chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: itching; blisters; hives; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th July 2019, 2 days after receiving Shingrix, the patient experienced injection site itching, injection site blisters and injection site hives. On an unknown date, the outcome of the injection site itching, injection site blisters and injection site hives were unknown.   It was unknown if the reporter considered the injection site itching, injection site blisters and injection site hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient began to notice itching, blisters and hives at the injection site a couple of days afterwards. The events had extended further beyond the injection site also.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Injection site vesicles
Clinical narrative: itching; blisters; hives; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 10th July 2019, 2 days after receiving Shingrix, the patient experienced injection site itching, injection site blisters and injection site hives. On an unknown date, the outcome of the injection site itching, injection site blisters and injection site hives were unknown.   It was unknown if the reporter considered the injection site itching, injection site blisters and injection site hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient began to notice itching, blisters and hives at the injection site a couple of days afterwards. The events had extended further beyond the injection site also.
Age: 56.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: large tender lump under armpit; large tender lump under armpit; Injection site reation; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site reaction. On 22nd July 2019, the patient experienced axillary lump and tenderness. On an unknown date, the outcome of the axillary lump, tenderness and injection site reaction were unknown.   It was unknown if the reporter considered the axillary lump, tenderness and injection site reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received Shingrix last Friday from the reporting date. At the time of reporting, the patient stated that he/she had the injection site reactions but the night before the reporting date, 3 days after Shingrix administration, discovered a large tender lump in armpit on the same side as injection. The patient was advised to visit to an internist or an infectious disease specialist, an urgent care provider would likely refer the patient to a primary care physician.
Age: 56.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: large tender lump under armpit; large tender lump under armpit; Injection site reation; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site reaction. On 22nd July 2019, the patient experienced axillary lump and tenderness. On an unknown date, the outcome of the axillary lump, tenderness and injection site reaction were unknown.   It was unknown if the reporter considered the axillary lump, tenderness and injection site reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received Shingrix last Friday from the reporting date. At the time of reporting, the patient stated that he/she had the injection site reactions but the night before the reporting date, 3 days after Shingrix administration, discovered a large tender lump in armpit on the same side as injection. The patient was advised to visit to an internist or an infectious disease specialist, an urgent care provider would likely refer the patient to a primary care physician.
Age: 56.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Axillary mass, Injection site reaction, Tenderness
Clinical narrative: large tender lump under armpit; large tender lump under armpit; Injection site reation; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site reaction. On 22nd July 2019, the patient experienced axillary lump and tenderness. On an unknown date, the outcome of the axillary lump, tenderness and injection site reaction were unknown.   It was unknown if the reporter considered the axillary lump, tenderness and injection site reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received Shingrix last Friday from the reporting date. At the time of reporting, the patient stated that he/she had the injection site reactions but the night before the reporting date, 3 days after Shingrix administration, discovered a large tender lump in armpit on the same side as injection. The patient was advised to visit to an internist or an infectious disease specialist, an urgent care provider would likely refer the patient to a primary care physician.
