chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Meniere's disease
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of meniere's disease aggravated in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included meniere's disease (The patient had a medical history of meniere's disease which has been in remission for 2 years). 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 meniere's disease aggravated (serious criteria GSK medically significant) and dizzy spells. On an unknown date, the outcome of the meniere's disease aggravated and dizzy spells were unknown.  It was unknown if the reporter considered the meniere's disease aggravated and dizzy spells to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. fter her first injection, she had her first bout of dizziness from meniere's disease.  The patient would call back if has additional information to provide. This was all the patient wanted to share at this time. It was okay to contact patient back regarding this report. This case has been linked with case US2019018258, reported by same reporter for same patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
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 71-year-old female patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received SHINGRIX (intramuscular). On 8th August 2018, immediately 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 in the left deltoid. The patient experienced soreness at the injection site. The healthcare professional (HCP) stated that, the soreness remained ongoing, and worsened with range of motion and movement. The vaccine was not administered by the reporting facility. The suspect vaccine batch number was unknown. The reporter gave consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received SHINGRIX for prophylaxis.  On 11th December 2018, the patient received the 1st dose of SHINGRIX. On 12th December 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling cold and pain. On 12th December 2018, the outcome of the influenza-like symptoms, feeling cold and pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling cold and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The day after receiving the vaccine, the patient experienced flu-like symptoms, felt cold and achy. The patient stated that, these symptoms lasted for approximately 24 hours. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a elderly male patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, pain and influenza-like symptoms. On an unknown date, the outcome of the shivering, pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the shivering, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced shivering, aches, pain and flu-like symptoms after receiving a dose of SHINGRIX. The reporter got disconnected the call before additional information could be gathered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ophthalmic herpes zoster. On 5th October 2018, the patient received the 1st dose of SHINGRIX. On 5th October 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 age at vaccination was not reported. The patient received SHINGRIX in the left arm. The patient experienced injection site pain after receiving a dose of SHINGRIX. The patient planned to continue follow-up with her physician on an unknown date. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Dizziness, Headache, Impaired driving ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Meniere's disease aggravated in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of dizziness (for tolerance of 1st dose, refer case US2019GSK022470). Concurrent medical conditions included Meniere's disease (The patient had a medical history of Meniere's disease which has been in remission for 2 years). On 27th December 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced Meniere's disease aggravated (serious criteria GSK medically significant), dizzy spells, nausea, vomiting, headache, debility and driving ability disturbed. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Meniere's disease aggravated, dizzy spells, nausea, vomiting, headache, debility and driving ability disturbed were unknown. It was unknown if the reporter considered the Meniere's disease aggravated, dizzy spells, nausea, vomiting, headache, debility and driving ability disturbed to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For the past two weeks, the patient had a couple of bouts of dizziness, nausea, vomiting, headache which was debilitating. The patient was unable to drive when experiencing this. The patient has a call into her physician and was wondering if the shot has made her more susceptible to these bouts. The patient would call back if has additional information to provide. This was all the patient wanted to share at this time. It was okay to contact patient back regarding this report.
Sex: F
Vaccine: VARZOS
Symptoms: Meniere's disease, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Meniere's disease aggravated in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of dizziness (for tolerance of 1st dose, refer case US2019GSK022470). Concurrent medical conditions included Meniere's disease (The patient had a medical history of Meniere's disease which has been in remission for 2 years). On 27th December 2018, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a month after receiving SHINGRIX, the patient experienced Meniere's disease aggravated (serious criteria GSK medically significant), dizzy spells, nausea, vomiting, headache, debility and driving ability disturbed. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the Meniere's disease aggravated, dizzy spells, nausea, vomiting, headache, debility and driving ability disturbed were unknown. It was unknown if the reporter considered the Meniere's disease aggravated, dizzy spells, nausea, vomiting, headache, debility and driving ability disturbed to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For the past two weeks, the patient had a couple of bouts of dizziness, nausea, vomiting, headache which was debilitating. The patient was unable to drive when experiencing this. The patient has a call into her physician and was wondering if the shot has made her more susceptible to these bouts. The patient would call back if has additional information to provide. This was all the patient wanted to share at this time. It was okay to contact patient back regarding this report.