chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Late-onset localized reaction at the site of the injection characterized by redness, increased warmth, and swelling. Reaction area is ovular in shape and was initially approximately 3 inches in length and 1.5 inches in diameter, but increased in size slightly over the course of 12 hours. As of 04:45AM on March 12, 2021, localized reaction has decreased in redness and swelling, but is not yet fully resolved. Area of the local reaction is equal in size to previous day.  Patient (self) has taken Zyrtec and Allegra over-the-counter medications for allergies daily, with no effect on the localized reaction. Patient has not taken any anti-inflammatory medications or medications other than those described above prior to or following onset of the localized reaction. No other symptoms have been observed at this time.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Severe headsche, nausea, vomiting
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Roughly 10 hours after receiving the shot I began experiencing Achyness and a fever.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Tenderness
Clinical narrative: Rash appeared on arm with tenderness and swelling 7 days after injection. Lymph nodes in neck were also tender.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Pain, Tinnitus
Clinical narrative: Severe ringing in ears for about 24 hrs.  Bad body aches  My head felt like it was going to explode  Spent the day in bed on Thursday until 6:30 pm. Only to go back to bed at 9 pm  Left arm sore and swollen through Friday
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101.7
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever of 101.6, chills, aches, and headache, began the morning after the shot and lasted until about midnight.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough that has persisted since March 7
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Dizziness, body aches, nausea
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: Client verbalized having a metallic taste in his mouth immediately after receiving vaccine.  Client seen by EMT and refused to be assessed and stated that taste went away as soon as he drank some water.  Cleared to go home by EMT.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives throughout the body, will treat with Benadryl at home but if I don?t see improvement I?ll go in to doctors office for evaluation. Janssen COVID-19 Vaccine EUA
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sinus congestion
Clinical narrative: 101 fever, body aches, sinus congestion
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: My eyes were swollen, rash on face and body, prednisone treatment 20 mg for 12 days and zyrtec
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: One week after receiving shot, I have a rash at injection site.  Rash is red, raised and itchy, approximately 2-3 inches in diameter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Muscle tightness
Clinical narrative: Pt. states she received vaccine and left the park but started to feel her jaw clenching and some tightness in the neck so she came back and was seen and assessed by EMT.  Vital signs: BP 134/84, HR 78, O2 96%.  20 min. into observation  she verbalized sensation began to decrease,  When asked, she said that she could swallow.  When asked if she had difficulty breathing, she said no difficulty breathing and felt no other symptoms at the moment.  Pt. advised to contact PCP, go to the ER or an urgent care if any other symptoms arise.  Client and daughter verbalized understanding of instruction and cleared to leave by EMT.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Osteoarthritis, Osteopenia, Tendon disorder
Clinical narrative: Left Shoulder pain and weakness leading to rotator cuff tendinopathy. This was addressed at our clinic initially on 2/8/21 and then on 3/3/21.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb abnormal
Clinical narrative: Left Shoulder pain and weakness leading to rotator cuff tendinopathy. This was addressed at our clinic initially on 2/8/21 and then on 3/3/21.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Thrombosis of the  vein branch of the left eye.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry mouth, Fatigue, Headache, Lip blister
Clinical narrative: Dry Mouth, Thick Tongue (Similar to previous allergies involving hives) Small, blister type, peeled skin on upper right lip Sore Throat Cough Headache Nauseous Fatigue
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Skin exfoliation, Tongue disorder
Clinical narrative: Dry Mouth, Thick Tongue (Similar to previous allergies involving hives) Small, blister type, peeled skin on upper right lip Sore Throat Cough Headache Nauseous Fatigue
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chills, Heart rate decreased, Injection site rash
Clinical narrative: 3"rash around site, chills and fever after 30 minutes of injection, fever for 36 hrs, then hives started on Monday 3/1, Went to emergency in early evening they gave me intravenous meds and released me 3 hours later.  On Tues 3/2/21 about 5:00 pm hives and itching continued and got worst. I went back to emergency and they treated me will pill form medications and released me about 3 hours later. I was still with hives and some itching. On Wed morning 3/3/21 I woke up with severe hives and itching and my face and lips had now blown up and were getting worst. about 3 times the size. We returned to Hospital and the admitted me. I stayed untill Sat morning 3/6/21. I was treated with high doses of steroids, wore a heart monitor because my heart rate dropped to 40 at night.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Pyrexia, Swelling face, Urticaria
