chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Sick with the flu; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick with the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Got the flu shot once. Sick with the flu. Not for everyone. Freedom of choice. And no thanks.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Sick for 10 days after each time with hard core flu; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick for 10 days after each time with hard core flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick for 10 days after each time with hard core flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that had to take flu shot twice once in boot camp once for a job. Sick for 10 days after each time with hard core flu. No more flu shots for patient.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: patient got flu shots every year and sometimes have a brief itchy spell after getting it; Initial information was received on 11-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown demography who received INFLUENZA VACCINE (flu shots) every year and sometimes have a brief itchy spell after getting it (pruritus).  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date (reported as every year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, sometimes the patient developed a non-serious brief itchy spell (pruritus) unknown latency following the administration of INFLUENZA VACCINE.  The patient stated that it seems to keep patient healthier by having it. Patient was a bit concerned having read recently that the vaccine contains mercury and formaldehyde and wondering why he/she need either of those in the body.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Patient got sicker than a dog; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who got sicker than a dog (illness), after patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date (year ago), the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date (year ago), the patient got sicker than a dog (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Additionally, it was reported by reporter that, patient will never take it again.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  It was reported that, patient got sicker than dog for 2 weeks but event outcome was not reported for illness at the time of reporting. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre syndrome; patient was paralised from the top of head to toes; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional via social media .   This case involves a patient of unknown age and gender who experienced Guillain-Barre syndrome and was paralyzed from the top of head to toes (paralysis), after he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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 (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain-Barre syndrome and was paralyzed from the top of head to toes (paralysis) (Unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Patient stated that  the reason she/he did not get a flu shot was it gave him/her a disease. Thank God it was temporarily. He/she would not wish this one anyone. The  Guillain-Barre syndrome can also have serious side effects after one gets well in two to three months. Patient requested to check it out and do some research before anyone got a flu shot. He/she never took the flu shot since then and that was 53 years ago. He/she wears a mask and washes hands a lot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a patient of unknown age who experienced Guillain-Barre syndrome and paralysis after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: given an expired Ipol vaccination/No AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00533472) and transmitted to Sanofi on 24-Mar-2021.  This case involves a 5 years old female patient who receive expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 15-Mar-2021, the patient received once 0.5 mL dose of suspect IPV (VERO) lot R1B25, expiry date 15-Mar-2021 via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient who was due for a dose of Menactra with no reported adverse event; Initial information with live follow up received on 25-Mar-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a female patient of unknown age who was due for a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (exposure during pregnancy).  The date of last menstrual period was not reported.  The estimated due date was not reported (unknown).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, pregnant patient who was due for a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (exposure during pregnancy).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not applicable.  There will be no information available regarding batch number in this case.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pruritus, Pain, Tremor
Clinical narrative: Chills, shaking, body aches about 12 hrs after shot.  Body aches 3 days total.  Injection site itchiness day after and continues.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Sudden vision loss  Saw retinologist, not an eye problem Saw PC doctor who ordered mri (scheduled) Have appt scheduled with cardiologist
