chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Headache, Injection site pain, Injection site pruritus, Laboratory test
Clinical narrative: PLEURISY; SORE ARM (ELBOW TO SHOULDER); HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; LIGHTHEADED; BLURRED VISION; ITCHY ARM AT INJECTION SITE; BRUISE ON RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: Patient was not sick prior to vaccine and have not had any vaccinations for at least 20 years. Patient did not have a family or personal history of heart disease, clotting issues, or cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid.  On 03-SEP-2021, the patient experienced lightheaded. On 03-SEP-2021, the patient experienced blurred vision. On 03-SEP-2021, the patient experienced itchy arm at injection site. On 03-SEP-2021, the patient experienced bruise on right leg. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced nausea. On 03-SEP-2021, the patient experienced sore arm at injection site. On 05-SEP-2021, the patient experienced pleurisy. On 05-SEP-2021, the patient experienced sore arm (elbow to shoulder). Laboratory data included: CAT scan (NR: not provided) No sign of blood clots, Chest X-ray (NR: not provided) No sign of blood clots, Electrocardiogram (NR: not provided) No sign of blood clots, Fibrin D dimer (NR: not provided) Elevated, and Laboratory test (NR: not provided) No sign of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, bruise on right leg, lightheaded, blurred vision, itchy arm at injection site, sore arm at injection site, sore arm (elbow to shoulder) and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Pleurisy, Vision blurred
Clinical narrative: PLEURISY; SORE ARM (ELBOW TO SHOULDER); HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; LIGHTHEADED; BLURRED VISION; ITCHY ARM AT INJECTION SITE; BRUISE ON RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: Patient was not sick prior to vaccine and have not had any vaccinations for at least 20 years. Patient did not have a family or personal history of heart disease, clotting issues, or cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid.  On 03-SEP-2021, the patient experienced lightheaded. On 03-SEP-2021, the patient experienced blurred vision. On 03-SEP-2021, the patient experienced itchy arm at injection site. On 03-SEP-2021, the patient experienced bruise on right leg. On 03-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced nausea. On 03-SEP-2021, the patient experienced sore arm at injection site. On 05-SEP-2021, the patient experienced pleurisy. On 05-SEP-2021, the patient experienced sore arm (elbow to shoulder). Laboratory data included: CAT scan (NR: not provided) No sign of blood clots, Chest X-ray (NR: not provided) No sign of blood clots, Electrocardiogram (NR: not provided) No sign of blood clots, Fibrin D dimer (NR: not provided) Elevated, and Laboratory test (NR: not provided) No sign of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, bruise on right leg, lightheaded, blurred vision, itchy arm at injection site, sore arm at injection site, sore arm (elbow to shoulder) and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Neck pain
Clinical narrative: Dizziness; Headache; Fever; Chills; Neck pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Aug2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have any known allergy. 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. Concomitant medications included fluoxetine hydrochloride (PROZAC), hydrochlorothiazide (MANUFACTURER UNKNOWN), phentermine (MANUFACTURER UNKNOWN) and unspecified vitamin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 07Aug2021 at 08:00, the patient experienced dizziness, headache, fever, chills, neck pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, headache, fever, chills, neck pain and fatigue were not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Dizziness; Headache; Fever; Chills; Neck pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Aug2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have any known allergy. 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. Concomitant medications included fluoxetine hydrochloride (PROZAC), hydrochlorothiazide (MANUFACTURER UNKNOWN), phentermine (MANUFACTURER UNKNOWN) and unspecified vitamin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 07Aug2021 at 08:00, the patient experienced dizziness, headache, fever, chills, neck pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, headache, fever, chills, neck pain and fatigue were not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Headache; Fever; Chills; Neck pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Aug2021 at 17:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have any known allergy. 