chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of improperly stored PROQUAD and VARlVAX; No additional adverse events reported; administration of improperly stored PROQUAD and VARlVAX; This spontaneous report was received from a consumer, referring to patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 30-AUG-2021, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T028137, expiration date reported and validated as 15-FEB-2022) as prophylaxis (product storage error).  On an unknown date, the patients were vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T025945, expiration date reported and validated as 30-JUL-2022) as prophylaxis (product storage error). No additional adverse events reported.  The vaccines underwent a temperature excursion between minus (-) 14 degrees Celsius (C) to -10C (-12.5C) for 1 hour, 28 minutes and 0 seconds. There was a previous temperature excursion between 6 degrees Fahrenheit (F) to 14F (10F) for 5 hours, 4 minutes and 0 seconds.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Caller stated the VARIVAX expired on 20-AUG-2021, but was administered today, 31-AUG-2021; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 31-AUG-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliters (ml) as prophylaxis (lot number S025913 which has been verified to be valid, expiration date reported and validated as 20-AUG-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, the reporter mentioned that the administered dose of the vaccine did not go through any temperature excursions. No additional adverse events were reported in the patient.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events reported; children received 2nd dose of VAQTA but it was the adult dosage not pediatric; This spontaneous report was received from a pharmacist intern referring to a 4 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-AUG-2021 (yesterday), the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (adult dose; strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered). No additional adverse events reported. No product quality complaints.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000681:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: the pain/discomfort even woke him from sleep; pain from the shot in his left arm; the pain from the shot in his left arm has moved up into his shoulder; This spontaneous report was received from a consumer referring to her husband, a 59 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 30-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration, lot# and expiration date were not reported) in the left arm for prophylaxis.         On 31-AUG-2021, the patient experienced pain from the shot in his left arm, the pain had moved up into his shoulder and the pain/discomfort even woke him from sleep. The outcome of the events was unknown.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pneumonia
Clinical narrative: pneumonia; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; She had a big, red and swollen spot on her arm and a fever of 100 degrees / was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees; This spontaneous report was received from a currently 68-year-old female patient referring to herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unreported date in 2014, the patient received her first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On an unreported date in 2014, the patient had a reaction to the vaccine - it was at the injection site only, she had a red the size of baseball and it was hot and had a fever of 100 degrees (unspecified). The patient reported this to FDA and FDA thought it was due to the preservative in the dose. On an unreported date, the patient had pneumonia (no details provided). On an unreported date in 2020, the patient received the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot# and expiration date were not provided; for prophylaxis) and had no reaction. The outcome of the events was not provided. The reporter considered vaccination site erythema, pyrexia, vaccination site warmth and vaccination site swelling to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the suspect and pneumonia was not provided.  Upon internal review, the event pneumonia was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, and route not specified) for the long-term prevention of shingles and zoster-related conditions, at a physician's office. Subsequently, on an unknown date, the patient was treated by a physician for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered as not recovered/not resolved. The reporter considered the herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 6.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events reported; children received 2nd dose of VAQTA but it was the adult dosage not pediatric; This spontaneous report was received from a pharmacist intern referring to a 6 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 30-AUG-2021 (yesterday), the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (adult dose; strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered). No additional adverse events reported. No product quality complaints.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000316:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired vaccine was administered to two patients; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 02-SEP-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml, orally, lot# 1691140, expiration date 10-JUL-2021, for prophylaxis (strength and frequency were not reported).  This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2109USA001063:
Age: 14.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; accidently administered PROQUAD and V ARlV AX concomitantly; a 14 year old patient accidently administered PROQUAD; accidently administered PROQUAD and V ARlV AX concomitantly; This spontaneous report was received from a licensed practical nurse referring to a 14 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 19-AUG-2021 the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) concomitantly (both: 0.5 milliliter; route, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration, product administered to patient of inappropriate age, accidental overdose). No additional AEs were reported.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; extra dose adnimistered; administered a 3rd PEDVAXHIB Dose which was administered in error on 11/13/2020; This spontaneous report was received from a nurse practitioner referring to a 6 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  For routine vaccinations, the patient was previously administered the 1st dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) on 10-JUL-2020 and she was administered the 2nd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) on an unknown in 2020. Then the patient was inadvertently administered a 3rd haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) which was administered in error on 13-NOV-2020 (inappropriate schedule of product administration) and which was discovered by the nurse practitioner on 02-SEP-2021. The patient was administered a haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) booster dose on 02-SEP-2021 (extra dose administered). Nurse practitioner evaluated patient on 02-SEP-2021. Patient had recovered from event on unknown date as confirmed by nurse practitioner at call time. No additional AE.
