chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Deformity, Diarrhoea, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the arm left on 19Apr2021 at 16:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical histories were reported as none. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the arm left on 28Mar2021 at 16:15(at the age of 42-year-old) as a single dose for COVID-19 immunisation. 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. On 03May2021 at 19:00, the patient experienced bad tummy ache, diarrhea, felt like she was about to faint, then legs went numb and felt weird all over and then her hands started to curl up like a ball. It went away after 5-10 minutes. The patient reported that she had been hurting in the shoulder (right arm) since she got the second dose, and it was hard to lift up and put a shirt on. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hands started to curl up like a ball was recovered on 03May2021(after 5-10 minutes), while that of bad tummy ache, diarrhea, felt like faint, numbness in legs, weird feeling and shoulder pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: To amend 1. Relevant history captured as none. 2. Treatment received ticked No for the events. 3. Description as reported for felt like faint updated to felt like I was about to faint. 4. "The patient did not receive any treatment for the events" and "The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care" added in narrative. "Felt like faint, numbness in legs, weird feeling, shoulder hurting (shoulder pain) and hands started to curl up like a ball" updated to "felt like she was about to faint, then legs went numb and felt weird all over and then her hands started to curl up like a ball. It went away after 5-10 minutes." in narrative.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the arm left on 19Apr2021 at 16:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical histories were reported as none. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the arm left on 28Mar2021 at 16:15(at the age of 42-year-old) as a single dose for COVID-19 immunisation. 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. On 03May2021 at 19:00, the patient experienced bad tummy ache, diarrhea, felt like she was about to faint, then legs went numb and felt weird all over and then her hands started to curl up like a ball. It went away after 5-10 minutes. The patient reported that she had been hurting in the shoulder (right arm) since she got the second dose, and it was hard to lift up and put a shirt on. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hands started to curl up like a ball was recovered on 03May2021(after 5-10 minutes), while that of bad tummy ache, diarrhea, felt like faint, numbness in legs, weird feeling and shoulder pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: To amend 1. Relevant history captured as none. 2. Treatment received ticked No for the events. 3. Description as reported for felt like faint updated to felt like I was about to faint. 4. "The patient did not receive any treatment for the events" and "The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care" added in narrative. "Felt like faint, numbness in legs, weird feeling, shoulder hurting (shoulder pain) and hands started to curl up like a ball" updated to "felt like she was about to faint, then legs went numb and felt weird all over and then her hands started to curl up like a ball. It went away after 5-10 minutes." in narrative.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Back pain, Fatigue, Headache, Nausea
Clinical narrative: Loss of taste; Back pain; neck pain; Fatigue; Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history was reported as The patient had allergy to penicillins.  The patient did not receive other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 08:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 09:00 the patient experienced loss of taste, back and neck pain, fatigue, headaches and nausea. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 28Apr2021 and on 03May2021, the patient underwent COVID-19 PCR tests (nasal swab) and the results were negative. The clinical outcome of the events loss of taste, back and neck pain, fatigue, headaches and nausea were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated treatment received as no and medical history data.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, SARS-CoV-2 test
Clinical narrative: Loss of taste; Back pain; neck pain; Fatigue; Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history was reported as The patient had allergy to penicillins.  The patient did not receive other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 08:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 09:00 the patient experienced loss of taste, back and neck pain, fatigue, headaches and nausea. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 28Apr2021 and on 03May2021, the patient underwent COVID-19 PCR tests (nasal swab) and the results were negative. The clinical outcome of the events loss of taste, back and neck pain, fatigue, headaches and nausea were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated treatment received as no and medical history data.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Flat rash at injection site
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness, Pain, Sleep disorder, Urine analysis
