chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Hypoacusis, Hypoaesthesia, Magnetic resonance imaging head, Muscular weakness
Clinical narrative: Uncontrollable shivering at 1:45 am following morning. Sat up with my wife and moved to the living room. Went unresponsive while sitting on couch for 45 seconds making a gurgling sound. I was disoriented when coming to and couldn?t hear. I went to the Er to be looked at and had a slightly abnormal ekg but felt comfortable discharging me even though my heart felt like it was squeezing.  I have since been dealing with more and more symptoms. Pain and numbness., shortness of breath, chronic pain, skin inflammation , palpitations, heart squeezing,  headaches, muscle weakness, facial numbness and pain, neurological symptoms  in limbs.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Pain, Palpitations, Unresponsive to stimuli
Clinical narrative: Uncontrollable shivering at 1:45 am following morning. Sat up with my wife and moved to the living room. Went unresponsive while sitting on couch for 45 seconds making a gurgling sound. I was disoriented when coming to and couldn?t hear. I went to the Er to be looked at and had a slightly abnormal ekg but felt comfortable discharging me even though my heart felt like it was squeezing.  I have since been dealing with more and more symptoms. Pain and numbness., shortness of breath, chronic pain, skin inflammation , palpitations, heart squeezing,  headaches, muscle weakness, facial numbness and pain, neurological symptoms  in limbs.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Goitre, Oropharyngeal pain
Clinical narrative: Enlarged thyroid and sore throat. My dentist first noticed it and charted it was also off center. It get enlarged while swallowing. It last for about 6-8 weeks.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Vision blurred
Clinical narrative: At 1259 client aged 19yo, was vaccinated in her left arm with the Janssen vaccine lot#205A21A.  At 1306 client  requested a bottle of water as she reported feeling dizzy.  Vaccine monitor brought a bottle of water to vaccination room and immediately observed client's eyes begin to lose focus, so client was supported as she fainted, and placed safely on the floor with her legs elevated her legs on a chair and within seconds she regained consciousness. RN conducted a neuro-check on client and confirmed client was AxO x4.  The zero gravity chair was retrieved and EMT summoned, and at 1310 client was assisted to her feet by Co-Lead RN and RN and transferred to this chair.  At 1311 water was offered to client and she took a few sips and admitted she felt a lot better.  At 1312 EMT took client's first set of vitals which were: BP 110/70, HR 60, RR18, and O2 98%.  Co-lead confirmed with Vaccinator that client had been appropriately screened, that client had denied past syncopal episodes and had ate food today at 1000.   At 1314, Co-Lead RN asked client again if she had ever experienced syncope, and she admitted that she had once when visiting her uncle in the hospital. Co-Lead then educated client that it is not uncommon to faint due to anxiety related to medical procedures and encouraged her to report this to her physician and to any medical personnel in the future during medical procedures so proper safety precautions can be engaged.  Co-Lead then applied a cold pack to the back of client's neck, and EMT took a second set of vitals: BP 120/70, HR 63, O2 100%.  Client remained in the vaccination room 1328 when she felt well enough to walk to the observation room escorted by EMT to complete a 30 minute observation period.  At 1339 when EMT approached client to take her vitals again, client stated she was dizzy again, so EMT requested she remain for another 15 minutes and have a snack.  At 1400, client stated she felt better, her vitals were taken for the last time by the EMT: BP 110/60, HR 56, O2 98%, and EMT then escorted client downstairs where her mother was waiting with the car.  EMT and Co-Lead RN educated client to take it easy for the rest of the day and seek additional care with her PCP or Urgent Care if symptoms worsened.  EMT observed client ambulating independently with a steady, even gait.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: I have developed a weird heartbeat since receiving the vaccine
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral
Clinical narrative: Loss of hearing in the left ear one minute after the injection of the vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in left arm at injection site. Pain, tingling and numbness running down left arm to fingers
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Decreased appetite, Fall, Injection site pain, Loss of consciousness