Age: 80.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Pain, Tremor
Clinical narrative: severe pain and shaking hours after vaccines
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Pt reported arm soreness immediately that has continued for 4 months past the vaccination.  It only hurts if she tries to raise her arm above her shoulder or reach behind her.  She is fine when her arm is down, but in pain when she raises it.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Limb discomfort, Muscle tightness
Clinical narrative: Nine and a half hours after injection I started to feel fatigued with a mild sense of tight back muscles.  I began to feel slightly chilled, thought about putting on a sweater, even though it was 76 degrees in the house.  Within an hour I was so tired I didn't think I could get off the couch.  I went to bed and my right arm (injection site) began to ache and feel very heavy.  As it progressed the feeling went all the way to my right thumb.  This was significant achy pain.  Not throbbing, but heavy and achy.  Hurt a lot.  I took two Advil at about 13 hours after injection when it was not subsiding and fell asleep trying not to move my arm.  All achy sensation or fatigue was gone by the morning, approximately 22 hours after injection.   I definitely feel that if the symptoms continued I would not be able to conduct my daily activities the next day.  This was my second of 2 shots.  I did not have any side effects at all with my first of 2 shots.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Nine and a half hours after injection I started to feel fatigued with a mild sense of tight back muscles.  I began to feel slightly chilled, thought about putting on a sweater, even though it was 76 degrees in the house.  Within an hour I was so tired I didn't think I could get off the couch.  I went to bed and my right arm (injection site) began to ache and feel very heavy.  As it progressed the feeling went all the way to my right thumb.  This was significant achy pain.  Not throbbing, but heavy and achy.  Hurt a lot.  I took two Advil at about 13 hours after injection when it was not subsiding and fell asleep trying not to move my arm.  All achy sensation or fatigue was gone by the morning, approximately 22 hours after injection.   I definitely feel that if the symptoms continued I would not be able to conduct my daily activities the next day.  This was my second of 2 shots.  I did not have any side effects at all with my first of 2 shots.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, chills, body and muscle pain
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear swelling, Eye swelling, Lymphadenopathy, Pharyngeal swelling, Swelling face
Clinical narrative: Significant swelling of lymph node in clavicle  Swelling of face, ear, left eye and throat.
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Peripheral swelling, Rash
Clinical narrative: rash on bottom of feet; swollen hands; blanching of legs; Information has been received from a nurse referring to a 22 years old female patient who was not pregnant. The patient's concomitant medications included birth control drugs. She had no medical history. The patient was allergic to acyclovir and sulfa.  On 08-JUL-2019, the patient received the second dose  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: R011630; expiration date: 12-DEC-2020; strength was not reported), intramuscularly for human papillomavirus (HPV) prevention. On 09-JUL-2019, the nurse reported that the patient experienced rash on bottom of feet, swollen hands and blanching of legs after receiving the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient called the office to seek medical attention. There was no treatment given to the events. Lab diagnostics or studies were not performed. The outcome of the events was recovering. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown.
Age: 29.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; unspecified 29 year old patient inadvertently received a dose of PROQUAD; Information has been received from a pharmacy intern referring to a 29 year old patient of unknown gender. Concomitant therapy included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided.   On an unspecified date in May 2019, the patient inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 dosage form; strength, frequency, route, batch/lot number and expiration date were unknown) for prophylaxis at an unspecified location (Adult use of a child product). No adverse effects were reported.
Sex: U
Vaccine: HEP, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Was vaccinated with ENGERIX-B instead ofGARDASIL 9.; This spontaneous report was received from an administrator and  refers to a patient of unknown age and gender. No information was given regarding the patient-s concurrent conditions, concomitant medications or medical history.     On 23-JUL-2019, the patient was vaccinated with  hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) for prophylaxis instead of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number and expiration date were not reported). However, no adverse effects were reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; The primary reporter reported that 1 patient was administered a dose of improperly stored VARlVAX; This spontaneous report was received from a licensed practical nurse, regarding a 5-year-old patient. The patient's concomitant medication included a well-stored sterile diluent (DILUENT MRK INJ). The patient's medical history, concurrent conditions and drug reactions or allergies were not provided.        On 25-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # R018139 with expiration date 25-JUN-2020, for prophylaxis (dose, frequency, route and anatomical location were not provided). The administered doses of vaccines underwent a temperature excursion between -9°C to 8°C (8°C) during 16 hours and 7 minutes, as recorded by a data logger. There were not previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product leakage
Clinical narrative: No adverse effects; She believes a drop or two came out of the syringe and full dose was not received; She believes a drop or two came out of the syringe and full dose was not received; This spontaneous report was received from a patient of unknown age and gender, reporting on theirself. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 29-JUL-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 PFU for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported).   On 29-JUL-2019, during the zoster vaccine live (ZOSTAVAX) administration, the patient stated that she believed that a drop or two came out of the syringe (product leakage) and full dose was not received (incorrect dose administered). No adverse effects were reported.   At the time of reporting, the outcome of product leakage was unknown.   The causal relationship between the vaccination with zoster vaccine live (ZOSTAVAX) and product leakage was not provided by the reporter.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported in the patient; A patient currently at the pharmacy received a dose of unknown hepatitis A vaccine 3 years ago and is currently at the pharmacy to get her second dose today.; This spontaneous report was received from a pharmacist, concerning to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant therapies were not reported.  In approximately July 2016 (reported as 3 years ago), the patient went to the pharmacy, and was vaccinated with the first dose of hepatitis a vaccine, inactivated (manufacturer unknown) and on 30-JUL-2019 (reported as today), the patient went to the pharmacy to get her second dose of hepatitis a vaccine, inactivated (manufacturer unknown) both vaccines were administered as prophylaxis (strengths, formulations, doses, and anatomical locations vaccination were not reported;  expiration dates and lot numbers were unknown by the reported). No adverse effects were reported.
