chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dysgeusia, Flushing, Paraesthesia
Clinical narrative: fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dry mouth, Dysgeusia, Flushing, Malaise
Clinical narrative: fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Headache, Nausea, Throat tightness
Clinical narrative: throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19 immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30, patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19 immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30, patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Oxygen saturation decreased
Clinical narrative: Per staff resident was observed lying in bed, with labored breathing then became unresponsive. Oxygen was initiated but few minutes later, noted stopped breathing with no pulse and no BP. Code blue was paged, staff started CPR, and 911 was called, IVF initiated as well. . Eventually was pronounced dead at 1859 by MD.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure immeasurable, Death, Dyspnoea, Oxygen therapy, Pulse absent
Clinical narrative: Per staff resident was observed lying in bed, with labored breathing then became unresponsive. Oxygen was initiated but few minutes later, noted stopped breathing with no pulse and no BP. Code blue was paged, staff started CPR, and 911 was called, IVF initiated as well. . Eventually was pronounced dead at 1859 by MD.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: Per staff resident was observed lying in bed, with labored breathing then became unresponsive. Oxygen was initiated but few minutes later, noted stopped breathing with no pulse and no BP. Code blue was paged, staff started CPR, and 911 was called, IVF initiated as well. . Eventually was pronounced dead at 1859 by MD.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pruritus
Clinical narrative: Patient presented post Covid vaccine. Patient was experiencing itching on back of neck, L forearm, inner thighs and tingling of lips. Patient advise to go to ED if symptoms worsened. Patient has personal 25 mg tab of Benadryl or 10 mg zrytec. Patient took zyrtec.  Patient ok with POC. Patient has no further questions or concerns at this time.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tongue pruritus, Tremor
Clinical narrative: Patient presented post Covid vaccine. Patient was experiencing itching on back of neck, L forearm, inner thighs and tingling of lips. Patient advise to go to ED if symptoms worsened. Patient has personal 25 mg tab of Benadryl or 10 mg zrytec. Patient took zyrtec.  Patient ok with POC. Patient has no further questions or concerns at this time.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Patient presented post Covid vaccine. Patient was experiencing itching on back of neck, L forearm, inner thighs and tingling of lips. Patient advise to go to ED if symptoms worsened. Patient has personal 25 mg tab of Benadryl or 10 mg zrytec. Patient took zyrtec.  Patient ok with POC. Patient has no further questions or concerns at this time.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death, Pulse absent, Respiratory arrest
Clinical narrative: Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of anaphylaxis were noted.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of anaphylaxis were noted.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Respiratory arrest
Clinical narrative: Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of anaphylaxis were noted.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Blood immunoglobulin E normal, Death, SARS-CoV-2 test negative, Toxicologic test normal
Clinical narrative: Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of anaphylaxis were noted.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tryptase, Unresponsive to stimuli
Clinical narrative: Resident was found without a pulse and not breathing 20 minutes after vaccine administration. Upon MD review, no signs of anaphylaxis were noted.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Periorbital oedema
Clinical narrative: Patient reports that approximately one hour after receiving the second dose of the vaccine she began to feel fatigued. The following morning, at 6:30 a.m., she awoke with orbital edema, chest tightness, and an itchy throat. The patient sought emergent care at Emergency Center and received Solumedrol IV, Benadryl IV, and 1 Liter of Normal Saline IV. The patient reports almost immediate relief after receiving medication.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Orbital oedema, Throat irritation
Clinical narrative: Patient reports that approximately one hour after receiving the second dose of the vaccine she began to feel fatigued. The following morning, at 6:30 a.m., she awoke with orbital edema, chest tightness, and an itchy throat. The patient sought emergent care at Emergency Center and received Solumedrol IV, Benadryl IV, and 1 Liter of Normal Saline IV. The patient reports almost immediate relief after receiving medication.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pharyngeal hypoaesthesia
Clinical narrative: My throat swelled up and felt as if it was numb. I felt dizzy and anxious .I notified the nurse where she gave me Benadryl at 12:16pm.  I remained at the site until 1pm.  I haven not had any other concerns since then.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Pharyngeal hypoaesthesia, Pharyngeal swelling
Clinical narrative: My throat swelled up and felt as if it was numb. I felt dizzy and anxious .I notified the nurse where she gave me Benadryl at 12:16pm.  I remained at the site until 1pm.  I haven not had any other concerns since then.