Clinical narrative: I received the 2nd shot of Moderna Covid-19 vaccine on 6/4/21 at 4pm and started to have  a lot of pain in the arm that received the vaccine from shoulder to wrist and 102.3 fever by 11pm on the same day. I took Tylenol and went to bed. Next morning on 6/5/21, I woke up with a lot of muscle aches and weakness and couldn't function, so I mostly spent the morning laying down. I didn't eat and drank very little. By 12pm on that day I started to feel nauseous, I got up and walked to the kitchen to have a drink. At that point everything started to go dark in front of my eyes and I fainted and fell on the floor. I was told by my son that I was unconscious for 2 or 3 minutes and when I started to regain my consciousness,  I realized I was moaning and my face was covered with cold sweat.  I had fever between 99.8 and 100.8 that whole day on 6/5/21 and felt better with no fever the next day on 6/6/21.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Moaning, Muscular weakness, Myalgia, Nausea, Pyrexia
Clinical narrative: I received the 2nd shot of Moderna Covid-19 vaccine on 6/4/21 at 4pm and started to have  a lot of pain in the arm that received the vaccine from shoulder to wrist and 102.3 fever by 11pm on the same day. I took Tylenol and went to bed. Next morning on 6/5/21, I woke up with a lot of muscle aches and weakness and couldn't function, so I mostly spent the morning laying down. I didn't eat and drank very little. By 12pm on that day I started to feel nauseous, I got up and walked to the kitchen to have a drink. At that point everything started to go dark in front of my eyes and I fainted and fell on the floor. I was told by my son that I was unconscious for 2 or 3 minutes and when I started to regain my consciousness,  I realized I was moaning and my face was covered with cold sweat.  I had fever between 99.8 and 100.8 that whole day on 6/5/21 and felt better with no fever the next day on 6/6/21.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Visual impairment
Clinical narrative: I received the 2nd shot of Moderna Covid-19 vaccine on 6/4/21 at 4pm and started to have  a lot of pain in the arm that received the vaccine from shoulder to wrist and 102.3 fever by 11pm on the same day. I took Tylenol and went to bed. Next morning on 6/5/21, I woke up with a lot of muscle aches and weakness and couldn't function, so I mostly spent the morning laying down. I didn't eat and drank very little. By 12pm on that day I started to feel nauseous, I got up and walked to the kitchen to have a drink. At that point everything started to go dark in front of my eyes and I fainted and fell on the floor. I was told by my son that I was unconscious for 2 or 3 minutes and when I started to regain my consciousness,  I realized I was moaning and my face was covered with cold sweat.  I had fever between 99.8 and 100.8 that whole day on 6/5/21 and felt better with no fever the next day on 6/6/21.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Chest pain, Menstruation irregular, Non-consummation
Clinical narrative: Not sexually active  No period in Feburary or March 2 months missed period 1 normal period in April  no period in May Currently no period as of June 16th  OTHER:  Chest pains Sharp
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Headache, Injection site bruising, Injection site pain
Clinical narrative: 1st shot- Just a sore arm, no major symptoms 2nd shot- Sore arm, felt headache, very very tired for 2 days. Tiredness continued for several days off and on. On the last Thursday in May, around 10 pm, noticed pain in left arm where shot was administered. Upon looking, it was swollen about the size of a large marble, very tender to the touch, and black and blue, which continued to spread down the shoulder over the next few days. I went to the doc and she had no idea why this happened.  I DID NOT bump my shoulder. I've shown it to several health professionals and no one can give me an idea of what this is. As of today, 6/16/2021, the lump is still there, still sore, and periodically itches. The bruising has subsided.  I can send pics if you want.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling, Lymphadenopathy, Pain in extremity, Pleural effusion
Clinical narrative: 1st shot- Just a sore arm, no major symptoms 2nd shot- Sore arm, felt headache, very very tired for 2 days. Tiredness continued for several days off and on. On the last Thursday in May, around 10 pm, noticed pain in left arm where shot was administered. Upon looking, it was swollen about the size of a large marble, very tender to the touch, and black and blue, which continued to spread down the shoulder over the next few days. I went to the doc and she had no idea why this happened.  I DID NOT bump my shoulder. I've shown it to several health professionals and no one can give me an idea of what this is. As of today, 6/16/2021, the lump is still there, still sore, and periodically itches. The bruising has subsided.  I can send pics if you want.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Urine analysis
Clinical narrative: Chest pain
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Condition aggravated, Diverticulitis, Vaccine positive rechallenge
Clinical narrative: Diverticulitis a couple weeks after the first vaccine. I then felt better after being hospitalized and then had the second vaccine and the diverticulitis flared up again.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 102F Same day as 2nd dose  Again fever 101.9f day 8 after 2nd dose  Again fever 102f day 10 after 2nd dose  Hives on arm 9 days after 2nd dose
