chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: The patient was given a vaccine on 5/2/18 which had expired on 12/27/17 in error. The patient had no adverse effects and information received from the manufacturer revealed that the vaccine was still safe to use even though it had been expired for four months.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Patient called to report redness around the needle stick on her arm, which was warm to the touch and was causing her discomfort.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Hypoaesthesia
Clinical narrative: High fever (102.4), beginning late 5.9.18 and lasting until early morning 5.10.18, accompanied with severe shivering. Muscle and body aches all day on 5.10 that felt like the flu. Extreme tiredness on 5.10.18 and 5.11.18, with sleeping over 14 hours night of 5.10.18 and then four hours during day of 5.11.18.  Very sore, red, and extremely itchy arm at site of injection with red circle measuring about 4 3/4 inch in diameter! Numbness and tingling in injection arm on 5.9.18. Mild nausea on 5.9.18 and 5.10.18 and headache on 1.9.18 and 5.10.18. Due to extreme localized reaction at injection site, high fever, and body aches that felt like flu, I do not believe I should have second SHINGRIX vaccination in series of two. Please note I have had several vaccinations without negative side effects in the past.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site pruritus, Injection site reaction, Limb discomfort
Clinical narrative: High fever (102.4), beginning late 5.9.18 and lasting until early morning 5.10.18, accompanied with severe shivering. Muscle and body aches all day on 5.10 that felt like the flu. Extreme tiredness on 5.10.18 and 5.11.18, with sleeping over 14 hours night of 5.10.18 and then four hours during day of 5.11.18.  Very sore, red, and extremely itchy arm at site of injection with red circle measuring about 4 3/4 inch in diameter! Numbness and tingling in injection arm on 5.9.18. Mild nausea on 5.9.18 and 5.10.18 and headache on 1.9.18 and 5.10.18. Due to extreme localized reaction at injection site, high fever, and body aches that felt like flu, I do not believe I should have second SHINGRIX vaccination in series of two. Please note I have had several vaccinations without negative side effects in the past.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: High fever (102.4), beginning late 5.9.18 and lasting until early morning 5.10.18, accompanied with severe shivering. Muscle and body aches all day on 5.10 that felt like the flu. Extreme tiredness on 5.10.18 and 5.11.18, with sleeping over 14 hours night of 5.10.18 and then four hours during day of 5.11.18.  Very sore, red, and extremely itchy arm at site of injection with red circle measuring about 4 3/4 inch in diameter! Numbness and tingling in injection arm on 5.9.18. Mild nausea on 5.9.18 and 5.10.18 and headache on 1.9.18 and 5.10.18. Due to extreme localized reaction at injection site, high fever, and body aches that felt like flu, I do not believe I should have second SHINGRIX vaccination in series of two. Please note I have had several vaccinations without negative side effects in the past.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm was swollen and hurt, patient was also experiencing dizziness.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Electromyogram, Formication, Limb discomfort, Muscle twitching
Clinical narrative: Bad reaction within a few hours after getting the vaccine, nerves went haywire. Sharp shooting pains firing randomly in legs, feet, arms. Also had skin crawling sensation, tingling, paresthesias, twitching, and burning and tingling sensations. Also developed some numbness in distal extremities, which gradually subsided. Pain and twitching/spasms were bothersome enough to make it difficult to fall asleep, sometimes taking up to a half hour to fall asleep. This was frequent and intense for at least several weeks, but continued for several months, and still persists today almost 2 years later. After a few months, since the symptoms were persisting, started on Low Dose Naltrexone, which helped the nerve pain symptoms. My entire right arm was very sore and achy for about a week following the Tdap injection. I had never had that painful muscles after prior vaccinations of Tetanus, expected a little soreness for a few days, but this was more pain than usual and lasted longer.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia, Pain, Paraesthesia
Clinical narrative: Bad reaction within a few hours after getting the vaccine, nerves went haywire. Sharp shooting pains firing randomly in legs, feet, arms. Also had skin crawling sensation, tingling, paresthesias, twitching, and burning and tingling sensations. Also developed some numbness in distal extremities, which gradually subsided. Pain and twitching/spasms were bothersome enough to make it difficult to fall asleep, sometimes taking up to a half hour to fall asleep. This was frequent and intense for at least several weeks, but continued for several months, and still persists today almost 2 years later. After a few months, since the symptoms were persisting, started on Low Dose Naltrexone, which helped the nerve pain symptoms. My entire right arm was very sore and achy for about a week following the Tdap injection. I had never had that painful muscles after prior vaccinations of Tetanus, expected a little soreness for a few days, but this was more pain than usual and lasted longer.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash and pain at the injection site (behind the arm).
