chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Insomnia, Muscle twitching, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hard of hearing in a 28-year-old female patient who received RABAVERT. Previously administered products included Tdap with an associated reaction of dizziness (see linked case US2018GSK078834) and RABAVERT with an associated reaction of phobia (1st dose received on 26th September 2011 (see linked case US2018074027)). Concomitant products included Meclizine. On 23rd April 2018, the patient received the 2nd dose of RABAVERT (intramuscular) 1 ml. In April 2018, less than a week after receiving RABAVERT, the patient experienced numbness in leg and twitching facial. On 23rd April 2018, the patient experienced hard of hearing, difficulty breathing, hot flashes, insomnia, dry mouth, injection site burning and vaccine administered at inappropriate site. On an unknown date, the outcome of the hard of hearing, difficulty breathing, hot flashes, insomnia, dry mouth, injection site burning, numbness in leg, twitching facial and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the hard of hearing, difficulty breathing, hot flashes, insomnia, dry mouth, injection site burning, numbness in leg and twitching facial to be related to RABAVERT. Additional details were provided as follows: The patient reported that she had another possible exposure to an animal that had rabies and her first injection of the series on 23rd April 2018 (the patient had another series at a different time from another rabies exposure on 26th September 2011). The patient had another exposure to Rabies and received the vaccine on Monday on 23rd April 2018 and had to get another one on day of reporting on 26th April 2018. The patient was having adverse reactions to the one that she received Monday on 23rd April 2018, her legs were numb and when she smiles her face twitches really bad. Before the patient was able to probe, she disconnected from the call. The caller also had questions about how much coverage she would have as when she had the vaccine years ago, she had 4 of the 5 series of doses (she did not complete the series). No other information available. The patient required emergency room visit. This case has been linked with US2018074037 and US2018GSK078834, reported by the same reporter for the same patient).
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pyrexia
Clinical narrative: 2 days after vaccine administration, pt developed swelling, redness and tenderness at injection site. Pt also developed pruritic rash on abdomen and back, along w/fever (101 degree F) and irritability. Treated w/MOTRIN, BENADRYL and warm compresses.
Age: 1.92
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Rash, Rash pruritic
Clinical narrative: 2 days after vaccine administration, pt developed swelling, redness and tenderness at injection site. Pt also developed pruritic rash on abdomen and back, along w/fever (101 degree F) and irritability. Treated w/MOTRIN, BENADRYL and warm compresses.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever (low grade), abd pain, nausea, muscle aches all over, headache.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Blister, Erythema, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Patient stated he experienced numbness feeling immediately after flu vaccine, but resolved. Then after 24 hours itching occurred and 48 hours later blisters appeared scattered all over body including legs, back, arms , stomach. Pt stated he had gone to his Primary physician and was taken off of all his meds at different times to try to figure out what might be the cause of his symptoms. He also went to a Dermatologist on many occasions, does not have specific dates at this time. Biopsy was done with inconclusive results. He also went to his Pulmonologist but was sent back to Dermotologist. Pt still has rash on legs, back, arms and stomach that continue sto itch, but not as bad as it did. Red/pinkish colored spots measuring approx 1/4 to 1/2 inch in diameter.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient stated he experienced numbness feeling immediately after flu vaccine, but resolved. Then after 24 hours itching occurred and 48 hours later blisters appeared scattered all over body including legs, back, arms , stomach. Pt stated he had gone to his Primary physician and was taken off of all his meds at different times to try to figure out what might be the cause of his symptoms. He also went to a Dermatologist on many occasions, does not have specific dates at this time. Biopsy was done with inconclusive results. He also went to his Pulmonologist but was sent back to Dermotologist. Pt still has rash on legs, back, arms and stomach that continue sto itch, but not as bad as it did. Red/pinkish colored spots measuring approx 1/4 to 1/2 inch in diameter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, difficulty lifting arm.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, difficulty lifting arm.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Urinary tract infection