Clinical narrative: 3"rash around site, chills and fever after 30 minutes of injection, fever for 36 hrs, then hives started on Monday 3/1, Went to emergency in early evening they gave me intravenous meds and released me 3 hours later.  On Tues 3/2/21 about 5:00 pm hives and itching continued and got worst. I went back to emergency and they treated me will pill form medications and released me about 3 hours later. I was still with hives and some itching. On Wed morning 3/3/21 I woke up with severe hives and itching and my face and lips had now blown up and were getting worst. about 3 times the size. We returned to Hospital and the admitted me. I stayed untill Sat morning 3/6/21. I was treated with high doses of steroids, wore a heart monitor because my heart rate dropped to 40 at night.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Night sweats
Clinical narrative: Fever onset about 7am 100.1, up to 102.8 at 1pm; chills; Tylenol given at 8pm; night sweats; body aches; extreme fatigue; nausea; headache;   7am next day no fever; continued body aches, fatigue and headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever onset about 7am 100.1, up to 102.8 at 1pm; chills; Tylenol given at 8pm; night sweats; body aches; extreme fatigue; nausea; headache;   7am next day no fever; continued body aches, fatigue and headache
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Thrombosis
Clinical narrative: Blood clot, swelling noticed a few hours aftee vaccine.  Probably coincidence but felt it should be reported. Im not sure if the doctor she saw for blood clot knew she got the vaccine. It was a different clinic.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Sleep disorder
Clinical narrative: I received the shot around 11AM on the 11th. By 5PM that evening I was beginning to have a headache and chills. I drove home from work and by 6PM I had severe chills, I was shaking so bad I could barely fill a cup of water and take ibuprofen, the water was sloshing out of the cup. I had a fever of 102 and spend the rest of the evening in bed, shaking. By around 10 PM the severe chills had subsided and my fever was 101.  I did not sleep much during the night due to a headache and alternating chills/sweating. This morning it is 7 AM and my temperature is 99.5 and I am beginning to feel more normal. I took advil at first and then tylenol every 4 hours during the night.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I received the shot around 11AM on the 11th. By 5PM that evening I was beginning to have a headache and chills. I drove home from work and by 6PM I had severe chills, I was shaking so bad I could barely fill a cup of water and take ibuprofen, the water was sloshing out of the cup. I had a fever of 102 and spend the rest of the evening in bed, shaking. By around 10 PM the severe chills had subsided and my fever was 101.  I did not sleep much during the night due to a headache and alternating chills/sweating. This morning it is 7 AM and my temperature is 99.5 and I am beginning to feel more normal. I took advil at first and then tylenol every 4 hours during the night.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Erythema of eyelid, Eyelids pruritus, Injection site rash, Injection site reaction
Clinical narrative: Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Pain
Clinical narrative: Woke up at midnight and had severe chills. A few hours later took my temperature and it was 101.3. Took 2 Tylenol. Few hours later temp was 99.1. For the remainder of the day had body aches, fatigue and large headaches. Finally subsided 24 hours later and now I feel relatively fine.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt fainted wile seated.  emergency services were called.  she recovered quickly. we gave some candy and water.  her bp was normal and osat was normal.  mother drove her home
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: 9 weeks
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Pain, Palpitations, Sleep deficit
Clinical narrative: Immediate face redness and swelling.  Later in evening no sleep and heart racing, next day no energy and body soreness.  Day 2 heart racing at night and no sleep.  Day 3 I was able to sleep through the night.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Immediate face redness and swelling.  Later in evening no sleep and heart racing, next day no energy and body soreness.  Day 2 heart racing at night and no sleep.  Day 3 I was able to sleep through the night.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Injection site swelling, Thrombophlebitis, Ultrasound Doppler
Clinical narrative: Site: Swelling at Injection Site-Severe, Systemic: DVT-Severe, Additional Details: Patient presented to office with swelling of right upper extremity occuring after first COVID 19 vaccine dose.  Was sent for duplex study which revealed acute deep vein thrombosis in right subclavian and axillary veins and superfficial thrombophlebitis of basilic vein in right arm.  Pharmacy was contacted 3/10/2021 by MD at hospital to report vaccine adverse event
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: On March 9th  walnut sized lumps on  BOTH arms by vain where blood is drawn  in elbow tracking up both arms   Still present on March 12