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 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 fever and muscle soreness. On an unknown date, the outcome of the fever and muscle soreness were unknown. It was unknown if the reporter considered the fever and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient chatted in to inquire about side effects of the 2nd dose of SHINGRIX. The patient mentioned a slight fever and soreness. Chat transcript disappeared due to technology glitch so unable to confirm details, the information provided was all that could be remembered.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 2 days after receiving SHINGRIX, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the sister of the patient. The age at vaccination was not reported but it could be 63 or 64 years old. The reporter stated that the patient was unable to move her arm or lift her arm. The reporter stated that the patient did follow up with her physician. The reporter did not know which arm and has no further information. The reporter did not consent to follow up. No physician information was given.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 69-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included PREVNAR 13 with an associated reaction of peripheral swelling (The patient also had a reaction to the PREVNAR 13 shot and that she had swelling to her left arm which moved down her arm and this happened 2 years ago). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient had an adverse reaction to the flu shot. The caller states that the patient left arm was swelled and became red and painful and its lasted a couple of days. The reporter did not consent to follow up. No HCP information was obtained.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, several hours after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, myalgia, fatigue and lower extremities weakness of. On an unknown date, the outcome of the fever, influenza-like symptoms, myalgia, fatigue and lower extremities weakness of were recovered/resolved. It was unknown if the reporter considered the fever, influenza-like symptoms, myalgia, fatigue and lower extremities weakness of to be related to SHINGRIX. Additional details were reported as follows: The patient experineced fever, flu like symptoms, myalgia, fatigue and weak in the knees within a matter of hours after SHINGRIX vaccine. The myalgia and fatigue were extreme within 12 hours.   The patient did not plan to get the 2nd shot at this time. The issues lasted for 1 week. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous case from the United states, initially received on 05-Oct-2018, reported by other healthcare professional (nurse), concerns a female patient of unspecified age. The patient's current condition included unspecified immune disease (since an unspecified date). On 03-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 03144611A, expiry date: 30-Jun-2019] for active immunization against influenza. On 04-Oct-2018, 1 day after vaccination, the patient developed a red circle of 5 cm. On 05-Oct-2018, 2 days after vaccination, the patient visited emergency room due to the swollen arm and was hospitalized. The patient's discharge details were not available. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as serious (medically significant and hospitalization). Non-significant follow-up information received on 04-Jan-2019: Med Info Number (SEQ18-07143) was added in the additional information tab. No changes were done in the narrative. Follow up received from other health professional on 28-Jan-2019: The reporter's address and county was added in the general tab. It was reported that the patient was hospitalized on 05-Oct-2018. Hence, added hospitalization as a serious criteria with hospitalization details for both the events swollen arm and redness. The outcome of both the events was changed from not recovered to unknown in the event tab. The narrative was amended accordingly.; Reporter's Comments: A female patient of unspecified age experienced erythema one day after vaccination and arm swelling two days after vaccination with AFLURIA QIV. Considering the plausible temporal relationship between vaccination to event onset and absence of alternate aetiologies, the company assessed the causality for all the events as possibly related to suspect vaccine.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Hyperhidrosis, Muscular weakness
Clinical narrative: Severe headache, muscle weakness, pain in joints - hands and feet, lower back pain, and sweating.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever began a few hours after vaccine administration. Fever was 101.9 after 48 hours.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient states woke up this morning with 3 red, itch welts on L arm, 3 welts on L leg, and 1 welt on L side. Welts were not there at time  patient went to bed last night. Patient called in around 11:00am, no more had appeared since the time she woke up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling of arm, hot to the touch, itching and sore...started 20 hours after vaccine and still continues 2/8/19 but not as severe. Low grade temperature, nausea, chills, joint aches...started 20 hours after vaccine and lasted two full days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: Severe swelling of arm, hot to the touch, itching and sore...started 20 hours after vaccine and still continues 2/8/19 but not as severe. Low grade temperature, nausea, chills, joint aches...started 20 hours after vaccine and lasted two full days.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Initially dull pain; chronic-progressed to sharp pain. Daily. No relief w/ice, heat, IBU, APAP, Alternating. Not every day but almost everyday. No improvement. Worse. Hurts to lift arm parallel to shoulder.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 6-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2017, reported as "about 2 years ago", the patient was vaccinated with a dose of M-M-R II (dose, lot #, expiration date and route of administration not reported). On an unknown date, reported as "recent", the patient presented with mumps. The outcome of mumps was unknown. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Optic neuritis, Optic neuropathy
