chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: The patient reported the development of rash to trunk and neck as well as itching the day after the COVID19 vaccine was given.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction- swollen, hard, erythema, and hot.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Defaecation urgency, Headache
Clinical narrative: slight headache, intestinal fluctuations, all fine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy
Clinical narrative: severe joint main in right arm (especially wrist and elbow) almost a week after receiving the vaccine. Pain in arm pit and swollem lymph node.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient reports dizziness and feeling hot about 10 minutes post vaccination.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lip oedema, Urticaria
Clinical narrative: Mild hives off and on on both arms and some times on torso, mostly in the mornings and self resolves in 2-3 hours without medicine.  Also.,  partial lip edema twice noticed in the morning  once on Dec31 and second time on January 4th.  Both times lip edema resolved with in 4-5 hrs. on its own without any medication.  Mild hives continue to show on arms and hand sporadically and self resolve with in few hours with any anti-histamine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphadenopathy
Clinical narrative: Late reaction of swollen lymph nodes in right axillary/breast area
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Neck pain, Pain
Clinical narrative: fever (2 days), chills (2 days), nausea (waves on and off 4 days), severe headache(4 days), body aches (3 days), neck pain (4 days). I still get a headache once a day since the vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever (2 days), chills (2 days), nausea (waves on and off 4 days), severe headache(4 days), body aches (3 days), neck pain (4 days). I still get a headache once a day since the vaccine
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Wrong technique in product usage process
Clinical narrative: Sore injection site. Injection was given via tuberculin syringe and did not penetrate the muscle, it was subcutaneous. My dose was a waste and I may not have immunity due to operator error.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches approximately 12 hours after vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chills, Headache, Hyperaesthesia
Clinical narrative: 12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Nausea, Pyrexia
Clinical narrative: 12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lethargy, Pyrexia
Clinical narrative: Fever 100-101degrees x 24hrs, Chills. Sweats, lethargy, headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Pain in extremity
Clinical narrative: Day 7/8 post first dose of vaccine developed redness, itching, swelling in left upper arm. Pain and tenderness in arm and lymph nodes in underarm
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Day 7/8 post first dose of vaccine developed redness, itching, swelling in left upper arm. Pain and tenderness in arm and lymph nodes in underarm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: I had severe chills all night 8 Jan, was unable to get warm.  Then I had  fatigue, headache and body ache on 9 Jan.  Felt better on 10 Jan and each day I feel a little better.  I did not got to doctor.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Chills, body aches, sweating, mildly sore right arm
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness
Clinical narrative: Chest tightness, dizziness, chills. No reported treatment and symptoms resolved.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: I had a delayed injection site reaction that began on day 8 distal to injection site, with redness, induration and mild itching.  It did not bother me so I paid little attention it.  But on day 13 I looked down on my arm and it was a lot larger, more erythema, more indurated, raised, warm- still not painful, only mildly pruritic.  The area measures approximately (irregular shape) 16.5 cm at the largest diameter.  Mow much improved after taking antihistamines.  I'm reporting because of the extent.  Not sure if there's any recommendation as far as premedication prior to second dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: I had a delayed injection site reaction that began on day 8 distal to injection site, with redness, induration and mild itching.  It did not bother me so I paid little attention it.  But on day 13 I looked down on my arm and it was a lot larger, more erythema, more indurated, raised, warm- still not painful, only mildly pruritic.  The area measures approximately (irregular shape) 16.5 cm at the largest diameter.  Mow much improved after taking antihistamines.  I'm reporting because of the extent.  Not sure if there's any recommendation as far as premedication prior to second dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: facial swelling in areas where I previously had facial fillers mostly in the temple and eyes. greater swelling in the right eye
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: The next day I had a sore arm which was expected. I also started with chills, extreme fatigue, headaches, and muscle soreness since receiving the vaccine and the symptoms still ongoing  with today being 1/12/21.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus, Myalgia, Pyrexia
Clinical narrative: Fever of 101, chills, muscle aches, headache about 13 hours after injection. All of those side effects are gone but I still have a red, itchy hot spot on arm where injection given.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cellulitis, Computerised tomogram, Eye swelling, Headache
Clinical narrative: Facial cellulitis, eye swelling, headache, nausea
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Facial cellulitis, eye swelling, headache, nausea
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Extreme chills, tachycardia at rest (130s), fever 101.5, shortness of breath at rest, tachypnea, headache, extreme weakness, sore throat, swollen throat, numbness in extremities.  Treatment- rest, benadryl, excedrin migraine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling, Pyrexia, Tachycardia, Tachypnoea
Clinical narrative: Extreme chills, tachycardia at rest (130s), fever 101.5, shortness of breath at rest, tachypnea, headache, extreme weakness, sore throat, swollen throat, numbness in extremities.  Treatment- rest, benadryl, excedrin migraine
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Awakened 0300 the next day, Saturday  the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea!  I felt bad most of Monday. Tuesday today, i feel fine!