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Fever, body ache, nausea, vomiting, eyes feel hot, head hurts, diarrhea,  I gave him 500mg Tylenol
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever, body ache, nausea, vomiting, eyes feel hot, head hurts, diarrhea,  I gave him 500mg Tylenol
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Pt. c/o nausea and dizziness.  Pt. seen and assessed by EMT and VS are: BP 104/71, HR 60, O2 100%.  Pt. voiced that she had not eaten prior to vaccine but started to feel better in 15 minutes into observations. Pt. cleared to go by EMT.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient became lightheaded, diaphoretic and passed out minutes after receiving vaccine.  Woke within seconds.  Patient was evaluated by medical professional.  BP normal and all symptoms resolved with 10minutes.  Kept in nurses offices for approx 45 minutes for observation and was released to his care.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Additional Details: Severe dizziness. Described as vertigo. No history of vertigo prior. Lasted 30 minutes before able to continue normal functioning.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Ear pain, Headache
Clinical narrative: ?Janssen COVID-19 Vaccine EUA?    chills, elevated temperature (101 degrees), body aches, nauseous,  extremely weak,  headache, ear ache, majority of symptoms resolved 2 days later  (still have slight headache, and a bit weak), but getting better
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: ?Janssen COVID-19 Vaccine EUA?    chills, elevated temperature (101 degrees), body aches, nauseous,  extremely weak,  headache, ear ache, majority of symptoms resolved 2 days later  (still have slight headache, and a bit weak), but getting better
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: MALAISE; ACHES; This case was reported by a nurse via other manufacturer and described the occurrence of malaise in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise and pain. On an unknown date, the outcome of the malaise and pain were recovered/resolved.   It was unknown if the reporter considered the malaise and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, for about 5 days after administration, the patient had malaise and had ache. The patient did not have nausea, stomach ache, and headache. The reporter stated, the symptoms were lasted for about 5 days. This case was linked with case US2021AMR007364, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR007364:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Body itching; This case was reported by a consumer via interactive digital media and described the occurrence of generalized pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported The age group was not reported but captured as per vaccine indication The patient received Shingrix and experienced body itching. No other information was available
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Neck pain, Pyrexia
Clinical narrative: neck ache; Fever up to 103 degrees; Loss of Appetite; Thirsty; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2021, the patient received Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced neck pain, fever, appetite lost, thirst, chills and headache. On an unknown date, the outcome of the neck pain, fever, appetite lost, thirst, chills and headache were unknown.   It was unknown if the reporter considered the neck pain, fever, appetite lost, thirst, chills and headache to be related to Shingrix.  Additional information was provided as follows: The patient received a dose of Shingrix in left arm and experienced loss of apetite, fever upto 103 degree fahrenheit, thirst, chills, headache and neck ache. The patient was tested negative for Covid test. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Thirst
Clinical narrative: neck ache; Fever up to 103 degrees; Loss of Appetite; Thirsty; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2021, the patient received Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced neck pain, fever, appetite lost, thirst, chills and headache. On an unknown date, the outcome of the neck pain, fever, appetite lost, thirst, chills and headache were unknown.   It was unknown if the reporter considered the neck pain, fever, appetite lost, thirst, chills and headache to be related to Shingrix.  Additional information was provided as follows: The patient received a dose of Shingrix in left arm and experienced loss of apetite, fever upto 103 degree fahrenheit, thirst, chills, headache and neck ache. The patient was tested negative for Covid test. The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Sore upper R arm at injection site, headache, severely swollen lymph-nodes under R armpit
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: After the injection I felt fine. After falling asleep that evening, I awoke around 12:30am with body aches and slight amount of nausea.  It lasted for a few hours through the night in which I did not sleep.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event
Clinical narrative: Pediarix vaccine (Diphtheria, tetanus toxoids, acellular pertussis, recombinant hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV)) was administered instead of Infanrix vaccine (Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP and Tdap)) on 3/11/21. Infanrix is what was ordered. Vaccine administered intramuscular to left thigh.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, Respiratory distress
