient was also extremely agitated and needed to be left alone so as not to offend others. After the second vaccine, patient had a splitting headache everyday for 18 days. It is the 19th day and patient have a slight headache on the day of reporting. Patient has been sleeping 9 hours per night and she has been tired and not able to do anything, but she is not as exhausted as with the first dose. Patient has been unwell for over a month now because of the vaccine and never want to get another one. Patient did not had covid prior to vaccination. Post vaccination, patient was not tested for Covid.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Insomnia, Nervousness
Clinical narrative: She has been a nervous wreck; Have done nothing but cry; Can't get any rest or sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Feb2021 (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 (First dose, right arm), administration date: 19Jan2021, for Covid-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset 13Feb2021, outcome "unknown", described as "She has been a nervous wreck"; CRYING (non-serious) with onset 13Feb2021, outcome "unknown", described as "Have done nothing but cry"; INSOMNIA (non-serious) with onset 13Feb2021, outcome "unknown", described as "Can't get any rest or sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Weight decreased
Clinical narrative: Dizzy; thin and weak; thin and weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; WEIGHT DECREASED (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "thin and weak".  Additional Information: The reporter (patient's brother) mentioned that the patient laid down because he went riding on a scooter and thought that it was what made the patient dizzy. The reporter further asked if it was common for the patient to feel dizzy and weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxious; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 13:30 (Lot number: EW0158) at the age of 23 years as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin for known allergies. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "anxious".  Additional information: Prior to vaccination, the patient had not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Patient stated wasn't sure if it was related to something i ate with first shot and being anxious.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Loss of personal independence in daily activities
Clinical narrative: non-stop irregular heartbeat; This side affect affects my daily activities; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 10:00 (Lot number: EW0176) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure under controlled" (unspecified if ongoing), notes: Other medical history: high blood pressure under controlled. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: ER8729,, Administration date: 06Apr2021,, time: 12:30 PM,, Dose number: 1,, Vaccine location: Left arm), administration date: 06Apr2021, for COVID 19 IMMUNISATION, reaction(s): "irregular heartbeat". The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 27Apr2021 14:00, outcome "not recovered", described as "non-stop irregular heartbeat"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 27Apr2021 14:00, outcome "not recovered", described as "This side affect affects my daily activities". The events "non-stop irregular heartbeat" and "this side affect affects my daily activities" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of heart rate irregular, loss of personal independence in daily activities.  Additional information: It was reported on 27Apr2021,4hrs after receiving 2nd dose of the Covid19 vaccine, patient had been experiencing almost non-stop irregular heartbeat, even after taking rest. This side effect affects her daily activities.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysarthria
Clinical narrative: slurred speech; confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Apr2021 09:30 (Lot number: ER8729) at the age of 65 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: DYSARTHRIA (non-serious) with onset 07Apr2021 12:00, outcome "unknown", described as "slurred speech"; CONFUSIONAL STATE (non-serious) with onset 07Apr2021 12:00, outcome "unknown", described as "confusion". Therapeutic measures were not taken as a result of dysarthria, confusional state. Additional information: Patient did not administer other vaccine in four week. Patient did not tested COVID prior vaccination nor post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Gait inability, Illness, SARS-CoV-2 test
Clinical narrative: Caller's neighbor was so sick; Could barely walk; Has not received second dose of the Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: Unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Condition" (unspecified if ongoing), notes: Kind of has a heart condition (Thinks this began about 12 years, ago. Caller's neighbour had a heart attack and a stent put in.; "Covid-19", start date: Oct2020 (unspecified if ongoing), notes: Tested positive and was sick with Covid before her first dose of Pfizer Covid Vaccine. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Caller's neighbor was so sick"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "Could barely walk"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 2021, outcome "unknown", described as "Has not received second dose of the Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was hospitalized for 6 weeks and was not sure was going to make it. Caller clarifies this hospitalization took place prior to the first dose Pfizer Covid Vaccination.  This hospitalization was in Oct2020 or middle of Nov2020.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.