chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menstrual disorder, Parosmia
Clinical narrative: rregularities in my menstrual cycle such as heavy bleeding and very large clots (2-3 in in size); irregularities in my menstrual cycle; terrible headache and stomach pain like none I had ever had before 10/10 pain scale; stomach pain; my sense of smell was off and still is. It's like a rancid smell?; unable to go about my daily activities; extremely fatigued; This is a spontaneous report from a contactable nurse (patient).   A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7533 and expiration date not provided), via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history includes Scoliosis, migraine, and COVID-19 on 13Jan2021 (lost my sense of smell for 5 days but it returned without any issues and I had only minimal symptoms). The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 22Apr2021 15:00, the patient experienced terrible headache and stomach pain like none I had ever had before 10/10 pain scale. The patient took 2 tablets of 500 mg of acetaminophen to treat the pain but it had no effect. After 8 hours past I then took 3 tablets of 200 mg ibuprofen which still had no response to pain. The patient sense of smell was off and still is. It is like a rancid smell? I gave it some time to see if it would go away but it is still present. The patient also experiencing irregularities in my menstrual cycle such as heavy bleeding and very large clots (2-3 in in size). It has made me unable to go about my daily activities and I have been extremely fatigued. I have never had this issue previously and am not on any kind of medications or birth control. No treatment was given for the events except for headache and stomach pain.  The outcome of the event was not recovered. The patient took the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) on 28Apr2021 administered on left arm for covid-19 immunisation.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry eye, Fatigue, Headache, Nasopharyngitis, Pain
Clinical narrative: a progressively sore arm; fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 14May2021 (lot number and expiry date: unknown) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The mother reported that her son (patient) got the first dose yesterday and he was currently experiencing a progressively sore arm for 27 hours and had fever. She gave her son Motrin for his fever. Outcome of the event a progressively sore arm was recovered on unspecified date in May2021, while for fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information has been expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: a progressively sore arm; fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 14May2021 (lot number and expiry date: unknown) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The mother reported that her son (patient) got the first dose yesterday and he was currently experiencing a progressively sore arm for 27 hours and had fever. She gave her son Motrin for his fever. Outcome of the event a progressively sore arm was recovered on unspecified date in May2021, while for fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information has been expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea
Clinical narrative: Pt c/o difficulty breathing and dizziness 12 minutes after receiving second dose of vaccine. She was assessed and monitored by NP, EMT and paramedic. Initial BP 143/95 repeated BP 128/86, HR 80, RR 14, O2 saturation 99% on RA. She has history of anxiety. She had mod anxiety, she was instructed on relaxation measures, given water, allowed to remove mask and taken outside for fresh air. She was kept at site until she was calm and had no complaints. She was at site with her husband and her father. They were given the Vaccination information sheet, reinforced instructions on ADRs/ SEs to call 911 and go to the ED, follow up with her PCP and register with V-safe. They verbalized understanding and willingness to comply. Pt left site with husband and father in no acute distress, calm, no complaints, awake, alert and oriented to person, place, time and situation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Oxygen saturation
Clinical narrative: Pt c/o difficulty breathing and dizziness 12 minutes after receiving second dose of vaccine. She was assessed and monitored by NP, EMT and paramedic. Initial BP 143/95 repeated BP 128/86, HR 80, RR 14, O2 saturation 99% on RA. She has history of anxiety. She had mod anxiety, she was instructed on relaxation measures, given water, allowed to remove mask and taken outside for fresh air. She was kept at site until she was calm and had no complaints. She was at site with her husband and her father. They were given the Vaccination information sheet, reinforced instructions on ADRs/ SEs to call 911 and go to the ED, follow up with her PCP and register with V-safe. They verbalized understanding and willingness to comply. Pt left site with husband and father in no acute distress, calm, no complaints, awake, alert and oriented to person, place, time and situation.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot Number: EW0176, expiration date: unknown), via an unspecified route of administration in the right arm on 28Apr2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included Asthma (diagnosed when 2 years old). Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot Number: EP7533, expiration date: unknown), via Intramuscular route of administration in the right arm on 07Apr2021 at 11:45 as a single dose for COVID-19 immunization. On 05May2021, her ears are ringing so loud, she can't sleep or hear, this started one week after she received the second dose of the Pfizer COVID-19 vaccine and she has an appointment tomorrow with ENT. The ringing was a little bit in her right ear, but it was more in the left ear. She wants to know why she feels tinnitus, why ringing in ears, hissing, and weird sounds are not listed as a side effect. She feels like it should be listed as a side effect since hundreds of people are saying it was a side effect. She stated, "it has ruined her life". The outcome of the event was not resolved.