chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Dementia, Parkinson's disease
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dementia in a female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dementia (serious criteria GSK medically significant) and Parkinson's disease (serious criteria GSK medically significant). On an unknown date, the outcome of the dementia and Parkinson's disease were unknown. It was unknown if the reporter considered the dementia and Parkinson's disease to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. When the patient received 1st dose of SHINGRIX, at the that time the patient was not diagnosed with the dementia-Parkinson's disease. The patient required by her healthcare provider to have their 2nd dose not later than end of 25th January 2019 (which was the prescribed 6 month window). The reporter wanted to know, was this 2nd dose vaccine really necessary or would it not gave bad side effects.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth, Malaise
Clinical narrative: PATIENT CALLED REPORTING A BRIGHT RED AND WARM NODULE AT THE SITE OF IMMUNIZATION. A NURSE AT THE SCHOOL SHE WORKS AT DREW A CIRCLE AROUND IT YESTERDAY AND THE RED HAS EXTENDED BEYOND THE CIRCLE. Pt FEELS LIKE THE NODULE GOES UP TO HER SHOULDER. SHE ALSO REPORTED FEELING OVERALL UNWELL TODAY.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in an elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient has had flu vaccines often in her life and they hurt at injection site. The reporter did not consent to follow up and the patient did not want to provide any details. For tolerance of SHINGRIX refer case US2019004829.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction took place however the patient called inquiring about TB testing and a technician informed her that we did that here. She came to the store and requested TB, the pharmacist at drop off immediately typed in Tdap. It was verified, sold and the patient filled out the form for BOOSTRIX Tdap vaccine. When giving her the shot, I verified the patient and DOB but did fail to describe the particular vaccine she was receiving, assuming that it was correct. After administering the vaccine she asked when she was to come back to get it read. That is when we realized she wanted the TB test, not the Tdap vaccine.
Sex: F
Vaccine: MENB
Symptoms: Ill-defined disorder, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sickness in a female patient who received BEXSERO for prophylaxis. In October 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced sickness and illness. On an unknown date, the outcome of the sickness and illness were unknown. It was unknown if the reporter considered the sickness and illness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported that was there any timeframe that the 2nd dose of BEXSERO could no longer be received as the patient got her 1st dose of BEXSERO in October and was very sick and did not end up getting 2nd injections due to illness. The reporter asked if she could receive the 2nd dose and get it covered or had to restart the injections and what was the last possible date to get an injection and it if it would still counted as part of the series. This case has been linked to the case US2019GSK005612 (first daughter), reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male 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, pain and myalgia. On an unknown date, the outcome of the fever, pain and myalgia were unknown. It was unknown if the reporter considered the fever, pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient had a temperature, soreness and myalgia for a few days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 7 days after receiving SHINGRIX, the patient experienced rash and shingles. The patient was treated with ACETIC ACID (APPLE CIDER VINEGAR). On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. The reporter considered the rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that about a week after receiving SHINGRIX the patient experienced rash which was stated as shingles and it appeared on both butt and cheeks. The size was 50 cent piece and lasted for a while. The patient called her physician and was told to place calamine lotion on it, but she used apple cider vinegar. She noted it never and it truly went away, but two to three weeks ago it returned but not as bad and remained. She was referred to her physician but unable to get the appointment till 30th January. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site atrophy, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and muscle atrophy. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the muscle atrophy was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and muscle atrophy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced soreness and muscle atrophy at injection site. Limited information was provided by the physician. The physician wanted to speak to GlaxoSmithKline Medical Information (MI).