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Deep vein thrombosis, Joint swelling, Ultrasound Doppler abnormal
Clinical narrative: Progressive swelling and pain around and below the right knee, first noticed 11 days after second covid vaccination.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Dizziness, Nausea, Body Aches, Fever, Chills, Chest Pain, Extreme Fatigue
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Dizziness, Nausea, Body Aches, Fever, Chills, Chest Pain, Extreme Fatigue
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Mobility decreased, Nausea, Syncope
Clinical narrative: Symptoms started morning after 1st shot and increased in severity through out the day.  Vertigo, dizziness, light headed and fainting. Mobility was mildly impaired in the morning.  By midday mobility was severely impaired, not able to walk straight, head spins, mild nausea.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Symptoms started morning after 1st shot and increased in severity through out the day.  Vertigo, dizziness, light headed and fainting. Mobility was mildly impaired in the morning.  By midday mobility was severely impaired, not able to walk straight, head spins, mild nausea.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Catheterisation cardiac normal, Chest pain, Computerised tomogram
Clinical narrative: 5 days later went to ER with severe chest pain. Determined it was a heart attack due to blood clot. Was in the hospital for 2 days. EKG, catheter to heart, cat scan, blood tests
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Intracardiac thrombus, Myocardial infarction
Clinical narrative: 5 days later went to ER with severe chest pain. Determined it was a heart attack due to blood clot. Was in the hospital for 2 days. EKG, catheter to heart, cat scan, blood tests
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pt states that about 8 days after receiving the vaccine he developed an itchy rash on both of his wrists. It did seem to grow in size to cover a little less than the size a dollar bill.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Fatigue, Headache
Clinical narrative: 7pm could not raise right arm.  Had severe headache & fatigue, chills and confusion ongoing, joint pain especially small joints. Have ongoing muscle pain, fatigue & confusion.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: 7pm could not raise right arm.  Had severe headache & fatigue, chills and confusion ongoing, joint pain especially small joints. Have ongoing muscle pain, fatigue & confusion.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Echocardiogram normal, Ejection fraction, Electrocardiogram normal
Clinical narrative: Patient received 2nd dose of Pfizer vaccine on 6/10/2021. Initially had typical symptoms of fatigue and arm pain. On 6/13/2021, woke up with  central chest pain and "fluttering" of his heart. Mother read the Agency website concerning possible myocarditis after Covid vaccinations so then took him to the ED.  The chest pain lasted about an hour (resolved in triage in the ED). There he had a normal ECG and chest x-ray. He was referred to see me in clinic on 6/15/2021. He had a normal echocardiogram. Due to the parental concern for possible myocarditis, I recommended a troponin which would show if his chest pain were possibly related to that. It returned mildly elevated at 0.21 ng/mL, prompting me to enter this as a possible mild case of myocarditis after vaccination.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myocarditis, Pain in extremity, Sinus rhythm, Troponin I increased
Clinical narrative: Patient received 2nd dose of Pfizer vaccine on 6/10/2021. Initially had typical symptoms of fatigue and arm pain. On 6/13/2021, woke up with  central chest pain and "fluttering" of his heart. Mother read the Agency website concerning possible myocarditis after Covid vaccinations so then took him to the ED.  The chest pain lasted about an hour (resolved in triage in the ED). There he had a normal ECG and chest x-ray. He was referred to see me in clinic on 6/15/2021. He had a normal echocardiogram. Due to the parental concern for possible myocarditis, I recommended a troponin which would show if his chest pain were possibly related to that. It returned mildly elevated at 0.21 ng/mL, prompting me to enter this as a possible mild case of myocarditis after vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid disorder, Hordeolum, Swelling of eyelid
Clinical narrative: Swelling and drooping of right eyelid. Painful to touch. Turned into a stye after several days. Believe it could be a reaction to a dermal filler.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: I've had Tinnitus for 11 years, however I experience a drastic spike in my Tinnitus after getting the first dose of the Moderna vaccine. It has since, lasted.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac arrest, Cardiac failure congestive
Clinical narrative: Congestive heart failure / heart stopped
