chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Tremor
Clinical narrative: Body was itching; Headache; Body is aching; Body pain; Numbness; Rash is still on my face and my chest; Eyes are red and itchy; Eyes are red and itchy; I have to be shaking shaking my self something; Joints are hurting me; Face is little bit swollen; Throat, I can't even eat anything; Loose appetite; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0187) via an unspecified route of administration, administered in arm left on 08Jul2021 at 12:10 pm (at the age of 51-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history related to event. The patient had no Family medical history related to event. There were no concomitant medications. No vaccination received 4 weeks prior to COVID 19 Vaccine. On 08Jul2021, at night after the vaccination, the patient experienced body was itching, headache and body was aching, body pain. On an unspecified date in Jul2021, it would be 10 to 12 hours time after the vaccination, the patient experienced, joints hurting, face was little bit swollen, throat she cannot even eat anything, loose appetite, numbness, rash still on her face and her chest, eyes are red and itchy. The clinical course of the events as follows: she stated she took the first dose of Pfizer Vaccine on Thursday on 8thJul. The very day she took it, and she waited there for 15 minutes and then she went to home in the night. She could believe it would be 10 to 12 hours time, I was (incomplete sentence). She felt that her body was itching and the whole night she felt headache and her body started aching. She continued having headache, body ache, and even her joints were hurting, it came to a point, her thigh, the leg to the bottom of her buttock was trying to be numb and she had to be shaking herself something. She stated that she put alcohol to stop the itching and then she takes Tylenol for headache almost every 4 hours, she said that she put alcohol on her face, the part which was itching the most and because of that alcohol she put it, her skin turned black. Her face was little bit swollen and her throat, she cannot even eat anything and she loose appetite. She stated the numbness would not stay for long but the itchy and rash was still on her face and her chest. She stated that she does not know if she is supposed to go to the ER. She stated that her second dose is supposed to be on 29thJul. She reported basically, it stays the same as the first time she experienced the rashes, it was the same and not going away and it was not getting worst either. No Investigation Assessment was provided. The outcome of the events body was itching, and rash was still on her face and chest was not resolved and the outcome of the other events was unknown at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: missed 4 doses due to a severe sinus infection; This is a spontaneous report from a contactable other HCP. A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization. Medical history included ongoing osteoporosis, anxiety disorder, ongoing chronic pain, ongoing essential hypertension, ongoing allergy to antibiotic. Patient previously took vancomycin and experienced allergy to vancomycin. Relevant surgical, social, or substance-usage history was not provided. Co-suspect medication included abaloparatide (TYMLOS) at 80 ug, 4x/day via subcutaneous route of administration from 13Apr2021 to unknown date for osteoporosis. Concomitant medications included albuterol [salbutamol], amlodipine, duloxetine, gabapentin, hydrochlorothiazide, montelukast, pantoprazole, rizatriptan, prednisone, potassium chloride, tizanidine, rosuvastatin, trazodone, venlafaxine, salbutamol sulfate (VENTOLINE [SALBUTAMOL SULFATE]). On an unspecified date in 2021, patient missed 4 doses due to a severe sinus infection. It was reported that the patient experienced sinusitis (sinus infection, start date the past 28 days), product dose omission issue. Per the physician the patient did not experience any adverse events from missing four doses of Tymlos. Information on treatment for the events was not provided, the physician could not determine what treatment was given for the sinusitis. No relevant lab or diagnostic tests were reported. The action taken with Tymlos treatment was does not changed. The relationship between Tymlos and the events of sinusitis and product omission issue was assessed as not related by the reporting physician. Per the physician, the patient reported the sinusitis was a symptom related to the Covid-19 vaccine. Additional information was received from physician on 15Jun2021. Casuality co-suspect medication and no adverse event from missed doses were reported. Additional case number for this patient included 2021 US000624 (alopecia). The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I developed something very similar to Covid19 in 2015 that developed into a longcovid like condition (asthma, migraines, auras, fatigue) and that your Covid vaccine cured it at least so far; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection); Lot/batch no: unspecified) via unspecified route, as dose number unknown, single on an unspecified date for COVID-19 immunization. Medical history included that patient was sick on/off for 6 years straight until the vaccine and asthma, migraine, aura and fatigue from 2015 till unknown date. Concomitant medications were not reported. It was reported that, patient developed something very similar to Covid19 in 2015 that developed into a long Covid like condition (asthma, migraines, auras, fatigue) and that Covid vaccine cured it at least so far. It was also stated that, patient might have had a mild case of MERS back then but did not know as no doctors ever tested patient for anything but was sick on/off for 6 years straight until the vaccine.The clinical outcome for event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Monoplegia, Nerve stimulation test
