chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle spasms, Myalgia, Pain, Pyrexia
Clinical narrative: blacked out from pain; blacked out from pain; Severe muscle cramping and pain; Severe muscle cramping and pain; unable to walk or stand; unable to walk or stand; Severe headaches; numbness and weakness in left arm still (7 days later); numbness and weakness in left arm still (7 days later); fever for 3 days; This is a spontaneous report from a contactable consumer (the patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 at 09:30 (Lot Number: EL9264), at the age of 35 years, as a single dose for COVID-19 immunisation.  Medical history included traumatic brain injury (TBI), and neuropathy. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 (Lot Number: E18982) administered in left arm on 16Mar2021 at 2:15 PM. The patient did not receive any other vaccines within four weeks prior to the vaccination  On 09Apr2021 at 18:00 the patient experienced blacked out from pain, severe muscle cramping and pain, unable to walk or stand for 4 days, severe headaches, numbness and weakness in left arm still (7 days later), and fever for 3 days. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of blacked out from pain, severe muscle cramping and pain, unable to walk or stand, severe headaches, numbness and weakness in left arm still (7 days later), and fever for 3 days included lidocaine injections to head. The clinical outcome of blacked out from pain, severe muscle cramping and pain, unable to walk or stand, severe headaches, numbness and weakness in left arm still (7 days later), fever for 3 days  was reported as recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hallucination, auditory, Tinnitus
Clinical narrative: auditory hallucinations; Initial extreme fatigue; weakness; worsening tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: not reported), via an unspecified route of administration in the left arm on 15Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cashews and pine nuts; back pain associated with herniated discs, major recurrent depression severe, generalized anxiety disorder. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), calcium levomefolate (DEPLIN), acetylsalicylic acid (ASPRIN), celecoxib (CELEBREX). There were no other vaccinations within four weeks of the vaccine. On 16Apr2021 at 23:45, the patient experienced initial extreme fatigue and weakness which had been replaced by auditory hallucinations and worsening tinnitus. It was unknown if the patient was treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of initial extreme fatigue, weakness, auditory hallucinations, and worsening tinnitus was not resolved.  Information on the Batch/Lot number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Postmenopausal haemorrhage
Clinical narrative: Extreme fatigue; muscle pain 10 days after vaccine.; Abnormal postmenopausal uterine bleeding nine days after both first and second vaccine shot.; This is a spontaneous report from a contactable consumer (the patient). A 53-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number ER8737), via an unspecified route of administration in the right arm on 08Apr2021 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took and had allergies to metronidazole. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the right arm on 18Mar2021 12:00 as a single dose for COVID-19 immunization and experienced abnormal postmenopausal uterine bleeding nine days after the dose. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced abnormal postmenopausal uterine bleeding nine days after both the first and second vaccine shot, on 17Apr2021 (reported as on 16Apr2021). Extreme fatigue and muscle pain 10 days after vaccine on 18Apr2021 (also reported as 16Apr2021). No treatment was received for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Cellulitis, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: sever with cellulitis; after sever itching requiring steroids and antibiotics; Hypersensitivity reaction on Right skin; hives on neck; systemic effects with vesicles forming on backs of hands; This is a spontaneous report from a contactable physician.   A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jan2021 (Batch/Lot Number: Ek4n6) as 2ND DOSE, SINGLE (at the age of 39 years) for covid-19 immunisation.  The patient took dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot Eh9899 with unspecified expiration date on 17Dec2020 in the right arm as 1ST DOSE SINGLE (at the age of 39 years) for COVID-19 immunisation.  The patient did not have COVID prior vaccination. The patient has no known allergies.  The patient medical history was not reported.     The patient had no other vaccine other than BNT162B2 in four weeks. There were no concomitant medications.  The patient experienced sever with cellulitis (medically significant) on 06Jan2021 with outcome of recovering, hypersensitivity reaction on right skin on 06Jan2021 with outcome of recovering, sever itching requiring steroids and antibiotics on 06Jan2021 with outcome of recovering, hives on neck on 06Jan2021 with outcome of recovering.  Additionally, the patient experiences systemic effects with vesicles forming on backs of hands on 06Jan2021 with outcome of recovering.   Therapeutic measures were taken as a result of sever with cellulitis, hypersensitivity reaction on right skin, hives on neck, and sever itching requiring steroids and antibiotics. The patient was not tested for COVID post vaccination.; Sender's Comments: Based on chronological connection to the vaccine causality between events sever cellulitis and severe pruritus and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be 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.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Deafness, Diarrhoea, Dyspnoea, Eye disorder