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: After patient was vaccinated, it was discovered that there was approx 1.4 mL of vaccine left in the vial of Moderna vaccine. Eye-witness accounts from fellow staff members report that patient may not have received a full dose of the vaccine. Guidance was sought and it was recommended by CDC that this dose needs to be repeated. Pt was called and dose was repeated same day at approx 17:30.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature increased, Chills, Fatigue
Clinical narrative: I first started to feel weak and achy around 6 pm. Around 7 pm the body aches started to intensify especially in my lower back and thighs. I started to get chills and had a temperature of 102.8. The next morning I woke up with a low fever of 100 and was very tired and had a headache the rest of the day. My arm at the site of the injection was mildly sore for 3-4 days after the vaccine
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: I first started to feel weak and achy around 6 pm. Around 7 pm the body aches started to intensify especially in my lower back and thighs. I started to get chills and had a temperature of 102.8. The next morning I woke up with a low fever of 100 and was very tired and had a headache the rest of the day. My arm at the site of the injection was mildly sore for 3-4 days after the vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Janssen-Covid 19- EUA 41 yo Female who recieved single dose of Janseen lot # 180890 at approx 910 this morning.  During observation pt had no complaint of any symptoms. Pt returned to work shortly after, pt started to feel itchy on her arms, neck and back.  pt also stated more red bumps on face.  Pt states possible reaction to shrimp last month but was unaware if it was or not. Pt denied any sob,diff breathing, pt did have rash on arms and shoulders. Fire was activated. pt signed ama with Fire Department.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever 100 degrees, headache, fatigue. Fever resolved with one dose Tylenol 650mg & headache improved slightly. Headache resolved the next day after one dose  Motrin 400mg. Fatigue resolved on day two.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dry throat, Dyspnoea, Paraesthesia, Throat tightness
Clinical narrative: Symptoms of tightness in chest and throat reported by patient at 6:15pm. Blood pressure at 6:15pm 185/91 and heart rate 73. Gave Benadryl 50 mg oral at 6:21 pm as symptoms were not subsiding. No improvement in symptoms and at 6:38 pm, patient reported now feeling tingling and dry throat. Called EMS at 6:39pm. Blood pressure at 6:49pm 168/98 and oxy sat 98%. Patient still reporting tightness in throat/chest and difficulty taking deep breaths. EMS recommended patient go to the hospital and she denied and went home.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Upper limb fracture, X-ray
Clinical narrative: Walked to my neighbors house and fell on the sidewalk.  Had my second shot in the morning.  Can?t figure out why it happened.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Chest discomfort, Disorientation, Dizziness, Dyspnoea
Clinical narrative: On 3/30/2021 Bronco spasm after 30 minutes of inoculation. He felt a tight chest, severe pain in the right lung, disorientation, headache, dizziness, and itchy throat. Quick use 2 inhalers: Albuterol Sulfate HFA and Symbicort. Also take 2 Benadryl 25mg. The next day 3/31/2021, use the inhalators preventively. Headache and muscle pain continued on 3/31/2021 and I took 2 Tylenol 600mg every 4 hours. On 4/1/2021, headache, muscle pain, and breathing problems decreased. At the moment there is mild pain in the head, arm and muscle.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pulmonary pain, Throat irritation
Clinical narrative: On 3/30/2021 Bronco spasm after 30 minutes of inoculation. He felt a tight chest, severe pain in the right lung, disorientation, headache, dizziness, and itchy throat. Quick use 2 inhalers: Albuterol Sulfate HFA and Symbicort. Also take 2 Benadryl 25mg. The next day 3/31/2021, use the inhalators preventively. Headache and muscle pain continued on 3/31/2021 and I took 2 Tylenol 600mg every 4 hours. On 4/1/2021, headache, muscle pain, and breathing problems decreased. At the moment there is mild pain in the head, arm and muscle.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Fatigue, Headache, Strabismus, Vision blurred
Clinical narrative: After 1st dose of vaccine experienced headache and extreme fatigue. Began about 2 hours post-injection. Headache lasted 8 hours. After 24 hours the fatigue was moderate and persisted a total of 36 hours. Blurred vision occurred 8 hours post-vaccine and  has persisted +72hours. Twitch in right eye-lid persistent with blurred vision from squinting.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given early, 15 days after the first
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever(101) headache chills
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Sleep disorder
Clinical narrative: Awoke at 1:15am the day after receiving the vaccine with flu symptoms and unable to fall back asleep. Symptoms continued through the day until 8:30pm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen, painful lymph node under arm pit.  Fever.  Chills. Achy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Low grade fever for 24hrs? still active: Full body muscle aches(primarily lower back, neck, and shoulders), pain at injection site, fatigue...
