chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON RIGHT ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, heart murmur, diastolic dysfunction, osteoporosis, gastric reflux, mitral valve insufficiency, and hyperlipidemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the subject experienced rash on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on right arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Headache, Insomnia, Tinnitus
Clinical narrative: RINGING IN EARS; HEADACHE; SLEEP DIFFICULT; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for diabetes. On 20-APR-2021, the subject experienced ringing in ears. On 20-APR-2021, the subject experienced headache. On 20-APR-2021, the subject experienced sleep difficult. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) Unknown. The action taken with covid-19 vaccine s was not applicable. The patient had not recovered from headache, ringing in ears, and sleep difficult. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, X-ray
Clinical narrative: SHORTNESS OF BREATH; LITTLE CHEST PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, Laboratory data included: ECG (NR: not provided) normal, and X-ray (NR: not provided) normal. On an unspecified date, the subject experienced shortness of breath, and little chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and little chest pain was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: ACHES AND PAINS; HEADACHE; This spontaneous report received from a consumer concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced aches and pains. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, and headache on 18-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: DRUG ADMINISTRATION ERROR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug administration error was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE PAIN IN THE ARM; This spontaneous report received from a consumer via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced little pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little pain in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503803.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Chronic Left arm pain still lasting for 30 days
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Fatigue, mild body ache, headache.  Diarrhea 20 hours later.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body Aches, chills, low grade fever, fatigue - treatment was rest  Lasted about afternoon of Monday (May 3) through the night.  Tuesday still had minor body aches and was tired.  Wednesday feel 100% now.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Uncontrollable shaking for 20 minutes
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: pt complaining about arm pain- says too high in shoulder- felt tingling sensation as if she hit funny bone and states is in too much pain. it was explained that it has not been 24 hours yet, but wants her side effect reported
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt is 17 Y/O and was vaccinated with Moderna
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling and severe itching on injection arm; blistering around injection site; redness.  Pain radiating down arm and up neck.  Swollen painful lymph nodes under arms and in neck (worse on side of injection)  Treatment:  benedryl and tylenol/advil.  significant swelling and itching, blistering and lymph node swelling resolved on 5/42021.  Minor itching and radiating pain continue, but are lessened by advil/tylenol and benedryl.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Swelling and severe itching on injection arm; blistering around injection site; redness.  Pain radiating down arm and up neck.  Swollen painful lymph nodes under arms and in neck (worse on side of injection)  Treatment:  benedryl and tylenol/advil.  significant swelling and itching, blistering and lymph node swelling resolved on 5/42021.  Minor itching and radiating pain continue, but are lessened by advil/tylenol and benedryl.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Heart rate increased, Hypoaesthesia
Clinical narrative: Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour.  Difficulty remaining conscious and numbness in my face.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Magnetic resonance imaging, Neck pain, Pain in extremity
Clinical narrative: Patient developed neck pain and right shoulder pain the day of her shot.  Then the pain started going down her right arm and she developed weakness and paresthesias.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient developed neck pain and right shoulder pain the day of her shot.  Then the pain started going down her right arm and she developed weakness and paresthesias.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Pain
Clinical narrative: Elevated heart rate/pulse, hasn't gone below 90 (normal pulse runs from 40-70) - ongoing Body aches Chills  Headache Fatigue
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Dizziness, High blood pressure
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Low fever, chills, body aches, fatigue
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient 16 at the time of vaccine. Moderna not approved for under 18 yrs of age. No adverse affects noted by mother 24 hours later.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia
Clinical narrative: Lost my Taste sense the following date after second vaccine shot.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, SARS-CoV-2 test, Scan
Clinical narrative: Lost my Taste sense the following date after second vaccine shot.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Epistaxis, Fatigue, Headache
Clinical narrative: Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, ankles), nose bleed, left armpit pain, fever, chills, night sweats began next day (5.4.21) and continued to 5.5.21. Adverse effects ongoing.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Left arm soreness, fatigue, headache all began same day. Migraine, joint stiffness (elbows, hips, ankles), nose bleed, left armpit pain, fever, chills, night sweats began next day (5.4.21) and continued to 5.5.21. Adverse effects ongoing.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was painful to the touch, hot, hard, and red. The redness swelled into a 3? area. After two weeks, the redness subsided, but there is still a hard ?knot? at the injection site, and it continues to be hard and painful if pushed.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180MCG OF PFIZER COVID 19 VACCINE IMx1.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell?s Palsy (right side of face)
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue beginning about 6 hours after the injection, fever and nausea beginning 12 hours after the injection and lasting 24 hours.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Blood culture positive, COVID-19, Confusional state
Clinical narrative: Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16).  Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake.  Found to be febrile, hypotensive w/increased confusion.  Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia.  Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Culture urine positive, Dyspnoea, Escherichia urinary tract infection, Hypophagia
Clinical narrative: Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16).  Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake.  Found to be febrile, hypotensive w/increased confusion.  Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia.  Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Loss of personal independence in daily activities, Lung opacity, Pleural effusion, Pyrexia
Clinical narrative: Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16).  Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake.  Found to be febrile, hypotensive w/increased confusion.  Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia.  Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Staphylococcal bacteraemia
Clinical narrative: Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16).  Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake.  Found to be febrile, hypotensive w/increased confusion.  Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia.  Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Influenza like illness, Pain
Clinical narrative: excruciating pain in lower right back for 24 hours. Still minor aches 4 weeks later  After second dose, flu like aches everywhere for 24 hours, especially in my back.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Hypoaesthesia oral, Nausea
Clinical narrative: Immediately had strong metallic taste, accompanied by mild nausea.  Began drinking lots of water, which did help.  Lips became numb, but did not swell, no difficulty breathing or tightness in chest.  Symptoms were mild, so no treatment was needed., so I went home to rest and hydrate.  Continued to drink lots of water.  Felt very fatigued and lips were numb for 4-5 hours post vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen and tender lymph nodes i left armpit for 7 days. This was a different pain from the injection site soreness I had too for a few days. From the lymph swelling my arm hurt for a full week.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Vertigo, Vomiting
Clinical narrative: Overall illness, fatigue, vomiting, joint pain, vertigo
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pruritus, Skin hyperpigmentation
Clinical narrative: red nodule forms in arm, itchy, then improves, skin gets hyperpigmented and nodule resolves. Then new nodule appears in different location on arm. the hyperpigmented areas remain and are itchy. All in right arm.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: complaint of dizziness, light headed
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, chills, vomiting, severe headache, swollen lymph nodes and fatigue.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever, chills, vomiting, severe headache, swollen lymph nodes and fatigue.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: vaccine 4/29/21 5/4/21 left arm red, painful, swollen and indurated
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Lethargy, Movement disorder, Peripheral swelling, Skin warm