Clinical narrative: Hearing loss; Inner ear issues / Damage to the inner ear; Breathing issues; Issues with eyes; Breast soreness on the right sore.; Sore lymph nodes; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose. This report is serious. The additional report is non-serious.   A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration in the right arm on 06Apr2021 (Batch/Lot Number: EP6955) as a single dose for COVID-19 immunization at a church. Medical history included MGUS (Monoclonal gammopathy of unknown significance / hypergammaglobulinaemia benign monoclonal) and drug hypersensitivity (the patient has known allergies to Penicillin and Macrobid). Historical vaccine included the patient previously received the first dose of BNT162B2 vaccine (Batch/Lot Number: unknown, at the age of 50 years) in the right arm on 16Mar2021 at 11:30 AM for COVID-19 immunisation and experienced soreness and arm pain at injection site along with minor breathing difficulties on 16Mar2021. The patient did not received any other vaccine within four weeks prior to receiving the BNT162B2 vaccine. The patient did not have COVID-19 infection prior to receiving the BNT162B2 vaccine. Concomitant medication included levothyroxine, liothyronine (NP THYROID), epinephrine (ADRENAL), estradiol and famotidine. Past drug history included the patient previously took clarithromycin (MACROBID) and Penicillin and experienced drug hypersensitivity. On 06Apr2021, the patient received the second dose of the BNT162B2  vaccine. In Apr2021, the patient still has breathing issues after two weeks. In Apr2021, a few days after the second dose of the vaccine, the patient started having inner ear issues, nausea when breathing gets more labored, diarrhea and issues with her eyes. The patient reported that the main issues are the breathing and the damage to the inner ear causing temporary hearing loss. This was the right ear. Also, she had really sore lymph nodes and breast soreness on the right side. Her ear was getting worse after two weeks. The events resulted in a doctor or other healthcare professional office/clinic visit. No treatment was received. The patient did not get tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440332 same patient, different events that occurred after each dose
Sex: F
Vaccine: COVID19
Symptoms: Inner ear disorder, Lymph node pain, Nausea
Clinical narrative: Hearing loss; Inner ear issues / Damage to the inner ear; Breathing issues; Issues with eyes; Breast soreness on the right sore.; Sore lymph nodes; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose. This report is serious. The additional report is non-serious.   A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration in the right arm on 06Apr2021 (Batch/Lot Number: EP6955) as a single dose for COVID-19 immunization at a church. Medical history included MGUS (Monoclonal gammopathy of unknown significance / hypergammaglobulinaemia benign monoclonal) and drug hypersensitivity (the patient has known allergies to Penicillin and Macrobid). Historical vaccine included the patient previously received the first dose of BNT162B2 vaccine (Batch/Lot Number: unknown, at the age of 50 years) in the right arm on 16Mar2021 at 11:30 AM for COVID-19 immunisation and experienced soreness and arm pain at injection site along with minor breathing difficulties on 16Mar2021. The patient did not received any other vaccine within four weeks prior to receiving the BNT162B2 vaccine. The patient did not have COVID-19 infection prior to receiving the BNT162B2 vaccine. Concomitant medication included levothyroxine, liothyronine (NP THYROID), epinephrine (ADRENAL), estradiol and famotidine. Past drug history included the patient previously took clarithromycin (MACROBID) and Penicillin and experienced drug hypersensitivity. On 06Apr2021, the patient received the second dose of the BNT162B2  vaccine. In Apr2021, the patient still has breathing issues after two weeks. In Apr2021, a few days after the second dose of the vaccine, the patient started having inner ear issues, nausea when breathing gets more labored, diarrhea and issues with her eyes. The patient reported that the main issues are the breathing and the damage to the inner ear causing temporary hearing loss. This was the right ear. Also, she had really sore lymph nodes and breast soreness on the right side. Her ear was getting worse after two weeks. The events resulted in a doctor or other healthcare professional office/clinic visit. No treatment was received. The patient did not get tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440332 same patient, different events that occurred after each dose