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Awakened 0300 the next day, Saturday  the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea!  I felt bad most of Monday. Tuesday today, i feel fine!
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Lethargy, Nausea
Clinical narrative: Very sore at the injection site, light nausea, fatigue, low grade fever, chills, lethargy, body aches.  All symptoms resolved within 24 hours of onset except for sore injection site and fatigue.  I am still having sore injection site and fatigue 48 hours after receiving the immunization.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Very sore at the injection site, light nausea, fatigue, low grade fever, chills, lethargy, body aches.  All symptoms resolved within 24 hours of onset except for sore injection site and fatigue.  I am still having sore injection site and fatigue 48 hours after receiving the immunization.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: severe muscle aches and fatigue. felt feverish
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: Started about 3pm with soreness in left arm on 1/11/2021.  By midnight, the left arm was very sore and heaviness/numbness down to fingers.  On 1/12/2021 (today), I could hardly raise my left arm over my head.  I took 2 Ibuprofen and plan to ensure I do range of motion stretches and basically just use the left arm.  I do not have a fever, and plan to drink plenty of water today.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Localized itching, swelling, hardness, tenderness, redness and heat on day 8 after vaccine was given
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Localized itching, swelling, hardness, tenderness, redness and heat on day 8 after vaccine was given
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature increased, Feeling abnormal, Limb discomfort, Mobility decreased
Clinical narrative: I received the shot at 8:10 am and felt nothing.  As the morning progressed, I developed a sore arm, similar to a flut shot.  However, it was worse, and I also felt achy in my neck.  I drove home from work around noon, and I couldn't even use my arm on the steering wheel.  These symptoms continued and I finally took Tylenol in the middle of the afternoon, and evening going to bed.  I slept horribly and woke up feeling like a train wreck.  I took my temperature. It was 102!  I started taking the Tylenol again.  I couldn't even raise my arm, either. My arm didn't hurt if it was just still, but it would hurt if it was touched, and I could not raise it for 3 days.  Despite taking the Tylenol, I felt awful all day and really had to stay bedridden.  I was also very thirsty both the day of the vaccine and this second day.  Saturday morning I woke up feeling better, but as the day wore on, the aches and fever came back.  Sunday was the same as Saturday.  Monday was similar, but better overall.  Today is Tuesday.   My arm still feels a little weird and I cannot completely raise it. I did have the COVID-19 back in March and have antibodies, as far as I know as I have donated to Red Cross 4 times.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, SARS-CoV-2 antibody test positive, Sleep disorder
Clinical narrative: I received the shot at 8:10 am and felt nothing.  As the morning progressed, I developed a sore arm, similar to a flut shot.  However, it was worse, and I also felt achy in my neck.  I drove home from work around noon, and I couldn't even use my arm on the steering wheel.  These symptoms continued and I finally took Tylenol in the middle of the afternoon, and evening going to bed.  I slept horribly and woke up feeling like a train wreck.  I took my temperature. It was 102!  I started taking the Tylenol again.  I couldn't even raise my arm, either. My arm didn't hurt if it was just still, but it would hurt if it was touched, and I could not raise it for 3 days.  Despite taking the Tylenol, I felt awful all day and really had to stay bedridden.  I was also very thirsty both the day of the vaccine and this second day.  Saturday morning I woke up feeling better, but as the day wore on, the aches and fever came back.  Sunday was the same as Saturday.  Monday was similar, but better overall.  Today is Tuesday.   My arm still feels a little weird and I cannot completely raise it. I did have the COVID-19 back in March and have antibodies, as far as I know as I have donated to Red Cross 4 times.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Thirst