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Rash, Urticaria
Clinical narrative: My son started getting a rash small sport in the area near the injection around 1:00pm on the 10th. At first, we thought maybe a spider bit him, but strange thing is that there were more than a few. That night, my son, went to sleep but was very irritable and fussy. The morning after, 11th, around 3am, I woke up and look at my son and notice a noticeable amount of hives\ rash on both legs and lower stomach area. I immediately contacted the nurse at clinic which advised me to call in a few hours to make a same day appointment. I called at 7am and got an appointment for 10am. I took my son in and seen M.D, she said she didn't think it was from the vax but it wasn't very convincing. After a couple of dosages of BENADRYL the hives have gone up to his chest and now to his neck and face area. I am very concerned.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 57-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On 11th March 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, malaise and pain. On an unknown date, the outcome of the fatigue, malaise and pain were unknown. It was unknown if the reporter considered the fatigue, malaise and pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced severe fatigue, general malaise and body aches. This case was linked to the case US2018GSK080273, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine. On 30th April 2018, the patient received SHINGRIX. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, headache and myalgia. On an unknown date, the outcome of the injection site pain, fever, headache and myalgia were unchanged. The reporter considered the injection site pain, fever, headache and myalgia to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient experienced soreness at the injection site. The patient also experienced fever (body temperature: 100.1 degree F).
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Mild case of hives-prednisolone- and BENADRYL. Hives lasted about a week then were gone.
Sex: F
Vaccine: VARZOS
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 66-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On 2nd January 2018, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm soreness after her 1st SHINGRIX vaccination. For tolerance after 2nd dose please check case US2018078716.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Immediate post-injection reaction, Influenza like illness, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received SHINGRIX. Concomitant products included trazodone. On 26th February 2018, the patient received the first dose of SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 26th February 2018, the patient experienced injection site pain and shoulder pain. On 27th February 2018, the patient experienced influenza-like symptoms and pain. On 27th March 2018, the patient  experienced joint pain. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, shoulder pain, joint pain, influenza-like symptoms and pain were recovered/resolved. The reporter considered the injection site pain, injection limb mobility decreased, shoulder pain, joint pain, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included Hytrone. The patient reported he received the SHINGRIX vaccine at 3:00 pm and less than a day post vaccination, experienced injection site soreness and by the 2nd day he felt like he got kicked by a horse. For a couple of days he had difficulty lifting his arm to put on his shirt and he needed assistance from his wife. The patient took MOTRIN for the pain and by Saturday or Monday he could press on his arm and there was no pain. The patient claimed that 1 day post vaccination, he felt like he had the flu for 5 days and his shoulder pain started right away after receiving the vaccination. The patient also had 1 day post vaccination, 5 days of feeling achy. All of the symptoms had resolved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received SHINGRIX. Concomitant products included trazodone. On 26th February 2018, the patient received the first dose of SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 26th February 2018, the patient experienced injection site pain and shoulder pain. On 27th February 2018, the patient experienced influenza-like symptoms and pain. On 27th March 2018, the patient  experienced joint pain. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, shoulder pain, joint pain, influenza-like symptoms and pain were recovered/resolved. The reporter considered the injection site pain, injection limb mobility decreased, shoulder pain, joint pain, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included Hytrone. The patient reported he received the SHINGRIX vaccine at 3:00 pm and less than a day post vaccination, experienced injection site soreness and by the 2nd day he felt like he got kicked by a horse. For a couple of days he had difficulty lifting his arm to put on his shirt and he needed assistance from his wife. The patient took MOTRIN for the pain and by Saturday or Monday he could press on his arm and there was no pain. The patient claimed that 1 day post vaccination, he felt like he had the flu for 5 days and his shoulder pain started right away after receiving the vaccination. The patient also had 1 day post vaccination, 5 days of feeling achy. All of the symptoms had resolved.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 82-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 20th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, less than a week after receiving SHINGRIX, the patient experienced feeling bad. On 21st February 2018, the patient experienced fatigue, pain and myalgia. On an unknown date, the outcome of the fatigue, pain, myalgia and feeling bad were recovered/resolved. The reporter considered the fatigue, pain and myalgia to be related to SHINGRIX. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were reported as follows: Before 10 am, the patient received SHINGRIX in the left deltoid. The next day the patient experienced fatigue, myalgia, felt achy (did not want to get out of bed) and tired. Less than a week after vaccination, the patient felt lousy for 1 to 2 days. The healthcare professional was unsure when symptoms subsided but the patient said it was after a couple days. The healthcare professional was unsure if the patient took anything for his symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, PNC13
Symptoms: Peripheral swelling, Rash
Clinical narrative: Rash, swelling of leg (left).
