chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Gastric disorder, Hyperhidrosis, Malaise, Skin warm
Clinical narrative: Patient states that after receiving the vaccine later that night, he started experiencing cold; shivering and went to bed early. The next morning he woke up experiencing dizziness and could not function. He was very thirsty, he drunk 10 glasses of water and felt very sick and his stomach could not digest water. He states he was experiencing intense sweats, very warm and very cold, tension in the head, feeling dizzy, coughing and loss of appetite in the past 4 - 5 days. Patient states that last night he was cold and had 2 - 3 layers of clothes and a blanket. He went to see his PCP for the severe thirst and they ran blood work. The results of this blood work are still pending as of this morning of 10/23/18 and patient stated feeling better today.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Tension headache, Thirst
Clinical narrative: Patient states that after receiving the vaccine later that night, he started experiencing cold; shivering and went to bed early. The next morning he woke up experiencing dizziness and could not function. He was very thirsty, he drunk 10 glasses of water and felt very sick and his stomach could not digest water. He states he was experiencing intense sweats, very warm and very cold, tension in the head, feeling dizzy, coughing and loss of appetite in the past 4 - 5 days. Patient states that last night he was cold and had 2 - 3 layers of clothes and a blanket. He went to see his PCP for the severe thirst and they ran blood work. The results of this blood work are still pending as of this morning of 10/23/18 and patient stated feeling better today.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Within a few minutes of given flu shot employee Stated: dizziness, "I don't feel well", employee asked and was given bottle of water. Witnessed: sips of water taken then syncopal episode; sweating, facial flushness then pale, skin hot to touch. Code White initiated; employee moved to floor, blood pressure machine initiated; juice given when employee became alert and oriented; then snack given. Employee stated he had not eaten since breakfast which was a bowl of cereal.  Code White team offered Emergency Department treatment but employee declined. Once stable, employee ambulated out of EOH with coworker who came in with employee also for flu shot, but declined. Stated "I haven't eaten either."
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Syncope
Clinical narrative: Within a few minutes of given flu shot employee Stated: dizziness, "I don't feel well", employee asked and was given bottle of water. Witnessed: sips of water taken then syncopal episode; sweating, facial flushness then pale, skin hot to touch. Code White initiated; employee moved to floor, blood pressure machine initiated; juice given when employee became alert and oriented; then snack given. Employee stated he had not eaten since breakfast which was a bowl of cereal.  Code White team offered Emergency Department treatment but employee declined. Once stable, employee ambulated out of EOH with coworker who came in with employee also for flu shot, but declined. Stated "I haven't eaten either."
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy, Malaise, Pain
Clinical narrative: 10/8/2019 Employee to Occ Health office c/o tenderness & enlarge "lymph node" to left neck area.  Measurements 2 fingers wide, and 1 finger long- very tender to touch. Afebrile with aches and not feeling well all weekend. Medical Director consulted and employee was advised to take Ibuprofen today and return to office 10/9. 10/9/2018 Employee returned to office with no improvement/ no changes- she is advised to see her PCP. 10/12/2018 Employee saw PCP who said this is a reaction from the flu shot. She is to continue ibuprofen and use an ice pack to the site.10/17/2018 She reported back to Occ Health that she is better, soreness gone and swelling is down tremendously.  She is to follow up with him if any further problems.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Hypoaesthesia
Clinical narrative: Patient presented to ER on 10/6 with numbness in right arm after influenza vaccine on 10/3/2018, patient presented to ER on 10/8 with numbness on his whole right side arm and leg as symptoms worsened.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Lymphadenopathy
Clinical narrative: Patient experienced swelling in a gland on her neck on the left side and increased blood pressure. Patient went to the emergency room where she was monitored and then released. The swelling and blood pressure has now reduced. Patient stated that they were unsure if it was an issue with her thyroid, the flu shot, or an allergic reaction to something she ate (she stated she was eating blueberries and cherry tomatoes).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature decreased, Peripheral coldness, Pyrexia
Clinical narrative: Pt fever prior to shots 100.7 rectal, 102.7 rectal on 10-17-18 after shots. 94.8 rectal on 2 thermometers and feels cool to touch. Pt responds normally and alert. This also happened after 4 mos shots on 8-22-18.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Approximately 2 weeks after the vaccine, I had an outbreak of shingles. I am perfectly health, no flu symptoms. Nothing else out of ordinary except receiving the flu vaccine.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Arm became red hot and itchy 30 minutes after vaccine, Redness extended down entire arm. Vaccine given 10/19/18, symptoms resolved completely on 10/21/19. BENADRYL was used every 6-8 hours for symptoms.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Rash, Urticaria, Vomiting
Clinical narrative: I because nauseous and had vomiting with hives and a rash on my chest, back and both arms. I am still experiencing nausea, dizzy spells, and rash.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Back pain, Chest pain, Dizziness, Headache, Pain
Clinical narrative: Patient left facility after vaccination (nurse) requested her to wait for 15 minutes- Mom reported "she was driving" and taking daughter out for breakfast"- returned to clinic one hour later-reportedly "CP, radiating to back, dizzy, and H/A- B/P 158/82 HR 96- patient denies dizziness at this time- reportedly ate a large breakfast after vaccinations, mom calling primary care provider Dr. - advised mom if CP would need to have her checked out in ER or Dr Office- patient did not faint- reports "feels better now, just has H/A".