Clinical narrative: Extreme lower back pain. It?s a deep, dull ache and tightening of the muscles that has not relented for over a month now. It prevents sleep at times. No traditional muscle pain-relieving remedies have helped.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: Extreme lower back pain. It?s a deep, dull ache and tightening of the muscles that has not relented for over a month now. It prevents sleep at times. No traditional muscle pain-relieving remedies have helped.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative, Tonsillar hypertrophy
Clinical narrative: Has had enlarged tonsils since receiving the second dose of the Pfizer COVID-19 vaccine diagnosed multiple times by urgent care, general practitioner and EMT.  Has been tested multiple times for strep (negative) and Mono/Epstein-Barr (also negative).  Never had swollen tonsils before.  Not improving.  Will likely have to have them removed.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash /itching on feet, hands , groin torso area , arm pits
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Nasal congestion
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/12/2021.  73 y/o with PMHx of HTN, CVA, CKD, and gout presents to ED with c/o nasal congestion, cough, fatigue and fever.  Pt tested Covid + in office and was advised to the ED for increased SOB and labored breathing.  Pt febrile, placed on O2 2L NC, pt states feels better.  Treated with steroids.  Remdesivir held due to kidney fx.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal impairment, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/12/2021.  73 y/o with PMHx of HTN, CVA, CKD, and gout presents to ED with c/o nasal congestion, cough, fatigue and fever.  Pt tested Covid + in office and was advised to the ED for increased SOB and labored breathing.  Pt febrile, placed on O2 2L NC, pt states feels better.  Treated with steroids.  Remdesivir held due to kidney fx.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Disorientation, Disturbance in attention, Headache, Injection site pain
Clinical narrative: Headache, body aches, nausea,  injection site soreness, congestion, loss of appetite, disorientation, lack of concentration, insomnia.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Respiratory tract congestion
Clinical narrative: Headache, body aches, nausea,  injection site soreness, congestion, loss of appetite, disorientation, lack of concentration, insomnia.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Frequent bowel movements, Tinnitus
Clinical narrative: Tinnitus--ringing in ears--constant-- Increased bowel movements--multiple times a day--was normal prior to booster shot
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Ringing in ears and hearing loss in left ear, Some hearing has returned but ringing has remained and is much worse than prior to the vaccine.  Right ear ringing has reduced substantially but is worse than prior to the vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Pyrexia, Tachycardia
Clinical narrative: 101 degree Fahrenheit Fever, malaise, tachycardia, dizziness, fatigue.  Experienced when alarm sounded at 6:00am the day after receiving the COVID-19 Vax injection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Basophil count decreased, Basophil percentage decreased, Blood bicarbonate normal, Blood chloride normal
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Calcium ionised, Differential white blood cell count, Electrocardiogram abnormal, Eosinophil count decreased, Eosinophil percentage decreased
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal, Headache
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin concentration normal
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell volume normal, Metabolic function test, Monocyte count decreased, Monocyte percentage, Myocardial injury
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neutrophil count increased, Neutrophil percentage increased, Pain assessment, Platelet count normal
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count normal, Red cell distribution width normal, Sinus tachycardia, Tachycardia, Troponin decreased
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: on 1/6/2022 Pt woke up with Nausea and headache. Pt has week of nausea and headache after dose 2 of moderna the previous year. around 10 am Pt used pulse ox to check HR/O2 due to feeling unwell.  HR was 132 sitting and jumped to 148 when standing. Pt drank fluids and went to lie down. After about an hour of rest hr was 105 laying down, 108 -112 sitting 133 standing  and still had Headache. After remaining up for a while HR stayed at 127 when sitting. Pt called PCP. PCP office advised to go to urgent care. Upon arrival to Urgent care EKG showed Snus Tachycardia with HR 134. Postural testing showed HR of 157 standing.  Fluid given repeated HR done.   Continued Tachycardia on 1/7/2022 and 1/8/2022 at a lower HR.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Erythema, Menstruation irregular, Rosacea
Clinical narrative: Following an endometrial ablation and absolutely no menstrual bleeding for 14 months, I started my period the night of the second Pfizer vaccine and am now dealing with period cylces about 25 days apart lasting 17-18 days.  Blood/hormone tests and biopsy have revealed no reason for this.  While I am a woman of perimenopausal age, I suspect the vaccine has played a part in this.  Almost as concerning is the fact that I have developed Rosacea that started a few days after the second vaccine.  Never had skin problems in my life.  Face is bright red.  Was most pronounced mid- to late-May 2021.  No topical treatments from dermatologist have worked.  Dermatologist noted they have seen an uptick in skin inflammation and Rosacea since vaccine became available.