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysarthria, Dyspnoea, Joint swelling, Pulmonary congestion
Clinical narrative: fluid in lungs; swelling in ankles; shortness of breath; slurring of words; my balance is off; This is a spontaneous report from a contactable consumer (patient).  This 78-year-old female patient received  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 18Mar2021 08:45 as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Medical history included allergies: Some high blood pressure medications. Concomitant medications included "Hyperion meds". The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9269), via an unspecified route of administration in the left arm on 25Feb2021 08:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported, "I had fluid in lungs and swelling in ankles. I now have slurring of words to the point I am unable to pronounce it, walk with a cane because my balance is off. I am walking very slow. I don't feel safe to drive and have canceled doctor's appointments. I also had shortness of breath." These adverse events were reported started on 25Mar2021 18:00 and resulted in emergency room/department or urgent care. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fluid in lungs and swelling in ankles, slurring of words and my balance is off, was not resolved as of 20Apr2021.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Dizziness, Pain, Vision blurred
Clinical narrative: feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of adrenaline rush; my vision was slightly askew as though I could not focus on objects.; my vision was slightly askew as though I could not focus on objects.; This is a spontaneous report from a contactable consumer, the patient. This 46-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) via unspecified route on 21Apr2021 at 10:00 (at the age of 46-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included migraines. Patient had  allergies to sulfa. Patient did not have COVID-19 prior to vaccination. There were no other vaccines received within four weeks of vaccination. Concomitant medications taken within two weeks included collagen, multivitamin and THC-free cannabidiol (CBD). On 21Apr2021 at 10:00, after a few seconds of being injected, patient felt faint. It could have been anxiety but then minutes later he had these inconsistent dizziness spells and a feeling of adrenaline rush. He felt many times like he could faint. It subsided after a few hours. Also his vision was slightly askew as though he could not focus on objects. On 22Apr2021, the next morning, he just felt minor aching. There was no treatment received for the events. The clinical outcome of the events felt faint/dizziness spells, anxiety, feeling of adrenaline rush, vision was slightly askew, could not focus on objects, and minor aching was recovering. Patient was not COVID tested post vaccination.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of adrenaline rush; my vision was slightly askew as though I could not focus on objects.; my vision was slightly askew as though I could not focus on objects.; This is a spontaneous report from a contactable consumer, the patient. This 46-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) via unspecified route on 21Apr2021 at 10:00 (at the age of 46-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included migraines. Patient had  allergies to sulfa. Patient did not have COVID-19 prior to vaccination. There were no other vaccines received within four weeks of vaccination. Concomitant medications taken within two weeks included collagen, multivitamin and THC-free cannabidiol (CBD). On 21Apr2021 at 10:00, after a few seconds of being injected, patient felt faint. It could have been anxiety but then minutes later he had these inconsistent dizziness spells and a feeling of adrenaline rush. He felt many times like he could faint. It subsided after a few hours. Also his vision was slightly askew as though he could not focus on objects. On 22Apr2021, the next morning, he just felt minor aching. There was no treatment received for the events. The clinical outcome of the events felt faint/dizziness spells, anxiety, feeling of adrenaline rush, vision was slightly askew, could not focus on objects, and minor aching was recovering. Patient was not COVID tested post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: minor swelling & tenderness of left axillary lymph node; minor swelling & tenderness of left axillary lymph node; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248, Expiration Date: not reported) via an unspecified route of administration in left arm on 21Apr2021 11:00 as 2nd dose, single dose for COVID-19 immunization. The patient previously took first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL3248, Expiration Date: not reported), via an unspecified route of administration, in left arm on 31Mar021 10:00AM at single dose for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included hypothyroidism, hypertension, osteoarthritis and asthma. Patient had known allergies to shellfish, bee venom, seasonal allergies, dust & mold.Concomitant medication(s) included within 2 weeks of vaccination, levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); lisinopril; budesonide, formoterol fumarate (SYMBICORT); diphenhydramine hydrochloride (BENADRYL). On 22Apr2021 19:00,The patient experienced minor swelling & tenderness of left axillary lymph node. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the adverse event. The outcome of the events was resolved on 28Apr21 at 05:00.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Pregnancy test
