chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: could not swallow; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 22Apr2021 at 08:30 (at the age of 63-years-old) as unknown, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included trazodone hydrochloride (TRAZADOL) taken for an unspecified indication, start and stop dates were not reported. After 30 minutes (22Apr2021 at 09:00), the patient felt that she could not swallow. The adverse event resulted in emergency room/department or urgent care. The patient was hospitalized for the event for 1 day.  Therapeutic measures were taken as a result of the event [Epi pen, diphenhydramine (BENADRYL), prednisone]. The outcome of the event was recovered on Apr2021.    Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Feeling abnormal, Headache, Malaise
Clinical narrative: mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth appears to be inflamed and beet red; cold symptoms/Worst cold she has had in her life; sneezy; headache; foggy; Woke up in the morning not feeling well; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration, administered in arm left on 04May2021 10:30 (at the age of 57-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient had cold symptoms and described as the worst cold she has had in her life, and experienced sneezy, headache and foggy. On 12May2021, the patient experienced mouth no taste or smell, and was concerned about her mouth appears to be inflamed and beet red. It was also reported that the patient woke up in the morning not feeling well on May2021. Therapeutic measures were taken as a result of the events as patient was treated with Claritin. The outcome of the cold symptom/worst cold she has had in her life, mouth no taste or smell and mouth appears to be inflamed and beet red was not recovered; outcome of sneezy, headache, foggy and woke up in the morning not feeling well was unknown. The events did not require a visit to emergency room or physician office. Reporter seriousness for the events was medically significant. Relatedness of drug to reactions/events: Reaction assessed: cold symptoms, mouth appears to be inflamed and beet red and no taste or smell. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179),  to reported events is possible based on temporal association and known profile of the product.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oral mucosal erythema, Sneezing, Stomatitis
Clinical narrative: mouth no taste or smell; mouth no taste or smell; Mouth appears to be inflamed and beet red; Mouth appears to be inflamed and beet red; cold symptoms/Worst cold she has had in her life; sneezy; headache; foggy; Woke up in the morning not feeling well; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), via an unspecified route of administration, administered in arm left on 04May2021 10:30 (at the age of 57-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient had cold symptoms and described as the worst cold she has had in her life, and experienced sneezy, headache and foggy. On 12May2021, the patient experienced mouth no taste or smell, and was concerned about her mouth appears to be inflamed and beet red. It was also reported that the patient woke up in the morning not feeling well on May2021. Therapeutic measures were taken as a result of the events as patient was treated with Claritin. The outcome of the cold symptom/worst cold she has had in her life, mouth no taste or smell and mouth appears to be inflamed and beet red was not recovered; outcome of sneezy, headache, foggy and woke up in the morning not feeling well was unknown. The events did not require a visit to emergency room or physician office. Reporter seriousness for the events was medically significant. Relatedness of drug to reactions/events: Reaction assessed: cold symptoms, mouth appears to be inflamed and beet red and no taste or smell. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179),  to reported events is possible based on temporal association and known profile of the product.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pruritus, Rash
Clinical narrative: Patient reported chest pain (CP); 7 days after dose 1 of Pfizer Vaccine and developed diverse rash on trunk and extremities with itching.; 7 days after dose 1 of Pfizer Vaccine and developed diverse rash on trunk and extremities with itching.; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included food allergy (chicken) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. There was no other vaccine in four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since vaccination. It was reported that on 11May2021 the patient experienced chest pain (CP), no shortness of breath and no radiation of pain approx. 7 days after dose 1 of the Vaccine and developed diverse rash on trunk and extremities with itching. No history of chest pain or GERD and takes no routine prescription medications. Treatment received includes: Antihistamine and Inhaled Corticosteroid. Events was considered serious. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Dyspnoea, Pain, Respiratory arrest
Clinical narrative: had a respiratory or breathing episode; did go into cardiac arrest; complaining of pain; breathing issues; This is a spontaneous report from a contactable consumer (patient's caregiver). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as 1st dose, single (patient was 60 years old at the time of vaccination) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, Friday or Saturday, the patent was complaining about breathing issues all of a sudden, he had respiratory or breathing episodes. The reported stated that that they called 911 right away, and they came and picked the patient up. The patient had trouble breathing and was complaining of pain, and he did go into cardiac arrest, but they checked, and it was not a stroke or a heart attack, none of those things, they cannot figure it out. It was reported that nothing was wrong with the lungs, and the hospital was treating the patient by currently having him sedated and treating his pain. The outcome of the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Investigation
