chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Arm swelled up terribly; allergies and the reaction to pneumonia vaccine; This is spontaneous report from a non-contactable consumer reported for herself. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported years ago the patient had gotten pneumonia vaccine. Arm swelled up terribly. The patient was unsure of name of vaccine or who made it. Healthcare professional told patient not to get covid vaccine. The patient had allergies and the reaction to pneumonia vaccine and wanted to know what Pfizer suggest. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site papule, Vaccination site swelling
Clinical narrative: Redness and swelling at injection site; Redness and swelling at injection site; Red bump at the injection site; This is a spontaneous report from a contactable pharmacist. A 71-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL3302), first dose administered intramuscularly in the left arm on 27Jan2021 at 09:00am (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The COVID-19 vaccine was administered at the pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient got redness and swelling at the injection site, and also a red bump at the injection site. It has decreased some but still visible 4 weeks later. The red bump is in the middle of the deltoid, but there was no shoulder involvement. The outcome of events redness, swelling and red bump at the injection site was reported as not recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Nausea, Pyrexia, Somnolence
Clinical narrative: Extreme Drowsiness; Fever like symptoms; disorientation confusion; disorientation confusion; nausea; This is a spontaneous report from a contactable consumer (patient). This 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no allergies and no concomitant medications. The patient had not been diagnosed with COVID prior to vaccination and had not received any other vaccines in four weeks. The patient previously received the first dose of BNT162B2 in the right arm on 26Jan2021 at 08:00 (at the age of 34-years-old) for COVID-19 immunisation. On 23Feb2021 at 12:00 the patient experienced extreme drowsiness, fever-like symptoms, disorientation confusion and nausea. No treatment was provided for the events. The clinical outcomes of extreme drowsiness, fever-like symptoms, disorientation confusion and nausea were recovered on unspecified dates. It was also reported the patient had not been tested for COVID since vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Fatigue, Limb discomfort, Somnolence
Clinical narrative: forcing out/stumbling over words as I struggle to stay awake; profound fatigue; forcing out/stumbling over words as I struggle to stay awake; Limbs are heavy; This is a spontaneous report from a non-contactable other healthcare professional (patient). This 30-year-old female patient received the second dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 01Mar2021 09:00 AM on the left arm for COVID-19 immunization. The vaccine was administered at a Health Clinic. She did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient had no COVID prior to vaccination. The patient was not pregnant. Medical history included depression and had unspecified known allergies (known allergies: Yes). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), on 08Feb2021 09:30 AM on the left arm for COVID-19 immunization at the age of 30-years-old. On 02Mar2021 12:00 PM, the patient experienced profound fatigue; feel like I forcing out/stumbling over words as I struggle to stay awake. Limbs are heavy. No corrective treatment was received. Outcome of the events was not recovered. The patient has not been covid tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: felt like I was going to faint/ dizziness; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), first dose via an unspecified route of administration, administered in Arm Left on 25Feb2021 14:30 (at 64-year-old) as single dose for COVID-19 immunization. Medical history included Lungs scarred from multiple bouts of pneumonia and bronchitis, known allergies: Bee stings, IVP dye (contrast dye). Patient is not pregnant. Facility type Vaccine was Pharmacy or Drug Store. Concomitant medication included escitalopram and bupropion hydrochloride (BUPROPION HCL ER). It was reported that there is no reaction day of injection at all. Dose was on Thursday (25Feb2021). Sunday evening (28Feb2021 18:30), the patient started experiencing dizziness when she was on her back in yoga. She sat up and felt like she was going to faint. She have had intermittent dizziness since Sunday evening, 28Feb2021. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema of lips; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 10Feb2021 at 09:00 AM (at the age of 64 years old) at a single dose for COVID-19 immunisation.  Medical history reported as none. The patient has no known allergies. Concomitant medications included bupropion and vitamin D3.  The patient experienced angioedema of lips on 23Feb2021 at 08:00 AM. The patient did not receive treatment for the event. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and not tested for COVID post vaccination. The patient is recovering from the event angioedema of lips.