chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash generalised, Rash pruritic
Clinical narrative: Patient called on 10/14 before closing at 6pm to explain that 12 hours after her shot at 1pm on 10/12 she had flu-like symptoms that lasted until 10/13 midday. On the morning on the 14th, she woke with  a rash all over her body. The rash did not hurt nor did it itch. She is concerned about a possible allergy and any issue with the upcoming booster.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient reported that injection site reaction occurred one hour after flu shot was given. The size increased to 8 X 6 cm had warmth and swelling. Patient was seen by provider on 10/14/18 and given KEFLEX and anithistamine for treatment.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram head, Headache, Mental impairment, Migraine
Clinical narrative: 9/22/18 6:30 AM She woke up with a headache, swollen tongue and trouble talking and thinking. After that she had a mild headache daily until it got worse on 9/27/18. I took my daughter to the ER at 6:30 PM for meds to relieve the headache, they did not work and I had her at a different ER on 9/29/18 at 2:30 AM for the pain. This ER sent her to a pediatric hospital to be admitted. She stayed the night in Hospital and received meds via IV to get relief from the pain. She was back in the ER on 10/10/18 due to yet another migraine that this time involved hand tingling and mouth tingling. She once again received an IV and fluids and medication. She was released the same day and we followed up with a neurologist on 10/11/18 where she has been put on a daily medication to try to limit the amount of headaches that she gets. She now has headaches daily and lives in fear of a bad one that will possibly land her back in the hospital. Prior to getting the GARDASIL vaccine my daughter was healthy and did not have migraines. Before this vaccine she rarely even got a headache at all, much less one that we couldn't get rid of!!!
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Paraesthesia, Paraesthesia oral, Speech disorder, Swollen tongue
Clinical narrative: 9/22/18 6:30 AM She woke up with a headache, swollen tongue and trouble talking and thinking. After that she had a mild headache daily until it got worse on 9/27/18. I took my daughter to the ER at 6:30 PM for meds to relieve the headache, they did not work and I had her at a different ER on 9/29/18 at 2:30 AM for the pain. This ER sent her to a pediatric hospital to be admitted. She stayed the night in Hospital and received meds via IV to get relief from the pain. She was back in the ER on 10/10/18 due to yet another migraine that this time involved hand tingling and mouth tingling. She once again received an IV and fluids and medication. She was released the same day and we followed up with a neurologist on 10/11/18 where she has been put on a daily medication to try to limit the amount of headaches that she gets. She now has headaches daily and lives in fear of a bad one that will possibly land her back in the hospital. Prior to getting the GARDASIL vaccine my daughter was healthy and did not have migraines. Before this vaccine she rarely even got a headache at all, much less one that we couldn't get rid of!!!
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3" x 3" red, hard, tender, itchy, hot raised area 1" distal to injection site. Treated with Tylenol and ice.  Lump still present on 10/15/2018, however no itchiness, no temperature differentiation and lessened swelling.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: 3" x 3" red, hard, tender, itchy, hot raised area 1" distal to injection site. Treated with Tylenol and ice.  Lump still present on 10/15/2018, however no itchiness, no temperature differentiation and lessened swelling.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Cellulitis, redness at the injection site.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The patient called this morning, 10/15/18, stating that she had a sore arm for about a week after the immunization that went away. She said she later had pain in the same arm again and now she cannot move that arm.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Blood magnesium normal, Borrelia test negative, Computerised tomogram head normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Seizure lasting 2-3 minutes followed by extreme lethargy.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Metabolic function test normal, Seizure, Urine analysis normal