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: Fast heart rate at random when sitting troubled breathing  increased tiredness and headaches
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, X-ray
Clinical narrative: Arm  Where injection site occurred has lingering pain that will not abate. No reason for pain no movement. But nerve just keeps acting up and going crazy. May not be related but it is at the injection site
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Postmenopausal haemorrhage
Clinical narrative: I got my period after not having it for over 2 years. It was very heavy and lasted almost two weeks.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erosion, Injection site erythema, Injection site pruritus
Clinical narrative: 1-2 in area of erythema at  injection site with excoriation from  scratching
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myeloid leukaemia, Pyrexia, Stomatitis, White blood cell count abnormal
Clinical narrative: Following a normal physician exam pt developed, mouth sores & then fever, Labs noted abnormal white Blood cells, over ensuing 1 week repeat Labs & specialist testing resulted in Diagnosis of acute myelogenous leukemia admitted for induction therapy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, FATIGUE AND CHILLS Narrative:  Other Relevant History:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Lethargy, Vein disorder
Clinical narrative: It started by feeling lethargic and loss of appetite. the scariest was the fact my veins all over my body became very prominent. It happened with the first shot but not as bad. I took pictures of my arms and neck on 05/23/2021. I did not seek any medical help because I knew it wasn't an allergic reaction so I assume it was not life threatening.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging spinal abnormal, Myelitis transverse, Quadriplegia
Clinical narrative: Acute transverse myelitis; Quadriplegia; This case was reported by a lawyer and described the occurrence of myelitis transverse in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   The initial information was received on 11 June 2021 via medical record. ( Case is medically confirmed). Recent shingles vaccination which occurred on 21 October 2019. On 10 December 2020, patient complaint had Transverse Myelitis. The patient had Acute transverse myelitis in demyelinating disease of cnsl at the cervical cord , now stable in the last few days, C spine MRI with abnormal signal at C3 level and Quadriplegia, unspecified.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Computerised tomogram normal, Contusion, Dizziness
Clinical narrative: Facial injury; Blade eye; Dizzy-walking; This is a spontaneous report from a contactable other hcp.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot number and expiry date was not reported) via intramuscular route of administration on arm left on an unspecified date, at 07:15 as a SINGLE DOSE for covid-19 immunisation (at the age of 61 years). The patient medical history and concomitant medications were not reported. The patient family medical history included breast cancer to mother (82 years old, dead) and father had Parkinsons (81 years old, dead). On an unspecified date, the patient experienced facial injury, blade eye, and dizzy walking. Dizzy-walking water on floor sounded by qms. Blade eye-L Facial injury. Injury to left eye. The time lag from stop date, if event occurred after cessation of treatment: 3 days for 2nd dose. The patient was not admitted to the hospital. The outcome of the evens was unknown.   The reporter considers the Pfizer product had a causal effect to the adverse event.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Fatigue, Full blood count normal, Loss of consciousness, Metabolic function test normal
Clinical narrative: Facial injury; Blade eye; Dizzy-walking; This is a spontaneous report from a contactable other hcp.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot number and expiry date was not reported) via intramuscular route of administration on arm left on an unspecified date, at 07:15 as a SINGLE DOSE for covid-19 immunisation (at the age of 61 years). The patient medical history and concomitant medications were not reported. The patient family medical history included breast cancer to mother (82 years old, dead) and father had Parkinsons (81 years old, dead). On an unspecified date, the patient experienced facial injury, blade eye, and dizzy walking. Dizzy-walking water on floor sounded by qms. Blade eye-L Facial injury. Injury to left eye. The time lag from stop date, if event occurred after cessation of treatment: 3 days for 2nd dose. The patient was not admitted to the hospital. The outcome of the evens was unknown.   The reporter considers the Pfizer product had a causal effect to the adverse event.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eye injury, Facial pain