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of short angioedema of lips due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of short of breath, throat tight and swallow difficulty due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed COVID-19  with Symptoms/COVID-19 PCR test positive/patient is still treated outpatient, but is decently sick; diagnosed COVID-19  with Symptoms/COVID-19 PCR test positive/patient is still treated outpatient, but is decently sick; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), second dose at 48-year-old vaccination age via an unspecified route of administration in the arm on 21Jan2021 (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as a single dose; and first dose at 48-year-old vaccination age via an unspecified route of administration in the arm on 26Dec2020 (Batch/Lot Number: EK5730; Expiration Date: Mar2021) as single dose for protect against COVID-19 (covid-19 immunisation). The patient has no medical history and concomitant medications. The patient did not receive additional vaccine on the same day as the Covid-19 vaccine. A pharmacist working with an infectious disease physician reported that the patient received second Pfizer COVID Vaccine five weeks ago (21Jan2021) and the patient was just diagnosed with COVID-19 Virus. The patient received the vaccine in a sponsored pavilion site location. The patient is still treated outpatient but is decently sick. Patient is having pretty bad symptoms. The patient had a positive COVID-19 PCR test 01Mar2021 while the COVID-19 symptoms began on 27Feb2021. The causality reported was that it was not due to the COVID-19 Vaccines, but a failure of it to be protected. The patient's sample was sent to the state to detect if her COVID-19 Virus is one of the resistant or variant strains (unknown results and  unknown date in 2021). The events did not require a visit. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bradyphrenia, Dizziness, Fatigue, Heart rate increased
Clinical narrative: fast heartbeat; dizziness; weakness; slow thinking; very tired; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion because of chronotropic incompetence. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamins and zolpidem tartrate (AMBIEN), both were taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 18Jan2021 14:00 as a single dose for COVID-19 immunization and experienced sweating, chills and tired. On an unspecified date in Feb2021 after receiving the second dose, the patient experienced fast heartbeat, dizziness, weakness, very tired and slow thinking. No treatment was received for the adverse events. The clinical outcome of the fast heartbeat, dizziness, weakness, very tired and slow thinking was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after the 1st shot; This is a spontaneous report from Pfizer Sponsored Program from a contactable consumer  (patient's friend). A 92-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown), dose 1 via an unspecified route of administration, on 17Feb2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea after the 1st shot on an unspecified date in 2021. It was reported that the patient wanted to cancel her scheduled 2nd dose on 10Mar2021. The clinical outcome of the event diarrhea was unknown.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Rash, Vaccination complication
Clinical narrative: Anaphylactic reaction; Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that on an unspecified date, she had a severe anaphylactic reaction to pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein), had a rash, severe side reactions and she ended up in the hospital. She wanted to know if any of the ingredients on the Prevnar 13 are the same as the ones on the Covid 19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood creatinine, Blood glucose, Full blood count, Guillain-Barre syndrome
Clinical narrative: ascending bilateral symmetrical paresthesias in the legs to upper thighs and fingers of both hands; slight weakness; Guillain-Barre Syndrome; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: unknown), via an unspecified route of administration in right arm on 25Feb2021 at 15:30 as single dose for COVID-19 immunization. The patient's medical history included hypertension, type 2 diabetes, and cardiac issues. Concomitant medication included dulaglutide (TRULICITY); metoprolol fumarate; alopurinol; atorvastatin calcium (LIPITOR ORIFARM); acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]); vitamin d3; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), all ongoing for unspecified indication. The patient previously took Flu vaccine on an unspecified date for immunization. In Mar2021 (reported as after several days), the patient developed ascending bilateral symmetrical paresthesias in the legs to upper thighs and fingers of both hands peaking at 7-8 days and now slightly improving but persistent and associated with slight weakness suggesting Guillain-Barre Syndrome. The patient underwent lab tests and procedures which included blood creatinine: 1.19 (slightly elevated), blood sugar 140-160, complete blood count (CBC): good, haemoglobin: 7.6 (out of range), metabolic function test: all good on 13Mar2021. The patient did not received treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Guillain-Barre syndrome cannot be excluded.  The case will be reassessed if additional information becomes 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.