Clinical narrative: Seizure lasting 2-3 minutes followed by extreme lethargy.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Injection site injury, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Vaccine injury at injection: Annual influenza vaccine, preservative-free by request (I don't know which type, brand name, etc.). I entered the clinic in the afternoon (I recall following work, around 3:00pm). Nurse introduced herself to me as the nurse "in charge" of (the vaccination administration/clinic). She checked to make sure it was ok with them for me to have the flu shot soon after my allergy desensitization injection. Nurse had me stand up as she gave me the injection very high up on my shoulder. I flinched and cried out a bit as the needle jabbed my shoulder inside. It was excruciatingly painful inside especially toward the front of my shoulder, and the pain branched out.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dysphagia, Headache, Pharyngeal oedema
Clinical narrative: Persistent headache x 4 days, joint pain in elbows, swollen throat and difficulty swallowing.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Cold sweat, Feeling hot, Nausea
Clinical narrative: 10/12/18 nausea beginning at 6 p.m. Severe vomiting began at 8:30 p.m. and continued until 1 a.m. on 10/13/18. Cold sweats, overheating throughout the evening. By 6 a.m. on Saturday 10/13/18, severe hip and knee pain in both legs. Unable to leave the bed or eat until Saturday evening. Felt slightly better on Sunday 10/14/18 but still weak. Left home in the late afternoon and experienced cold sweats again. Joint pain nearly gone by Sunday.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: 10/12/18 nausea beginning at 6 p.m. Severe vomiting began at 8:30 p.m. and continued until 1 a.m. on 10/13/18. Cold sweats, overheating throughout the evening. By 6 a.m. on Saturday 10/13/18, severe hip and knee pain in both legs. Unable to leave the bed or eat until Saturday evening. Felt slightly better on Sunday 10/14/18 but still weak. Left home in the late afternoon and experienced cold sweats again. Joint pain nearly gone by Sunday.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Injection site erythema, Retching
Clinical narrative: Headache, dizziness, chills, injection site redness, shaking, dry heaves.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Headache, dizziness, chills, injection site redness, shaking, dry heaves.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Pain in extremity
Clinical narrative: Events: very sore arm at site of vaccination; fever topped out at 101; chills; sweating; tired; flu-like symptoms. Treatment: at home care; TYLENOL q6 hours; rest. Outcome: symptoms lasted times 4 days, followed by arm soreness time 5 additional days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Events: very sore arm at site of vaccination; fever topped out at 101; chills; sweating; tired; flu-like symptoms. Treatment: at home care; TYLENOL q6 hours; rest. Outcome: symptoms lasted times 4 days, followed by arm soreness time 5 additional days.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Pt is experiencing body aches diffusely following immunization yesterday- SHINGRIX given to L deltoid. No pain to site of immunization but body aches as if he was getting the flu. He denies any other symptoms- no cold symptoms, no rashes, motor loss, neurosensory deficits, HA etc. No fever- checked on the call and 96.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: APPROXIMATELY 2 MINUTES AFTER GIVING THE INJECTION, A QUARTER SIZED LUMP APPEARED AT THE INJECTION SITE. AFTER 1 HOUR, THE LUMP HAD DISSIPATED.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Paraesthesia oral, Throat irritation
Clinical narrative: 2-3 minutes after receiving vaccine injection site was itchy and red with hives. Throat felt itchy, tongue felt full and itchy. Took BENADRYL x2. 4 hrs later hives spread to neck face and scalp, resolved after first dose of BENADRYL but returned when dose wore off.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Tongue pruritus, Urticaria
Clinical narrative: 2-3 minutes after receiving vaccine injection site was itchy and red with hives. Throat felt itchy, tongue felt full and itchy. Took BENADRYL x2. 4 hrs later hives spread to neck face and scalp, resolved after first dose of BENADRYL but returned when dose wore off.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Pt received SHINGRIX (1st shot) on 10/5/18 Friday (approximately 11:30 AM). He lost his consciousness and fainted in his bathroom on Sat morning (approximately 7-8 AM) 10/6/18 and he hurt his back side of head and taken to ER. He was advised to stay overnight at the hospital but he got discharged on his own.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA, MMR, VARCEL