Clinical narrative: Facial injury; Blade eye; Dizzy-walking; This is a spontaneous report from a contactable other hcp.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot number and expiry date was not reported) via intramuscular route of administration on arm left on an unspecified date, at 07:15 as a SINGLE DOSE for covid-19 immunisation (at the age of 61 years). The patient medical history and concomitant medications were not reported. The patient family medical history included breast cancer to mother (82 years old, dead) and father had Parkinsons (81 years old, dead). On an unspecified date, the patient experienced facial injury, blade eye, and dizzy walking. Dizzy-walking water on floor sounded by qms. Blade eye-L Facial injury. Injury to left eye. The time lag from stop date, if event occurred after cessation of treatment: 3 days for 2nd dose. The patient was not admitted to the hospital. The outcome of the evens was unknown.   The reporter considers the Pfizer product had a causal effect to the adverse event.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Lymphadenopathy, Odynophagia, Pain in jaw, Sensation of foreign body
Clinical narrative: I had soreness in my arm, jaw and ear. I couldn't chew for 5 days. My face and ear was swollen. Went to the ER. Reaction lasted a month. Had swollen joints in my jaw.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temporomandibular joint syndrome
Clinical narrative: I had soreness in my arm, jaw and ear. I couldn't chew for 5 days. My face and ear was swollen. Went to the ER. Reaction lasted a month. Had swollen joints in my jaw.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Ear swelling, Electrocardiogram, Mastication disorder, Pain in extremity
Clinical narrative: I had soreness in my arm, jaw and ear. I couldn't chew for 5 days. My face and ear was swollen. Went to the ER. Reaction lasted a month. Had swollen joints in my jaw.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Swelling face
Clinical narrative: I had soreness in my arm, jaw and ear. I couldn't chew for 5 days. My face and ear was swollen. Went to the ER. Reaction lasted a month. Had swollen joints in my jaw.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: She tested positive for Covid and was totally asymptomatic; This is a spontaneous report from a contactable. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EJ1686; Expiration Date: 31Mar2021), dose 1 via an unspecified route of administration on 28Dec2020 (at the age 62-years-old) as 1st single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. Patient tested positive for COVID-19 on 04Jan2021. Patient had been quarantine and was totally asymptomatic. Patient state that patient was due to get the second vaccine on 18Jan2021. The outcome of the events was unknown.  Follow-up (17Mar2021): No further information expected.  Follow-up (26Mar2021): New information includes: product investigation results. Conclusion: For this lot adverse event safety request for investigation and/or lack of effect was previously investigated. TA sample was not sent to the-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID [withheld]. The complaint for a positive COVID test after vaccination of Pfizer-BioNTech Covid-19 Vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ1686. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: She tested positive for Covid and was totally asymptomatic; This is a spontaneous report from a contactable. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EJ1686; Expiration Date: 31Mar2021), dose 1 via an unspecified route of administration on 28Dec2020 (at the age 62-years-old) as 1st single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. Patient tested positive for COVID-19 on 04Jan2021. Patient had been quarantine and was totally asymptomatic. Patient state that patient was due to get the second vaccine on 18Jan2021. The outcome of the events was unknown.  Follow-up (17Mar2021): No further information expected.  Follow-up (26Mar2021): New information includes: product investigation results. Conclusion: For this lot adverse event safety request for investigation and/or lack of effect was previously investigated. TA sample was not sent to the-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID [withheld]. The complaint for a positive COVID test after vaccination of Pfizer-BioNTech Covid-19 Vaccine was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ1686. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Peripheral swelling
Clinical narrative: Initial report on file in emergency room on 01/15/2021. Prednisone was given at the hospital. Went to see an Neurologist in March 10, 2021.  Acute Inflammatory Demiloinization  is like getting Multiple Scoliosis  within a couple hours but only in parts of her body. Waiting on Insurance plan for test to see the where her nerve is being affected.  Previously had COVID in March 2020.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Demyelination, Neurological examination
Clinical narrative: Initial report on file in emergency room on 01/15/2021. Prednisone was given at the hospital. Went to see an Neurologist in March 10, 2021.  Acute Inflammatory Demiloinization  is like getting Multiple Scoliosis  within a couple hours but only in parts of her body. Waiting on Insurance plan for test to see the where her nerve is being affected.  Previously had COVID in March 2020.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Paraesthesia, Sensation of foreign body, Swelling face, Swollen tongue