Clinical narrative: Left hand is completely paralyzed.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP 6955), via an unspecified route of administration at the age of 64-year-old administered in arm left on 18Mar2021 15:00 at single dose for covid-19 immunisation. Medical history included psoriasis and covid-19 (Prior vaccination patient had covid-19). The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left hand was completely paralyzed on 29Apr2021. The patient had MRI to rule out stroke. The event was serious for being disability. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient underwent lab tests included magnetic resonance imaging (MRI): unknown results on unspecified date, nerve testing: unknown results on unspecified date. The patient received treatment included physical therapy. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Tendonitis
Clinical narrative: feet starting having problems; Peroneus Brevis; wisted my ankle which actually got rid of the pain for a day; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Apr2021 (at age of 50 years old, no pregnant, Lot Number: EW0176) as a singled dose for covid-19 immunization. There were no medical history and concomitant medications. No known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at left arm on Apr2021 (Batch/lot number: CVS16506 EW0176) as a singled dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that 4 days after second dose on May2021, her feet starting having problems.  The patient did treatment RICE. Thought it was plantar fasciitis ruled that out because it switched feet. She was a marathon runner (so in good shape). She had not upped her activity level.  Hydrated. Nothing was working. Went to Dr, he thought it was Peroneus Brevis, did stretches etc, made it worse and twisted her ankle which actually got rid of the pain for a day and then was came back full force. The adverse event result in Doctor or other healthcare professional office/clinic visit. Received treatment included Stretching, RICE, Advil. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 test, Seizure
Clinical narrative: unconscious on the floor; seizure; This is a spontaneous report from a contactable other HCP (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 07Jan2021 09:00 (Batch/Lot Number: EL3249), dose 2 on 03Feb2021 09:00 (Batch/Lot Number: EL9261); both intramuscular, administered in Arm Left as single dose for covid-19 immunisation. Medical history included Graves Disease from 1997, type II diabetic, allergy to gadolineum. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin; sitagliptin phosphate (JANUVIA); sertraline hydrochloride (ZOLOFT); levothyroxine; magnesium; calcium; colecalciferol (VIT D3); curcuma longa (TURMERIC); atorvastatin calcium (LIPITOR); lisinopril. On the morning of 28Jan2021, the patient's grandson found her unconscious on the floor. She had a seizure and spent 3 days in the hospital. On 11Apr2021 during the night she had another seizure and spent 3 more days in the hospital. After 2nd seizure and hospital stay, the patient was put on anti-seizure medication. The patient underwent lab tests and procedures which included Nasal Swab (Covid test): negative on 02Jul2021. The patient recovered from the events. The case was serious as resulted in hospitalization.; Sender's Comments:  Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events unconsciousness and seizure cannot be excluded but also consider patient medical history of graves and DM2 as a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID after having received both doses of Pfizer Covid Vaccine; Contracted COVID after having received both doses of Pfizer Covid Vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX Support. The reporter reported same event for both him and his wife. This is the first of two reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on an unspecified date (Batch/Lot number was not reported), dose 2 on 30Jan2021 (Batch/Lot number was not reported), both via an unspecified route of administration as single dose as for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced contracted covid after having received both doses of pfizer covid vaccine in Jul2021 with outcome of unknown. Information about lot and batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021887202 Same reporter and drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID after having received both doses of Pfizer Covid Vaccine; Contracted COVID after having received both doses of Pfizer Covid Vaccine; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program COVAX US Support. The reporter reported same events for two patients, this is the second of two reports. A female patient of an unspecified age received BNT162B2, dose 1 on an unspecified date, dose 2 on 14Apr2021, both via an unspecified route of administration as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced contracted covid after having received both doses of pfizer covid vaccine on an unspecified date of Jul2021. The outcome of events was unknown.  Information about lot and batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021887180 Same reporter/drug/event, different patient