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. Concomitant medications included fluoxetine hydrochloride (PROZAC), hydrochlorothiazide (MANUFACTURER UNKNOWN), phentermine (MANUFACTURER UNKNOWN) and unspecified vitamin (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 07Aug2021 at 08:00, the patient experienced dizziness, headache, fever, chills, neck pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, headache, fever, chills, neck pain and fatigue were not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: PROBLEMS WALKING; CONSTANT PAIN; ASYMPTOMATIC COVID-19 (DELTA VARIANT); UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included: scarlet fever, spinal laminectomy surgery from the skull down, and auto accident, and concurrent conditions included: nerve damage in the spinal cord, asthma, depression, non-alcohol user, smoker, and incomplete quad, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient suffers from nerve damage in the spinal cord due to which she has not been able to feel her body for years. She was able to feel her fingers (tingling and pins stopped) couple of hours after vaccination. She felt pins/ needles, tingling and burning in her body all the time but after she received the vaccine, she was able to move, she could feel the tips of her fingers and numbing stopped in her legs, hands, arms and fingers. Patient had multiple surgeries. She had energy and the vaccine helped in calming down her muscle spasms. The patient experienced itch when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the patient experienced unexpected beneficial therapeutic response. On an unspecified date, the patient experienced problems walking, constant pain, and asymptomatic covid-19 (delta variant). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive (Delta variant). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from unexpected beneficial therapeutic response, had not recovered from problems walking, and constant pain, and the outcome of asymptomatic covid-19 (delta variant) was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Gait disturbance, Pain, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: PROBLEMS WALKING; CONSTANT PAIN; ASYMPTOMATIC COVID-19 (DELTA VARIANT); UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included: scarlet fever, spinal laminectomy surgery from the skull down, and auto accident, and concurrent conditions included: nerve damage in the spinal cord, asthma, depression, non-alcohol user, smoker, and incomplete quad, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient suffers from nerve damage in the spinal cord due to which she has not been able to feel her body for years. She was able to feel her fingers (tingling and pins stopped) couple of hours after vaccination. She felt pins/ needles, tingling and burning in her body all the time but after she received the vaccine, she was able to move, she could feel the tips of her fingers and numbing stopped in her legs, hands, arms and fingers. Patient had multiple surgeries. She had energy and the vaccine helped in calming down her muscle spasms. The patient experienced itch when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-APR-2021, the patient experienced unexpected beneficial therapeutic response. On an unspecified date, the patient experienced problems walking, constant pain, and asymptomatic covid-19 (delta variant). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive (Delta variant). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from unexpected beneficial therapeutic response, had not recovered from problems walking, and constant pain, and the outcome of asymptomatic covid-19 (delta variant) was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Headache; Fatigue; vaccine given by subcutaneous route; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 27th August 2021 05:00, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On 27th August 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 28th August 2021, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient reported that the she received Shingrix vaccine and had headache and fatigue. The vaccine was given by subcutaneous route, which led intramuscular formulation administered by other route. The reporter did not consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Incorrect route of product administration
Clinical narrative: Headache; Fatigue; vaccine given by subcutaneous route; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On 27th August 2021 05:00, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On 27th August 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 28th August 2021, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient reported that the she received Shingrix vaccine and had headache and fatigue. The vaccine was given by subcutaneous route, which led intramuscular formulation administered by other route. The reporter did not consented to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; severe headache; chills; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 029L20A and 040C21A) for COVID-19 vaccination.     Medical history was not provided.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). 