Age: 37.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 1/13- Redness around the injection site, approximately 2 inches in diameter, itchy, hot to touch; 1/14- Redness has increased slightly in diameter but is no longer itchy
Age: 37.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 1/13- Redness around the injection site, approximately 2 inches in diameter, itchy, hot to touch; 1/14- Redness has increased slightly in diameter but is no longer itchy
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia, Urticaria
Clinical narrative: 01/11/21: MOnday: Chills, feverish, headache, bodyache 01/12/21:Tuesday: Chills, fever (99.9), bodyache 01/13/21:Wednesday: chills, feverish, bodyache 01/14/21: Thursday: Hives all over body, itchy, Chills, feverish. Went to clinic. abbot now test done. NEgative for corona virus. allegra and benadryl taken.  01/15/21: Friday: Hives
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pruritus, Pyrexia
Clinical narrative: 01/11/21: MOnday: Chills, feverish, headache, bodyache 01/12/21:Tuesday: Chills, fever (99.9), bodyache 01/13/21:Wednesday: chills, feverish, bodyache 01/14/21: Thursday: Hives all over body, itchy, Chills, feverish. Went to clinic. abbot now test done. NEgative for corona virus. allegra and benadryl taken.  01/15/21: Friday: Hives
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Urticaria
Clinical narrative: 01/11/21: MOnday: Chills, feverish, headache, bodyache 01/12/21:Tuesday: Chills, fever (99.9), bodyache 01/13/21:Wednesday: chills, feverish, bodyache 01/14/21: Thursday: Hives all over body, itchy, Chills, feverish. Went to clinic. abbot now test done. NEgative for corona virus. allegra and benadryl taken.  01/15/21: Friday: Hives
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cold sweat, Pain
Clinical narrative: Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he had a fever, but no thermometer at his house.  EE reports he bought a thermometer later in the day and temp was 98.7.  Friday am, feelings of generalized achiness. Last day of work and shift - ? Monday Home remedies? -   rest Any improvement? - mild Recommendation? EE encouraged to take ibuprofen as outlined in the Medical Directive.  EE encouraged to continue to monitor his symptoms and to contact the Vaccine support line with additional questions and concerns.  EE reports he is not feeling well and is scheduled to work today.  EE educated to manage his RTW according to the Illness in the Workplace policy.  EE verbalized back understanding and denied further questions at this time.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: per spouse - client received vaccine at approximately 1300 on 1/13/21. They went home had dinner, no signs of distress noted. Spouse went to bed at 2100, leaving client in den reading the paper. At approximately 2300, spouse awoke thinking client was snoring and he was not. She noticed he was purple and clenching his jaw while making gurgling noises. She called EMS who arrived and worked client for 20 minutes prior to transportation to Hospital. Client was pronounced expired later that evening.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Breath sounds abnormal, Cyanosis, Death, Muscle tightness
Clinical narrative: per spouse - client received vaccine at approximately 1300 on 1/13/21. They went home had dinner, no signs of distress noted. Spouse went to bed at 2100, leaving client in den reading the paper. At approximately 2300, spouse awoke thinking client was snoring and he was not. She noticed he was purple and clenching his jaw while making gurgling noises. She called EMS who arrived and worked client for 20 minutes prior to transportation to Hospital. Client was pronounced expired later that evening.