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX, 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 SHINGRIX. Additional information was received as follows: The age at vaccination was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling in a child male patient who received MENVEO (batch number M16172, expiry date unknown). On 17th April 2018, the patient received MENVEO .5 ml. In April 2018, less than a week after receiving MENVEO, the patient experienced swelling, erythema and feeling of warmth. On an unknown date, the outcome of the swelling, erythema and feeling of warmth were recovered/resolved. It was unknown if the reporter considered the swelling, erythema and feeling of warmth to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe swelling, redness and warm and went to ED on 19th April 2018. The events were resolved shortly after ED visit.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). Concomitant products included ZETIA. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were not recovered/not resolved. The reporter considered the swelling arm and pain in arm to be probably related SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included PROAIR (not specified). At 11:15, the patient received SHINGRIX in the right deltoid. The patient had sore and swollen arm about 5 inches below the injection site where she received SHINGRIX.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of hallucination in a 50-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced hallucination. On an unknown date, the outcome of the hallucination was unknown. It was unknown if the reporter considered the hallucination to be related to SHINGRIX. Additional information was received as follows: The patient was about 50 years of age and received a dose of SHINGRIX from a retail pharmacy. The patient notified the clinic nurse on the following day that she experienced hallucinations. The reporter receive this information from another nurse working at a satellite clinic and they were affiliated with which in turn to share the information with the reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced chills and headache. On an unknown date, the patient experienced fatigue. On 1st May 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills was unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the chills, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced chills and headache which begun at night on the same day of vaccination. The headache lasted until the time of reporting. In 2018, less than a week after receiving SHINGRIX, the patient said she was very fatigued currently and would like to go home from work. The patient also stated that, the next time she gets SHINGRIX vaccine, she would do it on a Friday so she would not have to come to work the next day in case she experienced same reaction with the 2nd dose. The reporter agreed to be followed up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX. On 26th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th January 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. In February 2018, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown deltoid. The patient experienced flu like symptoms which started the day of vaccination and lasted for approximately about 2 weeks. All questions were asked. The reporter provided limited information.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of slu0like symptoms 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 experience flu-like symptoms. On an unknown date, the outcome of the flu-like symptoms was unknown. It was unknown if the reporter considered the flu-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The case was reported by a pharmacy student. The age at vaccination was not reported. The reporting pharmacy student stated that one of the pharmacists wanted to ask him about the adverse effects with SHINGRIX. The patient had flu-like symptoms. They were not sure exactly because not everyone has reported symptoms directly to them. Reporting pharmacy student did not have patient information at time of chat. This case has been linked with cases US2018077588 and case US2018GSK084008, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Hypoglycaemia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hypoglycemia in a adult female patient who received SHINGRIX. Concurrent medical conditions included diabetes mellitus. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On 30th April 2018, several hours after receiving SHINGRIX, the patient experienced hypoglycemia. On an unknown date, the outcome of the hypoglycemia was unknown. It was unknown if the reporter considered the hypoglycemia to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was recently on a dietary change, starting a Nutrisystem program approximately 2 weeks prior to the vaccine administration. On 30th April 2018, the patient was vaccinated with the 1st dose of SHINGRIX in the mid-afternoon. On the same evening of vaccination at bedtime, the patient reported a blood glucose reading of 45 and took orange juice to bring the blood glucose level to normal. On 1st May 2018, following day after vaccination the patient showed blood glucose level as 70.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Malaise, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 59-year-old male patient who received SHINGRIX. Concurrent medical conditions included ophthalmic herpes simplex. Concomitant products included VALTREX. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain, general body pain, pain in arm, malaise and fatigue. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the general body pain, pain in arm, malaise and fatigue were unknown. The reporter considered the joint pain, general body pain, pain in arm, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient reported that later that evening of vaccination he experienced the events. The patient had limited contact information for health care professional at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Impaired work ability, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 67-year-old female 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 SHINGRIX, the patient experienced muscle pain, fatigue, dizziness, headache and inability to work. On an unknown date, the outcome of the muscle pain, fatigue, dizziness, headache and inability to work were unknown. It was unknown if the reporter considered the muscle pain, fatigue, dizziness, headache and inability to work to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This was 1 of 2 cases, reported by same reporter for same patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Impaired work ability, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 67-year-old female patient who received SHINGRIX. On 1st May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain, fatigue, dizziness, headache and inability to work. On an unknown date, the outcome of the muscle pain, fatigue, dizziness, headache and inability to work were unknown. The reporter considered the muscle pain, fatigue, dizziness and headache to be related to SHINGRIX. It was unknown if the reporter considered the inability to work to be related to SHINGRIX. Additional details were provided as follows: The patient had the same side effects with the 1st dose. The patient was in a rush and did not answer any more questions. The patient stated that after getting the vaccine it wiped you out and she had been unable to work. The reporter stated that the personal identification needed a stronger warning for possible side effects. This is the 1 of 2 cases, reported by same reporter for same patient.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received SHINGRIX. The patient's past medical history included rotator cuff repair, tendon repair and mobility decreased (had about 80 percent movement of right arm after having the rotator cuff and tendon surgery 4 years before the reporting date). Previously administered products included ZOSTAVAX (received 13 years before the reporting date). Concomitant products included Levothyroxine and spironolactone. On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling, shoulder pain, injection site pain and pain. On 3rd May 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site pain and pain were recovering/resolving and the outcome of the shoulder pain and injected site mobility decreased were not recovered/not resolved. The reporter considered the injection site warmth, injection site swelling, shoulder pain, injected limb mobility decreased, injection site pain and pain to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included ADDERALL and hormone replacement therapy. Around in noon, the patient received SHINGRIX on the right arm. After the SHINGRIX injection she experienced soreness and warmth at the injection site with pain and it hurt and felt hot for about 24 hours. She received the injection around noon on Tuesday and she claimed that as long as her right arm is bent and her elbow was against her body she was fine but she questions if she was permanently disabled. She wanted to get back to lifting light weights like she did before the SHINGRIX vaccine. She could only lift her right arm about a foot with great pain and she used to be able to lift it higher. Because her shoulder hurt, she was sleeping on her back.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received SHINGRIX. The patient's past medical history included rotator cuff repair, tendon repair and mobility decreased (had about 80 percent movement of right arm after having the rotator cuff and tendon surgery 4 years before the reporting date). Previously administered products included ZOSTAVAX (received 13 years before the reporting date). Concomitant products included Levothyroxine and spironolactone. On 1st May 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, 1 hr after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling, shoulder pain, injection site pain and pain. On 3rd May 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site warmth, injection site swelling, injection site pain and pain were recovering/resolving and the outcome of the shoulder pain and injected site mobility decreased were not recovered/not resolved. The reporter considered the injection site warmth, injection site swelling, shoulder pain, injected limb mobility decreased, injection site pain and pain to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included ADDERALL and hormone replacement therapy. Around in noon, the patient received SHINGRIX on the right arm. After the SHINGRIX injection she experienced soreness and warmth at the injection site with pain and it hurt and felt hot for about 24 hours. She received the injection around noon on Tuesday and she claimed that as long as her right arm is bent and her elbow was against her body she was fine but she questions if she was permanently disabled. She wanted to get back to lifting light weights like she did before the SHINGRIX vaccine. She could only lift her right arm about a foot with great pain and she used to be able to lift it higher. Because her shoulder hurt, she was sleeping on her back.