chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: bilateral catharsis; This is a spontaneous report from a contactable consumer (patient) reporting herself.    A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history was concomitant medications not reported.  It was reported, stated, consumer on the line who has experienced a serious adverse reaction according to her and her ophthalmologist said that she had a "bilateral catharsis" (further not clarified). The patient wanted to know if she can get her second dose. She received the first dose of Pfizer Biotech Covid-19 Vaccine on 04Jun2021, and her next dose is tomorrow. Follow-up on (21Jun2021), it was reported that, patient is yet to know if she can get her second dose. The outcome for the event was unknown.  Information on lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Contusion, Fatigue, Platelet count decreased, Rash
Clinical narrative: CONFIRMED COVID-19 INFECTION; STOMATITIS; CONTUSION; RASH; FATIGUE; SARS-COV-2 TEST POSITIVE; PLATELET COUNT DECREASED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1368678); concerned a 43-year-old male. The patient's height, and weight were not reported. The patient had no known drug allergies, had no current illness and had no other known comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21AHRSA, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included ibuprofen.  On 29-MAY-2021, the patient was admitted to hospital with a platelet count 0 (platelet count decreased). Patient was presented with fatigue, mouth sores (stomatitis) and body rash and extensive bruising (contusion). Patient was also tested positive for covid-19. Patient was hospitalized for 7 days. Laboratory data included: Platelet count (NR: not provided) Decreased (0), and SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182747. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 22-JUN-2021. The following information was updated and incorporated into the case narrative: Added product quality complaint investigational resolution and narrative updated accordingly.; Sender's Comments: V1: Additional information updated include product quality complaint investigational resolution. This updated information does not alter the causality of previously reported events. 20210624567-Covid-19 vaccine ad26.cov2.s-Contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Stomatitis
Clinical narrative: CONFIRMED COVID-19 INFECTION; STOMATITIS; CONTUSION; RASH; FATIGUE; SARS-COV-2 TEST POSITIVE; PLATELET COUNT DECREASED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1368678); concerned a 43-year-old male. The patient's height, and weight were not reported. The patient had no known drug allergies, had no current illness and had no other known comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21AHRSA, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included ibuprofen.  On 29-MAY-2021, the patient was admitted to hospital with a platelet count 0 (platelet count decreased). Patient was presented with fatigue, mouth sores (stomatitis) and body rash and extensive bruising (contusion). Patient was also tested positive for covid-19. Patient was hospitalized for 7 days. Laboratory data included: Platelet count (NR: not provided) Decreased (0), and SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182747. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 22-JUN-2021. The following information was updated and incorporated into the case narrative: Added product quality complaint investigational resolution and narrative updated accordingly.; Sender's Comments: V1: Additional information updated include product quality complaint investigational resolution. This updated information does not alter the causality of previously reported events. 20210624567-Covid-19 vaccine ad26.cov2.s-Contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Contusion, Fatigue, Platelet count, Platelet count decreased
Clinical narrative: CONFIRMED COVID-19 INFECTION; STOMATITIS; CONTUSION; RASH; FATIGUE; SARS-COV-2 TEST POSITIVE; PLATELET COUNT DECREASED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1368678); concerned a 43-year-old male. The patient's height, and weight were not reported. The patient had no known drug allergies, had no current illness and had no other known comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21AHRSA, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included ibuprofen.  On 29-MAY-2021, the patient was admitted to hospital with a platelet count 0 (platelet count decreased). Patient was presented with fatigue, mouth sores (stomatitis) and body rash and extensive bruising (contusion). Patient was also tested positive for covid-19. Patient was hospitalized for 7 days. Laboratory data included: Platelet count (NR: not provided) Decreased (0), and SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182747. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 22-JUN-2021. The following information was updated and incorporated into the case narrative: Added product quality complaint investigational resolution and narrative updated accordingly.; Sender's Comments: V1: Additional information updated include product quality complaint investigational resolution. This updated information does not alter the causality of previously reported events. 20210624567-Covid-19 vaccine ad26.cov2.s-Contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, SARS-CoV-2 test positive, Stomatitis