Clinical narrative: Day of shots, warm to touch, lethargy. Question of swollen tongue. Next morning not using legs per mom. Left leg red and swollen. Did not use legs until the afternoon. Seemed a little shaky, but not clearly a seizure per mom. Staring at fingers more.  Seemed a little out of it. Mother also states that since the vaccines, his speech has regressed and she has concerns of autism.  The shots were given by another pediatric office. This was the first time I met the family.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Speech disorder, Staring, Tremor
Clinical narrative: Day of shots, warm to touch, lethargy. Question of swollen tongue. Next morning not using legs per mom. Left leg red and swollen. Did not use legs until the afternoon. Seemed a little shaky, but not clearly a seizure per mom. Staring at fingers more.  Seemed a little out of it. Mother also states that since the vaccines, his speech has regressed and she has concerns of autism.  The shots were given by another pediatric office. This was the first time I met the family.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Tunnel vision
Clinical narrative: Pt brought to med obs #1 via stretcher with c/o lightheadedness, tunnel vision, and brief LOC. Pt placed on floor with BLE elevated prior to stretcher arrival. Pt able to ambulate to stretcher without difficulty. Pt reports he felt better upon arrival to med obs #1. Reports he ate breakfast PTA. Accepted water, declined snack. VSS. Symptoms resolved. Sent home with parents. Escorted to exit with staff. VS are as follows: 1106: BP 124/75, HR 53, RR 18, O2 sat 99% on RA 1111: BP 134/71, HR 59, RR 18, O2 sat 98% on RA
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Tremor
Clinical narrative: Chills, uncontrollable shacking, nausea, extreme fatigue, on and off headaches,
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: CSF test abnormal, Cerebrovascular accident, Disorientation, Electroencephalogram, Encephalitis
Clinical narrative: presented to local ED lethargic, disoriented and unable to provide clear history on evening of 5/1/21 with severe frontal headache and increasing lethargy throughout the day.  Admitted to hospital with suspected subacute stroke.  Overnight developed LT sided weakness and RT gaze.  Transferred to another healthcare facility on 5/3/21 with suspected seizure / encephalitis.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis, Lethargy, Meningitis, Seizure
Clinical narrative: presented to local ED lethargic, disoriented and unable to provide clear history on evening of 5/1/21 with severe frontal headache and increasing lethargy throughout the day.  Admitted to hospital with suspected subacute stroke.  Overnight developed LT sided weakness and RT gaze.  Transferred to another healthcare facility on 5/3/21 with suspected seizure / encephalitis.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever blister outbreak that continued for 21 days despite regular use of Valcylovir prescription
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Terrible headache, chills, body aches, extreme fatigue
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: PT HERE FOR 2ND DOSE OF PFIZER. RN NOTICED PT RECD FIRST DOSE TO LEFT TRICEPT RATHER DELTOID, RESULTING A BRUISED. NO OTHER SYMPTOMS REPORTED FROM PT.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Dizziness, Dyspnoea, Sepsis
Clinical narrative: Pneumonia due to COVID-19 virus Sepsis   Shortness of Breath ? Weakness - Generalized ? Dizziness
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna was administered as the 2nd dose in error. Patient should have received Pfizer.
Age: 37.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and mild swelling in/near injection site (right arm) of Engerix-B vaccine. Pain increased day after vaccination.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dry skin, Feeling abnormal, Feeling hot
Clinical narrative: Several hours after the shot, I began to feel very hot all over my face and body. I got very dry to the touch and I became extremely thirsty. I also had full body tremors. When I woke up the next morning (5/4) around 10 a.m., I had a fever, headache, and serious brain fog. My legs ached, especially my hips and knees. The intense thirst and dryness also persisted. I felt lightly nauseous on and off. I took an extra strength Tylenol and drank a lot of water before sleeping again until around 4 p.m.. Once I woke up, I was still suffering from all the aforementioned symptoms, but with less severity. I had another extra strength Tylenol and drank water and a sports drink. I ate a granola bar right after the Tylenol and started to feel a little better. Then I got really hungry, so I ate a muffin and drank an energy+ juice drink that had 80mg caffeine derived from green and black tea. I started to feel a lot better after that, though I was still weak and experiencing aching in my legs and hips. I took another nap from 7 p.m. to 9 p.m. and then ate once more before going to sleep for the night around 1:30 a.m. I have woken up today (5/5) with a slight headache but no other symptoms save the injection site soreness that has also persisted since a few hours after the shot. A note for comparison: as reported, this is my 2nd dose. My first dose had no symptoms whatsoever aside from injection site soreness.