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a adult male patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX. In December 2018, less than a year after receiving BOOSTRIX, the patient experienced shoulder pain and difficulty sleeping. On 11th January 2019, the outcome of the shoulder pain was recovered/resolved. On an unknown date, the outcome of the difficulty sleeping was unknown. It was unknown if the reporter considered the shoulder pain and difficulty sleeping to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving BOOSTRIX, the patient experienced excruciating pain in his shoulder for 27 days. The patient was unable to sleep at night. The patient did not provide any further information.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 18-year-old female patient who received MENVEO for prophylaxis. On 4th January 2019, the patient received MENVEO (intramuscular). In January 2019, less than a week after receiving MENVEO, the patient experienced injection site pain, injection site erythema, injection site swelling, numbness in fingers and pain in arm. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, numbness in fingers and pain in arm were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, numbness in fingers and pain in arm to be related to MENVEO. Additional details were reported as follows: The patient received MENVEO vaccine on right arm. The onset of symptoms was not known. The patient was given the injection at a different clinic. The patient reported that she was experiencing numbness in the right ring finger, and the injection site was still swollen. Pain was also present at the injection site and was noted as a 6 on the pain scale. The swelling was described as 3 cm by 2 and 3 by 4 cm in size. The patient's circulation was intact. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Laziness, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old female patient who received SHINGRIX for prophylaxis.  On 30th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling unwell, laziness, tiredness and fever. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell, laziness, tiredness and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell, laziness, tiredness and fever to be related to SHINGRIX. Additional details were reported as follows: The caller asked about the medicine causing certain flu like symptoms was that normal. The patient had not received second shot. The caller stated she doesn't remember all of her symptoms but remembers that she did not feel well. She said she was tired and laggy and was on the couch. She said she might have had a fever but was not sure. The permission was not granted to contact MD. MD information was asked but caller refused.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Myalgia, 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 73-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included atrial fibrillation. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm. In June 2018, the patient experienced muscle pain. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the muscle pain was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. The reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient got a sore arm right away post vaccination with SHINGRIX. His sore arm was not that bad. About a week and a half to two weeks later, the patient came down with muscle pain in the back of the leg, butt, arms, across his neck, across his shoulders. The patient did not know if it was his atrial fibrillation that he had prior to SHINGRIX, so he changed medication and that did not take the pain away. He finally started receiving steroid shots to help him cope with the pain. The patient has not had any formal diagnosis but he was going back to the physician for blood test. The reporter was upset because she felt like the SHINGRIX activated this on both herself and her husband. The patient was late in receiving the 2nd dose of the SHINGRIX. The patient would not get the 2nd dose until it has been confirmed that SHINGRIX might not have caused these symptoms. The reporter did not consent to follow-up. This case has been linked to the case US2019004812, reported by same reporter for husband.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received SHINGRIX (batch number 02344621A, expiry date 20th June 2019) for prophylaxis. On 9th September 2018, the patient received the 1st dose of SHINGRIX. On 10th September 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, dizziness and nausea. On 12th September 2018, the outcome of the influenza-like symptoms, dizziness and nausea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, dizziness and nausea to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated 24 hours later the patient complained of flu like symptoms, light headedness, dizziness, and nausea. The healthcare professional stated these symptoms resolved in 48 hours. The reporter consented to follow up. A clarification request was sent for the batch number.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (for tolerance of Flu vaccine refer case US2019GSK009119). On 26th July 2018, the patient received the 1st dose of SHINGRIX. On 26th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The SHINGRIX vaccine had hurt the patient's injection site badly. The reporter did not consent to follow up and patient did not wanted to provide any details. The reporter did not gave consent to follow up. The patient did not want to provide any details. For tolerance of Flu vaccine refer case US2019GSK009119.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Underdose
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, vaccine administered at inappropriate site and accidental underdose. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the vaccine administered at inappropriate site and accidental underdose 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 age at the vaccination was not reported however; it could be 64 or 65 years old. The patient received vaccine higher on her arm, which led to vaccine administered at inappropriate site. The patient had pain for 2 days and was now concerned whether she would get full benefit. The patient was also concerned that a few drops of vaccine were wasted prior to being given to her, which led to accidental underdose. Consent for follow-up was not asked. The reporter left chat during interaction.