chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (After receiving 1st dose on 20th August 2018, refer case US2018218442). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. 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 reporter was the patient's husband. The patient received SHINGRIX in the left arm. The patient experienced left arm pain. The reporter gave consent for follow up. The physician contact details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin discoloration in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fall (Fell and cracked head open was bleeding, got knocked out). Previously administered products included ZOSTAVAX with an associated reaction of loss of consciousness and Shingrix with an associated reaction of pyrexia (fever after receiving 1st dose, see case US2018GSK219944). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was not reported. It was unknown if the reporter considered the skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced after receiving the 2nd shot in left arm. The skin discoloration occurred after the second shot. It did not bleed. It was about the size of a dime. It was goldfish or brownish in color. She was fair skinned. It had not resolved. It was not painful, not raised, no lesion. She did not experience a fever after the second SHINGRIX injection. This case has been linked with 1st dose case US2018GSK219944, reported by the same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Blood pressure increased, Dizziness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of asthenia (For tolerance to 1st dose please refer case US2018GSK219956). On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced loss of energy, dizziness, increased blood pressure and feeling anxious. Rechallenge with SHINGRIX was positive. On 3rd December 2018, the outcome of the loss of energy, dizziness, increased blood pressure and feeling anxious were recovered/resolved. It was unknown if the reporter considered the loss of energy, dizziness, increased blood pressure and feeling anxious to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had all the side effects experienced after the first shot but only for 1-1 and half days, then  continued to experience some side effects on and off until 3rd December 2018. On the day of reporting, this was the first day patient have energy, no dizziness. The patient also had elevated blood pressure for that interval and had a feeling of anxiety. At the day of reporting the patient was without those feelings and blood pressure was back in line. The patient went to physician. Lab Comments: Lab test was done on an unknown date.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Pain in extremity, Pruritus, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 15th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On 15th October 2018, the patient experienced tenderness, burning sensation, pruritus and pain in arm. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the tenderness, burning sensation and pruritus were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site pain, tenderness, burning sensation, pruritus and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient reported that, 30 days after receiving SHINGRIX, experienced tenderness, burning feeling and itching under his left arm and the left side of his belt line. The patient planned to follow-up with his physician on 4th December 2018. The reporter gave consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site mass, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number FK43S, expiry date 30th June 2019) for prophylaxis. Concurrent medical conditions included penicillin allergy and latex allergy. On 30th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 30th November 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced pruritus, injection site erythema, allergic reaction and injection site lump. The patient was treated with BENADRYL. On an unknown date, the outcome of the pruritus and injection site erythema were not recovered/not resolved and the outcome of the allergic reaction and injection site lump were unknown. It was unknown if the reporter considered the pruritus, injection site erythema, allergic reaction and injection site lump to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported via click to chat. The age at vaccination was not reported. The patient received FLULAVAL QUADRIVALENT 2018-2019 season shot and tried to find out the components to the vaccine as she had allergic reaction. The patient stated that, when the other nurse was giving the vaccine, it started to itch a little, and a few hours later the itching was more and enough to take a BENADRYL. The itching repeated again on Saturday, Sunday and at the time of reporting. The site had a knot, size of quarter and was red. At the time of reporting, the symptoms were ongoing. No further details were reported regarding the event. The reporter gave consent to follow up.
Age: 61.0