Clinical narrative: CONFIRMED COVID-19 INFECTION; STOMATITIS; CONTUSION; RASH; FATIGUE; SARS-COV-2 TEST POSITIVE; PLATELET COUNT DECREASED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1368678); concerned a 43-year-old male. The patient's height, and weight were not reported. The patient had no known drug allergies, had no current illness and had no other known comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21AHRSA, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included ibuprofen.  On 29-MAY-2021, the patient was admitted to hospital with a platelet count 0 (platelet count decreased). Patient was presented with fatigue, mouth sores (stomatitis) and body rash and extensive bruising (contusion). Patient was also tested positive for covid-19. Patient was hospitalized for 7 days. Laboratory data included: Platelet count (NR: not provided) Decreased (0), and SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182747. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.  Additional information was received from Regulatory Authority on 22-JUN-2021. The following information was updated and incorporated into the case narrative: Added product quality complaint investigational resolution and narrative updated accordingly.; Sender's Comments: V1: Additional information updated include product quality complaint investigational resolution. This updated information does not alter the causality of previously reported events. 20210624567-Covid-19 vaccine ad26.cov2.s-Contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Quadriplegia
Clinical narrative: Throwing up, arms and legs intense pain,   Numbness,  weakness, lost use of upper and lower extremities- GBS diagnosis
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Throwing up, arms and legs intense pain,   Numbness,  weakness, lost use of upper and lower extremities- GBS diagnosis
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal disorder, Pain in extremity, Vomiting
Clinical narrative: Throwing up, arms and legs intense pain,   Numbness,  weakness, lost use of upper and lower extremities- GBS diagnosis
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Guillain-Barre syndrome
Clinical narrative: Throwing up, arms and legs intense pain,   Numbness,  weakness, lost use of upper and lower extremities- GBS diagnosis
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Abdominal pain upper, Dysstasia, Thrombosis
Clinical narrative: fever; stomach pain; This is a spontaneous report from a contactable consumer (patient). A 68-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EN6198 or EN6208), via an unspecified route of administration, administered in arm on 26Feb2021 at 11:00 AM (at the age of 68 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Mar2021, the patient woke up with severe stomach pain at 2:00 am morning it lasted till 07:00 am it eased up, pain they lasted 4 or 5days, experienced fever on an unspecified date and it went away for about 4days then it set up. Outcome of the events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: fever; stomach pain; This is a spontaneous report from a contactable consumer (patient). A 68-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EN6198 or EN6208), via an unspecified route of administration, administered in arm on 26Feb2021 at 11:00 AM (at the age of 68 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Mar2021, the patient woke up with severe stomach pain at 2:00 am morning it lasted till 07:00 am it eased up, pain they lasted 4 or 5days, experienced fever on an unspecified date and it went away for about 4days then it set up. Outcome of the events was recovered on an unspecified date.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Fatigue, Lymphadenopathy
Clinical narrative: patient had covid several weeks prior to first dose of vaccine. patient experienced a loss of taste and a loss of smell for 3 days then the sense of taste and smell returned. patiene was quarantined after testing positive . Several weeks later patient received the 1 st dose of moderna 5/7/2021 then he received the second dose of moderna on 6/4/2021 patient loss his sense of taste and smell . Patient tested negative 3 times after receiving the vaccine but still loss his sense of taste and smell. Patient states that he has to force himself to eat and that he lost 15 pounds in 1 month . Patient states he is also experiencing cotton mouth and his mouth is constantly dry .
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Myalgia, Parosmia, Pyrexia, Taste disorder
Clinical narrative: patient had covid several weeks prior to first dose of vaccine. patient experienced a loss of taste and a loss of smell for 3 days then the sense of taste and smell returned. patiene was quarantined after testing positive . Several weeks later patient received the 1 st dose of moderna 5/7/2021 then he received the second dose of moderna on 6/4/2021 patient loss his sense of taste and smell . Patient tested negative 3 times after receiving the vaccine but still loss his sense of taste and smell. Patient states that he has to force himself to eat and that he lost 15 pounds in 1 month . Patient states he is also experiencing cotton mouth and his mouth is constantly dry .
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Blood test normal, Dry mouth, SARS-CoV-2 test negative
Clinical narrative: patient had covid several weeks prior to first dose of vaccine. patient experienced a loss of taste and a loss of smell for 3 days then the sense of taste and smell returned. patiene was quarantined after testing positive . Several weeks later patient received the 1 st dose of moderna 5/7/2021 then he received the second dose of moderna on 6/4/2021 patient loss his sense of taste and smell . Patient tested negative 3 times after receiving the vaccine but still loss his sense of taste and smell. Patient states that he has to force himself to eat and that he lost 15 pounds in 1 month . Patient states he is also experiencing cotton mouth and his mouth is constantly dry .