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Ear discomfort, Tinnitus, Vertigo
Clinical narrative: I experienced severe vertigo; severe vomiting X 4 hours; light-headedness/dizziness; losing my balance when walking or even standing still. ENT diagnosed; me with Vestibular Neuritis.; tinnitus; clogged ears; This is a spontaneous report from a contactable other hcp (nurse/Patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6203) via an unspecified route of administration in Arm Left on 04Feb2021 (age at vaccination 63-year) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Vit-D [vitamin d nos] (VIT D [VITAMIN D NOS]), Multivitamin, calcium supplement all taken for an unspecified indication, start and stop date were not reported. The patient previously took Aqua-Mephyton and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN9581) in left arm on an unspecified date at 08:00 AM at dose 1, single for COVID-19 immunization. The patient did not had COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient had no other vaccine in four weeks. The patient stated that she experienced severe vertigo, severe vomiting x 4 hours on 25Mar2021 08:00 AM (This was one month after Vaccine 2), went to an ENT after 2 weeks as she continued to have dizziness, light-headedness when changing position from lying to sitting to standing, turning in bed, turning my head, especially to the right, losing my balance when walking or even standing still. ENT diagnosed with Vestibular Neuritis. Patient had not been sick for more than one year and have never been diagnosed with this. After taking Prednisone for one week symptoms improved but have not disappeared. Patient continued to suffer from vertigo, tinnitus, clogged ears, dizziness, light-headness, unable to turn/sleep on right side. Went to an ENT that specializes in vertigo on 08Jul2021. After doing Epley manuver, little improvement so far. After reading about the many cases of people who have Vestibular Neuritis after COVID or the vaccine, patient decided to report her symptoms. The AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events medications included Meclizine, Zofran, prednisone. The clinical outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular neuronitis, Vomiting
Clinical narrative: I experienced severe vertigo; severe vomiting X 4 hours; light-headedness/dizziness; losing my balance when walking or even standing still. ENT diagnosed; me with Vestibular Neuritis.; tinnitus; clogged ears; This is a spontaneous report from a contactable other hcp (nurse/Patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6203) via an unspecified route of administration in Arm Left on 04Feb2021 (age at vaccination 63-year) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Vit-D [vitamin d nos] (VIT D [VITAMIN D NOS]), Multivitamin, calcium supplement all taken for an unspecified indication, start and stop date were not reported. The patient previously took Aqua-Mephyton and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN9581) in left arm on an unspecified date at 08:00 AM at dose 1, single for COVID-19 immunization. The patient did not had COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient had no other vaccine in four weeks. The patient stated that she experienced severe vertigo, severe vomiting x 4 hours on 25Mar2021 08:00 AM (This was one month after Vaccine 2), went to an ENT after 2 weeks as she continued to have dizziness, light-headedness when changing position from lying to sitting to standing, turning in bed, turning my head, especially to the right, losing my balance when walking or even standing still. ENT diagnosed with Vestibular Neuritis. Patient had not been sick for more than one year and have never been diagnosed with this. After taking Prednisone for one week symptoms improved but have not disappeared. Patient continued to suffer from vertigo, tinnitus, clogged ears, dizziness, light-headness, unable to turn/sleep on right side. Went to an ENT that specializes in vertigo on 08Jul2021. After doing Epley manuver, little improvement so far. After reading about the many cases of people who have Vestibular Neuritis after COVID or the vaccine, patient decided to report her symptoms. The AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse events medications included Meclizine, Zofran, prednisone. The clinical outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she has tested positive for COVID with a home test kit; she has tested positive for COVID with a home test kit; she says she did get sick on the second dose; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in upper left arm as single dose for COVID-19 immunization, dose 1 on 08Apr2021 18:00 (Lot Number: EW0153), dose 2 on 29Apr2021 18:00 (Lot Number: EW0153). Her children had COVID before she tested positive. Her children both tested positive on 06Jul2021 and then her children tested negative on 11Jul2021. She used to do dental hygiene and she was right handed so she always got her flu vaccine and everything in her left arm so her right arm would not be sore. There were no other medical history or family history. There were no concomitant medications. There were no vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had tested positive for COVID with a home test kit. One of her positive results was today 13Jul2021 and the first positive results she had was on 08Jul2021. Both of her children had it last week, neither of them are vaccinated and they both tested negative yesterday with the home kit. After second one the patient got sick but never ran fever, no medications were administered. No Emergency Room or Physician Office was required. The outcome of events was unknown.  