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Pain, Peripheral swelling
Clinical narrative: Swollen bicep, pain radiating to armpit- started after injection. Still having symptoms today 10/23. No redness or streaking.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Myalgia, Pain
Clinical narrative: Within 6 or 7 hours patient started to get severe muscle and joint aches, even throughout the night as her husband told her that she was complaining. The next morning she still hurt all over and about mid-day she noticed that her arm was reddened about 2 inches below the injection site on the left arm. It was red, warm and very large covering the front and side of her arm. She described it as a "lymphedema-like" reaction. Her muscle soreness began to improve the 3rd day, but the arm remained red and sore. Now 7 days later the redness is almost gone and the soreness is too. She did not apply any type of treatment for the redness.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Within 6 or 7 hours patient started to get severe muscle and joint aches, even throughout the night as her husband told her that she was complaining. The next morning she still hurt all over and about mid-day she noticed that her arm was reddened about 2 inches below the injection site on the left arm. It was red, warm and very large covering the front and side of her arm. She described it as a "lymphedema-like" reaction. Her muscle soreness began to improve the 3rd day, but the arm remained red and sore. Now 7 days later the redness is almost gone and the soreness is too. She did not apply any type of treatment for the redness.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Fatigue, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: The immunization was administered the morning of 10/13/18 and in the evening the patient felt very tired and showered and went to bed. 10/14/18 she had a fever which she was able to keep controlled with alternating tylenol and ibuprofen. She said by Monday 10/15/18 her left arm was red, hot, swollen and itching. The itching was relieved with hydrocortisone cream OTC but a week later is still slightly red and itching so she reported this to the pharmacy. I recommended benadryl instead of hydrocortisone and told her the likely culprit was the PNEUMOVAX since she has successfully taken flu shot in the past.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: The immunization was administered the morning of 10/13/18 and in the evening the patient felt very tired and showered and went to bed. 10/14/18 she had a fever which she was able to keep controlled with alternating tylenol and ibuprofen. She said by Monday 10/15/18 her left arm was red, hot, swollen and itching. The itching was relieved with hydrocortisone cream OTC but a week later is still slightly red and itching so she reported this to the pharmacy. I recommended benadryl instead of hydrocortisone and told her the likely culprit was the PNEUMOVAX since she has successfully taken flu shot in the past.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: PATIENT REPORTS ARM WAS FINE FOR 2 WEEKS AFTER SHOT, THEN BEGAN HURTING. STILL HURTS TO TOUCH AND RANGE OF MOTION IS IMPEDED. PATIENT HAS NOT SEEN PHYSICIAN, I HAVE RECOMENDED THAT HE DOES.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Eye pruritus, Eye swelling, Hypoaesthesia oral
Clinical narrative: About 4-5 hours after the vaccine: Tightness of throat - lump feeling at the level of the larynx, some coughing, really itchy runny red swollen eyes, numbness in the back of the mouth/oropharyngeal area, mild swelling of lips, fever/chills for about 8 hours. I took a CLARITIN 10mg tab, used an asthma inhaler - albuterol, and used allergy antihistamine eye drops and went to bed, the throat tightness took about 3 hours to resolve, my eyes and lips are still swollen about 12 hours later but are no where near as itchy, the chills have resolved, my head now hurts a little and my sense of taste seems to be affected.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Lacrimation increased, Lip swelling, Pyrexia, Sensation of foreign body, Throat tightness
Clinical narrative: About 4-5 hours after the vaccine: Tightness of throat - lump feeling at the level of the larynx, some coughing, really itchy runny red swollen eyes, numbness in the back of the mouth/oropharyngeal area, mild swelling of lips, fever/chills for about 8 hours. I took a CLARITIN 10mg tab, used an asthma inhaler - albuterol, and used allergy antihistamine eye drops and went to bed, the throat tightness took about 3 hours to resolve, my eyes and lips are still swollen about 12 hours later but are no where near as itchy, the chills have resolved, my head now hurts a little and my sense of taste seems to be affected.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV
Symptoms: Blister, Rash generalised, Rash macular, Scab, Urticaria
Clinical narrative: 10/22/18 - Pt had his vaccines on Thursday, pt's mom states he started getting a rash all over his body on Sunday! Otherwise acting normal, also blisters behind his ears, but have scabbed over due to him scratching. Advised to see M.D. Made appt to be seen on 10/23/18. 10/23/18 - Pt had appt w/MD. Rash (macular on trunk, hives on legs) advised to take ZYRTEC for rash. F/u as needed.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Fall, Laboratory test, Muscular weakness