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over from neck down in my feet, and they are red, swollen and itchy; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 09Jun2021 (Lot Number: ER8730) (at age of 28-year-old) as single dose for covid-19 immunisation.  Medical history was reported as No. The patient's concomitant medications were not reported. On 09Jun2021, the patient had hives all over from neck down in her feet, and they are red, swollen and itchy. The patient  took Benadryl last night (09Jun2021) as treatment. when ask dose of Benadryl: Consumer stated, "I don't know I threw the package away, so I am not sure about that." The outcome of the event was not resolved.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over from neck down in my feet, and they are red, swollen and itchy; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 09Jun2021 (Lot Number: ER8730) (at age of 28-year-old) as single dose for covid-19 immunisation.  Medical history was reported as No. The patient's concomitant medications were not reported. On 09Jun2021, the patient had hives all over from neck down in her feet, and they are red, swollen and itchy. The patient  took Benadryl last night (09Jun2021) as treatment. when ask dose of Benadryl: Consumer stated, "I don't know I threw the package away, so I am not sure about that." The outcome of the event was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; Beginning about 8 hours after the 2nd shot I started having body aches, and headache. As the night wore on I started having fever and chills with a SEVERE headache like nothing I have ever had before.; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left arm on 10Mar2021 08:15 as dose 2, single (at the age of 49-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included hypothyroidism. The concomitant medications included levothyroxine sodium (SYNTHROID), multivitamins [vitamins NOS] and OXYBUTYNIN. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left arm on 17Feb2021 13:15 for COVID-19 immunization. Patient did not have COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Patient did not receive any vaccine in four weeks. On 10Mar2021 at 15:00 Beginning about 8 hours after the 2nd shot patient started having body aches, and headache. As the night wore on she started having fever and chills with a severe headache like nothing she had ever had before. The following day was much of the same, fever, body aches, severe headache and extreme fatigue. 48 hours post injection all of the symptoms were gone with the exception of a headache which lingered about another 12 hours.  She was still having almost daily headaches 3 months later and not sure if it was vaccine related or coincidence but not normal for her. The patient did not receive any treatment for the adverse events. On an unspecified date in Mar2021, the outcome of the events was resolved with sequel.  Information about lot/ batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: I had fallen asleep in chair; wiped my nostril and saw blood. It bled profusely for almost 5 minutes/nasal bleeding; wiped my nostril and saw blood. It bled profusely for almost 5 minutes/nasal bleeding; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179), via intramuscular route of administration in the left arm on 11Jun2021 at 08:30 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization in pharmacy or drug store. Medical history included ongoing Hashimoto, more than 5 years ago, asthma from an unknown date in Mar2020 and ongoing, ongoing hypertension, more than 10 years ago. The family history included Hashimoto, asthma and hypertensive. Concomitant medications included lisinopril; magnesium, vitamin d nos; all for hypertension from an unspecified start date and ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she had fallen asleep in chair. It was in the afternoon; she woke up and her nose felt like it was running. She wiped her nostril and saw blood. It bled profusely for almost 5 minutes. She never had a nosebleed in her life (On 11Jun2021 at 17:15, the patient had nasal bleeding then again on 13Jun2021 at 17:15). The patient did not receive any treatment for the events. The outcome of the events was reported as resolved.  Additional information is requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Sleep disorder
Clinical narrative: I had fallen asleep in chair; wiped my nostril and saw blood. It bled profusely for almost 5 minutes/nasal bleeding; wiped my nostril and saw blood. It bled profusely for almost 5 minutes/nasal bleeding; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179), via intramuscular route of administration in the left arm on 11Jun2021 at 08:30 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization in pharmacy or drug store. Medical history included ongoing Hashimoto, more than 5 years ago, asthma from an unknown date in Mar2020 and ongoing, ongoing hypertension, more than 10 years ago. The family history included Hashimoto, asthma and hypertensive. Concomitant medications included lisinopril; magnesium, vitamin d nos; all for hypertension from an unspecified start date and ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she had fallen asleep in chair. It was in the afternoon; she woke up and her nose felt like it was running. She wiped her nostril and saw blood. It bled profusely for almost 5 minutes. She never had a nosebleed in her life (On 11Jun2021 at 17:15, the patient had nasal bleeding then again on 13Jun2021 at 17:15). The patient did not receive any treatment for the events. The outcome of the events was reported as resolved.  Additional information is requested.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Injected limb mobility decreased, Joint noise, Limb injury, Loss of personal independence in daily activities