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Pt awoke with severe headache, nausea, chills (hot/cold spikes) and exceptional neck stiffness. More mild (but significant) sx were injection site pain and distributed body pain. Pt had only mild sx for injections 1 and 2, which were also Pfizer from this clinic. It is worth noting 2 other Pts in the family went to the same clinic at the same time and received doses from the same lot without any significant sx.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pt awoke with severe headache, nausea, chills (hot/cold spikes) and exceptional neck stiffness. More mild (but significant) sx were injection site pain and distributed body pain. Pt had only mild sx for injections 1 and 2, which were also Pfizer from this clinic. It is worth noting 2 other Pts in the family went to the same clinic at the same time and received doses from the same lot without any significant sx.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose has been given for a booster vaccine. They were given a dose of 0.5mL instead of 0.3mL
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Wrong dose has been given for a booster vaccine. They were given a dose of 0.5mL instead of 0.3mL
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Musculoskeletal stiffness, Seizure, Tremor, Unresponsive to stimuli
Clinical narrative: My daughter had a seizure it lasted around 5 minutes. Her body became stiff and her hands were curled and her hands were shaking. After a few minutes, she opened her eyes but was unresponsive. She kept sleeping and around 2 am she yelled in her sleep and started to shake briefly again. She fell back asleep and I scheduled an appointment with her provider.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive a second dose of Janssen vaccine as a booster. A dose of Pfizer was given instead. Patient was told to contact us with any adverse events or symptoms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Intensive care, Night sweats
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 01/26/2021.  75 y/o with PMHX of myasthenias gravis, Whipple, pancreatitis, HLD Gerd took a home Covid test on 12/30 that was positive.  Pt attempted to treat self at home but presented to ER when home O2sat 88%.  Upon arrival, room air sat 69% and pt c/o fever, body aches, cough, congestion, chills, night sweats.  Pt placed on BIPAP and admitted to ICU.  Started IV steroids, Remdesivir and Tocilizumab.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Positive airway pressure therapy, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 01/26/2021.  75 y/o with PMHX of myasthenias gravis, Whipple, pancreatitis, HLD Gerd took a home Covid test on 12/30 that was positive.  Pt attempted to treat self at home but presented to ER when home O2sat 88%.  Upon arrival, room air sat 69% and pt c/o fever, body aches, cough, congestion, chills, night sweats.  Pt placed on BIPAP and admitted to ICU.  Started IV steroids, Remdesivir and Tocilizumab.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 01/26/2021.  75 y/o with PMHX of myasthenias gravis, Whipple, pancreatitis, HLD Gerd took a home Covid test on 12/30 that was positive.  Pt attempted to treat self at home but presented to ER when home O2sat 88%.  Upon arrival, room air sat 69% and pt c/o fever, body aches, cough, congestion, chills, night sweats.  Pt placed on BIPAP and admitted to ICU.  Started IV steroids, Remdesivir and Tocilizumab.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph node in armpit or left arm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Facial pain, Trigeminal neuralgia
Clinical narrative: I have a history of Trigeminal Neuralgia that is chronic, however after about 30 hours after getting the Moderna Booster, (previously had Pfizer) I have a severe flair of the condition. Normally has mild to no symptoms, and now I have severe pain to right side of face.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Muscle rigidity, Musculoskeletal stiffness, Nausea, Paraesthesia
Clinical narrative: Approximately 5 minutes following his vaccine, patient began signs of fainting or possible seizure activity due to rigid body, slurred speech, neck stiffening, tingling in fingers, nausea. this lasted approximately 10 minutes. 911 was immediately called. Patient was accessed and had a heart rate of 50 and a blood pressure of 96. It was recommended that he go to the hospital for an evaluation.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Approximately 5 minutes following his vaccine, patient began signs of fainting or possible seizure activity due to rigid body, slurred speech, neck stiffening, tingling in fingers, nausea. this lasted approximately 10 minutes. 911 was immediately called. Patient was accessed and had a heart rate of 50 and a blood pressure of 96. It was recommended that he go to the hospital for an evaluation.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Injection site haemorrhage, Injection site pain, Injection site swelling, Muscle swelling
Clinical narrative: Swelling of face with itchyness that lasted for about 4 hours.  Bleeding at injection site that lasted for about an hour.  Pain from injection site to fingertips on and off for about 24 hours - mainly when heart rate was elevated.  Swelling at injection site of muscle was pronounced for about 48 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Swelling face
Clinical narrative: Swelling of face with itchyness that lasted for about 4 hours.  Bleeding at injection site that lasted for about an hour.  Pain from injection site to fingertips on and off for about 24 hours - mainly when heart rate was elevated.  Swelling at injection site of muscle was pronounced for about 48 hours.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Diarrhoea, Menstruation delayed, Pain in extremity
