chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient, approximately 75 years old, was administered the ZOSTAVAX by a healthcare provider at a medical clinic (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a medical clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient had 1st dose of vaccine and experienced shingles. The patient had been trying to found a location that had the SHINGRIX vaccine for 2nd dose and had not been successful.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, injection site pain, large arm swelling and injection site lump. On an unknown date, the outcome of the pain in arm, injection site pain, large arm swelling and injection site lump were unknown. It was unknown if the reporter considered the pain in arm, injection site pain, large arm swelling and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter had 5 to 6 patient with reaction after SHINGRIX this included bad arm pain, large arm swelling, knots on arm at injection site.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, 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 patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain at injection site but was not extreme. The patient might have felt a little pain but was not as noticeable. The patient was concerned about how long the event would remain. The patient denied to receive a call back and would contact the provider. The patient was disappointed as the answer was not provided by GlaxoSmithKline. For tolerance to next dose, refer case US2019AMR043108.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain at injection site but was not extreme. The patient might have felt a little pain but was not as noticeable. The patient was concerned about how long the event would remain. The patient denied to receive a call back and would contact the provider. The patient was disappointed as the answer was not provided by GlaxoSmithKline. For tolerance to next dose, refer case US2019AMR043108.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, 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 patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on an unknown date, refer case number US2019GSK046524). On 5th March 2019, the patient received the 2nd dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2019, the patient experienced tiredness, general body pain and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, tiredness, general body pain and fever were unknown. It was unknown if the reporter considered the injection site pain, tiredness, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In late afternoon, the patient received the dose of SHINGRIX. The patient again experienced pain at injection site but was not extreme. On the day of reporting, the patient was tired and achy pretty much all over with light fever. The patient was concerned about how long the events will remain. The patient denied to receive a call back and would contact the provider. The patient was disappointed as the answer was not provided by GlaxoSmithKline.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on an unknown date, refer case number US2019GSK046524). On 5th March 2019, the patient received the 2nd dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 6th March 2019, the patient experienced tiredness, general body pain and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, tiredness, general body pain and fever were unknown. It was unknown if the reporter considered the injection site pain, tiredness, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In late afternoon, the patient received the dose of SHINGRIX. The patient again experienced pain at injection site but was not extreme. On the day of reporting, the patient was tired and achy pretty much all over with light fever. The patient was concerned about how long the events will remain. The patient denied to receive a call back and would contact the provider. The patient was disappointed as the answer was not provided by GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dry mouth 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 dry mouth and taste bitter. On an unknown date, the outcome of the dry mouth and taste bitter were unknown. It was unknown if the reporter considered the dry mouth and taste bitter to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she was experiencing mouth dryness and mouth bitterness after receiving the SHINGRIX vaccine. The caller did not want to provide any additional information, therefore limited information was available.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist and consumer (patient) reported a 49-year-old female patient received PREVNAR 13, (suspension for injection, lot number: X39675, expiration date: Oct2020) intramuscular in left upper arm on 25Feb2019 at 0.5 ml, single for immunization. Medical history included allergy to corn. There were no concomitant medications. On 25Feb2019, the reporter queried if there is a corn in PREVNAR 13. The patient is allergic to corn and had a reaction. The patient developed redness and a lump at the injection site within an hour of receiving PREVNAR 13. The patient has not recovered from redness and a lump at the injection site. The reporter assessed reaction to PREVNAR 13 as related.