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 adult female patient who received SHINGRIX for prophylaxis. On 20th August 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. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's husband. The patient received SHINGRIX in the left arm. experienced arm pain following the vaccine that lasted for approximately 3 days. The reporter gave consent for follow up. The physician contact details were provided. For tolerance to next dose, refer case US2018GSK223654.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site swelling. On 19th October 2018, the outcome of the injection site warmth and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on an unknown arm. Within 24 hours of receiving the dose of SHINGRIX, the patient noticed that the area around the injection site was very red, hot, and swollen. These symptoms persisted for at least 2 weeks before they started going away. The redness had improved, but continued till the reporting time. The healthcare professional stated that the reddened area was 2.5 inches long by 1.5 inches wide around the site of injection. The reporter gave consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a pharmacist via call center representative an described the occurrence of fever blister in a 78-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.  It was unknown if the reporter considered the fever blister to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient developed fever blisters on face and mouth following administration of SHINGRIX. On the date of reporting, the patient notified pharmacy of the fever blisters. The reporter gave consent to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a 76-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included insulin nos (Insulin). On 4th November 2018, the patient received SHINGRIX. On 5th November 2018, 1 days after receiving SHINGRIX, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was unknown. It was unknown if the reporter considered the blood sugar increased to be related to SHINGRIX. Additional details were reported as follows: The patient noted that his blood sugar readings increased the next day after vaccination and had remained high. The patient reported that prior to the injection, his morning glucose would be 107-117. The day after, the readings were 152. The patient's afternoon readings had been as high at 200.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient wanted to report side effects that she had after taking the SHINGRIX vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Back disorder, Chills, Gait disturbance, Inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient wanted to report side effects that she had after taking the SHINGRIX vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nervous system disorder, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient wanted to report side effects that she had after taking the SHINGRIX vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. In August 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 fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty. On an unknown date, the outcome of the fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty were not recovered/not resolved. The reporter considered the fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. There was no information about the patient's medical history. The patient received SHINGRIX vaccine in the middle of August 2018. She reported that, since that time, she had been experiencing several side effects. The patient experienced fever, chills, aches, inflammation flare up, back issues, inflammatory arthritis, nerve in leg flared up, and states she was barely able to walk.  At the time of reporting, she experiences these symptoms and was being treated by her primary care physician (PCP).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Back disorder, Chills, Gait disturbance, Inflammation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. In August 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 fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty. On an unknown date, the outcome of the fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty were not recovered/not resolved. The reporter considered the fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. There was no information about the patient's medical history. The patient received SHINGRIX vaccine in the middle of August 2018. She reported that, since that time, she had been experiencing several side effects. The patient experienced fever, chills, aches, inflammation flare up, back issues, inflammatory arthritis, nerve in leg flared up, and states she was barely able to walk.  At the time of reporting, she experiences these symptoms and was being treated by her primary care physician (PCP).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nervous system disorder, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. In August 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 fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty. On an unknown date, the outcome of the fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty were not recovered/not resolved. The reporter considered the fever, chills, pain, inflammation, back disorder, inflammatory arthritis, nervous system disorder and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. There was no information about the patient's medical history. The patient received SHINGRIX vaccine in the middle of August 2018. She reported that, since that time, she had been experiencing several side effects. The patient experienced fever, chills, aches, inflammation flare up, back issues, inflammatory arthritis, nerve in leg flared up, and states she was barely able to walk.  At the time of reporting, she experiences these symptoms and was being treated by her primary care physician (PCP).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 2nd December 2018, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm and product supply issue were unknown and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the deltoid and has been unable to find the 2nd dose since that time. She was given the vaccine high on her arm but could not say if it was in the deltoid area but was close to the bone the and not in the meaty area. She felt this might have been why her arm was so sore, she could not raise it for 4 days. Because the patient could not say it was given outside of the deltoid region, it was not listed as an adverse event. The reporter gave consent to follow up.