Clinical narrative: I received the shot at 8:10 am and felt nothing.  As the morning progressed, I developed a sore arm, similar to a flut shot.  However, it was worse, and I also felt achy in my neck.  I drove home from work around noon, and I couldn't even use my arm on the steering wheel.  These symptoms continued and I finally took Tylenol in the middle of the afternoon, and evening going to bed.  I slept horribly and woke up feeling like a train wreck.  I took my temperature. It was 102!  I started taking the Tylenol again.  I couldn't even raise my arm, either. My arm didn't hurt if it was just still, but it would hurt if it was touched, and I could not raise it for 3 days.  Despite taking the Tylenol, I felt awful all day and really had to stay bedridden.  I was also very thirsty both the day of the vaccine and this second day.  Saturday morning I woke up feeling better, but as the day wore on, the aches and fever came back.  Sunday was the same as Saturday.  Monday was similar, but better overall.  Today is Tuesday.   My arm still feels a little weird and I cannot completely raise it. I did have the COVID-19 back in March and have antibodies, as far as I know as I have donated to Red Cross 4 times.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 5 days later started itching, 6 days spread to trunk of body and neck,7days big welts wherever I scratched.  Still here at 8 days
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Hot flush
Clinical narrative: 12 HOURS AFTER VACCINATION EXPERIENCED HOT FLASH LASTING OVER 15 MINUTES WITH DRYNESS OF MOUTH
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Erythema, Eye swelling, Pharyngeal swelling, Tongue disorder
Clinical narrative: Approximately 25-30 minutes post first Moderna vaccine (after pt was discharged from clinic with no issues) patient started experiencing feeling of throat thick and eyes heavy. Called 911. Patient transported via EMS to ER where she presented with feeling of thickness in her throat and tongue, swollen eyes and redness in the forehead. Pt received dexamethasone 10 mg IV x 1 and epinephrine 0.3 mg IM x 1. Pt was prescribed prednisone 10 mg tab: 4 po x 1 dose tonight, 3 po in am, 2 po qd x 1 day, 1 po qd x 1 day (total 10 tabs) upon discharge to home. Provider recommended no second COVID dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient states that she received covid vaccine on 1/4/2021 to left arm and developed left arm redness and swelling on 1/10/2021. Pt. states that she took motrin and it is helping. Pt. states that left arm is tennis ball size, lightly red
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nervousness, Tearfulness, Tremor
Clinical narrative: Approximately 10 minutes after receiving the vaccine she became anxious. She stated, " I am nervous about the unknown. I wanted to get it." " I always get like this." 8:50am she was placed on vs monitor, BP 138/82, HR 115, O2sat 100%. 8:55am HR up to 124. She was tearful and trembling. 8:58am 133/92, HR 149, O2sat 100%, R 24. Code green was called. 9:05am She was taken by stretcher to ED for evaluation. BP 131/94, HR 132, O2 sat 100% when leaving the vaccine clinic area. She remained awake and alert throughout.  1/7/21 Followed up with her via phone conversation. She states she was discharged from ED yesterday. She was at work. She had a slight headache today, but had taken Advil and it was improving. Stated that last night the headache was worse. No other complaints today.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Paraesthesia oral, Pruritus, Rash, Stomatitis
Clinical narrative: 30 minutes after administration, my tongue and mouth became tingly and "fuzzy" causing me to have to continually clear my throat. My neck then began to itch and I broke out into a rash around the front of my neck.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Swelling, Tenderness
Clinical narrative: New redness, swelling, tenderness that began 6 days after vaccine (4 days after previous redness/soreness ended and many days without symptoms). Frequent to constant itching at injection site.  Increasing in size/severity over the past 2 days.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Nausea
Clinical narrative: Brain fog/cotton head and difficulty concentrating started around 1400. Later, around 1700, nausea requiring me to lie down but no vomiting. No medications taken. Resolved after a few hours of sleep.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Nausea
Clinical narrative: She took the vaccine on 12/28/2020.  She reports she was sick that day and 3 days after with headache, nausea, chills and extreme fatigue. She took Tylenol for her symptoms. Did not seek medical treatment. Symptoms have resolved except for fatigue.  She noticed  that her right arm was still sore on 1/10/2021 and she reports a red area that is very hot to touch.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin warm
Clinical narrative: She took the vaccine on 12/28/2020.  She reports she was sick that day and 3 days after with headache, nausea, chills and extreme fatigue. She took Tylenol for her symptoms. Did not seek medical treatment. Symptoms have resolved except for fatigue.  She noticed  that her right arm was still sore on 1/10/2021 and she reports a red area that is very hot to touch.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 2nd Injection received approx. 11:05 AM on Wednesday 1/6/2021. First symptoms of reaction seen between 8-10pm on Saturday, 1/9/2021 which included hives around neck and covering chest torso and arms. Treated with topical Benadryl.  Rash/hives continued to persist spread to entire body, head, neck, face, torso, arms, legs, feet.  On early Monday, 1/11/2021 - Contact with Employee Health Nurse and PCP Dr. and advised to take Benadryl as the only symptom was the rash/hives - no facial swelling or shortness of breath.  Tuesday, 1/12/2021 after taking advice of Employee Health Nurse and PCP symptoms are nearly fully resolved.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Systemic infection
