chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Laboratory test, Paraesthesia, Skin warm, Swollen tongue
Clinical narrative: Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Paraesthesia, Swollen tongue
Clinical narrative: Warm , tingly arm, dizziness, lightheaded, tongue swelling, difficulty swallowing, high blood pressure
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: My friend has been experiencing new onset intermittent unilateral blepharospasm starting 3 days after dose #2 of the Pfizer COVID-19 vaccine. My colleague is also experiencing this...in her case beginning 1 wk after dose #1 (I encouraged her to report this too not sure if she has yet). I find it fascinating both people are experiencing this after the vaccine and as an NP I felt compelled to report to help aggregate such data.  Both my friend and colleague obtained the vaccine around the same time at the same clinic.  Thank you!
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain, Pain in extremity
Clinical narrative: Body aches (lower back and legs mostly), Sore arm,  fatigue all for a little over a day the day after the second dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: The injection was administered in the left tricep versus deltoid. In the morning  following the injection, the patient experienced generalized malaise, muscle pain at the site of injection and fever. This lasted for 2 days. In the night following the injection the patient experienced an injection  site reaction - greater than 5 inches in diabetes area that is swollen, warm, red and painful to the touch. Following application of cold compress, some relief is notable not the area is still red, warm, swollen and tender to touch.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: The injection was administered in the left tricep versus deltoid. In the morning  following the injection, the patient experienced generalized malaise, muscle pain at the site of injection and fever. This lasted for 2 days. In the night following the injection the patient experienced an injection  site reaction - greater than 5 inches in diabetes area that is swollen, warm, red and painful to the touch. Following application of cold compress, some relief is notable not the area is still red, warm, swollen and tender to touch.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 3"  diameter round swelling and rash at injection site.  Itching.  I took Benadryl and put ice on the swelling on Sunday and  Monday .  It  is less annoying today but still red and hot.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Significant body aches starting 12 hours after injection lasting about 4 hours  Took Tylenol and went to sleep. Aches were gone by morning
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Mild hives. About 10-12 visible spots, mostly on left hand (injection on right hand). Only one spot was itchy. Hives went away within a few days, but most spots are still kinda visible if you look at it.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Pain, Pruritus
Clinical narrative: The first Pfizer shot I was very fatigued and had sore, stiff muscles on my left side of body.  The second dose:  I did not experience fatigue or the soreness... however, I started itching about 6-7 after the injection.  The itching was in random places, but the itching was more like a pinch - it was sharper, but not long lasting.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Restlessness, fatigue, headache, muscle aches, cold and hot sweats, exhaustion
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Restlessness, fatigue, headache, muscle aches, cold and hot sweats, exhaustion
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia
Clinical narrative: Chills, headache and muscle aches, lethargy
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over body. Started on stomach - is still spreading 5 days later. On most of body at this point, except face, hands, feet.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given Influenza 6 days after receiving the Covid-19 Moderna vaccine. Pt did not experience any adverse reactions. Only issue was that pt had received vaccine before the 2 week window.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful lump under ipsilateral arm (left arm)
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt experienced no Adverse reactions. Only concern was that pt had been given the Covid-19 Moderna Vaccine 8 days after pts Tdap.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site is raised, red and itchy.  No treatment.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Headache, Heart rate increased
Clinical narrative: Immediately afterwards - increased heart rate, dizziness, and headache. About 7 hours later - low grade fever, severe headache, joint pain, nausea, diarrhea, sore throat, stiff neck, and swollen lymph nodes in neck. Improved about 30-36 hours after vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Lymphadenopathy, Musculoskeletal stiffness, Nausea, Oropharyngeal pain
Clinical narrative: Immediately afterwards - increased heart rate, dizziness, and headache. About 7 hours later - low grade fever, severe headache, joint pain, nausea, diarrhea, sore throat, stiff neck, and swollen lymph nodes in neck. Improved about 30-36 hours after vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Immediately afterwards - increased heart rate, dizziness, and headache. About 7 hours later - low grade fever, severe headache, joint pain, nausea, diarrhea, sore throat, stiff neck, and swollen lymph nodes in neck. Improved about 30-36 hours after vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Extremely painful enlarged lymph nodes under right arm. Remain painful 11days later. It is about the size of a baseball.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Sensory disturbance, Skin discolouration
