chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breast atrophy, Breast disorder, Inappropriate schedule of product administration, Nipple disorder, SARS-CoV-2 test
Clinical narrative: My breasts both became very loose and soft changing in texture; My breasts both became very loose and soft changing in texture and reduced size.; Chest skin changed to white; As well as my nipples and surrounding tissues shrank in size and length; Tissues shrank in size and length; BNT162b2 Dose 2 was administered outside the window period of 19-42 days after Dose 1; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 51-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in left arm, administration date 31Dec2021 at 16:00 (Lot number: unknown) at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "Long COVID" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing) and "Milk allergy" (unspecified if ongoing), notes: Known allergies: Dairy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 14:00), administration date: 01Oct2021, when the patient was 50 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Dec2021 at 16:00, outcome "unknown", described as "BNT162b2 Dose 2 was administered outside the window period of 19-42 days after Dose 1"; BREAST DISORDER (non-serious) with onset 03Jan2022, outcome "not recovered", described as "My breasts both became very loose and soft changing in texture"; BREAST ATROPHY (non-serious) with onset 03Jan2022, outcome "not recovered", described as "My breasts both became very loose and soft changing in texture and reduced size"; SKIN DISCOLOURATION (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Chest skin changed to white"; NIPPLE DISORDER (non-serious) with onset 03Jan2022, outcome "not recovered", described as "As well as my nipples and surrounding tissues shrank in size and length"; SOFT TISSUE ATROPHY (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Tissues shrank in size and length". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast disorder, breast atrophy, skin discoloration, nipple disorder and soft tissue atrophy.  Additional Information: The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Soft tissue atrophy
Clinical narrative: My breasts both became very loose and soft changing in texture; My breasts both became very loose and soft changing in texture and reduced size.; Chest skin changed to white; As well as my nipples and surrounding tissues shrank in size and length; Tissues shrank in size and length; BNT162b2 Dose 2 was administered outside the window period of 19-42 days after Dose 1; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 51-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in left arm, administration date 31Dec2021 at 16:00 (Lot number: unknown) at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "Long COVID" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing) and "Milk allergy" (unspecified if ongoing), notes: Known allergies: Dairy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm, Administration time: 14:00), administration date: 01Oct2021, when the patient was 50 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Dec2021 at 16:00, outcome "unknown", described as "BNT162b2 Dose 2 was administered outside the window period of 19-42 days after Dose 1"; BREAST DISORDER (non-serious) with onset 03Jan2022, outcome "not recovered", described as "My breasts both became very loose and soft changing in texture"; BREAST ATROPHY (non-serious) with onset 03Jan2022, outcome "not recovered", described as "My breasts both became very loose and soft changing in texture and reduced size"; SKIN DISCOLOURATION (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Chest skin changed to white"; NIPPLE DISORDER (non-serious) with onset 03Jan2022, outcome "not recovered", described as "As well as my nipples and surrounding tissues shrank in size and length"; SOFT TISSUE ATROPHY (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Tissues shrank in size and length". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast disorder, breast atrophy, skin discoloration, nipple disorder and soft tissue atrophy.  Additional Information: The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: My hair has thinned out (loss of volume) and I have excessive hair loss. This was not an issue priori to receiving the vaccines.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 16Sep2021 (Lot number: EW0164) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Food allergy" (unspecified if ongoing), notes: Known allergies: sunflower seeds. Concomitant medication included: VENTOLIN. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: Known allergies: amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EL0164, Anatomical Location: Right arm), administration date: 26Aug2021, for COVID-19 immunisation.  The following information was reported: ALOPECIA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "My hair has thinned out (loss of volume) and I have excessive hair loss. This was not an issue prior to receiving the vaccines". Therapeutic measures were not taken as a result of alopecia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID breakthrough case; COVID breakthrough case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162B2 (BNT162B2), intramuscular, administered in arm right, administration date 15Oct2021 09:00 (Lot number: EW0217) at the age of 52 years as dose 3 (booster), single; intramuscular, administered in arm left, administration date 16Feb2021 09:00 (Lot number: EN5318) at the age of 51 years as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 10:00 (Lot number: EN5318) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history. The patient has no known allergies. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ADVIL [IBUPROFEN]. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient had no history of COVID-19 prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022 12:00, outcome "recovering" and all described as "COVID breakthrough case". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2022) negative, notes: Nasal Swab; (14Jan2022) negative, notes: Nasal Swab; (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Immunisation, Vaccination site pruritus