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 14-DEC-2015, the patient was administered ZOSTAVAX, (lot# and route unknown), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered permanent and debilitating injuries to her eyes, including vision loss and was diagnosed with optic neuritis and optic neuropathy. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Upon internal review optic neuritis and optic neuropathy were considered medically significant events. Optic neuritis and optic neuropathy were reported to be disabling. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a patient's mother and refers to the 2-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2016, the patient was vaccinated with M-M-R II injection, 0.5 milliliter (route of administration, injection site, lot # and expiration date were not reported) for prophylaxis. On 08-JUN-2016, the patient had a seizure and was brought to the emergency room (ER) at the hospital but was not admitted. No diagnostic test were performed. No treatment was given for the event. The outcome of seizure was reported as recovered. There was no causality assessment between M-M-R II and the event of seizure provided. Upon internal review, the event of seizure was considered to be medically significant. This is one of two reports concerning the same patient.; Sender's Comments: US-009507513-1902USA001457.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 29th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site pain and tiredness. On an unknown date, the outcome of the fever, muscle pain, injection site pain and tiredness were unknown.  It was unknown if the reporter considered the fever, muscle pain, injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient felt great prior to the shot on 29th January 2019 at 3 PM. The patient experienced side effects described as fever (body temperature 102 degree F), muscle aches and pain at injection site. The patient also had extreme tiredness. The patient stated that, the injection site was sore but there was no swelling or rash. The patient asked if these were normal reactions. A nurse at clinic said, these reactions were rare.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and experienced no adverse events). On 29th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced headache, chills, upset stomach, fatigue, general body pain, injection site pain and influenza like illness. On an unknown date, the outcome of the headache, chills, upset stomach, fatigue, general body pain, injection site pain and influenza like illness were not recovered/not resolved. It was unknown if the reporter considered the headache, chills, upset stomach, fatigue, general body pain, injection site pain and influenza like illness to be related to SHINGRIX. Additional details were reported as follows: The patient stated that he did not experience any adverse effects from the 1st SHINGRIX vaccination. However with the 2nd SHINGRIX vaccination he was currently experiencing symptoms (not resolved). The patient said they were bearable and that he almost feels like he had the flu. The patient experienced headache, chills, upset stomach, fatigue and soreness. The patient had pain at injection site but he also felt achy all over.
Age: 61.0
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 headache in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and experienced no adverse events). On 29th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced headache, chills, upset stomach, fatigue, general body pain, injection site pain and influenza like illness. On an unknown date, the outcome of the headache, chills, upset stomach, fatigue, general body pain, injection site pain and influenza like illness were not recovered/not resolved. It was unknown if the reporter considered the headache, chills, upset stomach, fatigue, general body pain, injection site pain and influenza like illness to be related to SHINGRIX. Additional details were reported as follows: The patient stated that he did not experience any adverse effects from the 1st SHINGRIX vaccination. However with the 2nd SHINGRIX vaccination he was currently experiencing symptoms (not resolved). The patient said they were bearable and that he almost feels like he had the flu. The patient experienced headache, chills, upset stomach, fatigue and soreness. The patient had pain at injection site but he also felt achy all over.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of taste loss in a 72-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 29th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th January 2019, 1 hr after receiving SHINGRIX, the patient experienced taste loss and swollen tongue. On an unknown date, the outcome of the taste loss was not recovered/not resolved and the outcome of the swollen tongue was unknown. It was unknown if the reporter considered the taste loss and swollen tongue to be related to SHINGRIX. Additional details were reported as follows: The patient's husband reported this case. The patient received SHINGRIX vaccine on left deltoid. An hour after receiving the SHINGRIX, the patient reported losing her sense of taste. The patient also reported that her tongue feels swollen although it did not look swollen. The reporter did not consent to follow up. This case has been linked to case US2019GSK017156, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 69-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th November 2018, immediately after receiving SHINGRIX, the patient experienced localized erythema, pain in arm and radiating pain. On an unknown date, the patient experienced local swelling. On an unknown date, the outcome of the localized erythema, local swelling and radiating 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 localized erythema, local swelling, pain in arm and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced localized redness, swelling, and pain which radiated down her arm to her elbow after receiving SHINGRIX. The redness and soreness started right away. The redness went away but patient still had soreness. The swelling started a couple days after receiving SHINGRIX and had since gone away. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 11th September 2018. Please refer the case US2019GSK022654). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 30th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, malaise and fatigue. On an unknown date, the patient experienced injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, malaise and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: Within a few hours of receiving the 2nd dose of the SHINGRIX vaccine, she developed pain at the injection site that lasted for 2 to 3 days and then resolved.  