Clinical narrative: Severe systemic illness for 1 week
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Malaise
Clinical narrative: Employee stated he did not feel well felt flush dizzy. Employee skin was diaphoretic. Walked employee to EMT station, he was able to walk without assistance. Rested on stretcher, stated he was feeling better and left the facility on his own at 1450
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient refers rash in the right side of the body.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Eye pain, Headache, Pain in jaw
Clinical narrative: Headache started overnight. Debilitating to the point of unable to think clearly without great effort. Aching headache felt on top of head and seems to radiate down to behind the eyes and to the sides of jaws.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: Employee reported significant pain and decreased ROM after Moderna COIVD vaccine, stated vaccine was administered "higher on my shoulder than I have experienced with other vaccines". Treated with OTC pain relief and email f/u with pcp who recommended continuing OTC analgesia and exercise of arm.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia
Clinical narrative: On Jan. 4th at 7am I had no immediate reaction. At 2pm that day got extremely nauseated, local injection site red and warm, muscle aches through out body experienced. No other symptoms at that time.  Arm redness started to fade and go away over the next three days. On January 11 at 9pm, Injection site became red, itchy and  warm to touch, Heart rate fluctuated in the 102 to 120 range intermittently. Normal heartrate is 85. Notified Employee Health and supervisor and made appointment with primary doctor for Wednesday Jan. 13th at 2pm. Applied cool compress to site all throughout the reactions.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: On Jan. 4th at 7am I had no immediate reaction. At 2pm that day got extremely nauseated, local injection site red and warm, muscle aches through out body experienced. No other symptoms at that time.  Arm redness started to fade and go away over the next three days. On January 11 at 9pm, Injection site became red, itchy and  warm to touch, Heart rate fluctuated in the 102 to 120 range intermittently. Normal heartrate is 85. Notified Employee Health and supervisor and made appointment with primary doctor for Wednesday Jan. 13th at 2pm. Applied cool compress to site all throughout the reactions.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Raised red rash that lasted 8 hours on hips, stomach. chest and thighs. Not bothersome .No treatment needed.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; has been administered since the temperature excursion; This spontaneous report was received from an agency referring to a patient of unknown age and gender. Information on pertinent medical history, concomitant medication and drug allergies/reactions was not reported.  On 23-DEC-2020 the patient was vaccinated with a temperature excursion of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S010729 with expiration date 01-DEC-2021; lot# 1637648 with expiration date 19-JUN-2022; dose and route were not reported) for prophylaxis (product storage error).     The administered doses of the vaccine experienced a temperature excursion 32.9 Fahrenheit (F) and 34 F for 24 minutes and 16 hours time frame. Whether there was previous temperature excursion was not applicable. The digital data logger was involved. No product to retrieve. Device was not available for evaluation (obtain was false). No other AE was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: HPV; This spontaneous report was received from a consumer via company representative referring to a female patient around 28 years old. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (she was unsure which vaccine was given).  On an unknown date, the patient had human papillomavirus (HPV) which was not covered by the vaccine.   The outcome of HPV was unknown. The causality assessment between the event and suspect vaccines was not provided by the reporter.   This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2101USA003845: US-009507513-2011USA010820:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: HPV; This spontaneous report was received from a consumer via company representative referring to a female patient around 28 year old. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (she was unsure which vaccine was given).  On an unknown date, the patient had human papillomavirus (HPV) strain Wart strain which was not covered by the vaccine.   The outcome of HPV was unknown. The causality assessment between the event and suspect vaccines was not provided by the reporter.  This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2011USA010820: US-009507513-2101USA003844:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Disturbance in attention, Ear pain, Feeling hot, Injected limb mobility decreased