Investigation results received on 15Jul2021 included Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts completed. No further information expected
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: feels crummy; Chills; a little headache; Low grade fever; a lump under her arm/has a lump under her right arm, this is also the injection site arm/swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization (age at vaccination: 61-year-old). Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date post vaccination, the patient woke up with chills in the morning, a little headache and a low-grade fever. The patient also reported that there is a lump under her arm, her right arm, the same arm she received her vaccine in. The lump is not at the injection site, it is under her armpit. The patient also felt crummy. The outcome of the events was reported as unknown at the time of report.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID-19 badly; Contracted COVID-19 badly; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. This consumer reported similar events for two patients (her parents). This is the first of two reports. A female patient (reporter's mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hospitalized for 5-10 days in mid Feb2021. The patient had to receive antibiotics as well as plasma during treatment process. The patient's concomitant medications were not reported. The reporter stated the patient was, as of about 3 weeks ago, fully vaccinated with the Pfizer vaccine. She was trying to be cautious since her mother contracted COVID-19 badly. The outcome of the event was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021888506 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer or other non hcp. A 13-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 12Jul2021 as dose 2, single for covid-19 immunisation. The patient previously received first dose of BNT162b2(Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot No: was not reported), via an unspecified route of administration on unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fever on an unspecified date.  Therapeutic measures were taken as a result of fever. Patient parents want to confirm about the patient had a fever around 3am last night and his wife gave her acetaminophen on the bottle it says to give 2 for people over 12 years old, but his wife only gave her one, should she have given her 2 and it is ok to give Tylenol. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyskinesia, Dysphagia, Facial discomfort
Clinical narrative: I experienced a tight feeling in my face and neck; I experienced a tight feeling in my face and neck; my throat and face were itching; My throat and face were itching; Then my throat started to burn and itch; I struggled to swallow; Uncomfortable feeling in my chest; Feel lightheaded; Fell over and sounds around me started to fade away; Uncontrollable arm and leg movements; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Jul2021 at 12:30 (at age of 33 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Ulcerative Colitis, severe seasonal allergies, Chronic Joint pain. Known allergies: Morphine, Peanut, Strawberry, Coconut, Avocado, Latex, Biologic Medication. Concomitant medications included mesalazine (DELZICOL), colecalciferol (VITAMIN D3 1000), origanum minutiflorum oil (OREGANO OIL), Oily Probiotic. On 10Jul2021 at 22:30, the patient experienced a tight feeling in my face and neck and her throat and face were itching. Then throat started to burn and itch, and she struggled to swallow. Had an uncomfortable feeling in chest, then stated to feel lightheaded and fell over and sounds around her started to fade away but didn't completely loose consciousness. Final thing that happened was uncontrollable arm and leg movements. Called and went to the ER. The ER doctor didn't do anything. The patient received Benadryl. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Muscle tightness, Oropharyngeal discomfort, Pruritus, Throat irritation