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received Heplisav-B as 1st Dose and Engerix as 2nd Dose; Initial Report Received on 21-Jul-2021 and 22-Jul-2021  A registered nurse reported that a 22 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported.   No relevant concomitant medications were reported.   On 21-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot # 933624 and NDC # 43528-003-05; expiration date and serial # were not reported) in the left deltoid at a doctor's office.  On 20-Jul-2021, the patient received the second dose with Engerix (Lot # and expiration date were not reported). No adverse effects of the injection were reported.  At the time of reporting, no other information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered Heplisav-B to a 5 Week-Old; Injection Location was Upper Right Thigh; Initial Report Received on 30-Jul-2021  A clinical administrator reported that a 5 week-old female (race and ethnicity not provided) was administered a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. There were no known drug allergies.  No relevant concomitant medications were reported.  On 30-Jul-2021, the 5 week-old female patient received a dose of HEPLISAV-B (Lot # 934600, Expiration 28-Feb-2022; NDC # 4342-8-003-01) in the upper right thigh from a licensed practical nurse. No adverse reactions were reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Medication Came Out and Dribbled on Patient's Arm; Initial Report Received on 18-Aug-2021 and 20-Aug-2021  A pharmacist reported that a 43 year-old male (race and ethnicity not provided) during administration of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, a small amount of medication dribbled on the patient's arm.  No relevant medical history was reported other than allergies to sulfa antibiotics.  No relevant concomitant medications were reported.    On 18-Aug-2021, the patient received a dose of HEPLISAV-B (Lot # 934598, expiration date 25-Feb-2022 and NDC # 4 3528-0003-05) in the right deltoid from a pharmacy intern. During administration of the injection, the patient flinched. A small amount of medication came out and dribbled on the patient's arm.  No additional information was reported. No quality investigation was conducted as it was not specified where the small amount of drug came out from nor were any other details provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Computerised tomogram, Cough, Pyrexia
Clinical narrative: Shivering; Fever; Cough; This case was reported by a consumer via other manufacturer and described the occurrence of shivering in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included MODERNA VACCINE AGAINST COVID-19 for prophylaxis and lenvatinib mesilate (Lenvima) for hepatic cancer.   Concurrent medical conditions included increased blood pressure (started in August 2021 and not recovered), constipation (started in August 2021 and not recovered), abdominal bloating (started in August 2021 and not recovered), chest pain (knot in the middle of chest/6 out of 10 pain level/at times, after a meal"), stomatitis (started in August 2021 and not recovered), back pain, abdominal pain and hepatic cancer.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season and MODERNA VACCINE AGAINST COVID-19. On 30th July 2021, the patient started Lenvima at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shivering, fever and cough. The action taken with Lenvima was unknown. On an unknown date, the outcome of the shivering, fever and cough were recovered/resolved.   It was unknown if the reporter considered the shivering, fever and cough to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received booster of Moderna vaccine and Flu vaccine had shivering, ever,cough but resolved after a day. The patient continued taking 8 mg daily per MD (off label starting dose and different from prescription (12 mg daily) as reported on 12th August 2021. After start of therapy, increase in blood pressure- improved; constipation or stomach bloating - on and off since last report. New report of  occasional knot in the middle of chest/6 out of 10 pain level/at times, after a meal, stomatitis, on and off lower back pain, abdominal pain (affecting night sleep)- MD aware and advised patient to miss one dose and take Lenvima in the morning (night sleep- improved), prescribed magic mouthwash for relief of stomatitis, and ordered Computed tomography scan on 25th AUgust 2021. The patient contact details were not reported hence follow up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccinated & still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got vaccinated with the Shingles and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: Got shingles; Rash; Painful; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles in January and got over them). Previously administered products included shingles vaccine (received original vaccine many years ago of reporting date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced shingles, rash and pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the rash and pain were unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the original vaccine many years ago and It was supposed to be lifetime but patient got shingles in January and it got over them. The patient was about to get the first of 2 injections of Shingles vaccine and which was said to be lifetime.  