20-Feb-2021, the patient experienced HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches) outcome was unknown.            This case was linked to MOD-2021-295649, MOD-2021-295635 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; severe headache; chills; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 029L20A and 040C21A) for COVID-19 vaccination.     Medical history was not provided.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). 20-Feb-2021, the patient experienced HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache), CHILLS (chills) and MYALGIA (aches) outcome was unknown.            This case was linked to MOD-2021-295649, MOD-2021-295635 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: blood on the urine; This is a spontaneous report from a Pfizer. A contactable consumer reported that a 92-year-old female patient received bnt162b2 (Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on 20Feb2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced blood on the urine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urine present
Clinical narrative: blood on the urine; This is a spontaneous report from a Pfizer. A contactable consumer reported that a 92-year-old female patient received bnt162b2 (Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on 20Feb2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced blood on the urine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was accidentally given a Pfizer Covid Vaccine instead of a flu shot by a vaccinating certified pharmacy technician. Patient was then given the correct shot which was Afluria Quad PF flu shot.  Patient did not experience any adverse effects to my knowledge. Patient has previously completed his 2 doses of Covid vaccine a little over a month previous to this. This event resulted in the patient getting a 3rd dose of Pfizer covid vaccine. Pt was told to wait 30 minutes for observation. Patient's mother called his doctor to discuss what possible adverse effects to watch out for.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid, Chest X-ray normal, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Intermittently febrile early morning on second day after J&J. Afternoon became suddenly dizzy and lightheaded. Briefly passed out. Was pale, had dusky lips and sudden, perfuse sweating. I drove him immediately to the hospital. On the way there he complained of tingling in both arm and I was unable to palpate a radial pulse. Had weak carotid pulse that skipped beats for a few seconds. Duskiness worsened during this, and improved when normal bets returned. Was weak and dizzy and unable to walk to into the ER. Had elevated BP 143/92. HR 74. O2 sat 96% Resp 17. Orthostatic BP obtained, no hypotension noted. Received 1L bolus of normal saline. Discharged after testing complete and syncope resolved, roughly 2 hours later. Remains intermittently febrile, fatigued, restless and "not feeling right", thought the evening at home.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count normal, Gait inability, Heart rate irregular, Hyperhidrosis
Clinical narrative: Intermittently febrile early morning on second day after J&J. Afternoon became suddenly dizzy and lightheaded. Briefly passed out. Was pale, had dusky lips and sudden, perfuse sweating. I drove him immediately to the hospital. On the way there he complained of tingling in both arm and I was unable to palpate a radial pulse. Had weak carotid pulse that skipped beats for a few seconds. Duskiness worsened during this, and improved when normal bets returned. Was weak and dizzy and unable to walk to into the ER. Had elevated BP 143/92. HR 74. O2 sat 96% Resp 17. Orthostatic BP obtained, no hypotension noted. Received 1L bolus of normal saline. Discharged after testing complete and syncope resolved, roughly 2 hours later. Remains intermittently febrile, fatigued, restless and "not feeling right", thought the evening at home.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lip dry, Metabolic function test, Pallor, Paraesthesia, Pulse absent
Clinical narrative: Intermittently febrile early morning on second day after J&J. Afternoon became suddenly dizzy and lightheaded. Briefly passed out. Was pale, had dusky lips and sudden, perfuse sweating. I drove him immediately to the hospital. On the way there he complained of tingling in both arm and I was unable to palpate a radial pulse. Had weak carotid pulse that skipped beats for a few seconds. Duskiness worsened during this, and improved when normal bets returned. Was weak and dizzy and unable to walk to into the ER. Had elevated BP 143/92. HR 74. O2 sat 96% Resp 17. Orthostatic BP obtained, no hypotension noted. Received 1L bolus of normal saline. Discharged after testing complete and syncope resolved, roughly 2 hours later. Remains intermittently febrile, fatigued, restless and "not feeling right", thought the evening at home.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Syncope, Troponin normal