Symptoms: Electroencephalogram, Influenza, Nasopharyngitis, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: My child came down with cold/flu symptoms a week after the immunizations then 3-4 weeks later starting having seizures.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Laboratory test normal, Pain, Paraesthesia, Rash
Clinical narrative: On the day after the injection, I felt a prickly sensation for several days after, like a sunburn. Then, I noticed some throbbing pain. On Sat., Sept. 14, 2018, I went to Emergency Room, thinking I had kidney stone. They could not diagnose it. On Sunday, rash over kidneys began to appear. It was shingles.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt came to clinic on 10/10/18 for eval due to 9cm by 9cm. Redden area on left deltoid swollen and painful.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hepatitis B surface antibody negative, Localised oedema, Oedema, Skin warm
Clinical narrative: Red, edematous, hot. Area about 5 cm.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood glucose normal, Cold sweat, Cough, Dyspnoea
Clinical narrative: Patient presented with shortness of breath, feeling weak, headache, and clammy. Patient was immediately placed on 2L of oxygen by nasal cannula. Vitals were taken, blood glucose level checked (98), and provider monitored and examined the patient. After 5 minutes vitals were performed with the provider present throughout the reaction and patient stated she felt better. Oxygen sat was 98 and patient denied any of the previously reported symptoms. Patient was called on 10/15/2018 to follow up and per the child's mother the patient ran fevers all weekend which she treated with MOTRIN and TYLENOL and has a cough. Patient is schedule to see the provider today at 2:15 PM.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pyrexia
Clinical narrative: Patient presented with shortness of breath, feeling weak, headache, and clammy. Patient was immediately placed on 2L of oxygen by nasal cannula. Vitals were taken, blood glucose level checked (98), and provider monitored and examined the patient. After 5 minutes vitals were performed with the provider present throughout the reaction and patient stated she felt better. Oxygen sat was 98 and patient denied any of the previously reported symptoms. Patient was called on 10/15/2018 to follow up and per the child's mother the patient ran fevers all weekend which she treated with MOTRIN and TYLENOL and has a cough. Patient is schedule to see the provider today at 2:15 PM.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Muscle spasms and pain in right deltoid, continuing over one week after vaccine received.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Headache, Impaired work ability, Insomnia
Clinical narrative: Several hours after vaccine developed a headache which then progressed in to "joint pain all over". "Every joint in my body hurt." Increased fluids and took Ibuprofen. Laid in bed".  Even the sheet touching my body hurt". Could not sleep related to discomfort. Called off work next day. Finally slept about 0700. Slept most of the day. Took more Ibuprofen. Upon awakening around 3 PM, felt better. Joints were stiff but he could move much better. By evening, symptoms resolved. There has been no reoccurrence.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Joint stiffness, Tenderness
Clinical narrative: Several hours after vaccine developed a headache which then progressed in to "joint pain all over". "Every joint in my body hurt." Increased fluids and took Ibuprofen. Laid in bed".  Even the sheet touching my body hurt". Could not sleep related to discomfort. Called off work next day. Finally slept about 0700. Slept most of the day. Took more Ibuprofen. Upon awakening around 3 PM, felt better. Joints were stiff but he could move much better. By evening, symptoms resolved. There has been no reoccurrence.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient stated experiencing radiating pain down the left arm beginning several days after the vaccine administrated. Patient went to ER for treatment.
Age: 0.67
Sex: M
Vaccine: DTAP, FLU4, HEP, PNC13, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given Varicella vaccine prematurely at 8 months.