Clinical narrative: Menstrual period was four days late with negative pregnancy test; Extreme cramping; heavy bleeding; This is a spontaneous report from a non-contactable nurse. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an intramuscular route of administration, administered in right arm on 16Apr2021 07:00 (Batch/Lot Number: Ew0150) (at the age of 30-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included penicillin (PCN) allergy. The patient's concomitant medications were none. The patient previously took nitrofurantoin (MACROBID) and experienced nitrofurantoin allergy. The patient didn't receive other vaccine in four weeks and didn't receive other medications in two weeks. The patient did not have COVID prior vaccination and didn't test for COVID post vaccination. The patient stated that her menstrual period was four days late with negative pregnancy test and experienced extreme cramping and heavy bleeding on 21Apr2021 08:00. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. The patient was treated with ibuprofen (ADVIL). The outcome of events, menstrual period was four days late with negative pregnancy test, extreme cramping and heavy bleeding, was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: dizziness/fainting within five mins; dizziness/fainting within five mins; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old [non-pregnant] adult female received the first dose of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 23Apr2021 at 10:30 (at 21-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. There were no concomitant medications reported. The patient denied any COVID prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 23Apr2021 at 10:35, within five minutes of receiving the vaccine that patient experienced dizziness and fainting. The patient has not been tested for COVID since the vaccine. The patient did not receive any treatment for the events; the events did not result in visit to Emergency Room or physician office/clinic.  The outcome of the events dizziness and fainting was recovered on 23Apr2021 at 10:45 after ten-minute duration.    Information on the Batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Photopsia, Retinal tear, Vitreous floaters
Clinical narrative: retinal tear; Floaters; flashes of light; dose 1 given 30Mar2021 and dose 2 given 13Apr2021; This is a spontaneous report from a contactable consumer (patient). This 51-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine)(Batch/Lot Number: EW0161), dose 2, via an unspecified route of administration, administered in the left arm on 13Apr2021 at 09:00 (at the age of 51-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EP7534), dose 1, via an unspecified route of administration, administered in the left arm on 30Mar2021 at 09:00 as 1ST DOSE, SINGLE for COVID-19 immunization with no adverse effects reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 18:00, the patient experienced floaters, flashes of light and retinal tear. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures taken included an unspecified "laser". Clinical outcome of floaters, flashes of light and retinal tear was recovered with sequelae (reported as recovered with lasting effects). Clinical outcome of inappropriate schedule of vaccine administration was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Immune system disorder, Indeterminate leprosy
Clinical narrative: I had a flare up of what I believe to be Leprosy, specifically in my left hand.; I had a flare up of what I believe to be Leprosy, specifically in my left hand.; vaccine caused my immune system to flare up, and once my immune system returned to normal I suspect that a pre-existing bacterial infection flared up.; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 at 12:00 (Batch/Lot Number: EW0153) as 1ST DOSE, SINGLE (at the age of 35 years old) for covid-19 immunisation.  Medical history included none. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient experienced had a flare up of what he believes to be leprosy, specifically in his left hand on 17Apr2021 with outcome of unknown, and vaccine caused his immune system to flare up, and once his immune system returned to normal he suspect that a pre-existing bacterial infection flared up on 17Apr2021 with outcome of unknown. Details were reported as follows: "I had a flare up of what I believe to be Leprosy, specifically in my left hand. What I suspect happened is that your vaccine caused my immune system to flare up, and once my immune system returned to normal I suspect that a pre-existing bacterial infection flared up. I have contacted my doctor however have yet to receive a response / treatment".  It was reported that the event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment was received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hallucination, Pain, Pyrexia