Clinical narrative: The employee reports that during the early morning I began with respiratory distress, severe pain at the base of the lung. Patient suffers from chronic asthma, thyroid cancer and masses in both lungs. The patient reports that her internist, Dr., Dr., pulmonologist, and Dr. told her that she could be vaccinated. Xopenex respiratory therapy and other routine asthma medications were administered at the time of symptoms. As of today, March 11, 2021, there are no symptoms.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Fall, Hypotension, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted, unfortunately did fall, however despite some bruises was ok. Waited for family to come to get him and was able to leave under his own power. Ambulance was called and he was checked, no issues found and did not leave with ambulance.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted, unfortunately did fall, however despite some bruises was ok. Waited for family to come to get him and was able to leave under his own power. Ambulance was called and he was checked, no issues found and did not leave with ambulance.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted immediately after injection. Immunizer (RN) administered epinephrine and the patient arose from her fainting state with no issues. Patient stated that she always faints from every needle stick (did not inform the immunizer beforehand). Patient was monitored for 30 minutes before leaving.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Not feeling great at night and sleepy. 2nd day Chills achey headache slight fever of 99.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Not feeling great at night and sleepy. 2nd day Chills achey headache slight fever of 99.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: Itchiness of scalp, face, neck, upper chest without hives or rash.  Feeling of itchiness of ear canals and a sense of a little tightening of the throat.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Mild
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: "34 Y O female reports that she received Moderna covid vaccine 3/5/2021 on her left arm and it has been hurting since then. It feels warm and hard when she touches it. Also reports chills, sharp frontal headache 5/10, nausea, blurred vision on and off. Last dose of excedrin was around 10am with no relief of symptoms."
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: "34 Y O female reports that she received Moderna covid vaccine 3/5/2021 on her left arm and it has been hurting since then. It feels warm and hard when she touches it. Also reports chills, sharp frontal headache 5/10, nausea, blurred vision on and off. Last dose of excedrin was around 10am with no relief of symptoms."
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu like symptoms--low grade fever, muscle and joint aches, diarrhea
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Rapid heart rate within 5 minutes of injection. Lightheaded. Shortness of breath.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Nausea, Oedema peripheral
Clinical narrative: Woke up the next day (3/11/21) with body aches, joint pain, headache, nausea, low grade fever (100.3), swollen glands in throat, right arm soreness that extended into tricep muscle and into axilla on right. The second day (3/12/21) after injection woke up with significant muscle soreness in right tricep and swelling in right axilla.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up the next day (3/11/21) with body aches, joint pain, headache, nausea, low grade fever (100.3), swollen glands in throat, right arm soreness that extended into tricep muscle and into axilla on right. The second day (3/12/21) after injection woke up with significant muscle soreness in right tricep and swelling in right axilla.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Thirst
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated they felt sweaty and thirsty and said they felt like they were going to pass out, then said they felt fine once they took their sweater off and were given some water. EMTs were called and escorted patient out of the pharmacy. She refused epinephrine injection and did not want EMTs called.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on leg and arms itching and bumpy
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Loss of consciousness, Nausea, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Within 10mins of vaccine, pt seem to have a mild seizure for less than 30sec. Pt had no hx of seizures, on no current medication. Pt recovered, and within 1-2mins she passed out. She was warm. She woke up within 1min, then started to vomit. Called emergency services. She felt better after throwing up. When ambulance arrived, she started to have tingling sensation on her finger tips. States she felt better. EMT advised her to go to the ER. Pt decided to go to ER to get checked up. Let with ambulance.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Skin warm, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Within 10mins of vaccine, pt seem to have a mild seizure for less than 30sec. Pt had no hx of seizures, on no current medication. Pt recovered, and within 1-2mins she passed out. She was warm. She woke up within 1min, then started to vomit. Called emergency services. She felt better after throwing up. When ambulance arrived, she started to have tingling sensation on her finger tips. States she felt better. EMT advised her to go to the ER. Pt decided to go to ER to get checked up. Let with ambulance.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt complained of feeling hot, then lost consciousness while seated for approx 10 sec, pt was given cold cloths and ice pack, given water to sip, and monitored for 30 min. when pt felt recovered, she left, and was followed up by phone call approx 1 hr later, experiencing no further adverse effects