Clinical narrative: Intermittently febrile early morning on second day after J&J. Afternoon became suddenly dizzy and lightheaded. Briefly passed out. Was pale, had dusky lips and sudden, perfuse sweating. I drove him immediately to the hospital. On the way there he complained of tingling in both arm and I was unable to palpate a radial pulse. Had weak carotid pulse that skipped beats for a few seconds. Duskiness worsened during this, and improved when normal bets returned. Was weak and dizzy and unable to walk to into the ER. Had elevated BP 143/92. HR 74. O2 sat 96% Resp 17. Orthostatic BP obtained, no hypotension noted. Received 1L bolus of normal saline. Discharged after testing complete and syncope resolved, roughly 2 hours later. Remains intermittently febrile, fatigued, restless and "not feeling right", thought the evening at home.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: patient started having left  shoulder pain and back pain 7 days after receiving injection. No numbing, tingling, or skin coclor change. Told patient to take Tylenol and seek medical care.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphoedema
Clinical narrative: Pt developed swelling & pain in armpit on injection side (sounds like lymphedema)
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye movement disorder, Syncope, Tension
Clinical narrative: Patient blanked out, tensed up, and rolled her eyes upward for a few seconds (about 3 seconds) and came out of it saying "what just happened?"  Her breathing became more labored and we had to support her to keep her sitting upright while telling  to keep taking slow, deep breath.  After about 5 mins, patient still did not recover and the ambulance was called.  She has a full physical check up, but nothing was administered.  After that, her mother chose to have her taken to the hospital via the ambulance.;
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Hypoaesthesia, Impaired work ability, Mobility decreased
Clinical narrative: On the day of the vaccine, all I had was the common shoulder ache and mild bilateral knee pain.  The next day I woke up with terrible pain in my spine from about the mid cervical spine to the mid thoracic spine.  It felt like it was in the vertebrae as opposed to a muscle and kept me in bed most of the day and I missed work (which is rare for me).      I then had return of nerve pain in my neck and arms and patchy intermittent numbness in both arms (only the right arm was affected in 2019, but I have more pinched nerves on the left).  The symptoms  resolved in maybe 3-6 weeks after the vaccine and the pain in my neck mostly resolved within about 2-3 months.  My hunch is I just had a severe inflammatory response that made areas with stenosis even smaller, encroaching on the nerve roots
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Neuralgia, Spinal pain
Clinical narrative: On the day of the vaccine, all I had was the common shoulder ache and mild bilateral knee pain.  The next day I woke up with terrible pain in my spine from about the mid cervical spine to the mid thoracic spine.  It felt like it was in the vertebrae as opposed to a muscle and kept me in bed most of the day and I missed work (which is rare for me).      I then had return of nerve pain in my neck and arms and patchy intermittent numbness in both arms (only the right arm was affected in 2019, but I have more pinched nerves on the left).  The symptoms  resolved in maybe 3-6 weeks after the vaccine and the pain in my neck mostly resolved within about 2-3 months.  My hunch is I just had a severe inflammatory response that made areas with stenosis even smaller, encroaching on the nerve roots
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chorioretinopathy
Clinical narrative: Developed a CSCR in my right eye
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chorioretinopathy
Clinical narrative: Developed a CSCR in my right eye
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: My left arm feels weak and is painful at times, especially at night.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I was going thru menopause but almost immediately after both vaccine shots I got a very heavy period twice in a month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Drainage, Fatigue, Injection site pain
Clinical narrative: Intense diarrhea for 2 weeks, achiness at the site, stuffed sinuses, headache due to sinuses, stuffy and runny nose, cough, exhaustion, drainage from sinuses to throat, etc
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Sinus headache
Clinical narrative: Intense diarrhea for 2 weeks, achiness at the site, stuffed sinuses, headache due to sinuses, stuffy and runny nose, cough, exhaustion, drainage from sinuses to throat, etc
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: THE INTENDED VACCINE WAS SHINGRIX.  THE ADMINISTERED VACCINE WAS COVID-19.  NO SYMPTOMS WERE EXPERIENCED AND NO TREATMENT WAS NECESSARY.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Irritable bowel syndrome