Clinical narrative: He experienced typical arm soreness in the left arm; shooting pain in shoulder; Experiencing loud popping sounds and feeling like his shoulder was dislocated; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 47-year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11May2021 16:00 (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunisation. Medical history was not reported. The patient had a no allergies. Concomitant medication(s) included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; omega-3 nos (OMEGA-3 NOS) taken for an unspecified indication, start and stop date were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient not had any other vaccine in four weeks. The patient not had a covid prior and post vaccination. On 12May2021 16:00, the patient experienced typical arm soreness in the left arm, where the shot was administered, within 24 hours of the shot. Within 48 hours, however, the soreness turned into shooting pain in his left shoulder. Within 7 days, He was experiencing loud popping sounds and feeling like his shoulder was dislocating with simple movements, like brushing teeth, typing or driving. The patient visited a teledoc on 31May2021 prior to his second dose on 01Jun2021, and the doctor encouraged him to continue with his 2nd shot, but do the right arm as a case study. He experienced no lasting issues from the 2nd shot. On 07Jun2021, withheld visited a physical therapist, and he did a physical exam. He knew it was not a rotator cuff issue, but was thinking it could be a laberal tear. And MRI would be required to diagnose. The MRI has not been ordered due to expense for the patient. The events seriousness was reported as disabling/incapacitating. The patient not received any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Pain, Pain in extremity
Clinical narrative: He experienced typical arm soreness in the left arm; shooting pain in shoulder; Experiencing loud popping sounds and feeling like his shoulder was dislocated; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 47-year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11May2021 16:00 (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunisation. Medical history was not reported. The patient had a no allergies. Concomitant medication(s) included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; omega-3 nos (OMEGA-3 NOS) taken for an unspecified indication, start and stop date were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient not had any other vaccine in four weeks. The patient not had a covid prior and post vaccination. On 12May2021 16:00, the patient experienced typical arm soreness in the left arm, where the shot was administered, within 24 hours of the shot. Within 48 hours, however, the soreness turned into shooting pain in his left shoulder. Within 7 days, He was experiencing loud popping sounds and feeling like his shoulder was dislocating with simple movements, like brushing teeth, typing or driving. The patient visited a teledoc on 31May2021 prior to his second dose on 01Jun2021, and the doctor encouraged him to continue with his 2nd shot, but do the right arm as a case study. He experienced no lasting issues from the 2nd shot. On 07Jun2021, withheld visited a physical therapist, and he did a physical exam. He knew it was not a rotator cuff issue, but was thinking it could be a laberal tear. And MRI would be required to diagnose. The MRI has not been ordered due to expense for the patient. The events seriousness was reported as disabling/incapacitating. The patient not received any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint dislocation, Pain in extremity
Clinical narrative: He experienced typical arm soreness in the left arm; shooting pain in shoulder; Experiencing loud popping sounds and feeling like his shoulder was dislocated; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 47-year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11May2021 16:00 (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunisation. Medical history was not reported. The patient had a no allergies. Concomitant medication(s) included multivitamins [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; omega-3 nos (OMEGA-3 NOS) taken for an unspecified indication, start and stop date were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient not had any other vaccine in four weeks. The patient not had a covid prior and post vaccination. On 12May2021 16:00, the patient experienced typical arm soreness in the left arm, where the shot was administered, within 24 hours of the shot. Within 48 hours, however, the soreness turned into shooting pain in his left shoulder. Within 7 days, He was experiencing loud popping sounds and feeling like his shoulder was dislocating with simple movements, like brushing teeth, typing or driving. The patient visited a teledoc on 31May2021 prior to his second dose on 01Jun2021, and the doctor encouraged him to continue with his 2nd shot, but do the right arm as a case study. He experienced no lasting issues from the 2nd shot. On 07Jun2021, withheld visited a physical therapist, and he did a physical exam. He knew it was not a rotator cuff issue, but was thinking it could be a laberal tear. And MRI would be required to diagnose. The MRI has not been ordered due to expense for the patient. The events seriousness was reported as disabling/incapacitating. The patient not received any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed shingles blisters; I developed shingles blisters; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch no/Lot number: Unknown), via an unspecified route of administration in the right arm on 15May2021 at 14:00pm (at the age of 54-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. Medical history included hidradenitis suppurativa from an unknown date and unknown if ongoing. Concomitant medications included taken within two weeks are atorvastatin, levothyroxine, estradiol, ibuprofen; all taken for an unspecified indication, start and stop date were not reported. Patient Known allergies were reported to Penicillin. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 24Apr2021 at 16:00 pm (at the age of 54-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not experience with COVID prior vaccination and not tested post vaccination. On 12Jun2021 at 08:00 am, the patient developed shingles blisters. The events are resulted in doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The patient received prednisone, valacyclovir, gabapentin as treatment for events. The outcome of the events was not recovered.  Information about lot/ batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: I developed shingles blisters; I developed shingles blisters; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch no/Lot number: Unknown), via an unspecified route of administration in the right arm on 15May2021 at 14:00pm (at the age of 54-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. Medical history included hidradenitis suppurativa from an unknown date and unknown if ongoing. Concomitant medications included taken within two weeks are atorvastatin, levothyroxine, estradiol, ibuprofen; all taken for an unspecified indication, start and stop date were not reported. Patient Known allergies were reported to Penicillin. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 24Apr2021 at 16:00 pm (at the age of 54-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not experience with COVID prior vaccination and not tested post vaccination. On 12Jun2021 at 08:00 am, the patient developed shingles blisters. The events are resulted in doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The patient received prednisone, valacyclovir, gabapentin as treatment for events. The outcome of the events was not recovered.  Information about lot/ batch number has been requested.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Malaise, Pyrexia
Clinical narrative: fever; she was really sick; she had a black bruise; she thinks the nurse put the bolus really close to the bone; she was having chronic sinus infections and the ears, nose and throat, doctor suggested she had it and it helped quite a bit; This spontaneous report was received from a female patient, referring to herself (when she was 33 years old). The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 1999 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided).       On 1999, the patient she had high fever (pyrexia), she was really sick (illness), she thinks the nurse put the bolus really close to the bone in her deltoid, she had a black bruise (vaccination site bruising). Patient stated the reason she did have that vaccine at such a young age was because she was having chronic sinus infections and the ears, nose, and throat doctor suggested she had it and it helped quite a bit. Onset Age:  The outcome of the events was unknown. The causal relationship between the event and the suspect therapy was not provided.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Malaise, Pyrexia, Vaccination site bruising
Clinical narrative: fever; she was really sick; she had a black bruise; she thinks the nurse put the bolus really close to the bone; she was having chronic sinus infections and the ears, nose and throat, doctor suggested she had it and it helped quite a bit; This spontaneous report was received from a female patient, referring to herself (when she was 33 years old). The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 1999 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, frequency, route, lot# and expiration date were not provided).       On 1999, the patient she had high fever (pyrexia), she was really sick (illness), she thinks the nurse put the bolus really close to the bone in her deltoid, she had a black bruise (vaccination site bruising). Patient stated the reason she did have that vaccine at such a young age was because she was having chronic sinus infections and the ears, nose, and throat doctor suggested she had it and it helped quite a bit. Onset Age:  The outcome of the events was unknown. The causal relationship between the event and the suspect therapy was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in Arm Left on 17Jun2021 15:20 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR,lot number OME2586A, expiry date Oct 2022) taken for an unspecified indication, start and stop date were not reported. The patient reported that her left arm got swollen, very red, and very painful after the first dose of the Pfizer BioNTech covid 19 vaccine yesterday,17Jun2021. The patient second dose is scheduled for 08Jul2021. She took Advil at 3:00 am and iced her arm and then the pain proceeded to run down her arm into her shoulder blade, the left side of her neck, and down into her left hand. The patient feels like she was kicked 4 times by a donkey or punched in the arm. It is like the patient has a Pop Eye Arm. There is a red spot where she was injected. The patient is also weak and tired. Other than the tetanus shot this is the worst thing that has ever happened to the her. The patient was told that if she is having this reaction then she is afraid of getting the