Doctor reported that would not be lifetime.  The patient stated, it was on calendar that, six weeks later on Tuesday, the second dose should be administered but the patient got shingles on Monday, day before vaccination. The patient experienced not a big breakout rash but still it was painful.  The patient guess that vaccine reduces the severity but not the shingles and thus advices to get the vaccine as it reduce the severity and it was worth it.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: swelled; Very sore; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling and pain. On an unknown date, the outcome of the swelling and pain were recovered/resolved.   It was unknown if the reporter considered the swelling and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had shingles vaccine and swelled 2 times and was very sore. Also stated that better than having shingles. No patient contact details were reported hence follow up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Nervous system disorder
Clinical narrative: Neurological issues; This case was reported by a consumer via interactive digital media and described the occurrence of neurological disorder nos in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neurological disorder nos. On an unknown date, the outcome of the neurological disorder nos was not recovered/not resolved.   It was unknown if the reporter considered the neurological disorder nos to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported aby the patient for herself or himself. The age at vaccination was not reported. The patient got the shingles vaccine shot and now suffering side effects and taking medicine to see if can overcome the neurological issues occurred after the vaccine for shingles. Also stated that to read the side effects before get it.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: permanent rash around my waistline; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got the vaccine and had a permanent rash around his/her waistline. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm is sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received first shingles shot and his/her arm was sore.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Feeling abnormal, Illness, Mobility decreased
Clinical narrative: could barely move/ down for the count.; joints ached; no appetite; itchy; AWFUL; sick; Fever; This case was reported by a consumer via interactive digital media  and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced sickness, fever, mobility decreased, joint pain, appetite absent, pruritus and feels awful. On an unknown date, the outcome of the sickness, mobility decreased, joint pain, appetite absent, pruritus and feels awful were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the sickness, fever, mobility decreased, joint pain, appetite absent, pruritus and feels awful to be related to Shingles vaccine.Additional details were provided as follows:  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles shot and was so deathly sick. The patient had fever for three days, the patient could barely move, joints ached severely, no appetite, itchy beyond belief, and down for the count. The patient received only the first of the series of two shots. The patient supposed to go back in October to get second one. The physician said that his/her immune system was working.  The patient did not need the 2nd shot and did not want to go through that ever again. It was awful.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: could barely move/ down for the count.; joints ached; no appetite; itchy; AWFUL; sick; Fever; This case was reported by a consumer via interactive digital media  and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced sickness, fever, mobility decreased, joint pain, appetite absent, pruritus and feels awful. On an unknown date, the outcome of the sickness, mobility decreased, joint pain, appetite absent, pruritus and feels awful were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the sickness, fever, mobility decreased, joint pain, appetite absent, pruritus and feels awful to be related to Shingles vaccine.Additional details were provided as follows:  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the shingles shot and was so deathly sick. The patient had fever for three days, the patient could barely move, joints ached severely, no appetite, itchy beyond belief, and down for the count. The patient received only the first of the series of two shots. The patient supposed to go back in October to get second one. The physician said that his/her immune system was working.  The patient did not need the 2nd shot and did not want to go through that ever again. It was awful.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle aches; Fatigue; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the muscle pain and fatigue were unknown.   It was unknown if the reporter considered the muscle pain and fatigue to be related to Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient experienced muscle aches and fatigue with 2nd dose. The reporter asked if anyone could have muscle aches and fatigue two weeks after the 2nd dose of shingle shot. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Eyelid cyst, Eyelid cyst removal, Rash vesicular
