chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Aphonia, Asthenia, Disturbance in attention, Dizziness
Clinical narrative: Severe dizziness; Felt disconnected from my body; Nausea; Tongue was numb; Loosing my voice; Aching headache; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; I felt very weak and like a brain clot like I had a hard time focusing; I felt very weak and like a brain clot like I had a hard time focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2), administration date 18Jun2021 (Lot number: EW0177) at the age of 66 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 18Jun2021, outcome "unknown", described as "Severe dizziness"; FEELING ABNORMAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Felt disconnected from my body"; NAUSEA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Nausea"; HYPOAESTHESIA ORAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Tongue was numb"; APHONIA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Loosing my voice"; HEADACHE (non-serious) with onset 18Jun2021, outcome "unknown", described as "Aching headache"; FACIAL PAIN (non-serious), EYE PAIN (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Victimized stomach, vomiting"; ASTHENIA (non-serious), DISTURBANCE IN ATTENTION (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "I felt very weak and like a brain clot like I had a hard time focusing".  Additional information: Patient reported that three hours later, patient had severe dizziness, aching headache, and felt disconnected from body. And then came very sharp sudden pain on both sides of temple behind eyes, temples on face on head and behind eyes and tongue was numb. Then came like nausea, victimized stomach, vomiting and was loosing voice. Patient felt very weak and like a brain clot like had a hard time focusing. Also reported the pain going behind eyes.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Facial pain, Feeling abnormal, Headache, Hypoaesthesia oral
Clinical narrative: Severe dizziness; Felt disconnected from my body; Nausea; Tongue was numb; Loosing my voice; Aching headache; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; I felt very weak and like a brain clot like I had a hard time focusing; I felt very weak and like a brain clot like I had a hard time focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2), administration date 18Jun2021 (Lot number: EW0177) at the age of 66 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 18Jun2021, outcome "unknown", described as "Severe dizziness"; FEELING ABNORMAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Felt disconnected from my body"; NAUSEA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Nausea"; HYPOAESTHESIA ORAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Tongue was numb"; APHONIA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Loosing my voice"; HEADACHE (non-serious) with onset 18Jun2021, outcome "unknown", described as "Aching headache"; FACIAL PAIN (non-serious), EYE PAIN (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Victimized stomach, vomiting"; ASTHENIA (non-serious), DISTURBANCE IN ATTENTION (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "I felt very weak and like a brain clot like I had a hard time focusing".  Additional information: Patient reported that three hours later, patient had severe dizziness, aching headache, and felt disconnected from body. And then came very sharp sudden pain on both sides of temple behind eyes, temples on face on head and behind eyes and tongue was numb. Then came like nausea, victimized stomach, vomiting and was loosing voice. Patient felt very weak and like a brain clot like had a hard time focusing. Also reported the pain going behind eyes.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe dizziness; Felt disconnected from my body; Nausea; Tongue was numb; Loosing my voice; Aching headache; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes; Victimized stomach, vomiting; I felt very weak and like a brain clot like I had a hard time focusing; I felt very weak and like a brain clot like I had a hard time focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2), administration date 18Jun2021 (Lot number: EW0177) at the age of 66 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 18Jun2021, outcome "unknown", described as "Severe dizziness"; FEELING ABNORMAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Felt disconnected from my body"; NAUSEA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Nausea"; HYPOAESTHESIA ORAL (non-serious) with onset 18Jun2021, outcome "unknown", described as "Tongue was numb"; APHONIA (non-serious) with onset 18Jun2021, outcome "unknown", described as "Loosing my voice"; HEADACHE (non-serious) with onset 18Jun2021, outcome "unknown", described as "Aching headache"; FACIAL PAIN (non-serious), EYE PAIN (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Very sharp sudden pain on both sides of my temple behind my eyes, my temples on my face on my head and behind my eyes"; ABDOMINAL PAIN UPPER (non-serious), VOMITING (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "Victimized stomach, vomiting"; ASTHENIA (non-serious), DISTURBANCE IN ATTENTION (non-serious) all with onset 18Jun2021, outcome "unknown" and all described as "I felt very weak and like a brain clot like I had a hard time focusing".  Additional information: Patient reported that three hours later, patient had severe dizziness, aching headache, and felt disconnected from body. And then came very sharp sudden pain on both sides of temple behind eyes, temples on face on head and behind eyes and tongue was numb. Then came like nausea, victimized stomach, vomiting and was loosing voice. Patient felt very weak and like a brain clot like had a hard time focusing. Also reported the pain going behind eyes.