Clinical narrative: Was diagnosed positive with Covid 3 days after receiving vaccine Extreme pain in left shoulder and arm for 4 weeks Excessive diarrhea for 2 months Delay in mensural cycle for 2 months
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, rash, face numbing, bruising, headache
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Muscle aches, fever, rash, face numbing, bruising, headache
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular periods
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received adult Pfizer dose instead of pediatric dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump developing in armpit 2 days following vaccine
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: she booked on-line for Pfizer vaccine and pharmacy was out of Pfizer and she received Modena for booster shot.  we contacted her family the next day and they were satisfied with the shot.  we also called the family doctor left msg.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Hypoaesthesia oral, Influenza, Lip swelling
Clinical narrative: Numbing sensation in lips with slight swelling, and higher blood pressure for about an hour and half after injection.  Again swelling and itchy face about 4 hours after shot.  Swelling in the arm muscles lasted for about 48 hours.  Flu symptoms started about 24 hours after shot and lasted for about 72 hours from that point: nausea, aches and chills fever.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Numbing sensation in lips with slight swelling, and higher blood pressure for about an hour and half after injection.  Again swelling and itchy face about 4 hours after shot.  Swelling in the arm muscles lasted for about 48 hours.  Flu symptoms started about 24 hours after shot and lasted for about 72 hours from that point: nausea, aches and chills fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: Headache, body aches, chills, dizziness,  soreness and swelling at injection site
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Headache, body aches, chills, dizziness,  soreness and swelling at injection site
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Headache, Pain in extremity
Clinical narrative: Booster shot. 4 days after normal arm pain and head ache  symptoms began to subside chest tightness developed associated with what appeared to be an anxiety attack from the symptoms despite no triggers for an anxiety attack. This shortness of breath lasted 1 week from the onset and appears to have subsided with sole time of shortness of breath in the morning.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling abnormal, Loss of personal independence in daily activities, Pain in extremity, Vomiting
Clinical narrative: Vomited once, temp rose during the day to 100F, sore arm, felt generally bad, missed school
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Chills, Dizziness, Pruritus
Clinical narrative: lump on left arm; Itching all over; Light headed; Aching joints; Chills; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old non-pregnant female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1070) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, sjogren's syndrome and asthma.  Patient had many allergies to food and drugs including flu shots. Concomitant medications included loratadine (CLARITIN), guaifenesin (MUCINEX), insulin human zinc suspension (HUMULIN U-500), empagliflozin (JARDIANCE) and mirtazapine (MIRAP), all from unknown dates for unknown indications. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. 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. On 28Apr2021 at 14:30, the patient experienced itching all over, lump on left arm, light headed, aching joints and chills. Its reported that patient had lump on left arm lasting 7 days (still detectable), itching all over responded to CLARITIN/antihistamine treatment lasted 3 days, light headed lasted 2 days, aching joints 3 days, and chills lasted for 1 day. Therapeutic measures were taken as a result of the event itching all over and included treatment with CLARITIN/antihistamine treatment on an unknown date. The clinical outcome of the event of itching all over  was recovered on 01May2021. The clinical outcome of the event of lump on left arm was recovering at the time of this report. The clinical outcome of the event of chills was recovered on 29Apr2021. The clinical outcome of the event of light headed was recovered on 30Apr2021. The clinical outcome of the event of  aching joints was recovered on 01May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated event data (Treatment Received selected as Yes and event onset time updated be 2:30pm; duration and stop date/time updated for events).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Injection site discolouration
Clinical narrative: Hands turned blue like they were not getting any circulation; hands turned blue like they were not getting any circulation/to the touch, the skin color would change. The left hand was worse, it's where the injection site was; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 01May2021 at 09:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 18:00 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. 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. On 02May2021 at 03:00, the patient's hands turned blue like they were not getting any circulation but they were getting because when touched, could see that the skin color would change. The left hand was worse, at the injection site. There was no treatment received for the events. The clinical outcome of the events cyanosis and injection site discoloration was recovered on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Treatment received updated to No.