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperventilation, Malaise, Pyrexia
Clinical narrative: 16 days after dose 1, I experienced a sudden hyperventilation at 7:00pm on March 15, 2021, which I calmed within moments.  Then at 9:00pm on March 15,2021, a sudden fever of 102.5 occurred, giving a significant feeling of unwellness, but with no cold or flu like symptoms.  I took Tylenol and the 102.5 fever dropped to 100 within hours.   The next morning the fever was gone, but an unwellness feeling remained with no cold or flu like symptoms.  Fever returned later that day but only to 99.2 and then was back normal that day.  The next day a uneasy unwellness feeling with no cold or flu like symptoms occurred, with no fever.   The third day I was recovered.   I had no social interactions between the day I received dose 1 on Feb 27.  Symptoms on Feb. 27th were minor.  No fever.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood 25-hydroxycholecalciferol decreased, Blood calcium, Blood chloride, Blood creatinine, Blood glucose normal
Clinical narrative: Patient was vaccinated at 11:58 AM. During her observation, she appeared to be resting/sitting quietly in her chair.  At approximately 1227, RN was trying to arouse patient.  On my arrival, patient was not responsive.  Shortly after that, patient became responsive to voice.  She was oriented to person, place and time.  Speech was slurred. Grips were weak bilaterally, No pronator drift.   Initial VS at 1230 were T- 37.0, HR- 108, R-16, BP 200/120, spO2 99% on 6L by NRB.  VS  at 1238- P- 113, SpO2 99% on 6L NRB, BP 180/90.   Patient's husband, located in parking lot and brought in. verified that patient was not acting normally.     EMS arrived at 1241.  SBAR report given.   RN CEN
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood sodium, Blood urea, Carbon dioxide, Chest X-ray
Clinical narrative: Patient was vaccinated at 11:58 AM. During her observation, she appeared to be resting/sitting quietly in her chair.  At approximately 1227, RN was trying to arouse patient.  On my arrival, patient was not responsive.  Shortly after that, patient became responsive to voice.  She was oriented to person, place and time.  Speech was slurred. Grips were weak bilaterally, No pronator drift.   Initial VS at 1230 were T- 37.0, HR- 108, R-16, BP 200/120, spO2 99% on 6L by NRB.  VS  at 1238- P- 113, SpO2 99% on 6L NRB, BP 180/90.   Patient's husband, located in parking lot and brought in. verified that patient was not acting normally.     EMS arrived at 1241.  SBAR report given.   RN CEN
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Eosinophil percentage decreased, Full blood count abnormal, Grip strength decreased, International normalised ratio increased
Clinical narrative: Patient was vaccinated at 11:58 AM. During her observation, she appeared to be resting/sitting quietly in her chair.  At approximately 1227, RN was trying to arouse patient.  On my arrival, patient was not responsive.  Shortly after that, patient became responsive to voice.  She was oriented to person, place and time.  Speech was slurred. Grips were weak bilaterally, No pronator drift.   Initial VS at 1230 were T- 37.0, HR- 108, R-16, BP 200/120, spO2 99% on 6L by NRB.  VS  at 1238- P- 113, SpO2 99% on 6L NRB, BP 180/90.   Patient's husband, located in parking lot and brought in. verified that patient was not acting normally.     EMS arrived at 1241.  SBAR report given.   RN CEN
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test abnormal, NIH stroke scale, Prothrombin time prolonged, Troponin, Unresponsive to stimuli
Clinical narrative: Patient was vaccinated at 11:58 AM. During her observation, she appeared to be resting/sitting quietly in her chair.  At approximately 1227, RN was trying to arouse patient.  On my arrival, patient was not responsive.  Shortly after that, patient became responsive to voice.  She was oriented to person, place and time.  Speech was slurred. Grips were weak bilaterally, No pronator drift.   Initial VS at 1230 were T- 37.0, HR- 108, R-16, BP 200/120, spO2 99% on 6L by NRB.  VS  at 1238- P- 113, SpO2 99% on 6L NRB, BP 180/90.   Patient's husband, located in parking lot and brought in. verified that patient was not acting normally.     EMS arrived at 1241.  SBAR report given.   RN CEN
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Slight fever, significant body aches, chills, and nausea.  Like a bad flu.  Went to bed at 7pm.  Felt better the next morning.  ~12 hours
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Heart rate increased, Myalgia
Clinical narrative: Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): emergency room visit
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): emergency room visit
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: rash on arms and legs.     muscle stiffness especially in the neck
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient reports  mild itching to her arms and farce, no rash or hives, no other symptoms. Patient was seen and cleared by EMS BP; 134/77, pulse :80, Spo2 100%