Clinical narrative: Abdominal pain Back pain IBS
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Rash
Clinical narrative: Moderate rash around the neck and the lower right side of the face. Soreness and redness around the injection site. Fatigue.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Intense ringing in both my ears about 90-120 minutes after receiving the vaccine.  Called a Dr and he said that this is a rare but known side effect. He said nothing can be done except  wait and see if it goes away.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Burning sensation, Chills, Dizziness
Clinical narrative: Approximately 12 hours after injection, began having weakness, fatigue, chills, nausea. At 14 hours developed dizziness, loss of balance, sensitivity to light, exceptionally painful headache, cycle of shivering and chills to extreme fever, full body pain and feeling as though I were being scalded with hot water. Symptoms continued through the entire night. Arose in the morning at 10:30 am feeling extreme weakness, nausea, loss of balance, fatigue, severe headache, extreme sensitivity to light (which compounded headache pain). Symptoms began subsiding around 1:00 pm. Finally felt normal at approximately 8:00 pm this evening with exception of high level of soreness of right arm at injection site. In short, this was the most horrible feeling I have ever experienced, and I came very close to dialing 911. I did not take anything to try and alleviate any of the symptoms, as I was fearful that it exacerbate some of the conditions.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Nausea
Clinical narrative: Approximately 12 hours after injection, began having weakness, fatigue, chills, nausea. At 14 hours developed dizziness, loss of balance, sensitivity to light, exceptionally painful headache, cycle of shivering and chills to extreme fever, full body pain and feeling as though I were being scalded with hot water. Symptoms continued through the entire night. Arose in the morning at 10:30 am feeling extreme weakness, nausea, loss of balance, fatigue, severe headache, extreme sensitivity to light (which compounded headache pain). Symptoms began subsiding around 1:00 pm. Finally felt normal at approximately 8:00 pm this evening with exception of high level of soreness of right arm at injection site. In short, this was the most horrible feeling I have ever experienced, and I came very close to dialing 911. I did not take anything to try and alleviate any of the symptoms, as I was fearful that it exacerbate some of the conditions.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Photophobia, Pyrexia
Clinical narrative: Approximately 12 hours after injection, began having weakness, fatigue, chills, nausea. At 14 hours developed dizziness, loss of balance, sensitivity to light, exceptionally painful headache, cycle of shivering and chills to extreme fever, full body pain and feeling as though I were being scalded with hot water. Symptoms continued through the entire night. Arose in the morning at 10:30 am feeling extreme weakness, nausea, loss of balance, fatigue, severe headache, extreme sensitivity to light (which compounded headache pain). Symptoms began subsiding around 1:00 pm. Finally felt normal at approximately 8:00 pm this evening with exception of high level of soreness of right arm at injection site. In short, this was the most horrible feeling I have ever experienced, and I came very close to dialing 911. I did not take anything to try and alleviate any of the symptoms, as I was fearful that it exacerbate some of the conditions.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: After first dose started feeling tingling and numbness in my uppper spine base of neck. After 2nd dose pain in my upper spine base of neck, upper left side of back through my collar bone and shoulder.  Went to urgent care on 9/10/21  was told I have Musculoskeletal pain and have been put on pain meds and a muscle relaxer.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain
Clinical narrative: After first dose started feeling tingling and numbness in my uppper spine base of neck. After 2nd dose pain in my upper spine base of neck, upper left side of back through my collar bone and shoulder.  Went to urgent care on 9/10/21  was told I have Musculoskeletal pain and have been put on pain meds and a muscle relaxer.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: Hsv1 genitalia outbreak. First in 6 years.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Delirium, Dyspnoea, Muscle spasms
Clinical narrative: Fever, body aches, chills, difficulty breathing (had to use inhaler three times). Spasms, severe abdominal pain and pain in lungs after inhaler use. Deliriousness from fever. Nausea, dry heaving but no vomiting. The symptoms started around 4:00pm, about two hours after receiving the vaccine. The worst of it lasted for about 14 hours, until around 6:00am the next morning, when I took painkillers to be able to sleep.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pulmonary pain, Pyrexia, Retching