Within 24 hours of receiving the vaccination she began to experience malaise and fatigue. These resolved after 24 hours. She also developed a thin, red, horizontal line running across the bicep just under the injection site on her left arm. This lasted for approximately one week and then resolved. The reporter gave permission for her physician to be contacted. The reporter gave consent to follow up. This case has been linked with case US2019GSK022654, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever and shivering. On an unknown date, the outcome of the headache, fever and shivering were recovered/resolved. The reporter considered the headache, fever and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after a dose of SHINGRIX she experienced headache, shivering and fever for about 3 days. She was wondering if she would experience this again with the 2nd dose. The reporter did not give permission to contact her physician. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vesicles in a 54-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) 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 vesicles, pruritus and burning sensation. On an unknown date, the outcome of the vesicles, pruritus and burning sensation were unknown. It was unknown if the reporter considered the vesicles, pruritus and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient developed pruritic burning vesicles on index finger. The reporter gave consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician and a consumer. A female patient of an unspecified age received TRUMENBA (lot number and expiration date were not provided), via an unspecified route of administration on 2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a really severe headache after receiving the meningococcal group b rlp2086, on early in the year of 2018. The outcome of the event was unknown.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Malaise, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Sore arm only for first 48 hours post-vaccine. However started feeling ill 48 hours after vaccine and then with fever of 101F, vomiting and stomach pains 72 hours after vaccination. Resolved by 96 hours post-vaccination.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 02/05/19 pm swelling at the site, blotchy, warm / painful to touch-- advised ibuprofen and cool compress and see am if no better. 02/07/2019  seen by Dr; Left arm swollen red / tender. Diagnosed as local allergic rx to influenza vaccine. Prescribed benadryl, Ibuprofen, ice pack compress. 2/08/2019 f/u phone call; Doing better / improving with medical treatment of above per mother.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Peripheral swelling, Rash macular, Tenderness
Clinical narrative: 02/05/19 pm swelling at the site, blotchy, warm / painful to touch-- advised ibuprofen and cool compress and see am if no better. 02/07/2019  seen by Dr; Left arm swollen red / tender. Diagnosed as local allergic rx to influenza vaccine. Prescribed benadryl, Ibuprofen, ice pack compress. 2/08/2019 f/u phone call; Doing better / improving with medical treatment of above per mother.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Swelling and knot at injection site starting day of injection and still there as of 2/8/2019. Somewhat painful, rates 2/10 on numeric pain scale. No erythema noted at site, skin is intact, warm, dry. Able to visualize and palpate knot approx. size of quarter at injection site. States pain increases a little with palpation to injection site.
Age: 0.42
Sex: F
Vaccine: FLU4, HEP, RV5
Symptoms: Electroencephalogram abnormal, Eye movement disorder, Infantile spasms, Posture abnormal
Clinical narrative: Within 2 hours of the vaccine mom called to report "unusual" symptoms - her eyes rolled back and to the right, her head dropped and this lasted for 5-10 minutes. This all occurred while nursing. She fell asleep afterwards. There were multiple episodes and she was sent to ER, then hospital. She diagnosed w/infantile spasms by EEG.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a certified medical assistant via company representative referring a female patient of an unknown age. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were unknown by the reporter. Concomitant therapies included with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified manufacturer) and with MENACTRA. On an unspecified date in 2019 (also reported as last week), the patient was vaccinated with GARDASIL 9 (dosage, route, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV). The nurse instructed the patient to remain seated in the office for 15 minutes for observation following the administration of the vaccine. When the patient stood up after 15 minutes, she fainted. There was not more information available at the time of the report. The outcome of the event of syncope was not provided. The causal relationship between the event of syncope and the therapy with GARDASIL 9 was not provided. Upon internal review, the event of syncope was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent (lot# M046369, expiration date 07-JUL-2019). The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date (also reported as on 07-AUG-2018), the patient was vaccinated with improperly stored VARIVAX (lot # N020016, expiration date 17-JUL-2019; dose and route were unknown) for prophylaxis. No adverse effects reported. The vaccine was stored at 9.9 degrees Fahrenheit for 45 minutes. There was no previous temperature excursion. A data logger involved. No PQC presented. The medical assistant called with a new temperature excursion which is ongoing. The medical assistant will call back when the vaccines are back in proper freezer range. The medical assistant confirmed that no further administration VARIVAX.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of taste loss in a 65-year-old male patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 29th January 2019 10:40, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th January 2019, less than an hour after receiving SHINGRIX, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved. It was unknown if the reporter considered the taste loss to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right deltoid. Within one hour of receiving the SHINGRIX, the patient reported losing his sense of taste. The reporter did not consent to follow up. This case has been linked to case US2019016635, reported by same reporter.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Exposure during pregnancy, Haematemesis