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given early, 15 days after the first.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bump and redness at injection site - grew from a quarter on March 30th to about 2 inches diameter on April 1.  Warm to touch.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: Headache, fever, chills, loss of appetite, vomiting, fatigue/hard of breath.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, fever, chills, loss of appetite, vomiting, fatigue/hard of breath.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: I have a rash on my hands, arms, legs. It starts out as little itchy bumps everywhere and after a few days they become a very itchy patch.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Fever started around 10:30 pm 3/13/21; splitting headache, nausea, 7/10 pain at site of injection; fever went as high as 102.7 on 3/14/21. Slept for 30 hours, with fever staying over 100 until the evening of 3/14/21.  Could not eat, due to nausea; got up every couple of hours to drink water and take temperature.  Awoke on Monday, 3/15/21 with no fever, no headache, no nausea, but feeling like I could still nap even after sleeping for 30 hours.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever started around 10:30 pm 3/13/21; splitting headache, nausea, 7/10 pain at site of injection; fever went as high as 102.7 on 3/14/21. Slept for 30 hours, with fever staying over 100 until the evening of 3/14/21.  Could not eat, due to nausea; got up every couple of hours to drink water and take temperature.  Awoke on Monday, 3/15/21 with no fever, no headache, no nausea, but feeling like I could still nap even after sleeping for 30 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, headache, aches on left side of body (neck, arm, back, leg) began around 9:30p, increasing in intensity over the next several hours. Took recommended dose of Tylenol around 2:30am. Chills had disappeared by 8am the next day.  Took another dose of Tylenol around 9am the next day to treat residual headache and body aches. Fever disappeared by 3p.  Headache and mild aches in arm and leg have continued this submission.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Feeling abnormal, Herpes zoster
Clinical narrative: I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple days guess 3rd day started seeing pimples in forehead and it started developing on my left forehead and until my left eye.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: aaaaaaaaaaaaaaaaaaaaaa
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: Chills with shaking, low grade fever, fatigue.  It started Friday night at 8:30 and went through the night into the next day.  The fever chills were over the next day, but I was very tired and slept most of the day.  By Sunday I was doing better, still tired.  I took tylenol the first night.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Mobility decreased
Clinical narrative: Less than two minutes after J & J vaccine I was unconscious and unable to move my entire body.  I could not move my eyelids, mouth, arms, legs...entire body . Upon becoming mentally alert it was more than two hours until I could move all of my body.   I was taken by ambulance to an emergency room.  IV fluids, potassium, and released 3 hours later.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Less than two minutes after J & J vaccine I was unconscious and unable to move my entire body.  I could not move my eyelids, mouth, arms, legs...entire body . Upon becoming mentally alert it was more than two hours until I could move all of my body.   I was taken by ambulance to an emergency room.  IV fluids, potassium, and released 3 hours later.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Left arm muscle soreness; slight AM headache and fatigue the next day.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT GOT MODERNA COVID 19 VACCINE WHEN 17 YEARS OLD
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Woke up at 4am shivering.  As the day progressed my fever rose to 101°F.  I had a really bad headache, pain in my joints, hips, knees, feet, elbows, hands, shoulders and neck.  I was nauseous and lost my appetite.  Sensitivity to bright light.  It hurt my head to even talk.  This lasted 24 hours.  The next day I was extremely fatigued for 24 hours.  The third day, 4/1/2021,  I'm still fatigued and out of breath when I climb 2 flights of stairs (which I do every day to get to my office), but it's not as bad as yesterday.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Neck pain, Pain in extremity, Photophobia
Clinical narrative: Woke up at 4am shivering.  As the day progressed my fever rose to 101°F.  I had a really bad headache, pain in my joints, hips, knees, feet, elbows, hands, shoulders and neck.  I was nauseous and lost my appetite.  Sensitivity to bright light.  It hurt my head to even talk.  This lasted 24 hours.  The next day I was extremely fatigued for 24 hours.  The third day, 4/1/2021,  I'm still fatigued and out of breath when I climb 2 flights of stairs (which I do every day to get to my office), but it's not as bad as yesterday.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Woke up at 4am shivering.  As the day progressed my fever rose to 101°F.  I had a really bad headache, pain in my joints, hips, knees, feet, elbows, hands, shoulders and neck.  I was nauseous and lost my appetite.  Sensitivity to bright light.  It hurt my head to even talk.  This lasted 24 hours.  The next day I was extremely fatigued for 24 hours.  The third day, 4/1/2021,  I'm still fatigued and out of breath when I climb 2 flights of stairs (which I do every day to get to my office), but it's not as bad as yesterday.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria on arms and trunk approximately 20 minutes after vaccination. Moved to scalp as symptoms progressed.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Erythema, Feeling hot, Headache
Clinical narrative: red hot raised area tender to touch since Monday a few hrs after injection Chills, and fever subsided Tuesday Still  has headache and pressure on face and back of head