Age: 13.0
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 13-year-old patient was administered the first dose of PROQUAD and VARIVAX series; No adverse effects; 13-year-old patient was administered the first dose of PROQUAD and VARIVAX series; This spontaneous report was received from a registered nurse refers to a 13-year-old patient of unknown gender and race. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medication.   On 30-JUL-2019, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration) (product administered to patient of inappropriate age); both vaccines were reconstituted with a sterile diluent all therapies were for prophylaxis (strength, dosage schedule, route of administration, lot number and expiration date were not reported). No adverse effect reported and there was no product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; On 30-JUL-2019 one patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.   On 30-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S004091, expiration date; 11-FEB-2021, route, dose and anatomical location were not reported) for prophylaxis. The sterile diluent (lot # N021583, expiration date; 18-NOV-2019) used to reconstitute the vaccine a was properly stored. The temperature excursion was for a time frame of 12 hours, from 15 to 46 degrees Fahrenheit and it was found by the digital data logger. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was possibly administered a expired dose of PROQUAD.; No adverse effects; This spontaneous report was received from a health care worker and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were unknown.  On 24-JAN-2019, the patient was vaccinated with a possibly expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # N020615 and expiration date 22-JAN-2019, for prophylaxis (dose, strength, frequency and route of administration were not provided).         The patient experienced no adverse events.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: the reporter stated that the patient "received VARIVAX about two months ago, but was unaware that she was pregnanct at the time"; This spontaneous prospective pregnancy report was received from the patient's friend and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On an unknown date, approximately in May 2019, reported as "about two months ago", the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis (reported as "it was recommended"), however the patient was unaware that she was pregnant at the time of vaccination. The patient's last menstrual period (LMP), and the estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending at the time of the report.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling  and pain at site of injection.  Area of redness was 4 inches and was warm to the touch
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effects were reported; Per the patient she received the MMRII via the incorrect route. Instead of receiving the vaccination subcutaneosly, she received the vaccination intramuscularly; This spontaneous report was received from a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 31-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), one vaccination intramuscularly instead of subcutaneously (dose, anatomical location, lot # and expiration date were not provided), for prophylaxis. No adverse event was reported.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Headache, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: About 2-3 minutes after vaccination the child complained of headache and became pale and diaphoretic.  She was sitting in chair with a nurse beside her.  She did pass out for about 10 seconds.  No injury.  Cool cloths applied to forehead and neck.  Feet elevated.  Mother was present along with 2 nurses.  Patient was also given a coke to drink once she was alert.  Patient was monitored for 20 minutes and released home in stable condition with her mother.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; The patient was inadvertenly administerted a dose of GARDASIL 9 that had been improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  There was no information about the patient's concomitant therapies or medical history provided.  On 22-JUL-2019, the patient received a dose of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose number, route of administration, anatomical location were not reported) (lot #: 1586752, expiration date: 16-FEB-2021) for prophylaxis (product storage error). The temperature excursion was 50.2 degrees Fahrenheit for a total time frame of 48 minutes. There was a previous temperature excursion, above 47 degrees Fahrenheit or 9 degrees Celsius (51.6 degrees Fahrenheit) for a total time frame of 3 hours and 55 minutes. The call was due to a data logger. No adverse effects were reported.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Cardiac discomfort, Electrocardiogram, Epicondylitis
Clinical narrative: My left arm, the one in which I had the Shingrix vaccine a week earlier, was aching when I woke up on July 26. I worked out that morning and felt no change. As the day went on, my arm was hurting more and my heart felt like a softball in my chest. A pharmacist gave me baby aspiring about 7:30 PM. When that didn't help, I called my cardiologist and was told to go to ER. I was kept overnight in Hospital which diagnosed tennis elbow. However, on July 29, my left arm had broken out into reddish blisters and holding light objects in my left hand was painful. Orthopedist at first thought I had a pinched nerve in my left armpit or shingles, but now thinks that it's surely shingles.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, X-ray