Clinical narrative: My left arm around the injection spot was itchy for 3 days; My left underarm was sore and tender, it felt as if there were a few bumps; My left underarm was sore and tender, it felt as if there were a few bumps; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 (Lot number: FJ1620) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FA6780; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 28Jun2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FA7484; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 26Jul2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PRURITUS (non-serious) with onset 15Jan2022, outcome "recovering", described as "My left arm around the injection spot was itchy for 3 days"; AXILLARY PAIN (non-serious), AXILLARY MASS (non-serious) all with onset 15Jan2022, outcome "recovering", and all described as "My left underarm was sore and tender, it felt as if there were a few bumps". Therapeutic measures were not taken as a result of vaccination site pruritus, axillary pain and axillary mass.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was also reported that the patient did some research on people who had experienced some lymph node swelling following the vaccine or booster. That was something not discussed as a side effect. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Oropharyngeal pain, SARS-CoV-2 test, Sneezing
Clinical narrative: got COVID; got COVID; sore throat; sneezing; third (booster) dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EP7534 expiry information not provided) as a single dose in the left arm on 22Feb2021 (at 22-years-old); the second dose of intramuscular BNT162B2 (solution for injection; Lot EP7534 expiry information not provided) as a single dose in the left arm on 17Mar2021 (at 22-years-old); and a third (booster) dose of intramuscular BNT162B2 (solution for injection; Lot FF8839 expiry information not provided) as a single dose in the left arm on 13Oct2021 (at 23-years-old). The patient had no medical history nor any known allergies. The patient denied being diagnosed with COVID-19 prior to receiving the vaccines. The patient denied receiving any other vaccine within four weeks of these vaccines or any other medications within two weeks; the patient was not pregnant at the time of vaccine. The patient reported that on 31Dec2021 she got COVID with mild symptoms of sore throat and sneezing. A SARs-COV2 nasal swab was positive on 31Dec2021. There was no treatment received for the events. The outcome of the events was recovered on unspecified dates.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: got COVID; got COVID; sore throat; sneezing; third (booster) dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EP7534 expiry information not provided) as a single dose in the left arm on 22Feb2021 (at 22-years-old); the second dose of intramuscular BNT162B2 (solution for injection; Lot EP7534 expiry information not provided) as a single dose in the left arm on 17Mar2021 (at 22-years-old); and a third (booster) dose of intramuscular BNT162B2 (solution for injection; Lot FF8839 expiry information not provided) as a single dose in the left arm on 13Oct2021 (at 23-years-old). The patient had no medical history nor any known allergies. The patient denied being diagnosed with COVID-19 prior to receiving the vaccines. The patient denied receiving any other vaccine within four weeks of these vaccines or any other medications within two weeks; the patient was not pregnant at the time of vaccine. The patient reported that on 31Dec2021 she got COVID with mild symptoms of sore throat and sneezing. A SARs-COV2 nasal swab was positive on 31Dec2021. There was no treatment received for the events. The outcome of the events was recovered on unspecified dates.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old adult male received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the left arm on 28Jan2021 (at 45-years-old); and the second dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the left arm on 18Feb2021 (at 46-years-old). Relevant medical history included Type 2 diabetes and no known allergies. The patient received unspecified concomitant medications. The patient denied being diagnosed with COVID-19 prior to receiving any vaccine. The patient denied receiving any other vaccine within four weeks of these vaccines. The patient reported that on 05Jan2022 he tested positive for COVID-19. The patient explained that on 04Jan2022 he underwent Covid test post vaccination with SARs-COV PCR via nasal swab which was negative and on 05Jan2022 another Covid test post vaccination with SARs-COV Antigen via nasal swab was positive. There was unspecified treatment received for the events. The outcome of the events Tested positive for Covid-19 was recovered on an unspecified date in Jan2022.