Clinical narrative: Patient called the Vaccination Information Line in regards to HPV vaccine she received starting on 11MAY2016. Patient reported beginning on UUU, described as, since receiving this vaccine, she has experienced, "so many" frequent urinary tract infections and is currently experiencing one at this time. Patient reported she has seen doctors, been to urgent care, and saw a urologist. The current UTI started "5 days ago", she was seen for the UTI, and is being treated with a medication. Event remained ongoing. No additional information was provided.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Burning sensation, Erythema, Nodule, Skin warm
Clinical narrative: Large fluid filled knot. Burning, redness and hot to touch  approx 6 inches from injection site by day 3, 12 inches by day 4. Taking benadryl and tylenol with no change in symptoms. Per dr, alternating heat and ice for discomfort. Cool showers and tylenol for fever, rest and fluids for joint and muscle aches.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Seizure
Clinical narrative: Pt had seizure 2 days following vaccine.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth
Clinical narrative: She developed severe right arm pain where injection was administered. Red, warm, and "streaks" going down her arm. Took NSAIDS, fine the next day. She never reacted like that to a vaccine before.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Erythema, Skin exfoliation
Clinical narrative: 4-25-2018: five blisters, each about 2-3 mm, appeared over my right eye. They were filled with clear fluid. As of today, they are gone and there is no scarring. 4-26-2018: four blisters, each about 3-4 mm, appeared on my left cheek. They were filled with clear fluid. The skin over the blisters was very "fragile" and all but one of the blisters ruptured when I very gently washed my face. For a couple of days after, tiny bits of skin flaked off in that area. (I am assuming that it was skin that was flaking off. It looked like tiny particles of white lint.) As of today, the blisters are gone and there is no scarring, although the skin where the blisters were looked a little red and "rough" for a few days. I did not feel ill and there are no lasting problems. I did have Chickenpox as a child.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Insomnia, Pyrexia
Clinical narrative: Pt experienced insomnia, headache, fever, chills, and loss of appetite X3 days after vaccination.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives. BENADRYL. Relief of hives.
Sex: U
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A more than 65 (unit unspecified) patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced welt under the skin on an unspecified date. Outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Merck & Co., Inc. reference number 00804190) from a contactable pharmacist and physician. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, in Mar2018, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling at site of injection with itching on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the events.
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age and ethnicity received second dose of PREVNAR 13, via an unspecified route of administration on 30Apr2018 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) for immunisation on unspecified date. On an unspecified date, it was reported that the patient's arm was extremely sore and  developed soreness/body aches all over. The outcome of the event 'soreness/body aches all over' was recovering (reported feeling better at the time of this report) and not recovered for 'arm is extremely sore'. Information regarding batch number and expiry date has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and slight swelling to site appx. 2 inches in diameter.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Mom states patient started vomiting profusely 2hr after vaccines were administered and all night. Mom 'lost count' of how many times he had vomited. No fever, no diarrhea. I spoke with mom 4/26/18 at 5pm via telephone and vomiting had improved. Has chronic spit up although mom states the vomiting was in excess. Mom denied any signs of dehydration.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Malaise, Pain, Pyrexia
Clinical narrative: Began with malaise the night of the shot. Patient had pretreated with ibuprofen 400mg x 1 and continued every 4-6 hours. Next morning there was a large red mark around injection site, about 3 inches in diameter, which grew throughout the day to 6 inches in diameter. Slight fever, (99-100F), flu symptoms (runny nose, achy body), later on these symptoms became so severe that the patient went home early from an event. Symptoms continued for 3-4 days till late Tuesday, with lack of energy persisting the longest. Patient was better by Wednesday morning.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Began with malaise the night of the shot. Patient had pretreated with ibuprofen 400mg x 1 and continued every 4-6 hours. Next morning there was a large red mark around injection site, about 3 inches in diameter, which grew throughout the day to 6 inches in diameter. Slight fever, (99-100F), flu symptoms (runny nose, achy body), later on these symptoms became so severe that the patient went home early from an event. Symptoms continued for 3-4 days till late Tuesday, with lack of energy persisting the longest. Patient was better by Wednesday morning.