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 70-year-old female patient received PREVNAR 13, intramuscular on 01Oct2018 at 0.5 ml, single dose for pneumococcal pneumonia prevention. Medical history and concomitant medications were reported as none. On 01Oct2018 the patient experienced swollen arm and arm red in color. The reporter was not sure if the patient received any treatment for the adverse events. The outcome of events was unknown. Information on the batch number has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: PATIENT REPORTED PAIN AT THE INJECTION SITE. MUSCLE SORENESS IN THE LEFT ARM. PATIENT STATES IT WAS HARD TO MOVE ARM ACROSS CHEST TO RIGHT SHOULDER OR LIFT ARM OVER HER HEAD. PATIENT STATES IT LASTED ABOUT 2 AND A HALF MONTHS. SHE DID REPORT IT TO HER DOCTOR BUT HE HAD NO REMARKS ABOUT IT.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare professional (Nurse) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 08-MAR-2019, the patient was vaccinated with improperly stored PNEUMOVAX 23 syringes (lot # R021048, expiry date: 14-APR-2020) for prophylaxis (product storage error). No adverse effect was reported. The vaccine was stored above 8 degree centigrade (10.0 degree centigrade) for 35 minutes, there was no previous temperature excursion. The outcome of product storage error and no adverse event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a male 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 ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reviewed the side effects associated with SHINGRIX. The patient was trying to find out if the ringing in his ears was a potential side effect. The reporter had talked with his physician and he did not have much more information than what's on the website. This case has been linked with US2019AMR041011, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced arm pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter stated that 1 in 10 patients he gives SHINGRIX and has severe arm pain. The reporter did not agree to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 4th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician on the line stating the patient who got SHINGRIX the day before reporting and had a 101 degree fahrenheit fever. The lot number or expiry date was unknown. No further information captured.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain, 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 female patient who received SHINGRIX for prophylaxis. On 2nd March 2019, the patient received the 1st dose of SHINGRIX. On 2nd March 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased and sleeplessness. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased and sleeplessness were recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and sleeplessness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller reported she got SHINGRIX on Saturday. After a few hours her arm started throbbing and she could not move it. The pain kept her up all Saturday night and she could not move her arm on Sunday. The patient can now move her arm again, but it still throbs. The pain was in her whole upper arm, not just at the injection site. The caller declined to provide any information other than her first name.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Appetite disorder, Decreased activity, Pyrexia
Clinical narrative: Fever of 99 degrees F began 3/13/2019. Fever increase to 100.5 degrees F on 3/14/2019. Patient developed change in appetite and activity.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Flu like symptoms and red area at injection site that gradually got redder and larger.Main area was approx 4x5 inches and below main area was slightly smaller.
Sex: U
Vaccine: HIBV, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patient. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, unspecified patients were inadvertently administered doses of VARIVAX (lot#: R018933, Expiration Date: 02-JUL-2020) and PROQUAD (lot#: R022564, Expiration Date: 04-FEB-2020; lot#: R022573, Expiration Date: 04-FEB-2020) for prophylaxis. All lots of VARIVAX and PROQUAD were reconstituted with properly stored sterile diluent. The administered doses experienced a temperature excursion at 32.9F for 13 hours. Previous excursions were reported as from 15F to 46F (16F) for 1 hour. The temperature excursions were detected by a data logger (Product storage error). Other suspect therapies included PEDVAXHIB (lot#: R014262, Expiration Date: 26-MAR-2021; lot#:R013572, expiration date: 21-Mar-2021). The administered doses experienced a temperature excursion at 48.4F for 15 minutes. Previous excursions were reported as total time and highest temperature above 47F/9 degree for 9 hours. No adverse effect reported. This is a non-valid case due to not have identifiable patient.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included systemic lupus erythematosus (diagnosed about 2 years before the reporting date). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. Now, the patient had ringing in her ears. Her physician did not know if it was connected or not, but this was the only recent change. The patient was generally in good health. This case has been linked with US2019AMR040982, reported by same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Hepatomegaly, Splenomegaly, Ultrasound abdomen abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 65-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced abdominal pain, spleen enlarged and liver enlargement. On an unknown date, the outcome of the abdominal pain, spleen enlarged and liver enlargement were unknown. It was unknown if the reporter considered the abdominal pain, spleen enlarged and liver enlargement to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX in August or September 2018. On 5th December 2018 ultrasound abdomen was performed and it was note that liver was mildly enlarged and spleen was enlarged. The patient also experienced abdominal pain after 1st dose.