Clinical narrative: PATIENT DESCRIBED WHAT SOUNDED LIKE COMPLETE MUSCLE WEAKNESS. HE SAYS HE WENT TO USE THE RESTROOM, BUT SLUMPED TO THE FLOOR. HE NEVER LOST CONSCIOUSNESS, BUT HAD TROUBLE/COULD NOT GET UP ON HIS OWN. HE STATED THIS HAPPENED ANOTHER TIME, BUT IT WAS AFTER TAKING AN EXTRA DOSE OF ONE OF HIS TABLETS. HE ASSUMED THE VACCINE CAUSED THE ISSUE, SINCE IT WAS THE MOST RECENT THING HE HAD HAD DONE.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Hypoaesthesia
Clinical narrative: Patient complained of arm numbness and a metallic  taste in her mouth .
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Lichen planus, Pain
Clinical narrative: As the son of a medical doctor, I have received an annual flu shot every year since my teens - or earlier. In 2015, as a senior, I opted for the FLUZONE High Dose Flu shot, my first. Within 2 weeks I developed genital lichen planus (confirmed by dermatologist) when I never suffered from this condition previously. It has not gone away since and is both painful and embarrassing. I will NEVER get the high dose flu shot again based on my experience, as well as my Registered Nurse (a senior) sister who experienced a violent reaction to the same vaccine. In addition, when I received my annual, REGULAR, flu shot yesterday, my physician advised against the high dose in my case.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, erythema, and mild swelling on upper left extremity.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fall, Swelling face, Syncope
Clinical narrative: Vasovagal syncope shortly after administration of vaccine with fall, bump to forehead. Pt recovered after event, awake and alert. Vitals stable, patient was neurologically intact. Ambulance was called, then declined.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Mass, Rash
Clinical narrative: The patient developed a rash and hard lump.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Gout, Pain, Pain in extremity, Swelling
Clinical narrative: Day 1 (08/17): Shot given; Day 2: Sore, swollen, red arm (almost entire upper arm); Day 3: Parkinson's plus symptoms (legs not working) returned after not being apparent for a while; Day 4: Woken up with SEVERE pain in right foot/big toe (gout-like, but patient does not have gout); Day 5: Toe still red and swollen, but pain has started to lessen; Day 6: Foot pain almost gone.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Drooling, Swollen tongue, Throat irritation, Wheezing
Clinical narrative: 30 minutes after the shot was administered, patient experienced sudden swelling of the tongue, irritation of the throat, coughing, profuse drooling, and slight wheezing.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Vaccination site rash
Clinical narrative: Daughter has a small rash patch on the left leg where the vaccine was administered. It first appeared 10-13-18. The mother put AVEENO hydro-cortisone cream on leg, and also at different times AQUAPHOR but did not notice it helping the rash. After a week I took her to her pediatrician, she commented it looked like a reaction from the shot. She said it just needed time, and there wasn't really anything we could do. At this point the coloring is getting darker, from the bright red. But it is still visible.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Pain, Photophobia
Clinical narrative: Patient complained of feeling awful, with headaches, light sensitivity, and achiness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: She had pain at the injection site for a few days after vaccination. Roughly one week later, she started some weightlifting (she states not very heavy weights, does not sweat during lifting) and noticed pain in the injection site again. The pain has continued and impacts her sleep. The pain radiates from her injection site down into her fingers and up into her shoulder. Ibuprofen and acetaminophen provide some relief but do not eliminate it completely. She stated that before she started lifting, she had no pain whatsoever after the first few days after the vaccine. She also stated that her left arm does not hurt at all, but the right arm (vaccine site) does.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular, Vaccination site pustule, Vaccination site scab
Clinical narrative: Pt states the scab fell off of his vaccination site 7 days ago and 2 days later pt noticed 2 pustules on his upper left arm near his vaccination and a larger pustule on the left side of his neck.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 62-year-old non-pregnant female patient with drug reaction/allergies to amoxicillin and prednisone. There was no information about the patient's medical histories provided. Concomitant therapies included atorvastatin, duloxetine hydrochloride, filgrastim, NEXIUM, sumatriptan and clonazepam. In September 2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular, lot # R012632 and expiration date: 15-JAN-2020 (exact dose was not reported) for history of pneumonia. In September 2018, the patient experienced low grade fever, pounding headache and welts on arm. The tramadol was given to the patient for headache. The outcome of the event was reported as recovered. The causality assessment between the event and PNEUMOVAX 23 was not provided.