Clinical narrative: I experienced a tight feeling in my face and neck; I experienced a tight feeling in my face and neck; my throat and face were itching; My throat and face were itching; Then my throat started to burn and itch; I struggled to swallow; Uncomfortable feeling in my chest; Feel lightheaded; Fell over and sounds around me started to fade away; Uncontrollable arm and leg movements; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Jul2021 at 12:30 (at age of 33 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Ulcerative Colitis, severe seasonal allergies, Chronic Joint pain. Known allergies: Morphine, Peanut, Strawberry, Coconut, Avocado, Latex, Biologic Medication. Concomitant medications included mesalazine (DELZICOL), colecalciferol (VITAMIN D3 1000), origanum minutiflorum oil (OREGANO OIL), Oily Probiotic. On 10Jul2021 at 22:30, the patient experienced a tight feeling in my face and neck and her throat and face were itching. Then throat started to burn and itch, and she struggled to swallow. Had an uncomfortable feeling in chest, then stated to feel lightheaded and fell over and sounds around her started to fade away but didn't completely loose consciousness. Final thing that happened was uncontrollable arm and leg movements. Called and went to the ER. The ER doctor didn't do anything. The patient received Benadryl. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Headache, Malaise, Speech disorder
Clinical narrative: Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything,  couldn't speak, shaking, weakness; the next day didn't know anything,  couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything,  couldn't speak, shaking, weakness; the next day didn't know anything,  couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Fatigue, Headache, Muscular weakness
Clinical narrative: a-fib, had rapid heart rate after receiving the 1st dose; her legs were initially wobbly, weak; headache; I was extremely tired and my legs were initially wobbly, weak; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 (at an unspecified age) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a-fib, had rapid heart rate after receiving the 1st dose on an unspecified date. The patient still had a headache everyday. She was extremely tired and her legs were initially wobbly, weak. The patient stated these last symptoms went away. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Fatigue, Headache, Heart rate increased, Muscular weakness
Clinical narrative: a-fib, had rapid heart rate after receiving the 1st dose; her legs were initially wobbly, weak; headache; I was extremely tired and my legs were initially wobbly, weak; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 (at an unspecified age) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a-fib, had rapid heart rate after receiving the 1st dose on an unspecified date. The patient still had a headache everyday. She was extremely tired and her legs were initially wobbly, weak. The patient stated these last symptoms went away. The outcome of the events was recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Fatigue, Headache, Muscular weakness
Clinical narrative: atrial fibrillation; Headaches everyday, after first vaccine; Rapid heartbeat for a week and a half, after first vaccine; Very weak legs, after first vaccine; Extremely tired, after first vaccine; This is a spontaneous report from a contactable consumer (patient).    An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported, expiration date not provided) at age of 82 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation, headaches everyday, after first vaccine, rapid heartbeat for a week and a half, after first vaccine, very weak legs, after first vaccine, extremely tired, after first vaccine, all on an unspecified date. Clinical course: Caller stated a few days later, she had some reactions to her first shot. Caller reported that she had headaches everyday, a rapid heart beat for a week and a half, very weak legs, and she was extremely tired. Caller states her Cardiologist knows about her health concerns, and she did go into atrial fibrillation, but he didn't give her any specific answers. Caller did not specify when she went into atrial fibrillation. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Fatigue, Headache, Heart rate increased, Muscular weakness
Clinical narrative: atrial fibrillation; Headaches everyday, after first vaccine; Rapid heartbeat for a week and a half, after first vaccine; Very weak legs, after first vaccine; Extremely tired, after first vaccine; This is a spontaneous report from a contactable consumer (patient).    An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported, expiration date not provided) at age of 82 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation, headaches everyday, after first vaccine, rapid heartbeat for a week and a half, after first vaccine, very weak legs, after first vaccine, extremely tired, after first vaccine, all on an unspecified date. Clinical course: Caller stated a few days later, she had some reactions to her first shot. Caller reported that she had headaches everyday, a rapid heart beat for a week and a half, very weak legs, and she was extremely tired. Caller states her Cardiologist knows about her health concerns, and she did go into atrial fibrillation, but he didn't give her any specific answers. Caller did not specify when she went into atrial fibrillation. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoaesthesia, Muscle tightness, Paraesthesia, Throat tightness