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: red hot raised area tender to touch since Monday a few hrs after injection Chills, and fever subsided Tuesday Still  has headache and pressure on face and back of head
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: PATIENT RECEIVED 2ND DOSE OF MODERNA VACCINE ON 3/29/2021. PATIENT EXPERIENCED SHORTNESS OF BREATH ON THE EVENING OF VACCINATION. ON 4/1/2021, PATIENT CALLED TO INFORM THE PHARMACY ABOUT SHORTNESS OF BREATH. PHARMACY INSTRUCTED THE PATIENT TO CONTACT HER PRIMARY CARE PHYSICIAN. PATIENT RECEIVED ANTIBIOTIC AND RESCUE INHALER FROM DOCTOR'S OFFICE ON 4/1/2021. PHARMACY COUNSELED ON THE CORRECT USE OF THE INHALER AND WILL CONTINUE TO FOLLOW-UP. AS OF 5:45 PM OF 4/1/2021, PATIENT STILL EXPERIENCES SHORTNESS OF BREATH.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Head discomfort, Hot flush, Paraesthesia, Pharyngeal swelling
Clinical narrative: Head rush and tingling in hands immediately after but dissipated within 10 minutes, hot flashes throughout day, red rash all over body next morning with pins and needs feelings. Throat swelling causing difficulty swallowing.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Head rush and tingling in hands immediately after but dissipated within 10 minutes, hot flashes throughout day, red rash all over body next morning with pins and needs feelings. Throat swelling causing difficulty swallowing.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Moderna COVID-19 Vaccine EUA-   3/30: - headache started around 2 pm,  ibuprofen taken at 5:30, nausea started around 7 pm  3/31: -woke up with a headache, felt fatigued all day, diarrhea around 5 pm, minimal appetite, nausea in the evening, brain fog on and off all day. No meds taken.   4/1: Woke up with headache, fatigued all day, nausea started around 4 pm, headache around 6 pm. No meds taken.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA-   3/30: - headache started around 2 pm,  ibuprofen taken at 5:30, nausea started around 7 pm  3/31: -woke up with a headache, felt fatigued all day, diarrhea around 5 pm, minimal appetite, nausea in the evening, brain fog on and off all day. No meds taken.   4/1: Woke up with headache, fatigued all day, nausea started around 4 pm, headache around 6 pm. No meds taken.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: Chest palpitations
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had his Vaccine on 2-28-2021.  Patient passed away on 3-3-2021.  Do not know the cause, just found out from our tech and thought we should report it in case.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, itchy, warm, red , hard spot on arm, under where shot was given. About 5 inches long, 4 inches high.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Pt reported felling hot. Provided with water, denies shortness of breath or difficulty, denies tingling of throat. Provided juice, pt reported feeling better and requested to leave.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: Severe tinnitus like pounding noise, headaches, dizziness,off balance,fatigue,neck pain, pain in left armpit.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Tinnitus
Clinical narrative: Severe tinnitus like pounding noise, headaches, dizziness,off balance,fatigue,neck pain, pain in left armpit.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site rash, Pain, Pyrexia
Clinical narrative: Severe body aches, chills, fever,  rash on shot site and severe headache lasting 48 hours so far.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site: Started about 6 hours after the injection and lasted for about a day. Less serious than the first dose.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Enlarged uvula
Clinical narrative: Three hours after receiving the vaccine she began experiencing swelling in the uvula.  Some mild difficulty breathing.  It took several days for the swelling to return to normal.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sleep disorder
Clinical narrative: Headache prior to shot but increased in intensity around 7 hours after injection, continued throughout night, disrupting sleep, severe the following morning, then began to recede in intensity about 24 hours after injection
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased
Clinical narrative: anxiety, increased hearbeat
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Hyperhidrosis, Injection site pain
Clinical narrative: Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating  and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vomiting
Clinical narrative: Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating  and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles from Pfizer vaccine
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Muscle spasms, Muscle twitching
Clinical narrative: I'm a C5-6 quadriplegic. Had intense muscle spasms and twtiching, fever and chills. They started at 1 am and started to calm down around 6 am. Slept from 6am - 3pm and awoke to use restroom and drink some gatorade. Didnt really have any strength. Went back to bed and slept until 11 pm. Ate some crackers and granola bars late that night and drank more gatorade. Next day (saturday)  strength started to come around but was hot. Had no fever but just sweated. By sunday most symptoms were gone
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I'm a C5-6 quadriplegic. Had intense muscle spasms and twtiching, fever and chills. They started at 1 am and started to calm down around 6 am. Slept from 6am - 3pm and awoke to use restroom and drink some gatorade. Didnt really have any strength. Went back to bed and slept until 11 pm. Ate some crackers and granola bars late that night and drank more gatorade. Next day (saturday)  strength started to come around but was hot. Had no fever but just sweated. By sunday most symptoms were gone