Clinical narrative: Hallucinations; Chills; Fever; Body aches; This is a spontaneous report from a contactable consumer. A non-pregnant 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), intramuscular in left arm, on 22Apr2021 at 10:00 AM (at the age of 26 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 on 01Apr2021 (at the age of 26 years) for COVID-19 immunization (arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a workplace clinic facility. On 22Apr2021 at 10:00 PM, the patient experienced chills, fever, hallucinations, and body aches. No treatment was received for the events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events in Apr2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: blackout; Shallow breathing; rapid heart rate; difficulty breathing or talking; dizziness; weakness; feeling unwell; nausea; numb arm; heat flash; chills; This is a spontaneous report from a contactable consumer.   An 18-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:30 (Batch/Lot number was not reported) (at the age of 18 years-old) as a single dose, for  COVID-19 immunisation. There was no medical history. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  No other vaccinations given within last 4 weeks. On 30Apr2021 at 1445, the patient experienced Shallow breathing, rapid heart rate, difficulty breathing or talking, dizziness and blackout, weakness, feeling unwell, nausea, numb arm, heat flash and chills. The outcome of the events was recovering. The patient did not have COVID prior to vaccination and was not tested post vaccination.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Hypopnoea, Loss of consciousness, Malaise
Clinical narrative: blackout; Shallow breathing; rapid heart rate; difficulty breathing or talking; dizziness; weakness; feeling unwell; nausea; numb arm; heat flash; chills; This is a spontaneous report from a contactable consumer.   An 18-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:30 (Batch/Lot number was not reported) (at the age of 18 years-old) as a single dose, for  COVID-19 immunisation. There was no medical history. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  No other vaccinations given within last 4 weeks. On 30Apr2021 at 1445, the patient experienced Shallow breathing, rapid heart rate, difficulty breathing or talking, dizziness and blackout, weakness, feeling unwell, nausea, numb arm, heat flash and chills. The outcome of the events was recovering. The patient did not have COVID prior to vaccination and was not tested post vaccination.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: blackout; Shallow breathing; rapid heart rate; difficulty breathing or talking; dizziness; weakness; feeling unwell; nausea; numb arm; heat flash; chills; This is a spontaneous report from a contactable consumer.   An 18-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:30 (Batch/Lot number was not reported) (at the age of 18 years-old) as a single dose, for  COVID-19 immunisation. There was no medical history. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  No other vaccinations given within last 4 weeks. On 30Apr2021 at 1445, the patient experienced Shallow breathing, rapid heart rate, difficulty breathing or talking, dizziness and blackout, weakness, feeling unwell, nausea, numb arm, heat flash and chills. The outcome of the events was recovering. The patient did not have COVID prior to vaccination and was not tested post vaccination.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep vein thrombosis in left gastrocnemius vein; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 20Apr2021 at 11:00 (at the age of 46 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included drug hypersensitivity (known allergies: Penicillin) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021 at 03:00, the patient experienced deep vein thrombosis in left gastrocnemius vein. Therapeutic measures taken as a result of the event deep vein thrombosis in left gastrocnemius vein included apixaban (ELIQUIS). The outcome of the event deep vein thrombosis in left gastrocnemius vein was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Insomnia, Lethargy