Sex: U
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: The patient noticed a rash and mild pain at the injection site at approximately 9:00pm on 4/30/18.  Approximately 24 hours after the vaccination (5/1/18 at 3:00pm) the patient experienced nausea, sweating, and felt feverish. He did not record his temperature. He observed that the rash looked larger and felt warm to the touch. The patient took ibuprofen 200mg and acetaminophen 500mg over the counter for the next few days and continued to experience the rash, intermittent pain, nausea, and feverish feeling in the evenings. The patient called the pharmacy on 5/3/18 to report his side effects and the pharmacist suggested that he also apply an ice pack and follow up with his physician if his symptoms did not improve. The patient was seen at an urgent care on 5/4/18; he came by the pharmacy afterwards. The rash appeared about 5 inches in diameter at the injection site; it was red, raised, and bumpy in appearance. On 5/4/18 the patient reported that the rash appears slightly smaller and the pain is mild, dull, and intermittent at the injection site. He also felt some tingling in his fingers and toes on the right side and is unsure if that is related.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: The patient noticed a rash and mild pain at the injection site at approximately 9:00pm on 4/30/18.  Approximately 24 hours after the vaccination (5/1/18 at 3:00pm) the patient experienced nausea, sweating, and felt feverish. He did not record his temperature. He observed that the rash looked larger and felt warm to the touch. The patient took ibuprofen 200mg and acetaminophen 500mg over the counter for the next few days and continued to experience the rash, intermittent pain, nausea, and feverish feeling in the evenings. The patient called the pharmacy on 5/3/18 to report his side effects and the pharmacist suggested that he also apply an ice pack and follow up with his physician if his symptoms did not improve. The patient was seen at an urgent care on 5/4/18; he came by the pharmacy afterwards. The rash appeared about 5 inches in diameter at the injection site; it was red, raised, and bumpy in appearance. On 5/4/18 the patient reported that the rash appears slightly smaller and the pain is mild, dull, and intermittent at the injection site. He also felt some tingling in his fingers and toes on the right side and is unsure if that is related.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Sore arm the night of the shot....next 2 days severe flu like symptoms....extreme muscle ache, skin sensitivity (even showering hurt), fever for 2 days, three days later (today) arm is still red, hot and sore. Basically could have stayed in bed for 2 full days with muscle pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Sore arm the night of the shot....next 2 days severe flu like symptoms....extreme muscle ache, skin sensitivity (even showering hurt), fever for 2 days, three days later (today) arm is still red, hot and sore. Basically could have stayed in bed for 2 full days with muscle pain.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Approximately one month after taking my third GARDASIL shot, I began experiencing hives all over my body. This continued for weeks and has now developed into chronic skin rashes with intense itchiness two years later.
Age: 29.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Middle insomnia, Neck pain, Pain in extremity, Rash macular
Clinical narrative: She received a tetanus booster and a pneumonia vaccine on her left upper arm at her HME on 5/2/2018. The day of her visit she felt fine. That night, she woke up once from arm pain during the night. She took Aleve which did not help. She states, "I am sure that I am fine." She had achy arm pain yesterday with a 100.6F temp. She took Tylenol which helped. Today, she took 2 Aleve at 7 AM this morning, and she has noticed less pain with arm movement. The pain is in her upper arm and neck area. She noticed red blotches on her upper arm today. No itching.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Muscular weakness, Musculoskeletal pain, Myalgia, Pyrexia
Clinical narrative: Left arm weakness, myalgias, fevers, chills, drowsiness with possible confusion, severe shoulder pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence
Clinical narrative: Left arm weakness, myalgias, fevers, chills, drowsiness with possible confusion, severe shoulder pain.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Swelling
Clinical narrative: Approximately 36 hours subsequent to the vaccine, patient developed pain and swelling at the base of the neck/occipital region ipsilateral to where vaccination was given.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient has pain and redness at injection site also noticed a rash that started in the inner portion of her elbow.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Ear pain, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Patient describes that on Monday afternoon (vaccine given the previous Friday afternoon) he felt very fatigued along with extreme tenderness on right hand side of head (described as very painful), right ear ache, dry cough, sore throat, whole body muscle aches. Now 4 weeks later (today) he says he still has tenderness on right side of head (it has improved "drastically") and still feels a little fatigued.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient describes that on Monday afternoon (vaccine given the previous Friday afternoon) he felt very fatigued along with extreme tenderness on right hand side of head (described as very painful), right ear ache, dry cough, sore throat, whole body muscle aches. Now 4 weeks later (today) he says he still has tenderness on right side of head (it has improved "drastically") and still feels a little fatigued.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Face injury, Fall, Haemorrhage, Swelling face
Clinical narrative: Client states she, "isn't good with shots" during administration. States she is feeling normal after vaccine is given. She leaves vaccine room and goes to lobby. Minutes later, client is on the ground in waiting room after having apparently fallen. Moved client to vaccine room. She has struck her left eyebrow on internal window sill and is bleeding slightly. The area is also swollen. Laid down, vitals taken, wounded area cleaned and iced. BP 108/75, pulse 60 at 1339. Called 911 for evaluation. EMS arrives minutes later and evaluates. Client denies EMS transport and elects to rest in vaccine room and then drive self home.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema