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: IBS flare up; 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. Other Case identifier(s): US-PFIZER INC-2021766601 (Pfizer).  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Lot number: EW0168) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing), notes: Verbatim: IBS, Diagnosed over 20 years ago; "Gastrooesophageal reflux disease" (unspecified if ongoing), notes: Verbatim: Acid reflux (esophageal), Diagnosed over 20 years ago; "Headache" (unspecified if ongoing). Concomitant medication(s) included: LINZESS; FOLIC ACID; VIT D; VITAMIN B COMPLEX. Past drug history included: Aleve for Headache, reaction(s): "acid reflux worse", notes: takes Aleve for headaches, The Aleve makes the acid reflux worse so the caller usually only takes a half.  The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 07May2021, outcome "not recovered", described as "IBS flare up".  Additional Information;The caller stated that IBS and has been pretty good about controlling his flare ups. The patient stated he had IBS flare ups 3-4 days after the first dose of the vaccine. The second vaccine was 3 weeks ago and the caller is getting another IBS flare up. The caller has not had any changes to his diet or stress levels.Caller stated he was feeling fine up until he took the vaccine and had more flare ups. Caller stated it could be coincidental or it could be something in the vaccine that triggered it.Reporter seriousness for IBS flare up was unspecified  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Product complaint
Clinical narrative: I got the first Pfizer shot in January and the second in February/It's been 6 months so I plan to go back to get another round of shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "I have glaucoma", start date: 2001 (not ongoing), notes: glaucoma, started on Latanoprost. went back 6 months later and was told that I don't have glaucoma.; "I have PTSD" (unspecified if ongoing), notes: really bad PTSD but I feel like I'm finally in the waking stage; "don't remember things" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dos=2), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (dose=2), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: PRODUCT COMPLAINT (non-serious), outcome "unknown", described as "I got the first Pfizer shot in January and the second in February/It's been 6 months so I plan to go back to get another round of shots". The patient got the first Pfizer shot in Jan2021 and the second in Feb2021. (Caller confirmed shots as Pfizer BioNTech covid vaccine). Now they was giving them away for free. It was 6 months so he plan to go back to get another round of shots to see what happens and use himself as a test dummy.  The patient not going to tell them that Ive already gotten the shots. 10 years ago, at the (Privacy) the patient was told he had glaucoma and was started on Latanoprost. The patient was going thru a bottle a month and his medication was always running out.  The patient got it through the (Privacy). The patient called Pfizer and their company told him that they would send him 5 bottles of it if the patient needed it.  The patient went back 6 months later and was told that the patient did not had glaucoma and did need to take.  (Caller confirmed he no longer uses Latanoprost.)  The patient calling because the (Privacy) lies about giving patients their medication and he want this call recorded and sent to doctor so she can help.  Caller stated the patient had PTSD, and did not remember things.  The patient wont remember their name 5 minutes after he hang up.  The patient take heart meds and others take cancer meds. The patient and other patients had to go into (Privacy) to get our medications because the (Privacy) doesnt give us what we need.  The (Privacy) has the highest suicide rate.  The patient had 18 friends, who had committed suicide mostly through overdose. The patient know of college students who buy fentanyl in (Privacy) and sell it on the streets as oxycontin.  The patient 74 years old with really bad PTSD but feel like the patient finally in the waking stage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported for a male patient (her dad).  A 89 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional Information: Reporter asked questions about covid vaccine Question: Can you take your thyroid medication with the Covid vaccine. Question: Caller wanted to know about the efficacy of the Pfizer covid vaccine. Question: Caller wanted to know about will the vaccine protect against the (delta) variant. Question: Caller wanted to know about should she take or not take the Pfizer covid vaccine. Caller (65 years old female) wanted to know about the side effects for the Pfizer covid vaccine. She said some people have no side effect and some have Headaches and tiredness. Her 89 years old dad had headache and tiredness after the Pfizer covid vaccine. Caller wanted to know how safe it was got that 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: Muscle spasms
Clinical narrative: leg cramps; 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), administration date 03Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset Jul2021, outcome "unknown", described as "leg cramps".  Additional Information: Patient called to report side effects after getting the first dose, she mentioned leg cramps which was a side effect after she got the first dose on 03Jul2021. As per the patient, she doesn't have a schedule for the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced illness, onset Mar 2021, with outcome of unknown. Patient stated this past week she got sick and has been sick all week, but tested negative 4 days ago. "Do you think I should repeat the test?" Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vision blurred