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt complained of feeling hot, then lost consciousness while seated for approx 10 sec, pt was given cold cloths and ice pack, given water to sip, and monitored for 30 min. when pt felt recovered, she left, and was followed up by phone call approx 1 hr later, experiencing no further adverse effects
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product formulation administered
Clinical narrative: Pediarix vaccine (Diphtheria, tetanus toxoids, acellular pertussis, recombinant hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV)) was administered instead of Infanrix vaccine (Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP and Tdap)) on 3/11/21.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Asthma prophylaxis, Body temperature increased, Chills, Condition aggravated
Clinical narrative: Started with aches during the night of 3-10-21. progressed to having to use inhaler , with resolution of those symptoms. progressing aches and headache in the morning of 3-11-2021. 10:30 am of 3-11-2021 started with shaking chills, exhaustion, headache, and overall malaise. Had 2 more chill/exhaustion/ aching spells with ongoing headache in the afternoon and evening . Nighttime of 3-11-21, continued exhaustion, headache, chills, aches with highest fever recorded around 101 at 2 am 3-12-21.  Better the morning of 3-12-21, still slight headache, temp. elevation, aching resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia, Tremor
Clinical narrative: Started with aches during the night of 3-10-21. progressed to having to use inhaler , with resolution of those symptoms. progressing aches and headache in the morning of 3-11-2021. 10:30 am of 3-11-2021 started with shaking chills, exhaustion, headache, and overall malaise. Had 2 more chill/exhaustion/ aching spells with ongoing headache in the afternoon and evening . Nighttime of 3-11-21, continued exhaustion, headache, chills, aches with highest fever recorded around 101 at 2 am 3-12-21.  Better the morning of 3-12-21, still slight headache, temp. elevation, aching resolved.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Presyncope, Tinnitus, Tunnel vision
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Violent chills
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling in injection sight, red, swollen, tender, and itchy
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Pallor, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient prone to fainting, sweaty, pale face. Laid patient down, lifted knees. Mother was with patient, denied emergency care. Patient recovered and was able to walk out of pharmacy unassisted after event.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Neck pain, Paraesthesia oral
Clinical narrative: Patient received injection and within 1 minute reported his "lips were tingling" and had pain in the left side neck. Vitals: 1045 195/139, 96%, HR 106; 1105 153/119, HR 105; 1119 182/115, HR 89.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Disorientation, Dizziness, Headache, Injection site pain
Clinical narrative: Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: fever 100 chills achy joints mild headache
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Chest pain, Computerised tomogram abdomen
Clinical narrative: 2/18/21 chest soreness, shortness of breath.   2/19/21 chest soreness, tired body aches, shortness of breath increased slightly.   Continued for 3 days.  2/23/21 seen Dr  extreme shortness of breath, chest pain, body aches, headaches, extreme tiredness. Blood work, chest X-ray, ekg ordered and completed that same day.   2/25/21 seen at clinic increase in symptoms, COVID test completed.  Evening of 2/25/21 went into a-fib hospitalized for 3 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: 2/18/21 chest soreness, shortness of breath.   2/19/21 chest soreness, tired body aches, shortness of breath increased slightly.   Continued for 3 days.  2/23/21 seen Dr  extreme shortness of breath, chest pain, body aches, headaches, extreme tiredness. Blood work, chest X-ray, ekg ordered and completed that same day.   2/25/21 seen at clinic increase in symptoms, COVID test completed.  Evening of 2/25/21 went into a-fib hospitalized for 3 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test
Clinical narrative: 2/18/21 chest soreness, shortness of breath.   2/19/21 chest soreness, tired body aches, shortness of breath increased slightly.   Continued for 3 days.  2/23/21 seen Dr  extreme shortness of breath, chest pain, body aches, headaches, extreme tiredness. Blood work, chest X-ray, ekg ordered and completed that same day.   2/25/21 seen at clinic increase in symptoms, COVID test completed.  Evening of 2/25/21 went into a-fib hospitalized for 3 days.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pyrexia
Clinical narrative: Fever and flu symptoms
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: "Had 2nd dose COVID-19 vaccines on 3/5/21, + nausea, fatigue arm sorenss and swelling"