Clinical narrative: growth under my eyelid; chickenpox looking things on right side of my face; This case was reported by a consumer via media and described the occurrence of eyelid cyst in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included pneumonia vaccine (dose received on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eyelid cyst (serious criteria clinically significant/intervention required) and varicella-like rash. On an unknown date, the outcome of the eyelid cyst and varicella-like rash were unknown.   The reporter considered the eyelid cyst and varicella-like rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingles vaccine and it caused chickenpox looking things on right side of face, also caused a growth under eyelid that grew to the size of a pea. It had to be surgically removed. The patient also mentioned that pneumonia vaccine literally almost killed her/him and the patient was able to get the flu shot. The follow up would not be possible as no contact details were available
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Emotional disorder, Emotional distress, Feeling abnormal, Fungal infection, Physical abuse
Clinical narrative: Got a fungal infection / after first vaccine; Im falling apart; No social life again, look like a swamp thing; Herpes went away after Shingrix 1st dose; trying to Kill me; Mental and physical abuse; Mental and physical abuse; Inappropriate age at vaccine administration; DOB 2/11/1983 / had herpes and took Shingrix; This case was reported by a consumer and described the occurrence of fungal infection in a 36-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   The patient's past medical history included herpes virus infection. Previously administered products included Flulaval trivalent (received Flulaval trivalent vaccine on 15th October 2015), Flu Quad (received on 15th October 2015, in right deltoid,batch number:H33J2, expiry date: 31st May 2016), Flu Quad (received on 4th December 2014, 0.5 ml in left deltoid,batch number:UI173AB, expiry date: 30 June 2015) and Tdap (received on 11th February 2012).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th April 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and drug use for unapproved indication. On an unknown date, the patient experienced fungal infection, emotional disorder, social withdrawal, unexpected therapeutic effect, feeling abnormal, physical abuse and mental distress. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the fungal infection, emotional disorder, social withdrawal, unexpected therapeutic effect, feeling abnormal, physical abuse, mental distress, inappropriate age at vaccine administration and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the fungal infection, emotional disorder, social withdrawal, unexpected therapeutic effect, feeling abnormal, physical abuse and mental distress to be related to Shingrix.  Additional details were provided as follows: The patient stated that he had herpes and took the Shingrix vaccine and the herpes went away, but he developed a fungal infection after the first vaccine and the fungal infection was now all over his body.  The patient stated that he had no herpes on his private parts, but had a fungal infection that progresses to get worse and worse.  The physician continued to give steroid cream that causes it to spread all over body. The patient stated that vaccine was trying to kill him. The patient was not even going to start talking about the issue. The patient would never having the opportunity to have a social life again. The patient was suffering from mental, and physical abuse. The vaccine was making him look like a swamp thing, spreading rumors around and about him. Locking him up in every year. The patient was falling apart, and GSK company was to blame.  The reporter was consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183425:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: arm hurt for six months, and the patient didn´t take the other doses; arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient did not had shingles, but his/her doctor gave him/her a shot of Shingles vaccine because of his/her age and his/her arm hurt for 6 months. The patient stated that he/she would never take another shot. Till the time of reporting, the patient did not receive 2nd shot, which led to incomplete course of vaccination. The follow up would not be possible as no contact details were available.