Clinical narrative: Next morning:  1 1/4 " pink rash adjacent to the vacc site 2 days and a few hrs later:  itching gone, rash less, but whole right arm feels weird, and the middle finger on that hand looked and felt  injured, i.e. 3/4" below the tip to the bottom of the 2nd joint was bluish purplish and felt as if it had been in a vise but hadn't  ( 8 hrs later both of these reactions had lessened)
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Flatulence, Headache
Clinical narrative: dizziness; nausea; pain all over the body; severe headache; excessive flatulence; Fever 40 Degree C/severe fever; pain in knees, ankles and foot the first day; pain in knees, ankles and foot the first day; administration date= 04Jan2021, dose number=2/administration date=18Dec2020, dose number=1; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ES1686), intramuscular on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 (first dose). The patient experienced fever 40 Degree C, pain in knees, ankles and foot the first day (on 04Jan2021 21:00); second day (05Jan2021) dizziness, nausea, severe fever, pain all over the body, severe headache, excessive flatulence. Symptoms lasted a week. Treatment included Panadol every 4 hours. The patient went for an emergency visit for the events. The outcome of the event was recovered in Jan2021.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: dizziness; nausea; pain all over the body; severe headache; excessive flatulence; Fever 40 Degree C/severe fever; pain in knees, ankles and foot the first day; pain in knees, ankles and foot the first day; administration date= 04Jan2021, dose number=2/administration date=18Dec2020, dose number=1; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ES1686), intramuscular on 04Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 (first dose). The patient experienced fever 40 Degree C, pain in knees, ankles and foot the first day (on 04Jan2021 21:00); second day (05Jan2021) dizziness, nausea, severe fever, pain all over the body, severe headache, excessive flatulence. Symptoms lasted a week. Treatment included Panadol every 4 hours. The patient went for an emergency visit for the events. The outcome of the event was recovered in Jan2021.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Headache, Nausea, Off label use, Pain
Clinical narrative: headaches; upset stomach; nausea; body aches; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 14:45, in left arm, at single dose, for Covid-19 immunization. Co-suspect drug included acetaminophen (unknown manufacturer) as preventive medication. The patient received the first dose of BNT162B2 vaccine on 16Jan2021 at 17:15, in left arm with preventive acetaminophen and she felt no effects. The patient had not been tested for COVID19 nor before neither since the vaccination. Concomitant medication taken within 2 weeks of vaccination included high pressure medication. On 19Jan2021 at 08:15 the patient experienced headaches, upset stomach, nausea and body aches. She forgot to take that morning her high pressure medication, she took it, but symptoms continued. She expressed that symptoms were mild but noticeable. No treatment was received. The action taken with acetaminophen was unknown. The events resolved on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product use issue
Clinical narrative: headaches; upset stomach; nausea; body aches; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; Administration date: dose 1: 16Dec2020, Dose 2: 18Jan2021; This is a spontaneous report from a contactable consumer. A 48-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 14:45, in left arm, at single dose, for Covid-19 immunization. Co-suspect drug included acetaminophen (unknown manufacturer) as preventive medication. The patient received the first dose of BNT162B2 vaccine on 16Jan2021 at 17:15, in left arm with preventive acetaminophen and she felt no effects. The patient had not been tested for COVID19 nor before neither since the vaccination. Concomitant medication taken within 2 weeks of vaccination included high pressure medication. On 19Jan2021 at 08:15 the patient experienced headaches, upset stomach, nausea and body aches. She forgot to take that morning her high pressure medication, she took it, but symptoms continued. She expressed that symptoms were mild but noticeable. No treatment was received. The action taken with acetaminophen was unknown. The events resolved on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 28-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (lot # 1660998, expiration date 03-MAY-2021) for prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (1.3 degree Celsius) for 24 minutes recorded by a data logger. The previous temperature excursion was reported as below 2 degree Celsius (1.6 degree Celsius) for 24 minutes. No additional adverse event (AE) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA001046: US-009507513-2101USA001003: US-009507513-2101USA001285: US-009507513-2101USA000963: US-009507513-2101USA000908:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Nurse called to report temperature excursion and states that the vaccine was administered to patient during the excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies was not provided.  On 23-DEC-2020, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliter orally (lot # 1684157, expiration date 26-JUN-2021) for prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of below 2 degree Celsius (1.3 degree Celsius) for 24 minutes recorded by a data logger. The previous temperature excursion was reported as below 2 degree Celsius (1.6 degree Celsius) for 24 minutes. No additional adverse event (AE) details.