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, which I have had for 20 years and was well habituated to, suddenly became much worse. Has made me nearly suicidal.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, fatigue, headaches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: As of this morning, nine days after the first dose of the vaccine, my left arm (at injection) is red and puffy, about 3 inches wide. It is itchy, red and hot. I can also feel my lymph nodes.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: A small rash approximately 2 cm in diameter appeared on my right anterior thigh about 4 inches above the knee.  It started off red and mildly itchy with significant warmth compared to the surrounding area.  A day or two later a similar rash appeared on my left wrist and posterior forearm that presented as raised bumps but was similarly itchy.  Another day later a similar rash appeared on my right posterior forearm.  I then decided to contact a telehealth provider who reviewed via video and decided to prescribe over-the-counter anti-histamine (zyrtec) and a topical ointment of mupirocin.  I continued to take the zyrtec and applied the ointment but over the last several days the rash on my leg has increased in size to 20cm x 15 cm with noticeable swelling, itchiness and mild aching pain.  Another noteworthy symptom is the area of the original rash on my thigh deepened in color and is now scaly and less itchy.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin discolouration, Skin exfoliation, Skin warm, Swelling
Clinical narrative: A small rash approximately 2 cm in diameter appeared on my right anterior thigh about 4 inches above the knee.  It started off red and mildly itchy with significant warmth compared to the surrounding area.  A day or two later a similar rash appeared on my left wrist and posterior forearm that presented as raised bumps but was similarly itchy.  Another day later a similar rash appeared on my right posterior forearm.  I then decided to contact a telehealth provider who reviewed via video and decided to prescribe over-the-counter anti-histamine (zyrtec) and a topical ointment of mupirocin.  I continued to take the zyrtec and applied the ointment but over the last several days the rash on my leg has increased in size to 20cm x 15 cm with noticeable swelling, itchiness and mild aching pain.  Another noteworthy symptom is the area of the original rash on my thigh deepened in color and is now scaly and less itchy.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Mild allergic reaction
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Hot itchy and red at injection site within 30 minutes. Hard and painful for 4 days, then faded on 6th day came back, warm to touch, hard to touch and odd shaped, red and itchy. It's manageable  but reporting to aid in tracking side effects.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Pain
Clinical narrative: Headache onset 12 hours after shot  Body aches about 24 hours after shot Fatigue - lethargy for the next 48 hours Still feeling tired/lethargic over a week later
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Feeling of body temperature change, Hypoaesthesia oral, Muscle tightness
Clinical narrative: Received dose on Friday, experienced a very sore arm and fatigue through Saturday evening.  Fatigue and sore arm dissipated by Sunday morning and random itching all over body became noticeable.  Itching became very intense on face along with a burning sensation on face. Itchy/ burning face continued though the next week along with tinging and numbness on the tongue and lips.  Antihistamines were taken but did not help very much.  A week after vaccine, extremely intense icy/hot burning sensations developed throughout body along with muscle tension in head, neck and jaw. Tension dissipated but burning sensation throughout body persisted.  Doctor prescribed 5 day prednisone treatment which did not alleviate symptoms. Now 26 days post 1st vaccine dose and neuropathic intense burning sensations throughout body have persisted for hours and days at a time.  Face/body itching  and burning has also retuned on day 25 post vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Pruritus
Clinical narrative: Received dose on Friday, experienced a very sore arm and fatigue through Saturday evening.  Fatigue and sore arm dissipated by Sunday morning and random itching all over body became noticeable.  Itching became very intense on face along with a burning sensation on face. Itchy/ burning face continued though the next week along with tinging and numbness on the tongue and lips.  Antihistamines were taken but did not help very much.  A week after vaccine, extremely intense icy/hot burning sensations developed throughout body along with muscle tension in head, neck and jaw. Tension dissipated but burning sensation throughout body persisted.  Doctor prescribed 5 day prednisone treatment which did not alleviate symptoms. Now 26 days post 1st vaccine dose and neuropathic intense burning sensations throughout body have persisted for hours and days at a time.  Face/body itching  and burning has also retuned on day 25 post vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Somnolence
Clinical narrative: Extreme fatigue, chills (on an 84-degree day), almost falling asleep at desk
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no problems with mobility).