Clinical narrative: My left arm, the one in which I had the Shingrix vaccine a week earlier, was aching when I woke up on July 26. I worked out that morning and felt no change. As the day went on, my arm was hurting more and my heart felt like a softball in my chest. A pharmacist gave me baby aspiring about 7:30 PM. When that didn't help, I called my cardiologist and was told to go to ER. I was kept overnight in Hospital which diagnosed tennis elbow. However, on July 29, my left arm had broken out into reddish blisters and holding light objects in my left hand was painful. Orthopedist at first thought I had a pinched nerve in my left armpit or shingles, but now thinks that it's surely shingles.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Peripheral swelling
Clinical narrative: Swelling on arm; Redness on arm; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date 5th July 2021) for prophylaxis.   On 27th April 2019, the patient received Shingrix (subcutaneous). On 27th April 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, the patient's husband was a doctor and was adamant that, the patient received dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter was from different pharmacy location in same town, who was notified of patient's events. The reporter was familiar with pharmacist who signed off on vaccination and believes that pharmacist knew what he was doing. This case was 1 of the 2 linked case. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovered or resolved with sequel).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Migraine, Vomiting
Clinical narrative: chills, headache & migraine, achy joints, vomit  Note that events were correlated in time, but not established to be caused by vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; got sick; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure, shingles and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had completed Shingrix protocol. The patient did not understand how a vaccine like this was ever approved by the Food and drug administration (FDA). The patient would expect therapies for cancer, human immunodeficiency virus (HIV) or other lifethreatening illnesses to have the effects that this vaccine. The patient think would have rather gotten the shingles. On top of that, the clinicals the patient researched indicate that it only has a full efficacy for 4 years. The patient would make my experience known to the FDA. Unfortunately they did not respond to patient calls. If they have any compassion toward the users this therapy targets, they will put their scientists to work on developing a decent vaccine that is not intended to make one sick in order to avoid getting sick with shingles. This case was considered as suspected vaccination failure as the details regarding vaccination schedule and time to onset for the event was unknown at the time of reporting.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Rash, Viral rash
Clinical narrative: Patient developed an non-pruritic rash on her face, then appeared on her upper and lower extremities. She has a low grade fever that started on 7/31/19, it is improving and thought to be viral exantham.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site swelling; Injection site redness; Fever; Injection site soreness; This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received Herpes zoster (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 swelling, injection site erythema, fever and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, fever and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee on behalf of her aunt. The age at vaccination was not reported.  It was reported that when the patient got the Shingrix vaccine she had the injection site swell and turn red for several days after the shot. The patient also ran a fever and the injection site was sore to the touch for a number of days afterwards. The patient said that none of her friends who also got the vaccine had the same reaction. She said they were both listed as side effects (unknown which two events) from the shots so she was not sure if she needed to report it or not so  erred on the side of caution and reported the incident. This case has been linked with the case US2019AMR134680, reported by same reporter for same patient (2nd dose).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Injection site swelling; Injection site redness; Fever; Injection site soreness; This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (received 1st dose on an unknown date, refer case US2019AMR134670).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, fever and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, fever and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee on behalf of her aunt. The age at vaccination was not reported. It was reported that when the patient got the Shingrix vaccine she had the injection site swell and turn red for several days after the shot. The patient also ran a fever and the injection site was sore to the touch for a number of days afterwards. The patient said that none of her friends who also got the vaccine had the same reaction. She said they were both listed as side effects (unknown which two events) from the shots so she was not sure if she needed to report it or not so erred on the side of caution and reported the incident.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (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 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 information received were as follows: The age at vaccination was not reported. The patient stated that she experienced sore arm. The reporter consented to follow up. No further details were provided.  For tolerance to 2nd dose of Shingrix, refer case US2019134748.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Rash