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of abnormal touch sensation in a adult male patient who received FLUARIX QUADRIVALENT 2017-2018 season) (batch number C559A, expiry date 30th June 2018) for prophylaxis. On 25th September 2017, the patient received FLUARIX QUADRIVALENT 2017-2018 season. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced abnormal touch sensation. On an unknown date, the outcome of the abnormal touch sensation was not recovered/not resolved. It was unknown if the reporter considered the abnormal touch sensation to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT 2017-2018 season in the left deltoid, very close to his small pox scar. The patient had a sensation when a light touch was passed over the injection site that felt like a thorn under the skin. If pressed directly on the area, there was no pain. The pharmacist stated that the patient did not mention this until his current year's influenza vaccine came up. The pharmacist provided as much detail as was available. The pharmacist consented to be followed-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injected limb mobility decreased, Nausea, 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 59-year-old female patient who received SHINGRIX for prophylaxis. On 14th July 2018, the patient received the 1st dose of SHINGRIX. On 14th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 15th July 2018, the patient experienced nausea, fever, dizziness and influenza-like symptoms. On 16th July 2018, the outcome of the pain in arm, injected limb mobility decreased, nausea, fever, dizziness and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm, injected limb mobility decreased, nausea, fever, dizziness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: On Saturday, the patient received SHINGRIX on her arm which became sore the same day and she had difficulty raising it. The next day, she awoke with flu like symptoms which included fever, nausea and dizziness. All the events were resolved on Monday and she was able to go to work. The patient reported all these symptoms to the pharmacist who would also report to VAERS. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 14th July 2018, the patient received the 1st dose of SHINGRIX. On 14th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and injected limb mobility decreased. On 15th July 2018, the patient experienced nausea, fever, dizziness and influenza-like symptoms. On 16th July 2018, the outcome of the pain in arm, injected limb mobility decreased, nausea, fever, dizziness and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm, injected limb mobility decreased, nausea, fever, dizziness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: On Saturday, the patient received SHINGRIX on her arm which became sore the same day and she had difficulty raising it. The next day, she awoke with flu like symptoms which included fever, nausea and dizziness. All the events were resolved on Monday and she was able to go to work. The patient reported all these symptoms to the pharmacist who would also report to VAERS. The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, 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 72-year-old female patient who received SHINGRIX for prophylaxis. On 30th November 2018, the patient received the 2nd dose of SHINGRIX. On 30th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 1st December 2018, the patient experienced sickness, fatigue, chills and headache. On 1st December 2018, the outcome of the pain in arm was recovered/resolved. On 4th December 2018, the outcome of the sickness, fatigue, chills and headache were recovered/resolved. It was unknown if the reporter considered the pain in arm, sickness, fatigue, chills and headache to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. On Friday, the patient received SHINGRIX on the left arm. The patient had pain in the arm of the shot and was sick for the next few days. The reporter explained sick as fatigue, chills and headache. The patient was in bed for Saturday and Sunday. At the time of reporting, the patient was felt back to like herself. The reporter had declined to provide the healthcare professional information. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Mental status changes, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 26th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th August 2018, several hours after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes. The patient was treated with non-drug therapy (Cold Pack). On 29th August 2018, the outcome of the erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes were recovered/resolved.  The reporter considered the erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes to be related to SHINGRIX. Additional details were reported as follows: At 11:00, the patient received SHINGRIX on the left arm. On the day of vaccination, by the evening, the patient's left arm was very red, swollen and painful. Less than day after vaccination, the patient was very feverish, weak and had an altered mental state. The patient used cold packs on the swelling and took a lots of showers to keep her fever down. On Wednesday evening, the symptoms had mostly resolved. The patient had decided not to receive the 2nd dose of SHINGRIX. The contact details of the physician was provided. The reporter had given consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 26th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th August 2018, several hours after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes. The patient was treated with non-drug therapy (Cold Pack). On 29th August 2018, the outcome of the erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes were recovered/resolved.  