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hunger, Injection site pain, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Several hours after the shot, I began to feel very hot all over my face and body. I got very dry to the touch and I became extremely thirsty. I also had full body tremors. When I woke up the next morning (5/4) around 10 a.m., I had a fever, headache, and serious brain fog. My legs ached, especially my hips and knees. The intense thirst and dryness also persisted. I felt lightly nauseous on and off. I took an extra strength Tylenol and drank a lot of water before sleeping again until around 4 p.m.. Once I woke up, I was still suffering from all the aforementioned symptoms, but with less severity. I had another extra strength Tylenol and drank water and a sports drink. I ate a granola bar right after the Tylenol and started to feel a little better. Then I got really hungry, so I ate a muffin and drank an energy+ juice drink that had 80mg caffeine derived from green and black tea. I started to feel a lot better after that, though I was still weak and experiencing aching in my legs and hips. I took another nap from 7 p.m. to 9 p.m. and then ate once more before going to sleep for the night around 1:30 a.m. I have woken up today (5/5) with a slight headache but no other symptoms save the injection site soreness that has also persisted since a few hours after the shot. A note for comparison: as reported, this is my 2nd dose. My first dose had no symptoms whatsoever aside from injection site soreness.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Thirst, Tremor
Clinical narrative: Several hours after the shot, I began to feel very hot all over my face and body. I got very dry to the touch and I became extremely thirsty. I also had full body tremors. When I woke up the next morning (5/4) around 10 a.m., I had a fever, headache, and serious brain fog. My legs ached, especially my hips and knees. The intense thirst and dryness also persisted. I felt lightly nauseous on and off. I took an extra strength Tylenol and drank a lot of water before sleeping again until around 4 p.m.. Once I woke up, I was still suffering from all the aforementioned symptoms, but with less severity. I had another extra strength Tylenol and drank water and a sports drink. I ate a granola bar right after the Tylenol and started to feel a little better. Then I got really hungry, so I ate a muffin and drank an energy+ juice drink that had 80mg caffeine derived from green and black tea. I started to feel a lot better after that, though I was still weak and experiencing aching in my legs and hips. I took another nap from 7 p.m. to 9 p.m. and then ate once more before going to sleep for the night around 1:30 a.m. I have woken up today (5/5) with a slight headache but no other symptoms save the injection site soreness that has also persisted since a few hours after the shot. A note for comparison: as reported, this is my 2nd dose. My first dose had no symptoms whatsoever aside from injection site soreness.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: Body aches, headache, fever/chills, nausea, enlarged lymph node at arm pit
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches, headache, fever/chills, nausea, enlarged lymph node at arm pit
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Coordination abnormal, Discomfort, Dizziness, Dyspnoea
Clinical narrative: Started with numbness and tingling throughout both legs and progressively worsening to severe full body burning/buzzing pain. Also experienced dizziness and slight loss of muscle strength/coordination. Difficulty breathing.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Started with numbness and tingling throughout both legs and progressively worsening to severe full body burning/buzzing pain. Also experienced dizziness and slight loss of muscle strength/coordination. Difficulty breathing.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: CLIENT STATES 4 DAYS AFTER 2ND DOSE MODERNA DEVELOPED "PARATHESIA" IN ARM SHOULDER DOWN - NOW IN  WRIST AND  CMC JOINT L ARM -
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180 MCG OF PFIZER COVID 19 VACCINE IM.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Eczema, Emotional distress, Feeling hot, Flatulence, Headache
Clinical narrative: Started November 2020 - Says my head is HOT. please put some water on my forehead. (Started Nov 12th 2020 - happens every day) he feels better after putting some water on his forehead. Issue Continues.  December 2020 - Biting Nails. He never bit his nails before this. Issue continues  December 2020 - High Emotions over every little thing. Issue Continues. December 2020 - Passing gas multiple times a day - Frequency is increasing. He probably passed gas once in 3 months. a sudden change. Issue Continues.   January 2021 - Eczema (starts with dryness on skin) on face, back of the knees, back of the ears. He has had some itchiness in the back in last 2 years but this is way beyond anything - ever. Issue Continues  January 2021 - Complaints of headache 3-4 times a week, he complains of a headache that lasts 2-3 minutes. If I massage his head, it goes away. this issue has subsided since Mid April.   February 2021 - Vomiting - Stomach is very sensitive now, He has vomited 6 times in February and March. this has subsided since.  February 2021 - Pee in pants every day. this never really happened before. it may have happened once in 6 months before. a drastic change. Issue Continues.  February 2021 - Sneezing in the morning specially (started mid-Feb 2021 Every day) Multiple sneezes for a couple of hours. Issue continues.   March 2021 - Stuffy Nose - this issue used happen 1-2 times a year, when he would get sick. Nothing like this before. Issue continues.   March/April 2021 - More Eczema issues appearing on face. Issue continues.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Nasal congestion, Onychophagia, Pruritus, Sneezing, Urinary incontinence