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Day 4 noticed rash under the skin on both arms and legs. Lacy pattern under the skin. Day 7 seems to be going away. Taking 25 mg of Benadryl at bedtime since I first noticed the rash.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fevers 101.8, body aches, chills.  Fevers respond to acetaminophen but recur within hours.  This is the 3rd day of symptoms
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immobile, Injected limb mobility decreased, Injection site pain, Insomnia, Movement disorder
Clinical narrative: Left arm was incapacitated for nearly a week after the initial injection. Arm could not be lifted more than a few inches away from torso, and pain felt like severe deep cramping constantly. No bruising or mark at the site of the injection just severe muscle pain that affected all movement and sleep.  After one week I regained more mobility but still had severe pain in the shoulder muscles around injection site. At the 3 week mark I have more mobility but still struggle with a full range of motion and lifting anything more than a few pounds.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm was incapacitated for nearly a week after the initial injection. Arm could not be lifted more than a few inches away from torso, and pain felt like severe deep cramping constantly. No bruising or mark at the site of the injection just severe muscle pain that affected all movement and sleep.  After one week I regained more mobility but still had severe pain in the shoulder muscles around injection site. At the 3 week mark I have more mobility but still struggle with a full range of motion and lifting anything more than a few pounds.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Heart rate decreased, Pain in extremity, Palpitations
Clinical narrative: After injection sore arm and fatigued.... but then low hear rate and palpitations developed
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Palpitations, Tachycardia
Clinical narrative: Dizziness, light headedness, tachycardia   Patient w/ co dizziness, lightheadedness, and palpitations immediately after receiving her first covid vaccine dose. Hx of hypertension, per patient controlled. Patient immediately brought to medical triage and evaluated by medical personnel.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Blood test abnormal, Chest X-ray, Computerised tomogram
Clinical narrative: blurred vision: unable to focus dizziness: blood pressure spike:  gradually rising.  185/110 after 90 minues
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: blurred vision: unable to focus dizziness: blood pressure spike:  gradually rising.  185/110 after 90 minues
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, hot to touch, lump has arisen, itchy - covid arm
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dizziness, Feeling hot
Clinical narrative: Anaphylaxis, lightheadedness  33F with hx epilepsy, asthma, and multiple food and drug allergies who reported that she was experiencing chest pain/heaviness as well as feeling warm and throat tightness shortly after receiving her first COVID vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Anaphylaxis, lightheadedness  33F with hx epilepsy, asthma, and multiple food and drug allergies who reported that she was experiencing chest pain/heaviness as well as feeling warm and throat tightness shortly after receiving her first COVID vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Moderna COVID-19 vaccine EUA. 03/09/21- 10:30 pm skin sensitivity; 11:30pm chills and body aches; 03/10/21- 12:00 pm fever, chills, body aches, fever throughout the following day of 101 with tylenol, extreme fatigue, headache, body ache with emphasis on joints; 03/11/21- 3:30 am fever piques, extreme sweats; 9:00am side effects almost entirely subsided except for minor heaches
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sensitive skin
Clinical narrative: Moderna COVID-19 vaccine EUA. 03/09/21- 10:30 pm skin sensitivity; 11:30pm chills and body aches; 03/10/21- 12:00 pm fever, chills, body aches, fever throughout the following day of 101 with tylenol, extreme fatigue, headache, body ache with emphasis on joints; 03/11/21- 3:30 am fever piques, extreme sweats; 9:00am side effects almost entirely subsided except for minor heaches
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiplegia
Clinical narrative: Loss use of entire right side
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear, nose and throat examination, Injection site pain, Sleep disorder, Tinnitus
Clinical narrative: None with first shot.  Just tender arm at injection site.  After the noonday second shot 2/25/2021 , within 24 hrs. I was awaken with ringing in my ears which still continues today.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Very bad headache for 18 hours
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: fever, dehydration, tiredness, hot spot at injection point, swelling of right arm and shoulder, inflammation in the neck
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: fever, dehydration, tiredness, hot spot at injection point, swelling of right arm and shoulder, inflammation in the neck
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Vestibular function test normal