second shot. The patient has given childbirth twice naturally and that was nothing compared to this. The patient still can't lift her arm, she feels like she has been shot with a gun, the bone marrow almost hurt. It is hard to say with the patient feeling weak and tired, she is pretty active at work and it was hot outside. The patient can't move her left arm. The patient had to call out of work today because it just wasn't happening ,can't sleep on her left side and has been tossing and turning. She stated when she woke up from the bed in the morning that couldn't lift her arm after receiving the vaccination and pain is an 8.5 on a scale of 1-10, she had taken Advil she stated that it didn't worked she bought the medication 5 weeks ago and product was described as Equate Ibuprofen, a bottle of 500 because of the reaction she was afraid to take the second dose of vaccination . Treatment was given for swelling, redness, pain in arm as Advil and ice. The outcome of the events asthenia, fatigue was not recovered and for all other events unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Bone pain, Erythema, Fatigue, Hypokinesia
Clinical narrative: the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in Arm Left on 17Jun2021 15:20 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR,lot number OME2586A, expiry date Oct 2022) taken for an unspecified indication, start and stop date were not reported. The patient reported that her left arm got swollen, very red, and very painful after the first dose of the Pfizer BioNTech covid 19 vaccine yesterday,17Jun2021. The patient second dose is scheduled for 08Jul2021. She took Advil at 3:00 am and iced her arm and then the pain proceeded to run down her arm into her shoulder blade, the left side of her neck, and down into her left hand. The patient feels like she was kicked 4 times by a donkey or punched in the arm. It is like the patient has a Pop Eye Arm. There is a red spot where she was injected. The patient is also weak and tired. Other than the tetanus shot this is the worst thing that has ever happened to the her. The patient was told that if she is having this reaction then she is afraid of getting the second shot. The patient has given childbirth twice naturally and that was nothing compared to this. The patient still can't lift her arm, she feels like she has been shot with a gun, the bone marrow almost hurt. It is hard to say with the patient feeling weak and tired, she is pretty active at work and it was hot outside. The patient can't move her left arm. The patient had to call out of work today because it just wasn't happening ,can't sleep on her left side and has been tossing and turning. She stated when she woke up from the bed in the morning that couldn't lift her arm after receiving the vaccination and pain is an 8.5 on a scale of 1-10, she had taken Advil she stated that it didn't worked she bought the medication 5 weeks ago and product was described as Equate Ibuprofen, a bottle of 500 because of the reaction she was afraid to take the second dose of vaccination . Treatment was given for swelling, redness, pain in arm as Advil and ice. The outcome of the events asthenia, fatigue was not recovered and for all other events unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: the bone marrow almost hurts; The caller can't move her left arm; Weak and tired; Weak and tired; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; her left arm, it got swollen, very red and very painful; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0217) via an unspecified route of administration, administered in Arm Left on 17Jun2021 15:20 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR,lot number OME2586A, expiry date Oct 2022) taken for an unspecified indication, start and stop date were not reported. The patient reported that her left arm got swollen, very red, and very painful after the first dose of the Pfizer BioNTech covid 19 vaccine yesterday,17Jun2021. The patient second dose is scheduled for 08Jul2021. She took Advil at 3:00 am and iced her arm and then the pain proceeded to run down her arm into her shoulder blade, the left side of her neck, and down into her left hand. The patient feels like she was kicked 4 times by a donkey or punched in the arm. It is like the patient has a Pop Eye Arm. There is a red spot where she was injected. The patient is also weak and tired. Other than the tetanus shot this is the worst thing that has ever happened to the her. The patient was told that if she is having this reaction then she is afraid of getting the second shot. The patient has given childbirth twice naturally and that was nothing compared to this. The patient still can't lift her arm, she feels like she has been shot with a gun, the bone marrow almost hurt. It is hard to say with the patient feeling weak and tired, she is pretty active at work and it was hot outside. The patient can't move her left arm. The patient had to call out of work today because it just wasn't happening ,can't sleep on her left side and has been tossing and turning. She stated when she woke up from the bed in the morning that couldn't lift her arm after receiving the vaccination and pain is an 8.5 on a scale of 1-10, she had taken Advil she stated that it didn't worked she bought the medication 5 weeks ago and product was described as Equate Ibuprofen, a bottle of 500 because of the reaction she was afraid to take the second dose of vaccination . Treatment was given for swelling, redness, pain in arm as Advil and ice. The outcome of the events asthenia, fatigue was not recovered and for all other events unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.