Clinical narrative: Started November 2020 - Says my head is HOT. please put some water on my forehead. (Started Nov 12th 2020 - happens every day) he feels better after putting some water on his forehead. Issue Continues.  December 2020 - Biting Nails. He never bit his nails before this. Issue continues  December 2020 - High Emotions over every little thing. Issue Continues. December 2020 - Passing gas multiple times a day - Frequency is increasing. He probably passed gas once in 3 months. a sudden change. Issue Continues.   January 2021 - Eczema (starts with dryness on skin) on face, back of the knees, back of the ears. He has had some itchiness in the back in last 2 years but this is way beyond anything - ever. Issue Continues  January 2021 - Complaints of headache 3-4 times a week, he complains of a headache that lasts 2-3 minutes. If I massage his head, it goes away. this issue has subsided since Mid April.   February 2021 - Vomiting - Stomach is very sensitive now, He has vomited 6 times in February and March. this has subsided since.  February 2021 - Pee in pants every day. this never really happened before. it may have happened once in 6 months before. a drastic change. Issue Continues.  February 2021 - Sneezing in the morning specially (started mid-Feb 2021 Every day) Multiple sneezes for a couple of hours. Issue continues.   March 2021 - Stuffy Nose - this issue used happen 1-2 times a year, when he would get sick. Nothing like this before. Issue continues.   March/April 2021 - More Eczema issues appearing on face. Issue continues.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Started November 2020 - Says my head is HOT. please put some water on my forehead. (Started Nov 12th 2020 - happens every day) he feels better after putting some water on his forehead. Issue Continues.  December 2020 - Biting Nails. He never bit his nails before this. Issue continues  December 2020 - High Emotions over every little thing. Issue Continues. December 2020 - Passing gas multiple times a day - Frequency is increasing. He probably passed gas once in 3 months. a sudden change. Issue Continues.   January 2021 - Eczema (starts with dryness on skin) on face, back of the knees, back of the ears. He has had some itchiness in the back in last 2 years but this is way beyond anything - ever. Issue Continues  January 2021 - Complaints of headache 3-4 times a week, he complains of a headache that lasts 2-3 minutes. If I massage his head, it goes away. this issue has subsided since Mid April.   February 2021 - Vomiting - Stomach is very sensitive now, He has vomited 6 times in February and March. this has subsided since.  February 2021 - Pee in pants every day. this never really happened before. it may have happened once in 6 months before. a drastic change. Issue Continues.  February 2021 - Sneezing in the morning specially (started mid-Feb 2021 Every day) Multiple sneezes for a couple of hours. Issue continues.   March 2021 - Stuffy Nose - this issue used happen 1-2 times a year, when he would get sick. Nothing like this before. Issue continues.   March/April 2021 - More Eczema issues appearing on face. Issue continues.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Moderna Covid-19 Vaccine EUA swelling and redness on arm around injection site fatigue
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: On 4/2/21, experienced facial swelling.  on 4/2/2021 and continuing to present, experienced whole body hives.  On 5/4/2021 and continuing to present, experienced facial swelling.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Needle issue, Underdose
Clinical narrative: Patient received less than half the dose of the vaccine due to a needle malfunction.  He was then given another dose of the vaccine.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received mRNA mixed vaccine series. Patient received first dose Moderna at outside facility and second dose as Pfizer. Manager notified of Pfizer vaccination. Patient information obtained, will f/up as needed. 30 minute obs completed. No reaction documented at this time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delayed period
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: Today is the first  day, started in the early morning hours, Vertigo , off balance, dizziness... I?ve never had this before