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: it hard to inject; some came out and squirted down her arm; some came out and squirted down her arm; he did not get the full 0.3mL dose; This is a spontaneous report from a contactable nurse (patient). A 74-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 05Jan2021 13:00 at single dose in the left arm for COVID-19 immunisation. Medical history included COPD and high cholesterol. Concomitant medications included Symbicort for COPD. Patient took COVID vaccine (Verbatim) since precaution as frontline healthcare worker. On Tuesday, she received the first dose of the Pfizer COVID Vaccine. The nurse who was injecting found it hard to inject, and at the end of the injection, it came back and squirted down her arm. It was a decent amount. She is unable to say if she got 0.1ml, 0.2ml, but she certainly did not get full 0.3ml. The hospital said they are just going to go ahead and give her the second dose, but she wanted to call and find out what would be the safest thing. Would it be best to receive another dose or go ahead with the second dose or get a third dose. She is due in 2 1/2 weeks to get second dose. She also has COPD and is a little more concerned than if she were 25 years old. There was no prescriber provided. When asked about other medications, she stated she has a list of medications, but did not think they were relevant. She was diagnosed with COPD last year and had a series of test. Reporter seriousness for "it came back and squirted down her arm" is medically significant. Outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship.  There is limited information provided in this report.   This case will be reassessed once additional information is available.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol increased, Exposure via skin contact, Needle issue, Underdose
Clinical narrative: it hard to inject; some came out and squirted down her arm; some came out and squirted down her arm; he did not get the full 0.3mL dose; This is a spontaneous report from a contactable nurse (patient). A 74-year-old-female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via Intramuscular on 05Jan2021 13:00 at single dose in the left arm for COVID-19 immunisation. Medical history included COPD and high cholesterol. Concomitant medications included Symbicort for COPD. Patient took COVID vaccine (Verbatim) since precaution as frontline healthcare worker. On Tuesday, she received the first dose of the Pfizer COVID Vaccine. The nurse who was injecting found it hard to inject, and at the end of the injection, it came back and squirted down her arm. It was a decent amount. She is unable to say if she got 0.1ml, 0.2ml, but she certainly did not get full 0.3ml. The hospital said they are just going to go ahead and give her the second dose, but she wanted to call and find out what would be the safest thing. Would it be best to receive another dose or go ahead with the second dose or get a third dose. She is due in 2 1/2 weeks to get second dose. She also has COPD and is a little more concerned than if she were 25 years old. There was no prescriber provided. When asked about other medications, she stated she has a list of medications, but did not think they were relevant. She was diagnosed with COPD last year and had a series of test. Reporter seriousness for "it came back and squirted down her arm" is medically significant. Outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship.  There is limited information provided in this report.   This case will be reassessed once additional information is available.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: I became very clammy in the hands and started to black out just 10 minutes after having the vaccination shot.  I was in the waiting room.  The staff member monitoring saw me going to the floor and called the head doctor over to help.  They called EMT's.  I was laid onto the floor on my back and legs up onto a chair.  The staff took my blood pressure which was low.  Approximately, 2 minutes later, they took my blood pressure and it went back up to a more normal level.  The EMT's helped me up and took my blood sugar levels and pulse oxygen levels which seemed normal.  I was able to feel better, but the color of my skin was yellowish and pale.  The EMT's suggested that I talk with my doctor before getting another vaccine and talk about my symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Peripheral coldness