Clinical narrative: Experienced shortness of breath from the next day after my 2nd dose of Pfizer vaccination.; a very high heart rate (resting heart rate was 110 reaching up to 150)/Heart rate was going 130 - 150; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01May2021 (Batch/Lot Number: PFIZEREWO167) as 2ND DOSE, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included thyroid. Concomitant medication (patient received within 2 weeks of vaccination) included levothyroxine sodium (THYROX) taken for an unspecified indication, start and stop date were not reported. The patient previous took first dose of BNT162B2 on 10Apr2021 at 04:45 PM (Lot number: PFIZEREWO161) administered in left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath from the next day after her 2nd dose of Pfizer vaccination (02May2021). A severe shortness of breath with a very high heart rate (resting heart rate was 110 reaching up to 150) after 2nd dose of Pfizer vaccination started on 02May2021. Symptoms were getting worse, got admitted in Emergency Hospital on 07May2021. As it was worsening day by day and the Heart rate was going 130 - 150, had to admit in Emergency room on 07May2021. All the test reports appeared negative. Patient had thyroid and was within range. Patient didn't see any reason of such a severe shortness of breath other than reaction of vaccination. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. When asking what treatment received for the adverse event, 'Please reach out to (withheld)'. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering. The reporter classified the events as serious with Seriousness criteria - Life threatening and Caused/prolonged hospitalization.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Headache, Seizure, Tachycardia
Clinical narrative: has a feeling that she described as an "internal seizure" that is not noticeable to the eye but that she feels in the brain and head; tachycardia; without strength in her legs and arms; headache; anxiety; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 for COVID-19 immunization. On 02Feb2021 (four days later), the patient experienced without strength in her legs and arms in addition to experiencing a headache. She was diagnosed with anxiety and prescribed with Prozac, after a few days of treatment she was studied and got good results. She has managed to regain strength in her arms and legs exercising but still had a headache. During the evenings (unspecified date), she experienced tachycardia and had a feeling that she described as an "internal seizure" that was not noticeable to the eye but that she felt in the brain and head. Therapeutic measures were taken as a result of without strength in her legs and arms, headache, and anxiety. The outcome of the events without strength in her legs and arms and anxiety was recovering; the outcome of the event headache was not recovered; and the outcome of the other events was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic intracranial hypertension
Clinical narrative: bilateral paplliodema and idiopathic increased intracranial pressure; This is a spontaneous report from a contactable consumer (nurse). A 33-year-old female patient received BNT162B2, via an unspecified route of administration, administered in the left arm on 10Feb2021 (Lot Number: EL3247) as unknown, single for COVID-19 immunization. Medical history included depression and Polycystic ovarian syndrome (PCOS), both from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included ziprasidone hydrochloride (GEODON [ZIPRASIDONE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, start and stop date were not reported. On 08Apr2021 12:00, the patient experienced bilateral paplliodema and idiopathic increased intracranial pressure. Therapeutic measures were taken as a result of bilateral paplliodema and idiopathic increased intracranial pressure which included lumbar puncture and acetazolamide. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of the event was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: cataract; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old female patient received second dose in bnt162b2 (BNT162B2), via an unspecified route of administration on 15Mar2021, at the age of 79-years-old, (Batch/Lot number was not reported) as 2NDDOSE, SINGLE for Covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 received on second week of Feb2021. The patient reported cataract on an unspecified date with outcome of unknown.    Information about batch/Lot number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test
