chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Insomnia, Malaise, Musculoskeletal pain, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of PREVNAR 13 (reported as PREVNAR 23, pending clarification), via an unspecified route of administration at left arm on 29Oct2018 13:45 at single dose for immunization. The patient had no other vaccines administered with suspect. Prior vaccinations within 4 weeks: None. Medical history included carotid artery surgery from Feb2018, strokes from 1997 (she had her first stroke in 1997, then had two more after her carotid artery surgery), arm was sore from 2017 to an unknown date (her arm was sore but nothing like this. She did not have a NDC, lot number or expiration date for the vaccine she got last year). The patient's concomitant medications were not reported. The patient previously took first dose of PREVNAR 13 (also reported as PREVNAR 23) for immunization in Dec2017 at pharmacy. The patient experienced sick and horribly sore, lost 4 pounds, on 29Oct2018. In evening of the 29Oct2018, she got extremely tired and her arm was real sore. During that night, she woke up and her whole left side was excruciatingly sore and she couldn't lay on that side or her back. She just couldn't sleep, she said that pain went from the shot area to her shoulder to her shoulder blade. Then down her side to under her left arm and into her back. On that Tuesday (30Oct2018), patient had chills and slept all day on her right side. She couldn't eat anything as she had no appetite and was nauseated. On that Tuesday night, she couldn't sleep again because the pain was so bad. Then yesterday (31Oct2018) she slept until about 10 am and woke up thinking she was feeling better. She felt better last night and could feel the pain going away on her left side. At time of report, she was fine but she said that she did lose 4 pounds since 29Oct2018.  The patient said that she was just about great at time of report, this was the first day she was well. There was no any event required a visit to emergency room or physician's office. The outcome of events sick and horribly sore was recovering, the outcome of the other events was unknown.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Somnolence, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of PREVNAR 13 (reported as PREVNAR 23, pending clarification), via an unspecified route of administration at left arm on 29Oct2018 13:45 at single dose for immunization. The patient had no other vaccines administered with suspect. Prior vaccinations within 4 weeks: None. Medical history included carotid artery surgery from Feb2018, strokes from 1997 (she had her first stroke in 1997, then had two more after her carotid artery surgery), arm was sore from 2017 to an unknown date (her arm was sore but nothing like this. She did not have a NDC, lot number or expiration date for the vaccine she got last year). The patient's concomitant medications were not reported. The patient previously took first dose of PREVNAR 13 (also reported as PREVNAR 23) for immunization in Dec2017 at pharmacy. The patient experienced sick and horribly sore, lost 4 pounds, on 29Oct2018. In evening of the 29Oct2018, she got extremely tired and her arm was real sore. During that night, she woke up and her whole left side was excruciatingly sore and she couldn't lay on that side or her back. She just couldn't sleep, she said that pain went from the shot area to her shoulder to her shoulder blade. Then down her side to under her left arm and into her back. On that Tuesday (30Oct2018), patient had chills and slept all day on her right side. She couldn't eat anything as she had no appetite and was nauseated. On that Tuesday night, she couldn't sleep again because the pain was so bad. Then yesterday (31Oct2018) she slept until about 10 am and woke up thinking she was feeling better. She felt better last night and could feel the pain going away on her left side. At time of report, she was fine but she said that she did lose 4 pounds since 29Oct2018.  The patient said that she was just about great at time of report, this was the first day she was well. There was no any event required a visit to emergency room or physician's office. The outcome of events sick and horribly sore was recovering, the outcome of the other events was unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Erythema, Headache, Incomplete course of vaccination
Clinical narrative: Large hot, swollen, hard red area-3 inches in diameter-red disappeared and then returned headache, fever of 2 degrees above my normal dizziness, lethargic; stayed in bed almost a week; nauseous raised blood pressure 165/95. My primary care told me NOT to get the second dose of SHINGRIX due to the difficulty I had with the initial dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Lethargy, Nausea, Pyrexia, Skin warm
Clinical narrative: Large hot, swollen, hard red area-3 inches in diameter-red disappeared and then returned headache, fever of 2 degrees above my normal dizziness, lethargic; stayed in bed almost a week; nauseous raised blood pressure 165/95. My primary care told me NOT to get the second dose of SHINGRIX due to the difficulty I had with the initial dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Large hot, swollen, hard red area-3 inches in diameter-red disappeared and then returned headache, fever of 2 degrees above my normal dizziness, lethargic; stayed in bed almost a week; nauseous raised blood pressure 165/95. My primary care told me NOT to get the second dose of SHINGRIX due to the difficulty I had with the initial dose.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat, slight fever, chills, weak, cough lasting for 3 weeks and still coughing.