Clinical narrative: I became very clammy in the hands and started to black out just 10 minutes after having the vaccination shot.  I was in the waiting room.  The staff member monitoring saw me going to the floor and called the head doctor over to help.  They called EMT's.  I was laid onto the floor on my back and legs up onto a chair.  The staff took my blood pressure which was low.  Approximately, 2 minutes later, they took my blood pressure and it went back up to a more normal level.  The EMT's helped me up and took my blood sugar levels and pulse oxygen levels which seemed normal.  I was able to feel better, but the color of my skin was yellowish and pale.  The EMT's suggested that I talk with my doctor before getting another vaccine and talk about my symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Hypotension, Pallor, Skin discolouration
Clinical narrative: I became very clammy in the hands and started to black out just 10 minutes after having the vaccination shot.  I was in the waiting room.  The staff member monitoring saw me going to the floor and called the head doctor over to help.  They called EMT's.  I was laid onto the floor on my back and legs up onto a chair.  The staff took my blood pressure which was low.  Approximately, 2 minutes later, they took my blood pressure and it went back up to a more normal level.  The EMT's helped me up and took my blood sugar levels and pulse oxygen levels which seemed normal.  I was able to feel better, but the color of my skin was yellowish and pale.  The EMT's suggested that I talk with my doctor before getting another vaccine and talk about my symptoms.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Exposure to SARS-CoV-2, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient observed in the bathroom on the floor, unresponsive, CPR initiated, EMS arrived and pronounced patient at 12:38 pm
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient observed in the bathroom on the floor, unresponsive, CPR initiated, EMS arrived and pronounced patient at 12:38 pm
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Feeling abnormal, Nausea, Pulse absent, Respiratory arrest
Clinical narrative: The patient stated " I just feel Blah". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified  Patient expired
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restlessness, Resuscitation, Unresponsive to stimuli
Clinical narrative: The patient stated " I just feel Blah". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified  Patient expired
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Feeling abnormal, Nausea, Restlessness, Resuscitation
Clinical narrative: The patient stated " I just feel Blah". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified  Patient expired
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: The patient stated " I just feel Blah". vital signs obtained. 156/75 p-84 spo2 94% via NC 2L. T-96.7, c/o feeling restless, c/o nausea with no vomiting. Patient observed at 0600 nonresponsive, CPR initiated, and EMS notified  Patient expired
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Hypoaesthesia oral, Neck pain, Skin warm, Swelling face
Clinical narrative: Called to see pt in drive up lane 7 min post vaccination. She immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.  Past medical history of breast cancer and axillary swelling.  Initial examination lungs CTA, regular tachycardia.  Pt moved to observation area.  Initial vitals:   BP: 154/82, HR 129, 97% O2  Benadryl 25 mg po given at 10:25am   EMS notified and first injection 3mg Epi pen injection given at 10:41am;   911 called. BP 154/82, 136, RR 20, O2 sat 99% 10:43am. Second epinephrine 3mg injection given at 10:44am. BP 162/84, HR 131, RR 22, O2 sat 100% at 10:49am. At 10:49am, she suddenly was short of breath, general mailais, delayed ear swelling, and was put on a stretcher and 10L non rebreather. She was brought to Medical Ctr at 10:54.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Called to see pt in drive up lane 7 min post vaccination. She immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.  