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Metabolic function test, Paraesthesia
Clinical narrative: ascending bilateral symmetrical paresthesias in the legs to upper thighs and fingers of both hands; slight weakness; Guillain-Barre Syndrome; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: unknown), via an unspecified route of administration in right arm on 25Feb2021 at 15:30 as single dose for COVID-19 immunization. The patient's medical history included hypertension, type 2 diabetes, and cardiac issues. Concomitant medication included dulaglutide (TRULICITY); metoprolol fumarate; alopurinol; atorvastatin calcium (LIPITOR ORIFARM); acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]); vitamin d3; bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), all ongoing for unspecified indication. The patient previously took Flu vaccine on an unspecified date for immunization. In Mar2021 (reported as after several days), the patient developed ascending bilateral symmetrical paresthesias in the legs to upper thighs and fingers of both hands peaking at 7-8 days and now slightly improving but persistent and associated with slight weakness suggesting Guillain-Barre Syndrome. The patient underwent lab tests and procedures which included blood creatinine: 1.19 (slightly elevated), blood sugar 140-160, complete blood count (CBC): good, haemoglobin: 7.6 (out of range), metabolic function test: all good on 13Mar2021. The patient did not received treatment for the events. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Guillain-Barre syndrome cannot be excluded.  The case will be reassessed if additional information becomes 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.
Sex: U
Vaccine: PNC13
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable physician. A patient of an unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not provided. It was reported that the patient had an anaphylactic reaction to PREVNAR 13 on an unspecified date. The physician would like to compare the ingredients in the Pfizer BioNtech COVID vaccine and was asking for a list of ingredients for PREVNAR 13. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The association between the event anaphylactic reaction with PREVNAR 13 can not be fully excluded.  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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Hallucination, Vision blurred
Clinical narrative: I don't know if I hallucinated that or not; I feel like I am on drugs like I on 'some acid'; my vision is blurry and it's kind of hard to concentrate on television; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported)\ via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included mental issues since 1988. The patient stated "I am calling about an adverse reaction to the second Pfizer shot. If you guys have anybody called in and find out if anybody is having the same. After the second shot, about a day after the shot, it was terrible. I got the shot last Tuesday and I feel like I am on drugs like I on 'some acid' (not clarified). But I am not hallucinating, I am not seeing things, I am not hearing things, I just physically feel that way. Everything is kind of blurry, my vision is blurry and it's kind of hard to concentrate on television and stuff like that. It seems like some people are playing mind games with it but I don't think they have (further clarification unknown, hence not captured as event). I don't know if I hallucinated that or not (consumer was not sure). That's pretty much here I feel like I am on drugs constantly and it is just kind of scary. I have mental issues since 1988, I take psych meds but it seems whenever I take my psych meds (unspecified medications) I feel worst for couple of hours." Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Coordination abnormal, Dysstasia, Magnetic resonance imaging
Clinical narrative: MRI did reveal that there was some bleeding in patient's brain; couldn't stood up; coordination with patient's left hand somehow degraded and patient was actually unable to tie the shoe properly; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 23Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included cerebral amyloid angioplasty. The patient's concomitant medications were not reported. When the patient went to bed that evening (unspecified date), the patient felt fine and slept well. The patient got up the next morning and couldn't stood up with the patient's shoe on and the patient tried to tie the shoe and found out that the patient's coordination with the patient's left hand somehow degraded, and the patient was actually unable to tie the shoe properly. The patient explained this symptom to the neurologist and the neurologist said, it would be good for the patient to go to the emergency room right away. The patient went to the emergency room and got an MRI. They kept the patient there for 2 to 3 days and "that's pretty much over I'm fine again" as stated by the patient, but the coincidence is several of the patient's friends and the patient have trouble just a bit (further clarification unknown). The patient had this issue with left hand. The patient was injected in the left arm. The MRI did reveal that there was some bleeding in patient's brain. It got better, it hasn't pass but it struck the patient as a potential effect of some ingredient may be in the vaccine. The patient asked if there is anything in the vaccine that one with Cerebral Angioplasty should avoid because of potential blood thinning impact of one of the ingredients. The patient was recovering from some bleeding in patient's brain. Outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chromatopsia, Fatigue, Fundoscopy, Hypersomnia