Clinical narrative: fatigue; blistering around left arm, waistband; rash around left arm, waistband; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date unknown) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix. On 18th July 2019, less than a day after receiving Shingrix, the patient experienced fatigue, blister and rash. On 21st July 2019, the outcome of the blister and rash were recovered/resolved. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, blister and rash to be related to Shingrix.  Additional information received were as follows: The patient believes that the side effects were related to Shingrix. The patient experienced blistering and rash around left arm and waistband, which persisted for 2-3 days. The patient experienced fatigue on first day and still persisted on the day of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Swelling
Clinical narrative: pain; swelling; headache; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pain, swelling and headache. On an unknown date, the outcome of the pain, swelling and headache were unknown.   It was unknown if the reporter considered the pain, swelling and headache to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient wanted to know how long would patient expect to suffer from pain, swelling and headache. No additonal information could be obtained.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: soreness; headache; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were unknown.   It was unknown if the reporter considered the pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient wanted to know how long would the soreness and headache usually last.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever; aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 2nd dose of Shingrix. On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, fever and pain. On an unknown date, the outcome of the influenza-like symptoms, fever and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller stated that the day before the reporting date she received Shingrix and on the reporting date experienced flu like symptoms. The patient explained more of a fever of 101 degree F. and aches. The reporter declined completing the adverse event report. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rash; itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (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 rash and pruritus. On an unknown date, the outcome of the rash and pruritus were unknown.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The caller was from a pharmacy who had a question about Shingles vaccine. The patient received 1st dose of Shingrix and next day broke out with rash on neck and spots on arms and itchiness, the patient wanted to know if she should get 2nd dose of Shingrix. The reporter asked how effective would it be at 1 dose. The reporter filed adverse event with limited information.
Sex: F
Vaccine: MENB, MENB
Symptoms: Accidental underdose, Exposure via skin contact, Headache, Immunisation, Injection site cellulitis
Clinical narrative: respiratory infection; rash; headache; nausea; stiff neck; cellulitis at injection site; Vaccine Administered at Inappropriate Site; exposure via skin contact; overdose; This case was reported by a pharmacist via call center representative and described the occurrence of respiratory infection in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and the 2nd dose of Bexsero. On an unknown date, not applicable after receiving Bexsero and unknown after receiving Bexsero, the patient experienced respiratory infection (serious criteria GSK medically significant), injection site rash, headache, nausea, stiff neck, injection site cellulitis, intramuscular formulation administered by other route, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the respiratory infection, injection site rash, headache, nausea, stiff neck, injection site cellulitis, intramuscular formulation administered by other route, exposure via skin contact and accidental underdose were unknown.   It was unknown if the reporter considered the respiratory infection, injection site rash, headache, nausea, stiff neck and injection site cellulitis to be related to Bexsero.  Additional details were provided as follows: The age at the vaccination was not reported. The patient told reporter that some of the vaccine liquid ran down her arm during the vaccination, so the person who administered the vaccine gave her a second Bexsero vaccine in the same location. The pharmacist said her niece subsequently had a rash form at the injection site, developed headache, nausea and a stiff neck.   The patient's doctor contributed the headache, nausea and stiff neck to a respiratory infection. He diagnosed her rash as cellulitis due to the vaccination.   The pharmacist stated she wonders if the vaccine might have been given subcutaneously, rather than intramuscularly, but she did not know for sure, which led to intramuscular formulation administered by other route. The reporter did not consent to follow-up. Nurse did not wish to provide further details, other than what she stated during course of conversation. She did not know other details, including batch number of product. She did not want to be contacted in the future regarding this event.