Clinical narrative: immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleeping; Lethargy; Nausea leading to a single vomit; Nausea leading to a single vomit; temperature of 101 degrees fahrenheit; Chills; Rash covering entire trunk of body the following evening; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation .  Medical history included   from an unknown date and unknown if ongoing.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)  dose 1  05Apr2021, administered at 11:15 AM on left arm.  There were no concomitant medications and no other vaccine in four weeks. It was reported that on 27Apr2021 at 12:00 AM, the patient experienced headache through the night, intermittent pain in right ear, difficulty sleeping, lethargy, nausea leading to a single vomit, temperature of 101 degrees Fahrenheit, chills immobility in left arm, rash covering entire trunk of body the following evening. The outcome of the events was recovered on unknown date. Therapeutic measures were taken as a result of events included Ibuprofen. Patient had no covid infection or tested positive for covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: immobility in left arm; Headache through the night; Intermittent pain in right ear; Difficulty sleeping; Lethargy; Nausea leading to a single vomit; Nausea leading to a single vomit; temperature of 101 degrees fahrenheit; Chills; Rash covering entire trunk of body the following evening; This is a spontaneous report from a contactable consumer. This 58-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 11:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation .  Medical history included   from an unknown date and unknown if ongoing.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)  dose 1  05Apr2021, administered at 11:15 AM on left arm.  There were no concomitant medications and no other vaccine in four weeks. It was reported that on 27Apr2021 at 12:00 AM, the patient experienced headache through the night, intermittent pain in right ear, difficulty sleeping, lethargy, nausea leading to a single vomit, temperature of 101 degrees Fahrenheit, chills immobility in left arm, rash covering entire trunk of body the following evening. The outcome of the events was recovered on unknown date. Therapeutic measures were taken as a result of events included Ibuprofen. Patient had no covid infection or tested positive for covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Pain
Clinical narrative: Usual ache and pain at first; chest is tight; can't breathe; Little bit of coughing; Headache; This is a spontaneous report received from a contactable consumer (patient). This 37-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0153) via an unspecified route of administration on 07May2021 at 08:45 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received sulfas and morphine from unknown dates for unknown indications and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EW0158) on 10Apr2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. On 09May2021 the patient experienced usual ache and pain at first. Now (10May2021) her chest was tight and she could not breathe. She had a little bit of coughing and a headache. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. It was unknown if the patient received any treatment for the events. The outcomes of ache, pain, chest tight, could not breathe, coughing, and headache were unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Sensory disturbance, Vertigo
Clinical narrative: Three weeks post-vaccination, experienced constant vertigo/dizzyness along with "brain fog". Difficulty concentrating especially when using computer screen. Felt like being on a boat or a dock that is moving. Still experiencing these symptoms intermittently for the past 2 weeks.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chills, Flushing, Muscle spasms, Muscle twitching
Clinical narrative: Approximately 12 hours post vaccine, she started experiencing intense muscle spasms/twitching and chills. This lasted approximately 3 hours. She stated she was unable to control her hands to work her phone to text or call for help. She stated she could not talk. After approximately 3 hours, she stated she got very flushed and then regained muscle control. She fell asleep amd felt fine when she awoke.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Writer's cramp
Clinical narrative: Approximately 12 hours post vaccine, she started experiencing intense muscle spasms/twitching and chills. This lasted approximately 3 hours. She stated she was unable to control her hands to work her phone to text or call for help. She stated she could not talk. After approximately 3 hours, she stated she got very flushed and then regained muscle control. She fell asleep amd felt fine when she awoke.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Pyrexia
Clinical narrative: Metal taste in mouth with 30 minutes of vaccine; low fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 06May2021 at 09:30 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metoprolol tartrate and doxazosin mesylate from unknown dates for unknown indications. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 (lot number EW0161) on 15Apr2021 at 16:30 as a single dose in the left arm for COVID-19 immunization. On 06May2021 at 10:00 the patient experienced metal taste in mouth within 30 minutes of vaccine, low fever, and body aches and pains. The patient did not receive any treatment for the events. The outcome of metal taste, low fever, and body aches and pains was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling cold, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Numbness on side of body receiving vaccine (left arm, left side of neck, left side of face) Heart palpitations Chest pain Flu-like symptoms (fever, headache, coldness, lethargy)