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I got Covid; I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old [non-pregnant] adult female received COVID-19 immunisation with the first dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the right arm on 20Jan2021 at 15:30 (at 50-years-old); the second dose of intramuscular BNT162B2 (solution for injection; Lot EL3247 expiry information not provided) as a single dose in the right arm on 08Feb2021 at 09:30 (at 50-years-old). Relevant medical history included a known penicillin allergy. The patient denied being diagnosed with COVID-19 prior to receiving the vaccines. The patient denied receiving any other vaccine within four weeks of these vaccine or any other medications within two weeks; the patient was not pregnant at the time of vaccine. The patient reported that on 30Dec2021 she got COVID which required a visit to doctor or other healthcare professional office /clinic. A SARs-COV2 nasal swab was positive on 31Dec2021. There was no treatment received for the events. The outcome of the events COVID was recovering.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got last year I got so sick from I was in the hospital for 2 weeks; Initial information received on 09-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp via Social media.  This case involves an unknown age and gender patient who reported got last year I got so sick from I was in the hospital for 2 weeks, while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported no and he/she will never do it again, the one he/she got last year he/she got so sick from was in the hospital for 2 weeks (illness) (unknown latency). The patient was hospitalized for this event during 14 days.  Action taken: Not applicable   It was not reported if the patient received a corrective treatment for the event (got last year I got so sick from I was in the hospital for 2 weeks).  At time of reporting, the outcome was Unknown for the event got last year i got so sick from i was in the hospital for 2 weeks.; Sender's Comments: Sanofi company comment dated 17-Jan-2022: This case concerns a patient who had hospitalization, after treated with Influenza vaccine. The time to onset is compatible with the role of the vaccine. However the lack of information regarding past drugs, relevant medical history, concurrent conditions, demographics, personal history, therapy details, latency and concomitant medications precludes a comprehensive assessment of this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Bell's palsy, Illness, Unevaluable event
Clinical narrative: bells palsy; blown up; Worst sickness; Initial information received from on 11-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves patient of unknown demographics who had Bell's palsy, blown up and worst sickness while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date were unknown) for prophylactic vaccination.  It was reported patient had worst sickness (illness), other than being blown up (unevaluable event) or having Bell's palsy (onset and latency: unknown).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: unknown  Seriousness criteria: medically significant for event bell's palsy and unevaluable event.; Sender's Comments: Sanofi company comment dated 11-Jan-2022: This case concerns patient of unknown demographics who had bell's palsy, unevaluable event with Influenza Vaccine (unknown manufacturer). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: F
Vaccine: DTAP
Symptoms: Lethargy
Clinical narrative: was lethargic for like a week; Initial information received on 11-Jan-2022 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who was lethargic for like a week after receiving vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "was lethargic for like a week" (lethargy) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (was lethargic for like a week).  At time of reporting, the outcome was Unknown for the event was lethargic for like a week.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: so sick; Initial information received on 11-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an Adult patient (unknown gender, age) who was so sick while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; route, strength, formulation: unknown) in unknown administration site as prophylactic vaccination (Flu vaccination).  On an unknown date the patient developed a non-serious event "so sick (illness)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on the Sanofi flu shot, we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I have had one flu shot it made me so sick I had to go get a shot to get over it never again that was in the early 90s. It is unknown if the patient experienced any additional symptoms/events".   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was unknown.  It was not reported if the patient received a corrective treatment for the event (so sick).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event so sick.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Epstein-Barr virus infection
Clinical narrative: Epstein Barr; covid 19; Initial information received from on 10-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age and unknown gender patient who had epstein barr and covid 19 while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 2019, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for immunization.  On an unknown date the patient had epstein barr (epstein-barr virus infection) (unknown latency). This event was assessed as medically significant.  On an unknown date in Mar-2020 the patient had covid 19 (covid-19)  (latency: few months approximately).  There were no lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Recovering for the event epstein barr and was Unknown for the event covid 19.; Sender's Comments: Sanofi Company comment dated 19-Jan-2022: This case involves an unknown age and unknown gender patient who had epstein barr while receiving vaccine INFLUENZA VACCINE. The event was assessed as medically significant. Further information regarding patient's medical condition at the time of vaccination, previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Dizziness, Flushing