Clinical narrative: Pain at the injected site; Pain at the injected site / makes it difficult for her to lift her left arm; Buzzing in her head; Cannot sleep; Earache in both the ears; Tip of her tongue is tingling; Feels heat in the inside of both her arms from the elbow to the palms/hands; Joint pain all over her body; Having difficulty focusing; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles on gabapentin for neuralgia states). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in right arm on 29th July 2020). Concomitant products included gabapentin.   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left arm. The reporter stated that, after vaccination the patient had pain at the injected site which makes it difficult for her to lift her left arm, buzzing in head, because of which cannot sleep, earache in both the ears, tongue was tingling, felts heat in the inside of both her arms from the elbow to the palms or hands and had joint pain all over body and difficulty focusing. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231823:Same reporter. 1st dose
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Paraesthesia oral, Tinnitus
Clinical narrative: Pain at the injected site; Pain at the injected site / makes it difficult for her to lift her left arm; Buzzing in her head; Cannot sleep; Earache in both the ears; Tip of her tongue is tingling; Feels heat in the inside of both her arms from the elbow to the palms/hands; Joint pain all over her body; Having difficulty focusing; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles on gabapentin for neuralgia states). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in right arm on 29th July 2020). Concomitant products included gabapentin.   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left arm. The reporter stated that, after vaccination the patient had pain at the injected site which makes it difficult for her to lift her left arm, buzzing in head, because of which cannot sleep, earache in both the ears, tongue was tingling, felts heat in the inside of both her arms from the elbow to the palms or hands and had joint pain all over body and difficulty focusing. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231823:Same reporter. 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: nauseated; fever; aches; headache; diarrhea; vomiting; This case was reported by a nurse and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced nausea, fever, pain, headache, diarrhea and vomiting. On an unknown date, the outcome of the nausea, fever, pain, headache, diarrhea and vomiting were recovered/resolved.   The reporter considered the nausea, fever, pain, headache, diarrhea and vomiting to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix vaccine and on the same day at 11 pm, the p atient experienced nausea, fever, pain, headache, diarrhea and vomiting. The reporter mentioned that, the events were resolved in 2 days. The reporter also mentioned that, the events had occurred because of the vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: nauseated; fever; aches; headache; diarrhea; vomiting; This case was reported by a nurse and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced nausea, fever, pain, headache, diarrhea and vomiting. On an unknown date, the outcome of the nausea, fever, pain, headache, diarrhea and vomiting were recovered/resolved.   The reporter considered the nausea, fever, pain, headache, diarrhea and vomiting to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix vaccine and on the same day at 11 pm, the p atient experienced nausea, fever, pain, headache, diarrhea and vomiting. The reporter mentioned that, the events were resolved in 2 days. The reporter also mentioned that, the events had occurred because of the vaccine. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: swelling; itching/ large red circle associated with pain and itching; pain/ large red circle associated with pain and itching; large red circle that progressively got bigger/ the mark is there faded; This case was reported by a physician and described the occurrence of swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy (allergies to other medications like prednisone pack, valtrex, antivirals).   On 6th November 2020, the patient received the 1st dose of Shingrix. On 7th November 2020, 1 days after receiving Shingrix, the patient experienced swelling, localized itching, pain localized and localized erythema. On 23rd November 2020, the outcome of the swelling, localized itching, pain localized and localized erythema were recovered/resolved.   It was unknown if the reporter considered the swelling, localized itching, pain localized and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient had allergies to other medications like prednisone pack, Valtrex, antivirals. The reporter did not know the route of administration or the lot and expiry details of Shingrix as the vaccine was administered at a local pharmacy. The patient experienced some pain, itching and swelling. The reporter upon escalation stated patient described it that it started the next day as large red circle that progressively got bigger a few days later and was associated with pain and itching. It was still there, the mark was there faded. The pain, itching and swelling had resolved. None of the other symptoms had persisted. The symptoms lasted a day before reporting for about 17 days. The reporter consented to follow up. This case has been linked with US2020AMR234423 reported for the same patient by same reporter. There was discrepancy in the reported duration for the events. The reporter stated the event stated the next day until a day before reporting that was 16 days, however he stated that the events lasted for about 17 days.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR234423:Same patient, Valtrex case