Past medical history of breast cancer and axillary swelling.  Initial examination lungs CTA, regular tachycardia.  Pt moved to observation area.  Initial vitals:   BP: 154/82, HR 129, 97% O2  Benadryl 25 mg po given at 10:25am   EMS notified and first injection 3mg Epi pen injection given at 10:41am;   911 called. BP 154/82, 136, RR 20, O2 sat 99% 10:43am. Second epinephrine 3mg injection given at 10:44am. BP 162/84, HR 131, RR 22, O2 sat 100% at 10:49am. At 10:49am, she suddenly was short of breath, general mailais, delayed ear swelling, and was put on a stretcher and 10L non rebreather. She was brought to Medical Ctr at 10:54.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Anxiety, Dyspnoea, Ear swelling, Hypoaesthesia
Clinical narrative: Called to see pt in drive up lane 7 min post vaccination. She immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.  Past medical history of breast cancer and axillary swelling.  Initial examination lungs CTA, regular tachycardia.  Pt moved to observation area.  Initial vitals:   BP: 154/82, HR 129, 97% O2  Benadryl 25 mg po given at 10:25am   EMS notified and first injection 3mg Epi pen injection given at 10:41am;   911 called. BP 154/82, 136, RR 20, O2 sat 99% 10:43am. Second epinephrine 3mg injection given at 10:44am. BP 162/84, HR 131, RR 22, O2 sat 100% at 10:49am. At 10:49am, she suddenly was short of breath, general mailais, delayed ear swelling, and was put on a stretcher and 10L non rebreather. She was brought to Medical Ctr at 10:54.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Paraesthesia, Swelling face, Swelling of eyelid
Clinical narrative: Called to see pt in drive up lane 7 min post vaccination. She immediately felt after the vaccination, numbness and tingling in L face on the buccal side and her L arm. She felt like her L side of the face and eyelids were swelling. She was agitated and worried.  Past medical history of breast cancer and axillary swelling.  Initial examination lungs CTA, regular tachycardia.  Pt moved to observation area.  Initial vitals:   BP: 154/82, HR 129, 97% O2  Benadryl 25 mg po given at 10:25am   EMS notified and first injection 3mg Epi pen injection given at 10:41am;   911 called. BP 154/82, 136, RR 20, O2 sat 99% 10:43am. Second epinephrine 3mg injection given at 10:44am. BP 162/84, HR 131, RR 22, O2 sat 100% at 10:49am. At 10:49am, she suddenly was short of breath, general mailais, delayed ear swelling, and was put on a stretcher and 10L non rebreather. She was brought to Medical Ctr at 10:54.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Palpitations
Clinical narrative: I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Electrocardiogram normal, Flushing, Heart rate increased, Palpitations
Clinical narrative: I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.
Age: 44.0
Sex: M
Vaccine: UNK, UNK, COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Wife reports that he initially developed a fever, headache, body aches, and chills shortly after receiving the vaccine. He took Tylenol to treat his symptoms. He had the symptoms for about 36-48 hours, then recovered. Afterwards, his wife reports that he still felt tired and was very thirsty. He was well enough to work, so he went to work Wednesday night.
Age: 44.0
Sex: M
Vaccine: UNK, UNK, COVID19
Symptoms: Somnolence
Clinical narrative: Wife reports that he initially developed a fever, headache, body aches, and chills shortly after receiving the vaccine. He took Tylenol to treat his symptoms. He had the symptoms for about 36-48 hours, then recovered. Afterwards, his wife reports that he still felt tired and was very thirsty. He was well enough to work, so he went to work Wednesday night.
Age: 44.0
Sex: M
Vaccine: UNK, UNK, COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Wife reports that he initially developed a fever, headache, body aches, and chills shortly after receiving the vaccine. He took Tylenol to treat his symptoms. He had the symptoms for about 36-48 hours, then recovered. Afterwards, his wife reports that he still felt tired and was very thirsty. He was well enough to work, so he went to work Wednesday night.