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of trigeminal neuralgia in a 76-year-old male patient who received SHINGRIX. On 23rd March 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced trigeminal neuralgia. The patient was treated with prednisone and antibiotics. On an unknown date, the outcome of the trigeminal neuralgia was not reported. It was unknown if the reporter considered the trigeminal neuralgia to be related to SHINGRIX. Additional details were provided as follows: The patient had a family history of trigeminal neuralgia. The patient experienced a gradual onset of trigeminal neuralgia pain. The patient did go to see his physician and was being treated at the time of reporting with antibiotics and Prednisone for the trigeminal neuralgia pain. The pharmacist said she was still unsure if the patient was actually diagnosed with trigeminal neuralgia. The pharmacist was unsure if vaccine was related to symptoms. The pharmacist did not have any additional details at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache 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 headache, fever, pain in arm and rash. On an unknown date, the outcome of the headache, fever and rash were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the headache, fever, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed splitting headache, fever (body temperature was recorded as 100.3 degree F). The patient's arm was still sore on day 3 and developed rash on breast.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Rash vesicular
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of blistery rash 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 blistery rash, pain in arm, fatigue and headache. The patient was treated with VALTREX. On an unknown date, the outcome of the blistery rash, pain in arm, fatigue and headache were unknown. It was unknown if the reporter considered the blistery rash, pain in arm, fatigue and headache to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced sore arm and blistering rash for which the patient was seen for. The reporter gave consent to be followed.
Sex: M
Vaccine: FLU4
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 adult male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine quadrivalent, the patient experienced pain in arm. On an unknown date, 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 influenza vaccine quadrivalent. Additional information was received as follows: The age at vaccination was not reported. Flu vaccine manufacturer and its specificities were unknown. This case has been linked to the case US2018078800 reported for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema of extremities 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 erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was in her 50s. The patient arm was red for an entire week after receiving SHINGRIX. The reporter did not agree to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, muscle pain, injection site and nausea. On an unknown date, the outcome of the fever, chills, muscle pain, injection site pain and nausea were recovered/resolved. The reporter considered the fever, chills, muscle pain, injection site pain and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 70 years or 71 years. The patient received SHINGRIX in the right deltoid. Fever, chills, nausea, muscle aches and injection site soreness were lasted up to 4 days after administration of SHINGRIX. The symptoms resolved completely with no complications. No medical visit was required.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX. Concomitant products included flecainide and XARELTO. On 2nd May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, 1 days after receiving SHINGRIX, the patient experienced headache and influenza-like symptoms. On an unknown date, the outcome of the headache and influenza-like symptoms were unchanged. The reporter considered the headache and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient reported this case for herself. At 15:30, the patient received SHINGRIX in the left arm. On 3rd May 2018, the patient woke up with headache and flu like symptoms. The reporter provided limited information due to time constraint.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythematous eruption in a female adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced erythematous eruption and generalized pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythematous eruption and generalized pruritus were recovered/resolved. The reporter considered the erythematous eruption and generalized pruritus to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at a pharmacy and developed a rash all over her body, followed by itchiness all over the body the next day. Pharmacist advised her to take BENADRYL, and the symptoms cleared up after 2 days. The patient shared the information with her allergist (reporting physician) who relayed the information to GlaxoSmithKline. The physician would likely recommend that the patient should not receive the 2nd dose of SHINGRIX. It was unknown if the course of vaccination was discontinued. This case was not associated with any of the seriousness criteria.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018. 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The reporter did not talk to patient directly, but one of his staff pharmacists mentioned to him. The case was also reported to VAERS. The age at the vaccination was not reported, however the patient was middle aged. The patient was administered SHINGRIX vaccine sometime in early April 2018 and experienced an episode of shingles about two weeks after receipt of the vaccine dose. The reporter did not think the episode was related to vaccination, but instead that the patient was in the prodromal stages of an episode and did not know it at the time of vaccination. The reporter did not agree to be contacted on follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Product storage error