Clinical narrative: PATIENT REPORTED TO PHARMACY BECAUSE HIS ARM WAS RED AND HAD SPREAD DOWN BELOW THE ELBOW. HE REPORTED NO PAIN, SWELLING, OR ITCHING JUST REDNESS. HE HAD CONTACTED HIS DOCTOR WHO HAD TOLD HIM TO KEEP AN EYE ON IT AND PATIENT WAS INSTRUCTED AT PHARMACY TO REPORT TO MD OR ER IF SYMPTOMS WORSEN OR ANY OTHER SYMPTOMS DEVELOP.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever over 102 lasting from 7 pm overnight into early morning.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Patient over 1 week later is still experiencing hives all over body including face, itching, swelling of some areas.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Patient woke up this morning and noticed a rash on inside of elbows, inner thighs and abdomen (pubic bone up to breast bone). Patient described rash over the phone. The rash is clusters of small red dots. The rash is slightly raised and warm to the touch. Patient states this rash is similar to rash she had in the past when she took ibuprofen and aleve.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain, Photophobia
Clinical narrative: Headache, bad body aches, ringing of ears, feeling very tired, have hard time focusing, eyes sensitive to light, very sore arm at injection spot.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Headache, bad body aches, ringing of ears, feeling very tired, have hard time focusing, eyes sensitive to light, very sore arm at injection spot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Fatigue, Peripheral swelling
Clinical narrative: Temp 103, fatigue, weakness and swelling in right arm, had to go see doctor is was so bad.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red Rash on lower Right and Left forearm / Top of both feet /  Back of thigh around the knee.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Hyperaesthesia, Neuralgia, Rash
Clinical narrative: Shot was given in my left arm. I developed a severe headache on the right side of my head three and one half days after my shot. I then developed a rash in localized spots on the upper portion of my right arm and at the base of my neck in back on the fourth day. The rash looks like many small blisters clustered together. I have pulsing nerve pain in my right shoulder and upper arm. The right side of my forehead feels sensitized, though not painful. The rash neither itches nor hurts at this time. My husband is a physician. He said the rash and symptoms are typical of shingles.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shot was given in my left arm. I developed a severe headache on the right side of my head three and one half days after my shot. I then developed a rash in localized spots on the upper portion of my right arm and at the base of my neck in back on the fourth day. The rash looks like many small blisters clustered together. I have pulsing nerve pain in my right shoulder and upper arm. The right side of my forehead feels sensitized, though not painful. The rash neither itches nor hurts at this time. My husband is a physician. He said the rash and symptoms are typical of shingles.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysphagia, Headache, Heart rate increased
Clinical narrative: Fever (101 degrees with taking Tylenol extra strength), shivering, chilling, headache, sore muscles, weakness, fast heart rate, trouble swallowing, redness, swelling, pain at injection site (approximately 2-inch x 3-inch in size), still had fever on 5/3/2018, finally began feeling better by 5/4/2018.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever (101 degrees with taking Tylenol extra strength), shivering, chilling, headache, sore muscles, weakness, fast heart rate, trouble swallowing, redness, swelling, pain at injection site (approximately 2-inch x 3-inch in size), still had fever on 5/3/2018, finally began feeling better by 5/4/2018.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient states that her right arm (same arm as injection site) had become red around the injection site, and it is also itchy and warm. The patient denies any shortness of breath or hives on anywhere on her body. She states that she feels ok besides the above reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. said the evening of getting the IMZ 5-1-18 her arm swelled up the area turned red and it was hot to the touch. Pt. came by pharmacy 5-4-18 to show reaction the swelling has gone down, but the area was still red the size of a baseball and still hot to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Myalgia, Pain
Clinical narrative: This case was reported by a physician and described the occurrence of muscle pain in a 72-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Tamsulosin, Vitamin C and XARELTO. On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain, pain, injection site itching, injection site erythema and injection site hives. In April 2018, the outcome of the muscle pain, pain, injection site itching, injection site erythema and injection site hives were recovered/resolved. The reporter considered the muscle pain, pain, injection site erythema and injection site hives to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included multivitamin. The reporter was the physician who received 1st dose of SHINGRIX in last week and experienced reactions. In the morning on 16th April 2018, the patient received SHINGRIX in right arm and for 2 days he had typical muscle ache and soreness. On 3rd day nothing was happened and on 4th day he developed a patch of itchy erythema close to the injection site that went away after an hour. On 5th day he developed a crop of hives on his right upper arm that lasted about 2 to 3 hours and then resolved. The all reactions have resolved. The patient reported that he had photos of the hives from his arm and was unable to provide lot number and expiration date for the SHINGRIX.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site tenderness in a adult female patient who received SHINGRIX. Concomitant products included PNEUMOVAX. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site tenderness, fever, general body pain and dizziness. On 20th April 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen. In April 2018, the outcome of the fever, general body pain, injection limb mobility decreased and dizziness were recovered/resolved. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved. The reporter considered the injection site tenderness, fever, general body pain, injected limb mobility decreased and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was placed on phone by retired GlaxoSmithKline employee. The patient received vaccine on Wednesday (on18th April 2018) and the next day experienced pain that got intense over the next few days. The patient stated that she could not roll on her arm to get out of bed and it got to where she could not lift her arm. The patient stated the issues had resolved except for tenderness still at the site at the time of reporting. This case has been linked with US2018071883 and US2018071884, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX. 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 fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a few patient had fever and chills from SHINGRIX.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX. Concomitant products included CRESTOR and Vitamin D3. On 18th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th February, less that a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The patient reported that she had a dose of SHINGRIX in her right arm. This case is linked with case US2018GSK078961, reported by the same reporter.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired MENACTRA vaccine on 04/30/2015. Vaccine expiration date 04/25/18. Patient has not had any side effects from vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX. Concomitant products included Alendronate and amlodipine. On 18th March 2018 11:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th March 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site erythema, injection site nodule and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site nodule were recovering/resolving and the outcome of the injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site erythema, injection site nodule and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient did not know the lot number or expiration date. At 11:30, the patient received SHINGRIX on right arm. The patient felt that the vaccine was administered too low on her arm in the biceps, which led to vaccine administered at inappropriate site. On an unknown date, a nodule occurred at injection site and the patient experienced redness about the size of a fifty cent piece and the site was also painful to touch. It grew for several days but was not almost resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving a SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recently received his SHINGRIX vaccine and wanted to know how long the patient had to wait before the patient would receive cortisone shot for the pain in the patients shoulder. The patient did not want to do anything that would interfere with the effectiveness of the SHINGRIX. The patient was waiting to hear back soon.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Vaccination error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received SHINGRIX. On 23rd April 2018 17:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error were unknown. Additional information was received as follows: The age at vaccination was not reported. The patient reported that she was given a dose of SHINGRIX on Monday in left arm. On Tuesday, 24th April 2018, the nurse called to the patient to tell her that she had incorrectly given the shot. The nurse mixed the dry ingredients with sterile saline and not the liquid product which supposed to be used, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. The administering nurse called her to report that the product the patient received incorrectly reconstituted with sterile water instead of the adjuvant suspension. The nurse told that she could come back into the office to receive the full vaccine. The patient asked if there was any harm in doing this since she was injected with the dry ingredients. The reporter gave permission for her physician to be contacted and provided the following information. The reporter was concerned because she not feel comfortable coming back into the office within a few days of receiving the vaccine and getting it again. The reporter said to the nurse told her that what the patient received initially was essentially just a placebo. The reporter indicated that the nurse told her that she had reported the situation to Glaxo Smith Kline (GSK) and was provided guidance from them. It was unable to find report but filed as follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Product preparation error, Tenderness, Vaccination error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, tenderness, wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. On an unknown date, the outcome of the injection site pain, tenderness, wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error were unknown. It was unknown if the reporter considered the injection site pain and tenderness to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that dose of SHINGRIX was inadvertently reconstituted using sterile saline, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and vaccination error. The patient experienced pain during administration of the vaccine. At the time of reporting, tenderness which remained ongoing. Vaccine was administered by patient's primary care physician and not by the reporting pharmacy. The health care professional had limited information. The health care professional was unsure of the exact site of administration but stated it might have been the patient's right arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concurrent medical conditions included unknown autoimmune problems and diabetes. Concomitant products included celecoxib, omeprazole, Propranolol, Ropinirole, fluoxetine and TYLENOL. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, stomach pain and pain in arm. On an unknown date, the outcome of the fever and stomach pain were recovered/resolved and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the fever, stomach pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 30th March 2018, the patient body temperature went high till 103.8 degree F.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a elderly female patient who received SHINGRIX. On 20th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema, pruritus and swelling. On an unknown date, the outcome of the localized erythema, pruritus and swelling were not recovered/not resolved. It was unknown if the reporter considered the localized erythema, pruritus and swelling to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient's age was about 66 to 67 years old. The batch number of SHINGRIX was unknown. The healthcare professional did not have time to give full adverse event report.