Sex: M
Vaccine: MENB
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of red rash in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown. It was unknown if the reporter considered the red rash to be related to BEXSERO. Additional details were provided as follows: The patient had red rash all over the body including face. The reporter agreed to follow up from GSK. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vesicular rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX and presented with a rash that appeared to look like shingles outbreak (not confirmed). The reporter agreed to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Cataract operation, Herpes zoster, Ophthalmic herpes zoster, Product supply issue, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and product supply issue. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles and product supply issue were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles 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 captured as adult as per vaccine indication. The patient received SHINGRIX just over 6 months before the date of reporting. As the providers had trouble getting more of the vaccine the patient's insurance could not indeed cover the vaccine. The patient could not find the vaccine and wanted it soon. The patient experienced shingles that attacked the upper right quadrant of head (including the right eye) at the same time the patient underwent cataract surgery on the right eye and it almost blinded. The patient very much wanted to receive the 2nd dose of SHINGRIX and realized it was the same as the initial one. The patient asked for help and made a habit of calling everywhere on a regular basis and had done all one could do.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Myalgia, Oral herpes, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose, refer case US2019042406). On 4th March 2019, the patient received the 2nd dose of SHINGRIX. On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities. On 5th March 2019, the patient experienced fever, feeling unwell, swelling arm and muscle pain. On 7th March 2019, the patient experienced sores mouth and fever blister. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, erythema of extremities, feeling unwell, swelling arm and muscle pain were unknown and the outcome of the sores mouth and fever blister were not recovered/not resolved. It was unknown if the reporter considered the fever, erythema of extremities, feeling unwell, swelling arm, muscle pain, sores mouth and fever blister to be related to SHINGRIX. Additional details were provided as follows: The patient's arm was red the night after the second dose of SHINGRIX. The next day the patient felt ill. One day after receiving SHINGRIX, the patient experienced fever, feeling unwell, swelling and muscle pain. After 3 days the patient experienced mouth sores and fever blister.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Stomatitis, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose, refer case US2019042406). On 4th March 2019, the patient received the 2nd dose of SHINGRIX. On 4th March 2019, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities. On 5th March 2019, the patient experienced fever, feeling unwell, swelling arm and muscle pain. On 7th March 2019, the patient experienced sores mouth and fever blister. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, erythema of extremities, feeling unwell, swelling arm and muscle pain were unknown and the outcome of the sores mouth and fever blister were not recovered/not resolved. It was unknown if the reporter considered the fever, erythema of extremities, feeling unwell, swelling arm, muscle pain, sores mouth and fever blister to be related to SHINGRIX. Additional details were provided as follows: The patient's arm was red the night after the second dose of SHINGRIX. The next day the patient felt ill. One day after receiving SHINGRIX, the patient experienced fever, feeling unwell, swelling and muscle pain. After 3 days the patient experienced mouth sores and fever blister.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site pain, Myalgia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on 12th September 2018, refer case US2019040249). On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 10th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and following day after shot, she experienced a sore left arm and muscle aches feeling like the flu. The muscle aches lasted a day. The sore arm lasted 4-5 days. There was a golf ball sized raised red spot that was swollen and sore to touch. The golf ball size circle was describing the red area not the swelling. The reporter gave consented to follow up. This case linked with US2019040263 and US2019040249, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on 12th September 2018, refer case US2019040249). On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 10th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and following day after shot, she experienced a sore left arm and muscle aches feeling like the flu. The muscle aches lasted a day. The sore arm lasted 4-5 days. There was a golf ball sized raised red spot that was swollen and sore to touch. The golf ball size circle was describing the red area not the swelling. The reporter gave consented to follow up. This case linked with US2019040263 and US2019040249, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site pain, Myalgia, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and following day after shot, she experienced a sore left arm and muscle aches feeling like the flu. The muscle aches lasted a day. The sore arm lasted 4-5 days. There was a golf ball sized raised red spot that was swollen and sore to touch.The golf ball size circle was describing the red area not the swelling. The reporter gave consented to follow up. This case linked with US2019040263 and US2019GSK046341, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, erythema, swelling, tenderness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and following day after shot, she experienced a sore left arm and muscle aches feeling like the flu. The muscle aches lasted a day. The sore arm lasted 4-5 days. There was a golf ball sized raised red spot that was swollen and sore to touch.The golf ball size circle was describing the red area not the swelling. The reporter gave consented to follow up. This case linked with US2019040263 and US2019GSK046341, reported by same reporter.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 79-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. Co-suspect products included Flu Vaccine (Name Unknown) for prophylaxis. On 6th September 2018, the patient received SHINGRIX. On an unknown date, the patient received Flu Vaccine (Name Unknown). On 6th September 2018, less than a day after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional case details were reported as follows: The patient also received high flu vaccine manufactured by Sanofi at time of SHINGRIX administration. The patient broke out in a rash across torso after receiving SHINGRIX vaccine. It was unknown if the reporter considered the rash to be related to Flu Vaccine (Name Unknown).