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to 16 years old patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00414283) and transmitted to Sanofi on 04-Jan-2021.  This case was linked with 2021SA002156, 2021SA002607, 2021SA002631, 2021SA002726, 2021SA002799, 2021SA002850, 2021SA003080, 2021SA003127, 2021SA003182, 2021SA002085 (same reporter)  This case involves a 16 year old male patient who was administered with a standard 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot UJ509AA, expiration date 10 May 2021) once via intramuscular route at the left deltoid for prophylactic vaccination on 30-Dec-2021 (Product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.   It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day).   Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season  At the time of reporting, no adverse event reported (reported as none).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Mother; approximately 12 hrs after fever, chills for about 8 hours. Diarrhea 3 days. Mother is pumping breastmilk. Injection was Friday.  11 month old infant had Fridays milk on Sat, Sat milk on Sunday. Infant fatigued and fussy with loose stools Sunday. Infant had diarrhea, vomited and spiked 102.2 fever Monday evening 1/11. Fever broke Tuesday morning 7 am. Infant still fussy and loose stools. Vomiting ceased.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Tachycardia- occurred about 14 hours after the vaccine, and lasted for about 12 hours. Resting heart rate is usually 70 and was 100. Any activity it would climb to the 120-130s.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Night sweats
Clinical narrative: Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache for 3 days, all resolved. Two doses of 1000 mg acetaminophen needed to resolve fever.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever/chills/night sweats for 1 day, body aches, injection site pain, nausea for 3 days, headache for 3 days, all resolved. Two doses of 1000 mg acetaminophen needed to resolve fever.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever from 3:00 am to 6:40 pm (99.7 - 101.4) treated with extra strength acetaminophen. Temperature is now 99.5 Fatigue for 1/11 and 1/12 Intermittent muscle aches on arms and calves
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: On 1/11 in the evening, I noticed a red bump on my arm where I had received the vaccine. It was hard, but small. Then I woke up this morning (1/12), and my arm had a red rash, about 2-3 cm each way from where the vaccine was administered. It is itchy and warm. I have no other symptoms.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: On 1/11 in the evening, I noticed a red bump on my arm where I had received the vaccine. It was hard, but small. Then I woke up this morning (1/12), and my arm had a red rash, about 2-3 cm each way from where the vaccine was administered. It is itchy and warm. I have no other symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site bruising, Injection site pain, Pain
Clinical narrative: 2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then resolved. Pain and tenderness persist at injection site. 1st dose - no reported adverse events
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: DAY 1- HEADACHE DAY 2-3 PAIN AT INJECTION SITE DAY 4-6- ITCHING AT INJECTION SITE DAY 7- SWELLING (GOLF BALL SIZE), REDDNESS, ITCHING DAY 8- SWELLING (TENNIS BALL SIZE), REDDNESS, ITCHING, TENDER
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fall, Fatigue
Clinical narrative: Severe pain in injection site getting progressively worse, fatigue, chills/hot flashes, stomach pain, diarrhea, falling (on 1/12/21 at 8:00 am I collapsed and fell but did not go unconscious).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site pain, Syncope
Clinical narrative: Severe pain in injection site getting progressively worse, fatigue, chills/hot flashes, stomach pain, diarrhea, falling (on 1/12/21 at 8:00 am I collapsed and fell but did not go unconscious).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Developed swollen and red arm at injection site 1 week later. Also has a knot at the site of injection.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received the Moderna vaccine on 12/29/20 and had pain at site for two days and went away. Two days ago (Wednesday 1/06/21), she noticed the site on her left arm is a bit reddened and did become a little painful like after receiving the vaccine. She have been taking ibuprofen but the redness has not gone away till now.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, SARS-CoV-2 test negative