Age: 65.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 65-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included spleen disorder (without spleen).   In August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In August 2021, 1 week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient reported the case for herself. The patient without spleen received Bexsero and 1 week after Bexero injection her arm was still sore. The patient wanted to know was this common.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: Sore arm (at the injection site); Been feeling fatigued/tired; Having lightheadedness; Achy joints; Bouts of nausea; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in June 2021 in left deltoid, refer case US2021183421).   On 18th August 2021, the patient received the 2nd dose of Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, light headedness, joint pain and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fatigue, light headedness, joint pain and nausea were not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix. The reporter considered the fatigue, light headedness, joint pain and nausea to be unrelated to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix in left deltoid and she had a sore arm (at the injection site) in the afternoon and in evening of the vaccination day and the following day, since then she had been feeling fatigued/tired, having lightheadedness, achy joints and bouts of nausea.   The patient did not know if the shots were given intramuscularly. The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not have information about lot number and expiration date. The patient did not receive any paperwork from pharmacy. The patient stated that she went to the doctor and the doctor ruled out (said she did not have) flu or Covid.  The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not want to provide her doctor of medicine (MD) contact information. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183421:Same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm (at the injection site); Been feeling fatigued/tired; Having lightheadedness; Achy joints; Bouts of nausea; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in June 2021 in left deltoid, refer case US2021183421).   On 18th August 2021, the patient received the 2nd dose of Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, light headedness, joint pain and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fatigue, light headedness, joint pain and nausea were not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix. The reporter considered the fatigue, light headedness, joint pain and nausea to be unrelated to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix in left deltoid and she had a sore arm (at the injection site) in the afternoon and in evening of the vaccination day and the following day, since then she had been feeling fatigued/tired, having lightheadedness, achy joints and bouts of nausea.   The patient did not know if the shots were given intramuscularly. The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not have information about lot number and expiration date. The patient did not receive any paperwork from pharmacy. The patient stated that she went to the doctor and the doctor ruled out (said she did not have) flu or Covid.  The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not want to provide her doctor of medicine (MD) contact information. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183421:Same reporter.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Pain
Clinical narrative: in the bed for two weeks; Pain; This case was reported by a consumer via )interactive digital media and described the occurrence of bedridden in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bedridden and pain. On an unknown date, the outcome of the bedridden was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the bedridden and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The patient got that shingles shot when the patient turned 50 years as the birthday gift.  The patient got the shingles shot and landed back to the doctor then in the bed for two weeks. The patient stated that never been in so much pain and literally been hit by a bus. The patient was pray to don't get the shingles, as it was two shots now. The patient contact details were not reported so follow up not possible
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself or herself. The age at vaccination was not reported. The patient got shingles shot and 2 weeks later got shingles. The patient stated that according to the doctor you cant get shingles from the shot, its a dead virus patient felt lucky.
Sex: U
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye pain, Eyelid function disorder, Migraine, Photophobia
Clinical narrative: inflammatory response in my eyes; couldn't keep them open; My eyes hurt/bright lights, heat or any stress causes them to hurt; severe migraines for 24 of the next 28 day; my eyes still are very sensitive, the sun can cause pain then migraine; Couldn't hardly see vision still isn't as it was before; This case was reported by a consumer and described the occurrence of eye inflammation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment. On an unknown date, the outcome of the eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment were not recovered/not resolved.   It was unknown if the reporter considered the eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and had an inflammatory response in his/her eyes, his/her eyes hurt so bad that could not keep them open, had severe migraines for 24 of the next 28 days.  A year later, the patient's eyes were still very sensitive and the sun could cause pain and  then migraine.  The patient's vision was not still as it was before, bright lights, heat or any stress causes them to hurt so bad and get migraines with the vaccine. The patient stated that his/her eyes mean more to him/her and could take recommended supplements and went to a doctor that would treat him/her. The patient stated not taking another vaccine. The patient stated that month as was going to lose eyes. The follow up could not be possible as no contact details were available. The case was linked with case US2021AMR186978 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186978:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: inflammatory response in my eyes; couldn't keep them open; My eyes hurt/bright lights, heat or any stress causes them to hurt; severe migraines for 24 of the next 28 day; my eyes still are very sensitive, the sun can cause pain then migraine; Couldn't hardly see vision still isn't as it was before; This case was reported by a consumer and described the occurrence of eye inflammation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment. On an unknown date, the outcome of the eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment were not recovered/not resolved.   It was unknown if the reporter considered the eye inflammation, eyelid function disorder, eye pain, migraine, eyes sensitive to sunlight and visual impairment to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and had an inflammatory response in his/her eyes, his/her eyes hurt so bad that could not keep them open, had severe migraines for 24 of the next 28 days.  A year later, the patient's eyes were still very sensitive and the sun could cause pain and  then migraine.  The patient's vision was not still as it was before, bright lights, heat or any stress causes them to hurt so bad and get migraines with the vaccine. The patient stated that his/her eyes mean more to him/her and could take recommended supplements and went to a doctor that would treat him/her. The patient stated not taking another vaccine. The patient stated that month as was going to lose eyes. The follow up could not be possible as no contact details were available. The case was linked with case US2021AMR186978 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186978:same reporter