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Insomnia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose some time in September 2018). On 7th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain. In January 2019, the patient experienced rash, raised rash, difficulty sleeping and injection site itching. On an unknown date, the outcome of the injection site pain, rash, raised rash, difficulty sleeping and injection site itching were unknown. It was unknown if the reporter considered the injection site pain, rash, raised rash, difficulty sleeping and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The next morning after receiving the SHINGRIX, the patient developed pain and soreness at the injection site. It had been difficult for him to sleep on this arm. The pain and soreness was starting to subside but now the injection site had become itchy. In approximately the last day her husband had developed a rash on the mid to lower part of his back and on the lower part of his stomach. There were at least a dozen spots, some of them raised, on both sides. The rash was not itchy, painful, or sore. The reporter did not consent to follow up. Reporter was unable to provide any additional information.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Fatigue, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of back pain aggravated in a 56-year-old male patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included chronic back pain. On 10th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced back pain aggravated, fever, fatigue and muscle pain. On an unknown date, the outcome of the back pain aggravated, fever, fatigue and muscle pain were unknown. It was unknown if the reporter considered the back pain aggravated, fever, fatigue and muscle pain to be related to SHINGRIX. Additional details were provided as follows: A day before reporting, the patient received SHINGRIX. The patient stated that after receiving SHINGRIX his back pain was worse and also experienced fever (body temperature: 102 degree F), fatigue and muscle aches.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 69-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th January 2019, 1 days after receiving SHINGRIX, the patient experienced weakness, fever, headache and chills. On 11th January 2019, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the weakness, fever, headache, chills, injection site erythema, injection site warmth and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the weakness, fever, headache, chills, injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pharmacist reported that the patient experienced adverse reactions after receiving the 2nd dose of the SHINGRIX. Two days after receiving vaccination, the patient experienced injection site erythema, injection site warmth and injection site induration.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 69-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. On 9th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th January 2019, 1 days after receiving SHINGRIX, the patient experienced weakness, fever, headache and chills. On 11th January 2019, the patient experienced injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the weakness, fever, headache, chills, injection site erythema, injection site warmth and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the weakness, fever, headache, chills, injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pharmacist reported that the patient experienced adverse reactions after receiving the 2nd dose of the SHINGRIX. Two days after receiving vaccination, the patient experienced injection site erythema, injection site warmth and injection site induration.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Haematochezia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a adult female patient who received SHINGRIX for prophylaxis. On 13th January 2019, the patient received the 1st dose of SHINGRIX. On 14th January 2019, 1 days after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), stomach pain, chills and diarrhea. On an unknown date, the outcome of the blood in stool, stomach pain, chills and diarrhea were unknown. It was unknown if the reporter considered the blood in stool, stomach pain, chills and diarrhea to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's daughter. The age at vaccination was not reported. The patient received 1st dose on the left deltoid. After vaccination, the patient experienced a terrible stomach pain at last night. The patient also experienced chills or shivering, but no fever. The patient had appointment with her physician. The reporter consented to follow up. In the source document the patient's date of birth and onset date of bloody stool was reported as future date, so we are processed this case as per narrative.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, pain, chills, hives and pruritus. On an unknown date, the outcome of the pain in arm, pain and chills were recovered/resolved and the outcome of the hives and pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain, chills, hives and pruritus to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. The patient experienced sore arm, aching and chills for 3 to 4 days and then those events resolved. A few days after the dose, the patient began experiencing hives and itching. The hives would show up, lasted for about an hour and then go away and the later would show up in a different area of the body and then go away. This was still occurring with the patient, at the time of reporting. The reporter did not consent to follow-up and declined the prescriber follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Analgesic therapy, Therapeutic response unexpected
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included post herpetic neuralgia (had pain relief from post herpetic neuralgia after receiving SHINGRIX). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient had pain relief from post herpetic neuralgia after receiving SHINGRIX and it was an unexpected positive result of vaccine.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 79-year-old male patient who received SHINGRIX (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. On 30th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reports that the patient experienced a rash everywhere on his body, from head to leg, after getting the 2nd dose of SHINGRIX.  The rash lasted about 7-10 days and was pretty much gone now.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, 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 male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 19 to 20 years before the date of reporting). Previously administered products included SHINGRIX (received 1st dose in April 2018). On 14th January 2019, the patient received the 2nd dose of SHINGRIX. On 14th January 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. In January 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and drug dose administration interval too long 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 age at vaccination was not reported. The patient finally received a dose of SHINGRIX and experienced sore arm. The patient wanted to know if he needs to get a 3rd dose of SHINGRIX since it had been more than 6 months for his 2nd dose of SHINGRIX which led to lengthening of vaccination schedule. The caller disconnected the call and no further details were provided and the patient was referred to health care professional.