Clinical narrative: On 12/31 finished having dinner. Thought sudden slight shortness of breath may be do to appetizer type foods we had. Drank water to help subside it with little effect. Went outside into cold air. Still had some slight shortness of breath. At 8PM continued to my other daughters home( where I've been going since pandemic) upon sitting there still felt slight shortness of breath but again manageable. We left at 11:30 as my breathing never really got better or worse. When I arrived home I Took my PROAIR-HFA inhaler that I use PRN. My symptoms resolved and went to bed. On Friday 1/1 I had again slight shortness of breath with no real excertion.  On 1/2 I went to work at Hospital in neurology dept. I was pushing collector up to SICU unit and then to M2 unit. On arrival to M2 I felt very winded and took my inhaler with results.  I then called my manager to make him aware that I was having dilemma do to fact that I didn't want to call Covid hot line as I felt symptoms were from vaccine not Covid!  I was put out of work by Covid hot line had test on 1/4 and negative results on 1/6. My symptoms seemed to subside on 1/6. I returned to work on 1/9 and am pushing collectors and patients with no symptoms
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Swelling and redness under eyes around tear trough dermal fillers noticed about 19 hours after receiving 2nd dose of the vaccine. Taking antihistamines at home, haven?t sought treatment from a provider at this time.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called and stated that she had "pain, swelling, redness, and bruising at the injection site"
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Sinus pain
Clinical narrative: Patient complained of Left Orbital headache 10/10 on pain scale post injection. Stated it was like having a sinus issue.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Approximately 13 minutes after the vaccine was administered the client became shaky and her care was taken over by the EMS who were monitoring clients post vaccine administration.  Client did not demonstrate any difficulty breathing and was conscious at all times.  Client agreed to EMS transport to ED for further evaluation.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache from 11:00pm Sunday night to 10:30am Monday.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Respiratory tract congestion
Clinical narrative: Fatigue Congestion lasting seems worse Cough lasting
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Received COVID-19 vaccine on 1/4/21, right arm.  On 1/11/21 about 5:30 pm, my right upper arm became itchy, red, swollen, warm and hives/welts developed around the vaccination site.  The itching lasted about an hour, the hives/welts resolved about 11:00 pm the same evening but the redness, warmth and swelling  are still present at time of reporting (9:21 am on 1/12/21).  To note, on 1/11/21 I received the PPD skin test in the left arm around 10:30 am.  As of this morning, there is no reaction, or symptoms noted in the left arm.  I reported symptoms to the Medical Director of the vaccine site (MD), and to my primary care provider (MD)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tuberculin test
Clinical narrative: Received COVID-19 vaccine on 1/4/21, right arm.  On 1/11/21 about 5:30 pm, my right upper arm became itchy, red, swollen, warm and hives/welts developed around the vaccination site.  The itching lasted about an hour, the hives/welts resolved about 11:00 pm the same evening but the redness, warmth and swelling  are still present at time of reporting (9:21 am on 1/12/21).  To note, on 1/11/21 I received the PPD skin test in the left arm around 10:30 am.  As of this morning, there is no reaction, or symptoms noted in the left arm.  I reported symptoms to the Medical Director of the vaccine site (MD), and to my primary care provider (MD)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site injury, Injection site pain, Injection site reaction
Clinical narrative: Severe headache that generated nausea and vomiting. Injury at injection site consisting of swelling, redness, warmth and pain. Injection site reaction lasted until 1/4/2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Severe headache that generated nausea and vomiting. Injury at injection site consisting of swelling, redness, warmth and pain. Injection site reaction lasted until 1/4/2021.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Facial pain, Pain in jaw
Clinical narrative: Right sided jaw/face pain - has lasted about a week now
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat tightness
Clinical narrative: C/o cough, upper throat tightness, no wheezing, administered benedryl 50 mg IM, called med team, sent to ER, o2 sat 98%, HR 107, Bp 162/93, Lung sounds CTA
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Erythema, Influenza virus test negative, Injection site bruising, Injection site cellulitis
Clinical narrative: Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.