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Electroencephalogram, Head injury, Seizure like phenomena, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure like phenomena in a 17-year-old female patient who received MENVEO for prophylaxis.  Co-suspect products included duloxetine (Cymbalta) unknown for an unknown indication. The patient's past medical history included syncope (occurred over the last two years before the reporting).  On 19th September 2018, the patient received MENVEO. On an unknown date, the patient started Cymbalta at an unknown dose and frequency. On 25th September 2018, 6 days after receiving MENVEO and less than a year after starting Cymbalta, the patient experienced syncope (serious criteria hospitalization) and head injury. On 2nd October 2018, the patient experienced seizure like phenomena (serious criteria hospitalization and GSK medically significant). The action taken with Cymbalta was unknown (Dechallenge was unknown). Rechallenge with Cymbalta was unknown. On an unknown date, the outcome of the seizure like phenomena, syncope and head injury were unknown. The reporter considered the seizure like phenomena, syncope and head injury to be unrelated to MENVEO and Cymbalta. Additional details were provided as follows: This case was reported by the patient's mother. The reporter's daughter had a two year history of syncope which were thought to be related to panic attacks. These episodes occurred when she was running for cross country and track. On 25th September 2018, the patient had syncope and hit her head. She went to the emergency room (ER) then was sent home. On Tuesday 2nd October 2018, while getting out of her car in the school parking lot, she had syncope again with seizure-like movements. She went home and later returned back to school on the same day. She had another syncope episode with seizure-like movements. On 3rd October 2018, the patient stayed home and was told by her physician to reduce her dose of Cymbalta from 40mg to 20mg because it was thought might be this medication might be causing the episodes. She did not have any episodes for the whole day. She went back to school on 4th October 2018 and had another syncope episode with seizure-like movements while sitting in the classroom. The nurse from school called the reporter and told her it looked like her daughter was having a seizure. On Friday, 5th October 2018, she went to the clinic where an EEG (electrocardiogram) was performed.  The physician told the reporter that her daughter's syncope episodes were not related to medication.  On Tuesday, 9th October 2018, the patient was admitted to the Clinic for a three day study. She did not experience any episodes while at the Clinic. Unable to determine the cause at this time although the reporter felt that it was related to the MENVEO product. The reporter gave permission for her daughter's (patient's) physician to be contacted for follow up. Unable to obtain additional information.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Fatigue, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 53-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 6 months and 1 day prior to the 2nd dose of SHINGRIX). On 9th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), injection site pain, injection site bruising, muscle pain, tiredness and injection site swelling. On an unknown date, the outcome of the cellulitis, injection site pain, muscle pain, tiredness and injection site swelling were recovered/resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the cellulitis, injection site pain, injection site bruising, muscle pain, tiredness and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: After a dose of SHINGRIX the patient had swelling and bruising at the injection site. It was painful, like he was hit in the arm by a bat, and he had some cellulitis going down his arm. He also experienced more general muscle pain and tiredness, but not enough to stop him from going to work. The patient was fine now.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 53-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 6 months and 1 day prior to the 2nd dose of SHINGRIX). On 9th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), injection site pain, injection site bruising, muscle pain, tiredness and injection site swelling. On an unknown date, the outcome of the cellulitis, injection site pain, muscle pain, tiredness and injection site swelling were recovered/resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the cellulitis, injection site pain, injection site bruising, muscle pain, tiredness and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: After a dose of SHINGRIX the patient had swelling and bruising at the injection site. It was painful, like he was hit in the arm by a bat, and he had some cellulitis going down his arm. He also experienced more general muscle pain and tiredness, but not enough to stop him from going to work. The patient was fine now.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye irritation, Eye pruritus, Lacrimation increased
Clinical narrative: Flu shot 10/19/18 eye started irritating her and itching and watery eyes. Apply cool compress and took BENADRYL.