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient felt weak, fainted once, slumped over in his chair forward, woke back up, was complaining of not being able to see, could only see maybe 2% of visual field, per patient. Paramedics showed up, he fainted again.  Pulse of 47, and O2 sats of 95.   Paramedics were leaning towards panic attack, but recommended patient go to ER just to be sure.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hyperventilation, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient felt weak, fainted once, slumped over in his chair forward, woke back up, was complaining of not being able to see, could only see maybe 2% of visual field, per patient. Paramedics showed up, he fainted again.  Pulse of 47, and O2 sats of 95.   Paramedics were leaning towards panic attack, but recommended patient go to ER just to be sure.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Mass
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient says after receiving the vaccine he received a lump on arm which resulted in pus coming out of the wound. Patient said it was itching and swollen and led to open wound that was leaking pus. After observing patient's arm, I think it was not due to incorrect administration but skin reaction. Also unsure if patient even received vaccination at that spot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Purulent discharge, Rash, Skin reaction, Swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient says after receiving the vaccine he received a lump on arm which resulted in pus coming out of the wound. Patient said it was itching and swollen and led to open wound that was leaking pus. After observing patient's arm, I think it was not due to incorrect administration but skin reaction. Also unsure if patient even received vaccination at that spot.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient says after receiving the vaccine he received a lump on arm which resulted in pus coming out of the wound. Patient said it was itching and swollen and led to open wound that was leaking pus. After observing patient's arm, I think it was not due to incorrect administration but skin reaction. Also unsure if patient even received vaccination at that spot.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Dizziness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: patient stated that he had  a similar reaction to his first shot but not his second shot. patient says his reaction to the first shot  went away in 30 minutes after he took enough rest. patient states he works in a healthcare setting ,and he is well aware of his reactions. patient declined the use of diphenhydramine. patient's bp was 118/79,and heart rate 73 when he left the store. patient got better after 1 hour of event.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Hyperhidrosis, Lethargy, Pyrexia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: patient stated that he had  a similar reaction to his first shot but not his second shot. patient says his reaction to the first shot  went away in 30 minutes after he took enough rest. patient states he works in a healthcare setting ,and he is well aware of his reactions. patient declined the use of diphenhydramine. patient's bp was 118/79,and heart rate 73 when he left the store. patient got better after 1 hour of event.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: Fever of 102 degrees Fahrenheit
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Fever-Severe, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: Fever of 102 degrees Fahrenheit
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: Electrocardiogram, Gait disturbance, Myocardial necrosis marker, Pain in extremity, Paraesthesia
Clinical narrative: Severe swelling and pain in left arm, tingling in all extremities, pain worse at night, affecting ambulating
Age: 54.0
Sex: F
Vaccine: FLUA4
Symptoms: Peripheral swelling
Clinical narrative: Severe swelling and pain in left arm, tingling in all extremities, pain worse at night, affecting ambulating
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt reports getting very anxious around needles and cautioned immunizer about history of getting dizzy/fainting with previous vaccines. About 5 minutes after vaccine was given, pt was feeling faint, dizzy and nauseous. Had patient lay on the floor and position her legs upright on a chair. She laid down for ~5 minutes and felt better. Pt did not fully lose consciousness. Did not want me to inform primary care doctor about situation because this is not a new phenomenon for her.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Disorientation, Eye movement disorder, Loss of consciousness, Pallor