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180 MCG OF PFIZER COVID 19 VACCINE IM.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: At this time patient has remained free of any s/sx of adverse reaction, reporting that he received the wrong dose of vaccine, on 5/4/2021 he was to receive 0.5ml of Jensen Covid vaccine and he received 2.5ml of the vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: 5/5/2021 57 y/o female with past medical of hypertension and anxiety, who presents with headache, dizziness and lightheadedness post vaccination. Patient states that this is her 2nd dose in the two-dose series. Patient states that with the first vaccination she experienced fever, headache, chills and tiredness. Patient states that she received her vaccination to the Left arm. NP and Paramedics at patient side. Patient placed on wheelchair and vital assessed. Patient BP 180/100 R arm, 98% RA, 75 P. Patient states that she took Metoprolol this am but forgot to take her Hydrochlorothiazide. Patient also states that she fears needles. Patient was monitored with repeat vitals and patient remained hypertensive, 179/102 BP, 213/116, 189/109, 187/107, 197/110, 208/110 with all other vitals within normal limits. Within 20 mins of monitoring patient it was determined that patient should be transported to the emergency room via fire rescue. Fire rescue arrived on scene, advised patient that she should be transported to the ER but the patient refused. Patient aware of the risks involved, such as hypertensive crisis, stroke or cardiac event. Patient signed out Against Medical Advice. CNO and PM aware.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Just a sudden onset of pain and tenderness  in the area shot was administered 11 days after receiving 2nd dose,  like receiving a shot all over again but the pain is more pronounced and lingering.  No treatment as of right now just a dull pain that?s lasted 2 days so far.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Excessive eye blinking, Hyperhidrosis, Syncope
Clinical narrative: DIZZY, DIAPHORETIC, EYES FLUTTERING, SYNCOPE, SEEN BY PARAMEDICS, BP 171/90 HR 97, BS: 99. PT HAS NO HX OF SYNCOPE, REFUSED TRANSPORT, AMA SIGNED.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Pain, SARS-CoV-2 test positive
Clinical narrative: Head cold, body aches, fatigue
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Client had a breakthrough infection.  Test date was 5/3/21 and symptoms started 5/3/21.  2nd Dose Moderna 3-19-21 Lot Number 012A21A
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient is a 31 y.o. female admitted on 5/1/2021     Please refer to the History and Physical report for information on presentation. 31-year-old female with no significant past medical history was admitted to the hospital due to left-sided flank pain radiating to the groin.  CAT scan abdomen pelvis was done which showed 3 mm obstructing ureteric calculi leading to left-sided hydronephrosis.  Additional nonobstructing stones of both kidneys were also noted.  Patient was started on Flomax for pain management.  UA was also grossly positive, patient was started on ceftriaxone.  Urology was consulted, recommended stent placement if patient unable to pass stone.  However patient was able to pass stone within 24 hours.  Patient will be discharged home on Ceftin to complete 7 days course.  Blood sugars were also noted to be elevated during her hospital course.  A1c not back at the time of discharge.  Patient was instructed to follow-up with her PCP, for results of A1c, and up titration of medication.  Patient will be discharged on 500 mg Metformin.  Patient understands the plan
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain lower, Back pain, Flank pain, Hepatic steatosis, Nausea
Clinical narrative: Patient is a 31 y.o. female admitted on 5/1/2021     Please refer to the History and Physical report for information on presentation. 31-year-old female with no significant past medical history was admitted to the hospital due to left-sided flank pain radiating to the groin.  CAT scan abdomen pelvis was done which showed 3 mm obstructing ureteric calculi leading to left-sided hydronephrosis.  Additional nonobstructing stones of both kidneys were also noted.  Patient was started on Flomax for pain management.  UA was also grossly positive, patient was started on ceftriaxone.  Urology was consulted, recommended stent placement if patient unable to pass stone.  However patient was able to pass stone within 24 hours.  Patient will be discharged home on Ceftin to complete 7 days course.  Blood sugars were also noted to be elevated during her hospital course.  A1c not back at the time of discharge.  Patient was instructed to follow-up with her PCP, for results of A1c, and up titration of medication.  Patient will be discharged on 500 mg Metformin.  Patient understands the plan
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nephrolithiasis, Urinary tract infection, Vomiting
Clinical narrative: Patient is a 31 y.o. female admitted on 5/1/2021     Please refer to the History and Physical report for information on presentation. 31-year-old female with no significant past medical history was admitted to the hospital due to left-sided flank pain radiating to the groin.  CAT scan abdomen pelvis was done which showed 3 mm obstructing ureteric calculi leading to left-sided hydronephrosis.  Additional nonobstructing stones of both kidneys were also noted.  Patient was started on Flomax for pain management.  UA was also grossly positive, patient was started on ceftriaxone.  Urology was consulted, recommended stent placement if patient unable to pass stone.  However patient was able to pass stone within 24 hours.  Patient will be discharged home on Ceftin to complete 7 days course.  Blood sugars were also noted to be elevated during her hospital course.  A1c not back at the time of discharge.  Patient was instructed to follow-up with her PCP, for results of A1c, and up titration of medication.  Patient will be discharged on 500 mg Metformin.  Patient understands the plan