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Patches of red hives on my body. Hives are located on my legs, stomach, hips, ribs, back, chest, neck, arms, and hands/fingers .; Patches of red hives; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 02May2021 at 13:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (ALTAVERA); on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 at 08:00, the patient experienced patches of red hives on body. Hives were located on legs, stomach, hips, ribs, back, chest, neck, arms, and hands/fingers. The patient did not receive any treatment for the events. The clinical outcome of patches of red hives on body and hives located on legs, stomach, hips, ribs, back, chest, neck, arms, and hands/fingers were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated treatment received as no for events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial pain, Pain, Pyrexia, Swelling face
Clinical narrative: Sore arm at injection site; Low grade fever; Body aches; Sore face along jawline and cheekbones 12-24hrs after injection.; Swelling in face (cheekbones & side of upper right lip) 1.5 days after injection.; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0T59) via an unspecified route of administration in the left arm on 21Apr2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included filler done on face on Oct-2019. Concomitant medications were not reported. The patient previously took (sulfa) Sulfonamide. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 31Mar2021, at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 at 10:45, the patient experienced sore arm at injection site, low grade fever, ache, sore face and swelling in face. The patient reported that she had sore arm at injection site, low grade fever, chills, body aches and started sore face along jawline and cheekbones 12-24hrs after injection. Swelling in face (cheekbones & side of upper right lip) 1.5 days after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of sore arm at injection site, low grade fever, ache, sore face and swelling in face included treatment with Benadryl on an unknown date. The clinical outcome of the events sore arm at injection site, low grade fever, ache, sore face and swelling in face were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated medical history data, event (chills), vaccination facility data.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; Low grade fever; Body aches; Sore face along jawline and cheekbones 12-24hrs after injection.; Swelling in face (cheekbones & side of upper right lip) 1.5 days after injection.; Chills; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0T59) via an unspecified route of administration in the left arm on 21Apr2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included filler done on face on Oct-2019. Concomitant medications were not reported. The patient previously took (sulfa) Sulfonamide. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 31Mar2021, at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 at 10:45, the patient experienced sore arm at injection site, low grade fever, ache, sore face and swelling in face. The patient reported that she had sore arm at injection site, low grade fever, chills, body aches and started sore face along jawline and cheekbones 12-24hrs after injection. Swelling in face (cheekbones & side of upper right lip) 1.5 days after injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of sore arm at injection site, low grade fever, ache, sore face and swelling in face included treatment with Benadryl on an unknown date. The clinical outcome of the events sore arm at injection site, low grade fever, ache, sore face and swelling in face were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated medical history data, event (chills), vaccination facility data.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: she had developed swollen lymph node near her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "she developed swollen lymph nodes in her arm". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she had developed swollen lymph node near her throat". Additional information: The patient received the second dose a week ago (date cannot be confirmed). The reporter wanted to know if the adverse event could be from BNT162B2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Blood clot during menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, it was unknown whether the patient was 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. On 14May2021, the patient experienced blood clot during menstrual cycle. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blood clot during menstrual cycle was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient last name updated, patient Email Address added in patient tab, "No further information is expected." was deleted from final sentence.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable other HCP (patient). A 72-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 72, in left arm left, on Jan 30, 2021, single dose, for COVID-19 immunisation (given: 9:00). The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), at the age of 72, left arm, on Jan 13, 2021, single dose, for COVID 19 immunisation (given: 9:00); and had a reaction(s): dizziness, fever, chills and malaise. The patient experienced vaccination site pain/pain at injection site, onset Jan 30, 2021, with outcome of recovering; and vaccination site discomfort/mild discomfort at injection site, onset 2021, with outcome of unknown. No therapeutic measures taken as a result of vaccination site pain or vaccination site discomfort. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.