Age: 63.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 102 F and chills for 2 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain
Clinical narrative: The IM injection was administered in the side of the arm, between the deltoid and the triceps muscle. SHINGRIX is an IM injection, and should be given in the deltoid muscle to prevent injury to the shoulder/arm. The injection was given and caused immediate pain. The pain continued, and I was unable to lift my arm higher than my shoulder for several days. I have more movement in the arm now, but it is still very painful when I raise it above my shoulder, especially when I reach it to the rear. It is important to note I had no reaction to the vaccine itself, but an injury to the soft tissue related to the anatomical site of injection. No treatment has been sought at this time. I have an appointment with Dr. soon, and plan on discussing/suggesting retraining of his staff that administers vaccines to prevent shoulder injury related to vaccine administration.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration, Soft tissue injury
Clinical narrative: The IM injection was administered in the side of the arm, between the deltoid and the triceps muscle. SHINGRIX is an IM injection, and should be given in the deltoid muscle to prevent injury to the shoulder/arm. The injection was given and caused immediate pain. The pain continued, and I was unable to lift my arm higher than my shoulder for several days. I have more movement in the arm now, but it is still very painful when I raise it above my shoulder, especially when I reach it to the rear. It is important to note I had no reaction to the vaccine itself, but an injury to the soft tissue related to the anatomical site of injection. No treatment has been sought at this time. I have an appointment with Dr. soon, and plan on discussing/suggesting retraining of his staff that administers vaccines to prevent shoulder injury related to vaccine administration.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, headache, muscle aches, chills.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain onset in upper and lower arm 2 days after injection. This was followed by weakness in shoulder muscles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Shivers, Fever, Severe Headache, Nausea, Muscle Aches and Pains, Soreness at injection site.  Inability to perform daily functions.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Shivers, Fever, Severe Headache, Nausea, Muscle Aches and Pains, Soreness at injection site.  Inability to perform daily functions.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Blindness, Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Patient walked to front of office and stated he felt nauseous and then fainted. Patient stated he could not see, was pale in color and diaphoretic. Patient was placed in a chair, VS were taken and within approx 5 min patient was able to stand and ambulate on his own.
Age: 66.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Vomiting
Clinical narrative: Severe abdominal pain beginning 2 hours after ingestion, vomiting began 4 hours after ingestion.  Vomiting for several hours, stomach pain gradually subsiding over 5 days. Patient (self) on bedrest for two days following with stomach pain and weakness. I am reporting this as I don't want anyone else to go through this if it happens to be a bad lot.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Injection site rash, Rash
Clinical narrative: Rash on bilateral legs. Fatgue.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Loss of consciousness, Muscle spasms
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of passed out in a 60-year-old female patient who received SHINGRIX (batch number GG2GA, expiry date 16th April 2021) for prophylaxis. On 4th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) 50 µg. On 4th November 2018, less than an hour after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), feeling hot and cramp in hand. On an unknown date, the outcome of the passed out, feeling hot and cramp in hand were recovered/resolved. It was unknown if the reporter considered the passed out, feeling hot and cramp in hand to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could 59 or 60 years. The pharmacist reported that the patient received a dose of SHINGRIX, within 2 minutes the patient passed out, got hot and her hands started locking up. The pharmacist called EMS and the patient was taken out in an ambulance. In November 2018, the symptoms had resolved. The reporter given consent to follow up. The patient required to visit emergency room (ER).
