chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Guillain-Barre syndrome, Investigation
Clinical narrative: guillain-barre syndrome;   An elderly female patient 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 single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced guillain-barre syndrome and was hospitalized. Lab data on unspecified dates included CSF test: showed albuminocytological dissociation; and investigation: fatigue and bilateral symmetric weakness of the lower limbs. Therapeutic measures were taken as a result of the event (IVIG). The outcome of the event was recovered on an unspecified date.  The detailed clinical course from article was as follows: The first case of GBS following COVID-19 vaccination was reported in February 2021 in an elderly female who presented 2 weeks after the first dose of the vaccine. The patient presented with fatigue and bilateral symmetric weakness of the lower limbs. CSF analysis showed albuminocytological dissociation and she was started on IVIG which led to improvement in the weakness. The patient recovered successfully and was discharged to a rehabilitation institute thereafter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: based on the availability of information the  causality between the event  GBS and suspect vaccine BNT162B2 cannot be completely ruled out
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fatigue; Sore Arm; Low-Grade Fever; Throwing Up; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 30Jul2021 at 10:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken from an unknown date for an unspecified indication. The patient received some unspecified vaccine on the 30Jul2021. The patient did not have any known allergies to food, medication or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 07Jul2021 at 15:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. On 31Jul2021 at 08:30, the patient experienced fatigue, sore arm, low-grade fever, and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, sore arm, low-grade fever, and throwing up were unknown at the time of this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Three days after receiving first shot the patient experienced an increase in volume of tinnitus.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: en6206) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 11:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within 2 weeks of vaccination. The patient had no known allergies. On an unknown date in Mar2021 at 11:15, three days after receiving his first shot, the patient experienced an increased in volume of his tinnitus. The patient had tinnitus in the right ear for many years but it had always been at a low volume and very manageable. After receiving his first shot, the volume increased to a high level and has remained that way ever since. The volume level since the shot was very distracting and at times very difficult to deal with. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event an increase in volume of the tinnitus was not recovered at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Systemic lupus erythematosus
Clinical narrative: I have lupus of the connective tissues and had just come out of my flare 4 weeks ago. 2 days ago I'm waiting till another flare; terrible terrible muscle weakness and it's really bad; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration  in Arm Right on 23Jul2021 10:00 (Batch/Lot Number: Ew0198) (at the age of 65-years-old) as single dose for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease, mitral valve disease, cardiac failure congestive, renal cancer stage III, pulmonary embolism from 06May2021, antiphospholipid syndrome from 2003, fibromyalgia from 2007, Sjogren's syndrome from 2007 , Lupus connective tissues 2007 from 2007 and drug allergy to Morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE) taken for an unspecified indication.  The patient  reported she had lupus of the connective tissues and had just come out of her flare 4 weeks before reporting. On 31Jul2021 02:00 she was waiting till another flare and she was having terrible terrible muscle weakness and it was really bad. The patient was treated with Muscle relaxant. Since the vaccination,  the patient has been tested for COVID-19. The outcome of the events was not recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Dyspnoea, Myocarditis, SARS-CoV-2 test
Clinical narrative: Enlarged heart (myocarditis); Enlarged heart (myocarditis); shortness of breath; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 06Jun2021 at 12:00 at the age of 56 years old  (Batch/Lot Number: Ew01191, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included high blood pressure, heart failure, and diabetes; all from an unknown date and unknown if ongoing. The patient had no relevant past drug history. Concomitant medications included metformin and glipizide; both taken for an unspecified indication, start and stop date were not reported; the patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via nasal swab with unknown result on an unspecified date. On 09Jun2021, the patient experienced enlarged heart (myocarditis) and shortness of breath, which all led to hospitalization and disability and were also considered medically significant. The patient considered them severe as he had been in an out of the hospital. The patient was hospitalized for enlarged heart (myocarditis) and shortness of breath for 3 days. The adverse events did result in an emergency room/department or urgent care. Therapeutic measures were taken as a result of enlarged heart (myocarditis) and shortness of breath, which included catheter heart surgery. The patient was not recovered from the events.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in left arm where vaccine was given.