Age: 44.0
Sex: M
Vaccine: UNK, UNK, COVID19
Symptoms: Thirst
Clinical narrative: Wife reports that he initially developed a fever, headache, body aches, and chills shortly after receiving the vaccine. He took Tylenol to treat his symptoms. He had the symptoms for about 36-48 hours, then recovered. Afterwards, his wife reports that he still felt tired and was very thirsty. He was well enough to work, so he went to work Wednesday night.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report from a non-contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received her second dose of bnt162b2 (BNT162B2 reported as Covid 19 vaccine/ Covid Vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient had the first dose on an unspecified date for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever after second dose of Covid 19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Rash pruritic
Clinical narrative: red itchy rash on anterloposterior torso, upper inner arms, neck groin, all apparent in a.m.; This spontaneous report was received from healthcare professional and refers to a male patient of an unknown age. The patient had no known allergy, no other illness at the time of vaccination and no chronic or long-standing health conditions. At the time of vaccination, the patient was taken unspecified herbal remedies. There was no information about the patient's medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (reported as HPV vaccine of Merck & Co but lot # S008154 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiration date was not provided but upon internal validation established as 20-NOV-2021), in the deltoid, intramuscularly for prophylaxis (exact dose was not provided) and influenza virus split virion 3v vaccine inactivated (FLUARIX) lot number: TAR35, intramuscularly in the deltoid, for prophylaxis (exact dose and expiration date were not provided) (age at vaccination was provided as 15years and 11 months).  On 01-OCT-2019 at 07:00 am, the patient awoke with red itchy rash on anterioposterior torso, upper inner arms, neck groin, all apparent in the morning. As treatment prednisone and methylprednisolon (MEDROL) dose pack were given. The patient had to follow prednisone dosing and cetirizine (ZYRTEC).  The outcome of the event was not recovered. The causality assessement was not provided.  Follow-up information was received from a medical assisstant on 04-JAN-2021. Additional information has been requested. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008154; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: MMR
Symptoms: Adverse reaction, Vaccination complication
Clinical narrative: severe adverse reaction; This spontaneous report was received from a health care professional via Pfizer and refers to a 64 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.         On approximately 2015 (reported as 5 to 7 years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (lot number was reported as unknown; strength, dose, frequency, route of administration and expiration date were not reported) for prophylaxis.   On an unknown date, the patient reacted severely to vaccination (vaccination complication). The outcome of vaccination complication was unknown.  The causal relationship between the event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; doses were administered following the excursion; This spontaneous report was received from a physician referring to a 13-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T021642, expiration date 21-DEC-2021, at a dose of  0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse event reported.   The vaccine was stored in a temperature of max 16.2  degree Fahrenheit (°F) for 2 hours 28 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion ROTATEQ/one dose of ROTATEQ being administered to a patient; This spontaneous report was received from a medical assistant referring to a 6-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 04-JAN-2021, the patient was vaccinated with  an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1691141, expiration date 01-NOV-2021, at a dose of 2 milliliter, orally for prophylaxis.       The vaccine was stored in a temperature of  8.6 degree Celsius (C) for 11 hours, 15 minutes and 8.7 C for 59 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional ae reported; PROQUAD was administered to a patient post-expiry; This spontaneous report was received from a nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      The nurse reported that one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # S021326 was administered to a patient post-expiry (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The administration was performed by a medical assistant with the practice, not the reporting nurse. She was calling to determine the "integrity" of the vaccine and if the dose needed to be repeated. The involved measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rha) (PROQUAD) expired on 05-JAN-2021 and was administered on 06-JAN-2021. No additional adverse event reported, and no further information provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported; Gardasil 9 had been stored in the freezer rathen than the refrigerator. It was administered one time this morning; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's, pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 11-JAN-2021 (also reported as: this morning), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (route of administration, anatomical location and vaccine scheme were not provided), lot number: R036913 has been verified to be a valid lot number, expiration date was on 23-SEP-2021 as prophylaxis. On the same date (reported as "when we came in today"), it was realized that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had been stored in the freezer rather than the refrigerator (product storage error ) and it was administered one time this morning. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -11 Fahrenheit (°F), for a time frame of 24 hours 0 minutes. A digital data logger was involved. There were no previous temperature excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp and Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired PNEUMOVAX administered; This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 12-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter for prophylaxis, which had expired on 03-DEC-2020 (dose, route and site of administration and lot number were not reported).   No adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error, Syringe issue
Clinical narrative: some of the liquid aerosolized and shot up and out; Syringe somewhat exploded; needle may not have been on all the way; A spontaneous report was received from a man concerning his wife, a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered, syringe issue, and product administration error.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During the administration, the reporter stated that when the nurse pushed the needle into the patient's muscle, the syringe somewhat exploded and some of the liquid aerosolized and shot up and out. The reporter stated that the nurse and pharmacist present during vaccine administration thought the needle may not have been on all the way which caused the issue. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, incorrect dose administered, syringe issue, and product administration error were considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered, Syringe issue, and Product administration error without any associated adverse events.