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient's wife called the evening after receiving the immunizations that afternoon. She said that he had a high fever and severe weakness. The right arm was slightly swollen and had a 3 inch red circle. Pharmacist on duty said to contact his doctor if he did not feel better by next day.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Herpes zoster, Nausea, Pyrexia, Rash
Clinical narrative: Patient reported an outbreak of shingles after 1st dose of SHINGRIX on 7/31/18. He did not give a time frame after which the rash started. It was resolved completely when patient came for 2nd shot on 10/11/18. Pt woke up 10/12/18 with a fever, nausea, diarrhea, vomiting and 1/2 dollar size shingles rash on right glute. Resolved within 10 day with Acyclovir 1 gram TID x 7 days.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient reported an outbreak of shingles after 1st dose of SHINGRIX on 7/31/18. He did not give a time frame after which the rash started. It was resolved completely when patient came for 2nd shot on 10/11/18. Pt woke up 10/12/18 with a fever, nausea, diarrhea, vomiting and 1/2 dollar size shingles rash on right glute. Resolved within 10 day with Acyclovir 1 gram TID x 7 days.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: On 9/7, developed painful, vesicular rash over R posterior neck. On 10/7, developed similar rash over B sacral spine and on 11/8, over R groin. On 10/19, she received PREVNAR-13, which she had previously received in 2015, and FLUZONE HIGH-DOSE. In 2012, she experienced a single vesicle after receiving the ZOSTAVAX vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain, Rash vesicular
Clinical narrative: On 9/7, developed painful, vesicular rash over R posterior neck. On 10/7, developed similar rash over B sacral spine and on 11/8, over R groin. On 10/19, she received PREVNAR-13, which she had previously received in 2015, and FLUZONE HIGH-DOSE. In 2012, she experienced a single vesicle after receiving the ZOSTAVAX vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Erythema.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Myalgia
Clinical narrative: Muscle pain all over body, fever, chills, weakness, dizziness, shortness of breath, pain with breathing Cleared up in its own in 48 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration, Pyrexia
Clinical narrative: Muscle pain all over body, fever, chills, weakness, dizziness, shortness of breath, pain with breathing Cleared up in its own in 48 hours.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: Patient stated that she had immediate pain. The patient as of 7:20am has pain which makes it difficult to move her arm, as well as a bruise.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site reaction
Clinical narrative: Subdeltoid bursitis of right shoulder joint.
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Numbness and tingling from the site of injection to distal metacarpals. No change since symptoms initiated on 10/07/2018. Went to occupational health for evaluation. No treatment ordered at this time.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: MOM STATES SHE HAD A RASH OVER HER BACK, TRUNK AND FACE THAT EVENING. SHE NORMALLY HAS A RASH DUE TO HER ECZEMA, BUT THIS HAD INCREASED REDNESS TO HER SKIN. TODAY, 11-14-2018, THE RASH HAS FADED BUT  STILL IS SLIGHTLY PRESENT.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: A review of patient provided responses to the vaccine screening form was not performed patient answered yes to question 10 which states "Do you have a child in the home less than one year of age".
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Extensive swelling of vaccinated limb, Feeling abnormal, Incorrect route of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) 50 ug. On 19th October 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 20th October 2018, the patient experienced extensive swelling of vaccinated limb, generalized aching, dizziness, erythema of extremities, mass, influenza like illness, nausea and feeling bad. On an unknown date, the outcome of the extensive swelling of vaccinated limb, generalized aching, dizziness, erythema of extremities, mass, influenza like illness, nausea and feeling bad were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, generalized aching, dizziness, erythema of extremities, mass, influenza like illness, nausea and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX subcutaneously, which led to incorrect route of vaccination. The patient woke up the next morning after vaccination and felt like she had been hit by a truck. Her whole body hurt from her head to her toes. She felt like she had the flu. Her arm was red and swollen from her shoulder to her elbow. She went back to sleep and felt even worse when she woke up. She felt dizzy and though she was going to throw up. The patient was starting to feel better, on the date of reporting. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mass, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) 50 ug. On 19th October 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 20th October 2018, the patient experienced extensive swelling of vaccinated limb, generalized aching, dizziness, erythema of extremities, mass, influenza like illness, nausea and feeling bad. On an unknown date, the outcome of the extensive swelling of vaccinated limb, generalized aching, dizziness, erythema of extremities, mass, influenza like illness, nausea and feeling bad were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, generalized aching, dizziness, erythema of extremities, mass, influenza like illness, nausea and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX subcutaneously, which led to incorrect route of vaccination. The patient woke up the next morning after vaccination and felt like she had been hit by a truck. Her whole body hurt from her head to her toes. She felt like she had the flu. Her arm was red and swollen from her shoulder to her elbow. She went back to sleep and felt even worse when she woke up. She felt dizzy and though she was going to throw up. The patient was starting to feel better, on the date of reporting. The patient had denied permission to contact their physician.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in an unspecified number of patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain, erythema of extremities and swelling. On an unknown date, the outcome of the pain, erythema of extremities and swelling were unknown. It was unknown if the reporter considered the pain, erythema of extremities and swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable. The medical assistant reported that 7 to 10 patients called back reporting pain, redness, and swelling. Redness extending from shoulder to elbow. Customers stated that they see these events more than compared with other vaccines.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in a male patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced hives. The patient was treated with Steroid Therapy. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with SHINGRIX on Monday afternoon and experienced a bad chicken pox like hives all over his body. The patient was put on steroid therapy by the doctor for his problem. The patient inquired is there anything else he could do.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (and localized redness at the injection after 1st dose, refer case US2018197797). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever and injection site erythema were recovered/resolved. It was unknown if the reporter considered the fever and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter indicated that he administered the first and second doses of the SHINGRIX vaccine to his sister. With both injections she experienced a fever and localized redness at the injection. The reporter did not consent to follow-up. The field representative was unable to provide additional information. The field representative reported three separate adverse reports from this reporter. This case has been linked with US2018197802 and US2018197775, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced headache and weakness. On an unknown date, the outcome of the headache and weakness were recovered/resolved. It was unknown if the reporter considered the headache and weakness to be related to SHINGRIX. Additional information was provided as follows: This case was reported by the patient's daughter. The patient received SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced headache and weakness, that was resolved but timeframe was unknown. The patient experienced adverse events with both doses of SHINGRIX. This case has been linked with case US2018195860, reported by same reporter for same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. 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 resolved with sequelae. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was reported by registered nurse (RN) supervisor. The patient received SHINGRIX on an unknown arm. The patient experienced redness in her whole injected arm. The reporter was uncertain of onset or duration of redness, but stated that it had resolved. The reporter gave consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site 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 59-year-old male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received SHINGRIX. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced pain at the injection site the day of the vaccination. The area was sore till the time of reporting. When he turns his hand one way or the other, the pain was felt up his arm in the muscle where the injection was administered.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a adult male patient who received SHINGRIX for prophylaxis. 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 unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was asking about what would happen if more than 6 months goes by between 1st and 2nd SHINGRIX injection. The reporter was attempted to be transferred to escalation nurse but none were available. Prior to transfer reporter stated in reference to his 1st shot of SHINGRIX that, he got ill from it. The GSK called him back to answer his question and to obtain further adverse event details but his voicemail box was full and we were unable to leave a message. No further details known.
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of local reaction in a adult male patient who received SHINGRIX for prophylaxis. 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 local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient could be 59 or 60 years old. The reporting healthcare professional was also the patient who had a localized reaction with initial dose of SHINGRIX, however no reaction with booster dose. No further details were reported. There was consent to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 3rd September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The reporter reported that her husband had SHINGRIX dose and the patient was still complaining pain at the injection site.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 97-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 27th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced varicella-like rash and pruritus. On an unknown date, the outcome of the varicella-like rash and pruritus were unknown. It was unknown if the reporter considered the varicella-like rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right deltoid (time of shot was not specified). The patient developed an itchy chicken pox type rash which had been there for 2 months on and off. The reporter asked in what part of the body itchy chicken pox type rash was developed and she stated that she did not know. The reporter consented to follow up.
Age: 61.0
Sex: M
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 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included nerve pain. On 31st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, 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 SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on unknown arm. The patient experienced mild arm pain. The reporter consented to follow up. For tolerance after 2nd dose refer case US2018196936.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. On 27th October 2018, the patient received the 1st dose of SHINGRIX. On 27th October 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, chills, headache and muscle pain. On an unknown date, the outcome of the fever, chills, headache and muscle pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, headache and muscle pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left deltoid. The reporter stated that the patient experienced fever, chills, headache, and muscle aches 6 to 8 hours after receiving her first dose of SHINGRIX. These symptoms subsided 24 hours later. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and injection site erythema. On an unknown date, the outcome of the fever and injection site erythema were recovered/resolved. It was unknown if the reporter considered the fever and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter indicated that he administered the first and second doses of the SHINGRIX vaccine to his sister. With both injections she experienced a fever and localized redness at the injection. The reporter did not consent to follow-up. The field representative was unable to provide additional information. The field representative reported three separate adverse reports from this reporter. This case has been linked with US2018197802 and US2018197797, reported by same reporter. For tolerance after 2nd dose refer case US2018GSK205390.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. For most patients, these symptoms resolved within 2 to 3 days. For a couple of patients, these symptoms resolved within 4 to 5 days. Did not consent to follow-up. The field representative was unable to provide additional information. The field representative reported three separate adverse reports from this reporter. This case has been linked with US2018197775, US2018GSK205390 and US2018197797, reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Headache, Laryngitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On 27th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat. On 27th October 2018, the patient experienced pain in arm, joint pain and pain. On an unknown date, the outcome of the pain in arm, joint pain, pain, dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat were unknown. It was unknown if the reporter considered the pain in arm, joint pain, pain, dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the healthcare professional for herself. The age at vaccination was not reported. The patient developed sore arm, joint pain, and right side pain on the day of vaccination. The patient also developed dizziness, low grade fever, stomach cramps, chest congestion, headache, bodyache, laryngitis, and sore throat the next day or two days after receiving the vaccine. The reporter gave consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On 27th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat. On 27th October 2018, the patient experienced pain in arm, joint pain and pain. On an unknown date, the outcome of the pain in arm, joint pain, pain, dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat were unknown. It was unknown if the reporter considered the pain in arm, joint pain, pain, dizziness, fever, stomach cramps, respiratory tract congestion, headache, laryngitis and sore throat to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information received as follows: The case was reported by the healthcare professional for herself. The age at vaccination was not reported. The patient developed sore arm, joint pain, and right side pain on the day of vaccination. The patient also developed dizziness, low grade fever, stomach cramps, chest congestion, headache, bodyache, laryngitis, and sore throat the next day or two days after receiving the vaccine. The reporter gave consent to follow up.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, tenderness, hot feeling in injection area.