Clinical narrative: tingling; tightness in her neck and throat; tightness in her neck and throat; numbness and tingling on the left side of her neck; really anxious; This is a spontaneous report from a contactable Pharmacist via Medical Information Team.   A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0217; Expiration date: Sep2021), via an unspecified route of administration in left deltoid on 13Jul2021 at 10:47 (at the age of 36 years old) as dose 1, 0.3 mL single for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jul2021 patient experienced tingling, tightness in her neck and throat, tightness in her neck and throat, numbness and tingling on the left side of her neck, really anxious. Reporter stated that she was a pharmacist and administered the vaccine to a patient who experienced tingling and tightness in her neck and throat on 13Jul2021.Tingling in the neck and throat included she did not let them know until the 15-minute observation period was over. She just kind of felt like her throat was tight and tingling in her neck. Reporter was not sure if she was still experiencing this now. Reporter stated that the patient was describing it as kind of a tight feeling but was not struggling to breathe. She was still breathing and everything, she was just really anxious. She just stood up and walked to the counter. She has been sitting there about 25 minutes. Reporter stated that the tightness has gone away now, the patient has been sitting at the pharmacy for 45 minutes and she was not struggling to breathe, and she was able to swallow water. The patient does still have some numbness and tingling on the left side of her neck. Reporter stated that the patient was now stating that the numbness and tightness have gone away but she was feeling tingling in her neck, on the side of administration, which was the left side. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not visit emergency room or physician office. Relatedness of drug to tingling in neck and throat and throat tightness and numbness reaction: Related as per source of assessment: Primary Source Reporter, method of assessment: Global Introspection.The outcome of events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: small hives on left side after second dose of vaccine/hives are on her arm/on her face and on her leg; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 22May2021 (at the age of 47-year-old) as single dose for covid-19 immunisation. Medical history included ongoing allergy to shellfish and ongoing Psoriatic arthritis diagnosed about 15 years ago from unknown date. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) 0.137mg one time a day, tablets been taking for about twenty years, taken for thyroid disorder from an unspecified start date and ongoing and ixekizumab (TALTZ), an injection into a muscle one time a month been taking about 2.5 years taken for psoriatic arthropathy from an unspecified start date and ongoing. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation and experienced no adverse event. Patient reported after receiving the second dose of the Pfizer Covid-19 Vaccine she has experienced small hives on the left side of her body on 23May2021. The hives are on her arm and they come and go, patient has an allergy to shellfish and knows what hives are because of this. Sometimes she gets 1 or 2 hives on her right arm, but not every day. She experienced hives on her upper arm on the left every day and one time on her face and on her leg. Her doctor has advised her to just take Benadryl, but something was wrong. She has no breathing involvement. She stated she has been taking pictures, that every day she will get one, and when she gets one the next day, she will get like seven. Patient states she can tell they are hives because she has an allergy to shellfish, not sure if that was in the vaccine or not, knows what her hives look like. Mostly on left sometimes on right. Got both doses in the left arm. Wondering if there was something in the vaccine that she had a reaction to. Hives started the day after the second vaccine, states the first vaccine was fine, states every day is different but it happens every day, states she was going to the doctor today and he will look at her arm again, treating it with Benadryl.  Therapeutic measures were taken as a result of the events with Benadryl. The outcome of the event was reported as not recovered.  Follow-up attempts needed. Further information requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dysgeusia, Feeling abnormal, Headache
Clinical narrative: she has lost 60% of her hearing in one ear/and 30% of her hearing in the other; headache; taste like metal; brain fog; This is a spontaneous report from a contactable consumer. This consumer reported for a 75-year-old female patient ( the reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration on an unspecified date at single dose, and second dose, via an unspecified route of administration on an unspecified date at single dose, all for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced lost 60% of her hearing in one ear, headache, taste like metal, brain fog, all on an unspecified date. The reporter stated her mom (the patient) received both doses of the Pfizer Covid-19 vaccine and has experienced headaches for awhile with other "really weird symptoms." The reporter stated the patient can't eat because everything tastes like metal and she had lost 60% of her hearing in one ear and 30% of her hearing in the other. The reporter stated patient experiences brain fog at times. The reporter stated that she was not sure if these symptoms were stemming from the vaccine or something else. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.