Age: 83.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal disorder, Pain in extremity, Peripheral swelling
Clinical narrative: Pt experience swelling in forearm, pain radiating to fingers, and soreness in hand. She stated she was not able to use her hand on 10/9 still. Pt was to follow up with MD on 10/10.
Age: 83.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Joint swelling, Pain in extremity
Clinical narrative: Pt experience swelling in forearm, pain radiating to fingers, and soreness in hand. She stated she was not able to use her hand on 10/9 still. Pt was to follow up with MD on 10/10.
Age: 83.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Peripheral swelling
Clinical narrative: Pt experience swelling in forearm, pain radiating to fingers, and soreness in hand. She stated she was not able to use her hand on 10/9 still. Pt was to follow up with MD on 10/10.
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Inflammation, Injection site inflammation, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Sore, swollen and inflamed upper arm. I received the shot on 10/16/18, on 10/18/18 left arm (deltoid) was swollen and inflamed. Dr. put me on CEFLEXON.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Mass, Pain, Ultrasound scan
Clinical narrative: Patient started with a sore, red lump a few days after the injection. 3 months later, continues to have an ill-defined lump underneath the site of injection in the right arm
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: She said her arm starting hurting right after the shot. Very sore. She same by pharmacy today, said it hurts to even lift her arm. She said it hurts constantly. No redness or swelling at the site of where the shot was given. She said she is going to see her primary MD about it tomorrow (10/24/18). I told her to please call me and tell me what they say.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Gillian-Barre Syndrome diagnosis, Tingling, numbness started in feet/ankles progress up leg to back, staggering gait, fever on and off, dizziness. Still having symptoms.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Gillian-Barre Syndrome diagnosis, Tingling, numbness started in feet/ankles progress up leg to back, staggering gait, fever on and off, dizziness. Still having symptoms.
Age: 47.0
Sex: M
Vaccine: RAB
Symptoms: Blood test, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Rheumatoid arthritis I had a series of vaccinations, including 3 rounds of rabies.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: While being administering the vaccine, the injection site burned terribly. About 3-4 hours later, I was hit like a ton of bricks with extreme muscle weakness and aching, joint aching, inability to keep temperature up (chattering teeth/icy hands despite being under 4 blankets), moderate headaches, mild nausea, vomited once. Day 1 I felt horrendous: like the worst flu ever. Day 2 I will still unable to get out of bed but was feeling somewhat better. Felt substantially better by Day 3 but injection site was still swollen, red and angry looking for days. A miserable experience! Worst vaccine I have ever had in my life. No preparation for this by the pharmacist. I'm afraid to take Vaccine # 2!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Muscular weakness
Clinical narrative: While being administering the vaccine, the injection site burned terribly. About 3-4 hours later, I was hit like a ton of bricks with extreme muscle weakness and aching, joint aching, inability to keep temperature up (chattering teeth/icy hands despite being under 4 blankets), moderate headaches, mild nausea, vomited once. Day 1 I felt horrendous: like the worst flu ever. Day 2 I will still unable to get out of bed but was feeling somewhat better. Felt substantially better by Day 3 but injection site was still swollen, red and angry looking for days. A miserable experience! Worst vaccine I have ever had in my life. No preparation for this by the pharmacist. I'm afraid to take Vaccine # 2!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Peripheral coldness, Vomiting
Clinical narrative: While being administering the vaccine, the injection site burned terribly. About 3-4 hours later, I was hit like a ton of bricks with extreme muscle weakness and aching, joint aching, inability to keep temperature up (chattering teeth/icy hands despite being under 4 blankets), moderate headaches, mild nausea, vomited once. Day 1 I felt horrendous: like the worst flu ever. Day 2 I will still unable to get out of bed but was feeling somewhat better. Felt substantially better by Day 3 but injection site was still swollen, red and angry looking for days. A miserable experience! Worst vaccine I have ever had in my life. No preparation for this by the pharmacist. I'm afraid to take Vaccine # 2!