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot Number: EW0176, expiration date: unknown), via an unspecified route of administration in the right arm on 28Apr2021 at 11:45 (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included Asthma (diagnosed when 2 years old). Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, lot Number: EP7533, expiration date: unknown), via Intramuscular route of administration in the right arm on 07Apr2021 at 11:45 as a single dose for COVID-19 immunization. On 05May2021, her ears are ringing so loud, she can't sleep or hear, this started one week after she received the second dose of the Pfizer COVID-19 vaccine and she has an appointment tomorrow with ENT. The ringing was a little bit in her right ear, but it was more in the left ear. She wants to know why she feels tinnitus, why ringing in ears, hissing, and weird sounds are not listed as a side effect. She feels like it should be listed as a side effect since hundreds of people are saying it was a side effect. She stated, "it has ruined her life". The outcome of the event was not resolved.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Gait disturbance, Gait inability, Injection site mass
Clinical narrative: Core and lower extremity paralysis, speech impairment, presumed multiple sclerosis exacerbation, loss of ability to sit, loss of ability to stand, loss of ability to walk.  Treatment: hospitalization, IV steroids, physical occupational and speech therapy.  Other treatments as well.  Outcomes as of 2 June 2021:  No return to prior function, slight improvement in speech.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Movement disorder
Clinical narrative: Core and lower extremity paralysis, speech impairment, presumed multiple sclerosis exacerbation, loss of ability to sit, loss of ability to stand, loss of ability to walk.  Treatment: hospitalization, IV steroids, physical occupational and speech therapy.  Other treatments as well.  Outcomes as of 2 June 2021:  No return to prior function, slight improvement in speech.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Gait inability, Monoplegia, Movement disorder, Multiple sclerosis
Clinical narrative: Core and lower extremity paralysis, speech impairment, presumed multiple sclerosis exacerbation, loss of ability to sit, loss of ability to stand, loss of ability to walk.  Treatment: hospitalization, IV steroids, physical occupational and speech therapy.  Other treatments as well.  Outcomes as of 2 June 2021:  No return to prior function, slight improvement in speech.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis, Speech disorder
Clinical narrative: Core and lower extremity paralysis, speech impairment, presumed multiple sclerosis exacerbation, loss of ability to sit, loss of ability to stand, loss of ability to walk.  Treatment: hospitalization, IV steroids, physical occupational and speech therapy.  Other treatments as well.  Outcomes as of 2 June 2021:  No return to prior function, slight improvement in speech.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Limb discomfort, Mobility decreased, Muscular weakness, Pallor
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Hyperhidrosis, Limb discomfort, Mobility decreased, Muscular weakness
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pallor, Paraesthesia
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Feeling abnormal, Hyperhidrosis, Hypoacusis
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Limb discomfort, Mobility decreased
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pallor, Paraesthesia, Visual impairment
Clinical narrative: Within minutes of receiving  covid-19  vaccine, I became very  excessive sweaty (my shirt was wet), felt eyesight was dimming,  space perception was completely off, very pale,  dizziness  and unable to hear when being spoken too, felt faint. Both of my arms had a very tingly feeling and felt  heavy  and then became completely  numb and I was unable to move to either arm for approximately 45 minutes.  Movement slowly came back  throughout the evening and over the next week. My legs felt tingly and heavy. I continue to have periodic tingly feeling in my joints through out my body. My chest felt heavy.  I felt like I was doing to die.  Large red swollen area where shot was given. I have COVID 19 in Feb, 2021. Health care profession suspects the reaction may have been related to having COVID-19, second dose not recommended. Likely to have antibodies. I have not felt 100 percent since receiving vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Pulmonary embolism
Clinical narrative: Blood clot in his lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clot in his lung) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BRINZOLAMIDE (AZOPT) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (Blood clot in his lung) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Blood clot in his lung) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clot in his lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clot in his lung) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BRINZOLAMIDE (AZOPT) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (Blood clot in his lung) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Blood clot in his lung) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cardioversion, Dizziness, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: SVT, supraventricular tachycardia, occurred 29.5 hours after vaccine given.  pt was transferred to hospital.  The arrhythmia spontaneously resolved while he was receiving care in the ED.  He had a cardiology evaluation subsequently.  He has had no symptoms since that time.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Supraventricular tachycardia