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The batch number was not reported. The medical assistant called in to report that the patient experienced flu-like symptoms from SHINGRIX. The health care professional questioned that should the patient receive the 2nd dose and if there was any information on if the flu-like symptoms would subside or continue. The health care professional did not have specific patient identifiers.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Oral herpes, Peripheral swelling, Pyrexia, Stomatitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 30th December 2018, 2 days after receiving SHINGRIX, the patient experienced fever, swelling arm and muscle pain. On 31st December 2018, the patient experienced sores mouth and fever blister. On an unknown date, the outcome of the fever, swelling arm, muscle pain, sores mouth and fever blister were recovered/resolved. It was unknown if the reporter considered the fever, swelling arm, muscle pain, sores mouth and fever blister to be related to SHINGRIX. Additional detail were provided as follows: The patient had fever, arm swelling, muscle aches after a couple days and mouth sores and fever blister about 3 days after. For tolerance to 2nd dose, refer case US2019GSK044633.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a unspecified number of patient's who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 8 hrs after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms, general body pain, fever and lethargy. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, general body pain, fever and lethargy were recovered/resolved. It was unknown if the reporter considered the pain in arm, influenza-like symptoms, general body pain, fever and lethargy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that in general, younger patients under 60 or in their 60s and with healthy immune system experiencing a sore arm about 8 hours after receiving SHINGRIX and then for about 24 hours they feel like they get the flu, flu- like symptoms including body aches, fever and lethargy then about 24 hours after their injection the symptoms all resolved. The reporter consented to follow up.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pustule, Rash erythematous
Clinical narrative: Patient reported red bumps on his torso (chest, stomach and back) 8 days after receiving smallpox vaccine. He reported no constitutional symptoms. His vaccine site showed a dime-sized white pustule, surrounded by erythema, less than 3 inches. Photos were viewed showing pustular-type lesions on an erythematous base. The on-call physician spoke with the patient and viewed the photos and determined this was mostly likely Non-viral Pustulosis after smallpox vaccination. At follow up with the patient 3 days later (day 11 post-vaccine), he reported the bumps had diminished in size and color and were not itchy or bothersome.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site, no treatment needed.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Dtap given to this patient. Patient should have received Tdap. Reported.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Vaccination site pain
Clinical narrative: Stomach upset x 3 days, arm pain at site of vaccinations-intense for 3 days, still sore 2 months later.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: CHILLS, FLU-LIKE SYMPTOMS.
Age: 1.58
Sex: F
Vaccine: PNC13
Symptoms: Allergy test, Amino acid level, Blood test, Cough, Emotional distress
Clinical narrative: At night of the vaccination day my daughter woke up screaming as if on fire and we could not calm her down. It happened 4 times that night. Day later she got sick with fever and cough. I called her pediatrician and was dismissed as a normal reaction and probably she was getting sick already.
Age: 1.58
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pyrexia, Screaming, Thyroid function test
Clinical narrative: At night of the vaccination day my daughter woke up screaming as if on fire and we could not calm her down. It happened 4 times that night. Day later she got sick with fever and cough. I called her pediatrician and was dismissed as a normal reaction and probably she was getting sick already.