Age: 1.08
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13 MONTH OLD RECEIVED 0.5 ML OF FLUCELVAX (INDICATED 4 YEARS OLD AND OLDER). NO ADVERSE REACTIONS OR EVENTS WERE REPORTED AND PER VERBAL FOLLOW UP WITH PATIENT'S PARENTS ON 10/13/2018 AT 1:12 PM; MOTHER WAS ADVISED THAT THERE SHOULD BE NO TOXICITY PER POISON CONTROL AND TO GO TO ED OR RETURN TO CLINIC IN THE EVENT THAT AN ADVERSE REACTION OR EVENT OCCURS.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient developed a mild fever and moderate chills that lasted 3 hours after the injections. Side effects resolved.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Insomnia, Mobility decreased, Muscular weakness
Clinical narrative: Muscle weakness started the afternoon after vaccine was administered. Right arm pain and weakness radiated down into fingers. She also C/O headache, fatigue, insomnia D/T pain, muscle tenderness and trouble lifting arm. Patient was started on Steroids 10/5/18. Advised to return with worsening symptoms. If no better by Tuesday will refer.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Muscle weakness started the afternoon after vaccine was administered. Right arm pain and weakness radiated down into fingers. She also C/O headache, fatigue, insomnia D/T pain, muscle tenderness and trouble lifting arm. Patient was started on Steroids 10/5/18. Advised to return with worsening symptoms. If no better by Tuesday will refer.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Flushing, Swelling face
Clinical narrative: Employee felt flushed. Raspy voice and the feeling of facial swelling approx. one hour after flu vaccine on 10/01/2018. Received BENADRYL 50mg IM in Employee Health at 3 PM.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have been given the Hepatitis B vaccine instead of the flu vaccine. Manufacturer has no data as they have not done studies on anyone under the age of 6 months. Mom was informed by MD regarding the injection. F/U done 10/12/2018 and 10/15/2018 mom reports no adverse effects or side effects.
Age: 12.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: After receiving the flu vaccine, client started to fall over to one side. Nurse helped child back to an upright position and used an ammonia ampule to arouse her. Client regained consciousness and seemed to be alright after a couple minutes. Child was also given water to drink. Childs' mom stated that the child had not eaten all day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Patient reports arm hurt more than normal during administration. By 5:30 am, next morning, had no feeling on left leg; it took 30 minutes to wear off. Patient did not go to doctor. Occasionally takes some BENADRYL to go to sleep; and experienced a similar episode. This time it passed quickly. Patient has not used BENADRYL since. Patient not sure whether to take next SHINGRIX dose because afraid of similar symptoms. Except for supplements patient has not taken any TYLENOL/ALEVE since. Patient will mention incident to doctor during next visit. In terms of recovery, patient not sure if episode will repeat again.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Mom reported a lump at injection site. Lump described as half the size of a softball. Warm to touch, not painful, no fever.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Blister at injection site 24 hours after injection.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Numbness in left hand and fingers, pain when lifting left arm above head.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Pt states he received vaccine on 10/11/18 and starting on 10/12/18 he developed cold chills and low grade fever. States the night of 10/12/18 he had a fever of 101.2, chills, body aches, and sweating. States this has continued for 3 days.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Redness surrounding injection site of about 4 cm noted the evening of the injection, pruritis and rash on the chest and upper back 2 days following and continued for several days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Blister appeared at the site of injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Night sweats, Pyrexia
Clinical narrative: 12hrs after shot-fever of 101 degrees night sweats throughout night chills, shaking, fever over next 3 days - dull constant headache across forehead, extreme fatigue over next 3 days. 4th day went to Doctor as I had never had anything this long. No appetite. Drank lot of fluids. If I did not take 1 ADVIL and 1 xstrength TYLENOL every 5 hours the headache, chills and fever would return. Its now 1 week later.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: 12hrs after shot-fever of 101 degrees night sweats throughout night chills, shaking, fever over next 3 days - dull constant headache across forehead, extreme fatigue over next 3 days. 4th day went to Doctor as I had never had anything this long. No appetite. Drank lot of fluids. If I did not take 1 ADVIL and 1 xstrength TYLENOL every 5 hours the headache, chills and fever would return. Its now 1 week later.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About 1-1/2 inch red swelling about 1 inch from injection site. Hard to touch and warm. Itchy to patient. Taking BENADRYL to relieve. If doesn't improve, will seek further medical attention.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient developed fever of 100 degrees. Inj. site was red, swollen and itchy. Mom gave MOTRIN and BENADRYL. Helped a little. Now arm is still swollen, itchy and is purplish in color at inj. site. Redness is spreading around and down right arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left arm was pink and warm from top of arm to elbow. It had improved since yesterday according to patient.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes virus infection, Influenza like illness, Injection site bruising, Injection site pain
Clinical narrative: Pain and bruising at the injection site lasting several weeks; Aching type pain in other limbs, accentuating any other muscle soreness; General fatigue and malaise (similar to flu, but without gastrointestinal) for 2-3 days; after a week or so, experienced very first ever eruption of a HV2 lesion (despite exposure over 14 years with no eruptions!).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Pain and bruising at the injection site lasting several weeks; Aching type pain in other limbs, accentuating any other muscle soreness; General fatigue and malaise (similar to flu, but without gastrointestinal) for 2-3 days; after a week or so, experienced very first ever eruption of a HV2 lesion (despite exposure over 14 years with no eruptions!).