Age: 71.0
Sex: F
Vaccine: IPV, IPV
Symptoms: Wrong product administered
Clinical narrative: I gave the patient a Poliovirus vaccine intradermally in right forearm instead of given the patient TUBERSOL. Patient was contacted and returned for a TB injection to be done in the left forearm on 11/13/18. No symptoms reported by patient.
Age: 71.0
Sex: F
Vaccine: IPV, IPV
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: I gave the patient a Poliovirus vaccine intradermally in right forearm instead of given the patient TUBERSOL. Patient was contacted and returned for a TB injection to be done in the left forearm on 11/13/18. No symptoms reported by patient.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Syncope. POTS Syndrome.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 59-year-old male patient. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD). The patient was allergic to penicillin and amlodipine besylate (NORVASC). Concomitant therapies included clonazepam(CLONOPIN), fluticasone furoate (+) vilanterol trifenatate(BREO), acetaminophen(TYLENOL), albuterol, buprenorphine hydrochloride, naloxone hydrochloride(SUBOXONE), doxepin hydrochloride(SINEQUAN), levetiracetam(KEPPRA), lisinopril, sertraline hydrochloride(ZOLOFT), chlormezanone(RESTORIL), tiotropium bromide(SPIRIVA) and unspecified medications. On 18-JUL-2018, the patient was vaccinated with first dose of PNEUMOVAX 23 for prevention of pneumococcal infection (dose, route and lot # was unspecified). On 30-OCT-2018, the patient was inadvertently vaccinated with second dose of PNEUMOVAX 23 (dose and route unspecified) from lot# N013521, expiry date: 23-JAN-2019 (incorrect dose administered). On the same day evening, the patient developed "pink around area of injection site, his arm was warm to touch, there was swelling around radius of arm near 80% around the arm and possibly cellulitis" (injection site cellulitis, injection site swelling, injection site warmth, injection site erythema). No treatment was provided for the events. The outcome of the events was reported as not recovered. Causality assessment for the events was not reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2018 the patient was vaccinated with VARIVAX (lot # R018139 and expiration date 25-JUN-2020), (dose, units were not reported) via intramuscular instead of subcutaneous route (incorrect route of product administration. No adverse effects were reported. There was no product quality compliant reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The pharmacist stated some patients had reported pain at the injection site post administration of SHINGRIX. The sales representative tried to clarify to get more specifics, but was only provided this general information. The pharmacist did not agree to have a follow up from GSK.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. In 2018, after 1st dose of SHINGRIX vaccination the patient experienced sore. It was reported that, the patient's 6 months window for 2nd inoculation of SHINGRIX was quickly closed. The patient's physician office continued saying to the patient, they could not get more vaccine. The patient wanted to know the 1st inoculation would be credited and the patient assumed that he needed to start all over.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site hives in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT2018-2019 season, the patient experienced injection site hives, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site hives, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site hives, injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient experienced oversized, raised redness and hives at the injection site and beyond. The reporter did not agree to be followed up.
Sex: U
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 patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown 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 age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had an episode of shingles before the second dose was given, reporter did not think it was related to vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis. The patient was treated with KEFLEX. On an unknown date, the outcome of the injection site cellulitis was recovered/resolved. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a licensed practical nurse (LPN). The age at vaccination was not reported. The patient received a dose of SHINGRIX in the left upper arm. On 4th September 2018, the patient was seen back at the physician's office for a cellulitis in the same region the vaccine was administered. The patient was prescribed KEFLEX and the cellulitis resolved without any complications. The reporter did not agree to be followed up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shivering and fatigue. On an unknown date, the outcome of the shivering and fatigue were unknown. It was unknown if the reporter considered the shivering and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient got SHINGRIX by itself and reported shivering and fatigue. This case has been linked to the US2018GSK177718 and US2018GSK177719 (the 2nd patient who received SHINGRIX and FLUAD both) and US2018172531 (the 1st patient who received SHINGRIX and FLUAD both), reported by the same reporter.