Clinical narrative: but my arm was excruciating, the pain was unbearable; nausea; vision was getting blurry; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "but my arm was excruciating, the pain was unbearable"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VISION BLURRED (non-serious), outcome "unknown", described as "vision was getting blurry".  Additional information: Caller states "I gotta talk to you, what happened was 07Jul2021 I got first dose, people I know got the first shot before me and said expect soreness in the arm. Alright that doesn't sound bad but my arm was excruciating, the pain was unbearable". Caller states "because shortly after they gave me the vaccine, my vision was getting blurry, but I do have cataracts in both eyes. Could it make it blurry because I have cataracts"?. Caller states "here's my crucial question. I had the first shot and I'm going back for the second shot any time after 28Jul. Is it true my pharmacist told me this is it true that after the second dose your side effects are worse"?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: feeling dizziness; weakness; he has fallen a couple of times; runny nose; My head is full; increasingly frustrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021907889 (Pfizer).  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 (Lot number: EW0182, Expiry date: Unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "stent put in heart" (unspecified if ongoing), notes: Had a stent put in his heart 10 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EW0182), administration date: 21Apr2021, when the patient was 81 years old, for Covid-19 immunisation.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "feeling dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; FALL (non-serious), outcome "unknown", described as "he has fallen a couple of times"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "My head is full"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "increasingly frustrated". Therapeutic measures were taken as a result of rhinorrhoea.  Additional Information: Patient received both doses of the vaccine on 21Apr2021 and 12May2021. About a week or so after the second dose he reports feeling dizziness, weakness, and he has fallen a couple of times. This has occurred for the last three weeks. Patient also stated that patient got his Covid 19 Vaccines and has been noticing the last couple of weeks that he is having dizziness and weakness. Asks if that would have anything to do with the vaccine. The dizziness and weakness has started within the last 3 weeks, and he fell down a couple of times. Patient started getting frustrated with the questions for the report. Patient also states that he didn't have any dizziness or weakness before getting the vaccines. The caller received the second dose of the Covid 19 vaccine 12May2021 and has been feeling dizzy and their nose is running. Caller states for the last couple of weeks, he has been taking Flonase and other stuff and it won't stop. Clarified that he filed the report about the dizziness and runny nose yesterday when he called. Caller does not have reference number from previous report. The health center he goes to recommended that he take it. He's got diabetes and high blood pressure. Had a stent put in his heart 10 years ago. There was a product complaint to report. Product strength and count size dispensed was not provided. There is a medical information request.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Chills; Sweating; Body Aching; Hurts to move/can not move with out pain; Sharp pains in hands and feet; Sharp pains in hands and feet; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jul2021 13:30 (Lot number: ER8731) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 14Jul2021, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 14Jul2021, outcome "recovering", described as "Sweating"; PAIN (non-serious) with onset 14Jul2021, outcome "recovering", described as "Body Aching"; PAIN (non-serious) with onset 14Jul2021, outcome "recovering", described as "Hurts to move/can not move with out pain"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Jul2021, outcome "recovering" and all described as "Sharp pains in hands and feet". Therapeutic measures were not taken as a result of chills, hyperhidrosis, pain, pain, pain in extremity, pain in extremity.  No follow-up attempts are possible. No further information is expected.  Facility type vaccine: Pharmacy or Drug Store. Patient did not received other vaccine in four weeks. It was unknown if patient had covid prior vaccination. Patient had not tested covid post vaccination. Adverse event: Chills, Sweating, Body Aching, Hurts To Move, Can Not Move With Out Pain, Sharp Pains In Hands And Feet  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nausea"; VOMITING (non-serious), outcome "unknown", described as "vomiting".  Additional Information: This Physician reported 2 pediatric patients. Patient number 1 experience nausea & vomiting following vaccination for Covid. Patient 2 was not vaccinated by this office but child reported shortness of breath and chest discomfort following vaccination for Covid. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast inflammation, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 45-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8736), at the age of 45, in left arm, on Apr 24, 2021, at 11:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced axillary pain, breast inflammation (my left armpit and left breast became inflamed) and pain (it has hurt ever since), onset 2021, with outcome of not recovered. No therapeutic measures not taken as a result of axillary pain, breast inflammation and pain. Additional information: Patient did not took any other vaccine in four weeks. Patient do not have COVID-19 infection prior to vaccination. Patient not tested COVID-19 post vaccination. The next day after the vaccination, my left armpit and left breast became inflamed and it has hurt ever since. It deflated a bit but it continues. No follow-up attempts possible. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: The patient fainted and unconscious for a few minutes. She woke-up after tapping and calling her name. Contacted emergency services.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Pruritus, Rash
Clinical narrative: Development of a pityriasis rosacea-like rash on back, stomach, upper arms and upper thighs associated with mild itching; which spontaneously resolved within about 6 weeks.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Urticaria
Clinical narrative: Patient immediately developed a hive around the size of a half-dollar after receiving the third dose of her covid vaccination. She also experienced a lot of pain after the vaccination. A couple of days later while showering she noticed that an avocado sized lump appeared under her armpit. This lump has remained for the last couple of months.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure abnormal, Blood test, Cerebrovascular accident, Feeling cold
Clinical narrative: May 16, 2021: Developed severe facial twitching and weakness. Early June: Experienced what was believed to be a stroke or a TIA, which was ruled-out; extreme tingling throughout my entire body (from head to toe), basically a feeling of getting splashed with ice cold water several times a week. Also, my blood pressure has been a constant roller coaster, ranging from 212/128 as low as 76/53 and everywhere in between while doing nothing.  I'm currently on 13 different medications.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Muscle twitching, Nerve conduction studies, Paraesthesia
Clinical narrative: May 16, 2021: Developed severe facial twitching and weakness. Early June: Experienced what was believed to be a stroke or a TIA, which was ruled-out; extreme tingling throughout my entire body (from head to toe), basically a feeling of getting splashed with ice cold water several times a week. Also, my blood pressure has been a constant roller coaster, ranging from 212/128 as low as 76/53 and everywhere in between while doing nothing.  I'm currently on 13 different medications.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, X-ray
Clinical narrative: May 16, 2021: Developed severe facial twitching and weakness. Early June: Experienced what was believed to be a stroke or a TIA, which was ruled-out; extreme tingling throughout my entire body (from head to toe), basically a feeling of getting splashed with ice cold water several times a week. Also, my blood pressure has been a constant roller coaster, ranging from 212/128 as low as 76/53 and everywhere in between while doing nothing.  I'm currently on 13 different medications.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received Sputnik Covid 19 Vaccine series 5/18/21 and 7/20/21.  This Moderna booster administered today should have been 0.25ml.  PATIENT RECEIVED 0.5ML INSTEAD
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: sore arm (pt was given higher dose of 30 mcg/0.3ml Pfizer vaccine)
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test abnormal, C-reactive protein increased, Dyspnoea, Exercise tolerance decreased
Clinical narrative: Elevated blood pressure and obvious blood thickening. 1. 4/6/21: triggered migraine 45 minutes after second shot. could not get out of bed for 5 days. 2. 4/13/21: blood draw for annual physical. 2. 4/27/21: results of blood test showed extremely high inflammation (C reactive protein). 3. 5/5/21: tried to donate blood. flow stopped after roughly a minute. technicians pulled out a 3-inch long blood clot with the needle upon giving up on the donation. 4. 8/10/21 & 8/17/21: blood draw and test results - verified inflammation reduction. 5. 11/15/21 & 12/27/21:  Doctor visit about elevated blood pressure since 2nd shot (160/120).  Ever since second shot, i cannot exercise due to immediate exhaustion. i get winded easily.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypercoagulation, Inflammation, Migraine, Mobility decreased
Clinical narrative: Elevated blood pressure and obvious blood thickening. 1. 4/6/21: triggered migraine 45 minutes after second shot. could not get out of bed for 5 days. 2. 4/13/21: blood draw for annual physical. 2. 4/27/21: results of blood test showed extremely high inflammation (C reactive protein). 3. 5/5/21: tried to donate blood. flow stopped after roughly a minute. technicians pulled out a 3-inch long blood clot with the needle upon giving up on the donation. 4. 8/10/21 & 8/17/21: blood draw and test results - verified inflammation reduction. 5. 11/15/21 & 12/27/21:  Doctor visit about elevated blood pressure since 2nd shot (160/120).  Ever since second shot, i cannot exercise due to immediate exhaustion. i get winded easily.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Elevated blood pressure and obvious blood thickening. 1. 4/6/21: triggered migraine 45 minutes after second shot. could not get out of bed for 5 days. 2. 4/13/21: blood draw for annual physical. 2. 4/27/21: results of blood test showed extremely high inflammation (C reactive protein). 3. 5/5/21: tried to donate blood. flow stopped after roughly a minute. technicians pulled out a 3-inch long blood clot with the needle upon giving up on the donation. 4. 8/10/21 & 8/17/21: blood draw and test results - verified inflammation reduction. 5. 11/15/21 & 12/27/21:  Doctor visit about elevated blood pressure since 2nd shot (160/120).  Ever since second shot, i cannot exercise due to immediate exhaustion. i get winded easily.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Cardiac stress test, Computerised tomogram, Cough, Discomfort