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Pain
Clinical narrative: Flu-like symptoms - Body aches, fatigue, severely sore injection site.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Pain, Peripheral swelling, Urticaria
Clinical narrative: Developed a 2 inch raised redness at injection site with a white center and then developed 3-4 inch sized painful lumps under skin in the forearm of the same arm vaccine was given- was seen 10/22 with left arm swelling most significant over inj site 4-5 cm milder swelling of forearm into left hand with 2 small wheals just distal to inj site. Painful to abduct arm and supinate.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Redness and swelling around arm below injection site of PNEUMOVAX. Patient also reported a fever, muscle weakness, aches/pains, headache, and pain/tenderness at PNEUMOVAX injection site (note, she also received a FLUAD vaccine the same day, but in the right arm, which did not have any redness/swelling/pain at injection site).
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Redness and swelling around arm below injection site of PNEUMOVAX. Patient also reported a fever, muscle weakness, aches/pains, headache, and pain/tenderness at PNEUMOVAX injection site (note, she also received a FLUAD vaccine the same day, but in the right arm, which did not have any redness/swelling/pain at injection site).
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient presented approximately 72 hours after receiving vaccination with complaint of erythema and tenderness at injection site as well as surrounding area. Patient also reported fever as high as 102, 24 hours after injection was received. On exam, right arm significantly erythematous, superior to injection approximately 5 x 5 cm, inferior to injection site approximately =10 x 13 cm, tenderness appreciated at injection site but not as tender surrounding site. No warmth appreciated. Treatment included BENADRYL Q6H, prednisone 20 mg BID x 5 days, cool compresses, ibuprofen PRN. Patient was already taking ZYRTEC OTC. (Patient hesitant to use BENADRYL 2/2 agitation).
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pyrexia, Tremor
Clinical narrative: High fever, chills, uncontrollable shaking/teeth chattering, nausea.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, VARCEL
Symptoms: Injection site cellulitis, Injection site warmth, Vaccination site discolouration, Vaccination site induration
Clinical narrative: Dx-Cellulitis to right upper thigh. Sx-Right thigh very hot to touch, 8cm x 8cm area of induration around vaccine sites, does not appear to be painful to touch, has dark skin, indurated area is darkened in coloration. Tx-Start Cephalexin Suspension Reconstituted, 250 MG/5ML, 10 ml, Orally, twice a day, 10 day(s), BENADRYL for itching, and cool compresses for comfort.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Bite, Chills, Erythema, Herpes zoster
Clinical narrative: 9/28/18 Redness/rash appeared on left rib cage. 9/29/18 Diagnosed as bite by MD. 10/2/18 Diagnosed as probable Shingles by dermatologist Prescribed Valacyclovir-1 gram dosage. No pain-widespread itching. After 8/6/18 immunization- fever, muscle aches, joint stiffness, site pain, nauseated, shivering, general malaise.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint stiffness, Lichenoid keratosis, Malaise, Myalgia
Clinical narrative: 9/28/18 Redness/rash appeared on left rib cage. 9/29/18 Diagnosed as bite by MD. 10/2/18 Diagnosed as probable Shingles by dermatologist Prescribed Valacyclovir-1 gram dosage. No pain-widespread itching. After 8/6/18 immunization- fever, muscle aches, joint stiffness, site pain, nauseated, shivering, general malaise.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: 9/28/18 Redness/rash appeared on left rib cage. 9/29/18 Diagnosed as bite by MD. 10/2/18 Diagnosed as probable Shingles by dermatologist Prescribed Valacyclovir-1 gram dosage. No pain-widespread itching. After 8/6/18 immunization- fever, muscle aches, joint stiffness, site pain, nauseated, shivering, general malaise.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Erythema at injection site and spread distally down (R) arm fever 101.9 achy flu like 10/20/18 10/22 red raised warm blotches over (R) upper arm fever 10/21 started antihistamine RTC for hive like lesions.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular, Urticaria