Clinical narrative: Fever, body aches, chills, difficulty breathing (had to use inhaler three times). Spasms, severe abdominal pain and pain in lungs after inhaler use. Deliriousness from fever. Nausea, dry heaving but no vomiting. The symptoms started around 4:00pm, about two hours after receiving the vaccine. The worst of it lasted for about 14 hours, until around 6:00am the next morning, when I took painkillers to be able to sleep.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever, body aches, chills, difficulty breathing (had to use inhaler three times). Spasms, severe abdominal pain and pain in lungs after inhaler use. Deliriousness from fever. Nausea, dry heaving but no vomiting. The symptoms started around 4:00pm, about two hours after receiving the vaccine. The worst of it lasted for about 14 hours, until around 6:00am the next morning, when I took painkillers to be able to sleep.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cheilitis, Lip swelling, Pain in extremity, Peripheral swelling
Clinical narrative: After vaccine, arm hurt, swollen for 3 days. Lips got swollen, rash on lips and surrounding lips, very itchy and burning, whole body itchy and rashy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After vaccine, arm hurt, swollen for 3 days. Lips got swollen, rash on lips and surrounding lips, very itchy and burning, whole body itchy and rashy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia
Clinical narrative: Since the first shot, my left arm where the injection was given is still painful and sore. After five months, the pain is still there. I have tried taking pain medications and massage, but nothing works. Sleeping is very hard.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site rash
Clinical narrative: On 9/1/2021 I received my first Moderna vaccine, and on the morning of 9/10/2021 noticed a fist-sized rash at the injection site. Rash does not itch, but I do feel a burning sensation coming from it.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Developed chronic knee pain in right knee, despite losing 180 lbs. Only appeared after vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Excessive sleepiness about 12 hours after injection lasting almost a day and a half.  A large hard red itchy bump at injection site starting about a week and 44 minutes after injection. (I still have it and so I don't know how long it will last so far it has been almost 14 hours)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Heavy menstrual bleeding, Menstrual disorder, Migraine, Mood altered
Clinical narrative: Change in menstruation.  This is my first ever "long period" in my 24 years of menstruation. Usually, I have a 5 day cycle with extremely predictable flow.   Scheduled period dates were August 27 through August 31. I experienced two days of spotting commencing on August 28th before starting seven days of moderate bleeding, with the last day of normal menstrual bleeding occurring on September 5th. This last day of normal period bleeding was followed by three days of spotting.   This menses was accompanied by the extension of other menstrual symptoms including several days of migraines. Usually I experience a two-day easily manageable migraine beginning a day before my period and extending into my second, and another two-day, easily manageable migraine beginning on the last day of my cycle and extending into the day after. During the "long period" my migraine commenced on the first day of spotting and ended at the end of my first day of menstruation. The end-of-cycle migraine occurred from the last day of my regular period through the period of spotting after, lessening each day.   Emotional moodiness followed the same pattern as the migraines.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Change in menstruation.  This is my first ever "long period" in my 24 years of menstruation. Usually, I have a 5 day cycle with extremely predictable flow.   Scheduled period dates were August 27 through August 31. I experienced two days of spotting commencing on August 28th before starting seven days of moderate bleeding, with the last day of normal menstrual bleeding occurring on September 5th. This last day of normal period bleeding was followed by three days of spotting.   This menses was accompanied by the extension of other menstrual symptoms including several days of migraines. Usually I experience a two-day easily manageable migraine beginning a day before my period and extending into my second, and another two-day, easily manageable migraine beginning on the last day of my cycle and extending into the day after. During the "long period" my migraine commenced on the first day of spotting and ended at the end of my first day of menstruation. The end-of-cycle migraine occurred from the last day of my regular period through the period of spotting after, lessening each day.   Emotional moodiness followed the same pattern as the migraines.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Paranasal sinus discomfort, Pyrexia, Rash