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA001046: US-009507513-2101USA001003: US-009507513-2101USA000963: US-009507513-2101USA000908: US-009507513-2101USA001280:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; an expired VAQTA was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.   On 12-JAN-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # S032359 has been verified to be a valid lot number, expiration date was 11-JAN-2021) via unknown route for prophylaxis (expired product administered). It was confirmed the hepatitis a vaccine, inactivated (VAQTA) had not had any temperature excursions. No additional AE reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Encephalitis
Clinical narrative: encephalitis; other zoster-related conditions; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 05-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the medical office. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, on or about 05-AUG-2015, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for encephalitis and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue 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 these injuries, including but not limited to medical losses and costs include 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 events was unknown. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of encephalitis was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Nurse calling to report at temperature excursion involving PROQUAD / the PROQUAD was administered to one patient this morning; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, number of administered dose, vaccination scheme, frequency, anatomical site of vaccination and route of administration were not reported; lot number T028139, which has been verified as valid, expiration date reported and validated as 15-FEB-2022) as prophylaxis, that experienced a temperature excursion (product storage error).  The vaccine underwent a temperature excursion of minus 13.8 degrees Celsius (C) for 12 minutes, as recorded by a data logger. There was no previous temperature excursion.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product container issue
Clinical narrative: Nurse calling inquiring about a 4 year old receiving second dose ofMMR-11 but some of the medication was sprayed out (probably 0.025mL) before the dose was administered.; Nurse calling inquiring about a 4 year old receiving second dose ofMMR-11 but some of the medication was sprayed out (probably 0.025mL) before the dose was administered.; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 27-JAN-2021, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.025 milliliter (ml)  due to some of the medication was sprayed out before the dose was administered (incorrect dose administered and product container issue) (formulation, strength, route of administration and anatomical site of vaccination were not reported; lot number T000892, which has been verified to be valid, expiration date reported and validated as 08-JAN-2022). No additional adverse event were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: varicella type rashes; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or around 30-OCT-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered varicella type rashes. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of rash vesicular was considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site 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 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 group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The reporter stated injection site pain from Shingrix vaccination and asked for remedies.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is very sore; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting, the patient received Shingrix vaccine and the patient's arm was very sore. The patient asked what they could recommend to help ease that pain.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Swelling; Redness; Hard lump; Itching; This case was reported by a consumer and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced swelling, erythema, induration and pruritus. On an unknown date, the outcome of the swelling, erythema, induration and pruritus were unknown.   It was unknown if the reporter considered the swelling, erythema, induration and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On Thursday, the patient received the second dose of Shingrix. The patient had a reaction which were not with the first dose. The patient experienced swelling, redness, hard lump and itching.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain
Clinical narrative: Uncle pain in neck; Uncle pain in / shoulders; This case was reported by a consumer and described the occurrence of neck pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced neck pain and shoulder pain. On an unknown date, the outcome of the neck pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the neck pain and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Three days before the date of reporting, the patient received Shingrix and experienced pain in neck and shoulders which was persistent till the date of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Where she got the shot is very red; Where she got the shot is very / tender; This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter said that a senior auntie got her shot about 4 days ago from the day of reporting, the spot where she got the shot was very red and tender.