Sex: M
Vaccine: TDAP
Symptoms: Gait inability, Immobile, Mobility decreased, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of immobile in a adult male patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced immobile (serious criteria GSK medically significant), nausea, mobility decreased and unable to walk. On an unknown date, the outcome of the immobile, nausea, mobility decreased and unable to walk were unknown. It was unknown if the reporter considered the immobile, nausea, mobility decreased and unable to walk to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was healthy and was an avid runner. At some point he received a BOOSTRIX vaccination and experienced nausea and was unable to get up and move or walk. The patient declined to provide any details regarding his event and stated that he would have his attorney contact GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult female 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 month after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, shingles and blister. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, shingles and blister were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, shingles and blister to be related to SHINGRIX. Additional details were provided as follows: The caller was a GSK account manager reporting an adverse event that was reported to her by a health care professional. The age at vaccination was not reported, but the patient could be 59 or 60 years old at the time of reporting. The patient experienced pain, warmness, and redness at the injection site after receiving the 1st dose of SHINGRIX. Three weeks after receiving the vaccine, the patient developed a mild patch of shingles on her shoulder. There was no itching or pain, however, the patch did blister. The patch lasted for 7 to 10 days before going away. The caller did not have any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This case reported by the pharmacist via GlaxoSmithKline website. The age at vaccination was not reported. In 2018, before the patient was able to get her 2nd dose of SHINGRIX, the patient had developed shingles. The call center representative, attempted to reach out to the healthcare professional to obtain additional details however, the healthcare professional was not available. The call center representative left message at pharmacy for a healthcare professional with  case number.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced feeling unwell, injection site pain and pain in arm. On an unknown date, the outcome of the feeling unwell and injection site pain were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the feeling unwell, injection site pain and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient felt sick a few days after the vaccination and that resolved in 12 to 14 hours. The patient also experienced injection site pain but that was resolved. The patient experienced arm pain below the injection site area that had persisted and was not resolved.
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 53-year-old female 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 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 details were provided as follows: The age at vaccination was not reported. The patient experienced arm hurt like she got punched after the vaccination. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bell's palsy 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, 21 days after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Three weeks after vaccination, the patient experienced bell's palsy. The emergency visit was required. The reporter consented to follow up.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. A 69-years-old female patient was allergic to pneumococcal vaccines, cefazolin, DEMEROL, erythromycin, indomethacin, lidocaine, CIPRO XR, CIPRO, DARVON, INDOCIN, PROCAINE, moxifloxacin, NITROFURANTOIN MONO/MAC, PROPOXYPHENE and procaine. Relevant medical history included sulfonamide allergy and adhesive tape allergy. The patient's concomitant medications were not reported. The action taken with all suspect drugs in response to the event and the outcome of the event were unknown. Follow-up (24Jan2017): Follow-up attempts are completed. No further information is expected. Follow-up (16Jan2019): This is a follow-up report combining information from duplicate reports 2018388022, 2018529712 and 2016580139. The current and all subsequent follow-up information will be reported under manufacturer report number 2016580139. New information from a contactable consumer and a contactable nurse includes: medical history and suspect drugs. The information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein), cefazolin, erythromycin, indomethacin and lidocaine in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein), cefazolin, erythromycin, indomethacin and lidocaine has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of PREVNAR 13, via an unspecified route of administration in Oct2018 at a single dose for immunization. The patient's medical history was and concomitant medications were not reported. The patient experienced swelling in arm, fever, vomiting, and diarrhea for 2 weeks. Outcome of the events was unknown. Information on batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had a very bad reaction from the vaccination. Her arm was swollen, and she was just like in bed almost 2 weeks. She got the vaccination from pharmacy name. The patient also had fever, was throwing up, and had diarrhea on an unknown date. Outcome of all the events was unknown. Information on batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration at the left upper arm, on 08Jan2019 at a single dose for immunization. Medical history included thyroid disorder. Concomitant