Clinical narrative: received his 1st dose last December 2020. He became COVID positive and received passive antibody treatment for COVID last February 2021.; received his 1st dose last December 2020. He became COVID positive and received passive antibody treatment for COVID last February 2021.; patient received his 1st dose last December 2020/He is asking if it will be okay for him to get his 2nd dose today; patient received his 1st dose last December 2020/He is asking if it will be okay for him to get his 2nd dose today; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist. An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (at the age of 79 years) via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his 1st dose last Dec2020 and became COVID positive and received passive antibody treatment for COVID last February 2021. The patient was hospitalized from Feb2021 to 04Feb2021. Outcome of the events was unknown. The events were reported as non-serious. He is asking if it will be okay for him to get his 2nd dose today and for how long should he wait before he does get the 2nd dose after getting antibody treatment.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.    There is limited information provided in this report.  This case will be reassessed once additional information is available. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: Woke up in the middle of the night to hallucinations of flapping wings of birds/proceeded to see black birds taking over the hallway and laundry room; fever; aches; terrible sweating; non stop nausea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 20Apr2021 10:00, as 1st dose, single dose, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient previously took loratadine (LORTAB) and amoxicillin and experienced allergy to both. Concomitant medications were not specified (reported as "other medications the patient received within 2 weeks of vaccination: Yes"). On 11May2021 at 02:00 AM, the patient woke up in the middle of the night to hallucinations of flapping wings of birds. She proceeded to see black birds taking over the hallway and laundry room. They had bright blue spots on their wings. The patient's son reassured her that nothing was in their home and he had to close all doors. This was on top of the fever, aches, terrible sweating and non-stop nausea. No treatment was given for the events. The 2nd dose of COVID-19 vaccine was administered on 11May2021 at 10:00 AM ((lot number unknown) in the left arm. The patient underwent COVID-19 nasal swab: negative on an unspecified date (since the vaccination). The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Woke up in the middle of the night to hallucinations of flapping wings of birds/proceeded to see black birds taking over the hallway and laundry room; fever; aches; terrible sweating; non stop nausea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 20Apr2021 10:00, as 1st dose, single dose, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient previously took loratadine (LORTAB) and amoxicillin and experienced allergy to both. Concomitant medications were not specified (reported as "other medications the patient received within 2 weeks of vaccination: Yes"). On 11May2021 at 02:00 AM, the patient woke up in the middle of the night to hallucinations of flapping wings of birds. She proceeded to see black birds taking over the hallway and laundry room. They had bright blue spots on their wings. The patient's son reassured her that nothing was in their home and he had to close all doors. This was on top of the fever, aches, terrible sweating and non-stop nausea. No treatment was given for the events. The 2nd dose of COVID-19 vaccine was administered on 11May2021 at 10:00 AM ((lot number unknown) in the left arm. The patient underwent COVID-19 nasal swab: negative on an unspecified date (since the vaccination). The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Multiple sclerosis, Vitamin D
Clinical narrative: multiple sclerosis; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Mar2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  Medical history included low iron and low vitamin D. Patient was not pregnant. There were no concomitant medication within 2 weeks and no other vaccine were administered 4 weeks prior to covid vaccine. Patient developed multiple sclerosis on 19Apr2021 (as reported), 19 days after the first injection. Patient had historically have low iron and low vitamin D and didn't realize that correlated to risk factors for multiple sclerosis. Patient stated who have those risk factors that they should not get the vaccine since it can create an immune response bringing out MS. The adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the adverse event included steroids and MS management medications. Outcome of the event was not recovered. Patient did not have covid prior to vaccination and had not been tested post-vaccination. The reporter considered the event serious (disabling).  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: a burst blood vessel in my eye; injection site pain; low grade fever; fatigue; body pain; This is a spontaneous report from a contactable consumer (patient). A adult female patient (age at vaccination 53-years-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 17:00 (Batch/Lot Number: EW0176) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Known Allergies: Seasonal allergies. The patient has no covid prior vaccination and not covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at the time of vaccination. The patient was vaccinated at Pharmacy/drug store. Concomitant medication included drospirenone, estradiol (ANGELIQ); cetirizine (CETIRIZINE) and; fluticasone (FLUTICASONE, reported as 50), all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6204) first dose on 15Apr2021 13:45 PM at the arm left for covid-19 immunization. It was reported that on "Saturday afternoon, about 48 hours (08May2021, 05:00 PM) after the shot, I noticed a burst blood vessel in my eye, which is atypical for me. I had not been coughing or vomiting, had only experienced low-grade fever, fatigue, body pain, and injection site pain since receiving the second shot." The outcome of the events was recovering. No treatment was initiated. Events were considered serious by the reporter.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Deafness, Gout, Mass