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Muscle tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received SHINGRIX. Concurrent medical conditions included fibromyalgia (past 30 years) and systemic lupus erythematous. On 22nd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was recently been diagnosed with Systemic lupus erythematosus (SLE). The patient's arm at the injection site was very swollen, hot and red. It was spreading down and around the area. The patient had very sore and tight muscles. The patient was asking how long do these side effects typically last. She asked her booster shot (the 2nd one) going to be the same for her. The patient wanted to know anything she could do to make it not so bad. Besides, taking ibuprofen a couple of hours before she goes on appointment day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received SHINGRIX. Concurrent medical conditions included fibromyalgia (past 30 years) and systemic lupus erythematous. On 22nd April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was recently been diagnosed with Systemic lupus erythematosus (SLE). The patient's arm at the injection site was very swollen, hot and red. It was spreading down and around the area. The patient had very sore and tight muscles. The patient was asking how long do these side effects typically last. She asked her booster shot (the 2nd one) going to be the same for her. The patient wanted to know anything she could do to make it not so bad. Besides, taking ibuprofen a couple of hours before she goes on appointment day.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of adverse event in a adult patient who received SHINGRIX. 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The case was reported during SHINGRIX Event. The reporter was an Adult Immunization Specialist. The age at vaccination was not applicable. The physician had patients who had experienced adverse events after receiving SHINGRIX. The field representative stated that he was unable to reach the physician due to the physician's schedule. He stated he had tried several times to get additional information from the provider, but had not been able to speak with him. No other information was provided at the time of reporting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number T5242, expiry date April 2019). The patient's past medical history included shingles. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in the left deltoid. The reporter stated that, the patient had a rash on her buttocks that looked like a shingles rash. The reporter stated that the patient has had shingles before and she stated that it looks like the rash she had when she had shingles. The reporter stated that the patient had not been diagnosed with shingles by a doctor for this event. The reporter did not have the original box to get the expiration date and provided the expiration date that was entered into the pharmacy's system when the patient received the vaccine. The reporter stated that their system forced them to put a shortened expiration date in the system so exact expiration date was not available, only month and year.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a adult female patient who received SHINGRIX. 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 injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced unspecified injection site reactions after an injection of SHINGRIX. The patient had denied permission to contact their physician. The pharmacist did not wish to participate in the safety report. This pharmacist said that her patient reported it via a Vaccine Adverse Event Reporting System (VAERS) but did not provide any further details and did not wish to be contacted. The patient wanted to be answered by Medical Information (MI). This case was not previously reported to anyone.
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol increased
Clinical narrative: This case was reported by a consumer and described the occurrence of blood cholesterol increased in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced blood cholesterol increased. On an unknown date, the outcome of the blood cholesterol increased was unknown. It was unknown if the reporter considered the blood cholesterol increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of SHINGRIX yesterday morning and had blood work drawn by another provider that afternoon, his cholesterol levels were a little elevated compared to his prior lipid test done 6 months prior. The patient noticed that the SHINGRIX vaccine contains cholesterol and was curious as to the impact that cholesterol would have on blood test.
Age: 81.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 81-year-old female patient who received SHINGRIX. Concomitant products included Pneumonia vaccine. On 25th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patent experienced general body pain, tiredness and fever. On an unknown date, the outcome of the general body pain, tiredness and fever were unchanged. The reporter considered the general body pain, tiredness and fever to be possibly related to SHINGRIX. Additional details were provided as follows: At 12:00 hours, the patient received SHINGRIX and Pneumonia vaccine at same time of different arms. The reporter did not have phone number of her physician to provide. All questions were asked but the reporter had provided limited information due to time constraint.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of malaise in a 54-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain (redness and swelling after receiving 1st dose, see case US2018GSK078814). In April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced malaise, exhaustion and chills. In April 2018, the outcome of the malaise, exhaustion and child were recovered/resolved. It was unknown if the reporter considered the malaise, exhaustion and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the week of 16th April 2018 and experienced extreme exhaustion, malaise and moderate or severe chills which lasted for 2 to 3 days. The 1st dose of SHINGRIX was systemically better tolerated compared to 2nd dose. The reporter agreed to contact on follow up, if necessary. This case had been linked with case US2018GSK078814, reported by the same reporter for the same patient (for the 1st dose).