Clinical narrative: MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lumbar puncture, Multiple sclerosis, Ophthalmological examination, Optic neuritis
Clinical narrative: MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: MS/Optic Neuritis; MS/Optic Neuritis; sore arm; fatigue; overslept; Color fading/washed out symptoms left eye/decrease color discernment; poor vision left eye/vision from 20/30 to 20/60 corrected in left eye/decreased vision; This is a spontaneous report from a contactable physician. A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198) intramuscularly administered in the right arm on 02Mar2021 08:00 as single dose for COVID-19 immunisation. Medical history included addison's disease, hypertension and optic neuritis from Aug2020 to Aug2020. Patient was not pregnant. Concomitant medications included hydrocortisone (HYDROCORTISONE), metoprolol (METOPROLOL), fludrocortisone (FLUDROCORTISONE), amlodipine (AMLODIPINE), estradiol (ESTRADIOL) and olmesartan (OLMESARTAN). Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265) intramuscularly administered in the right arm on 09Feb2021 02:00 PM as single dose for COVID-19 immunisation. On 03Mar2021 07:00, patient had multiple sclerosis (MS), optic neuritis, sore arm, overslept and fatigue. It was also reported that when the patient woke up on 03Mar2021 07:00, she had poor vision in the left eye and experienced color fading; further reported as washed out symptoms in the left eye. She went to the ophthalmologist and saw that she had decreased vision, further reported as from 20/30 to 20/60 corrected in left eye and decrease color discernment. Patient was treated with Methylprednisolone 250mg intravenous (IV) every 6 hours x 12 doses for the events multiple sclerosis (MS) and optic neuritis. The events resulted in physician office visit. The patient underwent lab tests and procedures which included CT angiogram: negative for arteritis on an unspecified date, fundoscopy: normal on an unspecified date, intraocular pressure (IOP): normal on an unspecified date, lumbar puncture: increased protein 79 ms panel pending on an unspecified date. Outcome of events was recovering.; Sender's Comments: The events most likely intercurrent conditions and unlikely related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198). This case will be reassessed when follow-up information is received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Headache, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Experienced blindness after first shot in right eye after first shot; TIA; headaches; This is a spontaneous report from a contactable consumer.  A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in  the left arm on 21Jan2021, 13:00 (Batch/Lot Number: EL 3249) as a single dose for covid-19 immunization. The patient's medical history included diabetes from an unknown date and unknown if ongoing. The patient was generally in good health. Concomitant medications included apixaban (ELIQUIS); pravastatin (PRAVASTATIN); and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and ceclor and experienced allergies. On 24Jan2021 at 13:00, the patient experienced blindness after first shot in right eye after first shot for about 20 minutes (Most likely a transient ischemic attack (TIA)). Have had headaches every day since the first shot. The patient underwent lab tests and procedures which included negative test for Covid-19 on 11Feb2021 (via nasal swab). The outcome of the event was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal haemorrhage, Vaccination site pain
Clinical narrative: Rectal Hemorrhage Pain in the administered area; Pain in the administered area; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 17Mar2021 14:00 as SINGLE DOSE for covid-19 immunisation. Medical history included meniere's disease. Concomitant medications included gabapentin; atorvastatin; pantoprazole; acetazolamide all taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient experienced rectal hemorrhage pain in the administered area on 17Mar2021 17:45 with outcome of unknown. Patient didn't receive treatment for the adverse events. Patient didn't have covid prior vaccination nor tested covid post vaccination.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dysstasia, Fatigue, Muscular weakness, SARS-CoV-2 test