Clinical narrative: Tinnitus; hearing loss; Gout; Dry heaves; extreme abdominal cramping; Chills/Fever; Chills/Fever; Body Aches; Slept most of the day; Extreme sore arm; Quarter size hard lump X3weeks;; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm, at age 61 years, on 03Feb2021 (Batch/Lot Number: EL9269) as 1st DOSE, SINGLE for COVID-19 immunisation.  Relevant medical history includes hypertension, asthma, glaucoma and cataracts, and blood clot from unspecified dates. Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date.  Concomitant medications included chlorthalidone; apixaban (ELIQUIS); losartan; and verapamil, all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received ciprofloxacin (CIPRO) and vancomycin on unspecified dates and experienced known allergies. On 03Feb2021 14:00, the 1st day, patient experienced extreme sore arm; quarter size hard lump X3weeks. On 04Feb2021 14:00, second day, patient experienced chills, fever, body aches, slept most of the day. On 05Feb2021 14:00, third day, patient experienced dry heaves for 2 hours followed by extreme abdominal cramping that required the patient to lay flat for the whole day. On 06Feb2021 14:00, fourth day, patient woke up to gout in his right big toe that lasted for a week. On 08Feb2021 14:00, sixth day, patient had tinnitus in both ears and hearing loss. ENT doctor prescribed oral steroids w/ taper and when that didn't work. Patient went through 4 torturous treatments where ear drum was initially punctured and shot of steroids was inserted through the hole. That didn't work either and around the time of reporting, patient was told that she have permanent hearing loss and the tinnitus has not gone away. She is now looking at needing hearing aids and will not be subjecting herself to the second dose. Hospitalization prolonged was not involved. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a doctor's office/urgent care. The outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Retching, Somnolence
Clinical narrative: Tinnitus; hearing loss; Gout; Dry heaves; extreme abdominal cramping; Chills/Fever; Chills/Fever; Body Aches; Slept most of the day; Extreme sore arm; Quarter size hard lump X3weeks;; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm, at age 61 years, on 03Feb2021 (Batch/Lot Number: EL9269) as 1st DOSE, SINGLE for COVID-19 immunisation.  Relevant medical history includes hypertension, asthma, glaucoma and cataracts, and blood clot from unspecified dates. Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date.  Concomitant medications included chlorthalidone; apixaban (ELIQUIS); losartan; and verapamil, all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received ciprofloxacin (CIPRO) and vancomycin on unspecified dates and experienced known allergies. On 03Feb2021 14:00, the 1st day, patient experienced extreme sore arm; quarter size hard lump X3weeks. On 04Feb2021 14:00, second day, patient experienced chills, fever, body aches, slept most of the day. On 05Feb2021 14:00, third day, patient experienced dry heaves for 2 hours followed by extreme abdominal cramping that required the patient to lay flat for the whole day. On 06Feb2021 14:00, fourth day, patient woke up to gout in his right big toe that lasted for a week. On 08Feb2021 14:00, sixth day, patient had tinnitus in both ears and hearing loss. ENT doctor prescribed oral steroids w/ taper and when that didn't work. Patient went through 4 torturous treatments where ear drum was initially punctured and shot of steroids was inserted through the hole. That didn't work either and around the time of reporting, patient was told that she have permanent hearing loss and the tinnitus has not gone away. She is now looking at needing hearing aids and will not be subjecting herself to the second dose. Hospitalization prolonged was not involved. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a doctor's office/urgent care. The outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; hearing loss; Gout; Dry heaves; extreme abdominal cramping; Chills/Fever; Chills/Fever; Body Aches; Slept most of the day; Extreme sore arm; Quarter size hard lump X3weeks;; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm, at age 61 years, on 03Feb2021 (Batch/Lot Number: EL9269) as 1st DOSE, SINGLE for COVID-19 immunisation.  Relevant medical history includes hypertension, asthma, glaucoma and cataracts, and blood clot from unspecified dates. Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date.  Concomitant medications included chlorthalidone; apixaban (ELIQUIS); losartan; and verapamil, all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received ciprofloxacin (CIPRO) and vancomycin on unspecified dates and experienced known allergies. On 03Feb2021 14:00, the 1st day, patient experienced extreme sore arm; quarter size hard lump X3weeks. On 04Feb2021 14:00, second day, patient experienced chills, fever, body aches, slept most of the day. On 05Feb2021 14:00, third day, patient experienced dry heaves for 2 hours followed by extreme abdominal cramping that required the patient to lay flat for the whole day. On 06Feb2021 14:00, fourth day, patient woke up to gout in his right big toe that lasted for a week. On 08Feb2021 14:00, sixth day, patient had tinnitus in both ears and hearing loss. ENT doctor prescribed oral steroids w/ taper and when that didn't work. Patient went through 4 torturous treatments where ear drum was initially punctured and shot of steroids was inserted through the hole. That didn't work either and around the time of reporting, patient was told that she have permanent hearing loss and the tinnitus has not gone away. She is now looking at needing hearing aids and will not be subjecting herself to the second dose. Hospitalization prolonged was not involved. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a doctor's office/urgent care. The outcome of the events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Computerised tomogram, Dehydration, Diarrhoea