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine administered too high, not in deltoid muscle, felt like at bone or AC joint. Very painful at administration, so much that I said, "ouch, oh my goodness that hurts" during the administration. Very painful when crossing arm in front of body.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: By the day after the shot I could not move my arm at all. Extremely painful. I have an appointment with my primary tomorrow.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity, X-ray
Clinical narrative: By the day after the shot I could not move my arm at all. Extremely painful. I have an appointment with my primary tomorrow.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: 10/11/18: PATIENT'S CAREGIVER CALLING TO REPORT THAT PATIENT HAD 2 VACCINES ADMINISTERED LAST WEEK (10/3/18). LEFT ARM - PNEUMOCOCCAL AND RIGHT ARM - HIGH DOSE FLU. SHE STATED THAT THE RIGHT ARM IS RED, INFLAMED, WARM TO TOUCH. PROVIDER ASKED THAT THE PATIENT APPLY ICE TID. STAFF CALLED ON 1013 ARM IS OK NOW.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 10/11 patient got the imz, that weekend patients arm got sore and swollen. Patient went to the ER for this over the weekend. They stated it might be an allergy to the imz or a problem with the alcohol used to clean the area  He came back to the pharmacy to let us know on 10/15 about the adverse reaction.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Depressed level of consciousness, Dyspnoea
Clinical narrative: I returned to patient's home approximately 160 minutes later after administering vaccination. Patient complained of feeling short of breath, feeling like going to black out, stating has to lean forward to breath.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site injury, Muscle tightness, Myalgia
Clinical narrative: Immediate burning, tightness, muscle soreness. Continued soreness now through week 2 unable to lift arm in front of/across face without severe pain. Appears to have been injected at incorrect (too high) site, causing either ligament, tendon or joint damage.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Immediate burning, tightness, muscle soreness. Continued soreness now through week 2 unable to lift arm in front of/across face without severe pain. Appears to have been injected at incorrect (too high) site, causing either ligament, tendon or joint damage.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Pain, Scar, Secretion discharge, Skin ulcer
Clinical narrative: Whether by coincidence or a legitimate reaction, one week after the vaccination, a sore broke out on my back. It could best be described as a sore or small boil (it popped and was drained two times). It took between two and three weeks for it to become a small scar. Three weeks after the vaccination, an identical sore or small boil broke out between my upper lip and nose. The sore is now reduced in size and no longer painful. Even though this is the first time for such an event, no doctor was consulted.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: On Saturday about 10:30 am noticed rash on her stomach and continued to get bigger and redder. Today has an irritated flat red rash over both sides of abdomen. None noted elsewhere.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Malaise, Nausea
Clinical narrative: 36 hrs - incredible headache, shiver, fever (feel like), nausea - vomit 2 times - 1st time 24 hrs after vaccine: 2nd time - 30 hrs after. No food eaten for 36 hrs, then small amount. At 48 hrs - headache less, stomach pain, injection site sore. Before: Feeling great and in good mood! Day 1: 3:15: Shot administered. 6pm dinner, then after dinner feel so full, no food rest of night. 11pm bed: Not feeling great, but sleep. 7am awaken with incredible headache, feel like have a fever, shiver, stomach nausea - didn't want to eat. Dysfunctional feeling.  Noon Eat a little bit. 1pm vomit. 6pm try again eat a little 9 pm - vomit. Intense condition lasts until 7am Day 2. Day 2 morning: above day's headache, fever, shiver, nausea lessens, Noon - eat a little. 3 pm - stomach.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: 36 hrs - incredible headache, shiver, fever (feel like), nausea - vomit 2 times - 1st time 24 hrs after vaccine: 2nd time - 30 hrs after. No food eaten for 36 hrs, then small amount. At 48 hrs - headache less, stomach pain, injection site sore. Before: Feeling great and in good mood! Day 1: 3:15: Shot administered. 6pm dinner, then after dinner feel so full, no food rest of night. 11pm bed: Not feeling great, but sleep. 7am awaken with incredible headache, feel like have a fever, shiver, stomach nausea - didn't want to eat. Dysfunctional feeling.  Noon Eat a little bit. 1pm vomit. 6pm try again eat a little 9 pm - vomit. Intense condition lasts until 7am Day 2. Day 2 morning: above day's headache, fever, shiver, nausea lessens, Noon - eat a little. 3 pm - stomach.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Contusion, Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Swelling, redness, bruising, severe arm pain, itching, hives even 5 days later.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Urticaria