medication included ARMOUR THYROID for thyroid. The patient reported on 16Jan2019 when she woke up, the injection site was very red, hot, itchy, and a little sore. The patient also reported that she felt the itching was getting worse. The pharmacist told her to take 2 ibuprofen and put ice on the area. Patient also mentioned that she will take an antihistamine, though she hasn't yet. The patient has not yet recovered from the events at the time of report. Information on batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on 06Jan2019 at single dose for immunization. Medical history been fighting cancer for 18 months and Immune system is not strong. The patient's concomitant medications were not reported. The patient experienced arm hurts, itchy and all red on Jan2019. The patient saw the doctor and was prescribed steroid medicine methylprednisolone 4mg. The outcome of the events was recovering. Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A currently 62-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain at the injection site 11 hrs after vaccination on an unspecified date with outcome of recovered. The patient took TYLENOL and felt much better and no longer had pain. The information on the lot number has been requested.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Erythema, Swelling
Clinical narrative: Initial information and live follow up regarding this unsolicited case from a Pharmacist and transmitted to Sanofi on 19-Oct-2018. This case involves a 28 year female patient who experienced Breathing difficult, redness, swelling and unevaluable event after starting ADMELOG with the use of medical device SOLOSTAR and FLUBLOK QIV. Relevant medical history and Concomitant medication were not reported. On an unknown date, the patient started therapy with Insulin Lispro Solution for injection of unknown dose and frequency via unknown route with the use of medical device SOLOSTAR (Batch number: unknown, Expiration date: unknown) for unknown indication and on 17-Oct-2018 patient took quadrivalent recombinant influenza vaccine at a dose of 0.5 daily (unit unknown) (batch number QFAA1810) via Intramuscular route in right arm. On an unknown date, latency unknown after the initiation of Insulin Lispro therapy with the use of medical device SOLOSTAR and FLUBLOK, the patient reported that she was having trouble breathing. It was also reported that the patient was going to discuss with her physician about possibly switching to HUMALOG. On an unknown date in October 2018 patient experienced redness, swelling and redness spreaded on upper arm. Action taken was unknown with ADMELOG and not applicable for quadrivalent recombinant influenza vaccine. Corrective treatment unknown. Outcome of the event was unknown for Breathing difficult and recovering for rest events. No further relevant information was reported. Additional information received on 03-Jan-2019. Patient age, height, weight, date of birth, quadrivalent recombinant influenza vaccine, redness, swelling and redness spreaded on upper arm added. Narrative and corresponding fields were updated accordingly.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 73 years old female patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 12-Jan-2019, the patient received a 0.5ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, prefilled syringe, lot UI809AB, expiry date 02-Mar-2018 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was expired FLUZONE HD (expiry date 02-Mar-2018) on 12-Jan-2019. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: Initial information received on 15-Jan-2019 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves a 26 years old female patient who received vaccine TYPHIM VI (lot NIK811M and expiry date 19-Oct-2019) via intramuscular route in the left deltoid on 14-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to occupational exposure to product as While vaccination it was observed that a moderate amount of vaccine was on the administrator's gloved hand. He did not observe where it was leaking from. I verified this fact twice with the caller. He did not keep the syringe. It was put in the sharps container. It was not reported if the patient had any adverse event. It was also a case of syringe issue. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Deafness, Deafness neurosensory, Deafness unilateral, Dizziness, Sudden hearing loss
Clinical narrative: This is a spontaneous case initially received from other non-healthcare professional on 13-Jan-2019, concerning a 38-year-old, adult, male patient. The patient's historical drug included Zantac (ranitidine; as needed) but had not used in past 5 months. The patient had no relevant medical history. On 27-Oct-2018, the patient was administered FLUCELVAX (QIVc) (influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252679 and expiry date: not reported) for influenza prophylaxis. On 18-Nov-2018, 22 days after the vaccination, the patient woke up with hearing loss in right ear, followed by vertigo, dizziness, and tinnitus. The patient went to the Internist on 29-Nov-2018, who misdiagnosed as congestion in the ear. As there was no improvement, the patient then saw an ear, nose, and throat specialist who diagnosed as sudden sensorineural hearing loss (reported as Sudden sensonoral hearing loss) and gave high dose of unspecified steroids. The patient had not recovered from the events and the side effects were continuing. The reporter assessed this case as non-serious. Reporter's Comments: A 38-year-old, male patient developed sudden sensorineural hearing loss manifested by vertigo, dizziness, and tinnitus 22 days after administration of FLUCELVAX QIV. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event (Sudden Sensorineural Hearing Loss) as serious (medically significant).