Clinical narrative: Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensation of lump in throat (throat closing); extreme thirst; low grade fever; This is a spontaneous report from a non-contactable consumer. This 56-year-old female consumer received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration of single dose (at the age of 54-year-old) on 14Feb2021 at 04:00 PM on right arm for COVID-19 immunization. Patient's allergies included allergies of Soy, corn and honey. The patient's medical history and concomitant medications were not reported. On 14Feb2021, at 04:30 PM patient experienced numbness of lower face, swelling of lower face and tongue, sensation of lump in throat (throat closing), extreme thirst and low grade fever. It was reported that patient required emergency room and patient was monitored for vitals 4.5 hr; and treatment of anti inflammatory and antihistaminic was given. It was reported that patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst, Throat tightness, Vital signs measurement
Clinical narrative: Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensation of lump in throat (throat closing); extreme thirst; low grade fever; This is a spontaneous report from a non-contactable consumer. This 56-year-old female consumer received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration of single dose (at the age of 54-year-old) on 14Feb2021 at 04:00 PM on right arm for COVID-19 immunization. Patient's allergies included allergies of Soy, corn and honey. The patient's medical history and concomitant medications were not reported. On 14Feb2021, at 04:30 PM patient experienced numbness of lower face, swelling of lower face and tongue, sensation of lump in throat (throat closing), extreme thirst and low grade fever. It was reported that patient required emergency room and patient was monitored for vitals 4.5 hr; and treatment of anti inflammatory and antihistaminic was given. It was reported that patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pyrexia, Swelling face, Swollen tongue, Thirst
Clinical narrative: Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensation of lump in throat (throat closing); extreme thirst; low grade fever; This is a spontaneous report from a non-contactable consumer. This 56-year-old female consumer received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration of single dose (at the age of 54-year-old) on 14Feb2021 at 04:00 PM on right arm for COVID-19 immunization. Patient's allergies included allergies of Soy, corn and honey. The patient's medical history and concomitant medications were not reported. On 14Feb2021, at 04:30 PM patient experienced numbness of lower face, swelling of lower face and tongue, sensation of lump in throat (throat closing), extreme thirst and low grade fever. It was reported that patient required emergency room and patient was monitored for vitals 4.5 hr; and treatment of anti inflammatory and antihistaminic was given. It was reported that patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Numbness of lower face; swelling of lower face and tongue; swelling of lower face and tongue; sensation of lump in throat (throat closing); extreme thirst; low grade fever; This is a spontaneous report from a non-contactable consumer. This 56-year-old female consumer received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN5318) via an unspecified route of administration of single dose (at the age of 54-year-old) on 14Feb2021 at 04:00 PM on right arm for COVID-19 immunization. Patient's allergies included allergies of Soy, corn and honey. The patient's medical history and concomitant medications were not reported. On 14Feb2021, at 04:30 PM patient experienced numbness of lower face, swelling of lower face and tongue, sensation of lump in throat (throat closing), extreme thirst and low grade fever. It was reported that patient required emergency room and patient was monitored for vitals 4.5 hr; and treatment of anti inflammatory and antihistaminic was given. It was reported that patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Injection site pain, Pain, X-ray
Clinical narrative: Costochondritis/ chest area quite painful/ lower left ribcage; Taking my breath away as I moved; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9809) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia (BPH), glaucoma, hypertension, and gastrooesophageal reflux disease, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included amlodipine, dutasteride, esomeprazole, and brimonidine tartrate (ALPHAGAN), all from unknown dates for unknown indications. The patient previously received sulfur from an unknown date for an unknown indication and experienced drug allergy; unspecified beta blockers from unknown dates for unknown indications and experienced drug allergy; and the first dose of BNT162B2 (lot number EL3247) in the left arm on 15Jan2021 (at the age of 83-years-old) for