Clinical narrative: Swelling, redness, bruising, severe arm pain, itching, hives even 5 days later.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Dysphagia, Erythema, Injection site bruising, Peripheral swelling, Skin warm
Clinical narrative: Swelling, redness, bruising, severe arm pain, itching, hives even 5 days later.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Musculoskeletal pain, Shoulder injury related to vaccine administration
Clinical narrative: This spontaneous report was received from a nurse practitioner, via field representative and refers to a 20-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route and site of administration, lot # and expiration date were not reported). On an unknown date in September 2018 (reported as 2-3 weeks ago), the patient was vaccinated with second dose of GARDASIL 9 (dose, route and site of administration, lot # and expiration date were not reported). On an unknown date in 2018, following vaccine administration, the patient experienced shoulder pain and she was unable to lift her arm. On an unknown date, she was seen by the nurse practitioner and the nurse believed that the patient had shoulder injury related to vaccine administration (SIRVA). The nurse practitioner referred the patient to see an orthopedist on an unspecified date. The patient's symptoms did not resolve at the reporting time. Therapy with GARDASIL 9 was discontinued. The reporter considered the event to be related to GARDASIL 9.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age and race. Concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that on 28-AUG-2018, the patient was administered the first dose of VAQTA lot number: N020689 (expiration date: 22-OCT-2018) (strength, dose and route were not reported) for prophylaxis; and on 03-OCT-2018, she received the second dose of VAQTA. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a Registered Nurse via a company representative, referring to a 17 year old patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On an unknown date, the patient was vaccinated with an adult dose of VAQTA injection, 50/1.0 U/ml (dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2016, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age who is also a company representative, referring to herself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, when the patient was 26 year old, she was vaccinated with the first dose GARDASIL 9 for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). On another unreported date, when the patient was 26 year old, she was vaccinated with the second dose GARDASIL 9 for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). No adverse effects were reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Discomfort, Fatigue, Incorrect dose administered, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 11th July 2018, the patient received SHINGRIX .5 ml. On 11th July 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The registered nurse reported that one of the other nurses did not mix the adjuvant with the powder, and only gave the patient the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter called back to provide the initials and birthdate for the patient as well as the date the vaccine was given. Follow up information received from other health care professional on 3rd October 2018: The nurse did not mix adjuvant with powder only adjuvant was given to the patient. The reporter spoke to the patient approximately 1 week ago and patient reported localized discomfort and injection site along with diarrhea and fatigue for 1 or 2 days after vaccine, which resolved on its own. The patient was uncertain if she would restart series at the time of reporting. The VAERS details were updated.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Left side head pain; soft tissue lesion distal to injection site; left side neck tightness/head muscle tightness; left arm stiffness; left arm sore; myalgia; flu like symptoms; pain at injection site; redness at injection site; GSK case number US2018167941 is a duplicate of US2018160725. All future correspondence will be submitted to US2018160725. Lab Comments: On an unknown date, the patient underwent blood test and X-ray.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle tightness, Musculoskeletal stiffness, Myalgia, Pain in extremity, X-ray normal