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Reported a buzzing in the ears that has been constant started 3 days after shot in the morning on 5/1/2021 and has not stopped since. She called today to report (5/5/2021) and it has not stopped she is currently still experience non stop tinnitus, pharmacist recommended visiting her physician to follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, nausea
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product preparation error
Clinical narrative: PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180 MCG OF PFIZER COVID 19 VACCINE IM.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Injection site pain, Myalgia, Nausea
Clinical narrative: Aching muscles & bones, nausea for approximately 24 hours. Sore arm at site of injection for 48+ hours.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: high fever to 104 (reported by patient), chills, fatigue, HA, and body aches. Red, pruritic raised rash to entire R upper arm, extending into axilla and R side of chest, lasting days
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: high fever to 104 (reported by patient), chills, fatigue, HA, and body aches. Red, pruritic raised rash to entire R upper arm, extending into axilla and R side of chest, lasting days
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle fatigue
Clinical narrative: Muscle fatigue,  headache, for 1 day
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgias, fever to 101, mild headache and mild cough all started within 24 hours of vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Induration, Pain, Pruritus
Clinical narrative: Minor soreness and headache day of and day after, then fine until one week later, when I noticed it itching quite a lot. The shoulder is hardened, slightly reddened and warm - still today as it was Sunday, May 2nd.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Minor soreness and headache day of and day after, then fine until one week later, when I noticed it itching quite a lot. The shoulder is hardened, slightly reddened and warm - still today as it was Sunday, May 2nd.
Age: 26.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse side affects per patient at this time, wrong vaccination given. IPOL was given instead of HPV.  Provider informed of vaccination error and patient to return to clinic for proper vaccine.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Nausea and sweaty for 5 minutes following vaccination
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pharyngeal swelling, Pruritus, Wheezing
Clinical narrative: 9:10AM - 2nd dose of Moderna given, reviewed common s/sx and signs of severe reaction, advised to do 30 min observation, pt agreed to plan. 9:20AM - Complaints of severe bilateral arm itching.  VS taken. BP 150/92, HR 66, O2 95% RA, RR 20. 9:25AM - Diphenhydramine 25mg PO given. 9:30AM - Developed severe coughing, shortness of breath, throat swelling. O2 Sat 92% RA. Lungs sounds - clear inspiration with expiratory wheezing. Pt refused epi-pen, symptoms continued to worsen, pt agreed to receive an injection of epi. 9:37AM - Epinephrine IM 0.3mg to the right thigh given. O2 given, non-rebreather with 8L/min. 9:45AM - Pt symptoms improved, breathing easily and talking. O2 Sat 99% on O2 8L/min. 09:50AM - Paramedics arrived. 10:00AM - Paramedics took a new set of VS. BP 188/94, HR 76, RR 20, O2 Sat 99% RA. No SOB, No itching. 10:15AM - Pt left via ambulance to Hospital.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: patient experienced a large swelling of the upper arm without breaking of the skin, this lasted 2 weeks before subsiding
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling of body temperature change, Headache, Lumbar vertebral fracture
Clinical narrative: Headache with flashing light; Hot and cold; Moderna arm / Red below deltoid muscle; Hot at the injection site; Itchy at the injection site; Extreme fatigue / Could not get up for 2 days / Lay down for 2 days; Headache with flashing light; Broke her L2 vertebra; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoporosis, Blood pressure high and Migraine.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light). At the time of the report, LUMBAR VERTEBRAL FRACTURE (Broke her L2 vertebra), PHOTOPSIA (Headache with flashing light), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), ERYTHEMA (Moderna arm / Red below deltoid muscle), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site), FATIGUE (Extreme fatigue / Could not get up for 2 days / Lay down for 2 days) and HEADACHE (Headache with flashing light) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for all events except Lumbar vertebral fracture which is unlikely.   This case was linked to MOD-2021-092132 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for all events except Lumbar vertebral fracture which is unlikely.