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 30Jul2021 at 16:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis and hypothyroidism. The patient had no known allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) "5 mg/10 mg"; all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did receive other vaccines within four weeks prior to the vaccination which included medroxyprogesterone acetate (DEPO PROVERA) in the left arm on 09Jul2021. On 30Jul2021 at 17:30, the patient experienced soreness in left arm where vaccine was given. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness in left arm where vaccine was given was resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jun2021 at 19:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome. The patient had known allergies to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, liothyronine (NP THYROID), metformin hydrochloride, empagliflozin (SYNJARDY), dulaglutide (TRULICITY) and levocetirizine dihydrochloride (XYZAL); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jul2021, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with antiviral medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was recovering at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy, Haematochezia, Haemorrhoids
Clinical narrative: Episodes of bright red Bleeding in stool; internal small hemmoroid; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration in left arm on 20Apr2021 at 09:00 (at the age of 51-years-old) at dose 1, single for COVID-19 immunization. There was no medical history. The patient was very healthy. Prior to vaccination, she was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D3, menaquinone-7 (K2), zinc, and magnesium. The patient previously took prednisone and experienced allergies. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. On 14Jul2021 at 08:00, the patient experienced episodes of bright red bleeding in stool. She had a colonoscopy which showed an internal small hemorrhoid but there was no bleeding at time of colonoscopy. She has regular bowel movements and eats whole foods, no sugar, and gluten diet for 21/2 years. She was very healthy and had great blood work at the time of colonoscopy on 20Jul2021. The doctor who performed the colonoscopy said there were no other issues. The events required emergency room/department or urgent care visit. She did not receive any treatment in response to the events. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: vision became cloudy; This is a spontaneous report from a contactable consumer, the patient. A 37-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The  medical history of the patient included COVID-19 on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient's vision became cloudy around 2-3 days after receiving the vaccine. It had occurred with both first and second doses and happened both times and it was still happening at the time of report, months after receiving these injections. It was not every day that the cloudy vision would occur. NO therapeutic measures was taken as a result of the event. The clinical outcome of the event vision became cloudy was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test
Clinical narrative: right ear being completely deaf; This is a spontaneous report from a contactable nurse (patient). A non-pregnant 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 28Jul2021 at 19:45 (Batch/Lot number was not reported) (at the age of 25-years-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The vaccination facility type was pharmacy or drug store. The patient had no relevant medical history, past drug history and concurrent conditions. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 31Jul2021 at 06:15, Saturday, the 3rd day after receiving the vaccine, the patient woke up with her right ear being completely deaf. This has never happened, and she was a regular at cleaning her ears. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination which included nasal swab SARS-CoV-2 test: negative on 31Jul2021. The patient did not receive any treatment. The outcome of the event was not recovered.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the close drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event deafness unilateral cannot be totally excluded/assessed.   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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Very sore and weak arm that got the injection; Weak arm that got the injection; Body aches; Sniffles; Sore throat; Tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780), via an unspecified route of administration in the left arm on 29Jul2021 at 15:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included barrett's esophagus, anemic, restless leg syndrome and major depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications from an unknown date for unknown indications. The patient previously took metronidazole (FLAGYL) on unknown date for an unspecified indication and experienced drug allergy. On 29Jul2021 at 17:00, the patient experienced very sore and weak arm that got the injection, body aches, sniffles, sore throat and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore and weak arm that got the injection, body aches, sniffles, sore throat and tired were resolving at the time of reporting.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Very sore and weak arm that got the injection; Weak arm that got the injection; Body aches; Sniffles; Sore throat; Tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780), via an unspecified route of administration in the left arm on 29Jul2021 at 15:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included barrett's esophagus, anemic, restless leg syndrome and major depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications from an unknown date for unknown indications. The patient previously took metronidazole (FLAGYL) on unknown date for an unspecified indication and experienced drug allergy. On 29Jul2021 at 17:00, the patient experienced very sore and weak arm that got the injection, body aches, sniffles, sore throat and tired. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore and weak arm that got the injection, body aches, sniffles, sore throat and tired were resolving at the time of reporting.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Hands begin to shake; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 31Jul2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C) from on an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Jul2021 at 14:45, the patient took the vaccine in left arm, sat for 15 minutes, monitoring and then the patient left. The patient went to gas station to get gas and his hands began to shake. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event hands began to shake was recovering at the time of this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Headache; Nausea; Tired; Swollen lymph node in armpit; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0185) via an unspecified route of administration in the left arm on 29Jul2021 at 10:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The medical history included bipolar 1, obsessive-compulsive disorder (OCD), sever depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included beclometasone dipropionate (QVAR), valproate semisodium (DEPAKOTE), montelukast sodium (SINGULAIR), ropinirole hydrochloride (REQUIP), cariprazine hydrochloride (VRAYLAR) and albendazole (ALB), all from unknown dates and  for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration in the left arm on 08Jul2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. On 31Jul2021 at 16:00, the patient experienced headache, nausea, tired and swollen lymph node in armpit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, tired and swollen lymph node in armpit were not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; weakness/I was weak; fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on 26Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced sore arm, weakness/I was weak, fever. Patient pharmacy told her to call regarding her side effects. Transferring agent stated, I have a consumer on the line, she is calling about side effects that she received from the first dose of the Pfizer Covid 19 vaccine- patient is a 44-year-old female who received the first dose on 26Jul2021 this year. She began having sore arm started around midnight in the same arm, the night she received the vaccine in the arm she was vaccinated in. Symptom has resolved. However she has developed weakness and fever in the morning that started yesterday and continued into today. Are these normal symptoms from the vaccine. Patient wants to know if the side effects can start that long after receiving the first dose. Patient stated, No, I called because my pharmacist told me to call, says you guys can help me. The lady before you said, It's normal. She said, You will experience it for 7 days. This is my 4th day. When, I got fever and I was weak. It must broke my fever in the morning. I was fine all day. All day all, before the morning. I was fine, even in the first week, I have another fever wake up in the morning, now weak again. Patient stated, No I don't have to transfer that. I don't need that. I cannot spend a week like that. She, If, told me, I am experiencing this until 7 days then it can extend up to 6 months with the second dose. Outcome of the events sore arm was recovered on an unspecified date in Jul2021 and outcome of remaining events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (PRD/SRD 23Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Hallucination, Limb discomfort, Pain in extremity, Skin discolouration
Clinical narrative: Hallucinations; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My left arm felt like it had carpel tunnel and it looked purple/blue in color; My arm hurt extremely bad; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0164; Expiration date was not reported) administered on the left arm on 29Jul2021 (15:00) as dose 2 single, with route of administration unspecified, for COVID-19 immunization at the public health department. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber: ER8733; Expiration date was not reported) on 01Jul2021 (11:15) (at the age of 39 years old) on the right arm for COVID-19 immunization. On 30Jul2021 (21:30), the patient had hallucinations (to the point where she had almost caused harm to her child); left arm had felt like it had carpel tunnel and it looked purple/blue in color; and arm hurt extremely bad. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Initial insomnia
Clinical narrative: Trouble staying asleep having very strange vivid dreams; Trouble staying asleep having very strange vivid dreams; This is a spontaneous report from contactable consumer, the patient. A 33-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the right arm on 31Jul2021 at 15:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 00:00, the patient had trouble staying asleep and had very strange vivid dreams. The patient was typically a sound sleeper and could not recall about the dreams or details when woke up the following morning. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events trouble staying asleep and had very strange vivid dreams were recovering at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Depressed mood