Clinical narrative: extremely fatigued; legs are very weak hard to stand sometime; legs are very weak hard to stand sometime; very thirsty; This is a spontaneous report from a contactable consumer reporting for himself. A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9263), via an unspecified route of administration in the right arm on 26Feb2021 09:30 AM (at the age of 72-years-old) as single dose for COVID-19 immunisation in the public health department.  Medical history included allergy with shellfish. The patient has no other medical history. The patient had no concomitant medications. The patient did not receive any other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3248) in the right arm on 05Feb2021 at 09:30 AM (at the age of 72-years-old) for COVID-19 immunization. The patient reported that there was no fever, no pain. Just extremely fatigued, legs were very weak, hard to stand sometime and very thirsty on 05Mar2021. The events resulted in emergency room/department or urgent care. The patient received four bags of fluids as treatment for the events. The patient was not diagnosed with COVID prior to vaccination. The patient tested negative in a COVID-19 test via nasal swab on 15Mar2021. The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Cough, Fatigue, Headache
Clinical narrative: lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on Feb2021 (reported as 27Jan2021; pending clarification) (lot number: EN62co) as single dose at the age of 71 years old for COVID-19 immunisation. Medical history included known allergies (unspecified). The patient was not pregnant at the time of vaccination. Concomitant medication included omeprazole (OMEPRAZEN), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 27Jan2021 05:30 PM (lot number: ELX47) for COVID-19 immunization. The patient developed a severe lung infection two weeks and two days after her second vaccine (06Mar2021 05:00). She had a horrible cough, headache, chills, sweats, nasal congestion and exhaustion. She has been in bed for 13 days. The AEs resulted in doctor or other healthcare professional office/clinic visit. The patient was given steroid shot and brea (unspecified) as treatment for the adverse events. The patient was not diagnosed with COVID prior to vaccination. The patient underwent lab tests and procedures which included two chest x-rays with unknown results, both on unspecified dates; and COVID-19 nasal swab: negative on 06Mar2021 and also negative on 08Mar2021. The patient has not recovered from all the events at the time of this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasal congestion, Pneumonia, SARS-CoV-2 test
Clinical narrative: lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on Feb2021 (reported as 27Jan2021; pending clarification) (lot number: EN62co) as single dose at the age of 71 years old for COVID-19 immunisation. Medical history included known allergies (unspecified). The patient was not pregnant at the time of vaccination. Concomitant medication included omeprazole (OMEPRAZEN), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 27Jan2021 05:30 PM (lot number: ELX47) for COVID-19 immunization. The patient developed a severe lung infection two weeks and two days after her second vaccine (06Mar2021 05:00). She had a horrible cough, headache, chills, sweats, nasal congestion and exhaustion. She has been in bed for 13 days. The AEs resulted in doctor or other healthcare professional office/clinic visit. The patient was given steroid shot and brea (unspecified) as treatment for the adverse events. The patient was not diagnosed with COVID prior to vaccination. The patient underwent lab tests and procedures which included two chest x-rays with unknown results, both on unspecified dates; and COVID-19 nasal swab: negative on 06Mar2021 and also negative on 08Mar2021. The patient has not recovered from all the events at the time of this report.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: Pain in left calf leading to development of blood clot above left knee cap near inside of quad; Pain in left calf leading to development of blood clot above left knee cap near inside of quad; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included U/L fasciatomy in same leg with nerve damage, Blood transfusion, previous clot in femoral during recovery, Shellfish (allergy). The patient has not had COVID prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on an unspecified date (lot number: unknown) at 38-years-old. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 16:00, the patient experienced Pain in left calf leading to development of blood clot above left kneecap near inside of quad. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events: Originally treated as cellulitis with doxy. The outcome of the events was recovering. The patient was not tested for COVID post vaccination.   Information about Lot/Batch number is requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Swelling, Thrombosis
Clinical narrative: Clot; Swelling and pain in left foot, ankle, and calf; Swelling and pain in left foot, ankle, and calf; This is a spontaneous report received from a contactable consumer (Patient's son). A 81-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number not reported), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (believes in afternoon) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient previously took history vaccine included shingles shot received on Nov2020 and Flu shot typically gets every year. On 02Jan2021, patient received first dose of COVID vaccine (BNT162B2) for covid-19 immunisation. The patient experienced severe swelling and pain in foot, calf, and ankle on the left side shortly after the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. She was hospitalized and placed on Xarelto for treatment