Clinical narrative: Dec 20, 2021, I called ambulance. I went to the ER. I was extremely dizzy, difficulty breathing, acute congestion, swelling and soreness. I had a burning sensation in chest around heart, left/right and behind heart. Lots of fluid in lungs; difficulty with coughing to expel phlegm. I was released after testing, although I was still in acute discomfort and having difficulties breathing. Dec 21, 2021, I drove myself to the hospital emergency room with same symptoms.  I was released in acute discomfort, distress and having difficulties breathing. Both times, I tested negative for COVID-19. I was told I had RSV, but I believe I had a reaction to my 3rd dose of Pfizer vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fluid retention, Pain
Clinical narrative: Dec 20, 2021, I called ambulance. I went to the ER. I was extremely dizzy, difficulty breathing, acute congestion, swelling and soreness. I had a burning sensation in chest around heart, left/right and behind heart. Lots of fluid in lungs; difficulty with coughing to expel phlegm. I was released after testing, although I was still in acute discomfort and having difficulties breathing. Dec 21, 2021, I drove myself to the hospital emergency room with same symptoms.  I was released in acute discomfort, distress and having difficulties breathing. Both times, I tested negative for COVID-19. I was told I had RSV, but I believe I had a reaction to my 3rd dose of Pfizer vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test, Respiratory syncytial virus infection, Respiratory tract congestion, Swelling, X-ray
Clinical narrative: Dec 20, 2021, I called ambulance. I went to the ER. I was extremely dizzy, difficulty breathing, acute congestion, swelling and soreness. I had a burning sensation in chest around heart, left/right and behind heart. Lots of fluid in lungs; difficulty with coughing to expel phlegm. I was released after testing, although I was still in acute discomfort and having difficulties breathing. Dec 21, 2021, I drove myself to the hospital emergency room with same symptoms.  I was released in acute discomfort, distress and having difficulties breathing. Both times, I tested negative for COVID-19. I was told I had RSV, but I believe I had a reaction to my 3rd dose of Pfizer vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was not eligible for booster yet but I did not realize that and administered a second dose of Janssen. Patient said his heart doctor told him to get a booster shot and he wanted to stick with Janssen. Patient received his first dose of Jannsen on 1/23/22 and would be eligible two months after that. I called patient after I realized he was not yet eligible and left a message for him to call back.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced axillary pain (had the underarm thing), with outcome of unknown. Additional information: Reporter read about the possibility of underarm pain. She stated she had a coworker who had the underarm thing. No further details provided about the coworker. Follow-up attempts completed. Information about batch/lot number cannot be obtained. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Pain in/under arm pit; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200092479 (Pfizer).  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2022 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); AMLODIPINE BESYLATE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: unknown, Expiration date: unknown, NDC: unknown), administration date: Mar2020, for Covid-19 immunisation; Bnt162b2 (Dose number: 2, Lot number: unknown, Expiration date: unknown, NDC: unknown), administration date: Mar2020, for Covid-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Pain in/under arm pit".  Additional information: Patient got the Pfizer Booster, clarified to be the Pfizer Covid Booster and she was having pain in her arm pit .She wanted to know if this was normal an reported it as a side effect to the vaccine. Patient had pain in arm pit/under arm pit. Confirmed this was on the left side. Time the vaccination was given was around noon. It was around bedtime, around 9:00 or 10:00 PM. Vaccination Facility Type was Hospital. Caller confirmed her previous doses were the Pfizer Covid Vaccine and had no details to provide. It was sometime in Mar2020. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations (within 4 weeks) and no adverse events following prior vaccinations. Relevant tests were reported as none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstrual disorder, SARS-CoV-2 test