Clinical narrative: Dramatically hair loss; Its is very much depressing; This is a spontaneous report from a contactable consumer reported for herself.  A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (at the age of 46-years-old), dose 2 via an unspecified route of administration on 2021 (Batch/Lot Number: Ew0182) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had received the first dose of the same vaccine from Lot number: Ew482 at the right arm.  There were no concomitant medications. The patient experienced dramatically hair loss (disability) on 11Jul2021 with outcome of not recovered, it is very much depressing (disability) on 11Jul2021 with outcome of not recovered.  Pregnancy at the time of Vaccination: No. The patient didn't receive any treatment for the adverse events.  Clinical course was reported as follows, "dramatically hair loss. I been losing my hair like I have never lost before. It is very much depressing as have great set of hair. No matter what do am not able to stop this hair lost close to 75% of my hair in last 3 weeks since I got my last shot. I don't see any other reason why I would be losing this much of hair as nothing else has changed in my diet or lifestyle."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate decreased, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Low heart rate; Brain fog; Say Teague and muscle spasms; Prolong next stiffness; Pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 26-years-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: Ew0186), via an unspecified route of administration, administered in Arm Left on 25May2021 18:15 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 26 Years). The patient medical history was not reported. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: Ew0176), via an unspecified route of administration, administered in Arm Left on 03May2021 06:00PM as DOSE 1, SINGLE for covid-19 immunization and No reaction on previous exposure to vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 27May2021 14:00, the patient experienced low heart rate, brain fog, say Teague and muscle spasms, prolong next stiffness and pain. The patient was hospitalized for all events for 2 days. The patient hospitalization was prolonged as a result of all events. The patient underwent lab tests which included heart rate: low on 27May2021. Since the vaccination, patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The events result in Emergency room/department or urgent care. It was unknown if the patient had received treatment for the events. The outcome for all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Low heart rate; Brain fog; Say Teague and muscle spasms; Prolong next stiffness; Pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 26-years-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: Ew0186), via an unspecified route of administration, administered in Arm Left on 25May2021 18:15 as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 26 Years). The patient medical history was not reported. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: Ew0176), via an unspecified route of administration, administered in Arm Left on 03May2021 06:00PM as DOSE 1, SINGLE for covid-19 immunization and No reaction on previous exposure to vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 27May2021 14:00, the patient experienced low heart rate, brain fog, say Teague and muscle spasms, prolong next stiffness and pain. The patient was hospitalized for all events for 2 days. The patient hospitalization was prolonged as a result of all events. The patient underwent lab tests which included heart rate: low on 27May2021. Since the vaccination, patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The events result in Emergency room/department or urgent care. It was unknown if the patient had received treatment for the events. The outcome for all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram, Loss of consciousness
Clinical narrative: 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness; Heart arrhythmia issues slowly subsided; This is a spontaneous report from a contactable consumer (patient).    A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Jul2021 11:15 (Lot Number: EW0153) as dose number unknown, single (at 59 years old) for COVID-19 immunisation.  Medical history included hypertension. Concomitant medications included amlodipine; levothyroxine sodium (SYNTHROID); potassium, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness on 30Jul2021 12:00 PM with outcome of unknown, heart arrhythmia issues slowly subsided on 30Jul2021 12:00 PM with outcome of recovering.   The clinical course was reported as follows: 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness. ECG indicated multiple events. Went to ER the next day. Admitted to hospital with multiple tests. Heart arrhythmia issues slowly subsided. No treatment required. The patient was hospitalized for the events for 1 days. Prior to vaccination, the patient was not diagnosed with COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6955) via an Intramuscular route of administration in left arm on 19Apr2021 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0162) via an intramuscular route of administration in left arm on 22Mar2021 as dose 1, single for COVID-19 immunization. Concomitant medications included turmeric curcuma longa rhizome (TURMERIC) taken for inflammation, start and stop date were not reported. On 27Jul2021 the patient diagnosed with COVID (COVID-19, vaccination failure). The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 27Jul2021 Nasal Swab. Therapeutic measures were taken as a result of event. On 04Aug2021 it was reported that, other medications taken as vitamins and turmeric for inflammation. It was reported that she did not receive other vaccine in four weeks. She did not diagnose with COVID prior vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse events treatment recommendation to take sudafed for congestion. Patient was not having known allergies. The outcome of the events was reported as not recovered.