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness/vertigo
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Hyperhidrosis, Hypotension, Seizure, Tremor
Clinical narrative: 10 seconds of tonic clonic seizure like activity 6 minutes after administration of the Moderna COVID-19 vaccine with associated hypotension, bradycardia, diaphoresis, and visual disturbance (spots in his vision) that self-resolved after being shaken.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: 10 seconds of tonic clonic seizure like activity 6 minutes after administration of the Moderna COVID-19 vaccine with associated hypotension, bradycardia, diaphoresis, and visual disturbance (spots in his vision) that self-resolved after being shaken.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Cellulitis, Hot flush, Injection site pain, Neck pain
Clinical narrative: Symptoms: Facial cellulitis, rash.  Description: Symptoms started with pain at the shot site on the 1/14, then shooting pain to the nick area (like nick pain) on 1/15 I noticed swelling in my face and jaw below the ears area, over that weekend my face swell more, no fever, just a feeling of higher temperature (as if I was having hot flashes). I seek  medical treatment at an urgent care on 1/18/2021, was prescribed antibiotics and followed up couple of days later with PCP on  1/22/2021 who extended my antibiotics treatment. The facial swelling improved.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Symptoms: Facial cellulitis, rash.  Description: Symptoms started with pain at the shot site on the 1/14, then shooting pain to the nick area (like nick pain) on 1/15 I noticed swelling in my face and jaw below the ears area, over that weekend my face swell more, no fever, just a feeling of higher temperature (as if I was having hot flashes). I seek  medical treatment at an urgent care on 1/18/2021, was prescribed antibiotics and followed up couple of days later with PCP on  1/22/2021 who extended my antibiotics treatment. The facial swelling improved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure increased, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient got light headed and fainted.  Was eased to the ground by RN. Elevated legs.  She regained consciousness in 1 mins and remained laying down with legs elevated for 10mins.  BP 138/68 at 14:20.  Given water and candy.  BP 118/68 at 14:26.  Observed for 15 more mins and feeling well to leave with husband who was had no adverse reactions.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: Patient got light headed and fainted.  Was eased to the ground by RN. Elevated legs.  She regained consciousness in 1 mins and remained laying down with legs elevated for 10mins.  BP 138/68 at 14:20.  Given water and candy.  BP 118/68 at 14:26.  Observed for 15 more mins and feeling well to leave with husband who was had no adverse reactions.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Nausea
Clinical narrative: Severe nausea, chills, cold-sweats, lightheadedness. Woke up abruptly with symptoms. Took two (8mg) Zofran tablets (I have a prescription due to my colitis) which subsided the nausea allowing me to get back to slip within an hour. No other affects since them.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient 22 days short of being 18.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Paraesthesia, Vision blurred
Clinical narrative: Tingling, vision blurry, flushing, slight feeling of wooziness, felt disconnected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cooling therapy, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Severe headache within 2 hour of vaccine.  Extremely fatigued,  headache, muscle ache and soreness at injection site lasted 4 days.  Treated with tylenol and ice packs.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age under 18
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Mobility decreased, Nausea
Clinical narrative: Excruciating headache Fever 102 Complete body aches-Muscle and joints Nausea Dizziness Injection site pain, couldn?t move arm for 4 days Fatigue  Started 6-8 hours post vaccine and lasted for 48 hours
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Excruciating headache Fever 102 Complete body aches-Muscle and joints Nausea Dizziness Injection site pain, couldn?t move arm for 4 days Fatigue  Started 6-8 hours post vaccine and lasted for 48 hours
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: The patient was seated and during the vaccination procedure the needle separated from the syringe containing the vaccine. At this point the patient was alerted and remained calm. The vaccinator alerted the pharmacist who contacted Moderna on how to proceed. It was determined that no more than one-half of the dose had been administered. The recommendation was to repeat the vaccination  with the additional one-half dose to provide a full dose for the first shot in a two shot series. This was done per protocol. The procedure was completed. The patient remained for the required 15 minute observation period and experienced no adverse effects and did not present any symptoms of adverse effects.