COVID-19 immunisation. The patient reported that on days 3-5 following the second shot, his entire chest area was quite painful, taking his breath away as he moved. On days 6 and 7, it was in the left side only, and on day 8 it settled in his lower left ribcage. The patient stated that over 3 months later, it was still there, some days were worse than others. He reported it was diagnosed as costochondritis, stating he visited urgent care, emergency room, two pulmonologists and his primary care physician. No treatment was received for the events. The clinical outcomes of costochondritis and taking his breath away as he moved were not recovered. It was also reported that on 29Mar2021 the patient was tested for COVID-19 via nasal swab, the results were not reported.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Costochondritis, Dyspnoea, SARS-CoV-2 antibody test
Clinical narrative: Costochondritis/ chest area quite painful/ lower left ribcage; Taking my breath away as I moved; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9809) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia (BPH), glaucoma, hypertension, and gastrooesophageal reflux disease, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included amlodipine, dutasteride, esomeprazole, and brimonidine tartrate (ALPHAGAN), all from unknown dates for unknown indications. The patient previously received sulfur from an unknown date for an unknown indication and experienced drug allergy; unspecified beta blockers from unknown dates for unknown indications and experienced drug allergy; and the first dose of BNT162B2 (lot number EL3247) in the left arm on 15Jan2021 (at the age of 83-years-old) for COVID-19 immunisation. The patient reported that on days 3-5 following the second shot, his entire chest area was quite painful, taking his breath away as he moved. On days 6 and 7, it was in the left side only, and on day 8 it settled in his lower left ribcage. The patient stated that over 3 months later, it was still there, some days were worse than others. He reported it was diagnosed as costochondritis, stating he visited urgent care, emergency room, two pulmonologists and his primary care physician. No treatment was received for the events. The clinical outcomes of costochondritis and taking his breath away as he moved were not recovered. It was also reported that on 29Mar2021 the patient was tested for COVID-19 via nasal swab, the results were not reported.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: This is a spontaneous report from two contactable Consumer or other non-HCP (Patient and Patient's Son). These two consumers reported for 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL9261; Expiry Date was not reported), via an unspecified route of administration in arm left on 02Feb2021, (80-years -old at the time of vaccination), as first dose, single dose for COVID-19 immunization. The patient's medical history included fall, she went to the hospital for this, was a year ago and diabetes mellitus. The patient's concomitant medications included Metformin that she could take it only when her blood sugar is up, and Flu shot had it 3 weeks ago. On 03Feb2021, the patient experienced face swelling, the swelling was mostly around the eyes as if she was sting, it looks like little water bags, it doesn't hurt, there was no pain, it was underneath both eyes and down the cheeks, just swelling, swelling feels warm to the touch, and the skin was red, it's not red all over but in patches on cheeks and below the eyes, there was also redness right below chin, and it stops at the chin and there was redness on the forehead. On an unspecified date, the patient underwent lab tests and procedures which included blood glucose: 98. The outcome of all the event face swelling was not recovered and the event swelling feels warm to the touch and the skin was red was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Erythema, Feeling hot, Swelling face
Clinical narrative: This is a spontaneous report from two contactable Consumer or other non-HCP (Patient and Patient's Son). These two consumers reported for 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL9261; Expiry Date was not reported), via an unspecified route of administration in arm left on 02Feb2021, (80-years -old at the time of vaccination), as first dose, single dose for COVID-19 immunization. The patient's medical history included fall, she went to the hospital for this, was a year ago and diabetes mellitus. The patient's concomitant medications included Metformin that she could take it only when her blood sugar is up, and Flu shot had it 3 weeks ago. On 03Feb2021, the patient experienced face swelling, the swelling was mostly around the eyes as if she was sting, it looks like little water bags, it doesn't hurt, there was no pain, it was underneath both eyes and down the cheeks, just swelling, swelling feels warm to the touch, and the skin was red, it's not red all over but in patches on cheeks and below the eyes, there was also redness right below chin, and it stops at the chin and there was redness on the forehead. On an unspecified date, the patient underwent lab tests and procedures which included blood glucose: 98. The outcome of all the event face swelling was not recovered and the event swelling feels warm to the touch and the skin was red was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram, Electromyogram, Fatigue, Headache