Clinical narrative: SVT, supraventricular tachycardia, occurred 29.5 hours after vaccine given.  pt was transferred to hospital.  The arrhythmia spontaneously resolved while he was receiving care in the ED.  He had a cardiology evaluation subsequently.  He has had no symptoms since that time.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Echocardiogram, Electrocardiogram, Supraventricular tachycardia
Clinical narrative: SVT, supraventricular tachycardia, occurred 29.5 hours after vaccine given.  pt was transferred to hospital.  The arrhythmia spontaneously resolved while he was receiving care in the ED.  He had a cardiology evaluation subsequently.  He has had no symptoms since that time.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: Terrible headaches lasting several days. Today the headache is very bad; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration in Arm Right on 21May2021 14:30 (Batch/Lot Number: Ew0161 RA, 56-years age at the time of vaccination) as single dose for covid-19 immunisation. Medical history included Sulfa drugs (Drug hypersensitivity) and some foods allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 21May2021 19:00, the patient experienced terrible headaches lasting several days. Today the headache is very bad. Patient was taking Aleve for terrible headaches; laying down. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event outcome of event was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Terrible headaches lasting several days. Today the headache is very bad; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration in Arm Right on 21May2021 14:30 (Batch/Lot Number: Ew0161 RA, 56-years age at the time of vaccination) as single dose for covid-19 immunisation. Medical history included Sulfa drugs (Drug hypersensitivity) and some foods allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 21May2021 19:00, the patient experienced terrible headaches lasting several days. Today the headache is very bad. Patient was taking Aleve for terrible headaches; laying down. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event outcome of event was not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Continued soreness and sharp pain in upper left arm since first dose; Disrupts sleep and concentration; Disrupts sleep and concentration; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left arm on Apr2021 10:00 am as 1st dose, single dose for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration in left arm on May2021 09:00 am as 2nd dose, single dose for COVID-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. The patient's concomitant medications were not reported.Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On Apr2021, the patient experienced continued soreness and sharp pain in upper left arm since first dose. Disrupts sleep and concentration. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Pain in extremity, Sleep disorder
Clinical narrative: Continued soreness and sharp pain in upper left arm since first dose; Disrupts sleep and concentration; Disrupts sleep and concentration; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left arm on Apr2021 10:00 am as 1st dose, single dose for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration in left arm on May2021 09:00 am as 2nd dose, single dose for COVID-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. The patient's concomitant medications were not reported.Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On Apr2021, the patient experienced continued soreness and sharp pain in upper left arm since first dose. Disrupts sleep and concentration. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable 34-year-old female consumer reported for herself. A 34-years-old female (Non-pregnant) patient received second dose of BNT162B2(PFIZER COVID 19 VACCINE; Formulation: Solution for injection; Batch/Lot Number: EW0177, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 22May2021 at 09:30 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient received historical vaccine first dose of BNT162B2 (PFIZER COVID 19 VACCINE; Formulation: Solution for injection; Batch/Lot Number: EW0167, expiry date: unknown), via an unspecified route of administration in right arm on 30Apr2021 as 1st dose single for COVID-19 immunization Patient had relevant past drug history included Mushrooms, Morphine and Penicillin. Patient medical history included food allergy, drug hypersensitivity from an unknown date and unknown if ongoing. and Morphine which cause allergies. The patient's concomitant medications were not reported.  The patient previously took morphine and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23May2021 the patient experienced lymph node was swollen, tender in the armpit area. The outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Groin pain, Herpes zoster, Lymphadenopathy
Clinical narrative: I developed shingles on my lower back; had swollen lymph nodes; pain in the sacral area; This is a spontaneous report from a Pfizer sponsored program. This 65-year-old other HCP (female patient) reported for herself that, a 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration in right arm on 15Feb2021 11:00 as 1st dose, single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included vein problems in leg. The patient previously had allergic reaction (no breathing) to local anaesthetic at dentist. The patient received shingles vaccine in 2018. There were no concomitant medications. Prior to the vaccination, the patient did not receive any other vaccines within four weeks, prior to the vaccination and not received any medications in two weeks. The patient did not have covid prior to vaccination. On March 1, 2021 approximately 2 weeks after 1st dose of Pfizer vaccine, she developed a very sore and stinging rash on the right upper buttocks and swelling of lymph nodes in right groin. she developed a pain in the right sacral area. The doctor diagnosed the rash as Shingles. She was wondering how an increased immune response from the COVID vaccine would unleash herpes zoster. Treatment received with Valacyclovir was received for a week. No covid-19 tested post vaccination. The reporter provided serious of the events as no. On an unspecified date in 2021, the patient was recovered from the events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Lymphadenopathy