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: After administering Fluzone & Moderna Booster, Patient became clammy & pale. His eyes rolled back in his head & he lost consciousness. He emptied his bladder while unconscious & was unresponsive for approximately 30 seconds.  I held him up by his shoulders as he was rolling forward so he would not fall out of the chair or hit his head.  I shook his shoulder several times & shouted his name to rouse him.  He came to and was disoriented.  EMS came and evaluated him and released him to go home.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: After administering Fluzone & Moderna Booster, Patient became clammy & pale. His eyes rolled back in his head & he lost consciousness. He emptied his bladder while unconscious & was unresponsive for approximately 30 seconds.  I held him up by his shoulders as he was rolling forward so he would not fall out of the chair or hit his head.  I shook his shoulder several times & shouted his name to rouse him.  He came to and was disoriented.  EMS came and evaluated him and released him to go home.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient returned to pharmacy 3 days after vaccine to report 1 x 2 inch red/swollen/painful area below the vaccination area. Started 1 day after vaccination administration and worst on 2nd day after, starting to improve but not resolved on day 3.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves  patient of unknown demographics who had flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"The worst case of flu I ever got was the year a got the flu shot."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reported appreciable lightheadedness within 2 minutes of receiving vaccination. Provided water from emergency kit and crackers at patient request. She later reported feeling better especially after consuming water.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Hypoacusis, Tinnitus
Clinical narrative: Extreme tiredness for two weeks after booster. Ear ringing much worse (I have tinnitus anyway). Distortion of hearing for about three days. Hearing distortions have resolved but ringing persists worse than it was before the booster.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong vaccine formulation (ex. different manufacturer initial and booster).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Intermittent moderate abdominal pain in upper right quadrant below rib cage.  Would come and go for first few weeks then became more consistent and severe.  Was examined by my primary care physician and no findings.  Pain is now more severe so will go back for re-check and possibly imaging.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis, Bedridden, Blood creatinine normal, Blood sodium increased, CSF glucose increased
Clinical narrative: Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: CSF lymphocyte count increased, CSF oligoclonal band absent, CSF red blood cell count, Cognitive disorder, Condition aggravated
Clinical narrative: Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Demyelination, Dysstasia, Fall, Fatigue
Clinical narrative: Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fine motor skill dysfunction, Gait disturbance, Headache, Hyponatraemia, Laboratory test normal
Clinical narrative: Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Lumbar puncture abnormal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Plasmapheresis
Clinical narrative: Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Speech disorder
Clinical narrative: Still currently hospitalized for Acute Disseminated Encephalomyelitis. Began with a fever, headache, and profound fatigue 1 week following Moderna booster. Only previous reaction to other COVID vaccines were generalized mild fatigue and fever. After 3 days of profound fatigue, HA, and fever, sought medical care via PCP. Placed on Omnicef for 7 days with noted worsening of the symptoms. Over this time, neuro findings were developing (lack of coordination, leg dragging, decreased coordination of fine motor skills). By the 3rd week of December, pt basically confined to bed as walking without assistance is now impossible. Cognition slowing and speech becoming unintelligible. Neurology cancelled appt that same week. Took pt to the ER on Jan 1st due to series of falls, unable to stand, speech issues, and slowed cognition. MRI showed significant demyelination in the midbrain, thalamus, cerebellar pons, tentorium, in the periventriculat white matter. Transferred at the General Hospital neuro demyelination team. He has now been there 3 weeks, tried high dose Solu Medrol, and now doing plasmapheresis, with continued worsening of the symptoms, as well as interval worsening of the MRI of both the brain, and now with demyelination along the spinal column. Significant concern for vaccine-mediated ADEM with continued worsening of symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, COVID-19, Computerised tomogram thorax abnormal, Diarrhoea
Clinical narrative: Covid19 breakthrough. 1st vaccine received on 03/08/2021. 45 y/o with recent diagnosis of Rectal Cancer, port placement and planning to initiate chemo. Patient presents to ED with 4 day HX of generalized weakness, abdominal pain, N/V/D, dizziness, SOB, rash on left side of ribs (shingles). CT chest-viral PNA and moderate pericardial effusion.  Of note, patient received Covid booster 10 days ago. Treating with steroids.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Herpes zoster, Nausea, Pericardial effusion
Clinical narrative: Covid19 breakthrough. 1st vaccine received on 03/08/2021. 45 y/o with recent diagnosis of Rectal Cancer, port placement and planning to initiate chemo. Patient presents to ED with 4 day HX of generalized weakness, abdominal pain, N/V/D, dizziness, SOB, rash on left side of ribs (shingles). CT chest-viral PNA and moderate pericardial effusion.  Of note, patient received Covid booster 10 days ago. Treating with steroids.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia viral, Rash, SARS-CoV-2 test positive, Vaccine breakthrough infection, Vomiting
Clinical narrative: Covid19 breakthrough. 1st vaccine received on 03/08/2021. 45 y/o with recent diagnosis of Rectal Cancer, port placement and planning to initiate chemo. Patient presents to ED with 4 day HX of generalized weakness, abdominal pain, N/V/D, dizziness, SOB, rash on left side of ribs (shingles). CT chest-viral PNA and moderate pericardial effusion.  Of note, patient received Covid booster 10 days ago. Treating with steroids.