Clinical narrative: She received her first dose of the Pfizer COVID vaccine about one month ago. Starting one day after, she has had intermittent new issues with her hands. She describes intermittent difficulty moving (extending) digits 4+5 in both hands and digit 3 on the left and digit 1 on the right. She has had some new numbness of the left hand digit 3. She has had worsening of her chronic Raynaud's. She has also had intermittent difficulty swallowing solids and her tongue felt weak. This lasted just about 1 week after the vaccine. Her chronic diplopia also worsened since the vaccine. She has had proximal weakness in the arms and legs.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: She received her first dose of the Pfizer COVID vaccine about one month ago. Starting one day after, she has had intermittent new issues with her hands. She describes intermittent difficulty moving (extending) digits 4+5 in both hands and digit 3 on the left and digit 1 on the right. She has had some new numbness of the left hand digit 3. She has had worsening of her chronic Raynaud's. She has also had intermittent difficulty swallowing solids and her tongue felt weak. This lasted just about 1 week after the vaccine. Her chronic diplopia also worsened since the vaccine. She has had proximal weakness in the arms and legs.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Diplopia, Dysphagia, Hypoaesthesia
Clinical narrative: She received her first dose of the Pfizer COVID vaccine about one month ago. Starting one day after, she has had intermittent new issues with her hands. She describes intermittent difficulty moving (extending) digits 4+5 in both hands and digit 3 on the left and digit 1 on the right. She has had some new numbness of the left hand digit 3. She has had worsening of her chronic Raynaud's. She has also had intermittent difficulty swallowing solids and her tongue felt weak. This lasted just about 1 week after the vaccine. Her chronic diplopia also worsened since the vaccine. She has had proximal weakness in the arms and legs.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia oral, Raynaud's phenomenon
Clinical narrative: She received her first dose of the Pfizer COVID vaccine about one month ago. Starting one day after, she has had intermittent new issues with her hands. She describes intermittent difficulty moving (extending) digits 4+5 in both hands and digit 3 on the left and digit 1 on the right. She has had some new numbness of the left hand digit 3. She has had worsening of her chronic Raynaud's. She has also had intermittent difficulty swallowing solids and her tongue felt weak. This lasted just about 1 week after the vaccine. Her chronic diplopia also worsened since the vaccine. She has had proximal weakness in the arms and legs.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Dysphagia, Headache, Throat tightness
Clinical narrative: metallic taste in my mouth; slight tightening of my throat; my throat swelling worsened making it difficult to swallow; my throat swelling worsened making it difficult to swallow; slight headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 27-Year-old Female patient (age at vaccination: 27 year) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Mar2021 at 13:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, environmental allergies and known allergies of chickpeas, pet dander and dust mites (from an unknown date and unknown if ongoing). Concomitant medications included loratadine (CLARITINE); fluticasone propionate (FLONASE) and multivitamins (Vitamins not otherwise specified (NOS)) daily (taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. It was unknown if patient had COVID prior vaccination. The patient was not tested for covid post vaccination. On 05Mar2021 at 13:35 hours (5 minutes after injection), the experienced a metallic taste in her mouth and a slight tightening of her throat. While in observation, this persisted so she told a nurse and PA on site, they assured her that she was fine if she had no history of severe allergic reactions. She left observation at 25 minutes after injection. Upon driving home about 35-40 minutes later her throat swelling worsened making it difficult to swallow, the metallic taste persisted, and she also had slight headache. She used her Albuterol HFA rescue inhaler. The throat swelling and difficulty swallowing resolved shortly thereafter. The metallic taste and headache persist currently +2 hours after injection. The patient received unknown treatment for the events metallic taste in my mouth and slight headache. The outcome of the events metallic taste in my mouth and slight headache was not resolved and for all other events, it was resolved on 05Mar2021.  No follow-up attempts are needed. No further information is expected.