Age: 80.0
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Headache, Musculoskeletal pain, Somnolence
Clinical narrative: Started with little pain in shoulder and became extreme pain after that, it is still very painful after 10 days also intermittent headache on the same side as injection. Ibuprofen 800 did not get rid of the pain, but took a little of the edge off it after about the 5th day. Took a muscle relaxer which made me dizzy and very sleepy. Only time I have no pain, is if I lay on the side of the injection so I have spend most of the days in bed.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Pyrexia, Tremor
Clinical narrative: Severe trembling, fever, cold, chills.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Asthenia, Headache, Pain, Pyrexia
Clinical narrative: 104 degree fever, headache, body aches, lack of energy.
Age: 1.17
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Cyanosis, Febrile convulsion, Pyrexia
Clinical narrative: High fever with febrile seizures 9 days after MMR. Walked in on a blue baby on day 10.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Hypersomnia, Mobility decreased, Pain in extremity
Clinical narrative: 1) Sore arm worsened over 24 hours. Pain extended from shoulder to wrist and was severe enough to prevent me from lifting my arm for first 24 hours. This is extremely unusual for me. I have never felt any discomfort that lasted more than an hour or two after any injection and I keep all of my immunizations up to date. Fatigue. I usually sleep 7 hours a night.  Last night I slept for 10 hours and I still feel very tired.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Herpes zoster, Meningitis
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 medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, for routine health maintenance and for the prevention of shingles. After receiving the vaccination, the patient suffered headaches, fatigue, generalized pain throughout her body and weakness. These symptoms intensified over time and culminated in her being hospitalized and ultimately diagnosed with meningitis. Thereafter, the patient suffered and continues to suffer from outbreaks of zoster rashes on her stomach and chest area, sudden sharp pains, headaches, fatigue and weakness. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
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 medications were not provided. The patient was inoculated with ZOSTAVAX vaccine, for routine health maintenance and for the prevention of shingles. After receiving the vaccination, the patient suffered headaches, fatigue, generalized pain throughout her body and weakness. These symptoms intensified over time and culminated in her being hospitalized and ultimately diagnosed with meningitis. Thereafter, the patient suffered and continues to suffer from outbreaks of zoster rashes on her stomach and chest area, sudden sharp pains, headaches, fatigue and weakness. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. Upon internal review meningitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 4th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, chills, general body pain and weakness. On an unknown date, the outcome of the fever, chills, general body pain and weakness were unknown. It was unknown if the reporter considered the fever, chills, general body pain and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, chills and body aches after receiving a dose of SHINGRIX. The patient was also feeling little bit weak. The patient was concerned if she was contagious or not.
Sex: M
Vaccine: TDAP
Symptoms: Eczema, Rash generalised, Rash pustular, Secretion discharge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eczema in a male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a day after receiving DTPa vaccine, the patient experienced eczema and pustular rash. On an unknown date, the outcome of the eczema and pustular rash were not recovered/not resolved. It was unknown if the reporter considered the eczema and pustular rash to be related to DTPa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient had his DTap shot and the following day his body broke out head to toe in an oozing rash. Eventually, the physician stated it was just eczema but it was severe eczema and year later had not gone away. The patient had pictures of the rash. It happened less than 24 hours after this shot.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced fever and malaise. On an unknown date, the outcome of the fever and malaise were unknown. It was unknown if the reporter considered the fever and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that many patients experienced fever and malaise after receiving SHINGRIX.
Age: 39.0
Sex: U
Vaccine: MENB
Symptoms: Asthenia, Bedridden, Headache, Migraine, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of migraine in a 39-year-old patient who received BEXSERO for prophylaxis. The patient's past medical history included splenectomy (spleen was removed in 1997 at the age of 17 years). On 14th February 2019, the patient received the 2nd dose of BEXSERO. On 17th February 2019, 3 days after receiving BEXSERO, the patient experienced migraine, nausea, bedridden and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the migraine, nausea and bedridden were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the migraine, nausea, bedridden and headache to be related to BEXSERO. Additional details were provided as follows: On 17th February 2019, by the evening the patient experienced migraine. The patient never experienced migraine previously. The patient was nauseous and bedridden for half the following day and had a constant, debilitating headache that never seemed to go away. The patient reported that, TYLENOL helps but cannot eat them like candy for the rest of life. The patient asked how long would these side effect last and what else can be told about the patient's condition.