by her cardiologist and was scheduled to follow-up to have other procedures performed as deemed needed. Doctor advised patient had a clot and was put on Xarelto. An angio and cath was suggested to see if she had something closing up in her. Patient was going back in a few weeks to see about the clot. she never had this clotting concern before, and this was all new right after the second COVID vaccine. Swelling and pain in left foot, ankle, and calf was either 04Feb2021 or 05Feb2021. she first noticed left foot was swollen. she stated her foot was sore. It was unknown if it went to her ankle and then from there. It was stated that the pain and swelling was better. She was informed by the nurse administering the COVID vaccine that second dose would be a little bit stronger. The patient underwent lab tests and procedures which included MRI on 15Feb2021 and diagnosed the clot. The outcome of the event Clot was unknown. For other events was recovered on unspecified date in 2021.  Information about Batch/Lot number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Lethargy, Syncope
Clinical narrative: felt very faint and weak; chills/shivers; cold sweating; felt very faint and weak; extreme lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 17Mar2021 10:45 (Lot Number: EL3247) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medication was reported as none. The patient previously had BNT162B2 first dose lot number: EL3247 on 24Feb2021 10:00 AM, in left arm for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the clinic. 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 has not been tested for COVID-19. On 17Mar2021 20:30, the patient experienced chills, shivers, cold sweating, felt very faint and weak and extreme lethargy. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Haemorrhoids, Hypothermia, Pulmonary embolism
Clinical narrative: Chills; seems to have some kind of hypothermia/kept reading 94.7; hemorrhoids; pulmonary embolism in his right lower lobe; This is a spontaneous report from a contactable pharmacist (patient).  A 68-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EN6198; Expiration Date: 30Jun2021), at the age of 68-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included paraplegic, he has been paralyzed for 45 years. The patient received first dose of the vaccine on 10Feb2021 with lot number: EN5318, expiration 31May2021. There were no concomitant medications.  The patient went on Monday to the ER for an unrelated condition and they did a CT scan and found a blood clot, a pulmonary embolism in his right lower lobe. He confirms the pulmonary embolism was diagnosed on Monday, 15Mar2021.  He got home that night and read the headline in the (Withheld) times that said several countries are pulling the Astra Zeneca vaccine over concerns about blood clots even though there has not been any causal relationship found. He thought that with the drug companies, they should be able to have data regarding potential adverse effects for Pfizer so he was calling report that. He discusses it with the ER doctor and he couldn't really figure out why he had a blood clot, it was incidental to what he was being scanned for, it surprised him. They put him on Eliquis so he is on an anticoagulant, which will cost him a fortune. Today will be the third day he has been on the Eliquis. He is at home and he would say his only concern is that he does have hemorrhoids so when he has bowel movement tomorrow, because he doesn't go every day, but when he goes he is concerned if he starts to bleed that the anti-coagulant might cause the bleeding to be more significant than it usually is. No further information provided. His only other concern is he seems to have some kind of hypothermia, he is not entirely sure because of his thermometer is not very good. That is the reason he went into the Emergency Department because it kept reading 94.7 and he googled it and it said if it is below 95 it is a medical emergency and go to the ER so he got to the Emergency Department and it was 97.6 and now he checked his temperature again with the thermometer and it was 96.8 so either he has a faulty thermometer or something but he is experiencing some kind of chills.  The outcome of the events was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Influenza like illness, Nasopharyngitis, Sneezing
Clinical narrative: flu systems; cold systems; coughing; sneezing; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who experienced flu systems (influenza like illness) and cold systems, coughing and sneezing (nasopharyngitis, cough, sneezing), after patient received INFLUENZA VACCINE.  It was reported that, every time patient had received influenza vaccine in past and had influenza like illness, nasopharyngitis, cough and sneezing.   Past medical treatment, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu systems (influenza like illness) and cold systems (nasopharyngitis) with symptoms of coughing (cough) and sneezing, (unknown latency) following the administration of INFLUENZA VACCINE.  Additionally, it was reported by the reporter that, that was patient's last one of that year.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for all reported events.   There will be no information available on the batch number for this case.