Clinical narrative: I developed shingles on my lower back; had swollen lymph nodes; pain in the sacral area; This is a spontaneous report from a Pfizer sponsored program. This 65-year-old other HCP (female patient) reported for herself that, a 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration in right arm on 15Feb2021 11:00 as 1st dose, single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included vein problems in leg. The patient previously had allergic reaction (no breathing) to local anaesthetic at dentist. The patient received shingles vaccine in 2018. There were no concomitant medications. Prior to the vaccination, the patient did not receive any other vaccines within four weeks, prior to the vaccination and not received any medications in two weeks. The patient did not have covid prior to vaccination. On March 1, 2021 approximately 2 weeks after 1st dose of Pfizer vaccine, she developed a very sore and stinging rash on the right upper buttocks and swelling of lymph nodes in right groin. she developed a pain in the right sacral area. The doctor diagnosed the rash as Shingles. She was wondering how an increased immune response from the COVID vaccine would unleash herpes zoster. Treatment received with Valacyclovir was received for a week. No covid-19 tested post vaccination. The reporter provided serious of the events as no. On an unspecified date in 2021, the patient was recovered from the events.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Chest pain, neck pain, and shortness of breath.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Fatigue, Hepatitis A antibody negative, Hepatitis B core antibody negative, Hepatitis B surface antigen negative
Clinical narrative: Chest pain, neck pain, and shortness of breath.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C antibody negative, Myocarditis, Palpitations, Red blood cell sedimentation rate increased, Respiratory viral panel
Clinical narrative: Chest pain, neck pain, and shortness of breath.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test positive, Troponin increased
Clinical narrative: Chest pain, neck pain, and shortness of breath.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Neck pain
Clinical narrative: Chest pain, neck pain, and shortness of breath.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pain, neck pain, and shortness of breath.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Dizziness, Dyspepsia, Eructation
Clinical narrative: Also I had to go to Emergency after a weak after 1st does as my Blood Pressure was high and got discharged after an hour.; This is a spontaneous report from a contactable consumer.A 36-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot Number: ER8731) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had to go to emergency after a weak after 1st does as my blood pressure was high and got discharged after an hour.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: high. IV was administered and EKG after a week of taking 1st dose. Outcome of event was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021557145 same patient, different vaccine dose/AE.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Head discomfort, Loss of personal independence in daily activities, SARS-CoV-2 test negative
Clinical narrative: Also I had to go to Emergency after a weak after 1st does as my Blood Pressure was high and got discharged after an hour.; This is a spontaneous report from a contactable consumer.A 36-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot Number: ER8731) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had to go to emergency after a weak after 1st does as my blood pressure was high and got discharged after an hour.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: high. IV was administered and EKG after a week of taking 1st dose. Outcome of event was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021557145 same patient, different vaccine dose/AE.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Also I had to go to Emergency after a weak after 1st does as my Blood Pressure was high and got discharged after an hour.; This is a spontaneous report from a contactable consumer.A 36-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot Number: ER8731) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had to go to emergency after a weak after 1st does as my blood pressure was high and got discharged after an hour.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: high. IV was administered and EKG after a week of taking 1st dose. Outcome of event was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021557145 same patient, different vaccine dose/AE.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Also I had to go to Emergency after a weak after 1st does as my Blood Pressure was high and got discharged after an hour.; This is a spontaneous report from a contactable consumer.A 36-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 (Batch/Lot Number: ER8731) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had to go to emergency after a weak after 1st does as my blood pressure was high and got discharged after an hour.