The reporter considered the erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes to be related to SHINGRIX. Additional details were reported as follows: At 11:00, the patient received SHINGRIX on the left arm. On the day of vaccination, by the evening, the patient's left arm was very red, swollen and painful. Less than day after vaccination, the patient was very feverish, weak and had an altered mental state. The patient used cold packs on the swelling and took a lots of showers to keep her fever down. On Wednesday evening, the symptoms had mostly resolved. The patient had decided not to receive the 2nd dose of SHINGRIX. The contact details of the physician was provided. The reporter had given consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Facial paralysis, Gingival swelling, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 31st October 2018, the patient received FLUARIX QUADRIVALENT .5 ml. On 8th November 2018, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced Bell's palsy (serious criteria GSK medically significant), enlargement of lymph nodes (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity. The patient was treated with antibiotics nos. On an unknown date, the outcome of the Bell's palsy, enlargement of lymph nodes, swallowing difficult, fever, numbness facial and tingling of extremity were recovered/resolved and the outcome of the facial swelling, neck swelling, gum swelling and gingival inflammation were recovering/resolving and the outcome of the temporomandibular joint arthralgia, numbness gingival and tingling gum were not recovered/not resolved. It was unknown if the reporter considered the Bell's palsy, enlargement of lymph nodes, swallowing difficult, facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was administered FLUARIX QUADRIVALENT in the right deltoid. The patient experienced swelling on the right side of her face, neck and her gums. The patient had her teeth checked and there was nothing found except for the gum inflammation with numbness and tingling. The numbness was also present to her chin and lower lip area. The patient described it as feeling like a mild case of Bell's palsy. The patient had pain at the temporomandibular joint that progressed to a fever. Her lymph nodes on the right side were also swollen. Tingling presented in her right leg down to her ankle. Due to the swollen lymph node, she was had trouble swallowing and sought treatment at the emergency room. The patient was treated with antibiotics and the lymph node swelling resolved a week later. The patient went to the emergency room at 3 pm Thursday and was admitted to a room at 9:00 pm. The patient was discharged at 2:30 in the afternoon on Friday. The patient still had numbness and tingling in her mouth. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Noninfective gingivitis, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 31st October 2018, the patient received FLUARIX QUADRIVALENT .5 ml. On 8th November 2018, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced Bell's palsy (serious criteria GSK medically significant), enlargement of lymph nodes (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity. The patient was treated with antibiotics nos. On an unknown date, the outcome of the Bell's palsy, enlargement of lymph nodes, swallowing difficult, fever, numbness facial and tingling of extremity were recovered/resolved and the outcome of the facial swelling, neck swelling, gum swelling and gingival inflammation were recovering/resolving and the outcome of the temporomandibular joint arthralgia, numbness gingival and tingling gum were not recovered/not resolved. It was unknown if the reporter considered the Bell's palsy, enlargement of lymph nodes, swallowing difficult, facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was administered FLUARIX QUADRIVALENT in the right deltoid. The patient experienced swelling on the right side of her face, neck and her gums. The patient had her teeth checked and there was nothing found except for the gum inflammation with numbness and tingling. The numbness was also present to her chin and lower lip area. The patient described it as feeling like a mild case of Bell's palsy. The patient had pain at the temporomandibular joint that progressed to a fever. Her lymph nodes on the right side were also swollen. Tingling presented in her right leg down to her ankle. Due to the swollen lymph node, she was had trouble swallowing and sought treatment at the emergency room. The patient was treated with antibiotics and the lymph node swelling resolved a week later. The patient went to the emergency room at 3 pm Thursday and was admitted to a room at 9:00 pm. The patient was discharged at 2:30 in the afternoon on Friday. The patient still had numbness and tingling in her mouth. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Swelling face, Temporomandibular joint syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult female patient who received FLUARIX QUADRIVALENT for prophylaxis. On 31st October 2018, the patient received FLUARIX QUADRIVALENT .5 ml. On 8th November 2018, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced Bell's palsy (serious criteria GSK medically significant), enlargement of lymph nodes (serious criteria hospitalization), swallowing difficult (serious criteria hospitalization), facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity. The patient was treated with antibiotics nos. On an unknown date, the outcome of the Bell's palsy, enlargement of lymph nodes, swallowing difficult, fever, numbness facial and tingling of extremity were recovered/resolved and the outcome of the facial swelling, neck swelling, gum swelling and gingival inflammation were recovering/resolving and the outcome of the temporomandibular joint arthralgia, numbness gingival and tingling gum were not recovered/not resolved. It was unknown if the reporter considered the Bell's palsy, enlargement of lymph nodes, swallowing difficult, facial swelling, temporomandibular joint arthralgia, fever, neck swelling, gum swelling, gingival inflammation, numbness gingival, tingling gum, numbness facial and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was administered FLUARIX QUADRIVALENT in the right deltoid. The patient experienced swelling on the right side of her face, neck and her gums. The patient had her teeth checked and there was nothing found except for the gum inflammation with numbness and tingling. The numbness was also present to her chin and lower lip area. The patient described it as feeling like a mild case of Bell's palsy. The patient had pain at the temporomandibular joint that progressed to a fever. Her lymph nodes on the right side were also swollen. Tingling presented in her right leg down to her ankle. Due to the swollen lymph node, she was had trouble swallowing and sought treatment at the emergency room. The patient was treated with antibiotics and the lymph node swelling resolved a week later. The patient went to the emergency room at 3 pm Thursday and was admitted to a room at 9:00 pm. The patient was discharged at 2:30 in the afternoon on Friday. The patient still had numbness and tingling in her mouth. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Generalised tonic-clonic seizure, Headache, Joint noise, Mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number YF64H, expiry date unknown) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 17th October 2018, several hours after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm (serious criteria hospitalization), back pain, headache and mobility decreased. On 28th November 2018, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant) and speech disorder. In December 2018, the patient experienced joint clicking (serious criteria hospitalization). The patient was treated with levetiracetam (Keppra), levetiracetam (Keppra), paracetamol (Tylenol) and non-drug therapy (Heating Therapy). On 5th December 2018, the outcome of the speech disorder was recovered/resolved. On an unknown date, the outcome of the pain in arm, back pain, headache and mobility decreased were recovered/resolved and the outcome of the grand mal seizure was recovering/resolving and the outcome of the joint clicking was unknown. It was unknown if the reporter considered the pain in arm, grand mal seizure, joint clicking, back pain, headache, mobility decreased and speech disorder to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information received as follows: In the morning, the patient received dose of SHINGRIX. In afternoon of same day of vaccination at approximately 4:30 pm she started to feel severe pain in her right arm, back and back of her head. The pain was so severe that she had to sit up in chair that night. She could not put any pressure on the areas. The pain was severe for 48 hour and she could not lift her arm for almost 7 days. The patient took Tylenol and used a heating pad. The patient had a grand mal seizure and was transported to the hospital. She was there for 48 hours and treated with Keppra IV therapy. In December 2018, she took 500 mg Keppra BID and was restricted from driving for 6 months. T the reporting time, the pain had resolved and shoulder clicks. On the day before the reporting day, first time she could make a complete sentence after the seizure. The flu brand name was unknown. Emergency room visit required. The reporter gave consent to follow up. The vaccination date of SHINGRIX was given in Argus core was 6th December 2018 same as GSK-receipt date, so it  was captured as 17th October 2018 from the narrative.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number YF64H, expiry date unknown) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 17th October 2018, several hours after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm (serious criteria hospitalization), back pain, headache and mobility decreased. On 28th November 2018, the patient experienced grand mal seizure (serious criteria hospitalization and GSK medically significant) and speech disorder. In December 2018, the patient experienced joint clicking (serious criteria hospitalization). The patient was treated with levetiracetam (Keppra), levetiracetam (Keppra), paracetamol (Tylenol) and non-drug therapy (Heating Therapy). On 5th December 2018, the outcome of the speech disorder was recovered/resolved. On an unknown date, the outcome of the pain in arm, back pain, headache and mobility decreased were recovered/resolved and the outcome of the grand mal seizure was recovering/resolving and the outcome of the joint clicking was unknown. It was unknown if the reporter considered the pain in arm, grand mal seizure, joint clicking, back pain, headache, mobility decreased and speech disorder to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information