Clinical narrative: Erythema at injection site and spread distally down (R) arm fever 101.9 achy flu like 10/20/18 10/22 red raised warm blotches over (R) upper arm fever 10/21 started antihistamine RTC for hive like lesions.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: A red curved line showed up on forearm and there was a raised red area about 3-4 inches long and 2-3 inches wide. Prescribed "8-1" course prednisone and BENADRYL.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Starting approx 4 days after getting the flu shot, the tip of my left thumb starting to feel numb. The next day or 2 later, the numbing sensation spread further down my thumb. Then, it spread to the distal part of my left 2nd digit. Now, about 12 days later, I have had sporadic tingling go up the inside of my legs, starting at my ankle and spread up to my inner thigh, bilaterally. Numbing sensation on both left fingers is a constant feeling and has yet to go away.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: Pt reported pain and difficulty moving left arm x3 days. This appears to be standard as several people have reported it. What is not frequently reported is the patient having a multiple body area rash, including trunk and back. Pt called MD and was told to take BENADRYL for 2 days and not get the second shot.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Headache, Loss of personal independence in daily activities
Clinical narrative: Mild chills; Mild fever; Loss of appetite; Headache; swelling and redness below injection site; Lost day of work.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Mild chills; Mild fever; Loss of appetite; Headache; swelling and redness below injection site; Lost day of work.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site bruising, Lip blister, Vomiting
Clinical narrative: Vaccine given around 9:15-9:30am on 10/18/18, That evening around 10 or 11pm the patient noticed chills and vomiting that evening, and then it resolved, starting Friday he also noticed blisters on his lips and it has not resolved. The injection site is also very bruised, which patient reports he noticed starting Friday or Saturday and was still bruised at time of reporting (10am on 10/23).
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysstasia, Fall, Hot flush, Immediate post-injection reaction
Clinical narrative: Around 10 am I received the flu vaccine. Immediately after I was nauseated and started having hot flashes. About 30-40 minutes later I started dry heaving and became extremely dizzy. I tried standing up and fell back down so I immediately got my boss and told her something was wrong and I needed to go to the ER. The room was spinning and I could barely lift my head up. A little while later the back of my neck and down my spine started hurting almost like a muscle ache. The nurses at hospital took me over to the ER where I was seen immediately. I loss consciousness twice while they gave me my IV. The doctors gave me benedryl mixed with a medicine that I cannot remember but it was copazine or something like that. I was there for about 2 hours then was discharged after I started to feel better and was able to stand.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Neck pain, Retching, Spinal pain
Clinical narrative: Around 10 am I received the flu vaccine. Immediately after I was nauseated and started having hot flashes. About 30-40 minutes later I started dry heaving and became extremely dizzy. I tried standing up and fell back down so I immediately got my boss and told her something was wrong and I needed to go to the ER. The room was spinning and I could barely lift my head up. A little while later the back of my neck and down my spine started hurting almost like a muscle ache. The nurses at hospital took me over to the ER where I was seen immediately. I loss consciousness twice while they gave me my IV. The doctors gave me benedryl mixed with a medicine that I cannot remember but it was copazine or something like that. I was there for about 2 hours then was discharged after I started to feel better and was able to stand.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Around 10 am I received the flu vaccine. Immediately after I was nauseated and started having hot flashes. About 30-40 minutes later I started dry heaving and became extremely dizzy. I tried standing up and fell back down so I immediately got my boss and told her something was wrong and I needed to go to the ER. The room was spinning and I could barely lift my head up. A little while later the back of my neck and down my spine started hurting almost like a muscle ache. The nurses at hospital took me over to the ER where I was seen immediately. I loss consciousness twice while they gave me my IV. The doctors gave me benedryl mixed with a medicine that I cannot remember but it was copazine or something like that. I was there for about 2 hours then was discharged after I started to feel better and was able to stand.