Clinical narrative: had two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine.; period with only cramps; a small spot of blood on one day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0182) at the age of 14 years as dose 1, single and administered in arm left, administration date 16Jun2021 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (non-serious) with onset Oct2021, outcome "unknown", described as "period with only cramps"; INTERMENSTRUAL BLEEDING (non-serious) with onset Oct2021, outcome "unknown", described as "a small spot of blood on one day"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "had two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine. ". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My 14 year old daughter has only had two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine. Had 1 period with only cramps and a small spot of blood on one day in Oct2021. This is very concerning. Spoken with practitioner about our concerns. She had been fairly regular since onset in 2019. No covid prior vaccination. Patient tested for COVID post vaccination.no other medications has been taken in two weeks. No other vaccine administered in four weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This is a spontaneous report received from a 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "unknown", described as "Cough".  Additional information: Caller with held would like to reschedule his appointment for the booster shot for the Pfizer covid-19 vaccine But She mentioned that She developed a little cough and decided that She did not want to come for the appointment.  Follow-up (28Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Tachycardia
Clinical narrative: Covid-19; Covid-19; tachycardia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4231662-00 (Agency).  A 40 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155992) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19"; TACHYCARDIA (non-serious), outcome "recovered", described as "tachycardia". The action taken for adalimumab was unknown.  Clinical Course: The reporter's causality for the events had covid twice with HUMIRA(ADALIMUMAB) was no reasonable possibility and Tachycardia Response when Received Pfizer Vaccine with HUMIRA(ADALIMUMAB) was a reasonable possibility. When the PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) with Covid-19 causality was not reported and Tachycardia response when received Pfizer vaccine causality was possible. The reporter considered "tachycardia" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (28Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE, covid-19, and TACHYCARDIA and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: fever; soreness in her arm; diarrhea; she vomits when she does eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in her arm"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "recovered", described as "she vomits when she does eat".  Additional Information: Reporter was calling about the BioNTech Covid 19 Vaccine. Reporter said that her daughter just had appointment with her doctor on 19Jan2022 and at the end of her appointment she got her 1st dose of the Covid 19 vaccine. Ever since then she hasn't been eating, she vomits when she does eat, has diarrhea, and a fever. She doesn't know what she should she do about it. States that she has the paper with the list of common side effects and some of these are listed on the paper, but some of them are not, so she just wants to make sure that these are all side effects from the vaccine. States that she spoke to her daughter this morning and she is not doing any more vomiting, but she still has diarrhea, and now she has a headache, and her fever keeps going up. Her daughter is 14. While reporting on her daughter, Reporter states that her mother in law had the Pfizer shot and she had the same symptoms, a fever, soreness in her arm and diarrhea. Then she had the 2nd shot and she was fine. Her mother in law said that the 2nd dose made her like speedy; clarified that made her really energetic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: has been flaring terribly since; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 20220114000484.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "has been flaring terribly since".  Additional information: Patient's age and gender was unknown. Doctor has a patient who has been on 200mg dose for over a year. Patient was doing great until 4 months ago the patient received the Pfizer Covid vaccine and has been flaring terribly since. It was questioned if it could be from the vaccine. The patient has an appointment to see the doctor on Saturday - and requested to send the information soon so the patient has it for the appointment.   Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Second dose: had this same thing with the second dose where her arm was red and swollen really big at that spot; Second dose: had this same thing with the second dose where her arm was red and swollen really big at that spot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 (BNT162B2), administration date 17May2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Borderline diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 Immunization, reaction(s): "didn't have a reaction with the first dose".  The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "Second dose: had this same thing with the second dose where her arm was red and swollen really big at that spot".  Additional information: Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations: None. History of all previous immunization with the Pfizer vaccine considered as suspect: None. There were no other additional vaccines administered on Same Date of the Pfizer Suspect. Events did not lead to visit Emergency Room and Physician Office. There is no Family Medical History Relevant to AE(s) and there were no Relevant Tests. The caller got her second dose on 17May2021, and they said just to put some ice on it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseated".  Additional Information: The patient have been nauseated for like 30 minutes yesterday evening.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.