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Illness, Mobility decreased, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis flare up; experienced inability to get out of bed; sickness; FACILITATED COLLECT This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in 2021 at dose 1, single and the second dose intramuscularly in 2021 at dose 2, single for COVID-19 immunisation; patient started to receive adalimumab (HUMIRA solution for injection in pre-filled pen, citrate free) subcutaneously for moderate to rheumatoid arthritis; prednisone for unspecified indication. Medical history included moderate to rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported. In 2021, the patient experienced inability to get out of bed, sickness and rheumatoid arthritis flare up. The patient also experienced prednisone with no effect. The events were reported as follows: patient experienced events of non-serious inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up with adalimumab. In 2021, the patient experienced inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up. Prednisone and BNT162b2 were also considered suspect. The action taken with adalimumab and prednisone was unknown. The patient was recovering from the events.    Causality for adalimumab: the reporter's causality for the event(s) of inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up was not provided.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Rheumatoid arthritis, Mobility decreased, and Illness and the suspect drugs.  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: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: I noticed a few hours ago that I have a very light swelling at my left arm that in my armpit area, I am assuming that would be the lymph node area, that it's on the same site of vaccine; Swelling at my left arm; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 2, SINGLE for an unspecified indication. The patient medical history was not reported. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) on an unspecified date for covid-19 immunization. The patient's concomitant medications were not reported. On an unspecified date the patient experienced i noticed a few hours ago that i have a very light swelling at my left arm that in my armpit area, i am assuming that would be the lymph node area, that it's on the same site of vaccine, swelling at my left arm. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspepsia, Headache, Heart rate, Heart rate increased
Clinical narrative: Heart rate, 113; Feel on and off like I can not feeling like too well; Mild headache that comes and go; Muscle ache; Sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off; Sense of anxiety; This is a spontaneous report received from a contactable consumer. This 36-year-old male consumer (patient) reported for himself. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection lot number was not reported) via an unspecified route of administration in arm right on 23Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing I had asthma as a child, but I think I cured out of it as a guy as I grow older. Concomitant medications were not reported. On 23Jul2021, it was reported by the patient that that I had symptoms that still kind off lingering around that mild headache that comes and go, sort of like muscle aches and then I had been through like sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off, I did not had any of that I was so, feeling a sense of anxiety and checked saturation and heart rate last night when I got home from work and wanted to check my heart rate, 113 for my heart rate and my saturation was fine, I can just feel on and off like I cannot feeling like too well. Treatment received was Tylenol and Ibuprofen, use for muscle ache. The patient underwent lab tests and procedures which included heart rate resulted as 113 on 29Jul2021, saturation resulted as fine on 29Jul2021. The clinical outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Oxygen saturation
Clinical narrative: Heart rate, 113; Feel on and off like I can not feeling like too well; Mild headache that comes and go; Muscle ache; Sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off; Sense of anxiety; This is a spontaneous report received from a contactable consumer. This 36-year-old male consumer (patient) reported for himself. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection lot number was not reported) via an unspecified route of administration in arm right on 23Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing I had asthma as a child, but I think I cured out of it as a guy as I grow older. Concomitant medications were not reported. On 23Jul2021, it was reported by the patient that that I had symptoms that still kind off lingering around that mild headache that comes and go, sort of like muscle aches and then I had been through like sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off, I did not had any of that I was so, feeling a sense of anxiety and checked saturation and heart rate last night when I got home from work and wanted to check my heart rate, 113 for my heart rate and my saturation was fine, I can just feel on and off like I cannot feeling like too well. Treatment received was Tylenol and Ibuprofen, use for muscle ache. The patient underwent lab tests and procedures which included heart rate resulted as 113 on 29Jul2021, saturation resulted as fine on 29Jul2021. The clinical outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Malaise
Clinical narrative: I feel not so good in my heart area; I feel like a pressure in the chest area; I do not feel good; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated I got the vaccine couple of hours ago (Like two hours ago) and i feel not so good in my heart area, i feel like a pressure in the chest area, i do not feel good on 29Jul2021. Patient stated tell me if it is normal or if it could be bad you know because I was afraid to get the vaccine and now I feel bad you know. Consumer wanted to know what to do if it would get worse whether to go to the hospital or something. The clinical outcome of event was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.