Clinical narrative: Exactly 2 week after receiving the second Covid-19 vaccine shot I woke up in the morning with a serious balance issue.  I felt like I was on a rocking boat.  This was a constant feeling, with some days worse than others, but balance was off for two weeks.  I also experienced slight "fogginess", which is still an issue.  I have never experienced any type of balance in my entire life.  This was most concerning.  After doing some intensive research, I found an article that some that recieved the vaccine did have some vestibular issues, balance/dizziness.  Which makes me think that my episode was vaccine related. I am only reporting this so that you can track a possible non-typical adverse reaction.  I am in no way indicating the vaccine was defective.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Electronystagmogram, Tinnitus
Clinical narrative: Exactly 2 week after receiving the second Covid-19 vaccine shot I woke up in the morning with a serious balance issue.  I felt like I was on a rocking boat.  This was a constant feeling, with some days worse than others, but balance was off for two weeks.  I also experienced slight "fogginess", which is still an issue.  I have never experienced any type of balance in my entire life.  This was most concerning.  After doing some intensive research, I found an article that some that recieved the vaccine did have some vestibular issues, balance/dizziness.  Which makes me think that my episode was vaccine related. I am only reporting this so that you can track a possible non-typical adverse reaction.  I am in no way indicating the vaccine was defective.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphemia
Clinical narrative: Intermittent stuttering
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Rash macular
Clinical narrative: Pt received vaccine and 10 minutes in reported red blotches on arm and that her "teeth hurt". She was moved to an observation area via wheelchair and monitored for 30 minutes.  Vitals: 1107 142/112, 98%, HR 69; 1129 159/114, HR 71. Pt reported she did not feel dizzy or have SOB and that her "blood pressure is normally high". Pt left ambulatory from vaccine center to home.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: COVID vaccine  Erythema and swelling right arm around injection site, injection site pain leading to use of prescription pain reliever or prevent daily activity Chills, Fatigue, Fever Fever documented: 39.0-40.0 C or 1021.1-104.0 F
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COVID vaccine  Erythema and swelling right arm around injection site, injection site pain leading to use of prescription pain reliever or prevent daily activity Chills, Fatigue, Fever Fever documented: 39.0-40.0 C or 1021.1-104.0 F
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Chills and fever that night, cold sweat, nausea, dizziness throughout night.  Some muscle weakness.  Fever of 102, likely was higher last night.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: I broke out in hives. Itching and pain was very severe.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Hallucination, Headache, Influenza
Clinical narrative: Intense flu symptoms, severe body pains, headache, confusion at night, hallucinations at night. Severe pain in injection site. Faintness
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Intense flu symptoms, severe body pains, headache, confusion at night, hallucinations at night. Severe pain in injection site. Faintness
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in neck and armpit on side of vaccination
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Moderna COVID-19 Vaccine EUA. Had a mild breakout of shingles three days after the vaccine.  Not my first bout of shingles and I've had the shingles shot.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Flushing, Headache, Swollen tongue
Clinical narrative: Patient began feeling tongue swelling, tightness in throat, progressed to headache, flushing, chest tightness. Patient refused 911-EMS. Ambulated to ER, escorted by RN.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient began feeling tongue swelling, tightness in throat, progressed to headache, flushing, chest tightness. Patient refused 911-EMS. Ambulated to ER, escorted by RN.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Loss of personal independence in daily activities, Pain
Clinical narrative: headache; potential fever; freezing cold; chills; body ache; felt lousy; Couldn't carry on normal activities; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on 15th October 2020 and had body ache and chills, for tolerance refer case US2021008377).   On 7th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th January 2021, less than a day after receiving Shingrix, the patient experienced headache, fever, cold, chills, general body pain, feeling bad and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, fever, cold, chills, general body pain, feeling bad and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the headache, fever, cold, chills, general body pain, feeling bad and activities of daily living impaired to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient for herself. The patient received 2nd doses of the Shingrix and had the side effects including headache, body ache, chills, freezing cold and a potential fever. The 2nd dose reactions started 3 to 6 hours after the injection and she felt lousy at 3 hours and by 6 hours she could not carry on normal activities due to the symptoms. Those reactions resolved after 24 to 36 hours. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008377:same reporter, 1st dose