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: high. IV was administered and EKG after a week of taking 1st dose. Outcome of event was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021557145 same patient, different vaccine dose/AE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Balance disorder, Dizziness, Head discomfort, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 38-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states she received her 1st COVID vaccine dose on 09Apr2021 and experienced some mild off imbalance feelings and some itching with small red areas on an unspecified date in Apr2021. The red areas are gone, but still itch a little bit. Caller has an MRI scheduled on Friday, 28May2021. She also had a VNG test and the test was normal. The caller went to the ED and all the tests were normal. The outcome of the event redness was recovered on an unspecified. Other events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Palpitations, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 38-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states she received her 1st COVID vaccine dose on 09Apr2021 and experienced some mild off imbalance feelings and some itching with small red areas on an unspecified date in Apr2021. The red areas are gone, but still itch a little bit. Caller has an MRI scheduled on Friday, 28May2021. She also had a VNG test and the test was normal. The caller went to the ED and all the tests were normal. The outcome of the event redness was recovered on an unspecified. Other events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Electronystagmogram, Erythema, Investigation, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 38-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states she received her 1st COVID vaccine dose on 09Apr2021 and experienced some mild off imbalance feelings and some itching with small red areas on an unspecified date in Apr2021. The red areas are gone, but still itch a little bit. Caller has an MRI scheduled on Friday, 28May2021. She also had a VNG test and the test was normal. The caller went to the ED and all the tests were normal. The outcome of the event redness was recovered on an unspecified. Other events was unknown. Information about lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Borrelia test, Chest pain, Coxsackie virus test, Cytomegalovirus test, Echocardiogram
Clinical narrative: Acute myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echovirus test, Ejection fraction decreased, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, HIV antibody negative
Clinical narrative: Acute myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: HIV antigen negative, Lymphadenopathy, Magnetic resonance imaging abnormal, Myocarditis, SARS-CoV-2 antibody test
Clinical narrative: Acute myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test positive, Toxicologic test normal, Troponin increased
Clinical narrative: Acute myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Chills, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Acute myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging heart, Myocarditis, Pain, Troponin increased
Clinical narrative: Acute myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Acute myocarditis
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is one of two report from same patient. A male patient (Age: 35; Unit: Unknown) of unspecified age received his second dose of BNT162B2 (COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 22May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter enquired for how long might side effects continue after the second dose. She stated that the second day after the vaccination, on 24May2021, the patient experienced chills and body ache, which improved by the third day (25May2021). On the third day, on 25May2021, he had onset of headache, which had resolved on the same day. The fourth day post vaccination, on 26May2021, he felt better during the day and went to work, but that night, he experienced dizziness and vertigo and was having trouble standing. On an unspecified date, the vertigo had gotten better, but had a brain fog and feeling drunk on an unknown date in May2021 which was continuing. He was now six days post vaccination and wanted to know if side effects could be lasting for this extended amount of time. His vaccination site stated side effects should resolve within three days. Outcome was resolved for the events chills, body ache, headache on 25May2021 and outcome was resolving for event vertigo and not resolved for event brain fog and feeling drunk. The outcome of the events dizziness and trouble standing was unknown. No PQC involved. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Tremor, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is one of two report from same patient. A male patient (Age: 35; Unit: Unknown) of unspecified age received his second dose of BNT162B2 (COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 22May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter enquired for how long might side effects continue after the second dose. She stated that the second day after the vaccination, on 24May2021, the patient experienced chills and body ache, which improved by the third day (25May2021). On the third day, on 25May2021, he had onset of headache, which had resolved on the same day. The fourth day post vaccination, on 26May2021, he felt better during the day and went to work, but that night, he experienced dizziness and vertigo and was having trouble standing. On an unspecified date, the vertigo had gotten better, but had a brain fog and feeling drunk on an unknown date in May2021 which was continuing. He was now six days post vaccination and wanted to know if side effects could be lasting for this extended amount of time. His vaccination site stated side effects should resolve within three days. Outcome was resolved for the events chills, body ache, headache on 25May2021 and outcome was resolving for event vertigo and not resolved for event brain fog and feeling drunk. The outcome of the events dizziness and trouble standing was unknown. No PQC involved. Information on the lot/batch number has been requested.