Clinical narrative: This is a prospective pregnancy case. This 16-year-old female subject was enrolled in an open label study titled BEXSERO pregnancy registry: an observational study on the safety of BEXSERO exposure in pregnant women and their offspring. The subject received BEXSERO on 11th January 2019, for prophylaxis. Co-suspect products included MENVEO for prophylaxis. The subject received BEXSERO during the first trimester of pregnancy. On 1st February 2019, 21 days after receiving BEXSERO, the subject developed vomiting blood. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of vomiting blood was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the vomiting blood to be related to BEXSERO. Other possible cause(s) of the vomiting blood included Men A Conjugate - CRM 197, Men C Conjugate - CRM 197, Men W Conjugate - CRM 197, Men Y Conjugate - CRM 197. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported but the patient could be 15 or 16 years old. The patient was about 6 weeks pregnant (estimated delivery date unknown) and received two meningitis vaccines but could not say with certainty if the vaccines were MENVEO or BEXSERO and the patient's provider did not know at the time she was pregnant. The reporter wanted to know if the vaccines could have harmed her daughter or the pregnancy and reported that at the morning of date of reporting the patient had to be taken to the hospital due to vomiting up blood. The patient was only seen as an outpatient and they released her with some medication to coat her stomach. The reporter provided permission for the Registry to share this information with GSK and for a representative to contact her directly. The reporter was advised that the Registry was closed to enrollments, but that her information would be shared with GlaxoSmithKline (GSK) and a representative would be in touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 23rd May 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 recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The lot numbers was unknown at the time of reporting. The patient reported pain at injection site after vaccination with SHINGRIX. The reporter did not consented to follow up. For 2nd dose refer case US2019017438.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th 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 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 age at vaccination was not reported. The reporter described that within a few hours of receiving the 1st dose of the SHINGRIX vaccine she developed pain at the injection site. The pain lasted for 2 to 3 days and then resolved. The reporter gave permission for her physician to be contacted. For tolerance after 2nd dose of SHINGRIX, refer case US2019018249.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Nasal flaring, Rash, Sinus congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pimples in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pimples, sinusitis, nasal flaring, rash and erythema. The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Cortisone (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pimples, sinusitis, nasal flaring, rash and erythema were unknown. It was unknown if the reporter considered the pimples, sinusitis, nasal flaring, rash and erythema to be related to SHINGRIX. Additional details were reported as follows: The spots on patient face got 100 percent worse. The spots appear all over her face and appear as huge red pimples that did not itch, but they did hurt. The patient had seen her family doctor, an allergist and an infectious disease physician, but none of them know what condition she had. The patient had been taking Benadryl orally and has had a cortisone shot, but neither was providing long-term relief. Please refer case US2019017437, for tolerance of 2nd dose. This case has linked with case US2019017451, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pimples in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pimples, sinusitis, nasal flaring, rash and erythema. The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Cortisone (Nos)). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pimples, sinusitis, nasal flaring, rash and erythema were unknown. It was unknown if the reporter considered the pimples, sinusitis, nasal flaring, rash and erythema to be related to SHINGRIX. Additional details were reported as follows: The spots on patient face got 100 percent worse. The spots appear all over her face and appear as huge red pimples that did not itch, but they did hurt. The patient had seen her family doctor, an allergist and an infectious disease physician, but none of them know what condition she had. The patient had been taking Benadryl orally and has had a cortisone shot, but neither was providing long-term relief. Please refer case US2019017437, for tolerance of 2nd dose. This case has linked with case US2019017451, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient 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 nausea, vomiting, chills and general body pain. On an unknown date, the outcome of the nausea, vomiting, chills and general body pain were unknown. It was unknown if the reporter considered the nausea, vomiting, chills and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had received SHINGRIX, 3 months ago from the date of reporting. The patient reported the side effects and asked if she could reach the Centers for Disease Control and Prevention and disconnected the call.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Limb discomfort, 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 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hodgkin's disease. On 23rd December 2018, the patient received the 1st dose of SHINGRIX (tendon inj). On 23rd December 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased and intramuscular formulation administered by other route. On an unknown date, the patient experienced pain in arm and arm discomfort. The patient was treated with paracetamol (Tylenol), tramadol, medication unknown (Ice Pack (Nos)) and non-drug therapy (Heat Therapy). On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, arm discomfort and intramuscular formulation administered by other route were unknown.  It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and arm discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On the day of vaccination, by 4:30 PM, she could not lift her arm. She used Tylenol, Tramadol, Ice and heat but they had no effect. For the next couple of weeks, the pain in her left upper arm has gotten worse. It hurts to lift things, she cannot carry things and she cannot lie on the arm. She was informed that, the vaccination was administered too high in a tendon instead of her deltoid, which led to incorrect route of vaccine administration.