Sex: F
Vaccine: VARZOS
Symptoms: Genital rash, Herpes virus infection, Rash, Rash pruritic, Rash vesicular
Clinical narrative: eruptions / herpes rash- itchy, drying and crushing over/Burning rash in the groin; herpes rash- itchy; burning rash in the groin; Dry rash; This case was reported by a nurse and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced itchy rash, vesicular rash, burning sensation and rash. On an unknown date, the outcome of the itchy rash, vesicular rash, burning sensation and rash were unknown.   It was unknown if the reporter considered the itchy rash, vesicular rash, burning sensation and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The day after receiving the dose, the patient had burning rash in the groin area, eruptions, in the providers words, similar to a herpes rash- itchy, drying and crushing over.  The reporter stated that there was no fever or systemic reaction to note. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: eruptions / herpes rash- itchy, drying and crushing over/Burning rash in the groin; herpes rash- itchy; burning rash in the groin; Dry rash; This case was reported by a nurse and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced itchy rash, vesicular rash, burning sensation and rash. On an unknown date, the outcome of the itchy rash, vesicular rash, burning sensation and rash were unknown.   It was unknown if the reporter considered the itchy rash, vesicular rash, burning sensation and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The day after receiving the dose, the patient had burning rash in the groin area, eruptions, in the providers words, similar to a herpes rash- itchy, drying and crushing over.  The reporter stated that there was no fever or systemic reaction to note. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Erythema, Injection site erythema, Injection site infection, Pyrexia
Clinical narrative: Second vaccine was worse / infected spread from shoulder to elbowarea / required antibiotics again; Second vaccine was worse/ Redness at the injection site; Second vaccine was worse/ Left her arm red; Second vaccine was worse/ fever; This case was reported by a consumer via other manufacturer and described the occurrence of infection aggravated in a female 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 infection aggravated, injection site erythema, erythema of extremities and fever. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the infection aggravated, injection site erythema, erythema of extremities and fever were unknown.   It was unknown if the reporter considered the infection aggravated, injection site erythema, erythema of extremities and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling on behalf of someone else (general public). There were no information on patient's history. The person received Shingrix from Pfizer on an unspecified date. The batch number was not provided. The reporter stated that, it was told on the news that if a person had an adverse event to other vaccines, that person should not receive Covid vaccine.  The reporter was calling for information as to whether this person should receive the Covid vaccine. The reporter wanted to know how she would know if the ingredients in Covid-19 vaccine and Shingrix vaccine were similar. The representative informed the reporter that the ingredients in Covid-19 vaccine could be found in EUA fact sheet and she may compare those to the ingredients in the Shingrix vaccine. The reporter asked for link to EUA fact sheet by email. The reporter also wanted a list of Shingrix vaccine ingredients. The reporter was provided with telephone number. The reporter was inquiring if it was accurate that someone who had an adverse event to any other vaccine should not take the Shingrix vaccine. The reporter mentioned a reaction to a previous Shingrix vaccine, on 2nd dose, the reaction was worse and was infected from shoulder to elbow area and required antibiotics again like 1st dose. The reporter consented to follow up and provided her name and email address, but did not provide patient's details to protect privacy. For the tolerance of 1st dose, refer linked case US2020AMR249478.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249478:1st shot,same patient, same reporter, same suspect
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Second vaccine was worse / infected spread from shoulder to elbowarea / required antibiotics again; Second vaccine was worse/ Redness at the injection site; Second vaccine was worse/ Left her arm red; Second vaccine was worse/ fever; This case was reported by a consumer via other manufacturer and described the occurrence of infection aggravated in a female 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 infection aggravated, injection site erythema, erythema of extremities and fever. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the infection aggravated, injection site erythema, erythema of extremities and fever were unknown.   It was unknown if the reporter considered the infection aggravated, injection site erythema, erythema of extremities and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling on behalf of someone else (general public). There were no information on patient's history. The person received Shingrix from Pfizer on an unspecified date. The batch number was not provided. The reporter stated that, it was told on the news that if a person had an adverse event to other vaccines, that person should not receive Covid vaccine.  The reporter was calling for information as to whether this person should receive the Covid vaccine. The reporter wanted to know how she would know if the ingredients in Covid-19 vaccine and Shingrix vaccine were similar. The representative informed the reporter that the ingredients in Covid-19 vaccine could be found in EUA fact sheet and she may compare those to the ingredients in the Shingrix vaccine. The reporter asked for link to EUA fact sheet by email. The reporter also wanted a list of Shingrix vaccine ingredients. The reporter was provided with telephone number. The reporter was inquiring if it was accurate that someone who had an adverse event to any other vaccine should not take the Shingrix vaccine. The reporter mentioned a reaction to a previous Shingrix vaccine, on 2nd dose, the reaction was worse and was infected from shoulder to elbow area and required antibiotics again like 1st dose. The reporter consented to follow up and provided her name and email address, but did not provide patient's details to protect privacy. For the tolerance of 1st dose, refer linked case US2020AMR249478.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249478:1st shot,same patient, same reporter, same suspect
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Coronavirus test negative