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Palpitations, Pyrexia
Clinical narrative: Numbness on side of body receiving vaccine (left arm, left side of neck, left side of face) Heart palpitations Chest pain Flu-like symptoms (fever, headache, coldness, lethargy)
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a non-contactable consumer (patient). This male patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had an appointment for the second dose of the Pfizer COVID-19 vaccine tomorrow (11May2021) but had to go to the hospital today (10May2021) because he had chest pain. The patient wanted to know if he could reschedule his appointment and get the vaccine today. The outcome of chest pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy; This is a spontaneous report from a contactable other HCP. A 75-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. Medical history included herpes 10 years ago. The patient's concomitant medications were not reported. The caller stated she received the second dose PFIZER-BIONTECH COVID-19 VACCINE in March 2021 and developed peripheral neuropathy 1-2 weeks after vaccination. She referred to her feet as the affected region. She explained she had shingles 10 years ago, but it affected different body parts. She specified "now 2 months" later, her symptoms were "finally dissipating". She explained she didn't take the "pharmaceutical route" as a treatment option and specified "didn't choose gabapentin". She mentioned she went for a "topical" treatment. She said she read in a study from Israel that some people had developed shingles from COVID-19 itself or the COVID-19 vaccines. She mentioned two of her friends developed reactions from the PFIZER-BIONTECH COVID-19 VACCINE. She specified her 75-years old female friend had a "cold sore, a type of herpes virus", while her 65-year-old male friend had "shingles". She further said her female friend's pharmacist said she encountered 2 additional people who had cold sores after getting the COVID-19 vaccine. She asked if peripheral neuropathy was reported as a side effect from the vaccine. She asked if cold sores or shingles were reported as a side effect from the vaccine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the event peripheral neuropathy and administration of BNT162B2 cannot be excluded. Due to limited information, a  complete medical assessment cannot be made. 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.,Linked Report(s) : US-PFIZER INC-2021545288 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021545286 Same reporter/ drug, different patients/ events
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Supraventricular tachycardia
Clinical narrative: heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance; SVT; light-headedness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06May2021 17:45 (Batch/Lot Number: EW0182) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included premature menopause from an unknown date and unknown if ongoing. Patient previously received the first dose via an unspecified route of administration, administered in the left arm on 15Apr2021 08:00 (Batch/Lot Number: EW0169), for covid-19 immunization. The patient's concomitant medications were unspecified (there are medications that the patient received within 2 weeks of vaccination). On 07May2021 18:45, the day after the second shot, patient's heart rate randomly increased to 180 BPM. 200-300 BPM in the ambulance. The ER cardiologist thought it was a SVT. She also had light-headedness. Events resulted in Emergency room/department or urgent care visit. Outcome of events was unknown.  No follow-up attempts are needed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Headache, Heart rate, SARS-CoV-2 test
Clinical narrative: Skipping beats; heart rate went to 100 or over at rest; Headache; loud ringing ING ears; Dizzy; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-  EW0172) via an unspecified route of administration in left arm on 18May2021 12:30 as 1st dose, single dose for COVID-19 immunization. Patient was 52-years-old and was not pregnant at the time of vaccination. Patient medical history included Raynaurds, active TB, Allergic to sulfa, penicillin, tetracycline, erythromycin, experienced drug reaction due to prednisone, alleve (muscle relaxants), allergies to antibiotics, latex and wasp, had shoulder surgery after which used cold medicines, was not getting another, COVID-19 in Nov2020. The concomitant medications included birth control, pseudoephedrine hydrochloride (SUDAFED 12-HOUR). Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 19May2021 at 10:00, patient experienced headache, loud ringing in ears, heart rate went to 100 or over at rest and was skipping beats and was out of rhythm, dizzy. She read studies from country that shows 1 shot for those who had covid is same as having 2 shot. She still was testing that she had antibodies. All she could do was drink water and wait till she metabolized whatever set her system off. She did not want go through that again. Device date was reported as 21May2021. Adverse events did not result in hospitalization. The outcome of the events was resolving.