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site rash, Musculoskeletal stiffness, Nausea, Respiratory tract infection
Clinical narrative: respiratory infection; rash; headache; nausea; stiff neck; cellulitis at injection site; Vaccine Administered at Inappropriate Site; exposure via skin contact; overdose; This case was reported by a pharmacist via call center representative and described the occurrence of respiratory infection in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose and the 2nd dose of Bexsero. On an unknown date, not applicable after receiving Bexsero and unknown after receiving Bexsero, the patient experienced respiratory infection (serious criteria GSK medically significant), injection site rash, headache, nausea, stiff neck, injection site cellulitis, intramuscular formulation administered by other route, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the respiratory infection, injection site rash, headache, nausea, stiff neck, injection site cellulitis, intramuscular formulation administered by other route, exposure via skin contact and accidental underdose were unknown.   It was unknown if the reporter considered the respiratory infection, injection site rash, headache, nausea, stiff neck and injection site cellulitis to be related to Bexsero.  Additional details were provided as follows: The age at the vaccination was not reported. The patient told reporter that some of the vaccine liquid ran down her arm during the vaccination, so the person who administered the vaccine gave her a second Bexsero vaccine in the same location. The pharmacist said her niece subsequently had a rash form at the injection site, developed headache, nausea and a stiff neck.   The patient's doctor contributed the headache, nausea and stiff neck to a respiratory infection. He diagnosed her rash as cellulitis due to the vaccination.   The pharmacist stated she wonders if the vaccine might have been given subcutaneously, rather than intramuscularly, but she did not know for sure, which led to intramuscular formulation administered by other route. The reporter did not consent to follow-up. Nurse did not wish to provide further details, other than what she stated during course of conversation. She did not know other details, including batch number of product. She did not want to be contacted in the future regarding this event.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received Shingrix (intramuscular). On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the day before reporting he received his Shingrix injection in his right arm and developed soreness in the right arm. The reporter did not consent to follow-up. The reporter declined to provide treating physician's contact information and his DOB.  The reporter did not have the lot number or expiration date. The case has been linked to the case US2019134711, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Influenza like illness
Clinical narrative: Chills; Flu Like Symptoms; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case: US2019AMR135288).   On 22nd July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced chills, influenza-like symptoms and dizziness. On an unknown date, the outcome of the chills and influenza-like symptoms were recovering/resolving and the outcome of the dizziness was unknown.   It was unknown if the reporter considered the chills, influenza-like symptoms and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient stated that with the second dose of Shingrix vaccine she experienced chills, flu like symptoms and dizziness. The chills and flu like symptoms had gotten better at the time of reporting. The reporter had consented to follow up. No further details were provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Heart rate increased, Herpes zoster, Injection site pain, Pyrexia
Clinical narrative: Shingles; blister inside nose (possibly shingles); soreness (at injection site); fever; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sinus operation (in September 2018).   On 19th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, fever and heart rate increased. On 23rd July 2019, the patient experienced shingles and blister. On 20th July 2019, the outcome of the injection site pain, fever and heart rate increased were recovered/resolved. On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, injection site pain, fever and heart rate increased to be related to Shingrix.  Additional information received were as follows: The patient experienced blister inside nose (possibly shingles). The patient planned to continue follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Pain, Rash
Clinical narrative: RASH; PAIN; Eczema; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 5th July 2021) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 2 days after receiving Shingrix, the patient experienced rash, pain and eczema. On an unknown date, the outcome of the rash, pain and eczema were recovered/resolved.   It was unknown if the reporter considered the rash, pain and eczema to be related to Shingrix.  Additional details were provided as follows: The patient received vaccine in right arm. The patient experienced rash on back and pain at sites where she had eczema. The symptoms begun over the 2-3 days following vaccination. The pain lasted for a few weeks then resolved. The rash lasted for a couple of days but then resolved. The reporter consented to follow up.