Clinical narrative: Left side head pain; soft tissue lesion distal to injection site; left side neck tightness/head muscle tightness; left arm stiffness; left arm sore; myalgia; flu like symptoms; pain at injection site; redness at injection site; GSK case number US2018167941 is a duplicate of US2018160725. All future correspondence will be submitted to US2018160725. Lab Comments: On an unknown date, the patient underwent blood test and X-ray.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle twitching, Wheezing
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of twitching of limbs in a 70-year-old male patient who received SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 26th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 26th September 2018, less than a day after receiving SHINGRIX, the patient experienced twitching of limbs. On an unknown date, the patient experienced wheezing. On an unknown date, the outcome of the twitching of limbs was not recovered/not resolved and the outcome of the wheezing was not recovered/not resolved. It was unknown if the reporter considered the twitching of limbs and wheezing to be related to SHINGRIX. Additional details were provided as follows: The patient had been experiencing muscle twitching in his arm and wheezing since the administration of SHINGRIX. The muscle twitching was started on the day of the vaccination and was not sure when the wheezing started.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Presyncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of presyncope in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced presyncope and injection site cellulitis. On an unknown date, the outcome of the presyncope and injection site cellulitis were unknown. It was unknown if the reporter considered the presyncope and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: This case was reported by pharmacy student. The age at vaccination was not applicable for this report. The health care professional reported several patients reported cellulitis site reaction and presyncopal episodes after receiving either the initial or booster dose of SHINGRIX. No further details were reported regarding the event.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Myalgia, Nasal congestion, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HIGH-DOSE for prophylaxis. Previously administered products included ZOSTAVAX. Concomitant products included SHINGRIX. On 1st October 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular) and FLUZONE HIGH-DOSE (intramuscular). On 1st October 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 1st October 2018 19:00, the patient experienced chills, throat tightness, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches. The patient was treated with acetylsalicylic acid (Aspirin), ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chills, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches were recovering/resolving and the outcome of the throat tightness was recovered/resolved and the outcome of the drug dose administration interval too short was unknown. The reporter considered the chills, throat tightness, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches to be unrelated to SHINGRIX. Additional details were reported as follows: On 16th August 2018, the patient stated that she received the 1st dose of SHINGRIX into left arm, concomitantly. The patient states that she did not realize that the SHINGRIX injection was 2 weeks early (inappropriate schedule of vaccine) until after she had already received the a dose of SHINGRIX, which led to shortening of the vaccination schedule. The patient received FLUZONE (manufacturer: Sanofi) in the right arm at the same time as SHINGRIX. The patient experienced pain during the SHINGRIX injection and the pain was better on the reporting date, however, when she lifts her left arm, it feels a little sore. The patient received both vaccine around 3pm and by 7pm she started to have experience the headache, fever, chills, tightness in the throat, nasal congestion, runny nose, muscle aches (all over the body), eye redness and eye irritation. The patient took baby aspirin, ibuprofen and Benadryl. The patient believed that the symptoms (other than injection site pain) came from the flu vaccine. The patient was certain that SHINGRIX was not causing her symptoms. She was relating it to the flu shot. It was unknown if the reporter considered headache, fever, chills, tightness in the throat, nasal congestion, runny nose, muscle aches (all over the body), eye redness and eye irritation to be related to FLUZONE HIGH DOSE 2018-2019 years. The patient did not want any follow up at all and specifically asked that she should not receive any mailing. The patient denied permission to contact. This case has been linked to the US2018GSK186061, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rhinorrhoea, Throat tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE HIGH-DOSE for prophylaxis. Previously administered products included ZOSTAVAX. Concomitant products included SHINGRIX. On 1st October 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular) and FLUZONE HIGH-DOSE (intramuscular). On 1st October 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 1st October 2018 19:00, the patient experienced chills, throat tightness, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches. The patient was treated with acetylsalicylic acid (Aspirin), ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chills, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches were recovering/resolving and the outcome of the throat tightness was recovered/resolved and the outcome of the drug dose administration interval too short was unknown. The reporter considered the chills, throat tightness, headache, runny nose, eye red, eye irritation, nasal congestion, injection site pain, fever and generalized muscle aches to be unrelated to SHINGRIX. Additional details were reported as follows: On 16th August 2018, the patient stated that she received the 1st dose of SHINGRIX into left arm, concomitantly. The patient states that she did not realize that the SHINGRIX injection was 2 weeks early (inappropriate schedule of vaccine) until after she had already received the a dose of SHINGRIX, which led to shortening of the vaccination schedule. The patient received FLUZONE (manufacturer: Sanofi) in the right arm at the same time as SHINGRIX. The patient experienced pain during the SHINGRIX injection and the pain was better on the reporting date, however, when she lifts her left arm, it feels a little sore. The patient received both vaccine around 3pm and by 7pm she started to have experience the headache, fever, chills, tightness in the throat, nasal congestion, runny nose, muscle aches (all over the body), eye redness and eye irritation. The patient took baby aspirin, ibuprofen and Benadryl. The patient believed that the symptoms (other than injection site pain) came from the flu vaccine. The patient was certain that SHINGRIX was not causing her symptoms. She was relating it to the flu shot. It was unknown if the reporter considered headache, fever, chills, tightness in the throat, nasal congestion, runny nose, muscle aches (all over the body), eye redness and eye irritation to be related to FLUZONE HIGH DOSE 2018-2019 years. The patient did not want any follow up at all and specifically asked that she should not receive any mailing. The patient denied permission to contact. This case has been linked to the US2018GSK186061, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Migraine, Night sweats, Pyrexia, Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ear buzzing in a 61-year-old female patient who SHINGRIX (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 28th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced ear buzzing, migraine, fever and chills. On 29th September 2018, the patient experienced night sweat. On an unknown date, the outcome of the ear buzzing and night sweat were not recovered/not resolved and the outcome of the migraine was recovering/resolving and the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the ear buzzing, night sweat, migraine, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccination and started to had side effects that evening. She woke up the next morning with night sweats which continued. The chills and fever resolved within 1 to 2 days. The patient had a light migraine which was improving at the time of reporting. She had buzzing in her right ear and possibly her left ear but the right side was so prominent she was not sure. The pharmacist was transferred to MI (medical information) for additional information. The pharmacist stated to send letter from Regulatory Authority to her and she would provide for the patient should she want to follow up on it.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tendonitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 75-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, fever and tendonitis. On an unknown date, the outcome of the pain and fever were recovered/resolved and the outcome of the tendonitis was not recovered/not resolved. It was unknown if the reporter considered the pain, fever and tendonitis to be related to SHINGRIX. Additional details were provided as follows: The pharmacist was reporting the adverse event on behalf of the patient. The patient received SHINGRIX vaccine in the left deltoid. The pharmacist stated that the patient experienced aches and fever after receiving the SHINGRIX vaccine. The pharmacist stated that the patient also developed pelvic tendonitis around the same time that she received the SHINGRIX vaccine and the patient was not sure if it was related to or caused by the SHINGRIX vaccine.