Clinical narrative: Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, fever on and off,; pain in left ankle and foot; extreme abdominal pain; dehydrated; lip started swelling; This is a spontaneous report from a contactable consumer.  A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06May2021 14:45 (Batch/Lot Number: EW0172) as 2nd dose, single (at the age of 58 years old) for COVID-19 immunisation.  Medical history included high heart rate, bp and prediabetic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide, triamterene (MAXZIDE) and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took VALIUM and experienced allergies;  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1, (lot number: EW0158) 14Apr2021 at 10:15 AM on left arm for COVID-19 immunisation and experienced lip swelling, bnt162b2 for covid-19 immunisation and experienced lower lip and chin swelling, Itchy chest, bumps, unable to walk and left knee severe joint pain.  The patient experienced 15 minutes after shot, lip started swelling on 06May2021 15:00. Severe vomiting, severe diarrhea, fever, extreme abdominal pain, extreme cold hands and feet, fever on and off, pain in left ankle and foot on 07May2021 12:30. The patient went to emergency room (er) 3 days after vaccine (dehydrated, extreme abdominal pain) 6 days later still have abdominal pain, diarrhea, vomiting and fever.  The patient received IV(intravenous fluids), potassium, abdominal CAT (computerized tomography) scan, Troponi (unknown drug). Prior to vaccination, was the patient not diagnosed with COVID-19 and been tested for COVID-19 (nasal swab) on 09May2021 and the result was negative. The outcome of the events were not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain in extremity, Peripheral coldness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, fever on and off,; pain in left ankle and foot; extreme abdominal pain; dehydrated; lip started swelling; This is a spontaneous report from a contactable consumer.  A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06May2021 14:45 (Batch/Lot Number: EW0172) as 2nd dose, single (at the age of 58 years old) for COVID-19 immunisation.  Medical history included high heart rate, bp and prediabetic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide, triamterene (MAXZIDE) and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took VALIUM and experienced allergies;  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1, (lot number: EW0158) 14Apr2021 at 10:15 AM on left arm for COVID-19 immunisation and experienced lip swelling, bnt162b2 for covid-19 immunisation and experienced lower lip and chin swelling, Itchy chest, bumps, unable to walk and left knee severe joint pain.  The patient experienced 15 minutes after shot, lip started swelling on 06May2021 15:00. Severe vomiting, severe diarrhea, fever, extreme abdominal pain, extreme cold hands and feet, fever on and off, pain in left ankle and foot on 07May2021 12:30. The patient went to emergency room (er) 3 days after vaccine (dehydrated, extreme abdominal pain) 6 days later still have abdominal pain, diarrhea, vomiting and fever.  The patient received IV(intravenous fluids), potassium, abdominal CAT (computerized tomography) scan, Troponi (unknown drug). Prior to vaccination, was the patient not diagnosed with COVID-19 and been tested for COVID-19 (nasal swab) on 09May2021 and the result was negative. The outcome of the events were not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, fever on and off,; pain in left ankle and foot; extreme abdominal pain; dehydrated; lip started swelling; This is a spontaneous report from a contactable consumer.  A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06May2021 14:45 (Batch/Lot Number: EW0172) as 2nd dose, single (at the age of 58 years old) for COVID-19 immunisation.  Medical history included high heart rate, bp and prediabetic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide, triamterene (MAXZIDE) and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took VALIUM and experienced allergies;  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1, (lot number: EW0158) 14Apr2021 at 10:15 AM on left arm for COVID-19 immunisation and experienced lip swelling, bnt162b2 for covid-19 immunisation and experienced lower lip and chin swelling, Itchy chest, bumps, unable to walk and left knee severe joint pain.  The patient experienced 15 minutes after shot, lip started swelling on 06May2021 15:00. Severe vomiting, severe diarrhea, fever, extreme abdominal pain, extreme cold hands and feet, fever on and off, pain in left ankle and foot on 07May2021 12:30. The patient went to emergency room (er) 3 days after vaccine (dehydrated, extreme abdominal pain) 6 days later still have abdominal pain, diarrhea, vomiting and fever.  The patient received IV(intravenous fluids), potassium, abdominal CAT (computerized tomography) scan, Troponi (unknown drug). Prior to vaccination, was the patient not diagnosed with COVID-19 and been tested for COVID-19 (nasal swab) on 09May2021 and the result was negative. The outcome of the events were not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: brief episode of faintness; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Rapid heart beat for 1-2 days; fatigue; chills; joint pain; nausea; low fever; headache; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 28-year-old via an unspecified route of administration in the left arm on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included IBS-D (irritable bowel syndrome - diarrhea), generalized anxiety, and on birth control. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included paroxetine for an unspecified indication; and ethinylestradiol, norethisterone (BALZIVA) for contraception, both therapy dates were not reported. The patient previously took metaxalone (SKELAXIN) as muscle relaxer but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 27-year-old on 17Apr2021 in the left arm for covid-19 immunisation. The patient did not receive other vaccine in the last four weeks prior to vaccination. On 10May2021, the patient had an unexpected severe abdominal (large intestine) and rectal pain lasting three days. The patient also had rapid heartbeat for 1-2 days and brief episode of faintness. It was further reported that there was a combined with expected side effects which included fatigue, chills, joint pain, nausea, low fever, headache, and swollen lymph node. The adverse events did not require treatment. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Lymphadenopathy, Nausea
Clinical narrative: brief episode of faintness; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Rapid heart beat for 1-2 days; fatigue; chills; joint pain; nausea; low fever; headache; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 28-year-old via an unspecified route of administration in the left arm on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included IBS-D (irritable bowel syndrome - diarrhea), generalized anxiety, and on birth control. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included paroxetine for an unspecified indication; and ethinylestradiol, norethisterone (BALZIVA) for contraception, both therapy dates were not reported. The patient previously took metaxalone (SKELAXIN) as muscle relaxer but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 27-year-old on 17Apr2021 in the left arm for covid-19 immunisation. The patient did not receive other vaccine in the last four weeks prior to vaccination. On 10May2021, the patient had an unexpected severe abdominal (large intestine) and rectal pain lasting three days. The patient also had rapid heartbeat for 1-2 days and brief episode of faintness. It was further reported that there was a combined with expected side effects which included fatigue, chills, joint pain, nausea, low fever, headache, and swollen lymph node. The adverse events did not require treatment. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Proctalgia, Pyrexia, Syncope
Clinical narrative: brief episode of faintness; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Unexpected severe abdominal (large intestine) and rectal pain lasting three days.; Rapid heart beat for 1-2 days; fatigue; chills; joint pain; nausea; low fever; headache; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 28-year-old via an unspecified route of administration in the left arm on 08May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included IBS-D (irritable bowel syndrome - diarrhea), generalized anxiety, and on birth control. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included paroxetine for an unspecified indication; and ethinylestradiol, norethisterone (BALZIVA) for contraception, both therapy dates were not reported. The patient previously took metaxalone (SKELAXIN) as muscle relaxer but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 27-year-old on 17Apr2021 in the left arm for covid-19 immunisation. The patient did not receive other vaccine in the last four weeks prior to vaccination. On 10May2021, the patient had an unexpected severe abdominal (large intestine) and rectal pain lasting three days. The patient also had rapid heartbeat for 1-2 days and brief episode of faintness. It was further reported that there was a combined with expected side effects which included fatigue, chills, joint pain, nausea, low fever, headache, and swollen lymph node. The adverse events did not require treatment. The patient has not been covid tested post vaccination. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Cough, Dizziness
Clinical narrative: About 20+ blood spots on my arms, left shoulder, chest, left thigh, and legs.; Shortness of breath; Dizzy; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Pain on my upper left back; Cough; Chest tightness; Rash on my forearms (not itchy); Joint pain; Muscle pain; This is a spontaneous report received from contactable consumer (patient). A 30-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 23Apr2021 10:30 (at the age of 30-years-old) as 1st dose, single for covid-19 immunization.  Medical history included cold sores and allergies with mango, peach, and mold. The patient's concomitant medications were not reported. The patient previously took penicillin and erythromycin and experienced drug allergy in both. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within an hour after getting the first dose on 23Apr2021 at 11:00 AM, the patient felt dizzy and saw rash on her forearms (not itchy); then she started to feel weird in her heart, like it felt cold/numb sometimes and hot sometimes; it also developed into pain on her upper left back. At the same time, her heart beat also became fast (90-100/min). These symptoms lasted about another 3 days, and then she started to cough and had chest tightness and shortness of breath. The difficulty of breathing worsened within 2 days, so she took some Benadryl and it helped a bit. Then she noticed that there were about 20+ blood spots on her arms, left shoulder, chest, left thigh, and legs. All the events occurred on 23Apr2021 at 11:00 AM. She had muscle pain and joint pain in the next 3 to 4 days (in Apr2021), then the rash on her forearms disappeared. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.