received as follows: In the morning, the patient received dose of SHINGRIX. In afternoon of same day of vaccination at approximately 4:30 pm she started to feel severe pain in her right arm, back and back of her head. The pain was so severe that she had to sit up in chair that night. She could not put any pressure on the areas. The pain was severe for 48 hour and she could not lift her arm for almost 7 days. The patient took Tylenol and used a heating pad. The patient had a grand mal seizure and was transported to the hospital. She was there for 48 hours and treated with Keppra IV therapy. In December 2018, she took 500 mg Keppra BID and was restricted from driving for 6 months. T the reporting time, the pain had resolved and shoulder clicks. On the day before the reporting day, first time she could make a complete sentence after the seizure. The flu brand name was unknown. Emergency room visit required. The reporter gave consent to follow up. The vaccination date of SHINGRIX was given in Argus core was 6th December 2018 same as GSK-receipt date, so it  was captured as 17th October 2018 from the narrative.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: The initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 06Dec2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. This consumer reported 10 similar reports. This is the 1st of 10 reports. A patient of unspecified age and gender received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at the clinic at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was exposed to a temporary low temperature excursion that reached 33.5 degrees Fahrenheit for 11 hours. The vaccine did not freeze during the low temperature excursion, but it was administered to the patient. Information on the lot/batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018512578 same reporter/drug/events, different patients;US-PFIZER INC-2018512579 same reporter/drug/events, different patients; US-PFIZER INC-2018512580 same reporter/drug/events, different patients; US-PFIZER INC-2018512581 same reporter/drug/events, different patients; US-PFIZER INC-2018512582 same reporter/drug/events, different patients; US-PFIZER INC-2018512583 same reporter/drug/events, different patients; US-PFIZER INC-2018512584 same reporter/drug/events, different patients; US-PFIZER INC-2018512585 same reporter/drug/events, different patients; US-PFIZER INC-2018512586 same reporter/drug/events, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (Lot number: T78676, Expiration date: Feb2020), via an unspecified route of administration on 01Dec (year unspecified) as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 01Dec and came into the pharmacy on 06Dec with a reaction of just redness and itchy. The area extended from the shoulder to about 2/3 of the way down the arm. No pain or swelling, just redness and itchiness. The outcome of the events was not recovered.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Injection was given at 8 pm. Six hours later he woke with itching and hives all over his hips and abdomen. He had no respiratory problems. Hives resolved with ZYRTEC and ZANTAC.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction, Swelling
Clinical narrative: Patient is having a local reaction to the PROQUAD vaccine, this is no uncommon and should resolve on its own in a few days. Cool compresses to dec swelling, pain meds as needed. May inc slightly over weekend, if significant increase if redness/ swelling/ pain or fever develops, call/ return visit. Patient Instructions: Patient is having a local reaction to the PROQUAD vaccine. This is not uncommon and should resolve on its own in a few days. Cool compresses to dec swelling. Pain meds as needed. May inc slightly over weekend,  if significant increase if redness/ swelling/ pain or fever develops, call/ return visit.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Infant was found unresponsive in his home on 12/1/2018. Taken to the hospital and after extensive resuscitation efforts, was pronounced dead.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of entire upper arm and extending slightly below elbow. Began the morning of 12/13/18 upon awakening. Advised cold compress, antihistamine oral and topical OTC corticosteroid.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cellulitis, Chills, Dehydration, Dizziness
Clinical narrative: 6 hours after injection started to feel, chills, fever, nausea, intermittent headaches. Arm became red, swollen, painful at site of injection. These symptoms continued until 12/4/2018 she became dizzy when walking. Continued to have fatigue, weakness, headaches. Was diagnosed with cellulitis and started on cephalexin 500 mg BID. Continued to have these symptoms through 12/6/2018 and was given IV fluids for dehydration. Arm redness and swelling improved on 12/06/2018. Started to feel better but continued with some fatigue and intermittent headaches but improving as of 12/12/2018.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 6 hours after injection started to feel, chills, fever, nausea, intermittent headaches. Arm became red, swollen, painful at site of injection. These symptoms continued until 12/4/2018 she became dizzy when walking. Continued to have fatigue, weakness, headaches. Was diagnosed with cellulitis and started on cephalexin 500 mg BID. Continued to have these symptoms through 12/6/2018 and was given IV fluids for dehydration. Arm redness and swelling improved on 12/06/2018. Started to feel better but continued with some fatigue and intermittent headaches but improving as of 12/12/2018.