Clinical narrative: Cough, sinus pressure, body covered in rash, fever, hard time breathing, white splotches on skin.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Cough, sinus pressure, body covered in rash, fever, hard time breathing, white splotches on skin.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea
Clinical narrative: I start having a light bleed 1 week prior to my actual period start time. It last 1-2 days if I continue taking my birth control pills on time. This last month (10/28) it was heavier than normal and I decided to not take my birth control. My period ended 9/4. This is very unusual. Being on birth control for 12+ years, I am normally right on track with the pill vs sugar pills
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Vomiting, nausea, chills, fatigue, headache, dizziness, coughing, runny nose, sinus pressure
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paranasal sinus discomfort, Rhinorrhoea, Vomiting
Clinical narrative: Vomiting, nausea, chills, fatigue, headache, dizziness, coughing, runny nose, sinus pressure
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaginal discharge
Clinical narrative: Extremely thick vaginal discharge- like a full cup of jelly on Friday. I have never seen that before.     Today it feels like I will be getting a period soon- cramping and uncomfortable.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Headache; Feeling queasy; Pyrexia; (Reference number: 2021TJP083289) on 29-Aug-2021 and was forwarded to Moderna on 09-Sep-2021.    This case was reported by a family member.  On 24-Aug-2021, the patient received this vaccine (unknown number of doses). Headache, feeling queasy, and pyrexia developed after the vaccination. A call for an ambulance was made.  On 29-Aug-2021, the symptoms resolved.  The outcome of headache, feeling queasy, and pyrexia was reported as recovered.  No follow-up investigation will be possible due to the reporters non-cooperation.  Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Skipped my upcoming period for an entire month including the PMS symptoms.  That has never happened since I?ve started my period as an adolescent. My periods have always been regular.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Myalgia, Pain in extremity
Clinical narrative: Muscle ache on left arm, hypo sugar level
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Heavy menstrual bleeding, Pruritus, Thrombosis, Urticaria
Clinical narrative: First vaccine 8/5/21:  I have an IUD and have not had a period requiring tampons in about 6 years. 8/7/21 had experienced extreme cramping in my lower abdomen. In the morning of 8/8/21 I had bright red heavy menstruation blood; something I have not had in over 6 years. The bleeding continued for about 2 weeks. I also had weird large dark red/purple blood clots coming out.   After about 2 weeks, the bleeding decreased, however, I still have weird discharge, clots, and spotting. After I received the second Pfizer vaccine on 8/27/21, the bleeding turned bright red again and increased for a few days.  Second vaccine 8/27/21 in the AM: On 8/28/21 I woke up covered in full body hives that were itchy, welted patches. Some with red around them. My right arm, which is the one I had the vaccine on, had different type of hives. My right arm was covered with flat red itchy hives that also burned.   I continued to have the full body hives until 8/31/21. Now I get random welted hive patches.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal discharge, Vaginal haemorrhage
Clinical narrative: First vaccine 8/5/21:  I have an IUD and have not had a period requiring tampons in about 6 years. 8/7/21 had experienced extreme cramping in my lower abdomen. In the morning of 8/8/21 I had bright red heavy menstruation blood; something I have not had in over 6 years. The bleeding continued for about 2 weeks. I also had weird large dark red/purple blood clots coming out.   After about 2 weeks, the bleeding decreased, however, I still have weird discharge, clots, and spotting. After I received the second Pfizer vaccine on 8/27/21, the bleeding turned bright red again and increased for a few days.  Second vaccine 8/27/21 in the AM: On 8/28/21 I woke up covered in full body hives that were itchy, welted patches. Some with red around them. My right arm, which is the one I had the vaccine on, had different type of hives. My right arm was covered with flat red itchy hives that also burned.   I continued to have the full body hives until 8/31/21. Now I get random welted hive patches.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Myalgia; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Myalgia), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Additional information received on 30 Aug 2021 contains non-significant information.