Clinical narrative: joint pain is remaining; This case was reported by a consumer and described the occurrence of joint pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lymphadenopathy (1st dose was received on 21st July 2020 and the patient experienced lymphadenopathy (see case US2020AMR252432)).   On 30th September 2020, the patient received the 2nd dose of Shingrix. In 2020, less than 3 months after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. After vaccination, the patient experienced joint pain.  The patient clarified that he did experience joint pain and not muscle pain. It seemed to be getting better, but it had not resolved.  The joint pain was remaining; it had been going on for a couple of months before the date of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252432:Same patient
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain, SARS-CoV-2 test negative
Clinical narrative: lymph nodes in neck, groin and armpits / active not painful but throbbing.; This case was reported by a consumer and described the occurrence of lymphadenopathy in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix. In 2020, less than 3 months after receiving Shingrix, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was recovering/resolving.   It was unknown if the reporter considered the lymphadenopathy to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient experienced lymph nodes in neck, groin and armpits which were active not painful but throbbing. This had partially resolved or had started to subside.  The lymph nodes of the groin and armpits were no longer active, but the lymph nodes of the neck were active till the time of reporting (going on a bit) despite the fact that the patient was not sick. The patient did not have a cold and had been tested a couple of times for COVID and was negative. For tolerance to the 2nd dose of Shingrix, refer case US2020AMR252391.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252391:Same patient
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a other health professional and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th January 2021, the patient received Shingrix. In January 2021, less than 3 weeks after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received Shingrix vaccine and seemed to have had an allergic reaction. The reporter had questioned as how long should the reaction last and could the patient get a COVID vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Have had shingles 7, yes SEVEN times; 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.   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 Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria GSK medically significant). 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 and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had received all the various shots for shingles and since the last 2 shots, the latest ones, the patient had shingles 7 times. This shot does not prevent shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: gastrointestinal symptoms; fever; shivering; fatigue; headache; myalgia; This case was reported by a consumer and described the occurrence of gastrointestinal symptom nos in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 24th December 2020, 1 days after receiving Shingrix, the patient experienced gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia. On an unknown date, the outcome of the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. On the day of reporting, in morning the patient experienced gastrointestinal symptoms, fever, shivering, fatigue, headache and myalgia. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: gastrointestinal symptoms; fever; shivering; fatigue; headache; myalgia; This case was reported by a consumer and described the occurrence of gastrointestinal symptom nos in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 24th December 2020, 1 days after receiving Shingrix, the patient experienced gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia. On an unknown date, the outcome of the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia were not recovered/not resolved.   It was unknown if the reporter considered the gastrointestinal symptom nos, fever, shivering, fatigue, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. On the day of reporting, in morning the patient experienced gastrointestinal symptoms, fever, shivering, fatigue, headache and myalgia. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Pyrexia
Clinical narrative: her mother / experienced a fever of 102.5F; This case was reported by a pharmacist and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's mother. The age at vaccination was not reported. The patient received vaccine under the watch and experienced a fever of 102.5 degree Fahrenheit, 2 weeks following administration. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter was friend.  The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm (at injection site) after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both).  The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014253:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Fatigue, Pain in extremity
Clinical narrative: Pain in her arms and legs; Fatigue; Arthritis in her thumbs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received HBV (Engerix B adult) (batch number 1106AA ?, expiry date April 2014) for prophylaxis.   On 12th March 2012, the patient received Engerix B adult (intramuscular). In March 2012, an unknown time after receiving Engerix B adult, the patient experienced pain in arm, fatigue and finger arthritis. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the finger arthritis was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue and finger arthritis to be related to Engerix B adult.  Additional information was provided as follows: The patient received Engerix B adult and experienced pain in arms and legs, fatigue and arthritis in thumbs. The patient provided the batch number and expiration date, but the batch number was not available in the sales data sheet or lot locator. The reporter was asking for the list of ingredients in the Engerix B. The reporter did not consent to follow up.  Note: The batch number was not available and hence, 1106AA ? was captured.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: Diagnosed with 20 percent hearing loss in the left ear /  significant difficult hearing phone calls through the left ear; Constant and ongoing ringing in the left ear; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluticasone propionate (Flonase), methylprednisolone (Medrol) and sulfamethoxazole + trimethoprim (Bactrim Ds).   On 29th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the hearing loss and ringing in ears were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss and ringing in ears to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a constant and ongoing ringing in the left ear approximately 2 to 3 days after receiving Shingrix.  The patient had significant difficulty in hearing phone calls through the left ear. The patient was diagnosed with 20 percent hearing loss in the left ear by audiologist.  The reporter consented to follow up. For tolerance of 2nd dose refer case, US2021AMR022441.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR022441:Same reporter.