Age: 31.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Leg numbness, tingling, stiff neck, lower back pain. Currently in testing.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity, Skin discolouration
Clinical narrative: Patient reports having mild pain in upper arm 2 days following vaccination. Purple bruise with yellow border was seen on patient's upper arm when in office.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Abnormal behaviour, Coordination abnormal, Diarrhoea, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Coordination disturbance, excessive diarrhea, high fever, rash and hives, hyperactivity, extreme behavioral changes.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Coordination disturbance, excessive diarrhea, high fever, rash and hives, hyperactivity, extreme behavioral changes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Diagnosed injection site infection, antibiotics prescribed.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: C/o on going left arm pain progressing after had flu shot 10/9/18. Initially " just sore arm" that night" took  advil, with some relief but "as days went on the shoulder started to hurt" feels like inside my shoulder is hurting, pain with any movement of the shoulder. No shoulder swelling, nor redness, no fever.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site rash
Clinical narrative: PATIENT DEVELOPED A RASH THAT RESOLVED AFTER A FEW DAYS. PATIENT ALSO GOT A FLUAD INFLUENZA VACCINE THE SAME DAY BUT IN THE OTHER ARM. THE RASH OCCURRED IN THE LEFT ARM WHERE THE PNEUMOVAX WAS ADMINISTERED.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of dizziness in a 17-year-old male patient who received MENVEO for prophylaxis. On an unknown date, the patient received MENVEO .5 ml. On an unknown date, unknown after receiving MENVEO, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to MENVEO. Additional details were provided as follows: The patient felt dizzy and referred in previous vaccinations (unspecified) felt the same way and reported only had breakfast at the time of vaccinations. The patient's initials and date of birth were unknown. The nurse agreed to be followed up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Incorrect route of product administration, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received SHINGRIX (subcutaneous). On 4th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The patient received SHINGRIX subcutaneously behind the right arm, which led to inappropriate route of vaccination. This case has been linked with US2018163138, reported by the same reporter. Follow up information received by a consumer on 16th October 2018: The new medical assistant gave the vaccine subcutaneously. In 2018, less than a month after receiving SHINGRIX, the patient experienced body ache, headache and sweats. The patient also being weaved by antidepressant at same time by his psychiatrist. No long term effects were noted. The VAERS details were updated.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving Flu shot, the patient experienced very sore arm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included FLUARIX (FLUARIX was given in the opposite arm, but no events were noted in that arm). On 6th October 2018, the patient received the 1st dose of BEXSERO. On 11th October 2018, 5 days after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were unknown and the outcome of the injection site swelling was resolved with sequelae. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site itching to be related to BEXSERO. Additional details were provided as follows: The case was reported by the mother of the patient. The age at the vaccination was not reported. The patient received BEXSERO in an unknown arm. FLUARIX was given in the opposite arm, but no events were noted in that arm, just the BEXSERO arm. The mother of the patient did not know which arm her daughter was injected with BEXSERO and her daughter did not specify.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2018GSK191892). Concomitant products included Influenza vaccine Quadrivalent 2018-2019 season. On 4th October 2018, the patient received the 2nd dose of SHINGRIX. On 4th October 2018, less than an hour after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On 7th October 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown deltoid. On 4th October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) on the opposite deltoid than that of SHINGRIX. The batch number and expiry date were not reported. Within 1 hour of vaccination, the patient experienced soreness in the injected arm. The soreness was lasted for 3 days. The reporter had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rotator cuff tear in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 1 day after receiving SHINGRIX, the patient experienced rotator cuff tear, injection site pain and shoulder pain. On an unknown date, the outcome of the rotator cuff tear was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the rotator cuff tear, injection site pain and shoulder pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The day following the injection, the patient experienced pain at the injection site and that was so severe. The patient went to the emergency room. The patient continued to have pain in her shoulder area since July's injection. The patient referred to an orthopedic physician after an appointment with her physician care provider. The orthopedic surgeon informed that, it was the SHINGRIX vaccination that caused her rotator cuff to be torn.