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 20200. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccination error. On an unknown date, the patient experienced pain in arm and incorrect storage of drug. On an unknown date, the outcome of the pain in arm, incorrect storage of drug and vaccination error were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in unknown deltoid. The patient received a SHINGRIX vaccine that had been frozen, which led to incorrect storage of vaccine and vaccination error. In 2018, less than a month after vaccination, the patient experienced soreness in arm. Nurse reported that, the office gave 10 patients SHINGRIX vaccine that had been frozen. The nurse reports this has been reported to their sales representative and another sales representative made a visit and had a physician from GlaxoSmithKline contact the practice as well. The nurse reported 8 of the 10 patients had been revaccinated. The last 2 were waiting a time period due to the other vaccines being given. The reported batch number of SHINGRIX was DY3X4 which does not exists as per sales data sheet and was updated to ZY3X4. The was one of the 10 linked cases reported by the same reporter.
Sex: M
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced myalgia. The patient was treated with ALEVE. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that every year that he received the flu shot it always makes him had horrible myalgias and he was laid out of several days. The patient currently pre-treating prior to and several days after with ALEVE.
Sex: U
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash scaly 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 rash scaly and erythematous rash. On an unknown date, the outcome of the rash scaly and erythematous rash were unknown. It was unknown if the reporter considered the rash scaly and erythematous to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that a patient that received their first dose of SHINGRIX about 62 days ago still had a red scaly rash on their left arm from the initial dose. No further information was available at the time of report.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pustule in a 81-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, blood cholesterol increased and diabetes. On 11th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 2nd May 2018, 21 days after receiving SHINGRIX, the patient experienced pustule. On an unknown date, the outcome of the pustule was recovered/resolved. It was unknown if the reporter considered the pustule to be related to SHINGRIX. Additional details were provided as follows: This case was reported to the pharmacist by the patient's daughter. The reporter was not sure if the patient took his medications on the day of the vaccine but he took medications for high blood pressure, diabetes and high cholesterol. After receiving SHINGRIX, the patient had little pustular sores on the right side of his waist and nothing on the left side. Exact onset date was unknown, it might had been a day before reporting or on the day of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rash in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 2 days after receiving SHINGRIX, the patient experienced rash and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient broke out in rash all over her face, chest and armpits after vaccination with SHINGRIX at a pharmacy. She went to the allergist and they recommended BENADRYL. The rash disappeared, but then she started itching in the areas where the rash had been. The physician did not wanted her information to be provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever 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 fever, muscle pain and injection site reaction. On an unknown date, the outcome of the fever, muscle pain and injection site reaction were unknown. It was unknown if the reporter considered the fever, muscle pain and injection site reaction to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporting pharmacy student stated in online chat, that one of the pharmacists wanted to ask him about the adverse effects with SHINGRIX. They had quite a few people get the fever, muscle aches and local injection site reactions. They had at least 5 or 6 patients with symptoms, one had flu-like symptoms (refer case US2018GSK083999). Some had just felt really fatigued (refer case US2018GSK084008). They were not sure exactly because not everyone has reported symptoms directly to them. Reporting pharmacy student did not have patient information at time of chat.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 65-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On 26th April 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue and malaise. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the fatigue, malaise and fever were unknown. It was unknown if the reporter considered the fatigue, malaise and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was approximately 65 years old. The patient experienced severe fatigue, general malaise and fever. The patient was on bed for 3 days. This case was linked to the case US2018GSK080274, reported by the same reporter.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Injection site erythema (skin) burning and pain that hurts down to her Right hand. Pt is to ice and heat and continue CLARITIN and if gets worse to go to the ER.